title: Trust in early phase research: therapeutic optimism and protective pessimism.
abstract: 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.
authors.affiliation: Department of Psychiatry, The Bioethics Program, The Center for Behavioral and Decision Sciences in Medicine, University of Michigan, 300 North Ingalls Street, 7C27, Ann Arbor, MI, 48109, USA. scottkim@umich.edu
authors.forename: Scott Y H
authors.initials: SY
authors.lastname: Kim
authors.forename: Robert G
authors.initials: RG
authors.lastname: Holloway
authors.forename: Samuel
authors.initials: S
authors.lastname: Frank
authors.forename: Renee
authors.initials: R
authors.lastname: Wilson
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000941:ethics / Q000379:methods*; D032962:Consent Forms / Q000941:ethics / Q000458:organization & administration*; D028744:Ethics Committees, Research; D005260:Female; D018014:Gene Transfer Techniques; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000628:therapy; D010465:Perception; D012107:Research Design; D035842:Research Subjects; D035502:Trust; D014481:United States