Federally Mandated Reporting/Disclosure Form

Program Title and Description:

Federal Wide Assurance on Human Subjects Protection Update/Renewal

Who is Responsible for Reporting?

Office of Sponsored Research and Programs

Where is Report Physically Located?

Office of Sponsored Research and Programs, CARR 407

What Should be Reported?

• The legal name of the institution filing for assurance
• Statement of Principles
• Name of Human Subjects Administrator and Signatory Official
• An updated committee roster indicating the IRB chairperson, each member’s primary scientific or nonscientific specialty, and affiliation with the institution

When Should it be Reported?

December 18, 2005 (Every 3 years)

Where is it to be Reported?

Division of Policy and Assurances
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Or

Fax: ATTN: Division of Policy and Assurances 301-402-0438

Why Should it be Reported?

To comply with United States Department of Health and Human Services guidelines

How is it Reported?

By mail or fax 

If notification is required, how is it reported?

Office for Human Research Protections must also be notified of any changes to the IRB chair or committee membership when they occur.