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Ethics of research in usual care settings: Data on point
Jeremy Sugarman

Conducting research in usual care settings—which includes pragmatic clinical trials, comparative effectiveness research, and analyses of clinical databases—is associated with an array of questions about the appropriate mechanisms to protect the rights, interests, and welfare of research participants. Not only is there a lack of agreement about many of the conceptual issues at hand, but there h...

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Target Article

The patient's perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure
Sherrie H. Kaplan, Adrijana Gombosev, Sheila Fireman, James Sabin, Lauren Heim, Lauren Shimelman, Rebecca Kaganov, Kathryn E. Osann, Thomas Tjoa & Susan S. Huang

Background: Recent efforts to study quality improvement (QI) efforts to improve the effectiveness and efficiency of healthcare have raised important questions about ethical boundaries for waiving informed consent. Confusion exists because similar projects can be undertaken for research or QI purposes, a distinction currently used to define Institutional Review Board oversight. However, patients ar...

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Patients' views concerning research on medical practices: Implications for consent
Kevin P. Weinfurt, Juli M. Bollinger, Kathleen M. Brelsford, Travis J. Crayton, Rachel J. Topazian, Nancy E. Kass, Laura M. Beskow & Jeremy Sugarman

Background: Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients’ views and opinions regarding a variety of different types of research on usual medical practices, espec...

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Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care
Ashley Kraybill, Laura M. Dember, Steven Joffe, Jason Karlawish, Susan S. Ellenberg, Vanessa Madden & Scott D. Halpern

Background: Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. Methods: We conducted scenario-based, semistructured in...

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Alternative consent models for comparative effectiveness studies: Views of patients from two institutions
Nancy Kass, Ruth Faden, Rachel E. Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner & James Pitcavage

Background: Informed consent requirements generally require a lengthy process and signed documentation for patients to participate in clinical research. With growing interest in comparative effectiveness research (CER), whereby patients receive approved (nonexperimental) medicines for their medical condition, questions have been raised whether the same consent requirements should apply. Little inp...

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Adrift in the gray zone: IRB perspectives on research in the learning health system
Sandra Soo-Jin Lee, Maureen Kelley, Mildred K. Cho, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N. Meyer, Douglas Diekema, Alexander M. Capron, Benjamin S. Wilfond & David Magnus

Background: Human subjects protection in health care contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called “research on medical practice” (...

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