POLICY STATEMENT

It is UAB policy that research will include additional safeguards to protect the rights and welfare of subjects when some or all of the subjects involved in research are prisoners. Prisoner is defined as any individual involuntarily confined or detained in a penal institution. The definition is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures, which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. This definition includes any individual who enrolls in a research study and then becomes a prisoner while in the study. All research involving prisoners, regardless of funding source, will receive review and approval under 45 CFR Part 46, Subpart C before research is initiated. (See PRO133 Procedure for Review when Prisoners are Involved as Participants in Research.)

The IRB will determine that the agency receives advanced written assurance that non-employees of the bureau may receive records in a form not individually identifiable and that the records will be used solely for statistical research or reporting.

When the IRB reviews research involving prisoners, in addition to other IRB composition requirements, the majority of the IRB (exclusive of prisoner members) will have no association with the prison(s) involved apart from their membership on the IRB and at least one voting member will be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity. Where a particular research project is reviewed by more than one IRB, only one IRB needs to satisfy this requirement. Research involving prisoners will not undergo review using expedited procedures.

In addition to its other prescribed responsibilities, the IRB will review research involving prisoners and approve such research only if it finds and documents the following criteria under 45 CFR 46.305 (or criteria for a waiver for epidemiologic research) are met:

The research under review represents one of the categories of research permissible under 45 CFR §46.306(a)(2) or the research qualifies for a Department of Health and Human Services (HHS) Waiver for Epidemiologic Research (see Attachment A);
Any possible advantages accruing to the prisoner through his/her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, are not of such a magnitude that his/her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.
The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
Procedures for selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the Investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
The information is presented in language that is understandable to the subject population;
Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his/her parole; and
Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provisions have been made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact.

When research is conducted within a federal prison facility under the Bureau of Prisons (BOP), the IRB will review the research under 28 CFR 46 and 28 CFR 512. Investigators are responsible for providing the IRB with necessary and sufficient information to make the additional determinations required under these regulations (see GUI341).

When research involving prisoners is conducted or sponsored by HHS, the IRB will certify to the Secretary, through OHRP, that it has reviewed and approved the research by finding that each element of the above criteria has been met. Research will not be permitted until OHRP, on behalf of the Secretary, determines that the research satisfies one of the permissible research categories under 45 CFR §46.306(a)(2) or meets the federal waiver provisions for epidemiologic research involving prisoners (see Attachment A).

Investigators are responsible for providing the IRB with necessary and sufficient information to make the above determinations. When a previously enrolled research subject becomes a prisoner and the relevant research protocol was not reviewed and approved in accordance with 45 CFR Part 46, Subpart C, the Investigator will:

Notify promptly the IRB of the event
Cease all research interactions and interventions with, and obtaining identifiable private information about, the prisoner-subject until the requirements of 45 CFR Part 46, Subpart C are satisfied
When the Investigator asserts that continued participation is in the best interest of the subject, seek the IRB Chair’s determination that the subject may continue participation in the study until 45 CFR 46, Subpart C is satisfied

The IRB will promptly review any research protocol in accordance with 45 CFR 46, Subpart C on receipt of notification that a previously enrolled subject has become a prisoner and the Investigator asserts continued participation in the research is in the subject’s best interest. The IRB will remind the Investigator to cease research activities with the subject, unless special circumstances exist, until the protocol is reviewed in accordance with 45 CFR Part 46, Subpart C.

ATTACHMENT A to POL033

CATEGORIES OF RESEARCH THAT MAY INVOVLE PRISONERS UNDER 45 CFR 46.306 and Waiver for Epidemiologic Research (68 FR 36929)

Definitions

Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Permissible Categories of Research in Prisoners and Criteria for Waiver for Epidemiological Research

For research involving prisoners the IRB must determine that the proposed research involves solely the following (Note: If research conducted or sponsored by HHS, then both the IRB and HHS must make these findings independently to proceed.):

Study of the possible causes, effects and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subject.
Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subject.
Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults). (For HHS-sponsored or -conducted research, provided that the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice in the Federal Register, of his/her interest to approve such research).
Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. (For HHS-conducted or -supported research, in those studies that require assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research).
Research that involves epidemiologic studies for which:
- The sole purposes of the research are either to (1) describe the prevalence or incidence of disease by identifying all cases; or (2) study potential risk factor associations for a disease;
- The research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects; and
- Prisoners are not a particular focus of the research.
- For HHS-conducted or -sponsored research, these findings must be certified to OHRP.