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.

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.

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.

The PI is ultimately responsible for all aspects of conducting the research study, including the supervising of all staff to whom study responsibilities are delegated. While the PI may delegate responsibilities as appropriate, it is the PI who is responsible for ensuring that all research activities are carried out correctly.

The PI must be qualified by education and training in the therapeutic area in which the research is being conducted. The PI must be familiar with the protocol and investigational articles being tested and must also comply with the applicable regulatory requirements Code of Federal Regulations, FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH GCP Guidelines), state statues, other applicable federal regulations, and institutional policies and guidelines.

PIs are responsible for the following:

Protecting the safety and welfare of research participants

• Conducting the study in an ethical manner, including protecting the rights and welfare of human subjects who are involved in the research project
• Ensuring that the resources necessary to protect participants are present before conducting the research study
• Reporting unexpected or serious adverse events to the IRB according the to the UCSF HRPP reporting guidance
• Reporting protocol violations and research-related incidents to the IRB according to the UCSF HRPP reporting guidance
• Reporting any correspondence to or from a regulatory agency regarding matters of regulatory compliance (e.g., FDA audit findings, PI audit response letter) to the IRB
• Responding to participants’ complaints/concerns or requests for information and reporting to the IRB any significant participant complaints/concerns
• Designing and carrying out the research study with adequate data and safety monitoring, when appropriate
• Assuring that the protected health information (PHI) requested, if any, is the minimum necessary to meet the research objectives, and that PHI is not reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law

Training and supervising collaborating faculty and staff

• Ensuring that all participating faculty and research staff observe pertinent laws, regulations, and institutional policies and guidelines
• Ensuring that key personnel performing the study are qualified, appropriately trained or re-trained and adhere to the provisions of the IRB-approved protocol

Adherence to regulatory and IRB requirements and guidance

• Completing IRB-required human subjects protection training (in addition to other sponsor-required training)
• Ensuring that all research involving human subjects receives IRB review and approval before commencement of the research, including screening or recruitment
• Seeking IRB guidance when in doubt about whether proposed research requires IRB review
• Complying with all IRB decisions, conditions and requirements
• Obtaining IRB review and approval before changes are made to approved protocols or consent forms (IRB modification request)
• Ensuring that no human subject is involved in the research prior to obtaining their consent
• Ensuring the adequacy of the informed consent process
• Ensuring that protocols receive continuing IRB review and approval at the appropriate interval
• Providing financial disclosure information or any other potential conflicts of interest that might affect the relationship with the research participant or the outcome of the research

Data Security Risk Assessment and Data Transfer Agreement

A Data Security Risk Assessment by UCSF IT Security & Policy AND Data Transfer Agreement by the Office of Sponsored Research (OSR -- Industry Contracts Division) must be completed if your study involves: the collection, transmission, or storage of information when that data will be shared with or be accessible to any non-UCSF entity (e.g., pharmaceutical companies, UCSF Affiliated Institutions) or individual. This includes the use of third-party or vendor-hosted applications. UCSF or department-hosted applications may also need to be assessed in accordance with UCOP Policy IS-3 Electronic Information Security, particularly if they are new applications or have never been reviewed by UCSF IT Security & Policy.

• Third-party or vendor-hosted applications include cloud-hosted applications and applications hosted by collaborating institutions
• UCSF or department-hosted applications include any application managed by UCSF or developed by the department

These requirements apply for both identifiable and de-identified data for funded and unfunded research. Questions about these policies must be directed to UCSF IT and OSR, not to the IRB.

• To determine if a Data Security Risk Assessment is required, contact the intake team at [email protected]. More information about the assessment process is available at https://it.ucsf.edu/service/it-security-risk-assessment
• For information about Data Sharing Reviews: Visit https://data.ucsf.edu/data-sharing or email [email protected]
• For information about establishing contracts for data sharing engagements: Visit https://icd.ucsf.edu/material-transfer-and-data-agreements or email [email protected]

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.

The CRC works with and under the direction of the PI. Although the PI is legally responsible for all aspects of the research study, the CRC often handles the bulk of the daily study activities and plays a key role in the study conduct and management. The CRC is frequently responsible for organizing the documentation and files pertaining to a study and for coordinating the activities of the investigators and the study participants.

