Recommendation 8: Directly Involve Research Participants in Accreditation Programs and HRPPPs
The formulation of accreditation standards, the accreditation process, and HRPPP operations should directly involve research participants. 3
Current regulations lay a foundation for and even invite stronger involvement of those representing the interests of those participating in research. Yet, some “noninstitutional” members of IRBs have little experience as participants in research; they may be independent of the institution, but it does not follow that they represent the perspective of research participants. The regulations are necessarily nonspecific about the involvement of research participants in the review process and set a low standard for qualification. When HRPPPs are regularly judging the benefits and risks of studies that involve particular populations, there should be evidence that the review process directly involved those who genuinely understand and represent the perspective of those populations. This requirement could be incorporated into accreditation standards.
Practices regarding membership on data safety and monitoring boards (DSMBs) are even more diverse. The only stipulated expertise on DSMBs is technical: a clinician familiar with the medical aspects and a statistician familiar with data analysis. In instances in which they attend explicitly to safety and the ethical conduct of research, DSMBs are more apt to include a bioethicist or a lawyer than someone who brings the perspective of research participants. Accreditation standards—and even more so, the guidance documents that accompany them by giving examples of good practices—can improve the HRPPP system to ensure stronger representation of the interests of the research participants.
Given the primacy of the concepts of autonomy in research ethics and the training of IRB members, the relative lack of attention to standards and measures that would systematically cultivate these concepts in both the PRIM&R and NCQA proposed standards is somewhat surprising (see the discussion in the What's Missing section below). Several measures can be taken to bolster these concepts to improve the ethical conduct of research involving human participants. IRBs, DSMBs, research design teams, and merit review committees should increase their level of attention to the involvement of research participants or those who genuinely represent participants' perspectives in the design, selection, review, and monitoring of research involving human participants. In
By “participants,” the committee refers to those whose background and expertise are credible to a lay constituency external to the research institution and who are knowledgeable about the research process and research protections. The term is further defined in Chapter 1.