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Reliance on external IRBs
Reliance on external IRBs
You may request that IU’s Institutional Review Board rely on an external IRB to review and approve your research project. Reliance can increase efficiency, but there is still a significant amount of work required to obtain IRB approval for a protocol or a specific site, and additional regulatory requirements apply.
Words to know
Reliance—When one or more relying institutions choose to accept IRB review and oversight for a research project from another institution’s reviewing IRB. In these situations, the reviewing IRB provides IRB review and oversight for conduct of the research at the relying institution(s).
How it works
The IU Human Subjects Office (HSO) approves the use of an external IRB on a case by case basis.
Even if a reliance request is granted, the IU principal investigator and study team, IU IRB, and involved institutions still retain considerable responsibility. When you rely on an external IRB, you must:
- Comply with the IU Standard Operating Procedures for Research Involving Human Subjects on Investigator Responsibilities.
- Obtain IRB approval for conduct of your research from the reviewing IRB and ensure all members of your study team are listed on the IRB documentation as required by the reviewing IRB.
- Ensure the IRB-approved documents accurately reflect how you will conduct the research at IU-affiliated locations.
- Follow the reviewing IRB’s policies and procedures, the IRB-approved documents and conditions of approval, and any applicable laws and regulations. For example, you are responsible for meeting the reviewing IRB’s expectations for:
- reporting adverse events, deviations, noncompliance, and other problems to the reviewing IRB
- updating personnel and enrollment status
- submitting amendments
- tracking subject enrollment and status
- Ensure all members of your study team are appropriately qualified and have met standards for eligibility to conduct research, including completion of human subjects protection training and disclosure of conflict of interest forms
Request reliance on an external IRB by submitting a Reliance Request
Plan ahead. When you submit a reliance request, be ready to provide the following materials:
- Documentation that the protocol has been reviewed and approved by the external IRB, unless reliance on a commercial/independent IRB is requested
- IRB-approved protocol or other documentation of the research plan
- IU standalone HIPAA authorization form, if you will enroll subjects
- Confirmation of approval by any ancillary review committees (e.g. Scientific Review Committee, Radiation Safety, etc.)
- Documents provided by the external IRB for completion by the IU IRB or HRPP (e.g. local context sheet, reliance agreement template, determination form, etc.)
If the Human Subjects Office determines that reliance is not appropriate, you must submit the study to the IU IRBs for review.
Approval of a reliance request by the HSO is only confirmation that reliance on the external IRB is appropriate. It is not an IRB approval. You are still responsible for obtaining IRB approval from the external IRB and cannot begin research until approval is granted.
When reliance is accepted, federal regulations require the relationship to be documented by a written agreement called a reliance agreement.
The HSO reliance team will facilitate completion of the reliance agreement.
Please be aware that reliance agreements can take several weeks to complete due to the complexity and institutional officials involved.
Once the HSO has granted your request for reliance and the external IRB has approved your study, you are still required to continue to submit some items to the IU IRB. Please submit amendments to the reliance request to report:
- The initial IRB-approved informed consent, assent, and HIPAA authorization documents
- PI and personnel changes
- Changes that require revisions to the HIPAA authorization
- Potential conflicts of interest, including institutional and potential financial interests, that could affect or be affected by the research
- Study closure