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Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB
Session Chair(s)
Kenneth Getz, MBA
Tufts Center for the Study of Drug Development
Center For the Study of Drug Development, United States
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 Objective : 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.
Speaker(s)
Best Practices for Returning Aggregate and Individual Trial Results to Patients
Jill McNair, MBA
Scott Clinical, United States
Key Account Director
The Role of the IRB in the Review of Lay Language Summaries
Lindsay McNair, MD, MPH, MS
Equipoise Consulting, United States
Principal Consultant
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