[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Proposed Rules]
[Pages 62432-62433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25205]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46


Proposed Waiver of the Applicability of Certain Provisions of 
Department of Health and Human Services Regulations for the Protection 
of Human Subjects for Department of Health and Human Services 
Epidemiologic Research Involving Prisoners as Subjects

AGENCY: Office for Human Research Protections, Office of Public Health 
and Science, Office of the Secretary, Department of Health and Human 
Services.

ACTION: Proposed notice of waiver.

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SUMMARY: The Department of Health and Human Services (DHHS) is 
proposing to waive the applicability of certain provisions of Subpart C 
of 45 CFR part 46, the DHHS regulations for the protection of human 
subjects, to specific types of epidemiological research involving 
prisoners as subjects. Subpart

[[Page 62433]]

C, entitled Additional DHHS Protections Pertaining to Biomedical and 
Behavioral Research Involving Prisoners as Subjects, sets forth 
specific requirements for any research involving prisoners that is 
conducted or supported by DHHS. Pursuant to 45 CFR 46.101(i), the 
Secretary of Health and Human Services proposes waiving the 
applicability of 45 CFR 46.305(a)(1) and 46.306(a)(2) to allow DHHS to 
conduct or support certain important and necessary epidemiologic 
research that presents no more than minimal risk and no more than 
inconvenience to prisoner-subjects.

DATES: Comments on the proposed waiver must be received on or before 
November 6, 2002.

ADDRESSES: Comments must be sent to: 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 
[email protected]. The Department invites written comments on 
the proposed waiver.

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 
[email protected]. Interested persons may obtain a copy of the 
current regulations for protection of human subjects, including subpart 
C, at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

SUPPLEMENTARY INFORMATION:

Proposed Waiver

    Pursuant to 45 CFR 46.101(i), the Secretary of Health and Human 
Services (HHS) proposes waiving the applicability of 45 CFR 
46.305(a)(1) and 46.306(a)(2) for certain research conducted or 
supported by DHHS. In specific, for DHHS conducted or supported 
research involving epidemiologic studies (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 (OHRP), acting on behalf of the Secretary, that 
the Institutional Review Board (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 Secretary of DHHS 
proposes waiving the requirements in sections 46.305(a)(1) and 
46.306(a)(2) that the IRB and the Secretary determine that the research 
involves one of the categories of research permissible under 45 CFR 
46.306(a)(2).

Background

    DHHS conducts or supports certain epidemiologic studies in which 
the purposes are: (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 IRB 
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 kind of research.
    Subpart C of the DHHS regulations, set forth in 45 CFR 46.301 et 
seq., defines four categories of research that may involve prisoners. 
Sections 45 CFR 46.305(a)(1) and 46 306(a)(2) require that IRBs and the 
Secretary, respectively, determine that research involving prisoners 
represent one of these four categories. The first three, paragraphs 
(i), (ii), and (iii) of 46.306(a)(2), require that the research target 
either (i) the 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, paragraph (iv) of 46.306(a)(2), permits research on practices 
which have the intent and reasonable probability of improving the 
health or well-being of the prisoner-subject. Certain epidemiologic 
studies conducted or supported by the DHHS do not fall into any of 
these four categories. Instead, the research focuses on a particular 
condition or disease which might affect prisoners as it would anyone 
else in the population.
    An example of an epidemiological study that would 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 potential risk factors for HIV. All states with 
mandatory HIV reporting laws report these cases to the Centers for 
Disease Control and Prevention (CDC). Each person who meets the study 
definition would be asked to participate, and prisoners could well be 
members of the potential study group.
    The range of studies to which the proposed waiver would apply 
includes chronic diseases, injuries, and environmental health. This 
type of research uses epidemiologic methods (such as interviews and 
collection of biologic specimens) that entails no more than minimal 
risk to the subjects.
    The specific type of epidemiological research conducted 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).

Periodic Review

    If implemented, 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.

    Dated: September 9, 2002.
Eve E. Slater,
Assistant Secretary for Health.
    Approved: September 26, 2002.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 02-25205 Filed 10-4-02; 8:45 am]
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