PI Responsibilities

Research Integrity

You may request the MUSC Institutional Review Board rely on an external IRB to provide review and approval of your research project or for MUSC to serve as the IRB of Record. Reliance arrangements have the opportunity to increase efficiency, but there is still significant work required to obtain IRB approval for a protocol or a specific site as well as additional regulatory requirements also apply. The PI’s roles and responsibilities are also very important to understand depending on whether we are serving as the Relying IRB or the Reviewing IRB. Outlined below is a list of PI responsibilities organized by relying and reviewing site.

MUSC Principal Investigator/Study Team Responsibilities When Serving as a Relying Site

As the Relying Site Investigator when MUSC is ceding IRB review to a Reviewing IRB, the Relying Site Investigator has direct responsibilities that include, but are not limited to, the following:

  1. Meet MUSC education requirements (e.g. CITI training)
  2. Comply with the determinations and requirements of the Reviewing IRB, which includes conducting the research in accordance with the reviewing IRB’s policies and procedures, the IRB-approved documents and conditions of approval, and any applicable laws and regulations.
  3. Ensure that the Reviewing Site PI has provided approval letter for the MUSC site before initiation of the research activities at MUSC.
  4. Maintain appropriate copies of all approvals, and other correspondence documenting the review and approval of the research as required by the regulations.
  5. Submit a modification to the MUSC IRB if/when:
    • New personnel are added to the study team
    • The study is modified in such a way that additional institutional approvals are required. (e.g. radiation safety, conflict of interest)
    • Changes are made which affect institutional policy/state law requirements
    • Changes to conflict of interest
  6. Report promptly to the Reviewing IRB any proposed changes in the research. No changes should be initiated in the research (including changes in the consent document) without prior Reviewing IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
  7. Report to the Reviewing IRB any unanticipated problems involving risks to participants or others; non-compliance or any complaints from a subject or other person regarding the research according to the Reviewing IRB’s reporting policy.
  8. Report to the Reviewing IRB protocol deviations according to the Reviewing IRB’s reporting policy.
  9. Report to the Reviewing IRB as well as the MUSC IRB any complaints from a subject or other person regarding the research.

Overall Principal Investigator/Lead Study Team Responsibilities MUSC as the Reviewing IRB

As the Lead PI/study team for a study where MUSC is serving as the sIRB, the Lead PI has the ultimate responsibility for the administration and organizational support for the study. This role includes additional responsibilities. The additional responsibilities include, but are not limited to the following:

  1. Coordinating Center (unless as determined different on a case by case basis as stipulated in agreement). The MUSC PI is responsible for notifying the relying site PI of the policies of the MUSC IRB and should provide these policies to the relying sites.
  2. The PI will work with the MUSC IRB to disseminate Reliance Agreements to the sites interested in relying on MUSC IRB.
  3. The PI will submit appropriate documents for MUSC IRB approval including protocol, consent form for local site, as well as consent template for the Relying Sites.
  4. Once the PI has initial approval, the PI will be responsible for adding each Relying site in the MUSC eIRB system.  This will include adding Relying site staff, local context information, and appropriate site-specific documents.
  5. The MUSC PI is responsible for ensuring appropriate communication regarding MUSC IRB approvals/requirements with the Relying Sites. The MUSC PI is responsible for notifying the relying site PI’s of all IRB determinations and communications. (Initial review, amendments, reportable events and continuing review).
  6. The MUSC PI is responsible for providing the Relying site PI with the IRB approved versions of all study documents.
  7. After Relying Site approval, the MUSC PI is responsible for:
    • coordinating the submission of any amendments for Relying Sites
    • coordinating the submission of information for continuing review from each site for review and approval by MUSC IRB
    • Reviewing all Relying Site regulatory documents/reports and submitting them for IRB review.  
    • Coordinating the submission of reportable events
  8. 8. Providing access, upon request, to study records for audit by the Relying Institution, the Reviewing IRB, and other regulatory or monitoring entities.