Addressing the Challenges of Human Tissues and Cell Products Regulation

David Forster, JD, MA, CIP | Chief Compliance Officer

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 joined Western IRB (WIRB) in 1996 and is currently the Chief Compliance Officer for the WIRB-Copernicus Group (WCG). A strong advocate for human subject protections, Mr. Forster co-chairs the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Harmonization. He previously served a four-year term as a member of SACHRP, and was previously a member of the SACHRP Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research. Mr. Forster also served on the Certified IRB Professional (CIP) Council. Mr. Forster has a law degree and a Masters in Medical Ethics from the University of Washington.
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