Criteria for IRB Approval: 45 CFR 46.111 (DHHS), 21 CFR 56.111 (FDA), and 38 CFR 16.111 (VA)

IRB Member Fact Sheet--Version Date: 4-8-2007

Introduction
The federal regulations governing human subjects research specify the conditions under which a research study can be approved and re-approved by an IRB.  DHHS, FDA, and VA regulations outline identical criteria that an IRB must determine are met in order to approve non-exempt research involving human subjects.  The staff reviews and primary reviewer sheets Health Sciences and Minimal Risk IRB members receive are designed to reflect these requirements and help ensure all of the federally prescribed criteria for IRB approval of a research protocol are met with each review.  

NOTE: IF THE IRB DOES NOT FIND THAT A PROTOCOL MEETS ALL THE CRITERIA NOTED BELOW AT THE TIME OF INITIAL OR CONTINUING REVIEW, IRBS ARE EXPECTED TO DEFER OR DISAPPROVE THE PROTOCOL.  

The guidance sections that follow the criteria for IRB approval have been adapted from the Institutional Review Board Guidebook developed by the Office for Human Research Protections.

Criteria that must be met for IRB approval
The DHHS, FDA, and VA regulations all describe that the following must be in place in order for an IRB to approve a research protocol involving human subjects:
Guidance for IRBs: Identification of risks and benefits
Guidance for IRBs: risk/benefit analysis