Institutional Review Board

Scenario 2

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

(MU IRB defers review to another IRB)

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 IRB of record. The MU IRB has the final determination whether relying on another IRB is acceptable.

  1. The local investigator completes the Reliance Request Form located 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 IRB of Record. 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 Reviewing 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 subjects will be enrolled locally, and the IRB of Record does not have a HIPAA privacy board, the MU IRB will need to acknowledge the local HIPAA Authorization and/or approve the local HIPAA waiver request since the MU IRB is a HIPAA privacy board. The PI must communicate to the MU IRB whether local HIPAA review is required.
    • The IRB approval letter(s)
    • All other documents approved by the IRB of Record
  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 IRB of Record)
    • 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 to the IRB of Record any local context issues relevant to the research protocol.
  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 Misc Reporting Form must be completed for all approvals, decisions, and determinations received by the IRB of Record. This includes, but is not limited to, the review and approval of all modifications and updates, unanticipated problems, noncompliance matters, monitoring reports, safety reports, etc.
  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, including consents if the study is still open to enrollment or subjects are continuing to provide consent.
  9. Local Events:
    • The Event Report must be submitted for all local events, including unanticipated problems and deviations.
  10. General Reporting and Other Responsibilities (unless otherwise indicated in the agreement):
    • Serve as the liaison for the MU site.
    • Regularly communicate with the overall PI.
    • Primarily responsible for safeguarding the rights and welfare of each research participant. The participant’s rights and welfare must take precedence over the goals and requirements of the research.
    • Comply with all determinations of the IRB of Record and notify the MU IRB of these determinations using the appropriate reliance reporting forms.
    • Monitor local protocol compliance and oversee the conduct of the research.
    • Provide to the IRB of Record 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, unanticipated problems, and deviations so these can be reported to the IRB of Record.
    • Report promptly to the MU IRB any local unanticipated problem or deviation according to the MU IRB SOPs.
    • Report promptly to the overall PI, according to IRBs policies, any proposed changes in the research so these can be reported to the IRB of Record. Changes cannot be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
    • 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 IRB of Record 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 IRB of Record approval.
    • Maintain records per institutional policy and additional sponsor requirements.
    • Obtain, document, and maintain records of informed consent for each subject or each subject’s legally authorized representative as required.
    • Provide a mechanism to receive and address concerns from local study participants and others about the conduct of the research.
    • Emergency medical care may be delivered without IRB review and approval to the extent permitted under applicable federal regulations and state law.
    • Comply with stipulations outlined in the Authorization Agreement or sponsor agreements.

 

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