Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants.
Read this white paper, co-authored by the Center for Information and Study of Clinical Research Participation (CISCRP) to learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided.
About the Author
Mr. Forster has a J.D. and a Masters in Medical Ethics from the University of Washington. He joined Western IRB (WIRB) in 1996 and is currently the Chief Compliance Officer for the WIRB-Copernicus Group (WCG). Mr. Forster co-chairs the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Harmonization (SOH). He previously served a four-year term as a member of SACHRP, and was a member of the SACHRP Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research (SIIIDR). Mr. Forster also serves on the Certified IRB Professional (CIP) Council.More Content by David Forster, JD, MA, CIP | Chief Compliance Officer