Trust in early phase research: therapeutic optimism and protective pessimism
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Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits and risks of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects’ perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects’ perceptions and the committee members’ views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a “protective pessimism” of the research ethics committee members. We discuss this discrepancy using “frameworks of trust” and demonstrate the need to incorporate these frameworks into the existing model of informed consent.
KeywordsTherapeutic misconception Early phase research IRBs Gene transfer Research ethics Trust in research Survey of IRBs
We thank the members of the IRBs who participated in this research. Supported by National Institutes of Health (USA) cooperative agreement U54-NS45309. S. Kim is also a Greenwall Faculty Scholar in Bioethics.
- Churchill, L.R., D.K. Nelson, G.E. Henderson, N.M. King, A.M. Davis, E. Leahey, and B.S. Wilfond. 2003. Assessing benefits in clinical research: Why diversity in benefit assessment can be risky. IRB: A Review of Human Subjects Research 25: 1–8.Google Scholar
- Jonsen, A.R. 1998. The birth of bioethics. New York: Oxford University Press.Google Scholar