Grand Rounds 4: Modifications and Waivers of Informed Consent in Pragmatic Clinical Trials

In this Grand Rounds, Jason Karlawish, MD, discusses waivers and alterations of written informed consent in pragmatic clinical trials. He provides two case studies of pragmatic clinical trials to determine whether or not it is appropriate to permit a modification or a waiver of research informed consent. Focusing on regulatory criteria addressing acceptable levels of research risk, the practicability of conducting the research with informed consent, and efforts to respect the rights and welfare of PLWD.



Webinar Date

February 20, 2020


Jason Karlawish, MD 

Learning Objectives

  1. Identify how consideration of ethical and regulatory issues in the design phase of an ePCT with PLWD can help make the study more pragmatic.
  2. Review the regulatory requirements for a waiver or alteration of informed consent and discuss related ethical considerations.
  3. Apply what we’ve covered to two case studies.

Watch the Webinar

Webinar Slides

Download the slides: IMPACT Grand Rounds February 20 2020.

Additional Resources

  • 45 CFR 46 – Protection of Human Subjects
  • Scott Kim and Frank Miller. “Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons.” IRB: Ethics and Human Research. January-February 2016, Vol 38, issue 1.
  • January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk,” available at