We are excited for the launch of Research Gateway IRB on July 1st. In conjunction with this transition, the Office of Research and the Human Research Protection Program (HRPP) are implementing several policy and process updates. These changes will take effect on July 1, 2026.
Here’s a summary of the changes you’ll find described in this bulletin:
- Study Team Member Role Changes – elimination of Co-PI role and new Not KSP (Admin only) role
- New Research Intake Form – complete before submitting to the IRB
- Changes to Letters of Support Requiring IRB Submission
When to Submit IRB Approval Letters from Other Sites
🔄Study Team Member Roles Changes
Elimination of the Co-PI Role
To align with practices at other institutions and funding agencies, the HRPP is eliminating the Co-PI role in our online submission system. Investigators other than the Principal Investigator (PI) should be designated as Co-Investigators in the Research Gateway IRB system.
Individuals who currently hold the Co-PI role in iRIS will retain that role following migration to Research Gateway IRB. However, no new individuals may be assigned the Co-PI role after July 1, 2026.
Postdoctoral Fellows, Clinical Fellows, and Residents Cannot Serve as PI
With the elimination of the Co-PI role, postdoctoral fellows, clinical fellows, and residents will no longer be eligible to serve as PI on IRB studies. This change aligns IRB PI eligibility requirements with institutional eligibility requirements for PI status on grant applications.
New "Not KSP (Admin only)" Role
The UCSF IRB requires that all Key Study Personnel (KSP) be listed on the IRB Study SmartForm.
If a study team member requires access to the study record but is not KSP, follow these instructions based on the type of access they need in Research Gateway IRB:
If they need to edit the study record: Add the individual to the Local Study Team Members section of the IRB Study SmartForm and assign the “Not KSP (Admin Only)” role.
If they need read-only access to the study: Review the different types of read-only access available in Research Gateway IRB and learn how to obtain the appropriate access type.
📝New Research Intake Form
The UCSF Office of Research is implementing a new Research Intake Form to help study teams identify approvals, resources, and support services that may be needed to conduct research at UCSF and its affiliate institutions.
The IRB does not review the Research Intake Form and cannot advise study teams on how to complete it. Investigators will be asked to provide the Research Intake Form reference number in the Research Gateway IRB Study SmartForm to confirm completion.
Investigators remain responsible for obtaining all required institutional approvals and ancillary reviews for their research and for maintaining documentation of those approvals in their research records.
✉️Changes to Letters of Support Requiring IRB Submission
As part of the transition to Research Gateway IRB, investigators will no longer be required to submit certain operational or departmental letters of support that do not directly affect IRB review.
Examples include:
- Patient Care Manager letters of support for studies conducted on patient care units
- Emergency Department approval letters
- Other departmental or operational support letters not required for IRB review
These approvals may still be required by the institution; however, they no longer need to be submitted to the IRB.
Approval Letters Still Required for IRB Approval
When applicable, investigators must continue to submit approval letters and documentation from the following required review committees:
- Radiation Safety Committee
- Laser Safety Committee
- Cancer Center Protocol Review and Monitoring Committee (PRMC)
- Cancer Center Site Committee
- Please refer to the Initial Submission Checklist for the complete list of letters, approvals, and supporting documentation that must be provided to the IRB.
📅Collaborative Studies: When to Submit IRB Approval Letters from Other Sites
For collaborative studies (see definition below), investigators are no longer required to submit IRB approval letters from collaborating domestic sites to the UCSF IRB.
If UCSF is serving as the lead site, the study team remains responsible for confirming that collaborating sites have obtained the necessary IRB approvals and for maintaining documentation of those approvals in the study records.
Exception: International Research Sites
Investigators must still upload IRB/Ethics Committee approval letters or letters of support from any sites located outside of the United States.
Definition of Collaborative Study
A collaborative study is a study in which two or more institutions coordinate, with each institution completing a portion of the research activities outlined in a specific protocol. Those sites must obtain their own IRB approval if they are engaged in the research.