Department of Health and Human Services
Federalwide Assurance of Protection for Human Subjects

VA ADDENDUM TO FEDERALWIDE ASSURANCE FOR
DEPARTMENT OF VETERANS AFFAIRS
VETERANS HEALTH ADMINISTRATION FACILITIES

Insert Institution Name
assures that all of its activities related to human subject research will comply with all requirements of Department of Veterans Affairs regulations at Title 38 Code of Federal Regulations Part 16 (38 CFR 16),
and all other applicable Department of Veterans Affairs policies and procedures, including policies and procedures of the Office of Research Oversight (ORO) and the Office of Research & Development (ORD), issued in Manuals, Handbooks and other relevant authorized Directives.

Designation on the FWA of an IRB operated by another institution requires a Memorandum of Understanding (MOU) between the institutions.  VA Institutional Official certifies on this Addendum that any MOU executed for the purpose of using an IRB operated by another institution will contain a commitment from that institution to provide complete access to all IRB records and related documents to the VA Medical Center.  This commitment applies to VA-affiliated medical and dental schools or any other IRBs approved for use by VA.  

(7a.) Official Legally Authorized to Represent the Institution (VA Medical Center Director):

Signature ____________________________________________ 	Date: ________________ 

	First Name			Middle Initial:		Last Name:

	Degree or Suffix (e.g., MD, PhD) 			Institutional Title:

	OHRP FWA Online Training Modules last taken on:     (date)

	Address:

	City:					State:			Zip Code:

Telephone:			FAX:				E-Mail:

(7b.) Official Legally Authorized to Concur in the Institution’s Approval (VHA VISN Director):

Signature ____________________________________________ 	Date: ________________ 

	First Name			Middle Initial:		Last Name:

	Degree or Suffix (e.g., MD, PhD) 			Institutional Title:  Director, VISN # 

	OHRP FWA Online Training Modules last taken on:     (date)

	Address:

	City:					State:			Zip Code:

Telephone:			FAX:				E-Mail:

Department of Health and Human Services
Federalwide Assurance of Protection for Human Subjects

VA ADDENDUM TO FEDERALWIDE ASSURANCE FOR
DEPARTMENT OF VETERANS AFFAIRS
VETERANS HEALTH ADMINISTRATION FACILITIES

(7c.) Department of Veterans Affairs Approval

Section below to be completed by the Office of Research Oversight

This Federalwide Assurance of Protection for Human Subjects is hereby approved for submission to the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP).

Signature of VA Approving Official:

				
Priscilla A. Craig							Date:
Health Science Specialist, Federalwide Assurances
Office of Research Oversight 
Office of Research Oversight (10R)
811 Vermont Avenue, NW, Suite 574
Washington, DC 20420

Phone:	(202) 565-8162
FAX:	(202) 565-9194

E-mail:	priscilla.craig@va.gov

Any Additional Comments: