§ 512.11 - Requirements for research projects and researchers.

§ 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 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.

[62 FR 6661, Feb. 12, 1997]