Office of Research Integrity and Assurance

Investigator Responsibilities Under Reliance Agreements

Principal Investigator Responsibilities Under Reliance Agreements

Introduction

GMU investigators are always responsible for conducting research in accordance with federal and state regulations, GMU policies, and IRB determinations.  When conducting research under a reliance agreement, each investigator has additional responsibilities depending on whether GMU is the Single IRB (sIRB) or a Relying Site.

PI Responsibilities When GMU is the sIRB
PI Responsibilities When GMU is a Relying Site

Principal Investigator Responsibilities When GMU is the sIRB

As the Lead PI/study team for a study where GMU 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:

  • Notifying the relying site PI of the policies of the GMU IRB and should provide these policies to the relying sites.
  • Coordinating and disseminating Reliance Agreements to the sites interested in relying on GMU IRB.
  • Submitting appropriate documents for GMU IRB approval including but not limited to: protocol, consent form for local site, study documents as well as consent template for the Relying Sites.
  • Obtaining the information for each relying site about local requirements, local research context issues, and local ancillary reviews that are relevant to the GMU IRB’s determination to oversee the external site for research that involves interactions with subjects at an external site.
  • Adding each Relying site in RAMP once initial approval has been received for GMU. This will include but not limited to: adding Relying site contact staff, local context information which includes information on ancillary review approvals, and site-specific documents (as appropriate).
  • Ensuring appropriate communication regarding GMU IRB approvals/requirements with the Relying Sites. The GMU PI is responsible for notifying the relying site PI’s of all GMU IRB determinations and communications.
  • Providing the Relying site PI with the IRB approved versions of all study documents.

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 the GMU IRB
  • Reviewing all Relying Site regulatory documents/reports and submitting them for IRB review.
  • Coordinating the submission of reportable events

Principal Investigator Responsibilities When GMU is the Relying Site

As the Relying Site Investigator when GMU is ceding IRB review to an External IRB, the GMU Investigator has direct responsibilities that include, but are not limited to, the following:

  • Meet GMU education requirements (e.g., CITI training)
  • Comply with the determinations and requirements of the External 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.
  • Ensure that the External Site PI has provided an approval letter for the GMU site before initiation of the research activities at GMU.
  • Maintain appropriate copies of all approvals, and other correspondence from the External IRB, including approvals of all continuing reviews and modifications.
  • Comply with all reporting requirements of the External IRB. In addition, the Principal Investigator must continue to submit a Site Modification to the GMU IRB via RAMP for the following:
    • Local study personnel changes
    • Changes which require revision to the HIPAA authorization (if applicable)
    • Changes to conflict-of-interest status
    • Changes are made which affect local context / institutional policy / state law requirements
  • Site Updates must continue to be submitted to the GMU IRB via RAMP for the following:
    • Status update with the External IRB’s Continuing Review approval (if required)
    • Closure Report after the External IRB closes the study.
  • Report promptly to the External IRB any proposed changes in the research. No changes should be initiated in the research (including changes in the consent document) without prior External  IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
  • Report to the External IRB any unanticipated problems involving risks to participants or others (UPs); non-compliance or any complaints from a subject or other person regarding the research according to the External IRB’s reporting policy. These events must also be reported to the GMU IRB in parallel with your submission to the External IRB.

 

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