[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Rules and Regulations]
[Pages 6660-6662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3394]
[[Page 6659]]
_______________________________________________________________________
Part III
Department of Justice
_______________________________________________________________________
Bureau of Prisons
_______________________________________________________________________
28 CFR Part 512
Research; Final Rule
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 /
Rules and Regulations
[[Page 6660]]
DEPARTMENT OF JUSTICE
Bureau of Prisons
28 CFR Part 512
[BOP-1008-F]
RIN 1120-AA14
Research
AGENCY: Bureau of Prisons, Justice.
ACTION: Finalization of Interim Rule.
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SUMMARY: In this document, the Bureau of Prisons is finalizing its
interim regulations on Research. In response to public comment the
Bureau is modifying its provisions for expedited review. For the sake
of administrative efficiency, the Bureau is also streamlining review
procedures for certain types of research requests.
EFFECTIVE DATE: February 12, 1997.
ADDRESSES: Office of General Counsel, Bureau of Prisons, HOLC Room 754,
320 First Street, NW., Washington, DC 20534.
FOR FURTHER INFORMATION CONTACT:
Roy Nanovic, Office of General Counsel, Bureau of Prisons, phone (202)
514-6655.
SUPPLEMENTARY INFORMATION: The Bureau of Prisons (Bureau) is finalizing
its regulations on Research. An interim rule on this subject was
published in the Federal Register March 23, 1994 (59 FR 13860).
The Bureau received comment from a university and from a
professional organization. The commenters expressed concern that the
provisions in Sec. 512.11 (b) and (c) which require that a project
contribute to the advancement of knowledge about corrections and which
prescribe projects involving medical experimentation, cosmetic
research, or pharmaceutical testing ``could serve to place at risk
individual prisoners with medical problems.'' The commenters argued
that, ``[i]n some cases, the only avenue for treating prisoners with
diseases for which there are no alternative treatments or for which the
standard of care has numerous side effects may be to enroll them in a
clinical trial involving an experimental drug, device or procedure.''
The commenters further argued, on general principles, that excluding a
class of subjects (i.e., prisoners) from participation in research
which has potential direct benefit to them was unfair. The commenters
noted that ``[t]he provisions as currently written appear to assume
that participation in research is a `burden' and do not take into
account that for individual prisoners there may be real benefits of
participating in medical research.''
The Bureau is strongly committed to its policy that medical
experimentation or pharmaceutical testing may not be conducted on
inmates in a research project. If a researcher initiated a request for
inmate participation in medical experimentation or pharmaceutical
testing, participation would not be permitted. The concerns raised by
the commenters for the treatment of individual prisoners with medical
problems are addressed under the Bureau's medical policy which follows
standard medical protocols. The Bureau's medical policy does not
preclude the use of U.S. Department of Health and Human Services-
approved clinical trials that may be warranted for diagnosis or
treatment of a specific inmate when recommended by the responsible
physician and approved by the Medical Director. Consistent with
standard medical protocols, such measures must have the prior written
consent of the patient (i.e., the inmate) and must be conducted under
conditions approved by the Department of Health and Human Services.
Therefore, the Bureau believes that no modification of its policy on
research is necessary.
The commenters also requested clarification on the relationship
between the Bureau's regulations and the Department of Justice's
requirements on research found in 28 CFR part 46. More specifically,
the commenters asked whether the Bureau Research Review Board (BRRB)
and the local research review boards will be expected to comply with
the requirements of Justice's regulations, noting as an example that
Justice's regulations required project review appropriate to the degree
of risk but not less than once per year, while the Bureau's ``interim
rule refers to yearly reviews.'' With respect to reviews of approved
research, the Bureau notes that the wording in Sec. 512.17 (``At a
minimum, yearly reviews will be conducted'') paraphrases the Justice
standard. In general, the BRRB meets the requirements specified in 28
CFR part 46; the Bureau's local research review boards are not required
to meet those criteria and accordingly adhere to the provisions of the
Bureau's regulations instead. The commenters also recommended that the
Bureau's regulations be consistent with the Department of Health and
Human Services' regulations in 45 CFR part 46, subpart C. The
Department of Justice, when issuing its regulations, noted in the
preamble that it intended to retain special (additional) protections
for prison populations (56 FR 28012). The Bureau's provisions in 28 CFR
part 512 serve this purpose. One protection is that the Bureau in 28
CFR part 512 requires a review of research proposals which are
technically exempt from 28 CFR part 46. Some of the additional
protections are similar to those in 45 CFR part 46, subpart C. With
respect to the Bureau's additional protection for medical
experimentation or pharmaceutical testing which is not present in 28
CFR part 46 or in subpart C of 45 CFR part 46, the Bureau received no
adverse comment on this point from either the Department of Justice or
the Department of Health and Human Services.
