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Cores : Regulatory/Ethics
NIH Collaboratory Cores and Working Groups



Co-Chairs: Jeremy Sugarman, Kevin Weinfurt

NIH Representative: David Wendler

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

Project Managers: 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 convened groups of stakeholders to produce academic articles on a set of 11 ethical and regulatory issues related to the conduct of pragmatic clinical trials. The papers review the issues, and where possible, identify best practices and provide guidance for future pragmatic clinical trials. The following topics are addressed:

Regulatory/Ethics topics figure

Recent Presentation

Greg Simon, MD, MPH, of Group Health Research Institute and Susan Ellenberg, PhD, of the University of Pennsylvania,
discuss data and safety monitoring in pragmatic trials.

Products and Publications

Clinical Trials Special Issue on Ethical and Regulatory Issues in Pragmatic Clinical Trials (October 2015)

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


2/13/2015: Grand Rounds Presentation: Data and Safety Monitoring in Pragmatic Trials (Video; Slides)

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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