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Cores : Regulatory/Ethics
NIH Collaboratory Cores and Working Groups



Chair: Jeremy Sugarman

NIH Representative: David Wendler

Members: Monique Anderson, Elaine Bergman, Laura Beskow, Denise Cifelli, Susan Ellenberg, Sheila Fireman, Adeola Jaiyeola, Katie James, Rebecca Kaganov, Lindsay Kindler, Julie Lima, Jeff Love, Rosemary Madigan, Ross McKinney, Susan Mitchell, Jim Sabin, Miguel Vazquez, Kevin Weinfurt, Doug Zatzick

Project Manager: Tammy Reece

The advent of pragmatic clinical trials that leverage electronic health records and use research methods such as cluster randomization promises to answer critical research questions with increased sample sizes at lower costs, and could greatly increase production of the evidence needed to improve healthcare. This research, which relies on data collected as part of routine clinical care and may evaluate similar treatments in comparative effectiveness studies, poses a unique set of regulatory and ethical challenges. The Regulatory/Ethics Core identifies areas of regulatory and ethical uncertainty and works with the Demonstration Projects to navigate regulatory and ethical complexities associated with pragmatic clinical trials conducted within healthcare systems.

The Core is developing policies and practices to provide a framework for the conduct of pragmatic clinical trials in an ethical manner and in compliance with federal and state regulations. Its activities supporting this work include the following:

Demonstration Project Regulatory/Ethics Discussions: Minutes and Supplementary Materials

The Core facilitated a series of discussions on ethical and regulatory issues relevant to the Demonstration Projects. These discussions, which took place as teleconferences, included representation from study principal investigators and study teams, members of the Collaboratory Regulatory/Ethics Core, NIH staff, and Collaboratory Coordinating Center personnel, with additional input provided by representatives from the Office for Human Research Protections.

Areas of Focus

The Core is currently working to synthesize evidence and formulate recommendations on the following ethics and regulatory issues related to the conduct of pragmatic clinical trials:

Regulatory/Ethics topics figure

Recent Presentation


Sharon Terry of Genetic Alliance and Rob Califf, MD, of Duke University discuss the ethical and regulatory landscape.

Products and Publications

Sugarman J, et al. JAMA 2014

Informed Consent Living Textbook Chapter

Regulatory Issues Living Textbook Chapter (preliminary draft version)

Conflict of Interest Living Textbook Chapter

Demonstration Project Regulatory and Ethics Support Documentation


8/20/2014: Overview of Ethics and Regulatory Issues Presentation at Steering Committee Meeting

8/19/2014: Regulatory/Ethics Core Presentation at Steering Committee Meeting

7/18/2014: Grand Rounds Presentation: The Ethics and Regulatory Landscape: Is a Massive Public Campaign Needed? (Video; Slides)

4/25/2014: Grand Rounds Presentation: CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives (Video; Slides)

10/25/2013: Grand Rounds Presentation: Synchronizing Operations, Ethics, and Regulatory Oversight, or Reducing Death and Disability Caused by Knowledge Deficits (Ignorance) (Video; Slides)


9/12/2014: Drs. Rob Califf and Jeremy Sugarman Discuss Regulatory and Ethical Issues around NIH Collaboratory Projects

10/23/2012: Dr. Jeremy Sugarman Discusses Ethical Issues and the Collaboratory

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