CPHS acknowledges the challenges that may exist with multiple IRB reviews in collaborative research projects. Under certain circumstances, to minimize duplicative IRB review, UC Berkeley (UCB) may be willing to rely on the review of another institution’s IRB or provide review for another institution or individual investigator. Projects that are subject to the single IRB (sIRB) requirement must have reliance agreement(s) in place to enable a single IRB to serve as the IRB of record.
All requests for UCB to rely on another institution or for UCB to serve as the IRB of record for another institution are subject to the approval of the OPHS Director under the delegation of authority from the UCB Institutional Official (IO), the Vice Chancellor for Research.
Requests for UCB to Rely on Another Institution’s IRB
Generally, the IRB performing the review on behalf of UCB should be another academic institution in the United States that has a Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP) and has its own institution-based IRB.
Reliances between UCB and another institution’s IRB are considered on a case-by-case basis. UCB investigators who are interested in a potential reliance on another institution’s IRB should fill out the following request form and submit it to firstname.lastname@example.org: UCB Request to Rely on Another IRB’s Review.
In general, a reliance with another institution’s IRB will require the execution of an Inter-Institutional Agreement (IIA) or a SMART Letter of Acknowledgement (LOA) to formalize the agreement. In certain circumstances, a reliance with another institution’s IRB may require execution of the agreement through an online system such as IREx or SMART IRB Online Reliance System.
Requests for UCB to Review for Another Institution or Individual Investigator
- Exempt and non-exempt eProtocol forms include a section on collaborative research (section 3). Be sure to complete this section thoroughly, explaining the role of the collaborating individual/institution, their human subjects research training, and a request to rely on UC Berkeley’s IRB review.
- If your request is for another institution to rely on UCB’s IRB review, fill out the following form and include it as an attachment in your eProtocol application: UCB Request to Review Research for Another Institution.
- If your request is for an individual investigator to rely on UCB’s IRB review, fill out the following form and include it as an attachment in your eProtocol application: UCB Request to Review Research for an Individual Investigator.
- During the protocol review process, the OPHS staff analyst will provide additional instructions and reliance materials, as needed.
UC-Issued Guidance and Information
Note: The CPHS IRB Reliance Policy and Guidelines on Reliance Agreements for Non-UC Collaborators are currently under revision. Please contact OPHS for more information: email@example.com