Prisoners

§46.306 Permitted research involving priso​ners.

(a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if:

1. The institution responsible for the conduct of the research has certified to the Secretary that the Institutional Review Board has approved the research under §46.305 of this subpart; AND 
2. In the judgment of the Secretary the proposed research involves solely the following:

• 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 subjects; 
• 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 subjects;
• 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) provided that 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 his intent to approve such research; or
• Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the 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.

(b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or supported by DHHS shall not involve prisoners as subjects. When an IRB is reviewing a protocol in which a prisoner is a subject or a proposed subject, the IRB must make, in addition to other requirements under 45 CFR 46, subpart A, seven additional findings under 45 CFR 46.305(a) in order to approve such research. They are:

1. The research under review represents one of the categories of research permissible under §46.306(a)(2);
2. Any possible advantages accruing to the prisoner through his or 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 or 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;
3. The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;
4. Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board 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;
5. The information is presented in language which is understandable to the subject population;
6. 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 or her parole; and 
7. Where the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact. (June 20th, 2003) The Secretary of Health and Human Services (DHHS), pursuant to 45 CFR 46.101(i), has waived the applicability of certain provisions of subpart C of 45 CFR part 46 (Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects) to specific types of epidemiological research involving prisoners as subjects.

This waiver, effective June 20, 2003, will allow DHHS to conduct or support certain important and necessary epidemiological research that would not otherwise be permitted under subpart C.

The Secretary of HHS has waived the applicability of 45 CFR 46.305(a)(1) and 46.306(a)(2) for certain epidemiologic research conducted or supported by DHHS

1. in which the sole purposes are:

• to describe the prevalence or incidence of a disease by identifying all cases, or
• to study potential risk factor associations for a disease, and

2. where the institution responsible for the conduct of the research certifies to the Office for Human Research Protections, acting on behalf of the Secretary, that:

• the institutional review board (IRB) approved the research and fulfilled its duties under 45 CFR 46.305(a)(2)-(7) and
• determined and documented that 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