BOP Program Statement 1075.01 § 3

(a) Except as provided for in paragraph (b) of this section, the Bureau requires the

following:

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(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.

The BRRB will determine if the project has an adequate research design and

contributes to the advancement of knowledge about corrections to a degree that

would justify the approval of a research project.

(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).

Informed consent is generally not necessary when only archival information in

Bureau records is being analyzed.

(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 and in the research methodology proposed.

(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

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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.

The information the Bureau collects is protected by the following legislation and

regulations, including amendments:

 Privacy Act of 1974

 Computer Matching and Privacy Protection Act of 1988

 Freedom of Information Act of 1966

 E-Government Act of 2002

 Federal Information Security Management Act of 2002, and

 OMB Circular A-130, Management of Federal Information Resources,

Appendix I

(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

BRRB approved studies are subject to the capability of the Bureau to

accommodate the research.

Researchers are required to submit a data destruction plan for review and

approval. Additionally, researchers are required to submit a confirmation of data

destruction to the BRRB as part of their closeout.

Researchers are expected to comply with all existing Bureau policies which

might impact the collection, management, and destruction of data.

(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 (DOJ) site or computer, records which contain non-disclosable

information directly traceable to a specific person may not be stored in, or

introduced into, non-DOJ approved computers or servers.

Non-disclosable information directly traceable to a specific person is also

known as “personally identifiable information” (PII).

(13) If the researcher is conducting a study of special interest to the Office of

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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.

If the study is a joint project between the ORE and a researcher, the researcher

may share individually identifiable data being collected with ORE. If the study is

not a joint project, ORE must obtain BRRB approval for any additional analysis.

(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.

2. § 512.12 Content of research proposal

When submitting a research proposal, the applicant must 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;

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and

(9) Indication of risk or discomfort involved as a result of participation.

(b) A comprehensive statement which includes:

 Review of related literature;

Bureau researchers should also include references to related, current, or past

studies by other Bureau components.

 Detailed description of the research method;

 Significance of anticipated results and their contribution to the

advancement of knowledge;

 Specific resources required from the Bureau;

 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;

 Description of steps taken to minimize any risks described in (b)(5) of this section;

 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.

 Description of any anticipated effects of the conduct of the research

project on institutional programs and operations; and

 Relevant research materials such as sample informed consent statements,

questionnaires, and interview schedules.

This must include a full curriculum vitae (CV) for the researcher(s) with primary

responsibility for the conduct of the project, demonstrating their competence in

the subject matter and in the appropriate methodology.

(c) A statement regarding assurances and certification required by 28 CFR part 46, if

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applicable.

3. § 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.

BRRB Members must have varying backgrounds and must not be associated, directly or

indirectly, with the conduct of the research. Members must avoid conflict of interest,

ensuring varied perspectives for comprehensive ethical review of human subjects

research.

(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.

A designated staff member from ORE will serve as both the BRRB administrator and the

Human Subjects Protection Officer.

a. The BRRB must include:

(1) At least one scientist.

(2) An individual with legal expertise, most typically from the Bureau’s Office of

General Counsel.

(3) A representative for inmates, typically a Bureau chaplain with experience in

correctional settings, whom the BRRB chairperson 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.

(4) One non-scientist.

(5) Members of both sexes.