[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
PROTECTIONS FOR FOSTER CHILDREN
ENROLLED IN CLINICAL TRIALS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HUMAN RESOURCES
of the
COMMITTEE ON WAYS AND MEANS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
MAY 18, 2005
__________
Serial No. 109-8
__________
Printed for the use of the Committee on Ways and Means
U.S. GOVERNMENT PRINTING OFFICE
36-660 PDF WASHINGTON DC: 2007
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COMMITTEE ON WAYS AND MEANS
BILL THOMAS, California, Chairman
E. CLAY SHAW, JR., Florida CHARLES B. RANGEL, New York
NANCY L. JOHNSON, Connecticut FORTNEY PETE STARK, California
WALLY HERGER, California SANDER M. LEVIN, Michigan
JIM MCCRERY, Louisiana BENJAMIN L. CARDIN, Maryland
DAVE CAMP, Michigan JIM MCDERMOTT, Washington
JIM RAMSTAD, Minnesota JOHN LEWIS, Georgia
JIM NUSSLE, Iowa RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas MICHAEL R. MCNULTY, New York
PHIL ENGLISH, Pennsylvania WILLIAM J. JEFFERSON, Louisiana
J.D. HAYWORTH, Arizona JOHN S. TANNER, Tennessee
JERRY WELLER, Illinois XAVIER BECERRA, California
KENNY C. HULSHOF, Missouri LLOYD DOGGETT, Texas
RON LEWIS, Kentucky EARL POMEROY, North Dakota
MARK FOLEY, Florida STEPHANIE TUBBS JONES, Ohio
KEVIN BRADY, Texas MIKE THOMPSON, California
THOMAS M. REYNOLDS, New York JOHN B. LARSON, Connecticut
PAUL RYAN, Wisconsin RAHM EMANUEL, Illinois
ERIC CANTOR, Virginia
JOHN LINDER, Georgia
BOB BEAUPREZ, Colorado
MELISSA A. HART, Pennsylvania
CHRIS CHOCOLA, Indiana
DEVIN NUNES, California
Allison H. Giles, Chief of Staff
Janice Mays, Minority Chief Counsel
______
SUBCOMMITTEE ON HUMAN RESOURCES
WALLY HERGER, California, Chairman
NANCY L. JOHNSON, Connecticut JIM MCDERMOTT, Washington
BOB BEAUPREZ, Colorado BENJAMIN L. CARDIN, Maryland
MELISSA A. HART, Pennsylvania FORTNEY PETE STARK, California
CHRIS CHOCOLA, Indiana XAVIER BECERRA, California
JIM MCCRERY, Louisiana RAHM EMANUEL, Illinois
DAVE CAMP, Michigan
PHIL ENGLISH, Pennsylvania
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
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C O N T E N T S
__________
Page
Advisory of May 11, 2005, announcing the hearing................. 2
WITNESSES
U.S. Department of Health and Human Services, Hon. Donald Young,
M.D., Principal Deputy Assistant Secretary for Planning and
Evaluation..................................................... 7
______
The New York Academy of Medicine, Alan Fleischman................ 27
Wisconsin Department of Health and Family Services, Roberta
Harris......................................................... 31
Association for the Accreditation of Human Research Protection
Programs, Inc., Marjorie Speers................................ 36
American Academy of Pediatrics, Moira Szilagyi................... 38
SUBMISSIONS FOR THE RECORD
Ablechild.org, New Canaan, CT, Sheila Matthews and Gloria M.
Wright, statement and attachment............................... 50
Alliance for Human Research Protection, New York, NY, Vera
Hassner Sharav and John H. Noble, Jr., Ph.D., statement........ 52
American Family Rights Association, Morongo Valley, CA, Cheri
Carlene Campbell, statement.................................... 55
Asplund, Linn, Waterbury, CT, statement.......................... 57
Child Welfare League of America, Alexandra Yoffie, statement..... 58
Jacobi Medical Center, Bronx, NY, Andrew Wiznia, letter.......... 58
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD,
Alfred Sommer, M.D., letter.................................... 60
National Institute of Allergy and Infectious Diseases, Division
of Aids, Office for Policy in Clinical Research Operations,
Potomac, MD, Jonathan M. Fishbein, M.D., letter................ 61
New York City Administration for Children's Services, New York,
NY, John Mattingly, statement.................................. 63
Pediatric Aids Clinical Trials Group, University of California,
San Diego, La Jolla, CA, Stephen A. Spector, M.D., statement... 67
Sabato, Patricia, Sandy Hook, CT, statement...................... 68
Schuldt, Sharon, Rockford, IL, letter............................ 69
William Glasser, Inc., Chatsworth, CA, William Glasser, M.D.,
letter......................................................... 71
PROTECTIONS FOR FOSTER CHILDREN
ENROLLED IN CLINICAL TRIALS
----------
WEDNESDAY, MAY 18, 2005
U.S. House of Representatives,
Committee on Ways and Means,
Subcommittee on Human Resources,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:09 p.m., in
room B-318, Rayburn House Office Building, Hon. Wally Herger
(Chairman of the Subcommittee) presiding.
[The advisory announcing the hearing follows:]
ADVISORY
FROM THE
COMMITTEE
ON WAYS
AND
MEANS
SUBCOMMITTEE ON HUMAN RESOURCES
CONTACT: (202) 225-1025
FOR IMMEDIATE RELEASE
May 11, 2005
No. HR-2
Herger Announces Hearing on Protections for
Foster Children Enrolled in Clinical Trials
Congressman Wally Herger (R-CA), Chairman, Subcommittee on Human
Resources of the Committee on Ways and Means, today announced that the
Subcommittee will hold a hearing on protections for foster children
enrolled in clinical trials. The hearing will take place on Wednesday,
May 18, 2005, in room B-318 Rayburn House Office Building, beginning at
2:00 p.m.
In view of the limited time available to hear witnesses, oral
testimony at this hearing will be from invited witnesses only. Invited
witnesses will include experts familiar with issues related to the
enrollment of foster children in clinical trials. However, any
individual or organization not scheduled for an oral appearance may
submit a written statement for consideration by the Subcommittee for
inclusion in the printed record of the hearing.
BACKGROUND:
Recent media reports raised concerns regarding protections in place
prior to the enrollment of foster children in clinical drug trials.
These included allegations that in some cases foster children may have
been enrolled in studies without the benefit of certain protections,
such as the appointment of an independent advocate for the child. At
the same time, individuals familiar with these studies contend that the
enrollment of foster children enhanced their health by offering the
best medical treatment available and that independent advocates were
not necessary in all cases.
For children who may not safely remain with their families, foster
care is a temporary setting in which foster parents, social workers,
and court personnel work to protect the child's best interests in lieu
of their biological parents. Federal policy has been enacted, most
recently with the Adoption and Safe Families Act of 1997 (P.L. 105-89),
to ensure that the safety of foster children is paramount in any
decision made on the child's behalf. This hearing will examine (1)
policy issues surrounding the enrollment of foster children in clinical
trials, and (2) whether adequate protections are in place to ensure the
safety and well-being of foster children in such trials.
In announcing the hearing, Chairman Wally Herger said: ``This
hearing will explore issues surrounding the placement of foster
children in clinical drug trials, including under what conditions
participation is permitted. We are concerned about recent allegations
involving the enrollment of foster children in such trials. This
hearing will help us assess whether there is any substance to these
allegations and if so, what response is appropriate.''
FOCUS OF THE HEARING:
The focus of the hearing is on protections for foster children
enrolled in clinical trials.
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Chairman HERGER. Good afternoon, and welcome to today's
hearing. To begin the hearing today, I would like to make note
that we have a new Member on the Subcommittee, Mr. Devin Nunes
of California. Welcome, Devin. We look forward to working with
you on the many important issues within the Subcommittee's
jurisdiction.
At today's hearing, the Subcommittee will examine an
extraordinarily sensitive topic, the enrollment of children in
foster care in clinical drug trials involving experimental but
potentially lifesaving drugs. Children in foster care have been
separated from their biological parents and placed in a
temporary setting which can last for years or, in some cases,
their entire childhood. Many of these children have special
medical needs, including life-threatening illnesses like
Acquired Immunodeficiency Syndrome (AIDS). Thousands of foster
children in the late 1980s and early 1990s were afflicted by
AIDS. Treatments for children had not yet been found or tested.
For some of these children, clinical trials were seen as a
promising and possibly only way to save, lengthen or improve
these young lives. When biological parents could not be found
or were incapacitated due to addiction or illness, social
workers, court personnel and others involved in the children's
care had to make life-and-death decisions about whether foster
children should be placed in clinical trials. Those trials
involved both hope and risk. Concerns have been raised about
the right balance between hope and risk, and who gets to make
that critical decision.
Recent news stories report that States have a variety of
policies for when children in foster care may or may not
participate in clinical trials. Even though there are Federal
guidelines, there is no consistent policy across States. These
reports also suggest that, in some cases, protections were
either not enforced or were inadequate. These are serious
allegations. That is why it is important that we closely
examine the facts. It seems to me there are three main
questions involved in today's hearings. First, should children
in foster care be involved in clinical trials? Second, if
foster children are permitted to participate in clinical
trials, what are the protections now in place to ensure their
safety? Third, are those protections adequate? Some States have
adopted the policy that children in foster care simply cannot
participate in clinical trials, as we will hear described
shortly. Other States permit participation, but only based on
the decision of a judge or following the naming of an
independent advocate to monitor the foster child's best
interest. Still other States rely on the foster care system and
its caseworkers, medical experts and foster parents to make
these decisions. In some cases, these decisions are made after
trying to consult the child's biological parents.
As I mentioned earlier, our purpose today is to understand
these various measures, all of which are designed to protect
children in foster care to determine whether those protections
are adequate and appropriate. In other words, how do we balance
risk and hope? Given the lack of available information on this
topic, I have asked the U.S. Department of Health and Human
Services (HHS) to survey the 50 States about the specific
policies and protections they have in place regarding the
enrollment of foster children in clinical trials. I look
forward to the results of that survey.
We welcome all our witnesses today to explore these issues.
I note there are no Democrat or Republican witnesses here
today. I appreciate the cooperation of Mr. McDermott and his
staff in selecting the witnesses appearing before us. Joining
us are experts on topics ranging from Federal protections for
children enrolled in clinical studies to individuals familiar
with State policies regarding foster child enrollment. I would
also note that we have written background information and
written testimony from a variety of sources who could not join
us today, including the child protection agencies of New York
City and the State of Illinois. The official record of this
hearing will remain open for 2 weeks should others wish to
offer their input for this Subcommittee's consideration.
We look forward to today's testimony and our witnesses'
help in answering our many questions and helping us decide how
best to proceed. Without objection, each Member will have the
opportunity to submit a written statement and have it included
in the record at this point. Mr. McDermott, would you care to
make a statement?
[The prepared statement of Chairman Herger follows:]
Opening Statement of The Honorable Wally Herger, Chairman, and a
Representative in Congress from the State of California
Today the Subcommittee will examine an extraordinarily sensitive
topic--the enrollment of children in foster care in clinical drug
trials involving experimental, but potentially life-saving drugs.
Children in foster care have been separated from their biological
parents and placed in a temporary setting which can last for years or,
in some cases, their entire childhood. Many of these children have
special medical needs, including life-threatening illnesses like AIDS.
AIDS afflicted thousands of foster children in the late 1980s and
early 1990s Treatments for children had not yet been found or tested.
For some of these children, clinical trials were seen as a promising,
and possibly only, way to save, lengthen or improve these young lives.
When biological parents could not be found or were incapacitated
due to addiction or illness, social workers, court personnel and others
involved in the children's care had to make life and death decisions
about whether foster children should be placed in clinical trials.
Those trials involved both hope and risk. Concerns have been raised
about the right balance between hope and risk, and who gets to make
that critical decision.
Recent news stories report that states have a variety of policies
for when children in foster care may or may not participate in clinical
trials. Even though there are federal guidelines, there is no
consistent policy across States.
These reports also suggest that in some cases, protections were
either not enforced or were inadequate. These are serious allegations.
That is why it is important that we closely examine the facts.
It seems to me there are three main questions involved in today's
hearing:
First, should children in foster care be involved in
clinical trials?
Second, if foster children are permitted to participate
in clinical trials, what are the protections now in place to ensure
their safety?
And third, are those protections adequate?
Some states have adopted the policy that children in foster care
simply cannot participate in clinical trials, as we will hear described
shortly.
Others states permit participation, but only based on the decision
of a judge, or following the naming of an independent advocate to
monitor the foster child's best interests.
Still other states rely on the foster care system and its
caseworkers, medical experts, and foster parents to make decisions
about whether foster children may be included in clinical trials, in
some cases after trying to consult the child's biological parents.
As I mentioned earlier, our purpose today is to understand these
various measures, all of which are designed to protect children in
foster care, to determine whether those protections are adequate and
appropriate.
In other words, how do we balance risk and hope.
Given the lack of available information on this topic, I have asked
the Department of Health and Human Services to survey states about the
specific policies and protections they have in place regarding the
enrollment of foster children in clinical trials. I look forward to the
results of that survey.
We welcome all our witnesses today to explore these issues. Joining
us are experts on topics ranging from federal protections for children
enrolled in clinical studies to state policies regarding foster child
enrollment.
I would also note that we have received background information and
written testimony from a variety of sources who could not join us
today, including the child protection agencies of New York City and the
State of Illinois.
And the official record of this hearing will remain open for two
weeks should others wish to offer their input for the Subcommittee's
consideration.
We look forward to today's testimony, and our witnesses' help in
answering our many questions and helping us decide how best to proceed.
Mr. MCDERMOTT. Surely. Thank you, Mr. Chairman. First of
all, I want to thank the Chairman for having this hearing. I
think it is an important issue and one that requires us to be
thoughtful. Sometimes issues like this can be sort of
explosive, but I think this is an issue to be thoughtful about
because I am sure many were shocked when they read the recent
press accounts of foster kids being involved in clinical trials
without adequate protection. As a physician, I know the role
medicine plays in saving and improving lives every day. I have
been involved in the AIDS epidemic beginning when I was with
the State Department in 1987, so I have seen the evolution of
the Department. Many of these cases we are talking about here
were late eighties cases, early nineties cases. I think we have
to put things in perspective of the real crash feeling there
was in those days about getting some treatment and figuring out
what we could do for a variety of people in this situation.
However, we learned through top-notch investigative
reporting by the AP that children in the child welfare system
had participated in scientific experiments used to determine
the effectiveness of AIDS medication, and that participating,
in my view, is not necessarily bad. I want to say that right up
front, because trials are scientific paths to new and more
effective treatments. I think what is true, however, is we must
be assured that the system defends the best interests of the
children involved in these studies. They are alone. They have
been taken away from their parents. They are without an
advocate. They are vulnerable, and they could be taken
advantage of by the system if it fails them.
Over the last 18 months, this Subcommittee has heard
hearings about a number of issues affecting kids in the
Federal, State child welfare programs, and this issue is like
many of them: It is has the potential for being explosive. The
child welfare program in the richest, most powerful country in
the world is and has been often an abysmal failure. Now, we
don't need proof of more of that. We can give you all kinds of
examples of it. We know about kids losing their lives in the
child welfare system. Practically every State legislature every
year deals with one case or another, and everybody wrings their
hands, and the problems go on. The kids are sometimes locked
up. Sometimes starved under the supervision of the agencies. We
know the children have been used without proper supervision for
drug testing.
Now, the question the public has to ask us and I think we
have to ask ourselves on this Subcommittee is, how do we give
that proper supervision? When are we going to reform the child
welfare system so that we protect these vulnerable kids and
provide them with the opportunity to succeed? They have enough
strikes against them going in because they are in the foster
system, and the question really is, what can we do not to make
it worse for them but to make it better?
We have a group of distinguished witnesses here today, and
I for one expect them to give us ideas about how we can improve
the system for children. The Subcommittee put out a press
release announcing today's hearing. Now, press releases are one
part of the political process, but our challenge and really
what the public should demand of us is a bipartisan
Subcommittee action. I really think, Mr. Chairman, we need to
act to improve the welfare of children that do not have a
stable and safe family. We really need reform on a variety of
things, but it takes courage and leadership and new resources,
but it needs to be done. It is not an easy job. I dealt with
these issues when I was in the State legislature, and they are
no less contentious now up here than they were down there. Our
Nation's children need us. They need what we put together in a
child welfare program that lifts them up rather than puts them
down or lets them down. I for one am grateful for you for
having this hearing, and I hope that we can come out of it with
some things that we can then put into law and actually do
something. We have talked a lot and listened a lot, but it is
time for us to do something. Thank you, Mr. Chairman.
Chairman HERGER. Thank you, Mr. McDermott. Before we move
on to our testimony, I want to remind our witnesses to limit
their oral statement to 5 minutes. However, without objection,
all the written testimony will be made a part of the permanent
record. To start our hearing this afternoon, we will hear from
the Honorable Donald Young, M.D., who is the acting principal
deputy assistant secretary for planning and evaluation at HHS.
Dr. Young, please proceed with your testimony.
STATEMENT OF DONALD YOUNG, M.D., ACTING PRINCIPAL DEPUTY
ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. YOUNG. Mr. Chairman, distinguished Members of the
Subcommittee, thank you for inviting me here today to discuss
Federal protections for foster children enrolled in clinical
trials. I am Dr. Donald Young, deputy assistant secretary for
planning and evaluation in HHS. The President and Secretary
Leavitt have as a first principle the protection of the most
vulnerable in our population. Foster children are certainly
vulnerable, and failing to protect them will not be tolerated.
Dramatic advances in prevention and treatment of disease
have been achieved through research. A crucial part of these
medical advances involves participation of human subjects,
including children, in clinical trials. The Department of
Health and Human Services is deeply committed to ensuring the
protection of the rights and welfare of every individual who
participates in clinical research. This afternoon, I will
discuss the evolution of the Human Immunodeficiency Virus
(HIV)/AIDS, the management of the disease, pediatric AIDS and
foster care, and the Federal protections in place to ensure the
safety of human subjects, including children, and children who
are wards.
In 1990, as many as 2,000 babies were born infected with
HIV. Now that number has been reduced to a bit more than 200 a
year in the United States.. HIV has evolved from a disease that
kills to a disease that is chronic and manageable. Clinical
research including research in children is necessary to make
advances in medicine. Clinical research involves risks,
however, and it is the responsibility of the medical research
community to ensure that all trial participants fully
understand both the potential benefits and the potential risks
of their participation.
It is estimated that, through 1989, between 16 and 22
percent of pediatric AIDS patients were children in foster
care. Many of these children were placed in foster care because
the caretaker parent had died or become incapacitated by AIDS,
or because of neglect, abuse, or abandonment associated with
parental drug abuse. The fact that fewer than 2 percent of
foster children diagnosed as HIV-positive in 1989 were
participating in clinical trials was viewed as evidence that
the foster care system had failed to completely and effectively
cope with the influx of HIV-infected children.
At the time, most State laws allowed only for standard
medical treatment for children in foster care; because there
were no standard treatments for HIV-infected children, this
limitation represented a critical barrier to medical care for
children with HIV. Federal regulations are in place to provide
protections for human subjects, including children and foster
children, involved in HHS conducted, supported or regulated
research. Ultimately, however, it is the State and in some
cases county foster care agencies that decide who provides
permission for these children to be enrolled in clinical
trials. Institutional review boards (IRB)--working with
researchers establish within Federal guidelines what procedures
should be followed to acquire consent in specific study
protocols. The HHS and Food and Drug Administration (FDA)
regulations also contain a number of other requirements
relating to IRB membership and procedures, criteria for IRB
approval of research, suspension or termination of IRB approval
research and general requirements for informed consent.
The regulations permit IRBs to approve three categories of
research or clinical investigation involving children as
research subjects. A fourth category requires an additional
level of review. First, research or clinical investigations not
involving greater than minimal risk to the children: There, the
IRB must determine that the research or clinical investigation
presents no greater than minimal risk to the children. Second,
research or clinical investigation involving greater than
minimal risk but preserving the prospect of direct benefit to
the individual child subjects: Here, the IRB must determine the
risk is justified by the anticipated benefits to the subjects,
the relation of the anticipated benefit to the risk presented
by the study is at least as favorable to the subjects as that
provided by alternative available approaches.
In each of the next two categories, HHS and FDA regulations
include a provision that provides additional protections for
children who are wards of the State or any other agency,
institution, or entity. First, research or clinical
investigations involving greater than minimal risk and no
prospect for direct benefit to the individual child subjects
but likely to yield generalizeable knowledge about the
subject's disorder or condition: The IRB must determine the
risk of the research or clinical investigation represents a
minor increase over minimal risk; the intervention or procedure
presents experiences to the child subjects that are reasonably
commensurate with those inherent in their actual or expected
medical, dental, psychological, social or educational
situations; the intervention or procedure is likely to yield
generalizeable knowledge about the subject's disorder or
condition which is of vital importance for the understanding or
amelioration of the disorder or condition. Second, research or
clinical investigation that the IRB believes does not meet the
above categories of the HHS or FDA regulations but finds that
the research presents a reasonable opportunity to further the
understanding, prevention or alleviation of a serious problem
affecting the health or welfare of children requires a specific
level of HHS review beyond that provided by the IRB.
In all cases, the IRB must ensure that adequate provisions
have been made for soliciting permission of parents or legal
guardians and the assent of the children to the extent required
by HHS and FDA regulations. Before children who are wards of
the State or any other agency, institution or entity can be
included in either of the last two categories of research or
clinical investigations, the research must meet the following
conditions: The research must either be related to the
children's status as wards or conducted in schools, camps,
hospitals, institutions or similar settings in which the
majority of children involved as subjects are not wards. The
IRB must require appointment of an advocate for each child who
is a ward in addition to any other individual acting on behalf
of the child as guardian.
The Office of Human Research Protections (OHRP) and FDA
have implemented oversight activities both to respond to
complaints and to monitor compliance with Federal regulations.
OHRP's compliance oversight activities can be divided into
three major categories. First, for-cause oversight
investigations; second, not-for-cause compliance oversight
surveillance evaluations; and, third, review and analysis of
institutional reports of noncompliance, unanticipated problems
involving risks to subjects, or suspensions or terminations of
IRB approval of research.
FDA regulation and oversight for clinical research extend
not only to IRBs and institutions but to clinical
investigators, research sponsors, contract research
organizations, laboratory facilities conducting preclinical
research and bioequivalence firms. As you know, Mr. Chairman,
of recent press reports there is an ongoing investigation, and
I will not be able to answer any questions related to the
investigation.
In conclusion, we continue to address challenges posed by
the threat of HIV/AIDS and are committed to basic and clinical
research to strengthen the Nation's ability to cope with this
infectious disease. The protection of human subjects, including
children, in clinical trials has been and will remain a top
priority for HHS. HHS is firmly committed to the protection of
the rights and welfare of every individual who participates in
human research, consistent with sound ethical standards and
regulatory requirements. I will be happy to answer any
questions.
[The prepared statement of Dr. Young follows:]
Statement of The Honorable Donald Young, M.D., Principal Deputy
Assistant Secretary for Planning and Evaluation, U.S. Department of
Health and Human Services
Mr. Chairman and Distinguished Members of the Subcommittee, thank
you for inviting me here today to discuss federal protections of foster
children enrolled in clinical trials. I am Dr. Donald Young, the Deputy
Assistant Secretary for Planning in Evaluation in the U.S. Department
of Health and Human Services. The President and Secretary Leavitt have
as a first principle the protection of the most vulnerable in our
population. Foster children are certainly vulnerable and failing to
protect them will not be tolerated. Dramatic advances in prevention and
treatment of disease have been achieved through research. A crucial
part of this research involves the participation of human subjects,
including children, in clinical trials. Clinical trials of drugs are
necessary in children to determine their safety and efficacy in this
age group of patients; studies in adults may not adequately predict
drug properties in children. Federal policy has sought to preserve the
benefits of this research, while at the same time protecting against
possible abuse or harm to research subjects. The Department of Health
and Human Services is deeply committed to ensure the protection of the
rights and welfare of every individual who participates in clinical
research.
To provide a better understanding of the issue, I will discuss with
you the evolution of HIV/AIDS and the management of the disease,
pediatric AIDS and foster care, and the federal protections in place to
ensure the safety of human subjects, including children and children
who are wards, in research.
Evolution in the Management of HIV/AIDS
Since the world first became aware of AIDS in 1981, the disease has
spread around the globe. Today, approximately 39.4 million people
worldwide are living with HIV/AIDS. Approximately 2.2 million children
are now living with HIV/AIDS. During the past year, approximately
640,000 new HIV infections and 510,000 deaths occurred in children.
Despite these sobering statistics, dramatic advances have been made
in the management of HIV infection since HIV was first discovered over
two decades ago. In 1990, as many as 2000 babies were born infected
with HIV; now that number has been reduced to a bit more than 200 a
year in the U.S. From 1985 to 1999, AIDS cases in U.S. children
decreased 81%. From 1998 to 2002, the estimated number of children
dying from AIDS decreased 68%.
Much has been accomplished since the early days of the HIV/AIDS
epidemic, including significant advances in treatment and prevention.
HIV has evolved from a disease that kills to a disease that is chronic
and manageable. Research has been pivotal to understanding HIV/AIDS and
managing the disease. In the United States and other western countries,
potent combinations of anti-HIV drugs have dramatically reduced the
numbers of new AIDS cases and deaths due to HIV/AIDS. Today, there are
over 20 antiretroviral medications that are approved by the Food and
Drug Administration (FDA). As another example of the success of
research, a pivotal National Institutes of Health (NIH)-supported study
conducted in Uganda demonstrated that a single dose of the drug
nevirapine given to an HIV-infected woman at the onset of labor,
combined with a single dose for the infant just after birth, was 50
percent more effective in preventing transmission to the baby than was
a short course of the drug AZT. Research is now underway to determine
if the use of nevirapine or other drugs can prevent transmission
through breastfeeding, a major mode of mother-to-infant transmission.
Other HIV prevention strategies include development of effective
chemical and physical barrier methods, research on the use of these
methods among different populations, and a study of how antiretroviral
therapy might prevent transmission by reducing how much virus a patient
sheds in their genital track or in breast milk. However, the early
clinical trials of these therapies were conducted only in adults.
Pediatric formulations of these treatments were not approved for young
children with HIV/AIDS because sufficient studies had not been
conducted in children.
Importance of Clinical Research
Clinical research, including research in children is necessary to
make advances in medicine. Clinical research involves risks, however,
and it is the responsibility of the medical research community to
ensure that all trial participants fully understand both the potential
benefits and the potential risks of their participation.
As I will describe in more detail below, federal regulations
provide specific protections for children and additional protections
for wards of the state participating in some forms of clinical trials.
Ultimately, however, it is the state, and in some cases county foster
care agencies that decide how informed consent is provided for these
children. Institutional Review Boards (IRBs) working with researchers,
establish, within federal guidelines, what procedures should be
followed to acquire consent in specific study protocols.
HHS continues to believe strongly that clinical trials to test new
treatments in children are essential and that the framework established
by the existing regulation offers adequate protection for individuals
participating in trials. We also recognize, however, the importance of
continued vigilance to ensure the regulations are adhered to by
investigators and the IRBs that oversee their activities.
