Note: if the source of your data is a covered entity, which does not have its own IRB, it may be appropriate for the HSC to serve this role for both protocol review (Common Rule) and privacy board (HIPAA Privacy Rule) functions. If in doubt, or for more information, please contact HSC Assistant Director Leslie Howes at (617) 384-5487.

The Importance of the Federal Wide Assurance

A Federal Assurance constitutes the legal permission an institution must maintain in order to conduct research with human subjects with (U.S.) Federal support. It is all about public trust. Until December 2000, the Office for Human Research Protections (OHRP) approved three basic types of assurances: the Multiple Project Assurance, the Cooperative Project Assurance, and the Single Project Assurance. At that time, HSPH operated under Multiple Project Assurance # M-1208.

Then OHRP developed a new Assurance system and Institutional Review Board (IRB) registry. These initiatives streamlined the assurance process to significantly reduce the administrative burden on individual institutions, other federal departments and agencies, and OHRP. HSPH applied for an FWA, which was approved for the period June 7, 2002 through June 7, 2005. Since this time we have renewed and updated our FWA. Our present FWA has approval through September 21, 2010.

Original FWA (PDF)
Updated FWA (PDF)

A Federal Assurance is not an unconditional permission; the federal government may restrict, suspend or revoke it, if an institution, its IRB and/or its individual investigators fail to comply with its terms. All human subjects activities designated under the Assurance, regardless of funding source, must be guided by the ethical principles established in the Belmont Report and comply with federal policy. We appreciate the efforts of each member of our research community to help ensure that human subjects are treated in a manner worthy of public trust. At HSPH, we are all bound individually and collectively under the same Assurance; each of our efforts or omissions can affect the whole.

• Please use the following whenever you are required to provide the School's federal assurance number: FWA#2642.
• A link to the Terms of Assurance is located below. We strongly encourage you to read them, especially if your research involves other entities as partners.

Terms of Assurance on OHRP's website

If you have any questions or concerns regarding HSC's FWA, please contact our assistant director Leslie Howes, MPH, CIP.

This page is maintained by HUMAN SUBJECTS COMMITTEE. To contact us with suggestions, comments, and questions, please e-mail: hsc@hsph.harvard.edu.

Human Subjects Committee
1552 Tremont Street, Boston, MA 02120
Phone: (617) 384-5480
Fax: (617) 384-5484