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Wednesday, June 26 • 2:00pm - 3:15pm
#361: Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-685-L04-P; CME 1.25; IACET 1.25; RN 1.25

Many sponsors are developing programs to provide the results of clinical trials to participants as “plain language summaries”. As sponsors develop plain language summary programs, they should consider best practices for the content and preparation

Learning Objectives

Describe current best practices for the content and preparation of plain language summaries; Discuss current guidance for how sponsors should work with Institutional Review Boards (IRBs) having oversight of the clinical trials for which the summaries are provided; Apply learnings from an industry sponsor’s firsthand experience with IRBs during the plain language summary creation/delivery process.

Chair

Kenneth A. Getz, MBA

Speaker

Best Practices for Returning Aggregate and Individual Trial Results to Patients
Jill McNair, MBA

The Role of the IRB in the Review of Lay Language Summaries
Lindsay McNair, MD, MPH, MSc



Speakers
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor (PHCM); Founder and Chairmen, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT; CISCRP
Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategies and tactics, outsourcing, and global... Read More →
avatar for Lindsay McNair

Lindsay McNair

Chief Medical Officer, WIRB-Copernicus Group (WCG)
Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory... Read More →
avatar for Jill McNair

Jill McNair

Senior Director, Health Communication Services, CISCRP
Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at CISCRP. In this role, she oversees a team dedicated to helping sponsor companies provide trial results summaries in plain language to study volunteers. She is passionate about... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA