6660 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations

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.

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

§ 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

§ 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 § 512.14(e) for modifications to a

research project. The provisions in

§ 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 § 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

§ 512.11 have been recodified within

paragraph (a) and a new paragraph (b)

has been added to specify that requests
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations 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 § 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:

§ 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 §§ 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 nonemployee 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 § 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:
6662 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations

§ 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:

* * * * *

§§ 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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