Addressing the “petty tyranny” of IRBs

Edward Abbey, author and radical environmentalist, once wrote: "No tyranny is so irksome as petty tyranny: the officious demands of policemen, government clerks, and electromechanical gadgets". If Abbey were a clinical scientist, IRBs might be on his short list. In a paper in this issue, Hunter identifies three factors in the demise of his study: funding problems, investigator time constraints, and obstacles created by ethics review [Hunter, 2005]. While each of these barriers probably deserves comment and broader discussion, the concerns over IRBs (or "Research Ethics Boards" in Canada) will be my focus here. To those who direct, chair, or serve on IRBs/REBs, the complaints raised by Hunter are familiar, and too often justified. Our challenge is, of course, not to simply catalog these frustrations but to think about how better policies and procedures might best protect human subjects while permitting quality research to go forward. This broad challenge is beyond the scope of this commentary, but I will outline several points that will expand on Hunter's critique. Hunter comments that "ethics review is seen as a wearisome obstruction, rather than a process to foster advances in research and patient care". However, the purpose of ethics review is not to foster scientific advances. That is the job of the scientist. Rather, ethics review is to assure the projection of human subjects involved in research. This assurance is conferred by peer review of the protocol and by promoting the informed consent process for participants or their surrogates. While I would argue that the IRB process often enhances the quality of the research by supporting the collaboration between subjects and investigators, this is not its primary purpose. The history of research amply illustrates that neither scientific research nor scientists are intrinsically ethical. Trusting scientists alone to adequately protect the subjects of their research was a failed social experiment [Rothman, 1987; Lock, 1995]. Peer review by oversight bodies with a multidisciplinary membership (and a complex set of regulations) were created to augment the judgment of investigators. And, truth be told, the quality of some proposals that reach IRBs is dreadful. So it is inevitable that scientists and oversight bodies will clash on occasion as they pursue their different tasks. Obviously an IRB would not be doing its job if it efficiently approved all protocols that came before it. A more specific point can be made in this regard about the protocol described briefly in Hunter's article. He describes the project as involving genetic testing for thrombophilia in children with limb defects and in unaffected controls. While this seems a good approach to establishing an association between limb defects and thrombophilia, the protocol raises some ethical concerns. The study seeks to identify children in both the affected and control groups who have genotypes associated with an increased risk of thrombotic events. But how should parents and physicians respond to such information? How would this genetic information affect the child's welfare, his or her future medical care, and the parent's view of the child's health? Screening for Factor V Leiden in asymptomatic individuals, for example, is not recommended due to the absence of clear preventative measures [Grody et al., 2001; Middeldorp et al., 2001]. Further, genetic testing of children for adult-onset conditions (such as thrombotic events) has been discouraged by the American Academy of Pediatrics and the American Society of Human Genetics unless there are interventions in the childhood years [American College of Medical Genetics/American Society of Human Genetics, 1995; AAP Committee on Bioethics, 2001]. Therefore, an IRB should carefully review a protocol that seeks to generate potentially frightening health information when there are no accepted interventions to reduce the risks identified by the study. The point is not that such a protocol should be disapproved, but that this probably is not an example of a study that should sail through any IRB. The inefficiency of some IRBs is legendary and a legitimate complaint for investigators. This inefficiency often is secondary to several factors that can be addressed at the institutional level. Like Hunter's colleagues in clinical genetics, IRBs are typically overworked and understaffed. IRBs request that the investigators make multiple photocopies of proposals because they typically do not have the money, staff, or digital alternatives for this simple task. Many research institutions have significantly increased their budgets for IRBs in recent years but this often is only a partial catch-up from years of serious funding deficiencies. Unfortunately, better funding for IRBs usually competes with other institutional research priorities. Investigators who want more efficient services from the IRB must be willing to accept this trade-off. Similarly, IRBs struggle to recruit members with expertise in a broad range of disciplines. Geneticists who seek better quality reviews of genetics protocols should volunteer their services or encourage their colleagues to serve on the IRB. Conflicts between investigators and the IRB (and the resulting delays) also can be reduced through better collaboration. IRBs should be open to investigators for pre-submission consultation and post-review discussions. The IRB should not be perceived as a "black box" that emits non-negotiable demands. It is often particularly valuable for the IRB to invite an investigator to a panel meeting to discuss a complicated or controversial protocol. In turn, it is also valuable for investigators to have a basic understanding of the regulations and policies under which IRBs function. To the extent that investigators can anticipate the IRBs major concerns in writing the proposal, the review process will be more efficient and effective. Finally, Hunter highlights the problem of multicenter trials that must go through an IRB review at each center. This can be very frustrating for local investigators who are not at liberty to negotiate changes in the protocol, yet they may be asked to defend protocol details and make numerous changes of potentially marginal value to consent forms. The limited literature to date suggests that local IRBs frequently do not improve the quality of multicenter protocols [McWilliams et al., 2003]. On the other hand, IRBs must feel comfortable that participants who are being recruited at the home institution have their interests evaluated and protected by the home institution [Loh and Meyer, 2004]. A central IRB process is being used for some multicenter projects funded by the National Cancer Institute at the NIH [Christian et al., 2002] but this alternative is not available for non-consortium related projects like Hunter's. Perhaps discussion between local IRBs should be encouraged so that the first review panel can work with the investigators to negotiate an acceptable protocol and consent process. Subsequent review panels, with the full initial review results in hand, can be asked to defer to this design as much as possible unless significant new issues are identified. IRBs also can do a better job of respecting the investigator's time and integrity by not demanding a wearisome list of minor changes. Research ethics review panels and investigators share the same fundamental goals of assuring that high quality research is conducted with a primary focus on the welfare of the research subjects. Each has different tasks in this process but improving communication, collaboration, and creative approaches may reduce the risk of petty tyranny to an acceptable level. Building a solid level of mutual respect between IRB/REBs and investigators is essential to this effort.

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