Prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary decision whether or not to participate as subjects in research. Additional safeguards are required, therefore, when prisoners are proposed as subjects.
Please note that the CPHS/IRB needs to be notified, and a new protocol will need to be submitted for review if currently enrolled subjects in a non-prisoner project become incarcerated.
It is strongly recommended that you contact Research Compliance Services (RCS) and/or consult with investigators experienced in research with prisoners when developing your protocol.
Types of Research with Prisoners
When using prisoners as subjects, only the following types of research are allowable:
- Study of possible causes, effects, or processes of incarceration or of criminal behavior
- Study of prisons as institutional structures or of prisoners as incarcerated persons
- Study of conditions particularly affecting prisoners as a class, including research on relevant social and psychological problems such as alcoholism, drug addiction, and sexual assault
- Study of practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the prisoner subjects
In all cases, the research is to present no more than minimal risk and inconvenience to subjects.
For research in the last two categories, consultation with the CPHS/IRB is necessary to determine possible need for approval by experts in penology medicine and ethics.
Any proposed biomedical research requires consultation with the CPHS/IRB.
DHHS-Funded Research with Prisoners
The institution responsible for conducting research involving prisoners that is supported by DHHS shall certify to the Secretary through the Office of Human Research Protections (OHRP) that the IRB has made the seven findings required under the regulations (45 CFR 46.305(a)). The institution must send to OHRP a certification letter to this effect, which should also include the name and address of the institution and specifically identify the research protocol in question and any relevant DHHS grant application or protocol. DHHS conducted or supported research involving prisoners as subjects may not proceed until OHRP issues its approval in writing to the institution on behalf of the Secretary under 45 CFR 46.306(a)(2).
Under its authority at 45 CFR 46.115(b), OHRP requires that the institution responsible for the conduct of the proposed research also submit to OHRP a copy of the research proposal so that OHRP can determine whether the proposed research involves one of the categories of research permissible under 45 CFR 46.306(a)(2), and if so, which one.
The term "research proposal" includes the IRB-approved protocol, any relevant HHS grant application or proposal, any IRB application forms required by the IRB, and any other information requested or required by the IRB to be considered during initial IRB review.
Prisoner Research: Additional Considerations
When using prisoners as subjects, the following additional concerns must be addressed:
- Selection of subjects within the prison is to be fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless providing justification otherwise, control subjects must be selected randomly from an appropriate population of prisoners.
- Any advantages accruing a prisoner subject, when compared to standard prison conditions, are not to be of such magnitude as to impair the prisoner's ability to weigh appropriately the risks of research participation in the limited choice environment of prison.
- The risks involved should be commensurate with risks that would be accepted by non-prisoner volunteers.
- Adequate evidence exists that parole boards will not take into account a prisoner's participation or non-participation in research and prisoners are informed in advance that participation or non-participation in the research will have no effect on parole decisions.
- Information must be provided to prisoners in language they can understand.
- An adolescent (e.g., age 14) detained in a juvenile detention facility is a prisoner.
- Where the CPHS/IRB finds there may be a need for follow-up examination or care of subjects after participation, adequate provision is made, taking into account the lengths of subjects' sentences, and subjects are informed.
- The guidelines apply whenever any human subject in a research project subject to 45 CFR 46 becomes a prisoner at any time during the study.
- If a subject becomes a prisoner after enrollment in research, the investigator should report this situation to Research Compliance Services immediately (541-346-2510.) If the investigator wishes to have the prisoner subject continue to participate in the research, all research interactions and interventions with and obtaining identifiable private information about the now-incarcerated prisoner-subject must cease until all requirements for research involving prisoners have been satisfied with respect to the relevant protocol.
- The exempt review categories do not apply to research involving subjects.
- The definition of minimal risk for research involving prisoners differs from the definition of minimal risk in subpart A of 45 CFR 46. See 45 CFR 46. 102(i). For research involving prisoners, the definition of minimal risk requires reference to physical or psychological harm, as opposed to harm or discomfort, to risks normally encountered in the daily lives, or routine medical, dental or psychological examination of healthy persons