The commenters questioned whether expedited review would be
possible under Sec. 512.14(e) for modifications to a research project.
The provisions in Sec. 512.14(e) govern the conditions under which
expedited review is possible. The requirement to submit planned
methodological changes in a research project is contained in
Sec. 512.11(n). The intent of these provisions is that these changes
can be approved by either the full Board or through expedited review
depending upon the impact of the changes in the methodology on the
subjects in the study.
Finally, the commenters urged the Bureau to obtain a Department of
Health and Human Services ``assurance'' for its BRRB so that the BRRB
could review research proposals in place of the research organization's
Institution Review Board (IRB). The Bureau is not eligible to obtain a
Multiple Project Assurance with the Department of Health and Human
Services. Therefore, the Bureau's IRBs cannot officially substitute for
an HHS-approved IRB. However, the Bureau is modifying its interim
regulations to allow for both review of non-HHS-funded research by the
BRRB and expedited review of research projects by the BRRB in place of
the research organization's IRB if the research has been approved by
another official IRB (either within or outside the Bureau).
In adopting the interim rules as final, the Bureau wishes to update
an address contained in the regulations and to make one further change
in order to streamline procedures for approval or disapproval of (1)
information requests from Federal agencies, the Congress, the Federal
judiciary, or State or local governments, and (2) requests by private
organizations for organizational rather than personal information from
Bureau staff. To this effect, the provisions in Sec. 512.11 have been
recodified within paragraph (a) and a new paragraph (b) has been added
to specify that requests
[[Page 6661]]
from Federal agencies, the Congress, the Federal judiciary, or State or
local governments to collect information about areas for which they are
responsible and requests by private organizations for organizational
rather than personal information from Bureau staff shall be reviewed by
the Office of Research and Evaluation to determine which requirements
may be waived without jeopardizing human subject protections and to
document the actual waiver of any specific provisions. The address for
the Office of Research and Evaluation, which appears in paragraphs (a)
and (c) of Sec. 512.14, is being modified to remove the obsolete room
reference ``202 NALC Building'.
Members of the public may submit comment concerning this rule by
writing the previously cited address. These comments will be considered
but will receive no response in the Federal Register.
The Bureau of Prisons has determined that this rule is not a
significant regulatory action for the purpose of E.O. 12866, and
accordingly this rule was not reviewed by the Office of Management and
Budget pursuant to E.O. 12866. After review of the law and regulations,
the Director, Bureau of Prisons has certified that this rule, for the
purpose of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), does
not have a significant economic impact on a substantial number of small
entities, within the meaning of the Act. The economic impact of the
Bureau's interim provisions on Research is primarily determined by the
existing requirements of the Federal government's common regulations
for the protection of human subjects (see 28 CFR part 46 and 45 CFR
part 46). The modifications to the Bureau's previously published
interim procedures further serve to reduce the economic impact of these
provisions in certain cases.
List of Subjects in 28 CFR Part 512
Human research subjects, Prisoners, Reporting and recordkeeping
requirements, Safety.
Kathleen M. Hawk,
Director, Bureau of Prisons.
Accordingly, pursuant to the rulemaking authority vested in the
Attorney General in 5 U.S.C. 552(a) and delegated to the Director,
Bureau of Prisons in 28 CFR 0.96(p), the interim rule which was
published at 59 FR 13860 on March 23, 1994, is adopted as final with
the following changes.
SUBCHAPTER A--GENERAL MANAGEMENT AND ADMINISTRATION
PART 512--RESEARCH
1. The authority citation for 28 CFR part 512 continues to read as
follows:
Authority: 5 U.S.C. 301; 18 U.S.C. 3621, 3622, 3624, 4001, 4042,
4081, 4082 (Repealed in part as to offenses committed on or after
November 1, 1987), 5006-5024 (Repealed October 12, 1984 as to
offenses committed after that date), 5039; 28 U.S.C. 509, 510; 28
CFR 0.95-0.99.
