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EDITORIAL

Frontiers in Bioethics
David Magnus

Last year a bioethics colleague from another institution was expressing her frustration and doubts about the direction of the field of bioethics to me. Her concern was what she perceived as the growing trend towards empirical research in American bioethics as exemplified by the direction of my research and the research of Stanford’s bioethics center as well as our peers. While I (obviously) do n...

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Randomized Trials are Deeply Offensive
John D. Lantos

In this issue, Macklin and Natanson examine some of the controversies that arise in randomized clinical trials (RCTs). They are particularly concerned that researchers may misrepresent novel interventions as “usual care.” This is problematic, they claim, both ethically and scientifically. Ethically, it misleads potential research participants into believing that studies have known and minimal ...

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Target Article

Ethics and Collateral Findings in Pragmatic Clinical Trials
Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra JH Mathews & Jeremy Sugarman

Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the ind...

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Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error
Ruth Macklin & Charles Natanson

Comparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case s...

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