Trust in early phase research: therapeutic optimism and protective pessimism

Medicine, Health Care and Philosophy 11 (4):393-401 (2008)

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
Keywords Medicine & Public Health   History of Medicine   Ethics   Medical Law   Theory of Medicine/Bioethics
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DOI 10.1007/s11019-008-9153-z
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References found in this work BETA

Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
Seven Vulnerabilities in the Pediatric Research Subject.Kenneth Kipnis - 2003 - Theoretical Medicine and Bioethics 24 (2):107-120.

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Citations of this work BETA

To Study, Perchance to Treat.Howard Trachtman - 2009 - American Journal of Bioethics 9 (2):11 – 12.

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