Notice Number: NOT-OD-06-015

Key Dates
Release Date: December 2, 2005

Issued by
National Institutes of Health (NIH), (http://www.nih.gov/)

Early this year, the Office for Human Research Protections (OHRP) announced the approval of Federalwide Assurance (FWA) forms and related documents and the institutional review board/independent ethics committee (IRB/IEC) registration form by the Office of Management and Budget. Since February 10, 2005 , the FWA is the only type of assurance accepted for review and approval by OHRP.

Institutions still holding a Multiple Project Assurance (MPA) or a Cooperative Project Assurance (CPA) have until December 31, 2005 , to convert to the FWA if an OHRP-approved assurance of compliance is still required. Single Project Assurances (SPA) currently approved by OHRP will remain in effect for the duration of the project and through all non-competitive award renewals.

To date, 96% (510) of the institutions holding an OHRP-approved MPA have converted to the FWA. However, only 58% (1,177) of the institutions holding an OHRP-approved CPA have converted to the FWA.

All institutions engaged in human subjects research, not otherwise exempt, conducted or supported by the Department of Health and Human Services (HHS) must hold an OHRP-approved FWA by December 31, 2005 . On January 1, 2006, any institution that has not obtained an OHRP -approved FWA will no longer be covered by an OHRP -approved assurance of compliance, and therefore, any ongoing HHS-supported human subjects research at such an institution that is not exempt will need to be suspended until the institution submits, and OHRP approves, an FWA. To ensure the continuity of human subjects research conducted at your institution under a previously recognized MPA or CPA, you should submit an FWA immediately.

Before an FWA may be approved, all IRBs/IECs designated on the assurance must be registered with OHRP, and the registration must be current. Please see http://ohrp.cit.nih.gov/efile/IrbStart.aspx to determine the status of any IRB/IEC registered with OHRP. The same website provides a list of all approved FWAs.

You are strongly encouraged to use the OHRP Electronic Submission System (ESS) for any new IRB/IEC registration or new FWA, as well as for all updates/renewals. Complete instructions on how to use the ESS are on the OHRP website at http://ohrp.cit.nih.gov/efile. If you choose to submit an IRB/IEC registration or an FWA in hard copy, the OMB-approved documents are posted on the OHRP website at http://www.dhhs.gov/ohrp.

If you have any questions about registering an IRB/IEC or submitting an FWA, please contact your regional coordinator at OHRP http://www.hhs.gov/ohrp/daqi-staff.html#staff.

OHRP welcomes comments on the FWA forms and related documents, the institutional review board/independent ethics committee (IRB/IEC) Registration form, and OHRP's new guidance document, "Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement." To submit comments, please go to the OHRP website at http://www.hhs.gov/ohrp and click on "Public Comments" in the left menu.