[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: 28CFR512.16]

[Page 462]
 
                    TITLE 28--JUDICIAL ADMINISTRATION
 
           CHAPTER V--BUREAU OF PRISONS, DEPARTMENT OF JUSTICE
 
PART 512--RESEARCH--Table of Contents
 
                           Subpart B--Research
 
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.