Literature DB >> 19998154

The duty to disclose adverse clinical trial results.

S Matthew Liao1, Mark Sheehan, Steve Clarke.   

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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Year:  2009        PMID: 19998154     DOI: 10.1080/15265160902984988

Source DB:  PubMed          Journal:  Am J Bioeth        ISSN: 1526-5161            Impact factor:   11.229


  1 in total

1.  Enhancing informed consent in clinical trials and exploring resistances to disclosing adverse clinical trial results.

Authors:  John D Banja; Boadie Dunlop
Journal:  Am J Bioeth       Date:  2009-08       Impact factor: 11.229

  1 in total

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