Pediatric AIDS and Foster Care--An Historical Perspective
Nearly three-quarters of the 3,000 pediatric AIDS cases recorded by
the Centers for Disease Control and Prevention by 1991 were in children
with at least one parent who was an intravenous drug user. Many of
these children were placed in foster care because the caretaker parent
had died or become incapacitated by AIDS, or because of neglect, abuse
or abandonment associated with parental drug abuse. This was also the
period during which ``boarder babies'' regularly made the headlines--
children abandoned in hospitals who were ready to leave but for whom
appropriate foster care placements were unavailable. It is estimated
that through 1989, that between 16 and 22 percent of pediatric AIDS
patients were children in foster care. This significant overlap between
risk factors for HIV and the need for foster care meant that pediatric
AIDS became a particular concern for child welfare agencies in large
cities, where most pediatric AIDS cases were concentrated.
As pediatric AIDS became more prevalent, little was known about the
effectiveness or proper dosages in children of drug therapies that were
yielding good results in adults. But these treatments seemed to hold
the promise of longer and higher quality life for many children who
otherwise seemed doomed. State child welfare agencies were strongly
urged to reduce barriers to foster children's participation in such
trials. The fact that fewer than 2% of foster children diagnosed as HIV
positive in 1989 were participating in clinical trials was viewed as
evidence that ``the foster care system has failed to competently and
effectively cope with the influx of HIV-infected children'' (McNutt,
1994).
A study published in 1990 found that only seven states had
implemented formal policies regarding the participation of foster
children in clinical trials, and five states had ``mechanisms'' through
which it was possible to enroll such children in trials. Although the
state had legal custody of the children, the permission of biological
parents was required in four of the twelve states that had either
``policies'' or ``mechanisms'' (Martin and Sacks, 1990). The same
research study found that 16 percent of 432 children enrolled in
pediatric AIDS trials at the time were in foster care (a total of 69
children), and that nearly three times that many foster children were
known to be eligible for those trials but could not be enrolled because
a parent or guardian's permission could not be obtained.
In the Omnibus Budget Reconciliation Act of 1987, (P.L. 100-203,
section 9138), Congress required the Secretary of HHS to provide
information about children with AIDS who had been placed in foster
care. The report prepared in response to this congressional mandate
found that, in 1989, the states were aware of 804 current and 979
cumulative cases of HIV positive children in foster care nationally,
most of them concentrated in just a few states. By that year only 6
states had seen at least 50 cumulative cases of HIV among children in
foster care, and 20 states had never cared for a foster child with HIV.
At the time, most state laws allowed only for ``standard medical
treatment'' for children in foster care. But because there were no
standard treatments for HIV-infected children, this limitation
represented a critical barrier to medical care for children with HIV.
The report recommended that ``State and local child welfare agencies
should create systems to manage the participation of children in foster
care in special medical treatment and experimental trials'' (HHS/ASPE,
1989, p. 60).
Efforts in the early 1990s to increase the enrollment of foster
children in clinical trials affected state policies that in many cases
continue to the present. Today, child welfare agencies continue to
differ in their policies regarding whether or under what circumstances
children in foster care may be enrolled in clinical trials. Information
gathered from several state foster care agencies suggests that
authority to provide permission for other than standard medical
treatment typically lies either with the judge supervising the foster
care case, with a senior official within the foster care agency, or
with a guardian ad litem. Some states continue to preclude the
enrollment of foster children in experimental trials altogether, or
will provide permission on behalf of the child only if the biological
parents also give permission for the child's participation. Under the
federal foster care program, health care decisions on behalf of
individual foster children are left to states that are acting as
parents with respect to children in their custody and that are
responsible for assuring the health care needs of foster children are
met. With respect to enrolling children in particular clinical trials,
the procedures established for each study by the IRB and researcher,
working within the federal human subjects regulations described below,
would guide children's participation.
Protection of Human Subjects Regulations
Federal Regulations are in place to provide protections for human
subjects involved in HHS conducted, supported, or regulated research.
Regulations exist to protect human subjects, including children and
foster children, who participate in research.
The HHS and FDA Protection of Human Subject Regulations are
codified at 45 CFR part 46, and 21 CFR part 50 and 56, respectively.
The regulations in subpart A of 45 CFR part 46 include basic
protections for human subjects involved in both biomedical and
behavioral research.
In 1991, 14 other Federal departments and agencies joined HHS in
adopting a uniform set of regulations that are identical to subpart A
of 45 CFR part 46. This uniform set of regulations is known as the
Federal Policy for the Protection of Human Subjects, also referred to
as the Common Rule. FDA's Protection of Human Subjects regulations at
21 CFR parts 50 and 56 are similar to those in the Common Rule.
The HHS protection of human subject regulations are based in large
part on the Belmont Report written in 1978 by the Congressionally
created National Commission for the Protection of Human Subjects of
Biomedical Behavioral Research. The Belmont Report identifies three
fundamental ethical principles for all human subjects research--respect
for persons, beneficence, and justice.
The HHS regulations at 45 CFR part 46 apply to all non-exempt
research involving human subjects that is conducted or supported by
HHS. These regulations include provisions for IRB review, informed
consent, and assurances of compliance. For example, through an
assurance of compliance that is approved by the Department's Office for
Human Research Protections (OHRP), an institution pledges to conduct
its HHS-funded or supported research in accordance with the human
subjects protections of 45 CFR part 46. An institution also may
voluntarily extend its assurance to apply to all human subjects
research it conducts regardless of funding source.
In addition to assurances of compliance required by the HHS
regulations at 45 CFR part 46, the HHS and FDA regulations also contain
a number of other requirements for institutions engaged in HHS-
conducted, -supported, or FDA regulated research involving humans,
including requirements relating to, for example, IRB membership and
procedures, criteria for IRB approval of research, suspension or
termination of IRB approval of research; and general requirements for
informed consent.
Additional Protections for Children Involved in Research
Children have long been recognized as a special and vulnerable
population, and are accorded special protections in many areas,
including research. In 1983, HHS adopted additional protections for
children involved as subjects in research at 45 CFR part 46, subpart D,
and in April 2001, FDA adopted similar requirements for children under
an Interim Final Rule, 21 CFR part 50, subpart D, Additional Safeguards
for Children in Clinical Investigations.
When a proposed research study involves children and is supported
or conducted by HHS funding, the research institution's IRB must take
into consideration the special regulatory requirements that provide
additional protections for the children who would be involved in
research. If the proposed research involves FDA-regulated products,
then FDA's parallel regulations would apply.
Both the HHS' and FDA's Subpart D regulations permit IRBs to
approve three categories of research or clinical investigations
involving children as research subjects:
45 CFR 46.404 and 21 CFR 50.51--Research or clinical investigations not
involving greater than minimal risk to the children. To approve a
research study or clinical investigation in this category, the IRB must
make the following determination:
the research or clinical investigation presents no
greater than minimal risk to the children.
45 CFR 46.405 and 21 CFR 50.52--Research or clinical investigations
involving greater than minimal risk but presenting the prospect of
direct benefit to the individual child subjects. To approve a research
study or clinical investigation in this category, the IRB must make the
following determinations:
the risk is justified by the anticipated benefits to the
subjects;
the relation of the anticipated benefit to the risk
presented by the study is at least as favorable to the subjects as that
provided by available alternative approaches.
45 CFR 46.406 and 21 CFR 50.53--Research or clinical investigations
involving greater than minimal risk and no prospect of direct benefit
to the individual child subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition. In order to
approve a research study or clinical investigation in this category,
the IRB must make the following determinations:
the risk of the research or clinical investigation
represents a minor increase over minimal risk;
the intervention or procedure presents experiences to the
child subjects that are reasonably commensurate with those inherent in
their actual, or expected medical, dental, psychological, social, or
educational situations;
the intervention or procedure is likely to yield
generalizable knowledge about the subject's disorder or condition which
is of vital importance for the understanding or amelioration of the
disorder or condition.
A fourth category of research or clinical investigation requires a
special level of HHS review beyond that provided by the IRB:
45 CFR 46.407 and 21 CFR 50.54--Research or clinical investigation that
the IRB believes does not meet the above categories of the HHS or FDA
regulations, but finds that the research presents a reasonable
opportunity to further the understanding, prevention, or alleviation of
a serious problem affecting the health or welfare of children. The
research or clinical investigation may proceed only if the following
conditions are met:
the IRB finds and documents that the research or clinical
investigation presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children; and
the HHS Secretary and/or FDA Commissioner, after
consultation with a panel of experts in pertinent disciplines (e.g.,
science, medicine, education, ethics, law) and following an opportunity
for public review and comment, determines either:
that the research in fact satisfies one or more of
the above categories of the HHS or FDA regulations (i.e., 45
CFR 46.404, 46.405, or 46.406 under the HHS regulations, and 21
CFR 50.51, 50.52, or 50.53 under the FDA regulations) or;
that the following conditions are met:
the research or clinical investigation presents a
reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the
health or welfare of children;
the research or clinical investigation will be
conducted in accordance with sound ethical principles.
In all cases noted above (i.e., 45 CFR 46.404, 46.405, 46.406, and
46.407), the IRB must ensure that adequate provisions have been made
for soliciting permission of parents or legal guardians and the assent
of the children, to the extent required by HHS and FDA regulations.
Additional Protections for Children Who are Wards
The HHS and FDA regulations also include a provision in subpart D
that provides additional protections for children who are wards of the
State or any other agency, institution, or entity. These special
protections for wards apply to two categories of research or clinical
investigations: (1) research or clinical investigations that involve
greater than minimal risk and no prospect of direct benefit to the
individual child subjects involved in the research or clinical
investigation (research/clinical investigations approved under 45 CFR
46.406 or 21 CFR 50.53); or (2) research or clinical investigations
determined by the IRB not to meet the conditions of the HHS regulations
at 45 CFR 46.404, 46.405, or 46.406, or FDA's regulations at 21 CFR
50.51, 50.52, or 50.53, but found to present a reasonable opportunity
to further the understanding, prevention, or alleviation of a serious
problem affecting the health or welfare of children (research/clinical
investigation approved under 45 CFR 46.407 or 21 CFR 50.54).
Before children who are wards of the State or any other agency,
institution, or entity can be included in either of the two categories
of research or clinical investigations described above, the research
must meet the following conditions:
the research must be either related to the children's
status as wards; or conducted in schools, camps, hospitals,
institutions, or similar settings in which the majority of children
involved as subjects are not wards;
and the IRB must require appointment of an advocate for
each child who is a ward, in addition to any other individual acting on
behalf of the child as guardian or in loco parentis.
One individual may serve as advocate for more than one child, and
must be an individual who has the background and experience to act in,
and agrees to act in, the best interests of the child for the duration
of the child's participation in the research. The advocate should
represent the individual child subject's interests throughout the
child's participation in the research. The HHS and FDA regulations
further require that the advocate not be associated in any way (except
in the role as advocate or member of the IRB) with the research, the
investigator(s), or the guardian organization.
HHS Compliance Oversight Activities
Due to the nature of the research that is subject to the HHS and
FDA regulations, each entity has developed its own system to respond to
complaints and monitor compliance with its regulations. These
activities are complementary, and the results are shared between OHRP
(implementing the HHS regulations) and FDA.
OHRP
OHRP's compliance oversight activities can be divided into three
major categories: (1) for-cause compliance oversight investigations;
(2) not-for-cause compliance oversight surveillance evaluations; and
(3) review and analysis of institutional reports of noncompliance,
unanticipated problems involving risks to subjects, or suspensions or
terminations of IRB approval of research.
For-Cause Compliance Oversight Investigations
OHRP initiates for-cause compliance oversight investigations in
response to substantive written allegations or indications of
noncompliance with the HHS regulations for the protection of human
subjects. Until recently, nearly all of OHRP's compliance oversight
activities involved for-cause compliance oversight investigations.
Institutions engaged in human subject research that is conducted or
supported by HHS must provide written Assurances of Compliance to HHS
describing the means that they will employ to comply with the HHS
Regulations. OHRP approves these Assurances on behalf of the HHS
Secretary. An Assurance approved by OHRP commits the institution(s) and
its personnel to full compliance with the HHS regulations. In carrying
out its oversight responsibility, OHRP evaluates all substantive
written allegations or indications of noncompliance with the HHS
regulations derived from any source.
OHRP holds accountable and depends upon institutional officials,
committees, research investigators, and other agents of the institution
to assure conformity with the institution's Assurance and, thus, with
the regulations. Only through the partnership established by the
Assurance can the shared responsibility to protect the rights and
welfare of human subjects be discharged in accordance with Section 491
of the Public Health Service Act.
Sequence of Events for an OHRP For-Cause Compliance Oversight
Investigation
The typical sequence of events to be followed in an OHRP compliance
oversight evaluation is as follows:
1. OHRP discovers or receives a substantive written allegation or
indication of noncompliance with the HHS Regulations (45 CFR Part 46).
2. OHRP determines that it has jurisdiction in the matter on the
basis of HHS support and/or an applicable Assurance of Compliance.
3. Upon confirmation that it has jurisdiction, OHRP initiates a
compliance oversight investigation by writing to appropriate
institutional officials to advise them of OHRP's investigation and to
request that the institution investigate the matter and report back to
OHRP by a specified date. Activities expected of the institution are
explained in writing initially and at appropriate times during the
course of the evaluation. Except in rare circumstances when sound
ethics dictates the need to act immediately, OHRP takes no action
against any institution without first affording the institution an
opportunity to offer information which might refute indications of
noncompliance or to develop satisfactory corrective actions if the
allegations or indications of noncompliance are substantiated.
4. OHRP evaluates the institution's report and any other pertinent
information to which it has access. OHRP may (a) request that the
institution submit additional information in writing; (b) conduct
telephone interviews with institutional officials, committee members,
and/or research investigators; or (c) conduct an on-site evaluation of
protections under the applicable Assurance of Compliance.
5. OHRP issues in writing a determination for each evaluation to
appropriate institutional officials. The determination letter to the
institution summarizes (i) findings of noncompliance with the HHS
Regulations, if any; and/or (ii) the corrective actions proposed and/or
implemented by the institution that appropriately address the findings
of noncompliance. In such circumstances, any complainant(s) are
ordinarily informed in writing of OHRP's determination upon completion
of its investigation.
6. An OHRP determination letteris made accessible on the OHRP
website http://www.hhs.gov/ohrp) once the document has been requested
under FOIA, or ten working days after the document is issued to the
institution, whichever occurs first.
7. An institution may request review by the Director of OHRP of
determinations and findings resulting from a compliance oversight
evaluation.
Possible Outcomes of an OHRP For-Cause Compliance Oversight
Investigation
Corrective actions based on compliance oversight investigations are
intended to remedy identified noncompliance with the HHS regulations
and to prevent reoccurrence. Because each case is different, OHRP
tailors its corrective actions to foster the best interests of human
research subjects, and to the extent possible, the institution, the
research community, and HHS. Most compliance oversight evaluations and
resultant corrective actions are resolved at the OHRP level. In some
instances, however, OHRP recommends actions to be taken by other HHS
officials.
OHRP's compliance oversight evaluations may result in one or more
of the following outcomes:
1. OHRP may determine that protections under an institution's
Assurance of Compliance are in compliance with the HHS Regulations.
2. OHRP may determine that protections under an institution's
Assurance of Compliance are in compliance with the HHS Regulations but
that recommended improvements to those protections have been
identified.
3. OHRP may determine that protections under an institution's
Assurance of Compliance are not in compliance with the HHS Regulations
and require that an institution develop and implement corrective
actions.
4. OHRP may restrict its approval of an institution's Assurance of
Compliance. Affected research projects continue to be supported by HHS
only if the terms of the restriction are being satisfied. Examples of
such restrictions include, but are not limited to:
a. suspending the Assurance's applicability relative to some or
all research projects until specified protections and corrective
actions have been implemented;
b. requiring prior OHRP review of some or all research projects
to be conducted under the Assurance;
c. requiring that some or all committee members and
institutional officials, as well as investigators conducting research
under the Assurance, receive appropriate human subject education; and
d. requiring special reporting to OHRP.
5. OHRP may withdraw its approval of an institution's Assurance of
Compliance. The institution's research projects cannot be supported by
any HHS component until an appropriate Assurance is approved by OHRP.
6. OHRP may recommend to appropriate HHS officials that:
a. an institution or an investigator be temporarily suspended or
permanently removed from participation in specific projects, and/or
b. peer review groups be notified of an institution's or an
investigator's past noncompliance prior to review of new projects.
7. OHRP may recommend to HHS that institutions or investigators be
declared ineligible to participate in HHS-supported research, known as
Debarment. Note that a suspension of eligibility for Federal funding
may precede a Debarment. If OHRP makes this recommendation, the
Debarment process will be initiated in accordance with the procedures
specified at 45 CFR Part 76. Any Debarment is Government-wide, and not
just applicable to HHS funding.
Not-for-cause Compliance Oversight Surveillance Evaluations
In 2001 OHRP initiated a not-for-cause compliance oversight
surveillance program. Under this program, OHRP selects institutions
without any active for-cause compliance oversight investigations and
conducts an assessment of their human subject protection programs. OHRP
initiates a not-for-cause compliance oversight evaluation by writing to
appropriate institutional officials at a selected institution to advise
them of OHRP's evaluation and to request that the institution provide
OHRP by a specified date with IRB records and other documents relevant
to the institution's program for the protection of human subjects. In
most cases, OHRP conducts a site visit following review of the
requested documents. OHRP issues a determination in writing for each
evaluation to appropriate institutional officials. The determination
letter to the institution summarizes: (i) findings of noncompliance
with the HHS regulations, if any; and/or (ii) the corrective actions
proposed and/or implemented by the institution that appropriately
address the findings of noncompliance. The possible outcomes of a not-
for-cause compliance oversight evaluation are the same as for a for-
cause investigation.
FDA
FDA's compliance oversight activities dovetail with some of OHRP's
activities described above. FDA has developed a Good Clinical Practice
Program, which has prominently displayed the process for filing
complaints with the Agency. This is available on FDA's website at:
http://www.fda.gov/oc/gcp/complaints.html. Generally, complaints are
investigated and handled by the particular Center within FDA (e.g.,
involving Drug Evaluation and Research; Devices; Biologics, etc.)
responsible for the study, which would also be the most knowledgeable
about the issues involved in the complaint.
FDA's Bioresearch Monitoring Program
FDA developed its Bioresearch Monitoring Program (BIMO Program) to
ensure the protection of the rights, safety, and welfare of human
research subjects and the quality and integrity of data submitted to
the agency. The BIMO Program encompasses all FDA product areas: drugs,
biological products, medical devices, radiological products, foods, and
veterinary products. Among other things, the BIMO Program involves site
visits to clinical investigators, sponsors, monitors, contract research
organizations, IRBs, nonclinical (animal) laboratories, and
bioequivalence analytical laboratories. FDA uses Compliance Policy
Guide Manuals (CPGM) to instruct its field personnel on the conduct of
inspectional and investigational activities. These are available at:
http://www.fda.gov/oc/gcp/compliance.html.
FDA conducts IRB inspections to determine if IRBs are operating in
compliance with current FDA regulations and if the IRBs are following
their own written procedures. The FDA regulations pertinent to IRBs
include 21 CFR Part 50 (Protection of Human Subjects), Part 56
(Institutional Review Boards), Part 312 (Investigational New Drug
Application), and Part 812 (Investigational Device Exemptions).
FDA inspections of IRBs generally fall into one of two categories:
Surveillance inspections--periodic, scheduled inspections
to review the overall operations and procedures of the IRB; and
Directed inspections--unscheduled inspections focused on
the IRB's review of a specific clinical trial or trials. Directed
inspections may result from a complaint, clinical investigator
misconduct, or safety issues pertaining to a trial or site.
During an inspection at the site of a clinical investigator, FDA
personnel typically verify:
who performed various aspects of the protocol (e.g., who
verified inclusion and exclusion criteria, who obtained informed
consent, who collected adverse event data);
the degree of delegation of authority (e.g., how the
clinical investigator supervised the conduct of the study);
where specific aspects of the study were performed;
the accuracy of the data submitted;
how accountability for the investigational product was
maintained;
how the monitor communicated with the clinical
investigator; and
how the monitor evaluated the study's progress.
FDA personnel also audit the study data by comparing the data filed
with the Agency or the sponsor with all available records that support
the data. These records may come from the doctor's office, hospital,
nursing home, laboratories, and other sources. FDA may also examine
patient records that predate the study to find out whether: the medical
condition under study was in fact diagnosed; the study eligibility
criteria were met; and the patient received a possibly-interfering
medication before the study began. FDA personnel may also review
records covering a reasonable period after completion of the study to
determine if there was proper follow-up as outlined in the protocol,
and if the clinical investigator reported all signs and symptoms
reasonably attributable to the product's use.
After headquarters review, one of the following types of letters is
typically sent from the Center to the IRB or clinical investigator
depending upon the type of inspection:
1. A letter that generally states that FDA observed no significant
deviations from the regulations. This letter does not require any
response. Note that a letter may not always be sent when FDA observes
no significant deviations.
2. An informational or untitled letter that identifies deviations
from regulations and good clinical practices. This letter may request a
response from the recipient. If FDA requests a response, the letter
will describe what is necessary and identify a contact person for
questions.
3. A Warning Letter that identifies serious deviations from
regulations needing prompt correction and a formal written response to
FDA. The letter will identify an Agency contact person for questions.
For investigator inspections, FDA may inform both the reviewing IRB and
the study sponsor of the deficiencies and advise the sponsor if the
clinical investigator's procedural deficiencies suggest ineffective
monitoring by the sponsor.
In addition to issuing these letters, FDA may take regulatory
actions for serious deviations from the regulations. FDA may disqualify
the IRB, institution, or clinical investigator. A disqualified clinical
investigator is ineligible to receive investigational products. FDA may
also place lesser administrative sanctions on the IRB.
Under the BIMO program, FDA conducts approximately 1000 inspections
annually of all of thevarious parties that conduct or oversee clinical
research studies (i.e., clinical investigators, sponsors, monitors,
contract research organizations, and IRBs). Of these inspections, about
two-thirds are clinical investigator inspections, approximately 250-300
are inspections of IRBs (mostly drawn from FDA's inventory of about
1600 IRBs identified as responsible for reviewing FDA-regulated
research), and the remainder are sponsor or monitor/contractresearch
organization inspections. For clinical investigations of drugs alone,
FDA conducted approximately 75 inspections of studies involving
pediatric subjects from 2001 to 2004.
Review and Analysis of Institutional Reports
The HHS and FDA regulations require that IRBs follow written
procedures to ensure the prompt reporting to the IRB, appropriate
institutional officials, and the pertinent agency head (OHRP Director
for research conducted under an OHRP-approved assurance or FDA
Commissioner for research involving FDA-regulated products) of the
following incidents:
1. any unanticipated problems involving risks to subjects or
others;
2. any serious or continuing noncompliance with this policy or the
requirements or determinations of the IRB; and
3. any suspension or termination of IRB approval.
(See 45 CFR 46.103(b)(4)(iii) for HHS-conducted or-supported
research and 21 CFR 56.108(b) for FDA-regulated research.)
When reviewing a report of an unanticipated problem, OHRP or FDA
assesses mostclosely the adequacy of the actions taken by the
institution to address the problem. Likewise, when reviewing reports of
non-compliance or suspension or termination of IRB approval, OHRP or
FDA assesses most closely the adequacy of the corrective actions taken
by the institution. In particular, an assessment is made whether or not
the corrective actions will help ensure that the incident will not
happen again, either with the investigator or protocol in question, or
with any other investigator or protocol. When appropriate, corrective
actions are applied institution-wide.
Conclusion
We continue to address challenges posed by the threat of HIV/AIDS
and are committed to basic and clinical research to strengthen the
nation's ability to cope with this infectious disease. The protection
of human subjects, including children, in clinical trials has been and
will remain a top priority for HHS. HHS is firmly committed to the
protection of the rights and welfare of every individual who
participates in human research consistent with sound ethical standards
and regulatory requirements.
Chairman HERGER. Thank you, Dr. Young. The gentleman from
California, Mr. Nunes, to inquire.
Mr. NUNES. Thank you, Mr. Chairman, and thank you for
welcoming me to the Subcommittee. Welcome, Dr. Young. In
relation to some of the news reports that have been out there
recently, do we know whether any children in foster care today
are participating in clinical trials? If so, do you know how
many?
Dr. YOUNG. I do not have that information. We know that
across the National Institutes of Health (NIH) there are a
number of clinical trials ongoing and children participating,
but I do not have numbers of children in foster care that might
be in that group.
Mr. NUNES. Okay. Could that be something that you could
find out? Could you submit that to the Subcommittee if you do?
Dr. YOUNG. If we can find it through our survey
information, I will.
Mr. NUNES. Okay. Another question. Your testimony says that
the State child welfare agencies were strongly urged to reduce
barriers to foster children's participation in such trials. In
the early days of the AIDS crisis, what were those barriers,
and who strongly urged State officials to reduce those
barriers?
Dr. YOUNG. I think that the desire to reduce those came
from across the community. In those years, as I said in my
testimony, there was no treatment unless you were involved in a
clinical trial. This was an emerging disease, and treatments
were just emerging at that time, so there was wide support. The
barriers included the State laws and requirements that I
mentioned in my testimony that said only standard care could be
given to individuals in foster care. That prevented them from
being enrolled, and the feeling was that the children in foster
care should have the same opportunity to make a decision, an
election or to have their wards do it for them, to participate
if they wanted to participate and get the value and advantage
of that trial.
Mr. NUNES. Thank you, Doctor. Thank you, Mr. Chairman.
Chairman HERGER. Thank you. The gentleman from Washington,
Mr. McDermott, to inquire.
Mr. MCDERMOTT. Thank you, Dr. Young. Good testimony and I
would like to ask you a couple questions about the structuring
of the clinical trials. Is there anything in the NIH
requirements that require a State to have in place an advocacy
requirement? Or can any physician who wants to do a trial in
whatever State send in an application and operate within the
laws of that State and be considered acceptable to NIH? In
other words, does NIH have a set of standards that require that
the State must fit?
Dr. YOUNG. The Office of Human Protection is the Federal
agency, has a baseline set of requirements that must be adhered
to and that the IRB must follow. That deals with, as I said in
my testimony, the last two categories, those clinical trials
where there is more than a minimal risk involved. Under those
circumstances, then, an advocate needs to be appointed for
children in foster care to make the decision and ensure that
the child is protected and fully informed.
Mr. MCDERMOTT. The question then comes down to these--it is
always words. In your testimony, you said you may say that
protection is not required if the research has minimal risk--
minimal being the operative word--or if it has the prospect of
direct benefit. Those again being the operative words. Who
makes those decisions as to what is minimal, what is direct
benefit to the child? How is that determined?
Dr. YOUNG. The Institutional Review Board has the
responsibility to approve all research protocols that are put
forward by investigators. Most of those institutional review
boards are under a hospital, academic medical center or other
place that also has the responsibility to ensure that there is
IRB compliance to that. There is a set of Federal rules. There
are then the requirements that the IRB must consider in making
a decision whether to approve the research as well as any
additional requirements that come from the institution. Beyond
that, there are a number of States that have also passed laws
that may--putting stronger requirements in place.
Mr. MCDERMOTT. Could it be possible today to have a child
brought into a clinical trial in a State where there was no
requirement for advocacy for something--these AIDS drugs when
we were looking back at them in 1987 and 1988 and 1989, there
was no children's research being done. What this was about is
really the first children's research. How did anybody decide it
was minimal risk or that it was a direct benefit to the kids?
