What is a Federalwide Assurance (FWA) and when is it required?
An FWA is an institution or organization's assurance to the federal government that human subject research conducted at that site is in compliance with federal regulations pertaining to the protection of human subjects.

CWRU or CWRU-affiliated investigators, who are performing federally-funded human subject research at site(s) that do not have an assurance with the federal government, are responsible for coordinating the FWA application process for such sites and for obtaining proper documentation for CWRU, who acts as the grantee. This website was constructed to help investigators perform this role.

Could you provide some examples of when a FWA may be required?
Example #1:
A UH psychiatric investigator has applied for an NIMH grant. The research requires that the investigator have access to patient files that are located in a hospital in India. The investigator requires access to identifiable information about living individuals. In giving the investigator access to this information, the hospital is acting as a "performance site" and therefore is required to obtain an international FWA.

Example #2:
A biotech start-up has applied for a federal grant. Human subject research will be performed at various academic medical centers. The company has asked a local VAMC investigator to perform the research. The company does not have a FWA and they want to rely on the VAMC's IRB for review. The biotech company is required to obtain a FWA and the local PI is responsible for obtaining authorization

Example #3:
A nursing professor has applied for a NIH grant. The research requires that blood samples and surveys be taken at local nursing homes. Staff at the nursing homes will be performing the research. Each nursing home would therefore be deemed a "performance site" and therefore required to obtain an FWA.

When should I start the process?
The granting agency will contact the PI to let him/her know whether he/she is required to complete the FWA process for performance sites described in the proposal. However, investigators may want to start the process when they are reasonably sure of being funded, as it may take considerable time to do so. Federal agencies will not make awards until the process is completed.

Why should local investigators bear the responsibility when the work is being performed elsewhere?
Principal Investigators for federally-funded projects are responsible for ensuring that all sites listed in the grant that act as performance sites for human subjects research have an FWA. In addition, if a site does not have a registered IRB and the site requests to use one or more of our local IRBs (CWRU, UH, MHS, or VAMC), the Principal Investigator is responsible for obtaining appropriate local authorization. Previously, investigators may have been required to obtain Single Project Assurances or SPAs for this same purpose. SPAs are no longer accepted by the federal government.

Go to the following website for more information on what constitutes a performance site:
http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm

Do I need to go through this process if I am a CWRU/MHS investigator who wants to recruit patients or perform federally-funded research at UH or the Cleveland VAMC?
No! This process is only required for performance sites not covered by the CWRU's, UH's, MHS's and VAMC's assurance. This assurance also covers some satellite facilities or "system" hospitals that are affiliated with UH, MHS, or VAMC. Call the Compliance Office (368-4513) or the appropriate IRB Office if you have questions about which facilities are covered.

What do I need to do to get a FWA processed and approved?
The Principal Investigator should contact the collaborating performance site to determine whether the site has an active FWA. If they do not he/she should provide them with a copy of the IRB-appropriate template (see below) and the link to the OHRP website (http://www.hhs.gov/ohrp/assurances/assurances_index.html).

If a performance site has an approved FWA and is using their own IRB then the Principal Investigator can provide the FWA number to the funding agency and does not need to go through this process for that performance site.

Once the institution has an OHRP-approved FWA, the IRB-appropriate Authorization agreement (two originals are needed) should be filled out by the PI, forwarded to the performance site for signature, and then forwarded to the CWRU Compliance Office for final approval.

Prior consultation by the local investigator with the CWRU Compliance Officer (Christian LaMantia, 368-4513 or clt@po.cwru.edu) is required if the authorization agreement is not limited to one award.

The CWRU Compliance Office will forward the approved authorization agreement back to the PI. The PI is responsible for providing a copy of the agreement to the performance site and to the appropriate IRB for each IRB protocol funded by the award where the performance site is involved. The following are templates that can be forwarded to performance sites:
CWRU IRB FWA
CWRU IRB Authorization Agreement
UH IRB FWA
UH IRB Authorization Agreement
MHS IRB FWA
MHS IRB Authorization Agreement
VAMC IRB FWA
VAMC IRB Authorization Agreement
VAMC/ORCA Additional Agreement (Required)

Are there additional human subject research education requirements?
No, the same requirements apply to all federally-funded grants. All key personnel named in the application who are involved in human subject research are required to receive and obtain proper documentation of training. Key personnel who are not affiliated with CWRU, UH, MHS or VAMC are not required to complete the local education program if they provide documentation of education from their home institution. However, if their home institution does not have an education program, then the local PI is responsible for ensuring that they complete our program. For more information on our program which is called CREC, Continuing Research Education Credits Program, please go to the following website: http://ora.ra.cwru.edu/main_edu_%20and_%20reg_page_1.htm

What do I do if the collaborating performance site is not located in the United States?
If the performance site is located outside of the United States and does not have an approved FWA, then the performance site must fill out the template located below. PIs may use the same Authorization Agreements located above. PIs must also remember that the IRB must perform a "local context review" in order to meet federal guidelines. OHRP guidance describes the requirements for such a review.

International FWA

What do I do if the study will utilize more than one of the local IRBs, for example University Hospitals and MetroHealth?
Multiple FWAs and Authorization Agreements are not needed in this case, simply modify the FWA template to include information concerning all relevant IRBs (cut and paste IRB information from other agreement templates). Modify the Authorization Agreement in the same fashion. Please remember that the PI is still responsible for providing a copy of the Authorization Agreement to each IRB for each protocol covered under the Agreement.

Who do I contact locally if I have any questions?
Philip A. Cola, Director of Clinical Research at (216) 844-5576 or philip.cola@uhhospitals.org. E-mail is preferred form of communication.