Despite notable efforts to promote patient involvement in research, often captured under the rubric of Patient Centered Outcomes Research (PCOR), scant attention has been paid to many of the ethical and oversight challenges PCOR raises. Indeed, there exists no formal regulatory or ethics guidance on PCOR from either the FDA, OHRP or other regulatory bodies. While the oversight challenges raised by PCOR are not entirely novel, certain ethical issues are more prominent in PCOR, due primarily to the more involved roles that patients play in PCOR than in traditional research.

In this webinar, Luke Gelinas, PhD, IRB Chair at Advarra, will lay out some of the oversight challenges raised by PCOR. He will also share policy recommendations for managing such challenges that were derived as part of a Patient Centered Outcomes Research Institute (PCORI)-funded project on ethical challenges with PCOR.

Presentation Objectives
Following this free webinar, attendees will be able to:

  • Demonstrate a better understanding of PCOR and how it differs from more traditional clinical research
  • Summarize the primary ethical and oversight challenges PCOR raises
  • Describe a set of recommendations addressing these challenges derived as part of a recent PCORI-funded project

Who Should Attend

  • IRB members and others involved in regulatory oversight of PCOR
  • Principal investigators and others involved in conceptualizing and running PCOR studies
  • Sponsors and others responsible for identifying and engaging patient partners in research

Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.

Wednesday, August 22nd
Presentation: 1:00-2:00pm ET
Q&A: 2:00-2:15pm ET

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