Scenario 2

MU IRB Relying on Another IRB (Commercial, Central, Institutional or Organizational IRB) – Submission Process

NOTE: The MU IRB will evaluate on a case-by-case basis whether it will defer review to another IRB. It is very important that the local investigator communicates with the MU IRB office prior to entering into agreements or arrangements with a sponsor or organization when requesting to use another IRB as the single IRB. The MU IRB has the final determination whether relying on another IRB is acceptable.

1. The local investigator completes the Initial Reliance Request Form, located in eCompliance under IRB Forms, to receive approval to utilize another IRB. When the initial acknowledgement is received in writing from the MU IRB office, submit the Reliance Form to complete the request. You can access this form by clicking on "Open Saved IRB Project" in eCompliance.
2. The local investigator(s) must have current IRB training.
3. The local investigator must upload copies of all IRB-approved documents by the single IRB. This may include, but is not limited to:
   • Protocol
   • Consent Form
     • If subjects will be consented locally, the PI may need to include site-specific language, such as – injury statement, local investigator/site contact information, and financial conflict of interest disclosures. Depending on the review requirements of the single IRB, the MU IRB may need to approve the local consent language. The PI must communicate to the MU IRB whether local consent review is required. 
   • HIPAA Documents
     • If a HIPAA waiver/alteration is needed at the local level and the Single IRB did not approve one for the MU site, a HIPAA waiver/alteration request can be made within the Reliance Form submission. The MU IRB will review and approve the request if HIPAA waiver/alteration requirements are met.
   • The IRB approval letter(s)
   • All other documents approved by the IRB
4. Depending on the local investigator’s role and circumstances, the following institutional reviews may be required:
   • Financial Disclosures to the MU Office of Research Conflict of Interest Committee (disclosures and management plans must be communicated to the single IRB)
   • Biosafety Committee (review of recombinant or synthetic nucleic acid molecules and/or biohazardous materials)
   • Radiation Safety Committee (review of radioactive materials)
   • Investigational Drug Pharmacy Approval (review of local drug dispensing)
5. The local investigator must provide any local context issues relevant to the research protocol to the single IRB.
6. The local investigator will work directly with both IRB offices to aid in executing the authorization agreement.
7. The investigator must report the following documentation post-initial IRB approval:
   • Reliance Reporting Form: Not all changes approved by central/single IRB are required to be submitted in eCompliance if they are not being implemented at our site, but still must be maintained by the research team in their records for compliance monitoring. The following changes approved by central/single IRB must be submitted within 30 days of the approval date:
     • Local informed consent documents, including assent forms.
     • Protocol
     • Local recruitment materials
     • Local context changes requiring institutional reviews
     • Protocol, consent, and other study documents/processes that resulted from IND safety reports submitted to the IRB.
   • Monitoring Report: Submit monitoring reports for local site reviews within 30 days of receipt from the sponsor/monitor. The monitoring report will be reviewed for reportable events to ensure proper reporting. If an event was cited involving major noncompliance, the Event Report must be completed based upon MU HRPP/IRB policy. For more information, see below.
   • Event Report: Submit an Event Report if a local event is required to be submitted to the central/single IRB. This includes unanticipated problems and noncompliance. This includes IND safety reports when the report includes local unanticipated problems.
   • Death Reports: Submit as necessary according to Unanticipated Problems SOP.
   • IRB of Record Continuing Review: Prior to project expiration, submit the central/single IRB continuing review approval letter. If a project is closing, an option is to instead submit the Completion/Withdrawal Report with the central/single IRB closure letter. 
     • If the central/single IRB continuing review approval is not provided prior to the expiration date, the local study project status will be updated to “expired” although the single/central IRB may still show active, and no local human subject activities can occur until the approval has been provided. 
   • Personnel Change Form: Submit all local personnel changes on the Personnel Change Form prior to an investigator participating in the study.
8. General Reporting and Other Responsibilities, including but not limited to:
   • Serve as the liaison for the MU site. 
   • Regularly communicate with the overall PI. 
   • Comply with the single IRB policies and procedures governing human subject research. 
   • Comply with all determinations of the single IRB and notify the MU IRB of these determinations. 
   • Monitor local protocol compliance and oversee the conduct of the research. 
   • Provide to the single IRB local context issues to assist the IRB review process. 
   • Report promptly to the overall PI, according to the IRBs policies, any local site visits, data safety monitoring reports, proposed changes, unanticipated problems, and noncompliance so these can be reported to the single IRB. 
   • Comply with the IRB-approved plan for the management of information that is relevant to the protection of human subjects, such as reporting unanticipated problems, protocol modifications, and interim results. 
   • Comply with all local, state, or institutional requirements that fall outside the scope of the single IRB review. 
   • Comply with requests by the MU IRB to monitor the study locally, in addition to other monitoring groups. Report to the lead PI any regulatory deficiencies cited in an onsite audit. 
   • Do not enroll subjects prior to the single IRB approval and local IRB acknowledgment. 
   • Comply with stipulations outlined in the authorization agreement.

Please see our Multisite Research and IRB Reliance Process SOP for additional guidance.