Institutional Review Board

Scenario 1

MU IRB is the Single IRB – Submission Process
  1. The local PI or designee will complete the Initial Request for MU to be the IRB of Record and will include information regarding the other sites external to MU that will be participating in the proposed study. The form will be reviewed, and a letter will be generated once this form is approved letting you know that MU will be able to serve as the IRB of Record. This does not indicate your study has IRB approval, this just indicates that MU will be able to serve as the IRB once an application has been submitted and approved.
    • If for some reason MU IRB cannot serve in this capacity, a notice will be sent explaining why.
  2. Once step #1 has been approved and a letter has been sent from eCompliance, you will access your IRB Application under the Open Saved IRB Project within the IRB dashboard. Please do not start a new application or the system will not recognize your previous submission for the Initial Request for MU to be the IRB of Record.
    • If you did not submit the initial form and already completed an IRB application for your multi-site study, go ahead and proceed with the IRB application submission. The next time you have a multi-site study, please make every effort to submit the Initial Request form first so the IRB has knowledge of this incoming multi-site study and can approve the proposed Single IRB plan in advance.
  3. Multi-Site Studies Where External Sites are Following the Entire Protocol: The investigator must seek approval for the MU site first with the study protocol and MU site-specific documents. As part of the MU approval, model documents (i.e. consent document, recruitment flyers) will need to be submitted for approval, if applicable. External sites will need to be added using the Amendment for External Sites, and external site-specific documents will need to be submitted for approval at that time.
    • It is not necessary to add external investigators to the MU IRB system. The relying site’s IRB should be managing the completion of IRB training and qualifications for their investigators.
  4. Reliance Agreement: The investigator will work with the local PI to aid in executing the IRB reliance agreement. This can happen at any time during the review and approval process. If relying sites are part of the SMART IRB platform, this agreement is preferred. If a master agreement is already in place with the site, this will be referenced with no additional agreement needed.
  5. External Site Investigators: Must comply with MU policies and procedures and responsibilities outlined in the authorization agreement.
  6. General MU Site Responsibilities:
    • The MU team will act as a single liaison for relying sites.
    • Ask each relying site to complete the Local Context Form located within the IRB Application and Amendment for External Sites and attach it to the IRB submission.
    • Report local and relying site's proposed changes, unanticipated problems, and non-compliance matters to the MU IRB, according to MU policies.
    • Communicate all MU IRB decisions and determinations to the relying site's study teams.
    • Utilize a process/system to share IRB approved documents, IRB approval notices, and other IRB communications.
    • Ensure all relying site investigators are trained on the MU IRB policies and procedures, conduct of the protocol, study procedures, changes to the protocol, and reporting requirements.
    • Monitor progress and oversee the conduct of the study at the MU site and all relying sites.
    • Responsible for the integrity and accuracy of data.
    • Documentation of regular communication with relying sites.
    • Comply with all stipulations outlined in the authorization agreement.

 

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