Vol. 13 No. 12 | December 2013

Vol. 13 No. 12 | December 2013

ISBN: 1526-5161

target articles

Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose...

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Open Peer Commentary

SUPPORT Asked the Wrong Question Jon F. Merz & Divya Yerramilli
Personalized Medicine in the NICU Keith J. Barrington
The “Research Misconception” and the SUPPORT Trial: Toward Evidence-Based Consensus Dominic J. C. Wilkinson, Nicole Gerrand, Melinda Cruz & William Tarnow-Mordi

The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP’s actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (...

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The Office of Human Research Protections was not justified in issuing findings against the SUPPORT Institutions. Our community can learn from the evolving healthcare transformation into learning health systems by thinking about the novel ethical issues about standard of care research raised by the SUPPORT with the same spirit of quality improvement. The current regulatory framework and the concept...

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