BOX 6-1Special Study Design and PRSA Monitoring Safeguards

Special Study Design Safeguards (D1–D7)

D1. Investigator should obtain a federal certificate of confidentiality to protect against the disclosure of prejudicial, confidential, or personal information.

D2. The proportion of prisoner-subjects to nonprisoner-subjects may not exceed 50 percent.

D3. Neither the PI nor any member of the research team or staff member of the institution/agency at which the study is conducted may receive financial or other incentives for meeting recruitment quotas.

D4. In clinical trials of medications in which some study arms provide for the administration of standard-of-care treatment, those same medications must be available to prisoners diagnosed with the same disease who are not recruited for, or if recruited decline to participate in, the clinical trial.

D5. The PI must demonstrate to the satisfaction of the IRB that the research setting is sufficiently open to permit regular, prompt, and proactive monitoring of prisoner-subjects’ clinical status by research staff or PRSA staff required by the research protocol.

D6. The PI must demonstrate, to the satisfaction of the IRB, that the quality of physical/mental health services in the particular correctional setting is adequate to respond in a timely and professionally responsible manner to complaints, problems, and side effects that may emerge from prisoners’ participation in a research study.a

D7. The researcher must present to the IRB how the research is proceeding after the first 30 days that subjects are enrolled.

Special PRSA Monitoring Safeguards (M1–M6)

M1. Periodic observation (spot-checking) of informed consent dialogues at recruitment.

M2. Soon after enrollment, test randomly selected subjects for comprehension of the consent disclosure.b

M3. Periodically debrief subjects to determine whether they experienced any pressure or coercive actions by investigators or correctional personnel regarding the prisoner-subject’s participation.

M4. Periodically observe (spot-check) protocol administrations to ensure fidelity to and compliance with the approved protocol.

M5. Periodically debrief subjects regarding personal reactions to research stimuli (e.g., interviews, questionnaires, medications, or devices).

M6. Periodically debrief subjects regarding timeliness and adequacy of investigator responses to any problems or complaints that the subjects associate with study participation (e.g., side effects or adverse reactions to medications or devices; adverse psychological reactions).

NOTE: PI, principal investigator.

a

See Chapter 5, page 154 for indirect measures for assessing adequacy of health-care services.

b

The PRSA needs to determine that the person understands, or has access to information that enables them to understand, the basic study parameters. This should not be a “memory test” of the consent disclosure. Subjects could display comprehension of the basic study parameters by retrieving their copy of the consent disclosure and “explaining” to the PRSA the information therein. A problem would exist, however, if a subject did not appear to understand the study parameters even with access to and opportunity to review the disclosure.

From: 6, Systems of Oversight, Safeguards, and Protections

Cover of Ethical Considerations for Research Involving Prisoners
Ethical Considerations for Research Involving Prisoners.
Institute of Medicine (US) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research; Gostin LO, Vanchieri C, Pope A, editors.
Washington (DC): National Academies Press (US); 2007.
Copyright © 2007, National Academy of Sciences.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.