TY - JOUR
T1 - The duty to disclose adverse clinical trial results
AU - Liao, S. Matthew
AU - Sheehan, Mark
AU - Clarke, Steve
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2009/8
Y1 - 2009/8
N2 - 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.
AB - 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.
KW - Clinical trial disclosure
KW - Clinical trial registry
KW - Jesse Gelsinger
KW - US FDA amendments act of 2007
KW - Vioxx
UR - http://www.scopus.com/inward/record.url?scp=70449614120&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=70449614120&partnerID=8YFLogxK
U2 - 10.1080/15265160902984988
DO - 10.1080/15265160902984988
M3 - Article
C2 - 19998154
AN - SCOPUS:70449614120
SN - 1526-5161
VL - 9
SP - 24
EP - 32
JO - American Journal of Bioethics
JF - American Journal of Bioethics
IS - 8
ER -