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Webinar: (2017-04) Studying Effectiveness: Ethical and Regulatory Considerations in Pragmatic Clinical Trials


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. (Presented on April 26, 2017)

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

Access Interval
Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.

If you'd prefer a paper form, please click here. Please send the completed form to registration@primr.org.