Ethics and Regulatory

Ethics and Regulatory

Overview

Products and Publications | Presentations

Co-chairs:

Headshot of Dr. Pearl O'Rourke

Pearl O'Rourke, MD

Dr. Stephanie Morain, lead author

Stephanie Morain, PhD

Jeremy Sugarman, MD, MPH, MA

Members

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 Ethics and Regulatory Core identifies areas of regulatory and ethical uncertainty and works with the NIH Collaboratory Trials to navigate regulatory and ethical complexities associated with pragmatic clinical trials conducted within healthcare systems.

Tools for Data and Safety Monitoring

 

The Core is helping to develop approaches to the ethical design and conduct of pragmatic clinical trials that are in compliance with policies and regulations. Its activities supporting this work include the following:

  • Address common areas of concern for pragmatic clinical trials, such as minimal risk criteria and informed consent requirements

  • Liaise with regulatory and ethical oversight bodies, including institutional review boards (IRBs), the US Food and Drug Administration, and the Office for Human Research Protections

  • Conduct empirical research, when needed, to inform these issues

  • Document experiences and lessons learned to serve as a guide for other entities engaging in research within healthcare systems

An icon representing a computer monitor on which a virtual meeting is displayed.NIH Collaboratory Trial Ethics/Regulatory Discussions: Minutes and Supplementary Materials

The Core facilitates discussions on ethical and regulatory issues relevant to each of the NIH Collaboratory Trials. These discussions typically include representation from study principal investigators and study teams, members of the Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel, with additional input sometimes 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:

The set of eleven ethical and regulatory issues are informed consent, the distinction between research and quality improvement, FDA-regulated products, identifying direct and indirect subjects, data monitoring, vulnerable subjects, gatekeepers, defining minimal risk, IRB harmonization, the nature of intervention, and privacy.

Interview

During the NIH Pragmatic Trials Collaboratory 2024 Steering Committee meeting, Drs. Stephanie Morain and Pearl O'Rourke discussed ethics and regulatory challenges and lessons learned.

Core Working Groups

News and Interviews


View More

Products and Publications

View More

Presentations

View More

Back to top