Synopses & Reviews
Synopsis
Excerpt from Problems in Securing Informed Consent of Subjects in Experimental Trials of Unapproved Drugs and Devices: Hearing Before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business House of Representatives, One Hundred Third Congress, Second Session, May 23, 1994
The consent forms I signed did not indicate the real purpose of the research which was to study the relapse of patients. The re searchers had published a scientific paper in the Journal of Ahmor mal Psychology, attached to my testimony, claiming that the study was an improvement over previous retrospective studies because this study was a prospective design that insured patients had se vere or extremely severe relapses.
Independent psychiatrists, psychologists and bioethicists con firmed our finding. We never knew any of these facts until much ater.
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