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Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box
Suzanne M. Rivera, Kyle B. Brothers, R. Jean Cadigan, Heather L. Harrell, Mark A. Rothstein, Richard R. Sharp & Aaron J. Goldenberg

We are a multidisciplinary collaborative made up of bioethicists, social scientists, clinicians, and lawyers whose work focuses on the ethical challenges posed by a networked approach to biorepositories. Like many, we have been concerned that our human research regulations had become woefully out of date. While the interventional, hypothesis-driven research envisioned by the 1991 Common Rule remai...

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Target Article

At Last! Aye, and There's the Rub
Alexander M. Capron

Mea culpa. In 1981 the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects research adopt “as a common core” the HHS regulations, “while permitting additions needed by a...

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A Proposed Process for Reliably Updating the Common Rule
Benjamin E. Berkman, David Wendler, Haley K. Sullivan & Christine Grady

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking (ANPRM) and notice of proposed rulemaking (NPRM). Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations (i.e.,...

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Rethinking the Belmont Report?
Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and...

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Examining Provisions Related to Consent in the Revised Common Rule
Jeremy Sugarman

The long-standing overarching policy governing research with human subjects conducted and supported by most federal agencies and departments in the United States, known as the Common Rule, has recently been revised, with most requirements slated to become effective in 2018. Although there are multiple alterations to the current regulations, some of the most significant changes aim to enhance conse...

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The Final Rule: When the Rubber Meets the Road
P. Pearl O'Rourke

The Common Rule originally issued in 1991 and last amended in 2005 is scheduled to be replaced on January 19, 2018 by a revised Common Rule (the final rule). The goal of the revisions is to modernize and improve applicability of the rule to a research landscape that has dramatically changed since 1991. Translating these changes into action will require comprehensive understanding of the final rule...

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