Number 93-01
Human Subject Protections

OPRR Reports

November 9, 1992 


Subject: Local IRB Review of Multicenter Clinical Trials

Dear Colleague: 

This letter is being forwarded to Institutional Officials and Institutional Review Board (IRB) Chairpersons throughout the country. Its purpose is to clarify procedures for local IRB review of National Institutes of Health (NIH) multicenter clinical trial protocols that include NIH-approved sample informed consent documents. These procedures complement the informed consent requirements of Department of Health and Human Services (DHHS) regulations as follows: 

(1) The Office for Protection from Research Risks (OPRR) now requires that each local IRB receive a copy of the NIH-approved sample informed consent document and the full NIH-approved protocol as a condition for review and approval of the local informed consent document. 

(2)  Any deletion or substantive modification of information concerning risks or alternative procedures contained in the sample informed consent document must be justified in writing by the investigator and approved by the IRB. 

(3)  The justification for and approval of such deletions or modifications must be reflected in the IRB minutes. For trials sponsored by the National Cancer Institute (NCI), investigators must forward copies of such IRB-approved changes, with their justifications, to the appropriate Cooperative Group headquarters. 

This policy should be implemented immediately for the initial local IRB review of any multicenter clinical trial protocol with an NIH-approved sample informed consent document. For trials that are currently in progress, the policy should be implemented at the next scheduled continuing IRB review.

This policy does not reflect any change in OPRR's policy concerning the importance of local IRB review or the local IRB's profound responsibility for protecting human subjects. Only the local IRB is familiar with the particular circumstances of its research setting and is in a position to weigh critical considerations like state and local laws, professional and community standards, institutional policies, and the needs of differing patient or subject populations. Thus, the local IRB is in the best position to ensure that persons deciding whether or not to enroll in research have the greatest level of accurate information necessary to make that decision. Each IRB must continue to review all protocols and informed consent documents with the greatest of care, regardless of any prior review at the national level.

Melody H. Lin, Ph.D.
Acting Director
Division of Human Subject Protections
John G. Miller, D.V.M
Acting Director