[Federal Register Volume 68, Number 119 (Friday, June 20, 2003)]
[Rules and Regulations]
[Pages 36929-36931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15580]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 46
Waiver of the Applicability of Certain Provisions of Department
of Health and Human Services Regulations for Protection of Human
Research Subjects for Department of Health and Human Services Conducted
or Supported Epidemiologic Research Involving Prisoners as Subjects
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Public Health and Science, Office for Human
Research Protections.
ACTION: Final action on waiver.
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SUMMARY: In a document published in the Federal Register on October 7,
2002 (67 FR 62432), the Secretary of Health and Human Services sought
public comment on a proposed waiver of the applicability of certain
requirements of the Department of Health and Human Services (DHHS or
Department) regulations for the protection of human subjects, 45 CFR
part 46, to allow DHHS to conduct or support certain important and
necessary epidemiologic research on prisoners that presents no more
than minimal risk and no more than inconvenience to the prisoner-
subjects. Pursuant to his authority under 45 CFR 46.101(i), the
Secretary proposed the waiver of Sec. Sec. 46.305(a)(l) and
46.306(a)(2) of the DHHS regulations for the protection of human
subjects, which sections set forth specific requirements for any
research involving prisoners that is conducted or supported by DHHS.
After consideration of the public comments received, the Secretary is
granting this waiver.
DATES: The waiver is effective June 20, 2003.
FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for
Human Research Protections (OHRP), The Tower Building, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852; telephone 301-496-7005; e-mail
istithco(osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION:
Regulatory Background
The Department of Health and Human Services (DHHS) regulates
research involving human subjects conducted or supported by DHHS
through regulations codified at 45 CFR part 46. Subpart C of 45 CFR
part 46, entitled ``Additional DHHS Protections Pertaining to
Biomedical and Behavioral Research Involving Prisoners as Subjects,''
provides additional regulatory protections to prisoners who are
research subjects.
Subpart C sets forth specific requirements for any research
involving prisoners as subjects that is conducted or supported by DHHS.
Subpart C lists four categories of research involving prisoners as
subjects that may be conducted or supported by DHHS. Sections 45 CER
46.305(a)(l) and 46 306(a)(2) require that the institutional review
board (TRB) reviewing the research and the Secretary, respectively,
determine that the research involving prisoners represent one of these
four categories. The first three categories, Sec. Sec.
46.306(a)(2)(i), (ii), and (iii), require that the research target
either (i) the possible causes, effects, or processes of incarceration
and of criminal behavior; (ii) the prison as an institution or prison
life; or (iii) conditions particularly affecting prisoners as a class.
The fourth category, Sec. 46.306(a)(2)(iv), permits research on
practices which have the intent and reasonable probability of improving
the health or well-being of the prisoner-subject.
DHHS Conducted or Supported Epidemiologic Research
DHHS conducts or supports certain epidemiologic studies in which
the purposes are as follows: (1) To describe the prevalence or
incidence of a disease by identifying all cases, and (2) To study
potential risk factor associations for a disease. For most such
studies, the institutional review board (IRB) reviewing the study
determines that the research at issue involves no more than minimal
risk and no more than inconvenience to the subjects. The human
participants in this type of public health research may include
prisoners in the study population. State health agencies are most
commonly the conduits for this type of research. Because certain
epidemiologic studies conducted or supported by DHHS focus on a
particular condition or disease that might affect prisoners as it would
any other members of the general population, such studies do not meet
any of the four categories of permissible research under subpart C, 45
CFR part 46.
Proposed Waiver
Pursuant to 45 CFR 46.101(i), the Secretary of DHHS has the
authority to waive the applicability of some or all of the provisions
of the DHHS regulations for the protection of human subjects to
specific research activities or classes of research activities
otherwise covered by the regulations. In a document published in the
Federal Register on October 7, 2002 (67 FR 62432), the Secretary of
DHHS sought public comment on a proposed waiver of the applicability of
certain requirements of subpart C, 45 CFR part 46, to allow DHHS to
conduct or support certain important and necessary epidemiologic
research on prisoners that presents no more than minimal risk and no
more than inconvenience to the prisoner-subjects. The Secretary of DHHS
specifically proposed waiving the applicability of 45 CFR 46.305(a)(l)
and 46.306(a)(2) for certain research conducted or supported by DHHS
that involves epidemiologic studies that meet the following criteria:
(1) In which the sole purposes are
(i) To describe the prevalence or incidence of a disease by
identifying all cases, or
(ii) To study potential risk factor associations for a disease, and
(2) Where the institution responsible for the conduct of the
research certifies to the Office for Human Research Protections, DHHS,
acting on behalf of
[[Page 36930]]
the Secretary, that the IRB approved the research and fulfilled its
duties under 45 CFR 46.305(a)(2)-(7) and determined and documented that
(i) The research presents no more than minimal risk and no more
than inconvenience to the prisoner-subjects, and
(ii) Prisoners are not a particular focus of the research.
