Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: Research Monitoring
that accommodate participant needs can improve recruitment and retention of participants and thereby strengthen the study. The presence of representatives of study participants on study design and oversight panels also adds credibility to the review and monitoring processes among participants.11
Those developing accreditation standards would do well to directly involve focus groups, consent monitors, and participant representatives (e.g., those who themselves have been involved in past studies and who represent a genuine constituency) in specifying the desired outcomes to be incorporated into accreditation standards. In his book on accreditation, Michael Hamm cited the example of groups representing people with disabling conditions who were able to list desirable attributes of buildings that would permit access (Hamm, 1997). Participant involvement includes participation with the study design and representation on IRBs, monitoring bodies, and oversight and advisory bodies for research institutions.
Research Monitoring
Research monitoring was foremost among the problems identified by DHHS OIG (DHHS OIG, 1998a,b,c,d,e, 2000b,c,d). The main function of IRBs has been and will remain the review of protocols for proposed research to ensure that the research design is sound, that participants give their informed consent, and that selection of subjects is fair. IRBs are already busy with their current responsibilities, and research monitoring is an additional duty. IRBs therefore may not be the unit best able to carry out the monitoring of research. The committee believes that research monitoring—including adverse event reporting, data safety and monitoring boards, ombudsman programs, reporting mechanisms for concerns or complaints, and consent monitoring programs —should be defined as part of an HRPPP but not laid solely at the feet of the IRB component of an HRPPP.
The significant role of research monitoring is evident through the many elements of the ICH-GCP guidelines that relate to reporting of adverse events and other aspects of research monitoring. Research under an FDA IND must comply with strict reporting requirements for adverse events, and the federal code requires reporting of “unanticipated problems posing risks to subjects.”.12 Research monitoring is incorporated into NCQA standards but is not a central theme of the proposed PRIM&R standards, in which it is mentioned in only one documentation standard. The committee believes that adverse event reporting and research moni-
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Involvement of the National Breast Cancer Coalition was instrumental, for example, in clinical trials of the drug herceptin, when early clinical trials were having difficulty recruiting participants. The National Breast Cancer Coalition became involved, however, only when it could directly participate in trial design and oversight (Bazell, 1998). |
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45 CFR 46.103 (b)(5). |
