VA Research: Actions Insufficient to Further Strengthen Human	 
Subject Protections (18-JUN-03, GAO-03-917T).			 
                                                                 
Every year thousands of veterans volunteer to participate in	 
research projects under the auspices of the VA. Research offers  
the possibility of benefits to individual participants and to	 
society, but it is not without risk to research subjects. VA	 
studies, like other federally funded research programs, are	 
governed by regulations designed to minimize risks and protect	 
the rights and welfare of research participants. VA must ensure  
that veterans have accurate and understandable information so	 
that they can make informed decisions about volunteering for	 
research. In September 2000, GAO reported on weaknesses it found 
in VA's systems for protecting human subjects. VA concurred with 
GAO's recommendations that its human subject protections could be
strengthened by taking actions in five domains--guidance,	 
training, monitoring and oversight, handling of adverse event	 
reports, and funding of human subject protection activities. (VA 
Research: Protections for Human Subjects Need to Be Strengthened,
[GAO/HEHS-00-155, Sept. 28, 2000]). GAO was asked to assess	 
whether VA has made sufficient progress in implementing the	 
recommendations and to examine the recent changes in VA's	 
organizational structure for monitoring and overseeing human	 
subject protections.						 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-03-917T					        
    ACCNO:   A07255						        
  TITLE:     VA Research: Actions Insufficient to Further Strengthen  
Human Subject Protections					 
     DATE:   06/18/2003 
  SUBJECT:   Internal controls					 
	     Medical research					 
	     Program evaluation 				 
	     Veterans						 
	     Informed consent (medical law)			 
	     Health research programs				 
	     Research program management			 
	     Safety regulation					 
	     Safety standards					 

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GAO-03-917T

Testimony Before the Subcommittee on Oversight and Investigations,
Committee on Veterans* Affairs, House of Representatives

United States General Accounting Office

GAO For Release on Delivery Expected at 10: 00 a. m. Wednesday, June 18,
2003 VA RESEARCH

Actions Insufficient to Further Strengthen Human Subject Protections

Statement of Cynthia A. Bascetta Director, Health Care* Veterans* Health
and Benefits Issues GAO- 03- 917T

VA has not taken sufficient actions to strengthen its human subject
protection systems since GAO made recommendations nearly 3 years ago.
Continuing weaknesses VA has not sufficiently addressed include ensuring
that

* its policy for implementing federal regulations for the protection of
human subjects is up to date;  training occurs periodically for all
personnel involved in human subject

protections;  those charged with reviewing risks have information that
can help them

interpret reports of adverse events; and  sufficient funding is allocated
to support human subject protection

activities. VA has taken some important steps to strengthen aspects of its
human subject protections by providing some necessary guidance and
offering training to research personnel. Moreover, it strengthened its
internal oversight and instituted an external accreditation program, with
reviews of

all its medical centers* human subject protection programs scheduled
through summer 2005.

VA is now in the midst of a reorganization of its headquarters research
offices that was begun without adequate planning and notice. VA did not
initially ensure the independence of compliance activities although more
recent actions appear to have restored the integrity of the compliance
function. VA has not clarified responsibilities for education, training,
and policy development. Until it does so, it is unclear how the
reorganization

will affect VA*s efforts to further strengthen its human subject
protections. Every year thousands of veterans volunteer to participate in
research projects under the auspices of the VA. Research offers the
possibility of benefits to individual

participants and to society, but it is not without risk to research
subjects. VA studies, like other federally funded research programs, are
governed by regulations designed to minimize risks and protect the rights
and welfare of research participants. VA must ensure that veterans have
accurate and understandable information so that they can make informed
decisions about volunteering for research.

In September 2000, GAO reported on weaknesses it found in VA*s systems for
protecting human subjects. VA concurred with GAO*s recommendations that
its human subject protections could be strengthened by taking actions in

five domains guidance, training, monitoring and oversight, handling of
adverse event reports, and funding of human subject protection activities.
( VA Research: Protections for Human Subjects Need to Be Strengthened,

[GAO/ HEHS- 00- 155, Sept. 28, 2000]).

