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EDITORIAL

The SUPPORT Controversy and the Debate Over Research Within the Standard of Care
David Magnus

The proximate occasion for this special issue of American Journal of Bioethics (AJOB) is the controversy over the SUPPORT study—but the issues in fact go far beyond the particulars of that controversy to the broader issue of how we should think about the requirements for research within the standard of care (particularly prospective randomized research). […] ...

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Target Article

What Should Be Disclosed to Research Participants?
David Wendler

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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Informed Consent and Standard of Care: What Must Be Disclosed
Ruth Macklin & Lois Shepherd

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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Quality Improvement Ethics: Lessons From the SUPPORT Study
Benjamin S. Wilfond

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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