IRB Authorization Agreements

There are several circumstances when an IRB Authorization Agreement may be used. 

• Situation # 1:  when a non- UVa company has obtained a small grant (e.g. SBIR) from NIH and wishes to contract all of the research work to be performed by a faculty/staff member at UVa.
• Situation # 2:  when a UVa employee/ faculty member wishes to work on a protocol that has or will be approved by an outside IRB and the subjects will not be enrolled at UVa and where the UVa  employee/ faculty member is not the overall PI

Situation # 1:  the following steps must be taken:

1. UVa researcher submits grant application and protocol to UVa IRB for the work that will be done at UVa.
2. UVa researcher works with OSP/ SOM Grants and Contracts office on contract.
3. The appropriate person at the outside company should sign one of the following
   • IRB Authorization Agreement-GRANT and PROTOCOL (use this form if this is the first time the grant has been submitted to the UVa IRB)
   • IRB Authorization Agreement-PROTOCOL (use this form if the UVa IRB has already reviewed and approved the grant and a new protocol is being added)
4. Submit the signed form to the IRB-HSR with the grant application.
5. The IRB-HSR will review the documents and submit the form to the Office of the VP for Research . 
6. After the form has been signed- a copy will be sent back to the outside company for their files.
7. At that time the outside entity may notify OHRP to add their company name to the UVa FWA. 

PLEASE NOTE:  OHRP will be notified to remove the name of any company added to the UVa FWA if it is added prior to these steps being taken. 

Situation # 2:   the following steps must be taken:

1. The UVa researcher will collect the most recent IRB approval along with the current protocol and consent(s) and other relevant documents from the  offsite institution.
2. The UVa researcher will obtain the signature of the offsite institution's signatory official on the IRB Authorization Agreement.
3. The UVa researcher will submit the complete packet of documents including the signed IRB Authorization Agreement to the IRB for review and approval.
4. The IRB-HSR will review the documents and submit the form to the Office of the VP for Research . 
5. If approved by the office of the VP for Research the outside IRB will be added to the UVa FWA and the IRB Authorization Agreement will be signed by the UVa Signatory Official (VP for Research).
6. Once signed the office of the VP for Research will forward a copy of the signed form to the IRB.
7. The IRB will send the original of the form to the UVa researcher and keep a copy in their files.
8. The UVa researcher should forward the original to the outside IRB and keep a copy for their records.