GAO was asked to assess whether VA has made sufficient progress in
implementing the recommendations and to examine the recent changes in VA*s
organizational structure for monitoring and overseeing human subject
protections.

www. gao. gov/ cgi- bin/ getrpt? GAO- 03- 917T. To view the full product,
including the scope and methodology, click on the link above. For more
information, contact Cynthia A. Bascetta at (202) 512- 7101. Highlights of
GAO- 03- 917T, a testimony before the Subcommittee on Oversight and
Investigations, Committee on Veterans* Affairs, House of Representatives

June 18, 2003

VA RESEARCH

Actions Insufficient to Further Strengthen Human Subject Protections

Page 1 GAO- 03- 917T Mr. Chairman and Members of the Subcommittee: I am
pleased to be here to discuss the protection of human subjects who
participate in research conducted through the Department of Veterans
Affairs (VA). Every year thousands of veterans volunteer to participate in
research projects under the auspices of VA. Research offers the
possibility of benefits to individual participants and to society, but it
is not without risk to research subjects. VA studies, like other federally
funded research programs, are governed by regulations designed to minimize
risks and

protect the rights and welfare of research participants. VA must ensure
that veterans who agree to become subjects in VA research are given
accurate and understandable information about procedures, risks, and
benefits so that they can make informed decisions about volunteering.
Concerns about VA*s protection of its human research subjects came to
national attention in March 1999. At that time, all human research was
suspended at the West Los Angeles VA Medical Center after officials there
failed to correct long- standing problems with its system for protecting
human subjects. 1 Recently, serious concerns were raised about the safety
of research programs at several VA medical centers, including the Albany
VA medical center, where the possibility of patient deaths related to
research is under investigation.

In September 2000, we testified before this subcommittee on weaknesses we
found in VA*s systems for protecting human subjects. 2 VA concurred with
our recommendations to take immediate steps to ensure that human subjects
would be protected in accordance with all applicable regulations. We made
specific recommendations for actions in five domains* guidance, training,
monitoring and oversight, handling of adverse event reports, and funding
of human subject protection activities. You asked us to assess whether VA
has made sufficient progress in implementing our recommendations and to
examine the recent changes in VA*s organizational structure for monitoring
and overseeing human subject protections.

1 The West Los Angeles VA Medical Center is now part of the VA Greater Los
Angeles Healthcare System. 2 See U. S. General Accounting Office, VA
Research: System for Protecting Human Subjects Needs Improvements, GAO/ T-
HEHS- 00- 203 (Washington, D. C.: Sept. 28, 2000) and VA Research:
Protections for Human Subjects Need to Be Strengthened, GAO/ HEHS- 00- 155
(Washington, D. C.: Sept. 28, 2000).

Page 2 GAO- 03- 917T My testimony is based on an update of VA*s progress
in implementing our September 2000 recommendations and a review of VA*s
recent and

ongoing reorganization of its research offices. To do our work, we
reviewed documents, including VA memorandums, policies, and guidance and
interviewed key officials in VA headquarters. We conducted our work from
May through June 2003 in accordance with generally accepted government
auditing standards.

In summary, VA has not taken sufficient action to strengthen protections
for human subjects, although it has made some progress. VA needs to
address continuing weaknesses we identified nearly 3 years ago.
Specifically, VA has not revised its policy for implementing federal
regulations for the protection of human subjects. VA also has not
established training requirements, in policy, to ensure that all research
personnel will be informed of, and stay current with, ways to comply with
all applicable regulations for the protection of human subjects. VA
actions regarding two other recommendations are incomplete. VA has not
ensured

that those charged with reviewing risks related to ongoing research
activities have information that can help them interpret reports of actual
adverse events that research subjects experience while participating in
studies. VA has also not ensured that sufficient funding is allocated to
support human subject protection activities. On the other hand, VA has

strengthened aspects of its human subject protections by providing some
necessary guidance and offering training to research personnel. Moreover,
it strengthened its internal oversight and instituted an external

accreditation program, with reviews of all its medical centers* human
subject protection programs scheduled through summer 2005.

In 2003, VA began a reorganization of its research offices without
adequate planning and notice. We found that VA did not initially ensure
the independence of compliance activities although more recent actions
appear to have restored the integrity of the compliance function. In
addition, VA has not clarified responsibilities for education, training,
and policy development. Until these responsibilities are clarified, it is
unclear how the reorganization will affect VA*s progress in further
responding to our recommendations to strengthen its human subject
protections.

