[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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