Webinar: Studying Effectiveness: Ethical and Regulatory Considerations in Pragmatic Clinical Trials

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When multiple options exist for treating the same condition, it is not always known which is best. Pragmatic clinical trials (which can include comparative effectiveness research studies) are designed to answer such questions. These trials evaluate the effectiveness of interventions under real-life, routine practice conditions.

But conducting research in "real-life, routine practice conditions" presents challenges for research design as well as for IRB oversight. It can also sometimes blur the distinction between research and clinical care. The challenges that IRBs face with pragmatic trials may not be new, but they are perhaps more complex than the issues typically raised by other types of research studies. During this intermediate-level webinar, presenters will:

  • Provide an introduction to pragmatic trials: what they are and how to recognize them
  • Explore some common areas of ethical and regulatory importance for IRBs when reviewing pragmatic clinical trials, including distinguishing clinical care from research and from QA/QI; informed consent; risk determination; and the nature of interventions
  • Describe some strategies that may be useful in addressing these issues

What will I learn?

After attending this webinar, attendees will be able to:

  • Define and recognize pragmatic clinical trials
  • Understand some of the primary ethical and regulatory issues associated with them
  • Describe some of the specific considerations for IRB review when it comes to pragmatic clinical trials

Who should attend?

This intermediate-level webinar will benefit IRB administrators, staff, and researchers who are involved with reviewing or conducting pragmatic clinical trials.

Continuing Education

CIP Credit labelWebinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »


Pearl ORourke WebinarP. Pearl O’Rourke, MD is the director of human research affairs at Partners HealthCare, Inc., and an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and human embryonic stem cell research. Dr. O'Rourke's career began as a pediatric critical care physician at Boston Children's Hospital, and then as the director of the Pediatric Intensive Care Unit at Children's Hospital, University of Washington. She did clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. Following a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy from 1997 to 2000, she was the deputy director of the Office of Science Policy in the Office of the Director at the National Institutes of Health, where she worked on issues such as privacy, gene therapy (transfer), embryonic stem cells, and genetic discrimination. Dr. O'Rourke has been actively involved with PRIM&R as both a member and past chair of the Board of Directors, and as a member of the AER Conference Core Conference Planning Committee (CCPC).

Jeremy SugarmannJeremy Sugarman, MD, MPH is the Harvey M. Meyerhoff Professor of Bioethics and Medicine and deputy director for medicine of the Berman Institute of Bioethics at The Johns Hopkins University. He is an internationally recognized leader in the field of biomedical ethics with particular expertise in the application of empirical methods and evidence-based standards for the evaluation and analysis of bioethical issues. Dr. Sugarman is the author of more than 200 articles, reviews, and book chapters. He has also edited or co-edited four books. He has worked with the White House Advisory Committee on Human Radiation Experiments, the National Bioethics Advisory Commission, the Presidential Commission for the Study of Bioethical Issues, and the Maryland Stem Cell Research Commission. In addition, he chairs the Ethics Working Group of the HIV Prevention Trials Network and is the ethics officer for the Resuscitation Outcomes Consortium. Dr. Sugarman has been elected as a member of the American Society for Clinical Investigation, the Association of American Physicians, and the IOM. He is also a fellow of the AAAS and The Hastings Center and has been actively involved with PRIM&R as a past board member and as a speaker at PRIM&R’s annual AER Conference.

Additional Resources

A collection of relevant background reading, further reading, links, templates, checklists, and/or charts accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs. Institutions are encouraged to explore other ways to apply their new knowledge at their institutions.

Background Reading: O’Rourke, P.P, Carrithers, J., Patrick-Lake, B., Rice, T.W., Corsmo, J., Hart, R., Drezner, M.K., Lantos, J.D. (2015). Harmonization and streamlining of research oversight for pragmatic clinical trials. Clinical Trials, 12(5), 449-456. doi:10.1177/1740774515597685


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