martes, 2 de agosto de 2016

FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued draft guidance titled, “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs”. This draft guidance was prepared jointly by FDA and OHRP and is intended to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for the IRB. This joint draft guidance is now available on FDA's website at, and OHRP’s website at

The draft guidance provides an IRB Written Procedures Checklist that incorporates the HHS and FDA regulatory requirements for IRB written procedures and additional topics that FDA and OHRP recommend including in IRB written procedures.

Comments are due by October 3, 2016.

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