This section of the Reliance Manual describes PI responsibilities and lines of communication important to ceded reviews.
Principal Investigator Responsibilities & Requirements
When UW-Madison agrees to cede IRB oversight for a study to an external IRB, the UW-Madison study team must still comply with relevant UW-Madison requirements. Study teams also must be familiar with the requirements of the reviewing IRB, which may be different from what might be required by UW-Madison. Several of these requirements must be met before the UW-Madison can agree to cede IRB oversight.
Responsibilities and requirements include:
- The UW-Madison PI for the study must fulfill the responsibilities described in the HRP-103-Investigator Manual.
- Study teams must ensure that all study team members complete and maintain current human participant research training certification and, if applicable, Good Clinical Practice training certification. All UW-Madison study team members must have complete and current training certifications before IRB oversight can be ceded to an external IRB.
- If applicable, UW Carbone Cancer Center Protocol and Monitoring Committee (UWCCC PRMC) review must be completed before IRB oversight can be ceded to another IRB.
- If the Clinical Research Unit (CRU) will be used, endorsement by the CRU must be in place before the cede review process can be completed.
- Study teams must adhere to the requirements of any UW-Madison ancillary reviews (e.g., conflict of interest, biosafety, Clinical Research Unit), as applicable. If ancillary committee review is required, this may need to be completed before IRB oversight can be ceded to an external IRB. For more information, see HRP 309-WORKSHEET-Ancillary Review Matrix.
- If study activities will involve UWHC personnel and/or occur at UWHC facilities, study teams are responsible for following UWHC policies.
- Study teams are responsible for ensuring that all budgetary and contractual issues relevant to the UW-Madison’s conduct of the study are resolved before starting their research.
- Study teams are responsible for ensuring language in consent forms (e.g., compensation for injury) does not conflict with clinical trial agreement or other funding agreement.
- Study teams are responsible for ensuring required agreements for data or biospecimen transfer (e.g., data use agreements, material transfer agreements) are in place prior to the UW-Madison receiving or transferring data or biospecimens. For more information, see the Data Transfer and Use Agreement section below.
- UW-Madison study teams are responsible for providing Research and Sponsored Programs (RSP) with documentation that a study has been ceded to and approved by an external IRB. For additional guidance, see Research and Sponsored Programs (RSP) Release of Grant Funds When Studies Are Ceded to Another Institution’s IRB for Review and Approval.
- The UW-Madison study team cannot begin any research activities for a study ceded to an external IRB until the reviewing IRB has formally agreed to assume IRB oversight (e.g., the IRB of record has signed an IRB authorization agreement) and the reviewing IRB has approved the UW-Madison’s involvement in the research. In addition, study activities cannot begin until all institutional requirements are met and approvals obtained, as applicable for each study.
- Study teams must report to the reviewing IRB any changes, reportable events, and continuing review progress reports in accordance with the reviewing IRB’s policies and procedures.
- Reporting for some types of submissions may also need to be submitted to the UW-Madison IRB. For more information, see the Follow-On Submissions sections.
- Potential unanticipated problems, subject injuries, significant subject complaints, or noncompliance that occur at UW-Madison or UWHC may need to be reported to the UW- Madison IRB in addition to the reviewing IRB. Study teams should contact RELIANT for guidance when such an event occurs. NOTE: For studies that rely on the National Cancer Institute’s Central IRB (NCI CIRB), only serious noncompliance incidents are submitted to the NCI CIRB. For more guidance, see National Cancer Institute Central Institutional Review Board (NCI CIRB) Algorithm to Assess Potential Noncompliance.
Lines of Communication
Multisite studies involve communication among many stakeholders and, as a relying site study team, you will be responsible for developing clear lines of communication with the lead study team. The study protocol should include a communication plan that clearly describes the roles and responsibilities of the four main groups involved in multisite studies:
- Lead study team (including the lead PI)
- Relying site study team (UW study team and UW PI)
- Reviewing IRB
- Relying site IRB/HRPP (UW-Madison)
Some of the elements of a communication plan include:
- Who provides IRB documentation to relying sites as well as how and when
- How changes to the overall study and/or sites will be prepared and submitted
- Management of continuing review information
- Plan for handling reportable events
If the study protocol does not include a communication plan, you will need to work with the lead study team to understand the arrangements for communication across study sites (e.g., remote meetings, regular updates) and dissemination of study documents. We recommend that you consult with the lead study team as early as possible to discuss these arrangements. This will help reduce confusion about who is responsible for what and allow your study to run more smoothly.
Please keep in mind that while RELIANT provides support to UW-Madison study teams navigating reliance and institutional requirements for human research, we cannot answer questions from the lead study team about their own institutional requirements or IRB submission processes, including how to request that the lead study team’s IRB serve as the reviewing IRB for UW-Madison. We encourage you to work closely with your collaborators to ensure they are in contact with their own IRB early in the reliance process; this will help make the review process move more efficiently.