Instructions for Obtaining a Federalwide Assurance

Overview

Many federal agencies require that a Federalwide Assurance be obtained if the human research will be conducted or supported by that agency (e.g. through federal grant funds). An institution needs to obtain a FWA if they will be engaged in MSU human research that is conducted or supported by a federal agency that requires a FWA (e.g. MSU is subcontracting with the site).

Instructions

1) Institution goes to the OHRP website (http://www.hhs.gov/ohrp)

2) Click on "IRBs & Assurances" menu (on the left hand side of the webpage)

3) Click on "Federalwide Assurances" menu (on the left hand side of the webpage)

4) Click on "File a New FWA" (on the left hand side of the webpage)

5) Follow the instructions provided by OHRP.

Designation of an IRB

Please note that the institution will need to (a) designate an internal IRB(s) for review of research under the Assurance; or (b) if it does not have an internal IRB, designate an external IRB for review of all research to which this FWA applies or, if multiple external IRBs are relied upon, designate the external IRB that reviews the largest percentage of research to which this FWA applies.

Written Policies and Procedures

In addition, the Institution submitting the FWA must have established written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, the head of any U.S. federal department or agency conducting or supporting the research (or designee), and OHRP of any: (1) unanticipated problems involving risks to subjects or others; (2) serious or continuing noncompliance with the applicable U.S. federal regulations or the requirements or determinations of the IRB(s); and (3) suspension or termination of IRB approval.

If MSU Will Serve as IRB of Record

If the Institution does not have an IRB, then the MSU HRPP will need to review a copy of the Institution's approved FWA and written policies and procedures for reporting as described above.

If the Institution Will Conduct its Own IRB Review

If the Institution will conduct its own review of the human research that must be conducted or supported under an FWA through which MSU is the primary awardee, an approval letter(s) from the Institution must be provided to the MSU IRB prior to engagement of the site in human research.