The specific type of epidemiological research conducted or
supported by DHHS and subject to the proposed waiver involves no more
than minimal risk and no more than inconvenience to the human subject
participants. The proposed waiver would allow DHHS to conduct or
support a type of minimal risk research that does not now fall within
the categories set out in 45 CFR 46.306(a)(2).
The range of studies to which the proposed waiver would apply
includes epidemiological research related to chronic diseases,
injuries, and environmental health. This type of research uses
epidemiologic methods (such as interviews and collection of biologic
specimens) that generally entail no more than minimal risk to the
subjects.
An example of an epidemiological study that could be permitted
under the proposed waiver is one in which all persons with HIV, but
with none of the known risk factors for HIV, are asked to participate
in a study involving an interview, review of medical records, and
collection of a blood specimen. The purpose of the study is to
determine other 5 potential risk factors for HIV. All states with
mandatory HIV reporting laws report these cases to the Centers for
Disease Control and Prevention (CDC), DHHS. Each person who meets the
study definition would be asked to participate, and prisoners could
well be members of the potential study group. In order for the study to
be approved under this waiver, the IRB would need to ensure that, among
other things, there are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of the data.
Periodic Review
The Secretary also proposed that a periodic review of the ways in
which DHHS implements the proposed waiver would be conducted by OHRP to
determine the adequacy of the waiver in meeting its intended need or if
adjustments to the waiver might be necessary and appropriate.
Discussion of Comments
During the public comment period that ended on November 6, 2002,
DHHS received 14 comments on the proposed waiver from interested
parties; 12 of which were supportive of the proposed waiver, one of
which objected to the proposed waiver, and one of which commented on
research on prisoners in general. The comments are summarized as
follows:
Scope of the Research Covered by the Waiver
DHHS proposed that the waiver of applicability of 45 CFR
46.305(a)(1) and 46.306(a)(2) would apply only to certain types of
research. Four commenters suggested that this waiver be expanded to
other types of research. Of these, one suggested that the waiver extend
to other research that poses a minimal risk and inconvenience to
prisoners, such as an interview for purposes of obtaining a prisoner's
oral history; one urged DHHS to consider regulatory change to 45 CFR
46.306(a)(2) to allow the type of epidemiologic research covered under
the proposed waiver to be an approvable category of research under
Subpart C; one suggested that the proposed waiver apply to studies in
which the risk of participation is not increased by being a prisoner,
or where the study involves minimal risk to the subject over the risk
already taken (e.g., as part of an ongoing epidemiologic or follow-up
study); and one requested that the waiver be extended to minimal risk
research focused on a particular disease or condition that could affect
prisoners as it would anyone else in the population.
The Department finds that it is appropriate to apply the proposed
waiver of applicability of 45 CFR 46.305(a)(1) and 46.306(a)(2) solely
to public health research that focuses on a particular condition or
disease in order to (1) describe its prevalence or incidence by
identifying all cases, including prisoner cases, or (2) study potential
risk factor associations, where the human subjects may include
prisoners in the study population but not exclusively as a target
group. The Department therefore declines to expand the scope of the
waiver as proposed.
One commenter stated that the proposed waiver should not be
approved because Subpart C already permits, under certain conditions,
the types of epidemiological studies under consideration. The commenter
asserts that if the objective of an epidemiological study is to
describe the prevalence of certain diseases or conditions among
prisoners--either alone or as compared to non-prisoners--then the
research should be permitted under 45 CFR 46.306(a)(2)(B).
The Department notes that, because the proposed waiver applies to
studies in which an IRB has found that prisoners are not a particular
focus of the study, the research, in fact, would not be approvable
under any of the current four categories of 45 CFR 46.306(a)(2):
(i) The causes, effects, or processes of incarceration and of
criminal behavior; (ii) the prison as an institution or prison life;
(iii) conditions particularly affecting prisoners as a class; or (iv)
research on practices which have the intent and reasonable probability
of improving the health or well-being of the prisoner-subject.
Certification
Two commenters questioned the certification requirement of the
proposed waiver. One commenter stated that the separate certification
called for in the proposed waiver is an unnecessary extra step and
should be eliminated; and one commenter stated that it is unclear what
additional protections will be afforded to subjects by the process of
certification and how, other than in timing, will this certification be
different than the current requirement.
The Department notes that the proposed waiver would not require
certification separate from the certification which institutions now
must make to the Secretary (through OHRP) affirming that the IRB
approved the research and fulfilled its duties under 45 CFR
46.305(a)(2)-(7). However, the proposed waiver would require that such
certification include the IRB's determination and documentation that
the research presents no more than minimal risk and no more than
inconvenience to the prisoner-subject, and that prisoners are not a
particular focus of the research.
Prisoner Representative
One commenter expressed the desire to be able to invoke the
proposed waiver without the IRB needing a prisoner representative to
participate in the review of the research. The Department finds that
the requirements of the DHHS regulations at 45 CFR 46.304(b) must be
satisfied for research that would be covered by the proposed waiver.
The Department notes that if a particular research project is reviewed
by more than one IRB, only one IRB needs to satisfy these requirements.
Periodic Review by OHRP
One commenter states that the proposed waiver should not be
approved because it does not provide sufficient assurances about how
the adequacy of the waiver or adjustments to the waiver will be
periodically
[[Page 36931]]
reviewed. The Department believes that the proposed waiver includes
adequate assurances that OHRP will conduct periodic reviews to
determine the adequacy of the waiver in meeting its intended need or if
adjustments to the waiver are necessary and appropriate. The Department
notes that OHRP will receive and review all certifications of research
covered by the proposed waiver.
Other
One commenter suggested that the DHHS regulations should permit
prisoners to complete a study in which they were enrolled before being
incarcerated. The Department finds that this comment is not relevant to
the proposed waiver. The Department may consider this issue at a future
time.
One commenter recommended that DHHS adopt a new rule or standard
for informed consent when a prisoner is participating as a research
subject and the consent occurred in the prison milieu. The Department
finds that this comment is not directly relevant to the proposed
waiver. The Department notes that because prisoner-subjects are
afforded all of the protections of the informed consent requirements
listed in Sec. 46.116 of 45 CFR part 46, subpart A, the current
standards for obtaining informed consent from prisoner-subjects are
adequate.
One commenter found the example given of when the proposed waiver
could be used to be incongruent with the requirement that the waiver
only may apply to minimal risk research. The commenter asserted that a
study of HIV is not minimal risk regarding a loss of confidentiality.
The Department believes that the example given could entail no more
than minimal risk for research involving prisoners as defined under 45
CFR 46.303(d): the probability and magnitude of physical or
psychological harm that is normally encountered in the daily lives, or
in the routine medical, dental, or psychological examination of healthy
persons.
One commenter stated that a prisoner should not be required to be a
``guinea pig'' and that a prisoner should be enrolled in research only
if the prisoner agrees to participate in writing. The Department notes
that the commenter's objections are not specific to the proposed
waiver. The Department further notes that under Sec. Sec. 46.116 and
46.117 of subpart A of the DHHS regulations for the protection of human
subjects, no investigator may involve a human being as a subject in
research covered by the regulations unless the investigator has
obtained and documented the informed consent of the subject in
accordance with, and to the extent required by, the DHHS regulations.
One commenter states that the proposed waiver should not be
approved because it represents a retreat from one of the most important
values underlying Subpart C: the fair distribution of the burdens and
benefits of research. The Department believes that the waiver as
proposed supports the fair distribution of burdens and benefits of
research permitting subjects, including some who are prisoners, to
participate in certain DHHS-supported or conducted research in which
the purposes are (1) to describe the prevalence or incidence of disease
by identifying all cases; and (2) to study potential risk factors
associations for a disease. Such studies would not be permitted without
the waiver.
Summary
After considering the comments, DHHS is adopting the waiver as
proposed. The waiver is effective June 20, 2003. All initial and
ongoing projects reviewed by IRBs under DHHS-approved assurances after
the effective date may be reviewed in accordance with this waiver.
Dated: April 28, 2003.
Richard H. Carmona,
Surgeon General and Acting Assistant Secretary for Health.
Approved: June 13, 2003.
Tommy Thompson,
Secretary, Department of Health and Human Services
[FR Doc. 03-15580 Filed 6-19-03; 8:45 am]
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