Multisite research and clinical trials increasingly rely on a single IRB (sIRB) for review. This increase reflects federal mandates, sponsor expectations, and the operational realities of modern multisite or cooperative research.
For institutions with a local IRB, this often means ceding review responsibilities to an external IRB for multisite research. This ceding is also known as relying on an external IRB.
These reliance relationships require significant communication and collaboration between the local human research protection program (HRPP) and the external IRB of record. For some organizations, this may be a new way of working and may make some uneasy.
In this blog we discuss why collaboration is so important to protecting participants. We also provide ideas for establishing an IRB partnership that reduces administrative burden without diminishing local context.
Why must local IRBs and HRPPs collaborate with external IRBs?
When institutions rely on an external IRB, it opens the door for more streamlined, collaborative research oversight, allowing local institutions to prioritize important research responsibilities only they can perform.
Rather than duplicating IRB reviews, local HRPPs and external IRBs should focus on their complementary roles.
A thoughtful partnership between the local HRPP and the external IRB helps promote efficiency, clarity, and participant safety—while reducing unnecessary administrative burden and potential confusion.
Why collaboration matters
Collaboration honors the purpose of the reliance agreement:
- Ceding IRB review reflects a shared understanding: The reviewing IRB will conduct the regulatory review as it relates to the role of an IRB.
- Working together and respecting that agreement fosters trust and ensures roles are clear from the start.
It supports efficiency and efforts to reduce redundancy:
- Repeating a full IRB review locally duplicates efforts for the reviewing IRB, the local HRPP, and the research team.
- Streamlined review processes allow the local HRPP to focus on local requirements and the local study team to prioritize readiness for activation and implementation.
It prevents conflicting decisions and guidance:
- Multiple duplicative IRB reviews for a single study may lead to conflicting determinations, especially around consent form language or requirements.
- Instead, local expectations (e.g., institutional language or policies) should be communicated early to the reviewing IRB and research team so they can be appropriately incorporated into the submitted materials.
It accelerates study approval, study startup, and needed changes:
- Avoiding duplicative IRB review can significantly speed up required processes, allowing investigators to meet timelines, support participant recruitment, implement changes required to protect participants, and keep approved research moving forward.
- Investigators and sponsors may face delays if they must go through multiple local IRBs as well as deal with the back and forth needed to reconcile any differences and requirements.
It promotes compliance and participant safety:
- Multiple layers of IRB oversight reduce the risk of confusion or missed updates.
- A clear, consistent review path helps ensure researchers stay in compliance and allows important changes, like new risk disclosures or protocol updates, to be implemented promptly.
A shared commitment to ethical research
By maintaining open communication, clearly defining roles and expectations, and avoiding unnecessary duplication, local HRPPs and reviewing IRBs can work together seamlessly. This collaborative approach helps:
- Protect research participants.
- Support investigators.
- Ensure regulatory compliance.
- Facilitate high-quality, efficient research.
Ultimately, everyone involved in human research protections shares the same goal: to support and facilitate research that is ethically sound, complies with applicable regulations, and has the potential to benefit human participants and communities and/or advance knowledge. Thoughtful coordination makes that goal more achievable—and more sustainable.
