Issues Related to the Involvement of Multiple IRBs

When researchers from different institutions are involved in a single project or when researchers from one institution share biospecimens or biodata with researchers from another, multiple IRBs are likely to become involved. This involvement of multiple IRBs can cause a variety of problems that have no easy solutions (Burman et al., 2001). As Meslin (2006, p. 279) notes: “All researchers have experienced the frustration of submitting a protocol for a multi-center study only to have one IRB approve it, another decline to approve it, and a third require extensive modifications that the other two did not.” This is a particularly difficult problem for multicenter biomedical research, and in November 2005 a national conference was held to discuss solutions. The conference was sponsored by the National Institutes of Health, OHRP, the Association of American Medical Colleges, and the American Society of Clinical Oncology. The workshop report details a number of the issues involved and some approaches to addressing them (National Institutes of Health, Office for Human Research Protections, Association of American Medical Colleges, and American Society of Clinical Oncology, 2005).

The issues to which Meslin refers are perhaps the most obvious ones that stem from the presence of multiple IRBs: How does an investigator proceed if one IRB approves the research plan and a second does not, or if one requires modifications that another does not? And what happens if two IRBs impose contradictory sets of conditions that both cannot be met? There are also concerns related to the IRBs’ continuing oversight of a project, as disagreements between them can be even more problematic once a project is under way, participants have been recruited, and specimens and data are being analyzed.

As biosocial surveys and studies become more common, it is likely that the number of projects requiring multiple IRBs will increase. To be sure, this issue is not limited to biosocial surveys, but it will become increasingly important to find new ways to provide the oversight that IRBs offer without the complications entailed in having to answer to independent and uncoordinated entities at multiple institutions. Two possible approaches are to develop procedures for centralized review or to find ways for IRBs at different institutions to cooperate in their reviews of multi-institution research (Wolf, Croughan, and Lo, 2002).

CONCLUSION

Social scientists planning to add the collection of biospecimens to their surveys are likely to find that the informed consent process is quite different from their past practice. The best way for them to deal with these new challenges is to consult with investigators at their institutions or others with prior experience with biosocial or biomedical research, who can provide practical information about developing an informed consent document and about what to expect from their IRBs.



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