Collaborative IRB Review
Given the rise of big data in recent years, artificial intelligence (AI) technology is increasingly being used for human research. To regulate its unique risks, ensure its safe and ethical use, and improve the review efficiency of multicenter collaborative, review principles and consensus for AI research have been established. The Multicentre Research Ethics Committee has been formed to promote institutional cooperation, reduce redundant reviews, and enhance clinical research efficiency.
Purpose
When a clinical trial involve two or more institutions, it must be reviewed and approved by the Institutional Review Board (IRB) of both the principal investigator's institution and the collaborating institutions prior to implementation. In an effort to reduce the burden of duplicate review by multiple IRBs for the same protocol and back-and-forth revisions between the investigator and multiple IRBs. Joint committee is established with the IRBs of institutions that have signed the protocol. The committee operates based on defined principles and procedures to ensure both review and clinical research efficiency.
Principles
The Joint Committee is not a newly established IRB, but collaborative effort based on the independent operation of each institution's IRB. Each institution's IRB, while respecting the review opinions of other institutions, may refer to the decision of the primary reviewer to streamline the review process and enhance operational efficiency. Institution without an IRB may delegate IRB review to another institution's IRB to ensure smooth execution of the research.
Operational
1. Primary Review Institution: The Primary Review Institution is the IRB at the institution of the principal investigator (PI).
2. Cooperative Institution: The cooperative institution refers to the primary previewer's reviews and adopts a simplified review framework; If deemed necessary, the cooperative Institution may use the meeting procedure to review.
3. Relying Institution: Relying Institution delegate IRB review to different/external IRB.
4. Consensus Meeting: Irregular invite institutions to participate in the consensus meeting (at least once a year) to discuss issues encountered during the review process. Institutions share updates on implementation to reach consensus and continuously optimize the review mechanism.
