NIH Pragmatic Trials Collaboratory Grand Rounds: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials

Friday, Oct 14, 2022
1:00 pm - 2:00 pm
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Berman Institute faculty Stephanie Morain and Joseph Ali will participate in a special Grand Rounds series that the NIH Pragmatic Trials Collaboratory is launching this fall 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 series will include 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 Ethical and Regulatory Dimensions of Pragmatic Trials series flyer and see the schedule below.

  • 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, 20222, 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 Talijaard, 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 sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.