Institutional Review Board
Human Research Protection Updates
· Independent IRB Review for industry-authored clinical trials is coming
To facilitate single IRB review of multi-site industry-authored clinical trials, UCI has signed an IRB reliance agreement with Western IRB (WIRB). When the study sponsor or the CRO contracts with WIRB for IRB services, UCI investigators may rely on WIRB for IRB services. More details will follow in January. In addition, we will be establishing reliance agreements with other independent IRBs in 2014.
· UCI IRB Fees
As of January 1, 2014, the UCI IRB will charge IRB fees for new clinical research submissions that are partially or fully supported by industry sponsors, including chart review studies. In addition, IRB fees will be assessed upon IRB approval. Fees will be recharged to the study account; if an agreement is not finalized, fees will be invoiced directly to the department. Current IRB fee rates will remain the same.
· Lead Researcher and Department Chair/Institute Director Signatures
We are experiencing delays in receiving signatures from Lead Researchers and Department Chairs / Institute Directors. These signatures are essential. The Lead Researcher’s signature is an acknowledgement of ultimate responsibility for the performance of the study, for the protection of the rights and welfare of the human subjects, and for adherence by the research team to all regulatory and institutional requirements.
The signature of the Department Chair / Institute Director is an assurance that the study protocol has been reviewed and that sufficient resources are available to support the research activities; that the research team is appropriately comprised; and that the research team has disclosed any personal financial interest related to the research.
Given the importance of these respective assurances, the submission of all requisite signatures is required prior to IRB review. For research requiring full board review, signatures are required by the IRB deadline. For exempt and expedited research, signatures are required prior to IRB review.
o Signatures can be in the form of a
§ Wet signature or
§ Electronic signature.
o Signed documents can be received
§ By email to IRB@uci.edu,
§ By fax to 949-824-1465, or
§ In hard copy, delivered to the IRB office.
Happy Holidays from the IRB Staff!
Best Wishes for a Happy, Healthy and Productive 2014!