[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]


      

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Part III





Department of Justice





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Bureau of Prisons



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28 CFR Part 512



Research; Final Rule

  Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / 
Rules and Regulations  

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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

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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:

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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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