How did they come up--without an advocate--it would seem to me
like you would want to automatically have an advocate in
something as new as that.
Dr. YOUNG. Yes. There are two parts to your question. One
is the advocate and the situations more than minimal risk that
there must be an advocate. That is not to say, however, in all
situations there isn't the State agency or a ward that is
making decisions. Somebody has to consent to it, and it has to
be an informed consent. It is only when the risk is more than
minimal and the conditions that I described in my testimony
that, in addition to that, you need a special advocate for the
patient. Now, the second part of that are the rules and
requirements for research to make sure that it is conducted
properly. You need an advocate, but you need a research
protocol that is laid out that protects the individuals in that
trial, whether they are foster children, adults or children not
in foster care.
Mr. MCDERMOTT. The reason I ask those questions, I can
envision a situation in which a child care worker who is
dealing with AIDS cases coming out of a city hospital or
whatever may have 30, 40 kids or 60 kids, and to expect the
child care worker to be on top of the case, it seems to me,
sets the ground for kids slipping through the cracks as they do
in a variety of different ways in the system. I wonder if you--
, if you don't have minimum requirements for how many--or
maximum requirements for how many kids a worker is responsible
for, to expect he or she to cover 60 kids, all of whom are in
AIDS treatment programs all over the city or whatever, it seems
like you would want to have somebody for each kid to look after
or at least--you can see my problem.
Dr. YOUNG. I do, and let me try to explain it one more
time. There is an advocate appointed for the children in foster
care. That advocate is different under the requirements. That
advocate is different than the State agency. That advocate
could be part of the PRB. It could be somebody who is
particularly interested in kids. Each advocate might have one,
two or three kids. This is not the caseworker who is the
advocate under those situations. The advocate is somebody in
addition to the State foster care agency.
Mr. MCDERMOTT. So, this is a volunteer who comes in and
gets involved in the advocacy program in the local State agency
and has three kids with maybe no background whatsoever in the
specific issues.
Dr. YOUNG. No. There are requirements also regarding the
advocacy that are part of the PRB requirements, that the
advocate have the knowledge and be familiar with the condition.
It is not anyone off the street can come in and be an advocate.
Mr. MCDERMOTT. I wasn't implying that they were just off
the street. This is a specific, very difficult decision to put
a kid into a treatment case., the reason I am sensitive about
this is, we have a cancer center in Seattle. I have seen what
happens when you are using advanced treatments in cancer and
then people later say, well, I didn't know the risks. There is
a whole lot of responding backward and forwards about what
people knew. In this case, you have a kid who doesn't have a
clue what is going on. He is being brought or she is being
brought, put into the system, and I am wondering how you know,
how you can guarantee that that kid has somebody who really
understands what is going on?
Dr. YOUNG. I understand your question. That is the issue of
what is informed consent, and how much knowledge must you have
to achieve informed consent? That question is directly relevant
to all research, and particularly to research on kids, and then
foster kids add an additional level and layer. So, there is a
responsibility to attempt to communicate as clearly as one can,
but as you know, in lay terms, it is sometimes difficult to
communicate fully and yet keep a message simple that people can
understand. That is a challenge for this kind of research. It
is a challenge for cancer research in children, any kind of
research that has substantial risks but substantial rewards.
Chairman HERGER. The gentleman's time has expired. The
gentleman from Colorado, Mr. Beauprez, to inquire.
Mr. BEAUPREZ. I thank the Chairman, and I thank Dr. Young
as well for his testimony and for being here with us today. I
think the gentleman from Washington has probably already begun
going down a path that is of most concern to the Subcommittee.
Let me stay in that track for a minute. Doctor, as I first
heard about this issue, I guess one of the knee-jerk reactions
would be, well, let us just not submit foster children to
clinical trials. That is not really where we want to go. Is it?
I am guessing that the numbers--they are staggering numbers,
frankly, that you shared with us of 16 to 22 percent of
children now with HIV back in 1990 were foster care children.
We would actually want them to have access to some of the
state-of-the-art treatment. I am assuming that that is correct?
Dr. YOUNG. Yes, sir, I agree with you. They should have the
opportunity to make their--their guardians should have the
opportunity to make the decision if they wish to participate.
If they choose not to, that is fine. To exclude them from even
having the opportunity to make that decision I don't believe is
correct.
Mr. BEAUPREZ. Unfortunately, sometimes, it is that very
population that disproportionately is burdened with some of the
diseases we would like to get a handle on.
Dr. YOUNG. That was particularly true back in the late
eighties for HIV/AIDS when clinical research, clinical trials
was the only opportunity, the only hope for treatment.
Mr. BEAUPREZ. The question becomes who then best make this
decision or assist the child in making this decision and that
is what I want to probe a little bit more with you. I contacted
some of our folks back in Colorado who wrestle with this, and
the idea of the child advocate seemed to make perfect sense to
me: Let us get someone out there who has maybe even met some
standard across some threshold on the per chance that we have
got a foster parent--because we hear about these tragic cases
where the foster parent was not the best choice for the child's
well-being, and we all are traumatized by that, as the child
who at least is traumatized. What I found out is that, in the
opinion at least of the medical professionals back in my State,
many, many, many times it is the foster parent on their way to
becoming the adoptive parent because, apparently, we have a
very high percentage of exactly that that happens, that may
well be the person with the child's best interest at heart. It
crosses my mind that we would not want to categorically
preclude foster parents from the process, either. Would that be
a fair assessment?
Dr. YOUNG. Yes, I think that is a fair assessment. We are
balancing a lot of different factors here. There is also the
biologic parent and what role they should have. Some States
allow both or even require both be appointed. Those kinds of
decisions in many cases are best made locally by the people who
know the State, know the procedures, know what is going on
there. There is room for Colorado to make modifications in
keeping with the broad set of Federal basic requirements.
Mr. BEAUPREZ. Which gets me to, I guess, the next question
I would raise of you. I understand that we have got Federal
guidelines, but as you testified just moments ago to us, really
it is up to State and local and many cases city and/or county
officials to not only apply the rules, but in some cases, I
suppose, adjust the rules. They have some local flexibility. Is
there more than ought to be done at the Federal level to
protect certainly the interests of the child? I will emphasize
again, the interest of the child can go both ways. We certainly
don't want them to get put into a clinical trial situation that
we would all think was inappropriate, too great a risk, but we
also don't want to somehow subjectively preclude them from
having the opportunity to have access to the latest state-of-
the-art medical techniques. What should we be doing at the
Federal level?
Dr. YOUNG. I think your points are good ones. I think one
of the things the Department will be doing very closely is,
following this hearing, following what you are learning and
hearing from the witnesses. We are not aware of any changes
that we believe need to be made. If they are identified, we
will be very happy to consider them and make a decision as how
best to proceed. We share with you the concern about the
adequate protection of foster children. At the same time, the
opportunity to let them participate and get the advantage of
clinical research, if that is theirs and their guardian's
decision.
Mr. BEAUPREZ. If there is a second left, can you comment on
the difference between assent and consent.
Dr. YOUNG. Consent means that you have the legal authority
to agree to participate, in this case in research. A minor,
generally under 18, legally cannot consent by law, but the
minor can assent. There are requirements that the subjects need
to assent to. That is to say, yes, I am willing to do this.
That doesn't carry the legal weight of consent, but it says
that the minor has agreed to participate. One is a legal
concept; one is a concept of agreeing.
Mr. BEAUPREZ. Thank you. Thank you, Mr. Chairman.
Chairman HERGER. Thank you. The gentleman from California,
Mr. Becerra, to inquire.
Mr. BECERRA. Thank you, Mr. Chairman. Dr. Young, thank you
for being with us and thank you for your testimony. Let me ask
a preliminary question, because I am not real familiar with how
this all works. How much knowledge does HHS have, first of all,
with regard to the number of foster care children who
participate in these different studies?
Dr. YOUNG. We do not have good detailed information on that
to answer that question.
Mr. BECERRA. Let me back up even further then. We know
there is value in some of the research and the clinical trials
that occur, and we know that, oftentimes, we want to be able to
help children because they have so many years of life ahead of
them if we are able to do some good work and help them
medically. At what point do we believe that our responsibility
by using taxpayer dollars to help fund some of this research or
these trials extends to ensuring that we know who those who are
conducting the trials or the research are when they approach
these children, especially foster children, are trying to
protect their rights?
Dr. YOUNG. That is where the Department's compliance
activities come into place. As I said, we will follow up where
we hear reports. We will do random surveys periodically. We
will talk to the State agencies, but that then becomes an issue
of Federal checking, investigation, if you would, of compliance
to identify problems and to correct those problems.
Mr. BECERRA. Now, how large is your Office of Human
Research Protection?
Dr. YOUNG. I am sorry. I will have to submit that for the
record. I do not know that.
Mr. BECERRA. Any idea? How many folks do you have to
investigate?
Dr. YOUNG. I am not in the Office of Human Protection and
Research. I am in HHS assistant secretary for planning and
evaluation. I just don't have that information.
Mr. BECERRA. Do you have anybody here with you who might be
able to answer that question?
Dr. YOUNG. I don't believe so.
Mr. BECERRA. Well, give me your sense from what you know of
how much--how much in resources do we have to try to provide
some surveillance, some oversight to ensure that, in the first
instance, those who are using Federal tax dollars to conduct
their research or these clinical trials are at least trying to
follow Federal law? Certainly, there must be State law that is
implicated because the State has custody of these foster care
children. Do you have any sense of what kind of resources we
spend?
Dr. YOUNG. I am sorry, sir, I just don't. As I say, that is
not an issue that I looked at in preparation for this hearing.
Mr. BECERRA. Mr. Chairman, perhaps what we could do is ask
Dr. Young to see if HHS could get back to us with some
information.
Dr. YOUNG. I would be happy to.
Mr. BECERRA. To get a better sense, because I suspect one
of the problems we have is you all just don't have the
resources to try to be more vigilant about how these clinical
trials or this research is being conducted. So, the first thing
is, we have to get a handle on whether or not folks are
following through and at least abiding by their commitments
when they obtain Federal funding to follow Federal law. I
suspect that the State probably would respond the same way and
all the different States would respond the same way, saying
they probably don't have enough money to probably do some
oversight over their wards, the children that are within their
custody through the foster care system. Let me ask. In terms of
the type of oversight that you might think would be helpful--
because we can't have someone overseeing every clinical trial
or every bit of research that we fund. Is there some guidance
you can give us on what we should be looking to see HHS do when
it comes to protecting the interest of that child as we try to
promote their well-being?
Dr. YOUNG. First, let me remind you again that the first
level of oversight is at the local institution, and there is
substantial oversight at that level; that these research
protocols are on patients who have physicians taking care of
them, who may or may not be involved in the research, who
provide oversight. The Institutional Review Board will provide
oversight.
Mr. BECERRA. Dr. Young, how do we ensure that that first
instance of oversight is occurring? We are giving Federal tax
dollars. Most of the research will be done locally in a
particular State. States have obligation to take care of these
wards, the wards of the State or kids who are in foster care.
How do we ensure that, when we release those Federal dollars,
that in fact, at that local level, that oversight will occur?
While locally there is more control and responsibility for the
child, I think all of us would still believe that we should not
relinquish whatever rights we have to ensure that that child is
taken care of or handled properly.
Dr. YOUNG. I absolutely agree with you. There is the level
that is local at the physician, the physician caring for the
patient. There is the Institutional Review Board. There is the
institution, that may be a hospital, in which the Institutional
Review Board is housed. There are the State agencies on foster
care, and then there is the Federal rules on compliance and on
investigations that flow from that compliance. We will get back
to you with the information you asked in terms of the size of
the agency budget, and so forth.
Mr. BECERRA. Mr. Chairman, may I ask one last question,
quick question?
Chairman HERGER. The gentleman's time has expired.
Mr. BECERRA. Fifteen seconds.
Chairman HERGER. One other quick question.
Mr. BECERRA. Just a quick comment. Then maybe what we can
do is, if you can tell us if there are any consequences for
those who we have found to not be following Federal regulations
or even State law in the--as they use these Federal tax dollars
to do their research or trials, clinical trials, to see how we
can try to get to those who aren't following through with their
own responsibility.
Dr. YOUNG. A very quick answer. Yes, there are ways to do
that. The FDA regulations in fact lay out, specifically,
sanctions that can be brought toward those who do not follow
the rules.
Mr. BECERRA. Thank you. Thank you, Mr. Chairman.
Chairman HERGER. Thank you. The gentleman from Michigan,
Mr. Camp, to inquire.
Mr. CAMP. Well, thank you, Mr. Chairman. I want to follow
up on that compliance line of questioning that Congressman
Becerra brought up. I realize you can't talk about ongoing HHS
investigations, but can you tell us about any previous findings
of noncompliance with HHS regulations involving children in
foster care and their participation in clinical trials?
Dr. YOUNG. I cannot. I simply don't have that information
as to the past history of any investigations and the outcome of
those.
Mr. CAMP. What happens if an institution is found to be out
of compliance in such cases? Are you aware of that?
Dr. YOUNG. Yes. Individuals cannot be allowed to
participate in research if the findings are egregious enough
from the research side. Or the Institutional Review Board will
be asked to restructure and to change its membership to get a
better mix of membership that is more appropriate to dealing
with the problems so that there are a number of ways that there
can be changes made if there are deficiencies going on. The
ultimate is, of course, not funding the research.
Mr. CAMP. Has that actually happened? Have institutions
been suspended from receiving Federal funding or declared
ineligible to participate?
Dr. YOUNG. As I said a moment ago, I simply don't know the
answer to that question.
Mr. CAMP. All right, so we don't know what institutions.
For what reasons?
Dr. YOUNG. There may be some information on that that I
simply don't have.
Mr. CAMP. All right, to Congressman Nunes, I believe your
response was that you don't have any knowledge of the number of
children in foster care in clinical trials.
Dr. YOUNG. That is correct.
Mr. CAMP. Are you making attempts to find that out? Is
there a process in place to determine that? Or is that not
something you are pursuing?
Dr. YOUNG. The Chairman mentioned the survey that is
ongoing, and I will have to look in more detail to see what the
content of that survey will be.
Mr. CAMP. All right. Do we have any idea of whether there
are any States that require independent advocates for children
to be--any foster children who might be participating in the
clinical trials?
Dr. YOUNG. The anecdotal reports, including those in the
press, suggested that there are some States. I do not have any
primary knowledge on that question one way or the other.
Mr. CAMP. Federal regulations require advocates under
certain circumstances, do you know how many persons have served
as advocates for children in clinical trials? Do you know of
any number.
Dr. YOUNG. I do not have information on that.
Mr. CAMP. I guess what I am trying to get at is, how do we
know about the nature of the trials, the relative risk and
benefit for children without that information?
Dr. YOUNG. We are depending primarily, again, at the local
level, on the Institutional Review Boards, the institutions,
and the oversight that is provided there. We in turn then at
the Federal level will do the investigations as currently being
reported in the press and the compliance activities. There is a
lot of reliance on what is happening locally, the medical and
research community at the local level.
Mr. CAMP. The Institutional Review Boards are charged with
determining how and under what conditions children may
participate in those trials. To what extent does that
information get back to HHS?
Dr. YOUNG. We don't routinely collect information from the
IRBs. We have the broad set of rules, and we will check
compliance overall, but we will not collect information.
Mr. CAMP. All right. Thank you, Mr. Chairman.
Chairman HERGER. Thank you. Dr. Young, there were several
questions that Mr. Camp inquired of and I believe another
Member. So, would you mind responding in writing to the
Subcommittee on that? Our record will be open for 2 weeks.
Dr. YOUNG. Yes.
Chairman HERGER. Thank you. The gentleman from California,
Mr. Stark, to inquire.
Mr. STARK. Dr. Young, I am sorry I missed your testimony,
but we did have a chance to review it. I want to go back to
this, as I just heard in the few minutes that you have been
responding to questions, that you feel that having an
independent advocate for each foster child is taken care of
locally, but in the Federal regulations, the rules state, for
example, that in experiments involving prisoners, the IRB has
to include a prisoner advocate to protect the rights of
prisoners. Why shouldn't children get that same protection?
Dr. YOUNG. The same rules apply to children as to----
Mr. STARK. No.
Dr. YOUNG. Well, just a moment. As to prisoners, there, the
rules are that, where there is a frequent IRB interaction, if
there is one prison study and a lot of others that are not, the
IRB does not have to. They are encouraged to have people who
understand and know the situation, whether it is children or
prisoners, but they do not have to have a prisoner if there is
a single research protocol that has gone forward through the
IRB.
Mr. STARK. Well, I am not at all sure that you and the
inspector of the GAO agree, but let us come back. I am going to
stick with my assertion from the CRS that the Federal
regulations in fact do require that the IRB has to include a
prisoner advocate if there is in fact a prisoner involved in
the study. Now, we can find that out subsequently, and I am
sure that your knowledge of the law is superior to mine. Based
on that, why in the world wouldn't it be--what would be wrong
with requiring an advocate for a child, for a foster care child
in these experiments?
Dr. YOUNG. The current rules do require an advocate. Now, I
am making a distinction between the IRB's composition and the
advocate. The advocate requirement is above and beyond the IRB,
and the advocate requirement is there when there is more than
minimal risk----
Mr. STARK. Okay.
Dr. YOUNG. When there is more than minimal risk and where
the value of it is not commensurate with that. There needs to
be----
Mr. STARK. Who decides whether there is more than minimal
risk?
Dr. YOUNG. The IRB.
Mr. STARK. You don't think it would be necessary on the IRB
to have a child's advocate?
Dr. YOUNG. If the IRB is involved in looking at a
substantial number of research protocols, for example, in a
pediatric hospital, then, yes, I think that is a very
reasonable requirement.
Mr. STARK. What about any program in which a foster child
is involved? Why shouldn't the IRB include an advocate for that
child?
Dr. YOUNG. If there is a--let me make sure I understand
your question. If there is a research protocol going through
that is no more than minimal risk, then the IRB will look at
it. That IRB does not need to have a pediatrician on the IRB,
and there is no requirement separate from that for an advocate.
I think that gives adequate protection.
Mr. STARK. Dr. McDermott, would you yield to me? Do you
think that is adequate protection?
Mr. MCDERMOTT. I don't know. Let me think about it.
Mr. STARK. Okay. I am talking to a pediatrician in his
former life.
Mr. MCDERMOTT. Psychiatrist.
Mr. STARK. Well, pediatric psychiatrist, as I recall, and
it just troubles me that my suspicion is that we have more
concern about prisoners and more protections than we do for
kids. We have seen so many examples of minimal risk in drug
testing, for instance. We have got to bring the pharmaceutical
industry to heel. They have been testing things, you know,
giving drugs to kids without involving them in tests. My
feeling is that children, and particularly children in foster
care who perhaps have a higher--we have an adverse selection
there. I would guess that it is fair to suggest, Mr. Chairman,
that children in foster care children tend to be poorer and
perhaps have had poorer health care for whatever reason as a
population and would be more apt to show up in many of these
studies. I am worried that the tendency is to say, well, it is
okay to let the local people take care of that, because I am
not sure that all local jurisdictions would be--for instance,
here in Washington, D.C., and I conclude, they can't find half
the kids in foster care. How would you like to have a foster
care child from the District of Columbia when its present
foster care system is in a State of upheaval and say, Gee, they
will take care of it? I don't think I believe that. I would
rather you doing it. I trust you.
Chairman HERGER. The gentleman's time has expired. Dr.
Young, what do Federal regulations require in terms of the
naming of independent advocates for foster children in clinical
trials?
Dr. YOUNG. If the clinical trial involves more than minimal
risk and if the value of the clinical trial is not commensurate
with that for the individual patient, then the advocate must be
appointed to make the decision for the child in foster care.
Chairman HERGER. Is there evidence to suggest that children
with advocates who participated in these trials had better
outcomes, they live longer, had better health, are still alive
today than those without advocates?
Dr. YOUNG. I don't believe there is any information on that
subject. I would not see why there would be any particular
difference related to the variable of an advocate only. The
advocate is there for a decisionmaking of yes or no. It is the
ethical structure of the clinical trial that determines whether
it is appropriate, number one, for the individual to even be
eligible for the trial. So, I don't know information of that,
but I would not expect that that would be a variable.
Chairman HERGER. Well, I thank you very much, Dr. Young,
for your testimony. With that, I would like to invite our next
panel to have seats at the table. On this panel we will be
hearing from Dr. Alan Fleischman, senior advisor at the New
York Academy of Medicine; Ms. Roberta Harris, Deputy Secretary
of the Wisconsin Department of Health and Family Services; Dr.
Marjorie Speers, executive director of the Association of
Accreditation of Human Research Protection Programs; and Dr.
Moira Szilagyi, on behalf of the American Academy of
Pediatrics. Dr. Fleischman.
STATEMENT OF ALAN FLEISCHMAN, M.D., SENIOR ADVISOR, THE NEW
YORK ACADEMY OF MEDICINE, NEW YORK, NEW YORK
Dr. FLEISCHMAN. Mr. Chairman, Subcommittee Members, thank
you for inviting me. My name is Alan Fleischman. I am a
physician, pediatrician and medical ethicist. My professional
background and expertise is in the written testimony, but I
speak today as and individual. Clinical research with
therapeutic intent involving children in foster care is an
ethical imperative and can, and was, performed in an
appropriate manner fully consistent with good ethical practice
and compliant with Federal regulations that govern research. In
order to understand the issue of enrollment, I will share with
you some of the data that Dr. Young did as well about the late
eighties and early nineties in HIV care and treatment of
children.
Twenty-five percent of babies born to women who were HIV-
infected developed HIV, AIDS was universally fatal in children,
and 25 percent of infected children died by age 5. Many of the
young children with HIV were boarder-babies, were in foster
care because they had become orphans due to the death of their
mothers or because their mothers were impaired. Great strides
were being made at that time with new drugs developed for the
treatment of HIV and AIDS and its complications, but initial
trials were only in adults. These new treatments were not
available for children, and there weren't any pediatric
formulations of the drugs available to the doctors caring for
such children.
The National Institutes of Health developed clinical
research trials, and that is our first step of safety for the
children in order to study the effectiveness of the various new
treatments in children. Some of the drugs had potential for
side effects. They were serious drugs. They were against a
serious virus, but those possible risks were far outweighed, as
doctors would know, by the potential therapeutic benefits. In
New York City, the agency responsible for supervision of foster
children developed mechanisms that made enrollment of foster
children in clinical trials possible, because it would have
been unjust not to offer these children the very best prospect
of life-saving treatments. The first protection was that
individual medical institutions conducted the trials only after
Institutional Review Board prospective review and approval.
The consent of biologic mothers or legal guardians was
obtained when possible. An agency permission on an individual
basis was required before the child could be enrolled in the
trial, and foster parents were involved in these discussions
because of their need to administer treatments and bring
children back for follow-up visits to the hospital in order to
be successful in the trials. The appointment of advocates for
the children, while a laudable procedural approach, was not
required. We did choose that approach in the Bronx, but we were
not required to do that by the Federal regulations.
Today, pediatric AIDS treatment in the United States is
different, because of clinical trials there are effective
treatments to prevent children from becoming infected in utero,
and there are effective treatments to prevent children from--
there are effective standard treatments for the smaller number
of children who are now infected. AIDS in children has become a
chronic disease with less than 1 percent mortality each year
for children treated in AIDS centers in the United States.
Children in foster care who are infected with AIDS today are
getting standard treatments and are rarely participating in
clinical trials because it is no longer a matter of life and
death. There may be a time in the future, perhaps with the
emergence of a new dreaded disease, when we will once again be
faced with the critical need to enroll foster children in
clinical trials in order to provide needed life-saving
treatments. Our past experience with HIV and AIDS and the
present Federal regulatory structure on research allows us to
do that, if we need to.
In conclusion, those of us involved in the treatment of
children infected with HIV knew that a large percentage of our
patients were poor, minority children, and many of those
children were in foster care. We demanded the very best
treatment for these vulnerable children. The only way to
provide it, in fact, to provide treatment in HIV care to any
child with AIDS, at that time was through clinical trials. We
enrolled children in treatment trials and gathered information
on the effects of the new drugs on children while we attempted
to save and enhance lives of our patients. It would have been
unethical to have behaved in any other way. Thank you.
[The prepared statement of Dr. Fleischman follows:]
Statement of Alan Fleischman, M.D., Senior Advisor, New York Academy of
Medicine; Ethics Advisor, National Children's Study at the National
Institute of Child Health and Human Development; Clinical Professor of
Pediatrics and Clinical Professor of Epidemiology and Population
Health, Albert Einstein College of Medicine in New York
Mr. Chairman and Committee members, thank you for inviting me to
share my views with the Committee on the issue of Protection of Foster
Children Enrolled in Clinical Trials. My name is Alan Fleischman; I am
a physician, pediatrician and medical ethicist. I am Senior Advisor at
The New York Academy of Medicine and Ethics Advisor to the National
Children's Study at the National Institute of Child Health and Human
Development, as well as Clinical Professor of Pediatrics and Clinical
Professor of Epidemiology and Population Health at the Albert Einstein
College of Medicine in New York. I speak today as an individual, the
opinions I will express represent my own and do not represent the views
or opinions of any organization or institution with which I am or have
been affiliated.
In the late 1980s and the early 1990s I was Professor of Pediatrics
and Professor of Epidemiology and Social Medicine at the Albert
Einstein College of Medicine in New York and served as Director of the
Division of Neonatology at the Montefiore Medical Center, that included
responsibility for the newborn services at the voluntary hospital,
Montefiore, and two public hospitals operated by the New York City
Health and Hospital Corporation, Jacobi Medical Center and North
Central Bronx Hospital. I was also a member of the two Institutional
Review Boards for research involving human subjects that was
responsible for approval of all research involving humans conducted at
each of these hospitals.
I was a member of the American Academy of Pediatrics National
Bioethics Committee from 1983-1989, and a member of the American
Academy of Pediatrics AIDS Committee from 1993-1999. In New York State,
I was a member of the Department of Health, AIDS Advisory Council Work
Group on Ethical Issues in Access to Treatment. In addition, I was
asked, in 2001, by the Secretary of the U.S. Department of Health and
Human Services (DHHS) to serve as a member of the National Human
Research Protections Advisory Committee to the Office for Human
Research Protections and to chair the review of the federal regulations
that govern research involving children. I have also served as an
expert advisor to the Institute of Medicine's Committee on Ethical
Conduct of Clinical Research Involving Children.
I am currently a member of the New York State Governor's Task Force
on Life and the Law, the New York City Mayor's Commission on Women's
Issues, the DHHS Secretary's Advisory Committee on Human Research
Protections' Subcommittee on Research Involving Children, and the
Institute of Medicine Committee on Ethical Issues in Housing-Related
Health Hazard Research Involving Children Youth, and Families.
I am here today to express my strong belief that clinical research
with therapeutic intent involving children in foster care is an ethical
imperative and can be performed in an appropriate manner fully
consistent with good ethical practice and compliant with federal
regulations that govern research.
