In 2017, the the New England Journal of Medicine revealed troubling findings related to clinical studies using stem cells, as reported in the New York Times.
Regulatory oversight of research involving stem cells is tricky. They have a distinct regulatory classification from drugs, biologics, and devices. Read this white paper, authored by WCG experts in ethical review, to learn sponsors, investigators, and IRBs need to know about how these distinct products are regulated.
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