UT System Reciprocity Agreement

STANDARD OPERATING PROCEDURE - INITIAL REVIEW

Policy

A research project may be approved by the Reviewing IRB under the scope of the reciprocity agreement with permission from the Relying Organization. Both the institutions may decline triggering the reciprocity for any particular protocol.

Procedure

• A research project is reviewed and approved at one participating organization.  The PI at this organization is called the Overall PI. The IRB that reviewed and approved the research proposal is called the Reviewing IRB.

• A wide range of research projects are covered under the scope of the reciprocity agreement:
• Multi-center clinical trial with lead PI at the institution of the reviewing IRB.
• Multi-center clinical trial sponsored by industry with no lead PI,
• Multi-center clinical trial with a lead PI at a non UT location,
• Research project being conducted at one UT component with certain parts of the research being done at another UT component,
• Research project being conducted at one UT component but has collaborators from another UT component,
• Other types of research projects that fall under the oversight of more than UT component HRPP..

• When a research project falls under the oversight of more than one UT component IRB, either the Overall PI or the Site PI may trigger the reciprocity agreement. Both the Overall PI and Site PI must understand and accept the additional responsibilities they would have if the research project is reviewed under the reciprocity agreement.

Triggering the Reciprocity Agreement

• The process is initiated by the Site PI at the Relying Organization. The Site PI must follow the Relying Organization’s procedure for seeking permission to rely on another IRB within the UT System.  In most UT component, this process is handled by the Relying Organization’s IRB office.

The Site PI must submit supporting documentation while seeking permission to rely on another UT IRB.  When the Relying Organization has an electronic IRB system, the organization may require the Site PI to complete an electronic application or registration and attach the supporting documents.  At the minimum, this should include:

• Completed Permission to Rely form
• Site Specific Consent form  (Site PI contact, local IRB contact)
• Protocol (if required by the Relying Organization)

Permission to Rely from Relying Organization

• Upon receipt of the request for permission to rely on another UT IRB, the Relying Organization should make sure that the Reviewing IRB is listed on the Relying Organizations FWA, especially if the research is federally funded or supported. If any affiliated organizations are involved, the Reviewing IRB should be listed on their FWA as well.  The Relying Organization should consider:
• Whether the research proposal falls within the scope of the UT System Reciprocity Agreement.
• Study team members human subjects training verification and COI disclosures.
• Concerns about the research submission
• Concerns about the qualifications of the Site Investigator / Site research team.
• Concerns about the resources available at the site.

• If the relying organization disapproves the request to rely, the site PI will submit a regular application to the Relying Organization’s IRB.

• If the Relying Organization approves the request to rely on another UT IRB, the Relying Organization should sign off on the Permission to Rely form and indicate their preferred method of communication with the Reviewing IRB. The Relying Organization should send the signed Permission to Rely form back to the Site PI.

• Preferably, all the communication with the Reviewing IRB should be through the Overall PI. The Site PI should submit the following documents to the Overall PI.
• Permission to Rely form with the Relying Organization’s signature
• Completed Addition of Site form
• CV of the Site PI
• Site specific Consent Document.

Review by Reviewing IRB

• If the research project had already been reviewed and approved by the Reviewing IRB at the time of the Site PI’s submission, the Overall PI will submit these documents as a protocol amendment / addition of site / change request submission. The Overall PI should clearly indicate that approval is being sought for inclusion of the site at the Relying Organization. If the research project has not yet been approved by the Reviewing IRB, the Overall PI will include the Site PI documents with the initial application to the Reviewing IRB.  

• The Reviewing IRB screens the request to rely and may decide to accept or decline the request to rely.  If the reviewing IRB accepts the request, this may be assigned for expedited or full board review. If the reviewing IRB declines, the submission is returned to the Overall PI with a letter declining the request to be the Reviewing IRB.

• If the Reviewing IRB accepts the request to rely, the application may be reviewed through expedited review or full board review.  In addition to the regulatory criteria for approval for approval of research at the Reviewing IRB’s  institution, the Reviewing IRB should consider the following:
• Investigator Qualifications - The Site PI should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.
• Study team - The Site PI should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.  Significant research -related duties may be delegated only to adequately qualified individuals.
• Recruitment plan and consent process – If the plan for recruitment and consent process is different from the strategy outlined by the Overall PI, the Reviewing IRB should assess whether the Site PI’s plan is appropriate.
• Conflict of interest disclosures and management plans, if any, by the Site PI and study team.

• If the Reviewing IRB requires more information or local context, the Reviewing IRB may seek help from the Relying Organization’s IRB. Local context may be provided by a member or staff of the IRB from the Relying Organization. This individual may provide information as Consultant for the Reviewing IRB and may participate in the Reviewing IRB’s meeting via teleconference. The Consultant does not have the right to vote at the Reviewing IRB’s meeting.

Post Review Communication

• If the addition of site is approved, the Reviewing IRB should send the approval letter and stamped consent document to the Overall PI. The approval letter should include information on the reporting requirements of the Reviewing IRB. If the Relying Organization requested for direct communication, the Reviewing IRB must send a copy of the approval letter to the Relying Organization. In all other cases, the Overall PI.

• Reviewing IRB staff should review the notification arrangement requested by the Relying Organization to make sure they can meet the requirements of the Relying Organization. If there is disagreement, the Reviewing IRB staff should communicate with the Relying Organization staff to come to a mutually acceptable arrangement.

• The Site PI must submit the approval letter, stamped consent form and any other documents requested by the Relying Organization. The Site PI must also submit relevant documents to any Affiliated Institution involved in the research. Research may not begin until all necessary approvals are in file.  Relying Institution IRB may issue an Activation Letter.

Responsibility
This guidance applies to those members of the clinical research team involved in conducting the clinical research.  This includes the following:

• Overall Principal Investigator
• Local Principal Investigator
• Reviewing IRB and IRB Office
• HRPP Staff at Relying Organization
• Staff at Affiliated Institution

Attachments

• Form – Permission to Rely
• Form – Addition of Site
• Template – Approval Letter
• Template – Activation Letter