In order to understand the issue of the enrollment of foster
children in AIDS clinical trials, you need to have a picture of AIDS
care for children in the late 1980s and the early 1990's:
-- 25% of babies born to women who were HIV infected developed HIV
through viral transmission in utero;
-- AIDS was a universally fatal disease in children, with 25% of
infected children dying by 5 years old;
-- many of the young children with HIV were ``boarder-babies'' who
stayed in hospitals or were placed in foster care because they had
become orphans due to the death of their mothers from AIDS, or because
their mothers were too ill or impaired to care for them;
-- great strides were being made with new drugs developed for the
treatment of HIV and AIDS and its complications, but initial trials of
these drugs included only adults; multiple drug therapy was shown to
save lives, and reverse some of the major life-threatening illnesses
associated with AIDS, but these new treatments were not available to
children;
-- in fact, pediatric formulations of these drugs were not
available to physicians caring for young children with HIV and AIDS;
-- the National Institutes of Health developed clinical research
trials in order to study the effectiveness of various new treatments in
children; Some of the drugs had the potential for side effects, but
those possible risks were viewed by doctors to be far out weighed by
the potential therapeutic benefit of the new drugs against AIDS, then a
uniformly and often rapidly fatal disease.
A large percent of the children with HIV and AIDS in the late 1980s
and the early 1990s in New York City and other parts of the country
were poor, minority children, and many of these children required
foster care. It would have been unconscionable and unjust, not to offer
these children the very best prospect of life saving and life-enhancing
treatment. Enrollment in clinical trials was the only way to accomplish
that goal. If the agencies responsible for supervising the care of
foster children in the early 1990s refused to allow children to be
enrolled in treatment trials, I and many other clinicians would have
demanded action in the interests of those children.
In New York, the Administration for Children's Services, the agency
responsible for supervision of foster children, developed mechanisms
that made enrollment of foster children in clinical trials possible.
Local Institutional Review Boards for research involving human
subjects, like ours in the Bronx, approved the NIH treatment trials for
use in all children infected with HIV and helped investigators and the
Administration for Children's Services to develop mechanisms to allow
enrollment of children in foster care.
The consent of biologic mothers was obtained when possible, agency
permission on an individual basis was obtained, and foster parents were
involved in these discussions because of their need to administer
treatments and bring children back for followup visits to the hospital.
Let me also comment on the federal regulations that govern research
involving children with a specific emphasis on the section on ``wards''
in the regulations (Sec. 45CFR46.409). I took the opportunity last week
to clarify the regulations with a senior member of the Office for Human
Research Protections at the U.S. Department of Health and Human
Services and I believe that my views of the regulations are consistent
with his.
Clinical trials that include treatment with the prospect of direct
benefit to the individual child are governed by section
Sec. 45CFR46.405 of the federal regulations. This section requires the
permission of the parent or legal guardian in order to enroll any child
in a study. It does not require the creation of an advocate for each
child that is a ward or in foster care. This approach is based on a
clinical treatment model. Only if the proposed research does NOT
provide the prospect of direct benefit for the individual child AND has
a level of risk greater than minimal is the creation of an advocate
required by the regulations (Sec. 45CFR46.409).
Let me add that virtually all of the research projects involving
foster children in New York City were treatment trials with therapeutic
intent. The individual institutions conducting the trials had an
Institutional Review Board that had to prospectively approve the
studies and may or may not have created special advocates or processes
for enrolling foster children. We did in the Bronx, but it was not
mandated by the regulations. What was required was the permission of
the biologic parent or of the guardian, either the legal guardian or
the agency fulfilling that responsibility for the child.
Today, Pediatric AIDS treatment in the U.S. is different. Because
of clinical trials conducted in the 1990s, there are effective
treatments to prevent children from becoming infected in utero and
standard treatments for the small number of children who are infected.
AIDS in children has become a chronic disease with less than 1%
mortality each year for children treated in AIDS centers in the U.S.
Children in foster care infected with HIV are getting standard
treatment and are rarely participating in clinical trials because it is
no longer a matter of life and death. But there may be a time in the
future, perhaps with the emergence of a new dreaded disease, when we
will once again be faced with the critical need to enroll foster
children in clinical trials in order to provide needed life saving
treatments. The present federal regulations allow us to do that, if we
had to.
In conclusion, those of us involved in the treatment of children
infected with HIV in the late 1980s and 1990s knew that a large
percentage of our patients were poor, minority children and many of
those children were in foster care. We demanded the very best treatment
for these vulnerable children. The only way to provide the best
treatment to any child with HIV at that time was through clinical
trials--the drugs were just not available any other way. We enrolled
children in treatment trials and gathered information on the effects of
the new drugs on children, while we attempted to save and enhance the
lives of our patients. It would have been unethical to have behaved in
any other way; if we denied those new treatments to children in foster
care we would stand today open to severe criticism for having allowed
our most vulnerable children to have suffered or even die rather than
offer them the best chance of survival and the possibility of a good
future quality of life. Thank you.
Chairman HERGER. Thank you, Dr. Fleischman. Ms. Harris.
STATEMENT OF ROBERTA HARRIS, DEPUTY SECRETARY, WISCONSIN
DEPARTMENT OF HEALTH AND FAMILY SERVICES, MADISON, WISCONSIN
Ms. HARRIS. Mr. Chairman, Members of the Subcommittee,
thank you for this opportunity to provide information to the
Subcommittee on this important topic. Children in the child
welfare system, whether in their own homes or in some form of
out-of-home care, are some of the most vulnerable children in
our country. We must do everything that we can to ensure that
these children are protected from any additional trauma.
Clearly we need legitimate medical and other research.
Significant advances are made every day as a result of well-
designed and implemented research studies. In Wisconsin, we
have not approved medical research on foster children or any
subgroup of foster children as a class. In the child welfare
system, we believe it is our responsibility to provide as much
safe--as much of a safe and nurturing environment for the
children in foster care as possible.
Today I would like to make some comments related to the
lack of homogeneity of foster children, the problems with
voluntary participation on the part of families, and the legal
framework of our authority to consent to such research. Let me
begin with lack of homogeneity. Research, whether medical or
otherwise, should not be limited to a particular group unless
there is some homogeneity within that group that is unique. In
this regard, there is very little, if anything, that can be
regarded as homogeneous among children in foster care other
than that they have been removed from their homes.
As many of us know, children in foster care are there for a
variety of reasons; abuse or neglect of themselves or their
siblings, mental health issues of a severe nature, medical or
developmental disabilities with special care and treatment
needs that cannot be provided by their parents, and/or
delinquency. Many of our children are also from low-income
families. As has been mentioned here today, recent news
articles have indicated that foster children have participated
in medical studies related to research endeavors dealing with
acquired immunodeficiency syndrome. It is true that some
children in foster care have HIV or AIDS. It is also true that
many children not in foster care have HIV or AIDS. To focus a
study on medication related to that condition only on children
in foster care where there are potential negative effects of
those medications certainly leads to a perception that somehow
foster children are valued less than other children.
In Wisconsin, our position on the involvement of foster
children in research, especially medical research, is based in
large part on a variety of ethical codes related to medicine,
social work, and mental health. These codes place great
emphasis on the voluntary nature of participation research. We
believe that our children and our child welfare system are
vulnerable, and it is our role to do what we can to ensure the
safety and welfare of the children in our system. In addition,
as I testified to earlier, many children in the child welfare
system are economically disadvantaged. We must recognize this
position and protect the family from giving consent under
duress. Voluntary consent goes to the heart of the nature of
the relationships among children, their families, and the child
welfare system. ``Voluntary'' is defined as acting or
performing without external persuasion or compulsion.
Generally, out-of-home placements are ordered by the court.
When the agency that has authority to determine when a child be
returned to the parent recommends to that parent that the
child's participation in medical research--recommends to that
parent that that parent approve the child's participation in
medical research, at least on a perceived basis it is
questionable whether the parent would feel that his or her
approval is truly voluntary.
This brings me to legal status. We need to look at the
issue of who can approve the involvement of a foster child in
any type of research, medical or otherwise. In the child
welfare system, there are generally four types of legal
relationship between a child and an individual agency acting on
behalf of that child: physical custody, legal custody,
guardianship and parental relationship. In most cases in
Wisconsin, the legal custody of a child in foster care remains
with the parent, because under Wisconsin statutes, there shall
be a policy of transferring custody of a child from the parent
only when there is no less drastic alternative.
If the parent's rights have not been terminated, and if
guardianship has not been inferred on another party, then it is
clear that the parent should make the medical decisions for the
child. As noted previously, however, if the request for
research participation comes to the parent through the agency
having the authority to decide when the child is returned to
the parent, one must legitimately question whether the approval
of the parent is given freely and voluntarily. If a
representative of the Wisconsin child welfare system has court-
appointed legal custody or guardianship and has the authority
to approve the participation of the foster child in medical
research, it is our position that the approval for such
participation should not be given solely on the basis of the
child being a foster child.
We are not opposed to the participation of a child--of a
foster child in appropriate and beneficial medical research on
a case-by-case basis if a foster children meets the
requirements for a medical research study based on some
physical, mental, emotional or developmental condition; and the
child's parent or parents were informed and, as is appropriate
to their legal status, approved of their child's participation;
and the child's personal physician, therapist and other
qualified professional recommends to the system authority the
child be involved in that research; and children with similar
or related conditions will also participate; and the group of
children, and other individuals in the study, include children
outside of the child welfare system; and finally, the child is
appointed an advocate with the express responsibility for
determining whether participation is in the child's best
interest, including, if possible, ascertaining the child's
position. If all of these are met, we would consider granting
that authority.
In summary, in Wisconsin, we believe it is our
responsibility to help provide a safe, nurturing environment
for the children in our foster care system so that they may
become thriving, healthy adults. We are opposed to a foster
child being involved in any such research solely because the
child is a foster children. It is inappropriate to single out
foster care children as a group for medical research based
simply on the fact that they are children in the child welfare
system. Thank you again for your invitation to address this
important issue. I trust that the legislative initiatives that
will be forwarded will reflect the values Wisconsin uses with
regard to foster child protection in medical studies.
[The prepared statement of Ms. Harris follows:]
Statement of Roberta Harris, Deputy Secretary, Wisconsin Department of
Health and Family Services, Madison, Wisconsin
Thank you for this opportunity to provide information to the
committee on this very important topic. Children in the child welfare
system, whether in their own homes or in some form of out-of-home care,
are some of the most vulnerable children in our nation. It is critical
that child welfare professionals, child advocates, medical
professionals, elected representatives, and the general public do all
that we can to ensure that these children are protected from any
additional trauma.
It is not my intent to denigrate the important work reflected in
most legitimate medical and other research. Clearly, significant
advances are made every day as a result of well designed and
implemented research studies.
In Wisconsin, we have not approved medical research on foster
children as a class, or any subgroup of foster children, because we
believe it is our responsibility to provide as much of a safe,
nurturing environment for the children in foster care as possible. The
types of research that have unfortunately occurred in our nation in the
past would also make it difficult for us to earn the trust and
confidence of the families we are seeking to help, who desperately need
the services we can offer.
As such, I would like to offer our comments on the topic related to
the lack of homogeneity of foster children, the problems with voluntary
participation on the part of families, and the legal realities of our
authority to consent to such research.
1. Lack of Homogeneity
Research, whether medical or otherwise, should not be limited
to a particular group, unless there is some homogeneity within that
group that is unique. In this regard, there is very little--if
anything--that can be regarded as homogenous among children in foster
care, other than that they have been removed from their homes; in most
cases, involuntarily.
Children in foster care are there for a variety of reasons:
some have been abused or neglected or had siblings who were abused or
neglected; some have mental health issues of a severe nature, sometimes
as a result of the trauma of being removed from their homes, parents,
and siblings; some are medically fragile or developmentally disabled
with special care and treatment needs that cannot be provided by their
parents; some children are delinquent. Certainly, many are from low
income families.
Recent news articles have indicated that several states have
allowed foster children to participate in medical studies related to
research endeavors dealing with Acquired Immunodeficiency Syndrome
(AIDS). It is certainly true that some children in foster care have HIV
or AIDS. It is also true that many children not in foster care have HIV
or AIDS. To focus a study, then, on medication related to that
condition only on children in foster care, when there are known
potential negative effects of those medications, certainly leads to a
perception that somehow foster children are valued less than other
children.
2. Voluntary Nature of Participation
In Wisconsin, our position on the involvement of foster
children in research, especially medical research, is based in large
part on a variety of ethical codes related to medicine, social work,
and mental health. A major document forming the basis of our position
is embodied in the The World Medical Association Declaration of
Helsinki, originally adopted in 1964, and as amended in 1975, 1983,
1989, 1996, 2000, 2002, and 2004, which places great emphasis on the
voluntary nature of participation in research.
Paragraph 1 of that document states, in part, that ``. . . Some
research populations are vulnerable and need special protection. The
particular needs of the economically and medically disadvantaged must
be recognized. Special attention is also required for those who cannot
give or refuse consent for themselves, for those who may be subject to
giving consent under duress. . . .''
We believe the children in our child welfare system are
vulnerable based upon the trauma within their home, along with the
distress that can be caused from being removed from their family and
placed into foster care. We believe it is our role to do what we can to
help ensure the safety and welfare of the children in our system. In
addition, as I testified to earlier, many children in the child welfare
system are economically disadvantaged. We must recognize their needs
and protect the family from giving consent under duress.
To continue from the World Medical Association Declaration of
Helsinki, Paragraph 20 states that ``The subjects must be volunteers
and informed participants in the research project.''
Paragraph 23 states ``When obtaining informed consent for the
research project the physician should be particularly cautious if the
subject is in a dependent relationship with the physician or may
consent under duress. In that case the informed consent should be
obtained by a well-informed physician who is not engaged in the
investigation and who is completely independent of this relationship.''
Paragraph 24 states that ``For a research subject who is
legally incompetent, physically or mentally incapable of giving consent
or is a legally incompetent minor, the investigator must obtain
informed consent from the legally authorized representative in
accordance with applicable law. These groups should not be included in
research unless the research is necessary to promote the health of the
population represented and this research cannot instead be performed on
legally competent persons.''
Paragraph 25 states that ``When a subject deemed legally
incompetent, such as a minor child, is able to give assent to decisions
about participation in research, the investigator must obtain that
assent in addition to the consent of the legally authorized
representative.''
I raise these issues related to consent because, to a certain
extent, they go to the heart of the nature of the relationships among
children, their families, and the child welfare system. In the context
noted above, two definitions of the term ``voluntary'' should be
carefully considered:
Voluntary: Done, given, or proceeding from the free or
unconstrained will of a person. [The World Book Dictionary]
Voluntary: Acting or performed without external persuasion or
compulsion. [The American Heritage Dictionary of the English Language]
With the exception of some of the small percent of voluntary
placements, out-of-home placements are ordered by the court. As such,
when the agency that has the authority to determine when a child will
be returned to the parent recommends that the parent approve the
child's participation in medical research, at least on a perceived
basis, it is questionable whether the parent would feel that his or her
approval is truly voluntary.
3. Legal Status
This brings us to the issue of who can approve the involvement
of a foster child in any type of research, medical or otherwise. In the
child welfare system, there are generally four types of legal
relationship between a child and an individual or agency acting on that
child's behalf. These are physical custody, legal custody,
guardianship, and the parental relationship, which are defined as the
following:
Physical custody means actual custody of the person in the
absence of a court order granting legal custody to the physical
custodian. [s. 48.02(14)] In the context of this hearing, the foster
parent would be a physical custodian only, because in Wisconsin, they
would not generally have legal custody.
Legal custody is a status created by the order of a court,
which confers the right and duty to protect, train and discipline the
child, and to provide food, shelter, legal services, education and
ordinary medical and dental care, subject to the rights, duties and
responsibilities of the guardian of the child and subject to any
residual parental rights and responsibilities and the provisions of any
court order. [s. 48.02(12)] In most cases in Wisconsin, the legal
custody of a child in foster care will remain with the parent because,
under our statutes, ``. . . there shall be a policy of transferring
custody of a child from the parent . . . only when there is no less
drastic alternative. If there is no less drastic alternative for a
child than transferring custody from the parent, the judge shall
consider transferring custody to a relative whenever possible.'' [s.
48.355(1)]
We believe that maintaining the parents' involvement,
responsibility, and authority when a child is placed outside of the
home is critical, if the goal is to reunify the child with the family.
Guardianship means a status granted by the court to a person
who has the duty and authority to make important decisions in matters
having a permanent effect on the life and development of the child and
the duty to be concerned about the child's general welfare, including
but not limited to:
The authority to consent to marriage, enlistment in the
U.S. armed forces, major medical, psychiatric and surgical treatment,
and obtaining a motor vehicle operator's license.
The authority to represent the child in legal actions
and make other decisions of substantial legal significance concerning
the child but not the authority to deny the child the assistance of
counsel as required by this chapter.
The right and duty of reasonable visitation of the
child.
The rights and responsibilities of legal custody except
when legal custody has been vested in another person or when the child
is under the supervision of the department of corrections . . . or the
supervision of a county department . . . [s. 48.023]
The parental relationship, of course, is one in which the
parent has all of the rights and responsibilities related to the care
of his or her child which have not been otherwise altered by the action
of a court.
Parental Authority for Participation. If parental rights have
not been terminated, and if guardianship has not been inferred on
another party, the parents retain the right to make medical decisions
for the child.
System Authorization for Participation. Occasionally, a
representative of the Wisconsin child welfare system is granted court-
appointed legal custodianship or guardianship and would have the
ability to approve the participation of a foster child in medical
research. In these instances, it is our position that approval for such
research participation should not be given solely on the basis of the
child being a foster child, but rather reviewed on a case-by-case basis
for medical benefits.
In other words, we are not opposed to the participation of a
foster child in appropriate and beneficial medical research if:
a foster child meets the requirements for a medical
research study based on some physical, mental, emotional, or
developmental condition and
the child's parent or parents were informed and, as
appropriate to their legal status, approved of their child's
participation and
the child's personal physician, therapist, or other
professional recommends to the system authority that the child be
involved in that research and
children with similar or related conditions will also
participate and
the group of children and other individuals in the
study include children outside of the child welfare system and
the child was appointed an advocate with the express
responsibility for determining whether participation is in the child's
best interest (including ascertaining the child's position),
the representative may consider granting that authority. In
Wisconsin, we believe it is our responsibility to help provide a safe,
nurturing environment for the children in foster care so that they may
become healthy, thriving adults. We are opposed to a foster child being
involved in any such research solely because the child is a foster
child. It is inappropriate to single out foster care children as a
group for medical research, based simply on the fact that they are in
the child welfare system.
Thank you again for your invitation to address this important
issue. I wish you well and trust that legislative initiatives will be
forwarded that reflect the values Wisconsin uses with regard to foster
child participation in medical studies.
Chairman HERGER. Thank you, Ms. Harris. Dr. Speers to
testify.
STATEMENT OF MARJORIE SPEERS, Ph.D., EXECUTIVE DIRECTOR,
ASSOCIATION FOR THE ACCREDITATION OF HUMAN RESEARCH PROTECTION
PROGRAMS, INC.
Ms. SPEERS. Good afternoon, and thank you for inviting me
to speak about the roles of IRBs and protections for children
when they are research subjects. IRBs have a broad
responsibility to safeguard the rights and welfare of research
subjects. Thus, they should be sufficiently qualified to review
the research that comes before them and to ascertain the
acceptability of proposed studies in terms of institutional
commitments and requirements, applicable law and standards of
professional practice. IRBs and institutions that receive funds
from the Department of Health and Human Services or review
research that the Food and Drug Administration regulates must
abide by Federal regulations to protect research subjects and
Subpart D, which provides additional protections for children
participating in research. As stipulated in the regulations,
IRBs must have at least five members with varying backgrounds
to promote complete and adequate review of research. At least
one member must have primary concerns in the scientific area,
at least one member must have primary concerns in nonscientific
areas, and at least one member must not be otherwise affiliated
with the institution.
The primary role of the IRB is to determine whether a
proposed study is ethically justifiable. The Federal
regulations lay out seven criteria for IRB approval of
research. They include risks to subjects are minimized; risks
to subjects are reasonable in relation to potential benefits,
including direct benefits to subjects and the importance of the
knowledge that might be gained; subjects are selected
equitably; informed consent is sought from each prospective
subject or legally authorized representative and documented;
and when appropriate, the research plan includes monitoring the
data to ensure the safety of subjects and includes provisions
to protect the privacy of subjects and to maintain the
confidentiality of the data. IRBs use written procedures,
checklists and other tools to assist them in complying with the
regulations. During IRB meetings, an IRB member usually
describes the proposed study, and all members discuss and
debate the ethical and scientific issues relating to the
protection of prospective subjects. In the end, they come to a
conclusion to approve or disapprove the study, request more
information, or require modifications of the study in order to
approve it.
Involving children in research poses special ethical
dilemmas. Aside from State laws governing the age of majority
and who may consent on behalf of the child to participate in
research, children, by nature of their developing cognitive
abilities, are unable to give voluntary informed consent to
participate in a study. IRBs consider this carefully in
research involving children. IRBs must make specific
determinations regarding the level of risk involved in a
proposed study and whether there is a prospect of direct
benefit to the individual subject. They may approve research
only when it falls into one of four permitted categories.
Research involving greater than minimal risk can only be
approved when it meets certain regulatory criteria. These
determinations are not easy to make because IRBs must interpret
regulatory terms such as ``minimal risk'' or ``minor increase
over minimal risk.''
One of the main protections for children is the requirement
that IRB approve research in which investigators solicit assent
from the child and permission from the parents or guardians,
individuals who are authorized under law to consent on behalf
of a child. Under the regulations, IRBs may approve research
involving children who are wards. Depending on the level of
risk and whether there is a possibility of direct benefit to
the child-subject, a child advocate might be required. For
example, in order to approve a study involving greater than
minimal risk and no prospect of direct benefit to the
individual subjects, IRBs must find that the research is
related to their status as wards or is conducted in settings
such as schools where the majority of children involved as
subjects are not wards. Further, IRBs must require the
appointment of an advocate for each child who is a ward, in
addition to anyone who is acting on behalf of the child as a
guardian.
In summary, there are a number of regulatory requirements
to ensure that children participating in research are
adequately protected. When IRBs and investigators implement
these additional protections, the system works well. Thank you
for the opportunity to address the Subcommittee.
[The prepared statement of Dr. Speers follows:]
Statement of Marjorie Speers, Ph.D., Executive Director, Association
for the Accreditation of Human Research Protection Programs, Inc.
Good afternoon. My name is Marjorie Speers. I am the Executive
Director of the Association for the Accreditation of Human Research
Protection Programs--an organization that accredits institutional
review boards, or IRBs, as part of a broader human research protection
program. I was invited to speak about the roles of IRBs and protections
for children when they are research subjects.
IRBs have a broad responsibility to safeguard the rights and
welfare of research subjects. Thus, they should be sufficiently
qualified to review the research that comes before them and to
ascertain the acceptability of proposed studies in terms of
institutional commitments and requirements, applicable law, and
standards of professional practice.
IRBs in institutions that receive funds from the Department of
Health and Human Services or review research that the Food and Drug
Administration regulates must abide by federal regulations to protect
research subjects and Subpart D, which provides additional protections
for children participating in research.
As stipulated in the regulations, IRBs must have ``at least five
members with varying backgrounds to promote complete and adequate
review of research,'' at least one member must have primary concerns in
the scientific area, at least one member must have primary concerns in
nonscientific areas, and at least one member must not be otherwise
affiliated with the institution.
The primary role of the IRB is to determine whether a proposed
study is ethically justifiable. The federal regulations lay out seven
criteria for IRB approval of research. Briefly, they include: risks to
subjects are minimized; risks to subjects are reasonable in relation to
potential benefits, including direct benefits to subjects and the
importance of the knowledge that might be gained; subjects are selected
equitably; informed consent is sought from each prospective subject or
legally authorized representative and documented; and when appropriate,
the research plan includes monitoring the data to ensure the safety of
subjects and includes provisions to protect the privacy of subjects and
to maintain the confidentiality of the data.
IRBs use written procedures, checklists, and other tools to assist
them in complying with the regulations. During IRB meetings, an IRB
member usually describes the proposed study and all discuss and debate
the ethical and scientific issues relating to the protection of
prospective subjects. In the end, they come to a conclusion to approve
or disapprove the study, request more information, or require
modifications of the study in order to approve it.
Involving children in research poses special ethical dilemmas.
Aside from state laws governing the age of majority and who may consent
on behalf of the child to participate in research, children by nature
of their developing cognitive abilities are unable to give voluntary
informed consent to participate in a study. IRBs consider very
carefully research involving children.
IRBs must make specific determinations regarding the level of risk
involved in a proposed study and whether there is a prospect of direct
benefit to the individual subjects. They may approve research only when
it falls into one of four permitted categories. Research involving
greater than minimal risk can only be approved when it meets certain
regulatory criteria. These determinations are not easy to make because
IRBs must interpret regulatory terms, such as ``minimal risk'' or
``minor increase over minimal risk.''
One of the main protections for children is the requirement that
IRBs approve research in which investigators solicit assent from the
child and permission from the parents or guardians--individuals who are
authorized under law to consent on behalf of a child. Under the
regulations, IRBs may approve research involving children who are
wards. Depending on the level of risk and whether there is a
possibility of direct benefit to the child-subject, a child advocate
might be required. For example, in order to approve a study involving
greater than minimal risk and no prospect of direct benefit to
individual subjects, IRBs must find that the research is related to
their status as wards or is conducted in settings, such as schools,
where the majority of children involved as subjects are not wards.
Further, IRBs must require the appointment of an advocate for each
child who is a ward, in addition to anyone who is acting on behalf of
the child as a guardian.
In summary, there are a number of regulatory requirements to ensure
that children participating in research are adequately protected. When
IRBs and investigators implement these additional protections, the
system works well. Thank you for the opportunity to address the
Subcommittee.
Chairman HERGER. Thank you, Dr. Speers. Dr. Szilagyi to
testify.
STATEMENT OF MOIRA SZILAGYI, M.D., Ph.D., FELLOW OF THE
AMERICAN ACADEMY OF PEDIATRICS, ON BEHALF OF THE AMERICAN
ACADEMY OF PEDIATRICS
Dr. SZILAGYI. Mr. Chairman, I am grateful for the
opportunity to testify as this important hearing on children in
foster care and clinical trials. My name is Dr. Moira Ann
Szilagyi, and I am proud to speak on behalf of 60,000 primary
care pediatricians, pediatric medical subspecialists and
pediatric surgical specialists of the American Academy of
Pediatrics. For the past 19 years, I have specialized in the
medical care and developmental issues of children in foster
care. I am an associate professor of pediatrics at the
University of Rochester Medical Center in Rochester, New York;
a medical director of Monroe County Department of Health's
Foster Care Pediatrics Clinic. I also serve on the American
Academy of Pediatrics Committee on Early Childhood, Adoption
and Dependent Care. The academy has a deep and abiding interest
in the health care provided to children in the child welfare
system. In fact, the academy has numerous published policy
statements, clinical guidelines and studies regarding children
in foster care, including this, a 170-page handbook for
pediatricians on health care standards for children in foster
care. I was proud to chair the District II Task Force on Health
Care for Children in Foster Care, which authored this resource
manual.
The 540,000 children in foster care comprise one of many
vulnerable populations to which the academy urges special
attention in the provision of health care. Compared with
children from the same socioeconomic background, children in
foster care have much higher rates of serious emotional and
behavioral problems, chronic physical disabilities, birth
defects, developmental delays, and poor school achievement.
