Grand Rounds Series: Ehical and Regulatory Dimensions of Pragmatic Clinical Trials

In 2022-2023, the NIH Pragmatic Trials Collaboratory held a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Throughout the program's history, the Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems.

In this Grand Rounds series, the Core brought together bioethicists, investigators, and regulatory experts to share lessons learned, discuss empirical findings, and explore remaining uncertainties. The sessions focused on a range of topics, including responding to signals of mental and behavioral health risk in pragmatic trials; the ethics of data sharing; ethical and regulatory considerations in the design and conduct of pragmatic trials; pragmatic research involving patients with dementia; and the use of waivers and alterations of consent.

Access the recordings:

• September 9, 2022: Keynote: Building an Academic Learning Health System: Why Is It So Hard?
  Speaker: Steven Joffe, MD, MPH
  Moderator: Stephanie Morain, PhD, MPH
• October 14, 2022: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials
  Speakers: Joseph Ali, JD; Leslie J. Crofford, MD; Tanya Matthews, PhD
  Moderator: Stephanie Morain, PhD, MPH
• November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape
  Speakers: Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics
  Moderator: P. Pearl O’Rourke, MD
• December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe?
  Speakers: David Magnus, PhD; Monica Taljaard, PhD
  Moderator: Stephanie Morain, PhD, MPH
• January 13, 2023: Ethical Considerations When Vulnerable Populations Are Subjects in Pragmatic Trials
  Speaker: Emily A. Largent, JD, PhD, RN
  Moderator: Stephanie Morain, PhD, MPH
• February 10, 2023: Informing and Consenting: What Are The Goals?
  Speakers: P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD
  Moderator: Stephanie Morain, PhD, MPH