Beginning with the July 7, 2021 launch of the Kuali IRB system, use of the forms on these pages will be gradually phased out. The process will be complete by the end of July 2022.
Please note the following:
The forms on these pages will only be used for transactions in the legacy e-IRB Services system.
This matrix breaks down when to use each system during the
transition period.
Forms for submitting new projects for IRB review will be removed by July 6, 2021. Starting July 7, all applications for new studies must be done in Kuali IRB and these forms will
not be accepted for upload into Kuali IRB.
Amendment, Report and Closure forms will continue to be available on these pages only for use with projects already active in e-IRB Services. These forms should only be used until
those projects either close or roll over into Kuali IRB at their next Continuing Review.
Continuing Review forms will continue to be available on these pages only for use with projects that will expire before August 30, 2021 or that will be complete by July 31, 2022.
Studies typically conducted by UCSD faculty, staff, and students affiliated with the UCSD Health
System or conducted at Rady Children's Hospital — San Diego
NEW: For compliance reasons, the Approval-in-Principle application and process are no longer available. In the rare case that a funding agency has explicitly requested that the
IRB document its awareness of a proposal that involves either indefinite plans or a delayed onset, please forward the following to irb@health.ucsd.edu:
The letter, email or award terms in which your funding agency explicitly requested IRB acknowledgment of a project that is not yet ready for IRB review.
The scientific design portion of the proposal (do not include budget or personnel information).
A brief summary of why you are not able to submit a protocol for IRB review at this time (e.g., animal work for Aims 1 and 2 needs to be completed before the human work for Aim 3 can be described for the
IRB).
A projected date for when you will be able to submit a protocol for IRB review.
Your acknowledgment that you will not use award funds for human subjects research activity until you have obtained either IRB approval or certification of exemption from IRB review.
This e-mail process will be discontinued as of Kuali IRB Go-Live on July 7, 2021. You will be able to request this acknowledgment and provide the above documentation via a short application in Kuali IRB.
Non-UCSD "Centralized" IRBs Forms
UCSD has entered into agreements with non-UCSD IRBs including Western IRB, Copernicus Group IRB,
Quorum Review IRB, and the NCI CIRB to provide "centralized" IRB oversight for specific types of
clinical trials and other research involving human subjects
NEW FOR HEALTH SCIENCES EBP/QA/QI PROJECTS: Instead of submitting your proposal for IRB review or exemption, please submit to the UC San Diego Health
Aligning and Coordinating QUality Improvement, Research, and Evaluation (ACQUIRE) Committee
(AD login required). The ACQUIRE Committee is authorized to determine and document that a project is not regulated as "human subjects research." Please only apply to the IRB if your EBP/QA/QI project
involves activities that are regulated as "human subjects research" or if the ACQUIRE Committee otherwise refers you for IRB review.
For Campus or Rady Children’s EBP/QA/QI projects, continue using the existing form(s) until July 7, 2021. Beginning July 7, you will use Kuali IRB for all new submissions. However,
only the following EBP/QA/QI projects should be submitted:
Those with activities that are regulated as “human subjects research” and need an IRB review or exemption
When you need an administrative determination that a project is not regulated as “human subjects research.”
Rady Children’s is preparing to launch an internal review process similar to UC San Diego Health’s ACQUIRE Committee. More information is expected this fall. For questions regarding QI projects at RCHSD, contact Dr.
Anthony Magit at amagit@health.ucsd.edu.
For projects that require review by the SCRO Committee, complete the following form(s) and follow the instructions provided
Human stem cells – hiPScs or hESCs used in vitro only
Human stem cells – for research involving contact with a living human person (both forms require completion, only the SCRO Facesheets data should be submitted via the web)