Typically these conditions are chronic, underidentified, and
undertreated, and they have an ongoing impact on all aspects of
their lives, even long after these children and adolescents
have left the foster care system. As a result, children in
foster care warrant special attention in all aspects of their
health care. One aspect in which children in foster care
deserve particularly close and special consideration is their
inclusion in clinical trials. It is the position of the
American Academy of Pediatrics that drugs be studied in
children to determine their safety and efficacy in this age
group. Indeed, the academy considers it a moral imperative to
formally study drugs in children so that they can enjoy equal
access to existing as well as new therapeutic agents.
Research participation is often beneficial to participants
and may allow them access to care they could not otherwise
receive. Therefore, children in foster care, as a population
that tends to have a greater preponderance of special health
care needs, should be afforded the same opportunities and
access to safe and effective treatments. However, special
consideration is necessary when allowing children in foster
care who are in the care and custody of the State to take part
in certain studies that may contain greater than minimal risk
to the child.
The academy has developed extensive guidelines and
standards related to the ethical conduct of clinical trials
involving children. The academy also agrees with the Department
of Health and Human Services' regulations governing the
inclusion of children in clinical research. For the purposes of
today's hearings, however, perhaps the most relevant standards
deal with consent. Young children are, by definition, incapable
of consenting to medical procedures. Consent must be given on
their behalf by a parent, a legal guardian or an individual or
institution acting in loco parentis; that is, in place the of
the parent. In all cases, however, the overriding consideration
must be the best interest of the child.
HHS regulations outline issues of consent. Consent must be
obtained from the adult acting legally on behalf of the child.
When developmentally appropriate, the assent of the child must
be gained prior to participation in any clinical trial. The
question, then, for children in foster care is whether adequate
safeguards are established when consent is obtained for trials
that contain above minimal risk to the child or when the
research does not hold the prospect of providing direct medical
benefit to the child him or herself.
For children in the foster care system, an important
safeguard is a special advocate who can help the foster family
or State agency navigate medical issues, ensure that the
child's medical care needs are being met, assist the child in
determining whether or not he or she should participate, and
provide a source of continuity for the child and the legal
guardians throughout the duration of the study. Even in cases
of less than minimal risk or studies with prospect of direct
benefit, an advocate, while not required, could play an
important role in the child's support system. It is my
understanding that the Subcommittee is concerned by press
reports about the participation of children in foster care in
clinical trials of HIV drug treatments that began in the late
eighties. My own professional experience includes a number of
cases of HIV-positive children in foster care in my community
who received HIV multidrug treatments during the early
nineties. When our patients took these drug combinations, we
saw a startling improvement in lifespan and quality of life.
Before the introduction of these combination drugs, our HIV-
positive children in care were literally wasting away before
our eyes.
There were some side effects with the drugs, but not that
many, and the side effects were nothing compared to the
devastation of the disease. I recall one 2-year-old child in
particular who was literally dying. One year after receiving
combination therapy, he was essentially indistinguishable from
his healthy peers. He was able to go to preschool, live in a
family instead of the hospital, and have hope for a longer
life. He is still alive today and was eventually adopted by his
foster family. Mr. Chairman, the decision to enroll a child in
a clinical trial is never an easy one, even in a traditional
family structure. While the headlines seem to suggest that
children in foster care were somehow singled out as hapless
guinea pigs, my experience indicates that children in foster
care are actually less likely than other children to be
considered for participation in a clinical trial. In fact,
numerous barriers exist for children in foster care to even
obtain routine health care and necessary health services.
Participation in a clinical trial where access would be far
more complex is even less likely to occur.
The American Academy of Pediatrics believes that children
in foster care deserve to be offered the same opportunities as
other children to benefit from newer drugs and treatment
protocols, especially when a child's condition is so grave that
there are few options available to them. Indeed, it would be
unethical to do otherwise and systematically deny access to
clinical trials that could have saved their lives or vastly
improved the health of critically ill children in foster care.
It is clear that children in foster care are a special
population, and that they deserve additional protections when
being considered for inclusion in clinical trials.
Mr. Chairman, and Members of the Subcommittee, I deeply
appreciate this opportunity to offer testimony on behalf of the
American Academy of Pediatrics. A more detailed version of my
testimony has been submitted for the record. I stand ready to
answer any questions you may have, and I thank you for your
commitment to the health of the children of our Nation.
[The prepared statement of Dr. Szilagyi follows:]
Statement of Moira Ann Szilagyi, M.D., Ph.D., Associate Professor of
Pediatrics at the University of Rochester Medical Center, Rochester,
New York; Medical Director, Foster Care Pediatrics Clinic, Monroe
County Department of Health; and Member, Committee on Early Childhood,
Adoption and Dependent Care, American Academy of Pediatrics
Mr. Chairman, I am grateful for the opportunity to testify at this
important hearing on children in foster care and clinical trials. My
name is Dr. Moira Ann Szilagyi, and I am proud to speak on behalf of
the 60,000 primary care pediatricians, pediatric medical
subspecialists, and pediatric surgical specialists of the American
Academy of Pediatrics. For the past 19 years, I have specialized in
medical care and developmental issues of children in foster care. I am
an associate professor of pediatrics at the University of Rochester
Medical Center in Rochester, New York and Medical Director of the
Monroe County Department of Health's Foster Care Pediatrics clinic. I
also serve on the American Academy of Pediatrics' Committee on Early
Childhood, Adoption and Dependent Care.
The Academy has a deep and abiding interest in the health care
provided to children in the child welfare system. In fact, the Academy
has published numerous policy statements, clinical guidelines, and
studies regarding children in foster care, including a 170-page
handbook for pediatricians on health care standards for children in
foster care. I was proud to chair the District II Task Force on Health
Care for Children in Foster Care, which authored that resource manual.
The 540,000 children in foster care comprise one of many vulnerable
populations to which the Academy urges special attention in the
provision of health care. Compared with children from the same
socioeconomic background, children in foster care have much higher
rates of serious emotional and behavioral problems, chronic physical
disabilities, birth defects, developmental delays, and poor school
achievement.\1\ Typically, these conditions are chronic, under-
identified, and under treated, and they have an ongoing impact on all
aspects of their lives, even long after these children and adolescents
have left the foster care system.\2\ As a result, children in foster
care warrant special attention in all aspects of their health care.
---------------------------------------------------------------------------
\1\ Committee on Early Childhood, Adoption and Dependent Care.
``Health Care of Young Children in Foster Care.'' Pediatrics, Vol. 109,
No. 3, March 2002.
\2\ Task Force on Health Care for Children in Foster Care.
Fostering Health: Health Care for Children in Foster Care. 2nd ed.
American Academy of Pediatrics, 2005.
---------------------------------------------------------------------------
One aspect in which children in foster care deserve particularly
close and special consideration is their inclusion in clinical trials.
It is the position of the American Academy of Pediatrics that drugs
must be studied in children to determine their safety and efficacy in
this age group. Indeed, the Academy considers it a moral imperative to
formally study drugs in children so that they can enjoy equal access to
existing, as well as new, therapeutic agents.\3\ Research participation
is often beneficial to the participants, and may allow them access to
care they could not otherwise receive. Therefore, children in foster
care, as a population that tends to have a greater preponderance of
special health care needs, should be afforded the same opportunities
and access to safe and effective treatments. However, special
consideration is necessary when allowing children in foster care who
are in the care and custody of the state to take part in certain
studies that may contain greater than minimal risk to the child.
---------------------------------------------------------------------------
\3\ Committee on Drugs. ``Guidelines for the Ethical Conduct of
Studies to Evaluate Drugs in Pediatric Populations.'' Pediatrics, Vol.
95, No. 2, February 1995.
---------------------------------------------------------------------------
The Academy has developed extensive guidelines and standards
related to the ethical conduct of clinical trials involving children.
The Academy also agrees with the Department of Health and Human
Services' (HHS) regulations governing the inclusion of children in
clinical research (CFR 45 Part 46, Subpart D). For the purposes of
today's hearing, however, perhaps the most relevant standards deal with
consent. Young children are, by definition, incapable of consenting to
medical procedures. Consent must be given on their behalf by a parent,
a legal guardian, or an individual or institution acting in loco
parentis --that is, in the place of the parent.
The Academy's foster care handbook, Fostering Health, dedicates an
entire chapter to medical consents for children and adolescents in
foster care.\4\ States and localities have varying laws and detailed
policies related to the ability of individuals involved in a child's
care to consent to medical care or procedures. Many localities have
convened multidisciplinary teams to determine what is in a child's best
interest when confronted with complex health issues for children in
their care. In general, legal guardianship remains with the birth
parents (a term which includes legal guardians) unless a child is freed
for adoption. There have certainly been cases when children who are in
foster care are enrolled in clinical trials with the full consent of
their birth parents. In certain cases when the birth parents are
unavailable or uncooperative, agencies may approve or seek a court
order for medical procedures--such as participation in clinical
trials--for which written consent is required and which are deemed to
be in the best interests of the child. Once a child is freed for
adoption, the state agency assumes sole responsibility for consenting
for a child's medical care.\5\ In all cases, however, the overriding
consideration must be the best interest of the child.
---------------------------------------------------------------------------
\4\ Committee on Drugs. ``Guidelines for the Ethical Conduct of
Studies to Evaluate Drugs in Pediatric Populations.'' Pediatrics, Vol.
95, No. 2, February 1995.
\5\ Task Force on Health Care for Children in Foster Care.
Fostering Health: Health Care for Children in Foster Care. 2nd ed.
American Academy of Pediatrics, 2005.
---------------------------------------------------------------------------
HHS regulations outline issues of consent: consent must be obtained
from the adult acting legally on behalf of the child, and, when
developmentally appropriate, the assent of the child must be gained
prior to participation in any clinical trial. The question, then, for
children in foster care is whether adequate safeguards are established
when consent is obtained for trials that contain above minimal risk to
the child, or when the research does not hold the prospect of providing
direct medical benefit to the child him or herself. For children in the
foster care system, an important safeguard is a special advocate who
can help the foster family or state agency navigate medical issues,
ensure that the child's medical care needs are being met, assist the
child in determining whether or not he or she should participate, and
provide a source of continuity for the child and legal guardians
throughout the duration of the study (section 46.409). Even in cases of
less than minimal risk or studies with prospect of direct benefit, an
advocate, while not required, could play an important role in the
child's support system.
HHS regulations state--and the Academy concurs--that children in
foster care should not be considered for studies which contain the
prospect of greater than minimal risk and in which there is no direct
benefit to the child him or herself (46.406-407). For these studies, it
is only appropriate to consider using children in foster care under
certain circumstances, such as if the research is related to their
status as wards of the state. In other words, they should only be
included when involvement of children in foster care is necessary since
the research aims to answer a question related to conditions
specifically affecting children in foster care. In these rare
instances, it is imperative that an advocate be appointed to act on
behalf of the child for the duration of the study to assist the child
and foster family for the reasons stated above: to navigate medical
issues, ensure that the child's medical care needs are being met,
assist the child in determining whether to participate, and provide a
source of continuity for the child and legal guardians throughout the
duration of the study.
It is my understanding that the subcommittee is concerned by recent
press reports about the participation of children in foster care in
clinical trials of HIV drug treatments that began in the late 1980s.
While attention has been paid specifically to these HIV drug trials,
children in foster care have been known to participate in other types
of clinical trials, including those focused on cancer treatment. My own
professional experience includes a number of cases of HIV-positive
children in foster care in my community who received HIV multi-drug
treatments during late 1980s and early 1990s. When our patients took
these drug combinations, we saw a startling improvement in lifespan and
quality of life. Before the introduction of these combination drugs,
our HIV-positive foster children were literally wasting away before our
eyes. There were some side effects with the drugs, but not that many. I
recall one two-year-old child in particular who was literally dying.
One year after receiving combination therapy, he was essentially
undistinguishable from his healthy peers. He was able to go to
preschool, live in a family instead of the hospital, and have hope for
a longer life. He is still alive today and was adopted by his foster
family.
Mr. Chairman, the decision to enroll a child in a clinical trial is
never an easy one, even in a ``traditional'' family structure. While
the headlines seem to suggest that children in foster care were somehow
singled out as hapless guinea pigs, my experience indicates that
children in foster care are actually less likely than other children to
be considered for participation in a clinical trial. In fact, numerous
barriers exist for children in foster care even to obtain routine
health care and necessary services. Participation in a clinical trial,
where care would be far more complex, is even less likely to occur.
The American Academy of Pediatrics believes that children in foster
care deserve to be offered the same opportunities as other children to
benefit from newer drugs and treatment protocols, especially when a
child's condition is so grave that there are few options available to
them. Indeed, it would be unethical to do otherwise and systematically
deny access to clinical trials that could have saved the lives or
vastly improved the health of critically ill children in foster care.
It is clear that children in foster care are a special population, and
that they deserve additional protections when being considered for
inclusion in clinical trials.
Mr. Chairman and Members of the Subcommittee, I deeply appreciate
this opportunity to offer testimony on behalf of the American Academy
of Pediatrics. I stand ready to answer any questions you may have, and
I thank you for your commitment to the health of the children of our
nation.
Chairman HERGER. Thank you, Dr. Szilagyi. The gentleman
from Colorado Mr. Beauprez to inquire.
Mr. BEAUPREZ. Thank you, Mr. Chairman. Doctor, let's just
start with you, if I might. I am intrigued by your testimony
and especially, I think, your closing assertion that the very
children that may need the opportunity to participate in these
trials, may need good health care in general, are ones that,
perhaps, are being denied, foster children. I am concerned that
perhaps in our zeal to do something, we maybe do too much.
Congress sometimes can do that. If you can enlighten me a
little bit, what maybe should we be doing; and even more
specifically, since we're focused on HIV/AIDS, and that seems
to be a situation that occurred quite a few years ago, tell me
from what you know, and you would appear to be a pretty good
expert at this, what sort of clinical trials are going on
today? We're talking a lot of about what went on 10 or 15 years
ago. What is going on today, and what, in your opinion, should
Congress do?
Dr. SZILAGYI. Are you asking me about specifically what
clinical drug trials or what types of trials?
Mr. BEAUPREZ. What type of trials?
Dr. SZILAGYI. I think most of the research that is centered
on children in foster care from the health perspective now has
to do with mental health interventions for children, and
possibly developmental interventions for children; visitation,
mentored visitation interventions. I put those in health
because I look at health as a very global issue for children in
foster care. There are still occasionally children who might be
enrolled in a drug trial, but those are usually children with
rare illnesses, childhood cancers that haven't responded to
more traditional therapies, and that they be offered the same
opportunity as any other child to become involved in a
therapeutic drug trial, that may be their own only last best
option for life. That is an extremely rare event. It has
happened--I have taken care of probably close to 9,000 children
in foster care over the last 19 years of my practice, and, you
know, that number--those faces change all the time because of
the nature of my practice. I have really only had occasion to
have that situation outside of the HIV situation come up
probably two other times. So, it is not--you know, we don't
have vast numbers of children involved in these randomized
controlled clinical trials.
Mr. BEAUPREZ. Ms. Harris, near the end of your testimony, I
think it is on page 4 of your written testimony, you outlined,
I believe, six different criteria for a child--a foster care
child to be included in a clinical trial. Are any of those--do
all of those have to be met in the affirmative in order for a
child to be included?
Ms. HARRIS. Yes, as stated.
Mr. BEAUPREZ. Which raises, actually, another question, and
I fully understand and appreciate how we could get to that
point. Another concern I actually had raised to me about the
very point you're talking about, about making these kind of
opportunities available, not precluding foster children from
the population, is that perhaps in our concern about making
sure the wrong thing doesn't happen to the wrong child for the
wrong reasons, that by an abundance of regulations and hoops to
jump through we actually do just that; that it is not a very
attractive target--a very attractive population, excuse me--a
very attractive population to even look at for clinical trials
because of the regulation burden we put in front of them.
Ms. HARRIS. Well, my guess is that most of these criteria,
with the exception of appointing an advocate, would be
applicable to all children that are going to be involved in
medical trials.
Mr. BEAUPREZ. So, in my case, if it were one of my
children, it would be another advocate. Would there--since I am
the parent, the biological parent, I have legal custody, we
wouldn't be setting up another hurdle, would we?
Ms. HARRIS. No, not with respect to the advocate.
Mr. BEAUPREZ. I am not suggesting the advocate go away.
Actually, Dr. Fleischman, I wanted to pursue that a little bit
with you. What exactly did you do in the Bronx? I want to be
sure and ask, I think, two related questions: Why is this-- if
most of this occurred--most of what we read in the press
occurred 10, 15 years ago, why are we just now kind of hearing
about it? It is being brought to light, and I think HHS
regulations neither preclude now nor mandate certainly that
there be any payment made, but are you familiar with payments
ever being made; and, if so, who gets paid for these clinical
trials?
Dr. FLEISCHMAN. The why now question, I think you're going
to have to ask people other than myself. I have no idea why
now. I find no rational reason for what I thought was a
rewriting of history in much of the media circus. In terms of
the question of why, what we did in the Bronx, we did appoint a
physician advocate who was in one of our public hospitals to
share his views on these trials with each of the foster
families, and we did use his expertise to help the foster
families, help decide whether the child ought to be in the
trial after the other steps had been gone through of
individualized consent from the agency, legal guardian or
parent, review. This was an adjunct, an added thing, that we at
the Albert Einstein College of Medicine felt was important. In
terms of the payment, families who enroll children in clinical
trials generally do receive some compensation for their efforts
in bringing the child to the clinic; transportation, time away
from work, things of that sort. To my knowledge, there were no
dollars in true payment for using children or commodifying
children in such clinical trials, and most IRBs would not
tolerate such.
Mr. BEAUPREZ. Good.
Chairman HERGER. The gentleman's time has expired.
Mr. BEAUPREZ. Thank you, Mr. Chairman.
Chairman HERGER. The gentleman from Washington Mr.
McDermott to inquire.
Mr. MCDERMOTT. Thank you, Mr. Chairman. As I listen to this
panel, I come away with a question. I guess it sounds like in
Wisconsin you wouldn't get into a clinical trial like this; is
that correct?
Ms. HARRIS. With foster care children as a class. We are
not saying that we don't think foster care children should be
eligible for clinical trials. If they are eligible, they should
be treated as any other child and have parental consent or
consent of the legal authority that has legal custody of the
child.
Mr. MCDERMOTT. I asked my staff after I listened to all of
you, why are we here? Not exactly Mr. Beauprez's question. I
read these articles from the Newsday and from the New York
papers that covered this issue. I tend to agree with Dr.
Fleischman. There seems to be a--this was a long time ago, and
a whole different scene. What I would really like to hear from
you, you all are advocates for children, all of you. Is there
anything that we should do to make a uniform system across the
country so that there is no real magical difference? This whole
question about should we override what goes on at the State
level, is that a good idea in this area? Or do you see
something where there is a Federal role that we should do? None
of you made any recommendations. I don't know whether that was
because you didn't have any or didn't think there should be any
changes, or it was all perfect out there. So, Dr. Fleischman?
Dr. FLEISCHMAN. I, individually, myself, had three
opportunities through service to the government to review the
regulations for children, and in each of those times, we felt
those regulations were adequate. The National Bioethics
Advisory Commission, Dr. Shalala, Secretary Shalala's Human
Research Protections Advisory Committee, and the now
Secretary's Advisory Committee have all suggested, as well as
the IOM Institute's reports, the Institute of Medicine reports,
all suggested that we would benefit in this country, not
specifically in the foster care, only in foster care, in a
basic data collection system that would assist us in
understanding who are the subjects of research in our country,
what are the criteria that IRBs are using in approving
research, and what are the outcomes based in those research
studies. The Office of Human Research Protection has not
requested that. They feel, I believe, that they don't have the
authority to do that. I don't speak for them, but we would be
well served by having a database that at least gives us the
baseline information about such. That is one. Two, all of those
groups have recommended that there be expertise in pediatrics--
you can call it advocates or experts in pediatrics--on any IRB
that is reviewing things related to children. It isn't required
in the regulations. It could be strongly urged, or it could be
required. All of those learned groups have made those
recommendations, and I believe for the most part IRBs fulfill
those recommendations. In these cases, since these were--these
research prospects were in AIDS clinical trials centers,
centers of excellence in our cities, all of those IRBs had
advocates for children and had children's experts on them. In
general, if we are looking to fix, or help, or support the
present regulatory structure of the data collection system and
expertise in the areas related to the kinds of subjects who are
being reviewed like prisoners, or children, or mentally ill
people, or retarded people, or people of any variety----
Mr. MCDERMOTT. Any of the others of you have a comment?
Dr. SZILAGYI. I probably have a broader perspective on the
whole issue of health care for children in foster care than the
more narrowly defined. I agree with everything Dr. Fleischman
said. Let me start there. I think that children in foster care
have huge health care needs. Forty-five percent of them have
chronic medical illness. Sixty percent of children under the
age of 5 have developmental disabilities. Forty-five percent of
our school-age children are in special education placements,
and eighty percent of children over the age of 4 have mental
health needs. Their access to health care services is abysmal
in this country. There are multiple barriers. One of you asked
about barriers before. Those barriers include their high
mobility in and out of the system; the high mobility of
professionals in the system; Medicaid as a funding resource,
which, while it offers some benefits in terms of routine
preventive care, is a barrier to many other types of care. The
whole system is underfunded and under-resourced, and I would
suggest that every child in foster care deserves to have a
medical home where they receive high-quality care that is
comprehensive, well-coordinated, and that works very closely
and in collaboration with the child welfare system. I think
that that would afford a high level of protection in terms of
enrolling children in clinical research trials. In our
community, whenever a question comes up about an end-of-life
issue for a child, a surgical procedure that is being offered
to a child, bone marrow transplant or child with cancer who
needs a more advanced protocol than is currently available as a
standard of care, those questions come back to our office where
we are the primary care doctor in the medical home. I think
trying to change the whole system of care for our kids so that
it was much more modeled on a medical home model would go a
long way toward preventing these types of issues.
Dr. FLEISCHMAN. Well said.
Mr. MCDERMOTT. If the Chairman would just give me 1 more
second. The database you are talking about, I remember when I
did some research when I was in my residency, and I found the
databases could give me two left-handed plumbers living in
towns of less than 20,000 people. Are you suggesting a national
database for all health care data so that we would then have
that capacity to do that kind of research? Do you think
politically that is possible?
Dr. FLEISCHMAN. No. I am suggesting that we have a database
on all subjects of research in this country.
Mr. MCDERMOTT. Oh, just research.
Dr. FLEISCHMAN. That we ask IRBs to review research, and we
ask investigators to tell IRBs and then tell the government how
many subjects, what was the kind of research, what were the
criteria in which the IRB reviewed the research, and move
forward with it.
Mr. MCDERMOTT. Thank you, Mr. Chairman.
Chairman HERGER. Thank you. The gentleman from California
Mr. Becerra to inquire.
Mr. BECERRA. Thank you, Mr. Chairman. Thank you all for
your testimony. I want to go back to the gentleman of
Washington's question, because I think it is the correct one.
Is there something we should be doing? My sense is that we are
trying to find out if there is this purgatory where children
are where it is not clear if they really should participate in
these clinical trials, and we are concerned that they actually
may be used as a commodity in some of these clinical trials. I
am not sure if you have answered that question for us to leave
us with a feeling that there is something we can do, or we
needn't do anything. So, if you can give us some clarity, is
there something we should do? If you say yes, please try to
give us a specific.
Ms. HARRIS. I think one of the questions that comes to mind
is is the determination of whether research carries minimal
risk and the child would directly benefit subjective? Who makes
that determination? What are the criteria? That is one of the
questions I think that is unanswered, and that was sort of
central to some of the HIV/AIDS research.
Mr. BECERRA. Before anyone goes on, Ms. Harris, let me ask,
are you saying then that Wisconsin, since you are more
restrictive than other States, and I think my State of
California is also very restrictive in requiring some judicial
order to allow a child, a foster child, to participate, are you
saying that there is a concern that, in fact, there might be a
problem in protecting that child sufficiently through the IRB
process without a child advocate?
Ms. HARRIS. Yes, and if there is, if there is, that right
now within the IRB process, there is lack of clarity with--in
that determination.
Mr. BECERRA. Thank you.
Ms. SPEERS. I would suggest three items. One is to just
reinforce what Dr. Fleischman suggested, which is any IRB that
is reviewing research involving children, that IRB should have
expertise in pediatrics; but more than just pediatrics, in the
interests of children so that it might not be a pediatrician.
It might be a social worker. It might be an individual school,
someone who understands the needs of children. That is not a
requirement in the Federal regulations at this time. Secondly,
the additional protections pertaining to children in Subpart D
are not universally adopted across the Federal agencies that
conduct or sponsor human research. Subpart D is followed by the
Department of Health and Human Services. It was added in 2001
to the Food and Drug Administration regulation.
Mr. BECERRA. Who else would be part of that, what other
agencies?
Ms. SPEERS. There are 16 other agencies.
Mr. BECERRA. Can you give us those you believe should fall
under the jurisdiction of Subpart D?
Ms. SPEERS. I want to say also that the Department of
Education does have Subpart D. Those are the three that do, but
the other ones, in particular one is the National Science
Foundation.
Mr. BECERRA. Do me a favor. If you could just submit those
so that way you can get to your third part, because otherwise I
am going to run out of time.
[The information was not received at time of printing.]
Ms. SPEERS. The third is I wanted to suggest that there
should be an education requirement for IRBs. IRB members now
have no education requirement under the Federal regulation. It
would be much easier for IRBs to follow the regulations and
understand the regulations if they had some type of education
requirement.
Mr. BECERRA. Dr. Szilagyi, I hope I pronounced that
correctly, do you have anything you would like to add?
Dr. SZILAGYI. No.
Mr. BECERRA. A quick question then before I run out of
time. Is there any standard throughout that is applied, that
should be applied, a best practices standard that we could use?
Ms. HARRIS. I am not aware of an existing best practices.
Mr. BECERRA. Is it good policy to allow the various States
to come up with what they believe is the best practice for
these decisions in regards to foster children?
Dr. FLEISCHMAN. One very powerful method is that Office of
Human Research Protection has the ability to give guidance to
all IRBs around the country.
Mr. BECERRA. Does it do so?
Dr. FLEISCHMAN. They do. They have not yet done that in
this area. The Secretary has an advisory committee to that
office on human research protection.
Mr. BECERRA. Should they do so?
Dr. FLEISCHMAN. I believe they should, as well as to
clarify for Ms. Harris the definitions of minimal risk, and
minor increase over minimal risk, and prospect of direct
benefit, which the Subcommittee on children has already
provided and requested that a guidance be produced.
Mr. BECERRA. One last question as my time runs out. If the
best interest of a child is not upheld, who should be
responsible?
Dr. FLEISCHMAN. Everyone. Starting with the investigators,
starting with those people in agencies who are responsible for
those children, and going back toward the IRB, the institution
that conducted that IRB. Ultimately, at the Federal level,
there is some responsibility. The real responsibility stands at
the local level.
Mr. BECERRA. Anyone else?
Chairman HERGER. Thank you. The gentleman from California
Mr. Stark may inquire.
Mr. STARK. Thank you, Mr. Chairman. Just a couple of
comments. Dr. Szilagyi, I am a little bit concerned. I
appreciate your idea that it is through experiments, and the
poor children can get health care, but I wonder is it right in
this country, and this is just an aside, should they have to be
guinea pigs to get health care? I think that is wrong.
