NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE MORE CURRENT INFORMATION CAN BE FOUND ON THE NIH WEBSITE AT http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iia_2.htm.

June 1, 1994

Subject: AWARDEE COMPLIANCE WITH 45 CFR 46 REQUIREMENTS

Dear Colleague:

This bulletin is being forwarded to PHS Components and other parts of DHHS that are involved in research activities that include human subjects. Its purpose is to clarify when a potential awardee (applicant institution) of a grant, contract, or cooperative agreement must initiate action to have its proposed project reviewed by an Institutional Review Board (IRB) and obtain approval of an Assurance from the Office for Protection from Research Risks (OPRR) as specified in 45 CFR 46.103.

Institutions that do not have an OPRR-approved Multiple Project Assurance (MPA) are required to have an IRB review and prepare an Assurance document for compliance with 45 CFR 46 only after the appropriate Program office has determined that the project will be funded. The Program Office and the Awards Office are authorized to request from OPRR negotiation of a Single Project Assurance (SPA). An SPA includes provision for certification of IRB review. OPRR will then send to the applicant institution a letter with explanatory and sample material. An Assurance is not required for grant, contract, or cooperative agreement applications before peer review - unless the project has been designated for expedited peer review (such as some AIDS projects). Section 45 CFR 46.103 (5) (f) specifies that an applicant institution (without an MPA) has 30 days after receipt of a request (from OPRR) to certify that its application or proposal has been approved by an IRB (full board review), and to complete an appropriate Assurance, as specified by OPRR. Therefore, please do not unnecessarily require of either the investigator or the awardee institution a Form 310 (formerly Form 596) for certification of IRB review, or an Assurance before peer review. Such untimely requirements cause avoidable stress for the applicant and numerous unnecessary telephone calls to OPRR.

The regulations [45 CFR 46.103 (5) (f) ] indicate that MPA institutions must submit certification of IRB review and approval with the application or proposal or by such later date as may be prescribed by the Department or Agency to which the application or proposal is submitted. NIH has determined that it will allow MPA institutions to submit certification of IRB review and approval 60 days after the submission of its application or by the date of the peer review meeting, whichever is shorter. The Form 596 is not included in the application kits anymore, so you may accept a letter certifying IRB review when appropriate or the new Form 310.

Your attention to this important matter is greatly appreciated.