Page 3 GAO- 03- 917T Conducting research is one of VA*s core missions. 3
VA researchers have been involved in a variety of important advances in
medical research,

including development of the cardiac pacemaker, kidney transplant
technology, prosthetic devices, and drug treatments for high blood
pressure and schizophrenia. In fiscal year 2002, VA supported studies by
more than 3,000 scientists at 115 VA facilities. VA researchers receive
additional grants and contracts from other federal agencies, such as the
National Institutes of Health, research foundations, and private industry
sponsors, including pharmaceutical companies.

To protect the rights and welfare of human research subjects, 17 federal
departments and agencies, including VA, have adopted regulations designed
to safeguard the rights of subjects and promote ethical research. These
regulations, known as the Common Rule, establish minimum standards for the
conduct and review of research to ensure that studies

are conducted in accordance with certain basic ethical principles. These
principles require that subjects voluntarily give their informed consent
to participate in research, that the risks of research are reasonable in
relation to the expected benefits to the individual or to society, and
that

procedures for selecting subjects are fair. 4 The Common Rule creates a
system in which the responsibility for protecting human subjects is
assigned to three groups:

 Investigators are responsible for conducting research in accordance with
regulations.

 Institutions are responsible for establishing oversight mechanisms for
research, including committees known as institutional review boards (IRB),
which are to review both research proposals and ongoing research to ensure
that the rights and welfare of human subjects are protected. VA medical
centers engaged in research involving human subjects may establish their
own IRBs or secure the services of an IRB at an affiliated university or
other VA medical center.

 Agencies, including VA, are responsible for ensuring that their IRBs
comply with applicable federal regulations and have sufficient space and
staff to accomplish their obligations.

3 VA*s four core health care missions are patient care, education,
research, and backup to the Department of Defense health system in war or
other emergencies. 4 38 C. F. R. pt. 16. VA regulations provide additional
protections to those participating in human subjects research. See 38 C.
F. R. S:17. 85. Background

Page 4 GAO- 03- 917T VA is responsible for ensuring that all human
research it conducts or supports meets the requirements of VA regulations,
regardless of whether that research is funded by VA, the research subjects
are veterans, or the studies are conducted on VA grounds. In addition, two
components of the Department of Health and Human Services (HHS) have
oversight

responsibilities for some VA research. The Food and Drug Administration
(FDA) is responsible for protecting the rights of human subjects enrolled
in research with products it regulates* drugs, medical devices, biologics,
foods, and cosmetics. HHS- funded research is subject to oversight by its
Office for Human Research Protections (OHRP). Both FDA and OHRP have the
authority to monitor those studies conducted under their jurisdiction, and
each can take action against investigators, IRBs, or institutions that
fail to comply with applicable regulations. To facilitate assurance of
compliance with federal regulations for the protection of human subjects,
VA awarded a contract to the National Committee for Quality Assurance
(NCQA) to provide external accreditation of its medical centers* human
research protection programs in August 2000.

Two VA headquarters offices have responsibilities that are directly
related to human subject protections. Responsibility for the
administration of VA*s research program rests with its Office of Research
and Development (ORD), which allocates appropriated research funds to VA
researchers. To

help ensure that VA research is conducted ethically, legally, and safely,
VA created an independent office to conduct compliance and oversight
activities* the Office of Research Compliance and Assurance (ORCA)* in
1999. This office was given responsibilities for promoting and enhancing

the ethical conduct of research and investigating allegations of research
noncompliance; it reported directly to the Under Secretary for Health. In
early 2003, VA reorganized its research offices and replaced ORCA with a

new office, the Office of Research Oversight (ORO). ORCA*s
responsibilities for education, training, and policy guidance were
transferred to ORD. ORCA*s responsibilities for compliance activities were
assigned to ORO.

In March 2003, ORD issued a memorandum announcing a 90- day national

*stand down* for VA human subject research to be effective from March 10
through June 6, 2003, although research was permitted to continue during
this period. The stand down was intended to focus efforts on identifying
and correcting problems with VA*s systems for protecting human subjects
and to notify investigators that disciplinary actions may result from
noncompliance with federal regulations governing the conduct of their

research. ORD also asked medical center managers to attest that their IRBs
are constituted as required by VA regulations and that they meet

