What are my obligations as Investigator when relying on an external IRB?
- Follow procedures to submit new study applications to this institution’s IRB for this institution’s IRB staff to make an initial assessment before seeking review by another IRB.
- Provide the reviewing IRB with the requested information about local requirements or local research context issues relevant to the IRB’s determination before IRB review.
- Disclose conflicts of interest determined by this institution, and as required by the reviewing IRB, and comply with any management plans that may result.
- Prepare consent and other study documents that are consistent with those approved by the external IRB (e.g., use the approved consent template to create site-specific documents).
- Cooperate in the reviewing IRB’s responsibility for initial and continuing review, record keeping, and reporting, and provide all information requested by the reviewing IRB promptly.
- Ensure that this institution’s study staff are appropriately qualified, have completed Human Subjects Protections training, and have been adequately trained to conduct the study in alignment with the reviewing IRB approved protocol.
- Comply with determinations and requirements of the reviewing IRB and maintain documentation following the reviewing IRB and this institution’s policies.
- Obtain all appropriate institution/organization permissions (i.e., IRB, SR, COI, etc.) before implementing procedures at this institution.
- Notify the reviewing IRB when local policies that impact IRB review are updated.
- Promptly report to the reviewing IRB any proposed changes to the research and do not implement those changes without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants.
- Promptly report to the reviewing IRB and this institution any unanticipated problems involving risks to participants or others, terminations, or suspensions of the study.
- Report non-compliance, participant complaints, protocol deviations, or other events to the reviewing IRB and this institution.
- When enrolling participants, obtain, document, and maintain records of consent for each participant or each participant's legally authorized representative.
- Provide the reviewing IRB with data safety monitoring reports following the reviewing IRB’s reporting policy.
- Specify the contact person and provide their contact information for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the use of the reviewing IRB.
- Fulfill any communication responsibilities as outlined in WORKSHEET: Communication and Responsibilities (HRP-830).