Organization Policy on Review of Research Involving Prisoners (Policy No. C304)
August 2007

It is the policy of the Organization that a Hopkins investigator, and the Organization, are “engaged” in research involving prisoners under the following conditions:

1. The investigator obtains data through intervention or interaction with a prisoner, or identifiable private information about a prisoner; AND

2. The investigator knows that one or more of the data subjects is a person whose circumstances meets the regulatory definition of “prisoner” under 45 CFR 46.303(c). 

The Organization takes the position that for the research to “involve” prisoners, the investigator must have actual knowledge of circumstances that would cause a data subject to meet the regulatory definition of prisoner.  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 Subpart C will then apply to the research.

For all research involving prisoners, an IRB member who qualifies as a prisoner representative must be present during the presentation, discussion, and vote of any study which involves individuals who meet the regulatory definition of “prisoner” under 45 CFR 46.303(c). For the purposes of human subject research, this definition includes any person who enrolls in a research study, and then becomes a prisoner while in the study.

It is the policy of the Organization that the additional responsibilities for IRB review of prisoner research under 45 CFR 46 Subpart C must be fulfilled.  The Subpart C criteria will be considered for all research involving prisoners, regardless of funding source.  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:

1. Whether the research under review represents one of the categories of research permissible under 45 CFR 46.306(a)(2);
   
2. Whether the advantages of participating in this 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 magnitude to impair the participant’s ability to weigh the risks of the research against the value of such advantages in the limited choice environment;
   
3. Whether the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers;
   
4. Whether the procedures for the selection of participants within the prison (or other institution) are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners;
   
5. Whether the information is presented in language that is understandable to the participant population;
   
6. Whether the JHM IRB has adequate assurance 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. If the IRB 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.

If a study is reviewed and approved by the IRB without prisoners as participants, and a participant becomes a prisoner during the study, the PI must inform the JHM IRB when the PI becomes aware of the change in status of the participant.  The PI must inform the IRB:

• If it is in the subject’s best interests to continue on the study as a prisoner, and whether the subject’s status as prisoner affects the risks of participation in the study or the potential benefits that might accrue from continued participation;
• If the subject wishes to continue as a study participant, and what the re-consent process will be;
• If there are practical complications of subject continuation in the study,
• If there is any other factor that is important for the JHM IRB to consider when determining whether the subject should continue as a participant in the study.

The JHM IRB must make the final determination whether the subject may continue as a participant.  If the Board determines that the participant may continue in the study, the IRB must review the study under the criteria on research involving prisoners, above.

If the IRB approves a study involving prisoners, and it is funded by a federal agency, the protocol will be submitted to the Secretary of Health and Human Services as required under 45 CFR 46.306.