Page 5 GAO- 03- 917T regularly enough to review research protocols and
adverse events; that their research staff has obtained training in human
subject protections; and that they have checked the credentials of all
personnel involved in research, including investigators, research team
members, IRB members

and staff, and research and development committee members. In 2000, we
concluded that medical centers we visited did not comply with all
regulations to protect the rights and welfare of research participants.
Based on our review of eight medical centers, we documented an uneven, but
disturbing, pattern of noncompliance with human subject protection
regulations. The cumulative weight of the evidence indicated failures to
consistently safeguard the rights and welfare of research subjects. Among
the problems we observed were failures to provide adequate information to
subjects before they participated in research, inadequate reviews of
proposed and ongoing research, insufficient staff and space for IRBs, and
incomplete documentation of IRB activities. We found relatively few
problems at some sites that had stronger systems to protect human
subjects, but we observed multiple problems at other sites. Although the
results of our visits to medical centers could not be projected to VA as a
whole, the extent of the problems we found strongly indicated that human
subject protections at VA needed to be strengthened.

Although primary responsibility for implementation of human subject
protections lies with medical centers, their IRBs, and investigators, we
identified three specific systemwide weaknesses that compromised VA*s
ability to protect human subjects. First, VA headquarters had not provided
medical center research staff with adequate guidance about human subject
protections and thus had not ensured that research staff had all the

information they needed to protect the rights and welfare of human
subjects. Second, insufficient monitoring and oversight of local human
subject protections by headquarters permitted noncompliance with
regulations to go undetected and uncorrected. Third, VA had not ensured
that funds needed for human subject protections were allocated for that
purpose at medical centers, with officials at some medical centers

reporting that they did not have sufficient resources for the staff,
space, training, and equipment necessary to accomplish their mandated
responsibilities.

To strengthen VA*s protections of the rights and welfare of human
subjects, we recommended that VA take immediate steps to ensure that VA
medical centers, their IRBs, and VA investigators comply with all

applicable regulations for the protection of human subjects. The specific
Earlier Evaluation Showed

VA Needed to Strengthen Human Subject Protections

Page 6 GAO- 03- 917T actions we recommended involved guidance, training,
monitoring and oversight, handling of information about adverse events,
and funding of human subject protection activities. VA concurred with our

recommendations. VA has not taken sufficient action to strengthen
protections for human subjects since we made our recommendations nearly 3
years ago although it has taken some important steps. ORD has not revised
its policy on

human subject protections, and it has not established training
requirements, in policy, to ensure that research personnel obtain periodic
training. Moreover, VA has not established a mechanism for handling
adverse event reports to ensure that IRBs have the information they need
to safeguard the rights and welfare of human research participants and it
has not ensured that sufficient resources are allocated to support human
subject protection activities. On the other hand, VA has strengthened
aspects of its human subject protection systems. ORCA developed a training
program and conducted oversight activities by investigating claims of
research improprieties or noncompliance and restricting or suspending four
medical centers* research activities when it found

evidence of serious problems. VA also instituted an external accreditation
program that has the potential to further strengthen VA*s oversight of
human subject protections.

In 2000, we reported that we had found problems with VA*s policy for
implementing federal regulations for the protection of human subjects.
These problems included requirements for obtaining and documenting
informed consent. For example, the policy requires use of a particular
form to document a subject*s consent to participate in research. This form
calls for the signature of a witness, but does not indicate who may serve
as

a witness, to what the witness is attesting, or the circumstances under
which a witness is needed.

In its comments to that report, VA indicated that ORD was in the process
of updating its policy on human subject protections and that it expected
to submit that policy for internal review by the end of August 2000. When
we followed up in September 2001, VA reported that comments were being
incorporated into the draft policy. In September 2002, VA reported that it
was awaiting final review but has not issued its revised policy as of June

2003. As a result, investigators, IRB members and staff, and other
research personnel do not yet have a clear, up- to- date policy to follow
when implementing human subject protections. Consequently, VA cannot
ensure Insufficient Action Taken to Strengthen

Protections for Human Subjects, Although VA Has Made Some Progress

Policy for Human Subject Protections Has Not Been Revised, but Other
Important Guidance Was Issued

Page 7 GAO- 03- 917T that research staff know what they need to do to
protect the rights and welfare of human research subjects.