Dr. SZILAGYI. I don't believe I said that.
Mr. STARK. Well, you didn't say that. To me it implies
that. One of the good things about getting foster children into
these programs is that they wouldn't get health care otherwise.
I am suggesting to you that that is a travesty. It is has
nothing to do with these rules, but that is one of the
travesties of having uninsured children.
Dr. SZILAGYI. Then I would like to clarify. What I intended
to say was that for some children in certain circumstances, and
the HIV/AIDS phenomenon of the early 1990s was one of those----
Mr. STARK. Let's move ahead, though. Dr. Szilagyi. ----the
only way for them to get certain kinds of care was actually for
them to be enrolled in studies because that was the only way to
obtain these drugs.
Mr. STARK. Going back, very quickly, and, Mr. Chairman, I
ask unanimous consent to put both subpart C and subpart D of
45(c) in the record.
[The information was not received at time of printing.]
Basically, there is a difference. Young was wrong. There
are additional protections for prisoners; and basically, if I
can just paraphrase in the time allowed, it says that all
regulations relative to prisoners will be enforced regardless
of other regulations in this subpart. It goes on to say that
because prisoners may be coerced, they have got to have an
advocate; yet subpart D for kids, and that is not there. There
is in my mind a question. If you still had an Eloise Anderson
around someplace, she would sacrifice children for--you don't
know who she was, do you? You dumped her from Wisconsin, did
the California, thank you very much, send her back and give you
three free kicks. There is a question that perhaps foster
children are--present company completely excepted--you and the
Committee are an easy target because they are there, and they
may not have to go through as much pleading with the parent and
explaining because it is a much more institutionalized group of
children, and you are able to find research subjects in that
population. That worries me. It would be a simple thing, it
seems to me, for us--what is good enough for Haldeman,
Erlichman or Martha Stewart ought to be good enough for my
kids, right? Prisoners can have an advocate required; it
doesn't seem to prohibit us from using prisoners in these
cases. I think maybe we could make some simple changes, which--
in States other than the ones represented here which don't have
such good protection. I think there are some States, Mr.
Chairman, where we find it has been more casual in their
outlook as to how foster children are protected. I don't think
we would impose any great impact or regulatory burden by
considering in this Subcommittee whether we might coordinate
the requirements for prisoners and children. I hope you all
will have staff look at these requirements, and we could ask
the witnesses perhaps to respond to us later whether the
prisoner requirements would unduly hamper research and the
opportunity for children to participate in these programs. Then
we could sleep a little better at night knowing that at least
we put in the requirement, the children would have adequate
advocates in the program. If anybody wants to disagree with
that, that is fine with me, but that is what I am reading here.
Dr. FLEISCHMAN. As long as you are aware of that, the
Office of Human Research Protection has just created the
Institute of Medicine broad-based study on prisoners research,
and the Secretary's Advisory Committee is taking up that issue
as well. There is a broad-based review of research with
prisoners that is going on as we speak. We need to be sure to
coordinate that thinking with whatever thinking you have.
Mr. STARK. I think, Mr. Chairman, with foster kids, they
don't have the complete freedom, just as a prisoner doesn't,
and it is that minor extra protection that we might want to
consider in any legislation that you might consider, Mr.
Chairman. I thank all of you for taking the time, and your
concerns. I thank you all for everything, except Eloise
Anderson. You can have her back.
Chairman HERGER. I thank the gentleman. Ms. Harris, beyond
participation in clinical trials, could you tell me about drug
use of children in foster care more generally? For example, who
decides whether children are to receive medications such as
antidepressants or stimulants, the doctors, foster parents,
caseworkers, all of the above? What do we know about the
medications provided children in foster care; for example, what
share are on medication and for how long?
Ms. HARRIS. I can't speak specifically to certain
medications. We can certainly get that information to the
Subcommittee. The determination is parents retain the rights of
any other parent with respect to children in Wisconsin's foster
care system, unless the parent is incapacitated or for some
other reason incapable of making that decision. Then the court
can grant authority for decisionmaking, either a temporary--
through temporary guardianship through the system. Generally,
even if the child is not physically placed with the parent, the
parent retains the right to make all decisions with respect to
all medical decisions.
Chairman HERGER. Thank you. Dr. Fleischman, the purpose of
this hearing this afternoon is that there has been some very
serious allegations made recently, especially about the
treatment of children in New York City, in clinical trials for
AIDS medicines in the late 1980s and 1990s. These go to race
and whether certain children were targeted because of their
race or their being in foster care. Our purpose today is to
review whether current protections are adequate or not.
Obviously, we are concerned about the allegations that have
been raised. You were not only there, but you treated many of
these children and sat on the Institutional Review Boards,
whose purpose was to determine the propriety of their
participation. Would you care to comment directly about some of
the more inflammatory charges that have been made of late?
Dr. FLEISCHMAN. The charges saddened me. I thought they
were extremely inaccurate; that the doctors, the Institutional
Review Boards and the institutions caring for children with HIV
and AIDS were extremely sensitive to the areas of cultural
sensitivity, race, ethnicity, the concerns of poverty. Our
children, all of our children with HIV, the vast majority, were
from poor families and minority families. We were very
sensitive to those issues. The IRBs were extremely concerned.
We believe we developed procedures that protected their
interests and enhanced their quality of life and their lives in
general.
Chairman HERGER. Thank you. I want to thank each of our
witnesses this afternoon for taking the time to appear here
today. I appreciate your help in understanding this issue
further. With that, the Subcommittee stands adjourned.
[Whereupon, at 3:55 p.m., the hearing was adjourned.]
[Submissions for the record follow:]
Statement of Sheila Matthews and Gloria M. Wright, Ablechild.org, New
Canaan, Connecticut
Wards of the State: Protection of human subjects ``Special Population''
Ablechild Background: a non-profit 501C-3 organization whose Board of
Directors consist of doctors, teachers, psychologists, and other mental
health providers dedicated to protecting the health and well-being of
children. These true professionals wholeheartedly support parental
rights, informed consent (full disclosure), and a parent's right to
choose regardless of legal status.We have spoken out on this issue in
many media outlets: CNN Today Show, CBS Evening News, Good Morning
America, Hannity & Colmes, A&E Investigative Reports, Montel Williams
Show, John Walsh Show, Discovery Health Gary Null Show, WXIA TV NBC
Atlanta, NBC Health Page, Time Magazine, New York Times, USA Today, G.
Gordon Liddy Show, Sean Hannity Radio Show, Armstrong Williams Show,
Martha Zoller Show, WDUN, The Riley Report Many Other Shows and
Publications Numerous Websites.
My name is Sheila Matthews and I am a Connecticut mother who
testified before the public health committee on the first law to
prohibit schools from recommending psychotropic ``medication'' to
children as a requirement for attending school. I am also the National
Vice President and Co-founder of Ablechild.org a non-profit national
parent organization that works on educating the public on the issues of
informed consent and the right to refuse psychiatric ``treatment''.
Our organization is very concerned with the outcome of this hearing
because we hear directly from parents victimized by the trafficking of
their children into clinical drug trials while in state custody.
Ablechild has documented cases of children that have been placed on
drugs, completely unaware if they are participating in a clinical drug
trial, and without knowing that they have the right to ``opt out'' of
participating. The fact is, the State holds the responsibility of
providing informed consent to parents and children, and lacks any
procedure to protect and safeguard this right.
A clear conflict of interests exists between the pharmaceutical
industry and the experimentation occurring on children within state
custody. This fact is clearly demonstrated by workshops sponsored by
the pharmaceutical and biotechnology industries designed to optimize
strategies for drug development and trials in children. One such
workshop was held in New Haven, Connecticut on May 19th-21st, 1997 and
brought together representatives of the drug industry, government, and
the academia.
The workshop was specifically designed to focus on ``New Pediatric
Regulations,'' ``Vaccine Development,'' ``Strategies for Identifying
New Gene Targets,'' ``Novel Drug Delivery Systems,'' and ``Neuro-
Behavioral Disorders''. What this workshop failed to focus on was the
informed consent process, the right to refuse process, and the special
rights afforded to the vulnerable population, ``Wards of the State''.
Sponsors included Yale Department of Pediatrics and Yale Child
health Research Center New Haven CT, Yale Child Study Center, New Haven
Connecticut, National Institute of Child Health and Human Development,
and NIH Bethesda, MD. Corporate Sponsors included Bayer Corporation,
Pfizer, Inc., SmithKline Beecham Pharmaceuticals, Biological Division,
Wyeth-Lederle Vaccines, and Pediatrics.
Our organization points out the problems that resulted from
strategies designed to target and exploit these children, strategies
that were highlighted at the workshop in 1997.
The Connecticut Advocate reported these resulting problems in its
June 5th, 2001 article, ``Study Calls for Review of Psychiatric Drugs
Prescribed to Kids.'' Within this news story, the authors of a new
study questioned why 396 children under 4 years old covered by Medicaid
were prescribed psychiatric drugs. Some of these children were less
than 1 year old.
Trafficking children into clinical drug trials is a violation of
basic human rights. Past history of this United States human rights
violation is clearly illustrated by one landmark case, Willowbrook that
was brought to public light in 1987. This case addressed the right to
informed consent of any institutionalized person. It is our hope that
these hearings will reform this human rights violation and uphold their
rights.
______
Ablechild.org
Hendersonville, NC 28791
May 18, 2005
Congressman Wally Herger
2268 Rayburn House Office Building
Washington, DC 20515
Dear Congressman Herger:
As a grandparent and a member and officer of Ablechild, a 501(C) 3
organization, I wish to bring to your attention our cry for the
protection of human rights of foster children across America!
Our organization frequently hears from parents across the nation
that implore us for assistance in the matter of the clinical trial/
experimental drugging of their children while in state custody and in
foster care. These children have been placed on clinical trial drugs
without a legal advocate responsible for safeguarding their health, nor
their life. As minors these children are unable to opt out of these
tests/experiments, the parents have been denied their right to dissent
and there obviously are no procedures in place to safeguard the rights
of the children.
Ablechild is aware of your committee's investigative hearings into
Child Protective Services which was held in March 2004. Wreckless
endangerment of children in the custody of most states across the
nation became fairly apparent during those hearings. Illegal seizure of
many children was noted. Methods used and justification to seize
children from the safekeeping and love of their parents and thus
placing them in foster care was well exposed at that time. Now these
very children are being forced into clinical trials--or
experimentation--while being forced to SURRENDER THEIR HUMAN RIGHTS
while at the same time endangering their present/future health.
Congressman Herger, Ablechild calls upon your committee to enact a
law whereby all pediatric clinical trials, without express consent of
the parents, be prohibited. This law should include children in foster
care and should not preclude those children who are at home with their
parents or custodial family members. Congressman, the importance of
such legislation goes beyond the giving of a pill to a child. This
matter is about Human Rights--and those rights of children have been
gravely sacrificed and the health and future of these children may have
been imperiled.
Ablechild stands ready to support you and your committee on behalf
of America's children and we would appreciate having dialogue with you
and/or your committee members in this matter and others that greatly
impact our America's children and their families.
Sincerely,
Gloria Wright
NC Vice President
Statement of Vera Hassner Sharav and John H. Noble Jr., Ph.D., Alliance
for Human Research Protection, New York, New York
On March 10, 2004, The ALLIANCE FOR HUMAN RESEARCH PROTECTION
(AHRP) filed a complaint with both the Food and Drug Administration and
the federal Office of Human Research Protection (OHRP) when we learned
that 36 Phase I and Phase II AIDS drug experiments had been conducted
on infants and children who were under the guardianship of the New York
City Administration for Children's Services (ACS). The children were
living at Incarnation Children's Center, a foster care facility under
contract with ACS and the Catholic Archdiocese. We had reason to
believe that the experiments were unethical, illegal, and coercive--and
that federal regulations have been violated. We did not know at the
time that children in foster care nationwide were subjected to research
exploitation at prestigious medical research institutions.
Historically such children have been abused and exploited in
medical experiments--for that reason, federal regulations were enacted
to restrict the use of foster care children in research. The Associated
Press confirms that for more than two decades, government officials
colluded with hospitals and researchers to facilitate the enrollment of
children who were in the care of the state for experimental drug
trials. Nationwide, an estimated 698 to 1,388 foster children were used
to test experimental AIDS drugs--at least 465 of those children were in
the care of NYC's ACS--almost all were children of color. How ironic it
is that children, who were placed by the courts into the protective
custody of foster care agencies pursuant to the provisions of the
Adoption and Safe Homes Act of 1997, should end up further victimized
by their caretakers.
These children were exposed to pain, risks, and potentially harmful
experimental drugs--the children suffered, some died. In some cases the
children were diagnosed with HIV infection--in other cases infants were
merely ``presumed'' to be HIV-infected.
The Code of Federal Regulations (45 CFR 46.409 and 21 CFR 50.56)
prohibits subjecting children who are wards of the state to experiments
involving greater than minimal risk:
(a) Children who are wards of the State or any other agency,
institution, or entity can be included in research approved under
46.406 or 46.407 only if such research is:
(1) related to their status as wards; or
(2) conducted in schools, camps, hospitals, institutions, or
similar setting in which the majority of children involved as subjects
are not wards.
(b) If the research is approved under paragraph (a) of this
section, the IRB shall require appointment of an advocate for each
child who is a ward, in addition to any other individual acting on
behalf of the child as guardian or in loco parentis.
The advocate shall be an individual who has the background and
experience to act in, and agrees to act in, the best interests of the
child for the duration of the child's participation in the research and
who is not associated in any way (except in the role as advocate or
member of the IRB) with the research, the investigator(s), or the
guardian organization.
The Phase I and Phase II experimental drug and vaccine trials in
question were unrelated to their status as wards--the NYC-ACS
enrollment guidelines applied to foster care children only. The ACS
guidelines falsely stated that the trials posed ``minimal risk,'' and
the guidelines clearly focused on facilitating rapid enrollment of as
many foster children as possible--rather than ensuring that the trials
were in the children's best interest: [Attached]
``ACS will review clinical trial protocols for HIV-infected
children as soon as such protocols become available, before a specific
hospital decides to participate in the study. The National Institutes
of Health (NIH) and pediatric AIDS specialists throughout New YorkState
will make ACS aware of protocols as soon as they are in final form,
before hospitals are ready to enroll children. This procedure will
expedite ACS' decision-making even before physicians are ready to start
treating children in the protocols.''
The Associated Press confirmed our suspicion that most of the
children in the care of ACS did not have a personal advocate--as
required under federal regulations. Indeed, of the 465 NYC children in
the experiments, only 142 had an advocate. Furthermore, ACS even waived
the requirement for individual consent for these children--encouraging
them to be herded en masse into drug trials as if they were animals.
Phase I and Phase II drug experiments involve the highest level of
risk, uncertainty, and discomfort--the safety and toxicity of drugs as
well as maximum dose tolerance are tested in these trials. Experiments
at that testing stage are unlikely to have any direct benefit for the
children in whom the drugs are tested. In some trials children were
diagnosed with HIV infection--in some cases infants were merely
``presumed'' to be HIV-infected:
#292: A Double-Blind Placebo-Controlled Trial of the Safety and
Immunogenicity of a Seve n Valent Pneumococcal Conjugate Vaccine in
Presumed HIV-Infected Infants
#345 A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive
Infants and Children, last amendment 3/13/2000.
``Replacement infants . . . are either presumed HIV infected or
have already been shown to be HIV-infected . . .''
Infants and children were exposed to experimental HIV vaccines--
which have never been successful:
#218 A Placebo-Controlled, Phase I Clinical Trial to Evaluate the
Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-
1gp160 and gp120 in Children >=1 Month Old with Asymptomatic HIV
Infection.
Although more than 4 AIDS drugs had never been tested in children,
foster care children were exposed to an 8 drug cocktail ``some at
higher than usual doses'' (which was reduced to 7 drugs because of
``significant toxicity'' 11/9/2001).
#1007 Multi-Drug Antiretroviral Therapy for Heavily Pretreated
Pediatric AIDS Patients: A Phase I Proof of Concept Trial
Among the drugs tested in foster care children, is Nevirapine, a
drug whose safety has been the center of controversy. [AP] Because
Nevirapine confers resistance following even a single (low) dose, its
manufacturer cautions that its use should be restricted to ``previously
untreated women with HIV infection who present at labor'' for the
prevention of mother-to-child transmission of HIV. Yet, 4 to 17 year
old children in foster care were exposed to Nevirapine.
A Phase I trial of a Glaxo Wellcome drug, Valacyclovir
hydrochloride was terminated in 1997--Why? Typically, trials terminated
at such an early stage show unacceptable levels of toxicity.
The Associated Press reported: ``Some foster children died during
studies, but state or city agencies said they could find no records
that any deaths were directly caused by experimental treatments.'' It
is not for those city agencies to decide the cause of death. ACS
Commissioner, John B. Mattingly, testified before a City Council
General Welfare Committee, that he knows of just 19 children--out of
465--who remain within the NYC foster care system.
In addition, a series of recent investigative mediareports from
Texas, Florida, Ohio, New York, California, Illinois, raise concerns
that over 50% of all children in foster care are currently being
prescribed untested, experimental combinations of powerful, mind
altering, psychotropic drugs--including antipsychotics (e.g.,
Risperdal, Zyprexa), anticonvulsants (e.g., Depakote, Neurontin),
antidepressants (Zoloft, Paxil, Prozac, Celexa and others),
tranquilizers (Klonopin, Xanax), stimulants (Ritalin, Adderall), as
well as heavily sedating drugs such as the anti-hypertensive medication
clonidine. These prescribing patterns are essentially uncontrolled
experimental drug trials. [See: The Columbus Dispatch series by
Encarnacion Pyle. Forced medication straitjackets kids, Sunday, April
24, 2005 http://www.dispatch.com/reports-story.php?story=dispatch/2005/
04/24/20050424-A1-00.html.
Clinical trials approved by the FDA study only a *single* drug
given in tightly controlled dosages. Combinations of two and three or
more different psychotropic drugs have simply never been studied in a
rigorous and responsible manner. Furthermore, the foster parents and
social workers who are mostly entrusted with supervising these children
have less than rudimentary knowledge about these drugs' adverse
effects, and even less skills in monitoring these children to avoid
dangerous drug reactions. This is of course less than the protection
afforded subjects in ordinary clinical trials. It is worth repeating:
none of these idiosyncratic drug combinations--called polypharmacy--
have ever been studied by any responsible government or other agency,
and the children receiving them may be considered guinea pigs in a
gigantic uncontrolled medical experiment.
How can the Congress fail to take strong corrective action?
The public has a right to know:
How many children in foster care have been enrolled in
clinical trials?
What happened to foster children who were used as human
guinea pigs?
What adverse effects did the children suffer during and
after participation?
How many children died during the experiments?
A question has been raised about the size of the cemetery
plot in which children in ACS custody are buried: Were any children
buried in mass graves?
What were the specific sources of funding for these Phase
I and Phase II clinical trials?
Did the foster care agencies or foster families receive
payment, fees, or other rewards for enrollment of the children in these
trials?
How much money was paid to the researchers and
participating hospitals?
What happened in 2001 that the AIDS drug trials in foster
children were stopped?
What other drug trials are being conducted on foster
children?
The other questions we pose below suggest that there may have been
a breakdown in the implementation of the Adoption and Safe Families Act
and/or related federal law governing the protection of children in
foster care. Our questions, by extension, suggest that the Council on
Accreditation of Family and Children Services (COA), and one of its two
founding organizations, the Child Welfare League of America (CWLA), may
not be meeting their obligations.
Child protection falls within the purview of the juvenile and
family court system, which remands abused and neglected children into
the care of public and private, non-profit foster care agencies. In our
view, the courts have ultimate jurisdiction and responsibility for what
happens to these vulnerable children.
The Congress may want to consider a dual approach in dealing with
the issues at hand. Child welfare laws operate by regulating the care-
givers. Child abuse reporting laws, for example, require health,
school, and social service personnel to report suspected child abuse.
If such laws were to define ``suspected child abuse'' to include
enrollment of foster children in Type I and Type II clinical trials, in
violation of the protections afforded by 45 CFR 46.409 and 21 CFR
50.56), there would be many more eyes watching to protect children from
overreaching biomedical researchers who, history has shown, have abused
their authority to exploit children in foster care.
Were there violations of the provisions of the Adoption
and Safe Families Act and/or related child welfare legislation by
officials of the foster care agencies that permitted enrollment of
foster children in Phase I and Phase II clinical trials?
Should not the supervising foster parents and/or social
workers have reported suspected child abuse in these high risk, Phase I
and Phase II clinical trials of experimental drugs and vaccines?
What training, if any, is provided to supervising foster
parents and/or social workers about the conditions that must be
satisfied by reference to 45 CFR 46.409 and 21 CFR 50.56 in order to
justify enrollment of foster children in ANY biomedical research
involving greater than minimal risk?
Is there a need for new federal legislation that would
amend the Adoption and Safe Families Act and/or 45 CFR 46.409 and 21
CFR 50.56 to expressly define children in foster care a ``protected
class,'' whose enrollment in ANY biomedical research would trigger
appointment of an independent research ombudsman under the supervision
of the juvenile or family court that remanded the foster child into
state custody?
Finally, if, as we argue, the courts have ultimate jurisdiction and
responsibility for what happens to children whom the courts remand to
the protective custody of state and private, non-profit foster care
agencies, then the Congress might wish to consider amending the
existing requirement for the appointment of a child advocate by the IRB
pursuant to 45 CFR 46.4.09 and 21 CFR 50.56 to require instead that the
child advocate be appointed by and be held accountable to the court of
original jurisdiction for foster children who may be subjected to
biomedical research involving greater than minimal risk. The courts, we
believe, are the last recourse that foster children have to protect
them from the predatory practices of those who would exploit and take
advantage of their vulnerability. We should remind ourselves that the
measure of a society is how it treats its most vulnerable citizens.
Statement of Cheri Carlene Campbell, American Family Rights
Association, Morongo Valley, California
This information has been assembled to help equip those attending
[and those who will influence the outcome of] the hearing on June 9,
2005 in an effort to protect the greater society. You must look closely
at the problems surrounding Dept. of Children's Services [DCS] to
discover that the real problem has nothing to do with how funding is
related to outcomes for children. It is your moral duty to find a
solution to this Nationwide dilemma which has been plaguing America for
decades.
On March 13, 2004 U.S. Congressman Joe Baca gave the victims of DCS
a voice and sent 163 evidence books to Washington. The people need to
know what our elected officials have done to protect us and our
Posterity since receiving the documents proving the ministerial
ineffectiveness of DCS.
Victorville, CA--Daily Press: ``United States Accuses 14 Nations of
allowing Modern Day Slavery'' reads: U.S. criticizes 14 other nations
of not doing enough to stop the modern day slave trade (prostitution,
child sex rings, and forced laborers) involving 800,000 annually.
Condolezza Rice stated, ``The U.S. has a particular duty to fight this
scourge because trafficking in persons is an affront to the principles
of human dignity and liberty upon which this nation was founded. U.S.
spends $96 million to help other countries combat trafficking.'' The
U.S. is not included on the list although R. Miller said the country is
far from immune . . . and includes the U.S.--June 4, 2005
American children and their families are the victims I speak of.
Children are routinely seized by DCS agents who blatantly violate Laws
in place to protect the familial bond which include the California and
U.S. Constitutions! DCS hides their practices under the confidentiality
clause, which was designed to protect families receiving public
assistance from embarrassment, not hide their devious practices. DCS is
a Government sanctioned agency that receives federal and state funding
in advance for obtaining children, which clearly makes this a problem
for each branch of Government.
I agree with Congressmen Herger who believes there should be better
outcomes for the safety and well being of our children. However, even
after thousands of complaints from victims of abuse under color of law
by DCS, our elected officials continue to look for a solution in the
wrong place.
Congresswoman Nancy L. Johnson shared the reasonable solution of
frontloading the money to help keep the family in tact. This would not
only save the government billions of dollars, it would effectively
spare the greater society a whole generation of shattered children and
adults who have no confidence whatsoever for those in authority.
The problem is multi-faceted and although they appear to be
complex, these issues are simple to correct. Cross references from
legal authorities have been used to substantiate the current immoral
practices and motives used to obtain, detain and adopt our children
without Due Process which include: California Benchguide [CAB] 100
Juvenile Dependency Initial or Detention Hearing--revised 2003; Welfare
and Institutions Code [WIC]; California Rules of Court [CRC]; CA Dept.
of Social Services Manual--Child Welfare Services Program [CWS]; Family
Code [FC]; National Association of Social Workers--Code of Ethics
[NASW].
Removal of a child: Federal Law mandates there must be a court
order or voluntary surrender. Cathy Cimbalo [San Bernardino Director of
DCS] states her social workers must have the agreement of a police
officer and a court order. When I offered to show the court order
during the unjust removal of our grandchildren, Deputy Porter stated
``I don't care what papers you have, we're taking the children!'' Out
of thousands of `removals,' no victim has ever seen a court order and
they have not voluntarily surrendered their child! In fact, many have
been arrested for verbally trying to dissuade the police officer during
the unjust removal of their children! CWS 361(b) no dependent child
shall be taken from his parents/guardian where he resides unless the
juvenile court finds clear and convincing evidence of: (1) substantial
danger; no reasonable means child can be protected without removing
him; WIC 300(e) [child has suffered severe physical abuse] shall
constitute prima facie evidence minor can not be safely left in custody
of parent/guardian with whom the minor resided at the time of injury.
Most children have no injuries, which is proven during the medical exam
performed after removal. This exculpatory evidence is deliberately
withheld, and is punishable pursuant to Government Code 820.21 which
strips away supposed immunity! CAB--100.9 Initiating the Hearing--If
the social worker determines that the child is to be detained, a
petition must be filed with the Juvenile Court [JC] clerk, who must set
the matter for hearing on the detention hearing calendar . . . WIC
311(a) Filing petition for retention of custody . . . Confrontation by
and cross-examination of witnesses [Due Process] Most [if not all]
parents/guardians do not contest due to threat [``if you contest
termination of guardianship, your children will be separated, adopted
out and you'll never see them again!''], duress and coercion; CRC
1442(b)--Time limit on custody, filing petition--A detained child must
be released within 48 hours . . . if no petition has been filed. The
contents of the petition are prescribed by WIC sect. 332--A petition to
commence proceedings . . . to declare a child a ward or a dependent
child of the court shall be verified . . . and CRC 1407--The petition
shall be verified and may be dismissed without prejudice if not
verified. An unverified petition may be dismissed without prejudice.
The laws are in place, but they are constantly violated! An internal
review is DCS' only watch dog, as they claim confidentiality prohibits
`outside' review.
Perverse financial incentive: WIC 319(c) If the matter is continued
pursuant to Section 322 or for any other reason, the court shall find
that the continuance of the child in the parent's or guardian's home is
contrary to the child's welfare at the initial petition hearing or
order the release of the child from custody. CAB JUDICIAL TIP: Failure
to make this finding [contrary to the child's welfare] may cause
permanent loss of federal funding for foster care. Herein lies the
problem: financial incentive; empires being built off the backs of our
children of tender years!