2. Section 512.11 is revised to read as follows:
Sec. 512.11 Requirements for research projects and researchers.
(a) Except as provided for in paragraph (b) of this section, the
Bureau requires the following:
(1) In all research projects the rights, health, and human dignity
of individuals involved must be respected.
(2) The project must have an adequate research design and
contribute to the advancement of knowledge about corrections.
(3) The project must not involve medical experimentation, cosmetic
research, or pharmaceutical testing.
(4) The project must minimize risk to subjects; risks to subjects
must be reasonable in relation to anticipated benefits. The selection
of subjects within any one institution must be equitable. When
applicable, informed consent must be sought and documented (see
Secs. 512.15 and 512.16).
(5) Incentives may not be offered to help persuade inmate subjects
to participate. However, soft drinks and snacks to be consumed at the
test setting may be offered. Reasonable accommodations such as nominal
monetary recompense for time and effort may be offered to non-confined
research subjects who are both:
(i) no longer in Bureau of Prisons custody, and
(ii) participating in authorized research being conducted by Bureau
employees or contractors.
(6) The researcher must have academic preparation or experience in
the area of study of the proposed research.
(7) The researcher must assume responsibility for actions of any
person engaged to participate in the research project as an associate,
assistant, or subcontractor to the researcher.
(8) Except as noted in the informed consent statement to the
subject, the researcher must not provide research information which
identifies a subject to any person without that subject's prior written
consent to release the information. For example, research information
identifiable to a particular individual cannot be admitted as evidence
or used for any purpose in any action, suit or other judicial,
administrative, or legislative proceeding without the written consent
of the individual to whom the data pertains.
(9) The researcher must adhere to applicable provisions of the
Privacy Act of 1974 and regulations pursuant to this Act.
(10) The research design must be compatible with both the operation
of prison facilities and protection of human subjects. The researcher
must observe the rules of the institution or office in which the
research is conducted.
(11) Any researcher who is a non-employee of the Bureau must sign a
statement in which the researcher agrees to adhere to the provisions of
this subpart.
(12) Except for computerized data records maintained at an official
Department of Justice site, records which contain nondisclosable
information directly traceable to a specific person may not be stored
in, or introduced into, an electronic retrieval system.
(13) If the researcher is conducting a study of special interest to
the Office of Research and Evaluation (ORE), but the study is not a
joint project involving ORE, the researcher may be asked to provide ORE
with the computerized research data, not identifiable to individual
subjects, accompanied by detailed documentation. These arrangements
must be negotiated prior to the beginning of the data collection phase
of the project.
(14) The researcher must submit planned methodological changes in a
research project to the IRB for approval, and may be required to revise
study procedures in accordance with the new methodology.
(b) Requests from Federal agencies, the Congress, the Federal
judiciary, or State or local governments to collect information about
areas for which they are responsible and requests by private
organizations for organizational rather than personal information from
Bureau staff shall be reviewed by ORE to determine which provisions of
this subpart may be waived without jeopardizing the safety of human
subjects. ORE shall document in writing the waiver of any specific
provision along with the justification.
3. In Sec. 512.14, paragraphs (a) and (c) are amended by removing
the phrase ``202 NALC Building,'', and the introductory text of
paragraph (e) is revised to read as follows:
[[Page 6662]]
Sec. 512.14 Submission and processing of proposal.
* * * * *
(e) The BRRB chairperson may exercise the authority of the full
BRRB under an expedited review process when another official IRB
(either within or outside the Bureau) has approved the research, or
when, in his/her judgment, the research proposal meets the minimal risk
standard and involves only the following:
* * * * *
Secs. 512.10, 512.20, 512.21 [Amended]
4. In addition to the amendments set forth above, in 28 CFR part
512, subpart B, remove the words ``this rule'' and add, in their place,
the words ``this subpart'' in the following places:
(a) Section 512.10;
(b) Section 512.20(a) introductory text and (b);
(c) Section 512.21 (b) and (c).
[FR Doc. 97-3394 Filed 2-11-97; 8:45 am]
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