Study Personnel

Key Study Personnel (KSP) include the Principal Investigator, other investigators, and research personnel at UCSF or its affiliated institutions who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the course of the research.

All Key Study Personnel at UCSF or its affiliated institutions must complete human subjects protection training on the Collaborative Institutional Training Initiative (CITI) website. The requirement to complete CITI training applies to all Human Subjects Research Key Study Personnel, including Exempt, Expedited and Full Board studies. IRB approval is contingent upon the fulfillment of this requirement.

The PI must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. The PI is ultimately responsible for all aspects of conducting the research study. See Responsibilities of the PI for more information.

For studies conducted under the auspices of an affiliated institution (e.g., SFVAHCS, UCSF-Fresno, etc.), the PI must meet eligibility criteria defined by that institution.

If you are not eligible for PI status based on your appointment, you must be approved for PI status to submit an application to the IRB. Attach a signed PI Status Waiver Form to your IRB Application.

New: Starting July 1, 2026, 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. Students also cannot serve as PI.

These individuals are required to seek the sponsorship of a UCSF faculty member, who will serve as the PI on the study. 

• UCSF KSP: List them in the “Key Study Personnel” question in the “Local Study Team Members” section of the IRB Study SmartForm.
• Non-KSP who need to edit the study: If any non-KSP study team members need to update the study in ReGI, also list them in the “Local Study Team Members” section of the Study SmartForm and assign them the “Not KSP (Admin only)” role. Individuals with the Not KSP (Admin only) role do not need to complete CITI training.
• Adding/removing study team members on an approved study: If you need to add or remove study team members on an approved study, follow the instructions on in the Study Team Member Changes user guide and review guidance on the Modification page. The IRB cannot add study team members to the IRB Study SmartForm.
• Individuals who need read-only access to a study: Individuals who need read-only access to your study can be added to the study’s Guest List. Review these guides for more information. 

• Please review our list of UCSF-affiliated institutions.
• UCSF-affiliated personnel should be listed in the IRB Study SmartForm if they meet the UCSF definition of Key Study Personnel (KSP). Key Study Personnel must have active CITI Human Subjects Protection Training.
• UCSF-affiliated personnel who are not Key Study Personnel do not need to be added to the IRB Study SmartForm.

If the affiliated KSP needs access to ReGI or other UC network programs:

• If the individual needs access to ReGI – for example, to help with IRB submissions, access study documents, or perform study-related financial oversight – they will need to be granted "affiliate access" to the UCSF network through the PI’s department. Please review our guidance on obtaining affiliate access. 
• After affiliate access has been granted, they can be added to the “Key Study Personnel” question in the IRB Study SmartForm.

If the affiliated KSP does NOT need access to ReGI or other UC network programs:

• If the individual does NOT need access to ReGI or other UC network programs, they do not need to request affiliate access. Follow the instructions in the "Affiliated Personnel" question in the "Local Study Team Members" section of the IRB Study SmartForm. Attach the Affiliated Study Personnel Form and CITI completion certificates for all individuals listed on that form.

Visiting faculty should be listed in the IRB SmartForm if they meet the UCSF definition of Key Study Personnel. Key Study Personnel must have active CITI Human Subjects Protection Training.

Consult with your HR representative for guidance about setting up a visiting faculty member. Once they are established with HR, follow the above instructions for UCSF Investigators and Staff.  

Students may join a research team for the specific purpose of gaining academic credit or professional advancement. Students are not considered volunteers, per Campus Volunteer Guidelines, and therefore their work on a study team must be guided by an appropriate affiliation or professional service agreement.

Students should be listed in the IRB application if they meet the UCSF definition of KSP.  As a reminder, KSP must have active CITI Human Subjects Protection Training.

UCSF Students

UCSF students should click on the ReGI link in MyAccess and follow the above instructions for UCSF Investigators and Staff. 

Non-UCSF Students

The UCSF PI’s department must work with Human Resources to get the appropriate UCSF access for the student. Once the student has a UCSF ID, the student will be able to login ReGI via MyAccess and can be listed in the “Local Study Team Members” section of the Study SmartForm.

UCSF: Volunteers are not permitted to work on research studies at UCSF, per UCSF Campus Volunteer Guidelines. 

SFVAHCS: Volunteers can work on research studies at the SF Veterans Affairs Health Care System. To add a volunteer to the study application, follow the instructions above for adding Staff from a UCSF-Affiliated Institution.