[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6849]


[[Page Unknown]]

[Federal Register: March 23, 1994]


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Part IX





Department of Justice





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Bureau of Prisons



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28 CFR Part 512




Research Regulations on Protection of Human Subjects; Interim Rule
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DEPARTMENT OF JUSTICE

Bureau of Prisons

28 CFR Part 512

[BOP-1008-I]
RIN 1120-AA14

 
Research

AGENCY: Bureau of Prisons, Justice.

ACTION: Interim rule.

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SUMMARY: In this document, the Bureau of Prisons is revising its rule 
on Research in order to conform to Departmental regulations on the 
Protection of Human Subjects requiring, among other provisions, the 
establishment of an institutional review board. Additional procedural 
changes have also been made in order to simplify the application 
process or to clarify policy.

DATES: Effective March 23, 1994; comments must be received by May 23, 
1994.

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 is amending its 
regulations on Research. A final rule on this subject was published in 
the Federal Register October 1, 1981 (46 FR 48577).
    Department of Justice regulations pertaining to the Protection of 
Human Subjects are contained in 28 CFR part 46. The Bureau's 
regulations on the conduct of research are consequently being revised 
in order to conform to Departmental requirements. In compliance with 
Departmental regulations, the Bureau Research Review Board (BRRB) is 
identified as the Bureau's institutional review board. Processing 
procedures are revised in order to stipulate the duties of the BRRB and 
supporting staff at institutions in its oversight of research projects. 
As a clarification, the Bureau notes that implementation of 
programmatic or operational initiatives made through pilot projects are 
not considered to be research.
    In addition to these conforming amendments, the Bureau is also 
making other procedural changes intended to simplify the research 
application process. For example, procedures on the submission of 
research proposals are revised to remove reference to distinctions 
between routine and non-routine requests. Revised procedures in 
Sec. 512.14 instead direct that requests be submitted either to the 
institution, if only one institution is involved, or to the Office of 
Research if more than one institution is involved.
    Section 512.15 restates provisions contained in former Sec. 512.17 
on access to Bureau of Prisons records. As revised, this section now 
includes reference to disclosure provisions of the Privacy Act.
    In addition, provisions on incentives in newly revised 
Sec. 512.11(e) have been clarified to allow for reasonable recompense 
for time and effort to be offered to research subjects no longer in 
Bureau custody. The intent of restrictions on incentives within the 
institution is to ensure that participation of current inmates is 
voluntary. The Bureau believes that there is no compelling need to 
extend such precautionary restriction to subjects who are not in the 
Bureau's custody.
    As revised, the regulations no longer contain a separate section on 
definitions. The terms contained in former Sec. 512.11 are now either 
defined in 28 CFR 46.102 or are explained in the regulations where 
necessary.
    Because these amendments are either administrative or conforming in 
nature and pose no additional restraints on inmates, the Bureau finds 
good cause for exempting the provisions of the Administrative Procedure 
Act (5 U.S.C. 553) requiring notice of proposed rulemaking and delay in 
effective date. While the Bureau believes it is necessary to implement 
these changes immediately, the Bureau is publishing the procedures as 
an interim rule in order to invite public comment. Members of the 
public may submit comments concerning this rule by writing to the 
previously cited address. These comments will be considered before the 
rule is finalized.
    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 (Pub. L. 96-354), does not 
have a significant impact on a substantial number of small entities.

List of Subjects in 28 CFR Part 512

    Prisoners.
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), part 512 in subchapter A of 28 
CFR, chapter V is amended as set forth below.

SUBCHAPTER A--GENERAL MANAGEMENT AND ADMINISTRATION

PART 512--RESEARCH

    1. The authority citation for 28 CFR part 512 is revised 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. Subpart B, consisting of Secs. 512.10 through 512.22, is revised 
to consist of Secs. 512.10 through 512.21 as follows:

Subpart B--Research

Sec.
512.10  Purpose and scope.
512.11  Requirements for research projects and researchers.
512.12  Content of research proposal.
512.13  Institutional Review Board.
512.14  Submission and processing of proposal.
512.15  Access to Bureau of Prisons records.
512.16  Informed consent.
512.17  Monitoring approved research projects.
512.18  Termination or suspension.
512.19  Reports.
512.20  Publication of results of research project.
512.21  Copyright provisions.

