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Recommendations for Study Sponsors on Informed Consent Documents

The 21st Century Cures Act, passed in 2017, required that OHRP and FDA harmonize their regulations so that all human subject research is effectively being conducted under the same rules. While the new Common Rule, effective on January 21, 2019, does not apply to FDA-regulated research, FDA has already made clear their intent to update their own regulations to become consistent with these changes. This document summarizes the regulatory changes that apply to informed consent documents  to provide extra-regulatory and informal guidance where helpful, to help sponsors update informed consent document templates to be compliant with the new regulations.

About the Author

Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

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