The 21st Century Cures Act: Implications for Human Subjects

The  21st Century Cures Act has an extensive set of regulations about the development of drugs, biologics, and medical devices, with implications for everyone involved in the conduct of clinical research. This Act will help to improve the efficacy of human subject research while appropriately reducing the administrative burden. Read this whitepaper to learn more about the Act and its implications for human subject protections.  
 

About the Author

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

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.

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The 21st Century Cures Act Easily Passed, But is it Good for Research Protection?
The 21st Century Cures Act Easily Passed, But is it Good for Research Protection?

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