In addition to the problems we noted with VA*s policy, we reported in 2000
that VA headquarters had not provided medical center staff with adequate
guidance to help them ensure the protection of human research subjects. VA
has made some progress in this area. For example, ORCA had begun
distributing some information to medical centers in early 2000. By January
2003, it had posted about 60 information letters and 14 alerts on its web
page and through electronic mail to research facilities. These letters and
alerts provide information about new HHS guidance and policies regarding
human subject protections, reports on research ethics, and problems that
ORCA staff observed during site visits to VA medical centers. In addition,

ORCA developed guidance about human subject protections. For example, ORCA
published a best practices guide for IRB procedures in September 2001 and
a tool for medical centers to use to assess their human subject protection
programs in October 2001. In 2000, we found that VA did not have a
systemwide educational program focused on human subject protection issues.
Although VA*s human subject protection regulations do not include any
specific educational requirements, we concluded that periodic training for
investigators, IRB members, and IRB staff is necessary to ensure that they
can meet their obligations to protect the rights and welfare of human
research subjects.

VA has not established training requirements in policy, although on two
occasions it has issued memorandums that required training. In August
2000, ORD issued a memorandum to medical center associate chiefs of

staff for research stating that all VA investigators had to meet specific
education requirements before submitting research proposals during 2001.
ORD*s memorandum regarding the March 2003 stand down stated that all
research personnel must provide documentation that they have completed
both a course on the protection of human research subjects and a course

on good clinical practices within the past year; otherwise all research
personnel must complete this training by June 6, 2003. These additional
personnel include research coordinators and research assistants involved
in human research; all members of VA research offices, research and

development committees, and IRBs; and IRB staff (except secretarial
staff). According to VA*s policy for distributing information, however,
memorandums are not used to establish permanent requirements or policy,
and education and training requirements for investigators were not
published in a directive or handbook, which are the documents VA uses to
Training Requirement Not Established in Policy,

Although Training Opportunities Offered

Page 8 GAO- 03- 917T communicate policy requirements. As a result,
headquarters cannot systematically ensure that all VA personnel involved
in human subject research will be informed of, and stay current with, ways
to comply with all applicable regulations for the protection of human
subjects.

Despite the lack of policies requiring human subject protections training,
both ORD and ORCA have provided information since we made our
recommendation about available educational programs to investigators and
other research personnel. ORCA worked with academic institutions to

develop an optional training program for use by VA investigators, IRB
members, IRB staff, research administrative staff, and medical center
officials. This web- based training program includes quizzes after each
module; certification of successful completion requires achieving a score

of at least 75 percent correct. ORCA also presented a seminar on research
compliance and assurance to senior managers of each of VA*s networks, 5
and ORD recently began providing training to senior managers about their

responsibilities regarding human subject protections. In 2000, we reported
that VA had not identified widespread weaknesses in its human subject
protection systems because of its low level of monitoring. VA has made
progress in strengthening its oversight. ORCA,

which was created in 1999, was charged with advising the Under Secretary
for Health on all matters related to human subject protections, promoting
the ethical conduct of research, and conducting prospective reviews and

*for cause* investigations. Since becoming operational, ORCA has
investigated claims of improper conduct of research and noncompliance. In
about a dozen cases, it sent teams to medical centers to conduct intensive
for cause reviews. ORCA also conducted six on- site reviews to follow up
on findings from external accreditation reviews. As a result of its
investigations, ORCA restricted or suspended research at four VA medical
centers until identified problems were corrected. For example, in March

2001, ORCA restricted one medical center*s human research activities by
suspending enrollment of new subjects in research after its investigation
revealed noncompliance with several regulations pertaining to IRBs. 6 5 VA
has 21 Veterans Integrated Service Networks that coordinate the activities
of, and

allocate funds to, VA medical centers, nursing homes, and other facilities
in each region. 6 The IRB of this medical center served as the IRB- of-
record for a second VA medical center. Therefore, human research at two
medical centers was affected. Internal and External

Oversight Strengthened

Page 9 GAO- 03- 917T ORCA lifted this restriction in February 2002 after
the medical center corrected the identified problems.

In addition to its internal oversight mechanisms, VA became the first
research organization to arrange for external accreditation of human
subject protection systems. External accreditation has the potential to
significantly strengthen oversight of human subject protections. In August
2000, VA awarded a $5.8 million, 5- year contract to NCQA to operate an

accreditation program to assess medical centers* compliance with federal
regulations for the protection of human subjects. VA*s contract with NCQA
requires it to develop accreditation standards, to conduct a site visit
every 3 years to each VA medical center conducting human research, and to
decide on the accreditation status of each facility. According to a 2001
report by the Institute of Medicine, the accreditation standards developed
by NCQA provide a promising basis for accreditation because they are
explicitly linked to federal regulations and pay attention to quality
improvement. 7 The Institute of Medicine recommended that the NCQA
standards be strengthened, for example, by specifying how research
subjects will be involved in human subject protection systems.

