PI Responsibilities

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.when the 

MUSC Principal Investigator/Study Team Responsibilities When MUSC is the 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 an 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 reviewing IRB has approved a change to recruitment or study procedures when ew and approval of the research as required by the regulations.
5. If the MUSC IRB has entered into a reliance agreement with another IRB that acts as the IRB of record, the Principal Investigator must comply with all reporting requirements of the IRB of record.  In addition, the Principal Investigator must continue to submit amendments to the MUSC IRB via eIRB for the following:
   1. MUSC study personnel changes when adding or removing study team members from the study application
   2. Changes which require revision to the HIPAA authorization
   3. Changes to conflict of interest
   4. Changes are made which affect local context / institutional policy / state law requirements
   5. The reviewing IRB has approved a change to the study procedures or recruitment and is modified in such a way that additional institutional approvals are required from one of the following:
      
      1. Conflict of Interest Committee
      2. Protocol Review Committee
      3. Radiation Safety Committee
      4. Institutional Biosafety Committee
      5. Other ancillary committees that require re-review
   6. The recruitment activities that were described in the initial application that require compliance with MUSC HRPP policies:
      1. Students, trainees, and employees;
      2. Persons with impaired decision-making capacity;
      3. Non-English speaking subjects;
      4. Children as subjects;
      5. Prisoners as subjects
6. Status Updates must continue to be submitted to the MUSC IRB via eIRB for the following:
   1. Status update with the IRB of Record's Continuing Review attached.
   2. Closure Report after the IRB of record closes the study.
7. 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.
8. 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.
9. Report to the Reviewing IRB protocol deviations according to the Reviewing IRB’s reporting policy.
10. 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 when MUSC is 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 Lead 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 Lead PI will work with the MUSC IRB to coordinate and disseminate Reliance Agreements to the sites interested in relying on MUSC IRB.
3. The Lead PI will submit appropriate documents for MUSC IRB approval including but not limited to: protocol, consent form for local site, study documents as well as consent template for the Relying Sites.
4. The Lead PI is responsible for obtaining the information for each relying site about local requirements, local research context issues, and local ancillary reviews that are relevant to the MUSC IRB's determination to oversee the external site for research that involves interactions with subjects at an external site.  Such information includes, when relevant, laws and regulations directly affecting the study; whether the sponsor requires compliance with ICH-GCP (E6); qualifications and expertise of researchers and research staff, recruitment and consent process; characteristics of the local population; plans to protect the confidentiality of information; plans for the storage, handling, and dispensing of drugs and medical devices; and conflicts of interest and their management.  This information will be provided to the IRB of record.
5. Once the Lead PI has initial approval, the PI will be responsible for adding each Relying site in the MUSC eIRB system.  This will include but not limited to: adding Relying site contact staff, local context information which includes information on ancillary review approvals, and appropriate site-specific documents.
6. The Lead 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 MUSC IRB determinations and communications. (Initial review, amendments, reportable events and continuing review).
7. The Lead PI is responsible for providing the Relying site PI with the IRB approved versions of all study documents.
8. After Relying Site approval, the Lead PI is responsible for:
   • coordinating the submission of any amendments for Relying Sites
   • coordinating the submission of information for continuing review from each relying 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
9. Providing access, upon request, to study records for audit by the Relying Institution, the MUSC IRB and other regulatory or monitoring entities.