Subpart B--Research


Sec. 512.10  Purpose and scope.

    General provisions for the protection of human subjects during the 
conduct of research are contained in 28 CFR part 46. The provisions of 
this subpart B specify additional requirements for prospective 
researchers (both employees and non-employees) to obtain approval to 
conduct research within the Bureau of Prisons (Bureau) and 
responsibilities of Bureau staff in processing proposals and monitoring 
research projects. Although some research may be exempt from 28 CFR 
part 46 under Sec. 46.101(b)(5), as determined by the Office of 
Research and Evaluation (ORE) of the Bureau, no research is exempt from 
28 CFR part 512. For the purpose of this rule, implementation of Bureau 
programmatic or operational initiatives made through pilot projects is 
not considered to be research.


Sec. 512.11  Requirements for research projects and researchers.

    The Bureau requires the following:
    (a) In all research projects the rights, health, and human dignity 
of individuals involved must be respected.
    (b) The project must have an adequate research design and 
contribute to the advancement of knowledge about corrections.
    (c) The project must not involve medical experimentation, cosmetic 
research, or pharmaceutical testing.
    (d) 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).
    (e) 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:
    (1) No longer in Bureau of Prisons custody, and
    (2) Participating in authorized research being conducted by Bureau 
employees or contractors.
    (f) The researcher must have academic preparation or experience in 
the area of study of the proposed research.
    (g) 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.
    (h) 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.
    (i) The researcher must adhere to applicable provisions of the 
Privacy Act of 1974 and regulations pursuant to this Act.
    (j) 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.
    (k) 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 rule.
    (l) 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.
    (m) 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.
    (n) 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.


Sec. 512.12  Content of research proposal.

    When submitting a research proposal, the applicant shall provide 
the following information:
    (a) A summary statement which includes:
    (1) Name(s) and current affiliation(s) of the researcher(s);
    (2) Title of the study;
    (3) Purpose of the project;
    (4) Location of the project;
    (5) Methods to be employed;
    (6) Anticipated results;
    (7) Duration of the study;
    (8) Number of subjects (staff/inmates) required and amount of time 
required from each; and
    (9) Indication of risk or discomfort involved as a result of 
participation.
    (b) A comprehensive statement which includes:
    (1) Review of related literature;
    (2) Detailed description of the research method;
    (3) Significance of anticipated results and their contribution to 
the advancement of knowledge;
    (4) Specific resources required from the Bureau;
    (5) Description of all possible risks, discomforts, and benefits to 
individual subjects or a class of subjects, and a discussion of the 
likelihood that the risks and discomforts will actually occur;
    (6) Description of steps taken to minimize any risks described in 
(b)(5) of this section.
    (7) Description of physical and/or administrative procedures to be 
followed to:
    (i) Ensure the security of any individually identifiable data that 
are being collected for the project, and
    (ii) Destroy research records or remove individual identifiers from 
those records when the research has been completed.
    (8) Description of any anticipated effects of the research project 
on institutional programs and operations; and
    (9) Relevant research materials such as vitae, endorsements, sample 
informed consent statements, questionnaires, and interview schedules.
    (c) A statement regarding assurances and certification required by 
28 CFR part 46, if applicable.


Sec. 512.13  Institutional Review Board.

    (a) The Bureau of Prisons' central institutional review board shall 
be called the Bureau Research Review Board (BRRB). It shall consist of 
the Chief, ORE, at least four other members, and one alternate, 
appointed by the Director, and shall meet a sufficient number of times 
to insure that each project covered by 28 CFR part 46 receives an 
annual review. A majority of members shall not be Bureau employees. The 
BRRB shall include an individual with legal expertise and a 
representative for inmates whom the Director determines is able to 
identify with inmate concerns and evaluate objectively a research 
proposal's impact on, and relevance to, inmates and to the correctional 
process.
    (b) The Chief, ORE, shall serve as chairperson of the BRRB. If a 
potential conflict of interest exists for the BRRB chairperson on a 
particular research proposal, the Assistant Director, Information, 
Policy, and Public Affairs Division, shall appoint another individual 
to serve as chairperson on matters pertaining to that project.