NCQA began accrediting VA medical centers and has revised its
accreditation process. NCQA conducted accreditation visits to 23 VA
facilities from September 2001 through May 2002. An ORD official told us
that, of those 23 facilities, 20 were accredited with conditions, 2 were
not accredited, and 1 withdrew from the process. A facility accredited
with

conditions met most of the accreditation standards. On the basis of its
experience and feedback on its standards, NCQA proposed* and ORD approved*
revising the standards. NCQA discontinued accreditation reviews while it
revised its standards for evaluating human subject protection programs.
Revisions involved clarification of standards, reduction of redundancies,
and changes to the scoring system. Some revisions were designed to respond
to comments from the Institute of Medicine. For example, NCQA adopted
standards to encourage a facility

to obtain input from research subjects to improve its human subject
protection system. ORD approved a new set of standards in April 2003. Site
visits are expected to resume in October 2003, with accreditation reviews
of all VA facilities involved in human subject research planned for
completion by summer 2005. 7 Institute of Medicine, Preserving Public
Trust: Accreditation and Human Research Participant Protection Programs
(Washington, D. C.: National Academy Press, 2001).

Page 10 GAO- 03- 917T In 2000, we reported that IRBs have difficulty
handling adverse event reports and often lack key information necessary
for their interpretation.

Since then, VA has not developed a mechanism for handling adverse event
reports to ensure that IRBs have information that can help them interpret
reports of actual adverse events that research subjects experience while
participating in studies. Federal regulations require investigators to
report to the IRB unanticipated problems involving risks to subjects. In
turn,

IRBs are to review these adverse event reports as part of their continuing
assessment of the adequacy of a study*s protections for human subjects.
ORD issued guidance stating that analyses of adverse events should be
provided to IRBs for those clinical trials that VA funds at multiple
medical

centers. ORCA staff participated in interagency discussions about how to
help IRBs handle adverse event reports and developed guidance regarding
what adverse events IRBs are to report to ORCA. As of June 2003, this
guidance has not been issued and VA still lacks comprehensive guidance to
help IRBs interpret reports of adverse events.

In 2000, we reported that VA did not know what level of funding was
necessary to support human subject protection activities and research
officials at five of eight medical centers we visited told us that they
had insufficient funds to ensure adequate operation of their human subject
protection systems. In May 2000, ORD provided networks with suggestions
for the level of administrative staffing of IRBs. ORD also commissioned a

study of the costs of operating IRBs within VA, which was completed in
June 2002. On June 13, 2003, VA issued a policy regarding funding for
human subject protection programs that medical centers are to obtain from
external sponsors of VA research. Specifically, the sponsor of each
industry- funded study is to be charged 10 percent of the direct costs of
the study or a flat fee of $1,200, whichever is greater, by the medical
center to help cover the costs of the human subject protection program. We
have not had the opportunity to study the potential for this mechanism to
help ensure sufficient funding. VA has not specified a procedure for
ensuring that its medical centers* which conduct VA- funded research and
research funded by federal agencies and research foundations as well as

industries*- will be allocated the funds necessary for their human subject
protection programs. Actions Regarding Adverse

Event Reports and Funding for Human Subject Protection Activities Are
Incomplete

Page 11 GAO- 03- 917T In 2003, VA began a reorganization of its research
offices without adequate planning and notice. We found that VA did not
initially ensure the

independence of compliance activities, although more recent actions appear
to have restored the integrity of the compliance function. In addition, VA
has not clarified responsibilities for education, training, and policy
development.

