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IRB-HSR > Special Issues>IRB Authorization Agreements

 

 

 

 

 

 

IRB Authorization Agreements

There are several circumstances when a non UVa IRB may be used as the IRB of record.
 
Company outside of UVa obtained grant funding and all human subject research to be performed by a faculty/staff member at UVa.

The following steps must be taken:

  • UVa researcher submits grant application and protocol (using Protocol Builder)  to UVa IRB for the work that will be done at UVa.
  • The Grant Information Form includes a request for an IRB Authorization Agreement.    This form is completed and submitted to the IRB.  IRB staff will then provide an IRB Authorization Agreement to the study team.  The form will be signed by the outside party and returned to the IRB. 
  • UVa researcher works with OSP/ SOM Grants and Contracts office on contract.
  • The IRB-HSR will review the documents and submit the form to the Office of the VP for Research for signature. 
  • After the form has been signed, a copy will be sent back to the local PI to share with the outside institution.

A UVa student, 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.

NOTE:  A Determination of  UVa Agent Form may also be applicable in this situation- Determination of UVa Agent Form

The following steps must be taken:

  • 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.
  • The UVa researcher will submit a Request for an IRB Authorization Agreement with the documents listed under item # 1, to the IRB office. 
  • IRB staff will then provide an IRB Authorization Agreement to the study team.  The form will be signed by the outside party and returned to the IRB-HSR. 
  • The UVa researcher will submit the complete packet of documents including the signed IRB Authorization Agreement to the IRB for review and approval.
  • The IRB-HSR will review the documents and submit the documents to the Office of the VP for Research. 
  • If approved the IRB Authorization Agreement will be signed by the UVa Signatory Official (Associate VP for Research) and returned to the IRB-HSR.
  • The IRB will send the original of the form to the UVa researcher and keep a copy in their files.
  • The UVa researcher should forward the original to the outside IRB and keep a copy for their records.
  • If funding for the project is coming through UVa, the IRB-HSR may determine if any additional documentation is required from local IRB (e.g. continuation approvals, unanticipated problem reports). 

Continued Access via Central IRB

Researchers wishing to open a continued access protocol may use a central IRB as the IRB of record for the protocol. Continued access is for patients at UVa who need continued access to an investigational drug/device or biologic outside of a clinical trial.  If Western IRB will be the central IRB, see steps to follow under Alternative IRB of Record.  If Western IRB will not be the CIRB see the information below.
Additional Information from FDA on Continued Access


Use of a Non- UVa IRB for a Single Protocol

UVa may allow the use of a single IRB outside of UVa if required by the sponsor (usually the NIH) or for a Continued Access Protocol.  Before beginning any submission, please contact the IRB-HSR Director to discuss the option of using the outside IRB.  If the use of the non- UVa IRB is agreed to, the PI will first submit the appropriate paperwork to establish an IRB Authorization Agreement between the IRB-HSR and the outside IRB.  The researchers will then proceed to Protocol Builder to create a submission to the IRB-HSR.  Even though the UVa IRB-HSR will not serve as the IRB of record, they are responsible for verifying that other compliance and educational requirements are met. 

 

UVa student, employee/ faculty member wishes to work on a multisite protocol.  Only some of the work on the project is being done at UVa.  Work to be done at UVa does not meet the criteria for coded, exempt or non-engaged.

 (e.g.- funding coming through UVa, subjects enrolled at another institution, samples analyzed at a third institution, UVa employee/faculty member will be involved in the analysis and publication.) Site where subjects are enrolled has an IRB and FWA and will be the IRB of record for work done at local site.  The outside IRB will be the IRB of record for work done on the project at UVa. 

The following steps must be taken:

  • 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.
  • The UVa researcher will submit a Request for an IRB Authorization Agreement with the documents listed under item # 1, to the IRB office.  
  • IRB staff will then provide an IRB Authorization Agreement to the study team.  The form will be signed by the outside party and returned to the IRB-HSR. 
  • The UVa researcher will submit the complete packet of documents including the signed IRB Authorization Agreement to the IRB for review and approval.
  • The IRB-HSR will review the documents and submit the documents to the Office of the VP for Research. 
  • If approved the IRB Authorization Agreement will be signed by the UVa Signatory Official (Associate VP for Research) and returned to the IRB-HSR.
  • The IRB will send the original of the form to the UVa researcher and keep a copy in their files.
  • The UVa researcher should forward the original to the outside IRB and keep a copy for their records.
  • If funding for the project is coming through UVa, the IRB-HSR may determine if any additional documentation is required from local IRB (e.g. continuation approvals, unanticipated problem reports).