Federal-Wide Assurance on Human Subjects Protection

Federally Mandated Reporting/Disclosure Form

Program Title and Description:

Federal-Wide Assurance (FWA) on Human Subjects Protection

Who is Responsible for Reporting?

Where is Report Physically Located?

CARR 405

What Should be Reported?

• The legal Name of the Institution Filing for Assurance
• Statement of Principles
• Applicability
• Designation of Institutional Review Boards (IRBs)
• Human Protections Administrator
• Signatory Official

When Should it be Reported?

Required every 3 - 5 years

Where is it to be Reported?

Electronically via the Office for Human Research Protections (OHRP) website

Why Should it be Reported?

To comply with the US Department of Health & Human Services regulations

How is it Reported?

Electronically

If notification is required, how is it reported?

An update to an FWA should be submitted when there are changes in the institution's FWA information on record with OHRP (e.g., change in Signatory Official or Human Protections Administrator (HPA)/ contact person, addition/deletion of an IRB, or changes in mailing addresses).