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  4. New FDA/OHRP joint guidance on written procedures for IRBs

New FDA/OHRP joint guidance on written procedures for IRBs

In their continuing and, um, not super expeditious campaign to harmonize regulations between their agencies, the Office for Human Research Protections and the Food and Drug Administration have issued a joint guidance about written procedures for IRBs. We encourage you to take a look at them to get an idea of the breadth of the IRB’s responsibilities. We also notice that some of the guidance’s advice mirrors what we tell researchers, e.g. “When preparing written procedures, institutions/IRBs should generally identify who carries out specific duties by reference to position title (e.g., IRB chairperson) rather than by name to avoid the need to update written procedures if duties change, or there are changes in IRB membership.“

Posted by Edith Paal on May 18, 2018

Filed Under: Institutional Review Board Members

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