- Key Study Personnel (KSP)
- Principal Investigator (PI)
- Co-Principal Investigator (Co-PI)
- Clinical Research Coordinator Responsibilities
- Volunteers
- Listing KSP on the IRB Application
- iRIS
- FAQs
- Resources
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.
Key Personnel also include faculty mentors/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
Requirements for KSP: CITI training
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.
Principal Investigator
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.
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.
Postdoctoral fellows, clinical fellows and residents are allowed to serve as PIs on IRB applications if the following two conditions are met:
- A UCSF faculty member who would otherwise qualify as a PI is identified as the Co-PI on the application, and
- A cover letter from the Co-PI faculty member is attached to the application stating that he or she agrees to serve as faculty support and/or a mentor to the fellow or resident listed as PI in the IRB Application.
Students cannot serve as PIs. They are required to seek the sponsorship of a UCSF faculty member, who will serve as the PI on the study. These studies are often smaller scale unfunded studies.
Co-Principal Investigator (Co-PI)
The Co-PI must be eligible to be a UCSF PI (see PI eligibility above). This means that study team members who do not meet the eligibility requirements (do not meet criteria for grant status noted above, are fellows, residents, specialists, etc.) cannot serve as Co-PI.
The Co-PI must be prepared to assume the responsibilities of the PI when the PI is unavailable. See above.
Clinical Research Coordinators (CRCs)
Volunteers
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 below for adding Staff from a UCSF-Affiliated Institution.
Listing KSP on the IRB Application
Include all UCSF KSP in the Key Study Personnel sections of the application. For help with iRIS, go to the iRIS Help Site and follow the guide titled, “Add or Remove Personnel from the IRB Application.” Note: the iRIS Help Site requires a MyAccess login.
If you need to add or remove KSP to/from an approved application, follow these instructions according to KSP role:
UCSF Principal Investigator
Submit a Personnel Changes form if the only changes being made are to the study personnel, or submit a Modification form if you are making personnel changes and additional changes. Attach these items to your submission:
- A letter signed by the outgoing PI requesting the change
- Revised IRB Application Form: Revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections to reflect the personnel changes
- Revised consent forms and other participant-contact documents that name the PI
UCSF Investigators and Staff
Researchers and staff who are Key Study Personnel:
Submit a Personnel Changes form if the only changes being made are to the study personnel, or submit a Modification form if you are making personnel changes and additional changes. Attach these items to your submission:
1. Revised IRB Application Form: Revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections to reflect the personnel changes
2. Revised consent forms and otehr particpant-contact documents that name the individuals being changed (if applicable)
Research support staff or study contacts who are NOT Key Study Personnel:
You do not need to submit a personnel changes for individuals who do not meet the definition of Key Study Personnel. Instead, someone already listed on the study should follow these steps:
- Open the study via My Studies.
- From the Submissions page, click on the “Study Management” tab.
- Click on the “Key Study Personnel” link.
- Add or remove the study staff and save.
Reminder: Only add or remove individuals who are not Key Study Personnel in the Study Management tab. DO NOT add or remove the PI, Other Investigators or other Key Study Personnel here. Making such changes without submitting a modification may result in a PROTOCOL VIOLATION. Exception: As explained, for exempt studies only, you can change Other Investigators or Key Study Personnel (not the PI) in the Study Management tab without submitting a modification. |
Staff from a UCSF-Affiliated Institution
Visiting Faculty
Visiting faculty should be listed in the IRB application if they meet the UCSF definition of Key Study Personnel. Key Study Personnel must have active CITI Human Subjects Protection Training.
Consult with your Human Resources 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
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 Key Study Personnel. Key Study Personnel must have active CITI Human Subjects Protection Training.
UCSF Students
UCSF students should follow the guidance for getting access to iRIS within MyAccess (Note: follow the instructions in the guidance; When requesting an iRIS account, the student must indicate their school or graduate program). Once iRIS access is established, follow the above instructions for UCSF Investigators and Staff.
Non-UCSF Students
The UCSF PI’s department must work with Human Resources to provide an academic appointment, UCSF ID card, and other required documentation for a new employee. Once they have a UCSF ID, the student should follow the guidance for getting access to iRIS within MyAccess (Note: follow the instructions in the guidance; When requesting an iRIS account, the student must indicate which school or graduate program the PI is affiliated with). Once iRIS access is established, follow the above instructions for UCSF Investigators and Staff.
Volunteers
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.
iRIS
Please review the following pages for guidance on the following:
- Getting an iRIS Account: Individuals with a UCSF ID
- Getting and iRIS Account: Individuals without a UCSF ID (Affiliate Access)
- Listing Non-UCSF Personnel in the IRB Application
FAQs
Can the IRB add me to my PI's study?
- The IRB cannot add personnel to the application. Someone who is already on the study team with access to the study in iRIS must add you. If your colleague needs guidance on how to add you to the study, please refer them here: https://irb.ucsf.edu/modification#personnel.
Can the IRB to provide “affiliate access” to iRIS for non-UCSF personnel?
- The HRPP stopped providing affiliate access for non-UCSF employees working on research projects for UCSF PIs in 2019:
- https://irb.ucsf.edu/news/irb-news-changes-affiliate-access
- https://irb.ucsf.edu/news/transition-management-affiliate-access-research-personnel-pi-departments
- Our website is up to date with instructions for UCSF to go through their departmental HR units to obtain affiliate access for non-UCSF personnel. That will provide all the necessary access to research support systems, including REDCap and iRIS.
Instructions for HR Analysts
- The IMED affiliate code is reserved for HRPP affiliate sponsorship of employees of affiliated institutions such as SF DPH, Vitalant, Gladstone, and UC Santa Cruz for which we have an institutional agreement to provide IRB review services when the PI DOES NOT have a UCSF appointment (with or without salary). None of those affiliates should be using any research administration systems other than iRIS for IRB submissions and approvals.
- UCSF-appointed PIs with research staff who are employed by any of the UCSF-affiliated institutions or unaffiliated institutions that have an IRB review agreement with UCSF are sponsored by the PI’s department with the AFFEMP title code.
- Non-UCSF research support staff who are not employees of one of the UCSF-affiliated institutions are typically granted affiliate access using the COLLAB title code.
Resources
- https://irb.ucsf.edu/news/guidance-updates#ksp
- https://irb.ucsf.edu/modification#personnel
- https://irb.ucsf.edu/citi-human-subjects-training#who
- https://irb.ucsf.edu/iris-accounts-and-access
- https://irb.ucsf.edu/research-needing-irb-review#eligibility
- https://irb.ucsf.edu/responsibilities-pis-and-crcs