VA*s initial action to reorganize its research offices failed to ensure
the independence of compliance activities. In January 2003, officials
announced that the existing compliance office, ORCA, would be disbanded
and the compliance function and staff reassigned to ORD. As a result,
compliance field personnel began reporting their activities to ORD,
potentially compromising the independence of their compliance
investigations. In a series of memorandums issued from March through

May of 2003, VA announced that a new office, ORO, would replace ORCA. VA
memorandums indicated that ORO, like ORCA, would be independent of ORD,
and that ORO would be organizationally responsible to the Under

Secretary for Health. According to generally accepted government auditing
standards, offices with responsibility for assessing regulatory compliance
should be organizationally independent of the offices they review and
should report to, and be accountable to, the head or deputy head of the
government entity. 8 Because VA considered making ORD responsible for
compliance

activities* where its independence would be compromised* legislation was
proposed in the House of Representatives to establish an independent
office within VA to oversee research compliance with federal regulations.
9 According to VA memorandums and discussions with agency officials, ORO
will have responsibility for investigating allegations of research
noncompliance, misconduct, and improprieties. However, it is not clear
whether ORO will have authority to review a medical center*s human subject
protection program in the absence of a prior allegation of a problem; that
is, whether it can conduct prospective investigations. While

8 HHS separated its compliance office from its administrative office after
we voiced similar concerns about independence. As a result, instead of
reporting to the National Institutes of Health, which conducts and funds
research, OHRP has been reporting to HHS*s Assistant

Secretary for Health since June 2000. See U. S. General Accounting Office,
Scientific Research: Continued Vigilance Critical to Protecting Human
Subjects, GAO/ HEHS- 96- 72 (Washington, D. C.: Mar. 8, 1996). 9 H. R.
1585, 108th Cong. (2003). Recent Reorganization Appears to Maintain
Independent

Compliance Function, but Other Roles and Responsibilities Unclear

Page 12 GAO- 03- 917T VA memorandums indicate that ORO will have the same
compliance responsibilities that ORCA had and specify that for cause
inspections will be conducted; they are silent on routine inspections.
Experts in human

subject protections have said that these routine inspections, sometimes
referred to as prospective inspections, are an essential way to help
prevent noncompliance. As of June 2003, a directive to formalize the
authorities and responsibilities of ORO has not been issued. Consequently,
ORO*s compliance responsibilities remain unclear.

Other roles and responsibilities are also unclear. For example, ORCA
previously had responsibilities for education and training. VA*s
reorganization now assigns these responsibilities solely to ORD. The
implications of this transfer of responsibilities for strengthening human
subject protections are unclear. For example, when ORCA conducted

compliance reviews or followed up on results of accreditation reviews, it
provided instruction about what steps would be necessary to correct
identified problems. It is not clear whether or to what extent such
instruction, including technical assistance regarding a specific area of
noncompliance, would be considered to be education and training and
therefore not within ORO*s responsibilities.

ORCA also had responsibility to participate in the development of policies
involving human subject protections. Under the reorganization, ORD would
have responsibility for policy development. Existing memorandums are
silent on whether ORO will have any role in, or can contribute its
expertise to, policy development. ORCA had been created with the

understanding that it would collaborate with ORD on dissemination of
information, communication, and policy development. It is not clear to
what extent VA*s efforts to strengthen its human subject protections will
bring to bear the collective expertise of the staff in its compliance and
operational research offices. However, having ORD take the lead on
policies regarding compliance functions or activities could be
inappropriate to the extent that it interferes with ORO*s independence in

executing its compliance functions. Mr. Chairman, this concludes my
prepared remarks. I will be pleased to answer any questions you or other
members of the subcommittee may have.

Page 13 GAO- 03- 917T For further information regarding this testimony,
please contact Cynthia A. Bascetta at (202) 512- 7101. Kristen Joan
Anderson, Jacquelyn Clinton, Pamela Dooley, Lesia Mandzia, Marcia Mann,
and Daniel Montinez also

contributed to this statement. Contact and Acknowledgments

Page 14 GAO- 03- 917T Human Subjects Research: HHS Takes Steps to
Strengthen Protections, but Concerns Remain. GAO- 01- 775T. Washington, D.
C.: May 23, 2001.

VA Research: Protections for Human Subjects Need to Be Strengthened. GAO/
HEHS- 00- 155. Washington, D. C.: September 28, 2000.

VA Research: System for Protecting Human Subjects Needs Improvements. GAO/
T- HEHS- 00- 203. Washington, D. C.: September 28, 2000. Scientific
Research: Continued Vigilance Critical to Protecting Human Subjects. GAO/
T- HEHS- 96- 102. Washington, D. C.: March 12, 1996.

Scientific Research: Continued Vigilance Critical to Protecting Human
Subjects. GAO/ HEHS- 96- 72. Washington, D. C.: March 8, 1996. Related GAO
Products (290294)

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