Article | July 22, 2020

Patient Engagement And The IRB

Source: Advarra

By Luke Gelinas, PhD, IRB Chairperson

Doctor Patient Engagement

Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. This approach is reflected in the founding of the Patient Centered Outcomes Research Institute (PCORI) as well as statements from the US Institute of Medicine and Food and Drug Administration (FDA) on the importance of including participant perspectives at every stage of the research process—from the design of studies through their implementation and the dissemination of research results.

While these efforts promise to promote public trust and increase research value, they also raise novel regulatory and ethical questions that could impact IRB review. At what point does engaging patients in study design and implementation require IRB review? Are there any special obligations or risks for sponsors that might arise when working closely with patient advocacy groups? What role, if any, should the IRB play in scrutinizing conflicts of interest that may arise for patient partners?

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: