University of Minnesota School of Medicine
Minneapolis, MN
Dr. Biros also is a well-known leader in the national emergency medicine community, and is the Interim Chief of Emergency Medicine at the University of Minnesota Medical School . In 1994 , she organized the Coalition for Acute Resuscitation and Critical Care Research to assist the FDA and DHHS in the development of the Final Rule for Exception from Informed Consent in Emergency Research ( 21 CFR50.24) . In this capacity, she facilitated communications among clinician- scientists , federal agencies, and concerned public on issues related to waiver of/ exception from consent, research integrity and biomedical ethics . She is considered a national expert on EFIC , and has served on several advisory committees for multicenter clinical trials that implement EFIC. Her recent research interest has centered around the EFIC regulations, the especially the development of best practices for Community Consultation. Dr. Biros is a lead IRB Chair at the University of Minnesota. She helped plan and moderated an NIH- FDA FDA sponsored conference evaluating at a number of models for centralizing IRB activities, and the impact this would have on EFIC studies. Because of her national work on EFIC, she was elected to the Institute of Medicine in 2009.
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Panel III: Exception from Informed Consent (EFIC) for Research at 25
Thursday, November 18, 2021
11:30 AM – 12:45 PM ET