The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems. With this new Grand Rounds series, the Core is bringing together bioethicists, investigators, and regulatory experts to share lessons learned, discuss empirical findings, and explore remaining uncertainties.
The webinar series, Ethical and Regulatory Dimensions of Pragmatic Clinical Trials, will kick off on Friday, September 9, at 1:00 pm ET with a keynote presentation by Dr. Steven Joffe, chair of the Department of Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania.
The series will include an additional 5 moderated webinar discussions with panels of experts. The sessions will focus 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.
Download the series flyer and see the full schedule below.
- September 9, 2022, 1:00 pm ET: Keynote: Building an Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH; Moderator: Stephanie Morain, PhD, MPH)
- October 14, 2022, 1:00 pm ET: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Leslie J. Crofford, MD; Tanya Matthews, PhD; Moderator: Stephanie Morain, PhD, MPH)
- November 11, 2022, 1:00 pm ET: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics; Moderator: P. Pearl O’Rourke, MD)
- December 9, 2022, 1:00 pm ET: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (David Magnus, PhD; Monica Taljaard, PhD; Moderator: Stephanie Morain, PhD, MPH)
- January 13, 2023, 1:00 pm ET: Ethical Considerations When Vulnerable Populations Are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN; Moderator: Stephanie Morain, PhD, MPH)
- February 10, 2023, 1:00 pm ET: Informing and Consenting: What Are The Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD; Moderator: Stephanie Morain, PhD, MPH)
All session are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.
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