The duty to disclose adverse clinical trial results
| Abstract | Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in considerations of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. | |||||||||
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Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine and Ethics 38 (2):257-266.
Kavita Shah & Frances Batzer (2009). Improving Subject Recruitment By Maintaining Truly Informed Consent: A Practical Benefit of Disclosing Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):36-37.
Anthony Vernillo (2009). Disclosure of Adverse Clinical Trial Results—Should Legal Immunity Be Granted to Drug Companies? American Journal of Bioethics 9 (8):45-47.
Jacek Spławiński, Jerzy Kuźniar, Krzysztof Filipiak & Waldemar Zieliński (2006). Evaluation of Drug Toxicity in Clinical Trials. Science and Engineering Ethics 12 (1):139-145.
John Banja & Boadie Dunlop (2009). Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):39-41.
Nicole Hassoun (2009). The Duty to Disclose (Even More) Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):33-34.
S. Matthew Liao, Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24-32.
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