Sec. 512.14  Submission and processing of proposal.

    (a) An applicant may submit a preliminary research proposal for 
review by the Office of Research and Evaluation, Federal Bureau of 
Prisons, 320 First Street, NW., 202 NALC Building, Washington, DC 
20534. Staff response to the preliminary proposal does not constitute a 
final decision.
    (b) If the study is to be conducted at only one institution, the 
applicant shall submit a formal proposal to the warden of that 
institution. Proposal processing will be as follows:
    (1) The warden shall appoint a local research review board to 
consult with operational staff, to evaluate the proposal for compliance 
with research policy, and to make recommendations to the warden. The 
local research review board is encouraged, but not required, to meet 
the membership requirements of an IRB, as specified in 28 CFR part 46.
    (2) The warden shall review the comments of the board, make a 
recommendation regarding the proposal, and forward the proposal package 
to the Regional Director, with a copy to the Chief, ORE.
    (3) The Regional Director shall review the proposal and forward 
recommendations to the Chief, ORE.
    (c) If the study is to be conducted at more than one institution or 
at any other Bureau location, the applicant shall submit the research 
proposal to the Chief, Office of Research and Evaluation, Federal 
Bureau of Prisons, 320 First Street, NW., 202 NALC Building, 
Washington, DC 20534. The Chief, ORE, shall determine an appropriate 
review process.
    (d) All formal proposals will be reviewed by the BRRB.
    (e) The BRRB chairperson may exercise the authority of the full 
BRRB under an expedited review process when, in his/her judgment, the 
research proposal meets the minimal risk standard and involves only the 
following:
    (1) The study of existing data, documents, or records; and/or
    (2) The study of individual or group behavior or characteristics of 
individuals, where the investigator does not manipulate subjects' 
behavior and the research will not involve stress to subjects. Such 
research would include test development and studies of perception, 
cognition, or game theory. If a proposal is processed under expedited 
review, the BRRB chairperson must document in writing the reason for 
that determination.
    (f) The Chief, ORE, shall review all recommendations made and shall 
submit them in writing to the Director, Bureau of Prisons.
    (g) The Director, Bureau of Prisons, has final authority to approve 
or disapprove all research proposals. The Director may delegate this 
authority to the Assistant Director, Information, Policy, and Public 
Affairs Division.
    (h) The approving authority shall notify in writing the involved 
region(s), institution(s), and the prospective researcher of the final 
decision on a research proposal.


Sec. 512.15  Access to Bureau of Prisons records.

    (a) Employees, including consultants, of the Bureau who are 
conducting authorized research projects shall have access to those 
records relating to the subject which are necessary to the purpose of 
the research project without having to obtain the subject's consent.
    (b) A non-employee of the Bureau is limited in access to 
information available under the Freedom of Information Act (5 U.S.C. 
552).
    (c) A non-employee of the Bureau may receive records in a form not 
individually identifiable when advance adequate written assurance that 
the record will be used solely as a statistical research or reporting 
record is provided to the agency (5 U.S.C. 552a(b)(5)).


Sec. 512.16  Informed consent.

