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Who is a “prisoner” according to DHHS regulations and when are investigators “engaged” in prisoner research?
For the purposes of human subjects research, a prisoner is defined in 45 CFR 46.303(c) as “any individual involuntarily confined or detained in a penal institution. The term 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.”
It is the policy of the Organization that a Hopkins investigator and the Organization are "engaged" in research involving prisoners when both of the following circumstances apply:
The Organization takes the position that for the research to "involve" prisoners, the investigator must have actual knowledge of circumstances that would cause a subject to fall under the regulatory definition. The Organization does not require investigators to determine prospectively whether each potential subject is or may become a prisoner.
For example, if an investigator proposes to perform a chart review of patients who have been treated for a particular disease, it is unlikely that the investigator will know or discover as a result of reviewing charts that one or more of the patients in the cohort is a prisoner. The investigator is not required to seek information about subjects' prisoner status if such information is not necessary to answer the research question. If, however, the investigator should happen to learn that one or more subjects is actually a prisoner, the protections and requirements of 45 CFR 46 Subpart C will then apply to the research if that individual is to be enrolled in the study.
It is the policy of the Organization that the responsibilities for IRB review of prisoner research under Subpart C must be fulfilled for all research involving prisoners, regardless of funding source.
IRB Review of Research Involving Prisoners:
For all research involving prisoners, an IRB member who qualifies as a prisoner representative must be present at the convened meeting of the IRB and during the presentation, discussion, and vote of any study which involves prisoners. A majority of the IRB members (exclusive of prisoner members) must have no association with the prison involved, apart from their membership on the IRBs.
The prisoner representative:
The JHM IRBs must make the required determinations when reviewing an application involving prisoner research and will use a checklist to document the determinations required by the regulations noted below along with protocol specific findings justifying those determinations:
Continuing review must occur using the same procedures for initial review, including the responsibility of the prisoner representative to review the continuing review materials and participate in the meeting (as described above). (If no subjects have been enrolled, the research may receive continuing review using the expedited procedure under expedited category #8).
Modifications involving more than a minor change reviewed by the convened IRB must use the same procedures for initial review including the responsibility of the prisoner representative to review the modification and participate in the meeting (as described above).
Minor modifications to research involving prisoners may be reviewed using the expedited procedures described below, based on the type of modification.
Research involving prisoners may not receive exempt review.
Expedited IRB Review Procedures for Research Involving Prisoners
For research involving interaction with prisoners:
For research that does not involve interaction with prisoners (e.g. existing data, record review) reviewed by the expedited procedure:
Review of modifications and continuing review must use the same procedures as initial review.
When a Participant Becomes a Prisoner While Enrolled in a Study:
For studies originally reviewed and approved by the IRB without prisoners as participants, if the PI learns that a participant has become a prisoner during the study, the PI must submit a Further Study Action (Problem Event Report) to inform the JHM IRB of the individual’s change in status. In this report, the PI must indicate whether the individual’s incarceration is expected to be temporary and, if not, whether the PI intends for the subjects to continue as a participant while incarcerated. If so, the PI must also submit a Further Study Action (Change in Research), requesting IRB approval for prisoners as a study population under Subpart C and indicating the following:
The JHM IRB must make the final determination whether the subject may continue as a participant. If a subject becomes a prisoner while enrolled in a research study that was not previously reviewed by the IRB according to Subpart C:
Note: If a subject is incarcerated temporarily while enrolled in a study, the IRB will determine the following:
For Department of Defense-regulated research, JHM IRB will not allow the inclusion of prisoners.
DHHS Reporting Requirements for Prisoner Research
“Under 45 CFR 46.305(c), the institution responsible for conducting research involving prisoners that is supported by HHS shall certify to the Secretary (through OHRP) that the IRB has made the seven findings required under 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 HHS grant application or protocol. HHS 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.”