Prima Facie Evidence: Most Americans still trust the Justice System
even though millions of its victims exist. CRC 1445(a) Requirements for
detention--(1) a prima facie [Latin for: at first view] showing has
been made that the child is described by WIC 300 [child abuse, neglect,
etc], (2) One or more of the grounds for detention in CRC 1446 is
found; CRC 1446(a) Grounds for detention--There is a substantial danger
to the child's physical health, or the child is seriously emotionally
damaged and removal is the only way to protect the child. DCS agents
have created ``emergencies'' believing they will never be forced to
prove the petition's allegations. Most court reports and verbage are
almost identical in all cases.
Furthering the destruction of the familial bond without Due Process
is demonstrated in: CRC 1447 Detention hearings; prima facie hearings
(d) [Hearing for further evidence; prima facie case--If the court
orders the child detained, and the child, a parent, a guardian or
counsel requests that evidence of the prima facie case be presented,
the court shall set a . . . hearing within three court days to consider
evidence of the prima facie case, or set a jurisdiction hearing within
10 court days. If at the hearing petitioner fails to establish the
prima facie case, the child shall be released from custody. WIC 321 If
the minor, a parent or guardian or the minor's attorney . . . requests
evidence of the prima facie case, a rehearing shall be held within
three judicial days to consider evidence . . . if [it] is not
established, the minor shall be released from detention. Most victims
do not have a clue these laws exist until it is too late and although
Cathy Cimbalo continues to say ``we must trust the justice system'' and
that her ``460 `professionals' only do what the court says,'' we have
found this to be a deadly combination. Social worker's libelous reports
are not challenged and are `found to be true' at the next hearing, we
are rarely allowed to speak in court and our public defenders do not
defend our rights!
In 2004, the Federal Government provided more than $7 billion in
dedicated funds for child protection. The bulk of these funds [almost
$5 billion] supported children who had been removed from their homes.
All this money spent to ``protect'' those in foster/adopt/group homes
where far too many children have been killed or tortured, proves that
more money is not the solution. Maybe it's time to try a new approach.
Carefully consider what you have read. Our right to fair and honest
government, government accountability to the people, and redress has
thus far been denied. More importantly, our God given inalienable
rights have been violated!
You must invoke the power to open DCS files for the sake of
investigating the current immoral and illegal practices [full Thesis
available connecting the above Legal references]. We the people
nominate expert family advocate Bill Tower and Jane Flickinger at
Pacific Justice Institute as overseers of this Commission.
We have sought redress from the proper chain of command and found
no remedy. San Bernardino [S.B.] County Board of Supervisors were duly
noticed regarding DCS practices of non-compliance to State and Federal
mandates; were informed that DCS' ministerial ineffectiveness is
causing irreparable damage to the greater society; and Chairman Dennis
Hansberger publicly stated 'his hands are tied'. S.B. Grand Jury
received 13 official complaints against DCS via certified mail in 2004
and replied, ``After a thorough review [of complaints, evidence], we
have decided not to investigate.'' S.B. Assistant District Attorney
Mike Risley was given copies of these complaints, but no remedy or
acknowledgement has been given to date.
In conclusion, I must remind you that the U.S. has a particular
duty to fight this scourge. Trafficking in persons is an affront to the
principles of human dignity and liberty upon which this nation was
founded. The following questions remain unanswered: How will this
Government offer a gentle return of our children when the mask is torn
off these ``child protectors''? How many more Logan Marr's will have to
die or be tortured while in the State's care before DCS is completely
reformed and held accountable? June 9th is our granddaughter Rainya's
7th birthday and almost 2 years since we've seen our beautiful
grandchildren . . . today is a great day to start protecting your
constituents!
Thank you for your quick resolve in stopping this egregious silent
epidemic that is now shouting for remedy. Your response, nomination of
Bill Tower and Jane Flickinger to oversee the investigation of DCS and
its inter-related service practitioners, and an outline of remedy will
be expected within 20 days of this communique. We are not just a few
disgruntled people, we are millions that are growing weary. We will not
be comforted for the unjust loss of our Posterity. You must assure the
people that our Nation's officials are going to stop this modern day
domestic terrorism and pledge to restore democracy in our own backyard.
Statement of Linn Asplund, Waterbury, Connecticut
Thank you for considering my testimony. When me son was 10 years
old, he was attending Washington School in Waterbury, CT. He started
having problems in the beginning of third grade, September 1999. He was
being picked on and bullied by the other children. His grades started
suffering and he too started having discipline problems. This bullying
was brought to the schools attention, but it still went on. The
principal suggested a PPT. I agreed and at the first PPT I agreed to
have him tested. I was then told he was ``LD'' (Learning Disabled), but
it `was not that bad.' I told the school I wanted him to go to a school
where they had smaller classes in which he could learn at his own pace
and not be picked on. I knew of schools with such classes. I was denied
this and told by the Special Education Supervisor there was no such
class. Next they told me they wanted him to see a psychologist for a
psychological evaluation, I agreed. I obtained a copy of the
evaluation. My son told the Doctor that he had no friends at school. He
liked it better at home and would wake up repeatedly at night with
thoughts of how to quit school. By this time Dr. Abramavich said my son
was psychotic and needed to be medicated. I refused. The next thing I
knew, DCF (Department of Children and Families) was at my door telling
me the school said my son has special needs that need to be taken care
of. I still refused the psychiatric drugs. I brought him to ``child
guidance'' and was told that he was a normal child.
After several visits form DCF I still refused to drug my son. On
March 16th 2000, I found court papers on my doorstep. In them my
husband and I were charged with abuse and neglect and were informed
that DCF was going to take our son from us. Later that day a social
worker and police officer arrived and took him away.
Two weeks later, DCF placed him in Waterbury Hospital where Dr.
Edwards gave my son Haldol and Attavan--mind altering drugs not
approved for use in children. A few days after this, Dr. Mennessen put
him on 100 mg of Wellbutrin a day; also not FDA approved for use in
children. When I asked Dr. Mennessen why he was giving my son this drug
without my consent, his reply was ``we need a number of cases to get it
FDA approved.'' Some of the side effects I saw were loss of hair, dry &
scaly skin, large hive like rashes and very pale skin. While in DCF's
care my son lost weight and appeared malnourished.
There were numerous, outright lies in the documents that DCF had
from the initial ``anonymous'' report from the school, I can provide
this information and numerous other internal DCF documents regarding my
sons ``treatment'' should you require it. This of course is a very
brief summary of what happened to my family. I finally got my son back
from DCF in August of 2002. This entire nightmare began because I
refused to put my son on dangerous, mind-altering drugs.
Statement of Alexandra Yoffie, Child Welfare League of America
CWLA STATEMENT ON PERMISSIONS FOR CHILDREN IN FOSTER CARE TO
PARTICIPATE IN TREATMENT RESEARCH FOR HIV INFECTION
The Child Welfare League of America and its nearly 900 member
agencies believe every child and youth is unique, has an intrinsic
value to society, and is entitled to have their basic care needs met,
to be nurtured and protected, to heal when harm is done, and to have
the opportunity to develop to his or her potential. Ensuring that each
child receives needed primary and preventive health care is an
essential part of meeting these universal needs.
CWLA's Standards for Health Care Services for Children in Out-of-
Home Care serve as a guide for the delivery of routine and specialized
health services to children in foster care and assert that these
children have human rights that should be protected. Because of the
vulnerability of children in foster care and the responsibility of the
child welfare agency toward children in its care, recognition and
safeguarding of these rights are foremost considerations.
Concerns have been expressed regarding states that have allowed
children in foster care to receive experimental treatments for HIV
infections without adequate safeguards. CWLA's Standards of Excellence
for Family Foster Care Services provide guidance in this area, stating,
``The foster care agency should obtain written consent [for medical
care] from the child's parents, or alternatively, from the court. . . .
Parents should grant written consent for their child's medical care,''
and for those children whose parent's rights have been terminated, the
agency ``should obtain written consent from the courts.'' This
provision applies to all forms of medical care, including treatment for
HIV infection.
Allowing children in foster care to receive experimental drugs for
the treatment of HIV infection without providing an independent
advocate to protect and ensure the child's safety and well-being-, is
contrary to CWLA's Standards for Health Care Services for Children in
Out-of-Home Care and our Standards of Excellence for Family Foster Care
Services.
As of December 2002, 821,470 adults and adolescents, and 8,804
children under age 13, had been diagnosed with HIV/AIDS in the United
States. Many children, particularly those with HIV/AIDS, lack the kind
of health care coverage that would allow them to receive state-of-the-
art medical care. Children in foster care should not, as a matter of
course, be denied access to appropriately reviewed and approved
treatment research. Nonetheless, it is in their best interests for the
parents or guardians and the child, when appropriate, to participate to
the fullest extent possible in the development and implementation of
the health care plan so that each child's unique needs and concerns are
considered in any treatment decision.
We encourage all concerned to take this opportunity to more
comprehensively examine the health care needs of children in foster
care, including those who are disabled or have mental health needs. In
many instances, these children are without adequate care to address
their treatment needs. Priority must be given to providing the advocacy
and protections that would help ensure all children in foster care
receive needed services so they might best heal from the harms of child
abuse and neglect
Jacobi Medical Center
Bronx, New York 10461
May 17, 2005
Congressman Wally Herger
Chairman, Subcommittee on Human Resources
Committee on Ways and Means
To the Committee:
I am currently the Director of Pediatric HIV Services at Jacobi
Medical Center, a member of the NYC Health and Hospital Corporation,
located in the Bronx, New York and have a pediatric HIV provider in the
Bronx for over 20 years. Our program is one of the largest single site
programs in the United States and provides integrated, comprehensive,
multidisciplinary care to HIV infected children and HIV-exposed,
uninfected children as well as integrative care for infected adults and
other family members. As the Director of a recognized HIV Center of
Excellence, our program has worked closely with foster care agencies
and the NYC Administration for Children's Services in managing the
healthcare of infected children in foster care.
In addition, I have been involved in clinical trials involving HIV-
infected children as a member of the NIH funded Pediatric AIDS Clinical
Trials Group (PACTG)as well as a site investigator in clinical trials
sponsored by pharmaceutical companies. I am currently the Chairperson
of the PACTG Primary Therapy Research Action Committee which oversees
HIV therapeutic treatment protocols sponsored by the PACTG and NIH.
I would like to present a brief personal historical synopsis of how
therapies for HIV-infected children have evolved since the first
description of the pediatric HIV-epidemic since its inception in the
early 1980's. At that time, most HIV-infected children entered care as
a result of clinical conditions which resulted from their HIV
associated immunodeficiency. Treatment focused on the child's clinical
symptoms such as anti-fungals for thrush, nutritional support for
weight loss and antibiotics for bacterial infections or pneumocystis
carinii pneumonia (PCP) but without therapies directed at the
underlying illness (now known to be HIV), the immunodeficiency
progressed, the child deteriorated and, frequently, death ensued. For
example, in 1989, I personally attended 1-2 funerals per month for
children or their parents who were in our care.
Late in the 1980's, there were rays of hope as new therapeutic
agents, with limited but real efficacy, began to emerge. Unfortunately,
due to many fiscal, practical and regulatory reasons associated with
drug development for FDA approval, children did not have availability
to these agents for 1-3 years after they were available for use in
adults. The only way for an HIV-infected child to gain access to AZT
(zidovudine, Retrovir) was through a compassionate access protocol
sponsored by the manufacturer, which required an informed consent by a
guardian or parent. While this agent, as monotherapy, has extremely
limited efficacy, for many, especially those who were very ill and
rapidly deteriorating, the alternative therapy was no therapy. I can
remember giving out the first pediatric AZT bottles to children and
their families during our 1989 Christmas party and the joy, tears and
hugs that accompanied this ``gift.'' To the families and children, it
was the first concrete impression that there was hope that this
therapy, or future ones, would significantly prolong lives. At that
time, if there was no mechanism available for obtaining consent, many
children in foster care would not be afforded this therapy, subsequent
therapies and, the hope, for clinical improvement and life extension.
In fact, this hope has been born out as demonstrated by HIV
survival data (both pediatric and adult) throughout the medical
literature as well as statistics from the CDC. On a more local level,
our program is providing care to over 250 HIV-infected children; over
the past 12 months only 1 child has died. Some 50% of children in our
care have ``undetectable viral loads'' which suggests suppression of
HIV replication and, in general, the majority of children in our care,
are immunologically (as measured by CD4 numbers and percentages)
healthier now than they were in 1993. While all therapies have
potential and real toxicities, especially HIV medications, these
children are significantly healthier now than in the past and most are
fully involved in school, after school and other activities shared by
healthy children.
I am in total agreement with the need for well defined systems to
protect the rights of children in foster care systems including the
appointment of an independent advocate for the child. However, I
strongly believe as a health care professional caring for children with
a chronic, life threatening illness, that a reactionary posture in
response to localized cases where some administrative oversight has
been missed would be an ethically unacceptable position for our
society. How can one refuse therapy to a child of a therapy which has
been demonstrated, in rigorously controlled clinical trials, to be
effective, simply because there is no one legally capable of signing
consent for a trial which makes that therapy available? If you are HIV
infected, severely immunocompromised and resistant to all available
therapies, shouldn't society be able to provide a mechanism which
balances the potential for clinical improvement and well-being for this
child with a mechanism that respects their rights as a participant in a
clinical trial? As an HIV clinician, I have experienced the pain and
suffering associated with the lack of access of therapies.
I would also like to quickly comment on some of the allegations
about the content of many of the clinical trials in which children in
foster care may have been participants. In NYC, the ACS had strict
guidelines for approving clinical trials for children: the bottom line
was that the trial had to provide the potential of benefit for that
individual trial. For example, foster children in NYC, in the absence
of maternal consent, were not allowed to participate in the PACTG 219
study which was a long-term, natural history study where data was
collected during regularly scheduled visits. While the result of this
study has benefited HIV infected children, there clearly was no benefit
to the individual child.
However, the Alliance for Human Research Protection listed in their
3/10/05 letter to the OHRP and FDA that foster children were
inappropriately enrolled into numerous NIH-PACTG trials. Included in
this list was PACTG 377 of which I was the co-chairperson. This trial,
a Phase I/II (not purely a Phase I) trial, strategically compared a
number of therapeutic regimens for advancing the treatment of HIV
infected children when contrasted with standard of care. This study was
linked to PACTG 338 which demonstrated that a protease inhibitor
containing regimen was superior to the existing standard of care (two
nuclosides). Importantly, these studies were invaluable as they
contained provisions that the first 8 children in each arm participate
in an intensive pharmacokinetic (pk) evaluation to ensure that the
dosing was appropriate when compared to drug exposure that had been
demonstrated, in adults, to be safe and effective. This component of
the study, which required it to be partially labeled a Phase I study,
protected the study participants as demonstrating the correct dose
prevented the overdosing of children which would lead to increased
toxicity or underdosing the child which would lead to inadequate drug
exposure and rapid development of resistance to that therapy and,
potentially, other agents in that treatment (i.e.; protease inhibitor)
class. These studies clearly demonstrated that children metabolize many
of these agents much more rapidly than adults and that to achieve
equivalent efficacy with adults, drug dosing in children needed to be
higher than one would expect.
In fact, it was data from this study and other studies which were
important in the signing, by President Bush on 12/3/03, the Pediatric
Research Equity Act of 2003 (S. 650/H.R. 2857), which restores the
protections of the Food and Drug Administration's (FDA) 1998 Pediatric
Rule. This legislation was hailed as a necessary safety net for
children.
In addition to ensuring that the dosing was correct (the protocol
provided provisions for dose modification if needed from the pk
evaluation), these studies also contain extensive, real time, safety
evaluations and patient management requirements to protect the health
of children on the study. The information concerning the safety, dosing
and efficacy of therapies included in this study, and others, has
significantly advanced our knowledge about treating pediatric HIV
infection. This information has been essential for advances in care
which have been translated into improved health and survival for
children residing in the developed world. This, I see, every day, when
I walk into our outpatient pediatric HIV clinic and am greeted by
healthy looking, HIV-infected children, adolescents and young adults.
Without early access to therapy for all, including those in foster
care, I do not believe that this would have been possible.
The proper response for future children living in foster care with
chronic, terminal illnesses should not be to have policies which
prohibit and withhold therapies. In 1986, there were only a handful of
people who thought that an HIV-infected child would survive to
adulthood. This is now common in the Bronx.
We just need to be more diligent in ensuring that successful
policies and procedures are in place to protect the rights of these
children. Their rights, however, include having access to therapies
that provide hope.
If needed, I am willing to work with this subcommittee, on this or
any related matter.
Sincerely,
Andrew Wiznia
Director of HIV Services
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland 21205
May 31, 2005
Representative Wally Herger, Chairman
Representative Jim McDermott, Ranking Member
Subcommittee on Human Resources
Ways and Means Committee
United States House of Representatives
Washington, DC
Dear Chairman Herger and Ranking Member McDermott,
We are aware that the Subcommittee on Human Resources of the House
Ways and Means Committee is reviewing the required procedures for
protecting children, including children who are wards of the state,
when they become subjects in research studies. I am writing to describe
briefly the procedures used by the Institutional Review Boards (IRBs)
of this School to ensure that all children, including wards, receive
the additional protections required because of their vulnerable status.
I also wish to convey our strong support for the current federal
regulations that govern research that involves children (45 CFR 46,
Subpart D).
It is the understanding of our IRBs that the principle of justice,
as described in the Belmont Report, requires that all populations,
including children, have the opportunity to take part in research and
to share in its benefits. Furthermore, we support the strong
recommendations of both the American Academy of Pediatrics and the FDA
that research on children is essential in order to determine how new
findings can be safely and most effectively used for their benefit.
To achieve these objectives our IRBs require that children be
included in all of this School's human research activities unless there
are specific scientific or ethical reasons for excluding them.
Following the principle of justice, we also require that all children
have equal opportunity to take part in research unless, again, there
are scientific or ethical reasons for excluding particular individuals
or members of specific groups or populations.
When reviewing proposed research that would include children our
IRBs follow very carefully the requirements of Subpart D to determine
the category of research and the requirements for consent and assent
(46.404, 46.405 or 46.406). The IRBs focus especially on the assessment
of risk to the child and on the prospect for direct benefit for the
child. Our assessment of risk is, if anything, overly cautious in favor
of the child, and the prospect for direct benefit, if any, is
consistently weighed against this cautious assessment of risk. We
believe that the categorizations made by our IRBs are consistent with
the federal requirements and, more importantly, ensure appropriate
protections for each child.
In accord with the position described above, we firmly believe that
children who are wards of the state deserve the opportunity to
participate in research, and especially so when they suffer
disproportionately from the condition being studied, an example being
HIV/AIDS. We would emphasize, however, that wards are not targeted for
inclusion. Rather, their status as wards is simply coincidental to
their being eligible for enrollment in the study. We also share the
view that children who are wards of the state require special
protection because of their uniquely vulnerable situation. We believe,
however, that this is adequately ensured by the requirements outlined
in 46.409, which require an advocate for each child involved in a study
categorized as involving greater than minimal risk and having no
prospect of direct benefit for the child (46.406). In our view,
extending the requirement for an advocate to studies that are greater
than minimal risk but having the prospect for direct benefit for the
child (46.405) would create a substantial barrier to conducting such
studies while providing no clear added protection for the child.
We hope that these comments and our strong support for maintaining
the current federal regulations concerning protection of children will
be of help to the Subcommittee in its deliberations. I would, of
course, be pleased to respond to any specific queries that may arise.
Sincerely,
Alfred Sommer, MD, MHS
Dean
National Institute of Allergy and Infectious Diseases
Potomac, Maryland 20854
May 9, 2005
The Honorable Daniel R. Levinson
Inspector General
U.S. Department of Health and Human Services
330 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Mr. Levinson:
I am writing you in fulfillment of my obligation as a federal
employee of the National Institutes of Health to report possible waste
and fraud under Executive Order 12674 and 12731, and NIH Policy Manual,
Section 1754(C)(1)(a),(b) and (c). Currently I am the Director of the
Office of Policy in Clinical Research Operations (OPCRO) in the
Division of AIDS of the National Institute of Allergy and Infectious
Diseases (NIAID).
On Wednesday, May 4th, the Associated Press (AP) reported:
Government-funded researchers tested AIDS drugs on hundreds of
foster children over the past two decades, often without providing them
a basic protection afforded in federal law and required by some states.
The basic protection denied these foster children was the
appointment of an advocate ``to act in the best interests of the
child,'' as explicitly required by 45 CFR 46.409:
Sec. 46.409 Wards.
(a) Children who are wards of the State or any other agency,
institution, or entity can be included in research approved under
Sec. 46.406 or Sec. 46.407 only if such research is:
(1) related to their status as wards; or
(2) conducted in schools, camps, hospitals, institutions, or
similar settings in which the majority of children involved as subjects
are not wards.
(b) If the research is approved under paragraph (a) of this
section, the IRB shall require appointment of an advocate for each
child who is a ward, in addition to any other individual acting on
behalf of the child as guardian or in loco parentis. One individual may
serve as advocate for more than one child. The advocate shall be an
individual who has the background and experience to act in, and agrees
to act in, the best interests of the child for the duration of the
child's participation in the research and who is not associated in any
way (except in the role as advocate or member of the IRB) with the
research, the investigator(s), or the guardian organization.
The AP report further states:
The research was conducted in at least seven states--Illinois,
Louisiana, Maryland, New York, North Carolina, Colorado and Texas--and
involved more than four dozen different studies. The foster children
ranged from infants to late teens, according to interviews and
government records.
These clinical research studies were funded primarily through
grants awarded to researchers by the Division of AIDS (DAIDS).
I would like to bring to your attention that according to the NIAID
Clinical Terms of Award: All clinical research supported by NIAID must
comply with applicable Parts of U.S. Code of Federal Regulations, Title
45, Part 46 ``Protection of human subjects.'' (Emphasis added)
The failure of numerous DAIDS/NIAID-sponsored researchers and their
institutions to assure that foster children enrolled in their research
were appointed individual advocates even where a foster parent exists
constitutes a violation of the terms of their grant awards. By any
definition, this is a severe violation because it directly impacts the
health and safety of foster children, among the most vulnerable
populations in our society.
Please be advised that 45 CFR 46.409 contains no exceptions to the
requirement that foster children enrolled in research must be provided
with advocates, although an advocate may serve more than one child.
The claim by some researchers that ``oversight boards may decline
to appoint advocates if they conclude the experimental treatment
affords the same or better risk-benefit possibilities than alternate
treatments already in the marketplace'' is simply false. There is no
provision in either law or regulation that allows researchers or their
oversight boards to waive the rights of children in clinical trials to
have advocates.
I ask that the your office immediately conduct an investigation to
determine which foster children were denied their rights under the law
and to seek a full recovery of grant funds from the researchers
responsible for this lapse.
Furthermore, I respectfully suggest that your review include a
comprehensive financial and protocol audit of each of the research
entities and clinical trial sites involved in these studies. As part of
this inquiry, the medical and study records of each foster child
enrolled in their respective AIDS clinical trial should be examined to
determine whether any of these children were subjected to unnecessary
risk or injury owing to the toxicity of the drugs administered to them,
and whether the researchers complied with their obligations to report
all adverse events.
Your office should be aware that DAIDS/NIAID currently is
soliciting applications for HIV/AIDS Clinical Trials Networks and
Clinical Trial Units. Applications are due this month and in July,
2005, respectively. Funding for both is expected to total up to $300
million for the first year and may continue for up to seven years.
(See: http://www2.niaid.nih.gov/newsroom/Releases/ctu2005).
It is expected that many of the investigators and their
institutions responsible for enrolling foster children in AIDS clinical
trials without the appointment of advocates will be competing for the
upcoming award.
It is wholly inappropriate for DAIDS/NIAID to consider making
awards to any of these applicants who have violated basic human
research protections until a full, open and independent investigation
has concluded and full restitution is made to both the government and
the victims of these unlawful experiments.
Thank you for your time and attention to this important matter.
Please feel free to contact me at my home telephone number, 301/983-
4370 if I can be of further assistance.
Sincerely,
Jonathan M. Fishbein, M.D.
Director
Division of Aids
Office for Policy in Clinical Research Operations
Submission of John Mattingly, New York City Administration for
Children's Services, New York, New York
Good afternoon Chairman Herger and Members of the Subcommittee. I
am John Mattingly, Commissioner of the New York City Administration for
Children's Services (Children's Services) and I submit this testimony
on behalf of Children's Services regarding participation of children in
foster care in HIV/AIDS clinical trials during the late 1980's and
early 1990's.
As a professional whose career has been focused in child welfare
for over 30 years, I want to begin by stating that it is imperative--
both in terms of our own institutional integrity and our critically
important relations with the communities we serve--that the serious
questions that have been raised regarding inclusion of children in
foster care in HIV clinical trials are fully explored, and that that
review process be transparent to the public and conducted with due
diligence.
That is why I have asked the Vera Institute, a New York-based not-
for-profit research institute which works with government to study a
variety of social issues, to conduct a comprehensive analysis. An
independent Medical Oversight Committee, consisting of nationally known
experts in pediatric AIDS, medical ethics, and the taxonomy of clinical
trials, will review, respond to, and provide guidance to the Vera
Institute's review of cases. Having said that, I want to make equally
clear that I have seen no evidence to date of any wrongdoing or
malfeasance in regard to these clinical trials, and much of what I've
seen speaks to the good faith of those who had decision-making
authority at that time.
History of Clinical Trials in New York City
Along these lines, I would first like to bring us back to the
calamity that befell New York City and its children in the late 1980's
and early 1990's with the arrival of the AIDS epidemic in the lives of
infants and children.
At that time, HIV/AIDS, fueled in part by the crack crisis, had
reached epidemic levels in New York City, and no effective treatment or
medical regimen to manage the disease had yet been found for children,
nor did such treatment appear imminent. The mortality rate for those
who suffered from full-blown AIDS was 100 percent. Newspapers and
scientific journals, as well as doctors, social workers and
administrators in the child welfare system, hospitals and beyond,
struggled with stemming the ominous tide of a disease that, at that
time, had no end in sight.
The impact the disease was having on many of the City's children
and families was devastating. Media accounts from those years described
the funerals of children who had died of AIDS, of children desperately
trying to hide from their friends the fact that they had been infected
with the HIV virus, and of boys and girls who were spending their early
years in and out of the hospital, suffering from repeated bouts of
pneumonia and other illnesses as a result of their HIV infection. All
this suffering occurred without any medical regimen available to even
begin addressing their illness.
At that same time, the scientific community was advocating strongly
for making available to children those HIV/AIDS drugs that were
beginning to make a difference for adults afflicted with AIDS and the
HIV virus. The journal Science, one of the most respected scientific
publications in the world, published an October 1989 article on the
subject. The author described as ``heartrending,'' the lack of
availability of AIDS drugs for children, who were characterized as
``being left out in the cold.''
Some of the doctors and nurses who treated children infected with
HIV/AIDS as well as social workers who cared for many of them have told
us about the heartbreak they experienced, as they watched children
suffer and die. They also told us of their heartrending frustrations
that there was so little they could offer by way of treatment.
The cold numbers bear out what the written historical record
reveals: in March 1987, 183 children under the age of 13 with full-
blown AIDS had been reported to the City's Department of Health (DOH).
In 1991, just four years later, DOH reported that the number of
children in the City with the disease had nearly quadrupled, to 745. By
then, these reported cases comprised 26 percent of the nationwide
pediatric caseload. Even more alarming was the fact that City health
officials at the time believed that there were far more children
infected with the HIV virus who had not yet developed the AIDS disease.