The responsibilities of the CRC will vary at each site, but may include the following:

Protecting the rights and welfare of human subjects

• Understanding the regulatory, institutional, sponsor and protocol requirements for the study
• Completing IRB required human subjects protection training (in addition to any other sponsor required training)
• Complying with all IRB decisions, conditions and requirements
• Capturing and reporting adverse events and protocol violations to the study PI, the IRB and the study sponsor
• Ensuring that PHI will not be reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law
• Making sure that all studies have current IRB approvals before any study is initiated, continued beyond the period of current approval (usually 1 or 3 years) or modified in any way

Important note: These responsibilities always apply regardless of research site or research setting.

Evaluating new protocols for feasibility

This may include:

• Reviewing the protocol and other materials (e.g., Investigator’s Brochure, data collection forms and sample consent forms) for practical procedures, safety issues and establishment of a study budget
• Reviewing study participant eligibility requirements and determining if those participants would be available in sufficient numbers to achieve study enrollment goals
• Assessing the logistical requirements and resources necessary to conduct the study

Preparing the site for study conduct

This may include:

• Preparing documents for submission to the IRB
• Preparing documents for submission to the Office of Sponsored Research
• Setting up and organizing study files
• Training all people involved in the study conduct (e.g., faculty, study staff, ancillary personnel, etc.)
• Collaborating with other departments (e.g.; laboratory, pharmacy, etc.) as indicated
• Attending the investigator start-up meeting
• Scheduling and facilitating a site-initiation visit with the study sponsor
• Creating or reviewing study-specific source documents
• Collecting the documents needed to initiate the study and sending them to the study sponsor

Participating in the informed consent process

This may include:

• Writing study consent forms according to IRB guidelines
• Working with the sponsor and/or IRB on consent form wording issues
• Obtaining translations of the consent forms into other languages, when necessary
• When indicated in the IRB Application, conducting the informed consent process with potential participant (or a potential participant’s authorized legal representative or surrogate)
• Providing potential participants with the Experimental Subject’s Bill of Rights, when required
• Discussing all aspects of study participation
• Reviewing the consent form with the potential study participant
• Answering questions and assessing potential study participant’s comprehension
• Ensuring that all necessary signatures and dates are on the informed consent forms
• Documenting, distributing and filing signed informed consent forms appropriately
• Ensuring that all amended consent forms are appropriately implemented and signed
• Ensuring that the consent process is ongoing and continues throughout the duration of the study

Important note: Informed consent is not just a signature on a document. It is an ongoing process.

Managing study conduct

This may include:

• Recruiting and screening potential participants
• Ensuring adherence to the study inclusion/exclusion criteria
• Scheduling and managing study participant study visits (e.g., ensuring that all appropriate study procedures are done and documented)
• Managing laboratory procedures (drawing samples, processing, packaging and shipping)
• Reviewing case report form entries for completeness and correctness
• Reviewing case report forms and source documents for adverse events (AE)

Important Note: While it is a direct responsibility of the CRC to capture and report all AEs to the PI, CRCs are not allowed to determine the cause of an AE unless they are an appropriately licensed health care professional (i.e.; MD, PA or NP) who also holds investigator status on the study.

• Scheduling and facilitating sponsor monitoring visits
• Ensuring that test article accountability is done correctly for each study participant and overall

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:

1. Open the study via My Studies.
2. From the Submissions page, click on the “Study Management” tab.
3. Click on the “Key Study Personnel” link.
4. Add or remove the study staff and save.

Please review our list of UCSF-affiliated institutions.

UCSF-affiliated personnel 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-affiliated personnel who are not Key Study Personnel do not need to be added to the IRB application.

If the affiliated KSP needs access to iRIS or other UC Network programs:

If the individual needs access to iRIS (e.g., to assist with IRB submissions, access study documents such as approved consent forms, the Sponsors Protocol, or IRB approval letters, or to carry out financial oversight responsibilities for studies in iRIS) or to any other UCSF Programs which are only accessible via MyAccess, 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.

Once affiliate access is granted, 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 other participant-contact documents that name the individuals being changed (if applicable)

If the affiliated KSP does NOT need access to iRIS or other UC Network programs:

If the individual does NOT need access to iRIS or any other UCSF Programs which are only accessible via the UCSF MyAccess Landing Page, they do not need to request affiliate access.

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: Do not list the individual in the “Grant Key Study Personnel (KSP) Access to the Study” section. Instead, list them in the “Affiliated Personnel” table within the “Qualifications of Key Study Personnel” section.
2. Revised consent forms and other participant-contact documents that name the individuals being changed (if applicable)
3. CITI completion certificates for all individuals added to the “Affiliated Personnel” table

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 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. 

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.

• 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.

• 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.

• 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.