    (a) Before commencing a research project requiring participation by 
staff or inmates, the researcher shall give each participant a written 
informed consent statement containing the following information:
    (1) Identification of the principal investigator(s);
    (2) Objectives of the research project;
    (3) Procedures to be followed in the conduct of research;
    (4) Purpose of each procedure;
    (5) Anticipated uses of the results of the research;
    (6) A statement of benefits reasonably to be expected;
    (7) A declaration concerning discomfort and risk, including a 
description of anticipated discomfort and risk;
    (8) A statement that participation is completely voluntary and that 
the participant may withdraw consent and end participation in the 
project at any time without penalty or prejudice (the inmate will be 
returned to regular assignment or activity by staff as soon as 
practicable);
    (9) A statement regarding the confidentiality of the research 
information and exceptions to any guarantees of confidentiality 
required by federal or state law. For example, a researcher may not 
guarantee confidentiality when the subject indicates an intent to 
commit future criminal conduct or harm himself/herself or someone else, 
or, if the subject is an inmate, indicates an intent to leave the 
facility without authorization.
    (10) A statement that participation in the research project will 
have no effect on the inmate participant's release date or parole 
eligibility;
    (11) An offer to answer questions about the research project; and
    (12) Appropriate additional information as needed to describe 
adequately the nature and risks of the research.
    (b) A researcher who is an employee of the Bureau shall include in 
the informed consent statement a declaration of the authority under 
which the research is conducted.
    (c) A researcher who is an employee of the Bureau, in addition to 
presenting the statement of informed consent to the subject, shall also 
obtain the subject's signature on the statement of informed consent, 
when:
    (1) The subject's activity requires something other than response 
to a questionnaire or interview; or
    (2) The Chief, ORE, determines the research project or data-
collection instrument is of a sensitive nature.
    (d) A researcher who is a non-employee of the Bureau, in addition 
to presenting the statement of informed consent to the subject, shall 
also obtain the subject's signature on the statement of informed 
consent prior to initiating the research activity. The researcher may 
not be required to obtain the signature if the researcher can 
demonstrate that the only link to the subject's identity is the signed 
statement of informed consent or that there is significantly more risk 
to the subject if the statement is signed. The signed statement shall 
be submitted to the chairperson of the appropriate local research 
review board.


Sec. 512.17  Monitoring approved research projects.

    The BRRB shall monitor all research projects for compliance with 
Bureau policies. At a minimum, yearly reviews will be conducted.


Sec. 512.18  Termination or suspension.

    The Director, Bureau of Prisons, may suspend or terminate a 
research project if it is believed that the project violates research 
policy or that its continuation may prove detrimental to the inmate 
population, the staff, or the orderly operation of the institution.


Sec. 512.19  Reports.

    The researcher shall prepare reports of progress on the research 
and at least one report of findings.
    (a) At least once a year, the researcher shall provide the Chief, 
ORE, with a report on the progress of the research.
    (b) At least 12 working days before any report of findings is to be 
released, the researcher shall distribute one copy of the report to 
each of the following: the chairperson of the BRRB, the regional 
director, and the warden of each institution which provided data or 
assistance. The researcher shall include an abstract in the report of 
findings.


Sec. 512.20  Publication of results of research project.

    (a) A researcher may publish in book form and professional journals 
the results of any research project conducted under this rule.
    (1) In any publication of results, the researcher shall acknowledge 
the Bureau's participation in the research project.
    (2) The researcher shall expressly disclaim approval or endorsement 
of the published material as an expression of the policies or views of 
the Bureau.
    (b) Prior to submitting for publication the results of a research 
project conducted under this rule, the researcher shall provide two 
copies of the material, for informational purposes only, to the Chief, 
Office of Research and Evaluation, Central Office, Bureau of Prisons.


Sec. 512.21  Copyright provisions.

    (a) An employee of the Bureau may not copyright any work prepared 
as part of his/her official duties.
    (b) As a precondition to the conduct of research under this rule, a 
non-employee shall grant in writing to the Bureau a royalty-free, non-
exclusive, and irrevocable license to reproduce, publish, translate, 
and otherwise use and authorize others to publish and use original 
materials developed as a result of research conducted under this rule.
    (c) Subject to a royalty-free, non-exclusive and irrevocable 
license, which the Bureau of Prisons reserves, to reproduce, publish, 
translate, and otherwise use and authorize others to publish and use 
such materials, a non-employee may copyright original materials 
developed as a result of research conducted under this rule.

[FR Doc. 94-6849 Filed 3-22-94; 8:45 am]
BILLING CODE 4410-05-P