Regulatory and ethical challenges
Can research subjects be “wronged” even if not physically injured in a clinical trial? Thorny questions of how to account for such intangible harm currently challenge the courts, regulatory agencies, and IRBs. This presentation will consider the legal, ethical, and policy implications of noteworthy cases involving intangible harm, including alleged breach of dignitary rights, abrupt termination of studies, and failure to disseminate trial results.
Richard S. Saver, JD is Arch T. Allen Distinguished Professor of Law at UNC.