Institutional Review Board

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 communicate 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 to receive approval to utilize another IRB. When approval is received in writing from the MU IRB office, submit the Reliance Form to complete the request.
  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. Changes and other Reportable Items:
    • The Reliance Reporting Form must be completed for all approvals, decisions, and determinations received by the single IRB. This includes, but is not limited to, the review and approval of all modifications and updates.
    • The Monitoring Report for all local monitoring reports from the sponsor within one week of receipt.
  8. Continuing Review:
    • The IRB of Record Continuing Review form must be submitted with the annual (or other set date) continuing review of the protocol. All supportive documentation approved during the continuing review must be uploaded to this form.
  9. Local Events:
    • The Event Report must be submitted for all local events, including unanticipated problems and noncompliance within 5 business days. The single IRB review determination must be uploaded if received by the time of submission, or upon receipt.
  10. 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 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 acknowledgement.
    • Comply with stipulations outlined in the authorization agreement.

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