Study Team Responsibilities When IRB Oversight Is Ceded to a Non-UW-Madison IRB

July 2012 Revised February 2014 Revised March 2015

When the Health Sciences IRBs agree to cede IRB oversight for a study to a non-UW-Madison 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 IRB of record, which may be different from what might be required by the Health Sciences IRBs. Several of these requirements must be met before the HS-IRBs can agree to cede IRB oversight. These responsibilities and requirements include:

1. The UW-Madison PI for the study must fulfill the responsibilities described in the Summary of Investigator Responsibilities document.

2. The UW-Madison study team must ensure that all their study team members complete and maintain current human subjects research training certification as required by the UW-Madison and adhere to any other training requirements of the IRB of record. All UW-Madison study team members must have complete and current human subjects research training certification before IRB oversight can be ceded to another IRB.

3. UW Carbone Cancer Center Protocol and Monitoring Committee (UWCCC PRMC) review or ICTR scientific review must be completed before IRB oversight can be ceded to another IRB, as applicable.

4. Study teams must adhere to the requirements of any UW-Madison ancillary committees (e.g., conflict of interest, biosafety), as applicable. If ancillary committee review is required, this typically will need to be completed before IRB oversight can be ceded to another IRB.

5. UW-Madison 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.

6. UW-Madison study teams are responsible for ensuring required agreements for data or sample/specimen transfer (e.g., data use agreements, material transfer agreements, etc.) are in place prior to the UW-Madison receiving or transferring samples/specimens.

7. 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 a non-UW-Madison 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.

8. The UW-Madison cannot begin any research activities for a study ceded to a non-UW-Madison IRB until the IRB of record has formally agreed to assume IRB oversight (e.g., the IRB of record has signed an IRB authorization agreement) and the IRB of record has approved the UW-Madison’s involvement in the research.

9. The study team must report to the IRB of record any changes (including funding changes and personnel changes), reportable events, and continuing review progress reports in accordance with the IRB of record’s policies and procedures.

10. Potential unanticipated problems, serious adverse events, or noncompliance that occur at UW-Madison or UW Health sites may need to be reported to the Health Sciences IRBs in addition to the IRB of record. Study teams should contact the HS-IRBs' Reliance Team for guidance when such an event occurs. NOTE: For studies that rely on the National Cancer Institute's Central IRB (NCI CIRB), reportable events are submitted only to the NCI CIRB. For more guidance on the NCI CIRB, see National Cancer Institute Central Institutional Review Board (NCI CIRB) .

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Keywords:deferral, deferred, oversight, irb of record, cede   Doc ID:25350
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-07-30 12:19 CDTUpdated:2015-03-20 14:57 CDT
Sites:Health Sciences IRBs
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