The vast majority of HIV positive children contracted the virus
perinatally. Of the 131,498 babies born in New York City in 1990,
1,644, or 1.25 percent, tested positive for HIV.
Nationally, according to the Centers for Disease Control, some
14,000 children under age 13 had been diagnosed as HIV positive or had
developed AIDS between the time of the emergence of the illness in the
mid 1980's and 1993. During the same period in New York City, 3,634
children under 13 were diagnosed as HIV positive or as having developed
AIDS.
In 1989, the NIH AIDS Program Advisory Committee recommended
``cutting through'' bureaucracies that prevent children from receiving
potentially beneficial treatment through involvement in research. The
NIH sponsored clinical trials in seven states: Colorado, Illinois,
Louisiana, Maryland, New York, North Carolina and Texas. Also, in 1989,
the Secretary for Health and Human Services' Workgroup on Pediatric HIV
Infection and Disease, supported by the AmericanAcademy of Pediatrics,
recommended that guidelines be developed governing the participation of
foster care children in HIV clinical trials.
The City of New York's Previous Procedures
In 1988, at the urging of local hospitals, health care workers, and
advocacy groups, the New York City Human Resources Administration (HRA)
and its Child Welfare Administration (CWA), first began to develop its
policy to allow children in foster care to participate in HIV clinical
trials. This decision was made in the face of the rising number of HIV
positive children in the New York City foster care system with high
rates of illness and death.
Those urging HRA to develop such a policy argued that foster
children with HIV/AIDS should not be categorically denied access to
promising treatments that were available to children not in foster care
who were already being enrolled in these trials by their parents. At
the time, AZT had just been approved for use in adults and was about to
begin trials in children; it was the first medication demonstrated to
slow the progression of AIDS. The only way to receive the medication or
medication regimen was to participate in a clinical trial. These
medications were not available to children outside of the trials, even
though in many cases adults were receiving the medications with
prescriptions.
Before making the policy decision that HRA would consider the
enrollment of children in foster care in HIV clinical trials when
appropriate, HRA conducted an exhaustive review of the ethical,
medical, and legal implications of foster child participation in
clinical trials. The decision to go forward was also made after meeting
with representatives from the NIH and with several of the New York City
investigating physicians who were conducting clinical trials. A series
of discussions with NIH were held in order to clarify the process for
its scientific approval of protocols. Consultations were also held with
representatives from the New York City Department of Health, the New
York State AIDS Institute, and the National Medical Association.
On January 24, 1989, HRA approved the first HIV clinical trial for
participation by children in its care. HRA made an initial decision
that because certain clinical trials offered children a therapeutic
benefit they fell under the umbrella of ``medical treatment'' and
outside the definition of human research. The essential criterion for
permitting such participation was a determination by HRA that the trial
offered each participating foster child a significant potential
treatment benefit, along with concomitant minimal risk of injury or
harm.
The early approach to assessing a clinical trial and then agreeing
to enroll a child from foster care was so cautious and the review
process in place was so cumbersome that the medical community and
advocacy groups excoriated HRA for delaying critical medical care for
terminally ill children, and urged HRA to speed up its clinical trial
approval process. Otherwise, these groups argued, children would miss
the opportunity to enroll, or their disease would progress to a point
where they could no longer benefit from the new treatments.
In response, HRA developed a new procedure, which provided
comparable safeguards for children, while addressing the need for
timely response. Beginning in 1991, the NIH agreed to forward approved
clinical trial protocols to HRA while local hospital Institutional
Review Boards were conducting their own reviews. HRA then convened a
panel of two to four physicians specializing in pediatric HIV/AIDS, as
well as program staff from the HRA/CWA Pediatric AIDS Unit (PAU) and
HRA legal staff. The physicians on the panel would conduct a scientific
and medical analysis, including whether there was a significant
potential medical benefit for the participants, and a discussion of the
risks associated with the trial. CWA program staff would weigh in,
offering opinions on the protocol based on the agency's policy.
Next, the legal staff would synthesize this material, write a
description and analysis of the protocol for the HRA Commissioner and
state a legal opinion regarding whether enrollment in the protocol was
allowable under state law. The final determination for permitting
children to enroll in the HIV clinical trial was made by the
Commissioner. For approved trials, a letter of agreement was signed
between the investigating physician at the hospital and the HRA
Commissioner.
When the Commissioner of HRA agreed to permit the enrollment of
children in foster care in particular clinical trials, it was because,
after a multi-level review that included the participation of medical
professionals, the Commissioner had determined that those trials
provided significant potential medical treatment not available outside
of the clinical trial. The determination as to whether it was
appropriate for a particular child to participate in a particular trial
would follow the approval of the trial itself for potential enrollment
by children in care. That determined, the consent from the parent would
then be sought and obtained, unless the parents' whereabouts were
unknown or the child was freed for adoption, in which case the
Commissioner or his/her designee would consent.
Those HIV protocols that had been approved for foster children all
had a treatment arm that offered a promising drug or therapy that would
otherwise be unavailable to foster children and were being provided to
children not in foster care who were enrolled in the clinical trials.
While it was recognized that there were some risks involved in the use
of these treatments, such risks were deemed minimal compared to the
contemplated benefits for these children.
As the number of pediatric AIDS cases increased across the United
States, the National Institutes of Health (NIH) AIDS Program Advisory
Committee (as reported in a 1992 U.S. Surgeon General report entitled
``Points to Consider: Involving HIV Positive Foster Children Who Are
Wards Of The State in HIV/AIDS Research'') raised issues concerning
foster children in clinical trials. ``Committee members recommended
``cutting through'' bureaucracies that prevent children from receiving
potentially beneficial treatment through involvement in research. The
American Academy of Pediatrics (AAP) Committee on Drugs endorsed the
inclusion of children in state care/custody in clinical trials in
certain circumstances. The AAP also raised concern about the lack of
participation of children in clinical research and reported that only a
small fraction of all drugs marketed in the U.S. had clinical trials
performed in pediatric patients. The AAP has continually supported the
inclusion of children in clinical trials as a way of protecting
children not only from the harms of life threatening diseases, but
because clinical trials are a controlled setting, they also protect
children from harms which might result from children taking medications
whose dosages have only been tested in adult populations.''
In 1996, the New York City Administration for Children's Services
was established. The policies and procedures from CWA were continued
under Children's Services unless specifically changed. In 1998,
Children's Services revised its HIV testing and assessment procedure
and included in the new procedure a section on clinical trial
enrollment, modifying the existing HRA procedure.
Through this new procedure, the threshold question when a foster
child's participation in a clinical trial was being considered
continued to be whether the clinical trial offered a significant
potential benefit to the child, with a concomitant minimal risk of
injury or harm. Children's Services continued to convene its panel of
experts in pediatric HIV disease to advise the agency of the risks and
benefits of proposed studies or trials for children in foster care
suffering with HIV/AIDS. This panel of experts, together with
Children's Services professional staff, then heard a presentation given
by the lead physician at the hospital conducting the trial.
The Commissioner, after reviewing the recommendations made by
Children's Services legal and medical staff, as well as the written
scientific evaluation and the protocol from the physicians on the
panel, then decided whether that trial was appropriate for children in
foster care. Also, for a foster child to be enrolled in the trial, the
child's mother or legally acknowledged father had to consent to the
child's participation if her or his whereabouts were known to
Children's Services. The child's foster parent could not provide
consent. If the child's birth parent could not be located after written
and documented reasonable efforts, Children's Services would make the
decision.
One key addition was included in the policy enacted in 1998: once
all of the appropriate actions were taken leading up to an executed
agreement for the trial, it then required that an independent physician
would review each child's case to confirm that the study enrollment
would provide the best available treatment for that child.
In most of the clinical trials that Children's Services has
reviewed to date, the medications had already been FDA approved for
adults and the clinical trials were intended to determine what dosage
of the medication would be advantageous for children. In other trials,
the medications had been individually FDA approved and these clinical
trials were to evaluate the effects of combination treatments and
dosage involving those medications. In fact, Children's Services only
approved clinical trials where risks and discomforts to children were
minimized and the therapeutic value outweighed the risks.
The vast majority of clinical trials were conducted very early on
in the HIV/AIDS epidemic and only half the clinical trials reviewed
were accepted for participation. Between 1996, when Children's Services
was established as an independent agency, and 2001, only four trials
were approved and one of these was approved for one child only. No
clinical trials have been approved since 2001.
In the late 1990's, there was a dramatic shift in the field of
pediatric AIDS, as effective treatments were at last available outside
of clinical trials, treatments which had been developed as a result of
the information learned from earlier clinical trials. At the same time,
fewer infants were born HIV positive due to medical interventions that
dramatically reduced the rate of perinatal transmission. As noted in a
New York Times article dated January 30, 2005, ``AIDS among infants . .
. may be on the verge of being eliminated in the United States. . . .''
As a result, there was no longer a pressing need for children to have
access to clinical trials, except in isolated instances, where HIV
infected children had developed resistance to existing medications.
Recent Events
Beginning in March 2004, Children's Services initiated an extensive
review of the agency's PAU hard copy files on HIV children who
participated in clinical trials. This review garnered a list of 89
children who appeared to have participated in clinical trials at some
point between 1989 and 2001.
To have a more complete understanding of the clinical trial
enrollment process, 24 cases were selected for a detailed medical
record review. The sample included 11 children currently in foster
care; 7 children who, at the time, had been discharged from foster care
within the past 2 years, either through adoption or reunification; and
6 children who died while in foster care. All of the six children who
were deceased had died between 1992 and 1998. There was nothing in the
records to suggest that clinical trial medications contributed in any
way to the children's deaths. On the contrary, it appears that the
medications extended the lives of many children. Five of the children
died of AIDS-related illnesses and one died of unrelated causes.
I decided to conduct an internal query of agency records to be sure
that Children's Services had identified and reviewed all information
pertaining to the enrollment of foster children in clinical trials. It
was determined through that review that more children had been enrolled
in clinical trials than were identified in the initial review. At this
time, Children's Services believes that approximately 465 children were
enrolled in clinical trials.
Development of New Policy
We are now near finalization of a new policy governing the
enrollment of children in clinical trials. Beginning last summer, this
policy was developed after a series of meetings with focus groups and
interviews with a multidisciplinary group of experts in pediatric HIV/
AIDS. It will add additional protections for children in care including
clarification regarding the importance of parental consent and child
assent. This proposed policy would further protect children, by
guarding against any potential conflicts of interest or appearances
thereof on the part of physicians who review clinical trials and make
recommendations regarding enrollment of children in foster care.
It is important to note that this policy is being revised to
provide further protections as an additional safeguard; not because any
information suggests children were inappropriately enrolled in clinical
trials was uncovered. We will be glad to share this new policy upon
completion of its revision.
Vera Institute of Justice Review
I have asked the Vera Institute of Justice, to research Children's
Services' policies and procedures to ensure that HIV-positive children
and children with AIDS who were in our care were appropriately enrolled
in clinical trials. The Vera Institute is particularly well qualified
to carry out this kind of investigation. Over more than four decades,
Vera has developed an international reputation as an independent,
nonprofit organization that provides the highest quality research on a
wide range of justice-related issues. The analysis organized by the
Vera Institute will also examine whether:
all necessary consents by parents and other guardians
were obtained,
the individual children's enrollments in clinical trials
were reasonable and appropriate, given the scientific knowledge and
medical options available at the time,
NIH protocols were followed, and
HRA and Children's Services properly monitored children
after they were enrolled.
The Vera Institute will also seek to locate the children who
participated in these trials while in foster care to ascertain their
current medical condition and solicit their feedback regarding the
medical care they received.
We have asked Vera to conduct this study in order to address
ongoing questions from the public and the press about the history of
clinical trials. Vera is committed to developing this comprehensive and
transparent understanding of Children's Services' policies and
practices during this period. Although we believe that the policies in
place at the time reflected good practice, and while we have seen no
evidence that would cast doubt on the intentions of those in decision-
making authority at the time, we are committed to providing transparent
and accurate information in our dealings with the public.
In order for us to be effective in our mission to protect New York
City's children, it is my firm belief that we must have a sense of
mutual trust with those families we seek to serve. I have only been the
Commissioner of ACS since August of 2004 but I have worked in the field
of child welfare for most of my professional life, and I certainly
understand why this is a subject that causes great concern. It involves
the well being of children, sick children, and vulnerable children who
were in the care of Children's Services and not in the care of their
own parents. We will do all we can to ensure that Vera's review fully
answers all public concerns about the participation of New York City
foster children in HIV clinical trials, in the late 1980's and 1990's.
Vera will organize a review of case records and medical records for
all of the children identified as clinical trial participants, and will
prepare a public report regarding its findings. Vera's work will be
reviewed by an independent Medical Oversight Committee (Committee),
consisting of nationally known experts in pediatric AIDS, medical
ethics, and taxonomy of clinical trials. These independent experts--
whose work will be funded by private foundations--will provide
oversight for Children's Services' current policies and comment on the
Vera review. This Committee will provide additional expertise and
accountability for all of the City's actions as part of the Vera
Institute's review. The Committee's findings will include
recommendations for future Children's Services policy regarding
clinical trial participation, as well as an analysis of the procedures
and protocols that were used in the past. Dr. Robert L. Johnson, an
expert on HIV/AIDS, will chair the Committee. As with the Vera
Institute's report, the Committee's comments will be public.
Concurrent with the Vera Institute's review, Children's Services
will conduct additional case record reviews to ensure that every child
in foster care who participated in clinical trials has been identified,
and will continue to interview Children's Services staff members who
played a role in developing and implementing the HIV clinical trial
policy over the last eighteen years.
Conclusion
Faced with an AIDS epidemic in the late 1980's and early 1990's,
left without effective treatment for children, and at the urging of
medical professionals, HRA developed its policy in an effort to allow
children in foster care to have access to medication that was being
made available to children not in foster care. The essential criterion
for permitting the participation of children in foster care was a
determination by HRA that the trial offered each participating child a
significant potential treatment benefit, along with concomitant minimal
risk of injury or harm.
Statement of Stephen A. Spector, M.D., Pediatric Aids Clinical Trials
Group, and University of California, San Diego, La Jolla, California
My name is Stephen A. Spector, M.D. I am a Professor of Pediatrics
at the University of California, San Diego, and Principal Investigator
and Chair of the Executive Committee of the Pediatric AIDS Clinical
Trials Group (PACTG). Over the past 15 years the PACTG, funded by the
National Institute of Allergy and Infectious Diseases and National
Institute of Child Health and Development, has been the world leader in
the development of therapies to prevent the HIV mother-to-child-
transmission and to treat children infected with HIV. It is the
organization that is most responsible for changing pediatric HIV/AIDS
from a once invariably fatal disease to a chronic illness. I believe my
comments, in large part, reflect the opinions of all PACTG
investigators and the American Academy of Pediatrics.
I am pleased to have an opportunity to respond to the unfounded
suggestions by some that HIV-infected foster children were
inappropriately enrolled in clinical trials. In the 1980s and for much
of the 1990s, HIV/AIDS was a fatal disease with many children not
surviving beyond their first few years of life. Limited treatments were
available and the only access for children to potentially life saving
medications was through clinical trials. These experimental therapies
were unproven, but offered hope for HIV-infected children and their
families. Investigators of the PACTG offered children the opportunity
to participate in clinical trials regardless of race, ethnicity, creed
or financial status. As pediatricians and child advocates, every effort
was made to make these potentially life saving treatments available to
children who were HIV infected and in foster care. At no time were
clinical trials targeted for foster children and foster children
comprised only a small proportion children who participated in any
study. The suggestion that foster children were specifically singled
out for participation in studies of new treatments is not only false,
but undermines the heroic efforts of many dedicated health
professionals who worked tirelessly to help save the lives of all
children with HIV/AIDS. In fact, many foster children are alive today
because they able to receive ``experimental'' drugs that were only
available, at that time, as part of clinical trials. To have left
foster children out of these clinical trials would have deprived them
of benefits provided to other children.
All children, including those in foster care, are perhaps the most
vulnerable group of the general population with regard to possible
exploitation in clinical research protocols, and yet they are the group
that can often have the most significant and prolonged benefit from
such studies. Every effort must be made to retain the dignity and well-
being of children in every step of the clinical protocol process. This
includes the request for study participation, explanation of risks and
benefits of a study, obtaining consent from parents (and in the case of
foster children, a court appointed advocate) and assent from children
of appropriate age, monitoring for treatment side effects, and
presentation and publication of research findings. The success of
treatments for children with HIV/AIDS demonstrates the benefits that
studies of new drugs can provide not only for HIV-infected children but
also for children with other potentially fatal diseases. To deny
children in foster care an opportunity to benefit from such treatments
would be medically unacceptable and morally reprehensible.
Despite the many advances that have been made in the treatment of
children with HIV/AIDS, much research remains to be done before there
is a cure. HIV-infected children must continue to have access to new
treatments. The differences of biological and chemical handling of
drugs in children is well known, and the assumption that drug
processing will be similar to that in adults and will require a simple
dose reduction for children, has proven time and again to be flawed.
Thus, therapeutic and preventive interventions must be studied in
children and not extrapolated from studies in adults. Investigators,
sponsors, research review boards, regulators, and others engaged in
pediatric research are rightly held to a higher standard of concern
because of the fragile nature of children and their rights to a life as
free as possible from pain and suffering. However, the zeal to protect
children from any harm in entering into clinical trials must be
transformed into a passion to provide children with scientific
information on drugs that might vastly improve the quality of their
lives.
Although we can celebrate the great strides that have been made in
treating children infected with HIV, many improvements are still
required to optimize and hopefully one day cure HIV/AIDS. All HIV-
infected children, including those in foster care, should continue to
have an opportunity to receive treatment with these new potentially
beneficial drugs as they become available.
Statement of Patricia Sabato, Sandy Hook, Connecticut
My name is Patricia Sabato. I'm from Newtown, CT and am writing to
you regarding the hearings on clinical drug trials in children. My son
Stephen was put on Dexedrine Spansule by Dr. Irivin Jennings of Family
and Children's Aid in Danbury. CT. He was seven years old and he ended
up hospitalized at Elmcrest Hospital in Portland, CT and was kept on
the same medication. In 1998 Stephen was, once again hospitalized. He
went to Four Wind's Hospital in Katonah, NY. He was put on Prozac and
Clonadine and received at least one injection of Thorazine. From here
he went to Hallbrooke Hospital in Westport, CT and remained on these
drugs. When he returned home, the Dr. at the Danbury Hospital CCATS
program changed him to Wellbutrin. Dr. Jennings kept Stephen on this
medication until 1999. Despite my efforts not to medicate my son
because of the negative side effects and the behaviors he was
demonstrating, and knowing some of these drugs were not FDA approved
for children, I was ordered to continue him on these drugs. July 1999
he was placed in a Residential Treatment Center called Green Chimney's
in Brewster, NY for one year. I was assured I would be included in his
full treatment plan, I was not. Stephen remembers having his blood
taken frequently and was not sure why. He was discharged June of 2000.I
have had a hard time obtaining any record's of Stephen's. There were no
safeguards for the right to refuse drugs administered to my child
during our involvement with The Department Of Children And Families of
CT or his placement at Green Chimney's in NY. I have no idea if any
information was derived from the forced drugging of FDA unapproved
medications and wonder if my son was any part of a clinical drug study.
Rockford, IL 61103
May 31, 2005
Subcommittee on Human Resources
Committee on Ways and Means
United States House of Representatives
Chairman Herger:
The testimony of Donald Young, M.D., of U.S. Department of Health
and Human Services referred to as Protections of Children Enrolled in
Clinical Trials raises questions and concerns, as does the statement of
Elizabeth Monk, of the Illinois Department of Children and Family
Services.
Dr. Young testifies on page 3, that, ``HHS continues to believe
strongly that clinical trials to test new treatments in children are
essential and that the framework established by the existing regulation
offers adequate protection for individuals participating in trials.'' I
am appalled that any children are used as subjects in any clinical
trials and that it is sanctioned and aggressively pursued by a U.S.
department! There can be no justification for this kind of conduct! The
existence of ``framework established by the existing regulation'' does
not protect and does not remove the sting of offering up children for
medical experiments! The young and old of our society, the innocent,
the weak, the defenseless and vulnerable need protection, yes, not from
a regulation of appointing an advocate, but protection from being in a
class of humans upon which researchers can gain access.
Apparently, at least one of the states do not insist on appointing
an advocate unless there is significant risk. Ms Monk of Illinois DCFS
testifies that, ``If DCFS ever decided to approve a research study that
has more risk with the prospect of direct benefit, these clinic IRBs
are prepared to assign an independent advocate for our wards in
compliance with federal regulations.'' There can be risk in taking an
aspirin! A clinical trial involving any drugs could cause serious
adverse effects or even aggravate an existing condition, cause pain and
suffering and even cause death. That is a risk! Experimenting with
dosage levels causes risk and even death, all of which I understand is
a concern for this hearing.
Dr. Young, on pages 5 and 6 refers to the lack of a ``standard
medical treatment'' for HIV for children in foster care and that a
report prepared by HHS recommended that State and local child welfare
agencies should create systems to manage the participation of children
in foster care in special medical treatment and experimental trials.''
Again, no children should be subjected to medical experiments! Further,
if there is no standard medical treatment, THEN A STANDARD SHOULD BE
DEVELOPED using the best known treatment! Just because there is a lack
of a standard that does not justify or give leave for this Government
to subject children to experimental trials, let alone children who are
most vulnerable, who cannot give informed consent, and whose biological
parents may be under distress and duress and cannot give informed
consent.
Refer to the testimony of Deputy Secretary Roberta Harris of
Wisconsin Department of Health and Family Services of May 18, 2005, at
page 2 refers to World Medical Association Declaration of Helsinki's
position on the voluntary nature of participation in research. Ms
Harris states that the children in their welfare system are vulnerable
because of conditions in the homes they come from. There is the stress
and trauma of being removed from their homes and an economic
disadvantage may cause consent under duress. Her comments and quotes
indicate how difficult it is to reach a status of informed consent for
all parties involved.
How well can one be informed in order to give INFORMED consent?
Some adult clinical trials have had tragic results, some of which have
been halted before completed. Even though the subjects in those studies
were adults were they truly able to get enough information? Are there
protections in place even for the adult to be adequately informed of
risks?
Dr. Young's statement refers to ``Efforts in the early 1990's to
increase the enrollment of foster children in clinical trials affected
state policies. Today, child welfare agencies continue to differ in
their policies regarding whether or under what circumstances children
in foster care may be enrolled in clinical trials.'' It is disturbing
that HHS was conduction ``Efforts'' to get children in clinical trials.
What were these ``Efforts''? And how aggressively were they pursued?
Who and what department or what group(s) were behind the efforts? I
would urge this Committee to determine what was done to get the states
to turn over their wards to the researchers. It appears, and to their
credit, some states resisted.
The Associated Press articles refer to some children having serious
adverse effects from these medical experiments and even death may have
resulted from experimenting with dosage levels. I trust this committee
will investigate these matters fully and demand accountability.
I emphasize again that no children should become subjects of
medical experiments or clinical trials. Just because a procedure was
put in place to give each child an independent advocate to monitor a
child subjected to clinical trials does not justify or make more
acceptable giving access to the most vulnerable of our society to
medical researchers.
I refer to page 2 of Ms Monk's (of Illinois) statement. ``If DCFS
ever decided to approve a research study that has more risk without the
prospect of direct benefit, these clinic IRBs are prepared to assign an
independent advocate for our wards in compliance with federal
regulations.'' What? It appears that NO independent advocate has been
assigned and further it appears someone preordained the experiments to
be without risk!
Also, note Ms Monk says ``one drug protects them from the flu.''
Isn't there a standard medical treatment in place for the flu? If there
is a standard medical treatment in place for flu, how and why would
Illinois give access to their wards for research on flu vaccines?
I would hope that all of the Illinois cases be studied carefully.
It might not be as rosy of a picture as she paints. How many died? Were
the deaths attributed to the clinical trials? Ms Monk says 20 kids
presently are on 5 research studies. That's twenty children too many.
What are these studies for? Children as well as foster children should
not be subjected to medical experiments. The foster children in most
cases lack a loving, caring and attentive parent to protect them and
cannot really give informed consent.
There was horrific disregard for humanity that took place in World
War II Germany, some of which started out being directed toward the
weak and vulnerable, in orphanages and hospitals, but then was directed
to millions who lost their lives in the concentration camps. A society
does not just lose their regard for human life overnight. It is a step
at a time downward and soon that society slips further and faster
downward. Many vowed, ``Never Again.'' We in the U.S. cannot and should
not be allowing access to our children for medical research. There is
no argument that justifies it! Perhaps we need to review the
transcripts of the Nuremberg trials. There were many, including doctors
who were held accountable.
An immediate halt should be called to medical experiments on
children. Further, any unused grant money should be returned to the
U.S. Treasury and any grants used for clinical studies on children who
did not get an independent advocate should be repaid. That money won't
compensate for loss society experiences from such conduct, but our tax
money should not be used in this manner. It's a disgrace! If the weak
and vulnerable continue to be treated in this manner, Lord help us, it
becomes a slippery slope.
Respectfully submitted,
Sharon Schuldt
William Glasser, Inc.
Chatsworth, California 91311
May 20, 2005
Congressman Wally Herger
Rayburn House Office Building
Washington, D.C. 20515
I am very interested in the Congressional Hearing focused on
protecting children from being involved in experimental psychiatric
drugs or drugs of any kind. Most of the children enrolled are foster
children or children who aren't really looked after by any protective
agency. I believe the government should become the protective agency.
I am a Board Certified Psychiatrist who has been working in mental
health for over forty years. I've worked not only with children and
adults, but also extensively in the schools. In the schools that are
following my ideas, no children are given any kind of psychiatric drugs
at the instigation of the schools. We can't stop parents from giving
their children these drugs, but we can certainly advise parents that
these drugs are really not necessary. These Glasser Quality Schools are
highly successful and are perhaps the most successful schools in the
country where students are not taking any psychiatric drugs.
Your legislation can certainly close a big gap to the practice of
using children who have no way of protecting themselves and no parents
who are really that interested in them. That should not be allowed.
There should be some sort of protection for the children and that
protective operation should swing into operation if any children are
asked to participate in any kind of medical experimentation at all.
As a Board Member of an organization called Ablechild, I am working
with Gloria Wright and other members to reduce the drugging of all
children and the practice of advising parents to put their children on
drugs. No one knows what the long-term effects are from these drugs.
The short-term effects, in many cases, are somewhat disastrous and
include violent activity and suicide.
I am the President of The William Glasser Institute. We teach and
train people to deal with mental health all over the world with adults
and children. I am very well known and have been spending most of the
latter part of my professional life warning people about the dangers of
psychiatric drugs. There is no evidence that the drugs are in any way
helpful, but there is a great deal of evidence that they may be
harmful. If the purpose of our government is to protect people against
unwarranted intrusions into their privacy from the people who are
making money off of these intrusions and paying little or no attention
to the children, then this is a wrong you should certainly right.
If you would like to learn more about my work, my website address
is www.wglasser.com. You will see that there is a lot of information on
the website that supports what I am saying here.
I also appreciate being on the Ablechild Board of Directors and I
am doing everything I can to help them.
Cordially,
William Glasser, M.D.
Board Certified Psychiatrist