End of COVID Public Health Emergency: Changes to Single IRB Exceptions

By Bouvier Grant Group

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Upon conclusion of the COVID-19 Public Health Emergency on May 11, 2023, the single IRB exception for multisite research will also expire and cannot be applied to additional studies. This means that as of that date, NIH will no longer be able to grant single IRB exceptions for multi-site research that is subject to the revised Common Rule. Exceptions granted by NIH prior to May 11, 2023 will be valid for the duration of the research or the time they were granted, as indicated in the determination letters. 

Submissions made prior to May 11th should follow the process outlined here and should be made as soon as possible to be reviewed and a determination made prior to the May 11th deadline.

Author:
Dr. Meg Bouvier

Margaret Bouvier received her PhD in 1995 in Biomedical Sciences from the Mount Sinai School of Medicine. After an NINDS post-doctoral fellowship, she worked as a staff writer for long-standing NIH Director Dr. Francis Collins in the Office of Press, Policy, and Communications for the Human Genome Project and NHGRI. Since 2007, Meg has specialized in editing and advising on NIH submissions, and began offering virtual courses in 2015. She's recently worked with more than 40% of the nation's highest-performing hospitals*, four of the top 10 cancer hospitals, three of the top five medical schools for research, and 14 NCI-designated cancer centers. Her experience at NIH as both a bench scientist and staff writer greatly informs her approach to NIH grantwriting. She has helped clients land over half a billion in federal funding. Bouvier Grant Group is a woman-owned small business.

*Our clients include 9 of the top 22 hospitals as recognized by the 2023/24 US News & World Report honor roll

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