[Code of Federal Regulations]
[Title 28, Volume 2]
[Revised as of July 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 28CFR512.11]

[Page 459-460]
 
                    TITLE 28--JUDICIAL ADMINISTRATION
 
           CHAPTER V--BUREAU OF PRISONS, DEPARTMENT OF JUSTICE
 
PART 512--RESEARCH--Table of Contents
 
                           Subpart B--Research
 
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.

[[Page 460]]

    (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]