All researchers should be conducting their IRB approved protocols in accordance with requirements in the Investigator Manual. This document is designed to guide you through policies and procedures related to the conduct of human research that are specific to University of California, Davis. The IRB requires that all researchers review this manual before submitting to the IRB and researchers follow the these requirements when conducting human subjects research.
In This Section
- Principal Investigator Qualifications
- Principal Investigator Responsibilities
- Changes in Principal Investigator (PI) or Co-Principal Investigator (Co-PI)
- Investigator Manual
- Research Personnel List
- Student/Medical Resident Researchers
- Faculty Advisor Responsibilities
Who is eligible to be a Principal Investigator?
This Institution’s faculty members with paid appointments and UC Davis staff may serve as the principal investigator on a research project involving human subjects. However, if the research is to be funded by an external entity, UC Davis requires principal investigators to have a paid faculty appointment of at least 50 percent. In some instances, investigators will be granted an exception to this policy. An application for an exception can be found here.
All New Project submissions must include a completed FORM: ADMINISTRATIVE APPROVAL (HRP-226) signed by the Department Chair, Dean or Director indicating approval to conduct the research.
The protection of the rights and welfare of human subjects in research does not end with the IRB review. Researchers are ultimately responsible for the conduct of their research. Though research responsibility may be delegated to research staff, researchers must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.
When do Principal Investigators need to obtain a Faculty Advisor?
The UC Davis IRB requires additional oversight to guide and sign off on research when the PI may be new to the institution or here for a limited time. Principal Investigators that need a Faculty Advisor are those who hold any of the following titles at UC Davis:
- Undergraduate Student
- Graduate Student
- Medical Student
- Medical Resident
- Visiting Scholar
Principal Investigators do not need a Faculty Advisor if they hold any of the following titles at UC Davis:
- Post Doctoral Scholar
- Medical Fellow
What are the Requirements for a Faculty Advisor?
The requirements for a Faculty Advisor are:
- Have a paid faculty appointment
- Complete required training
- Provide mentoring and over site of student research
- Listed on FORM: Administrative Approvals (HRP-226)and sign using the IRBNet “Sign this Package” feature
- Have “Full” access to the project in IRBNet
- Be listed as part of the research personnel (staff)
Responsibilities of the investigator include, but are not limited to:
- Obtain IRB approval or an exemption determination before conducting research involving human subjects.
- Do not start Human Research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval prior to commencing research that involves additional resources. For instance when an investigational drug or biologic is involved, you are required to defer responsibility for accounting, storage and dispensing, etc. to Investigational Drug Services (IDS) Pharmacy.
- Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
- Ensure that Research Staff are qualified (e.g., including but not limited to training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study.
- Personally conduct or supervise the Human Research.
- Protect the rights, safety, and welfare of subjects involved in the research.
- Comply with the current protocol as approved by the IRB.
- When required by the IRB, ensure that consent or permission is obtained as required by the protocol and as indicated in your submission.
- Do not modify the Human Research without or implement a planned deviation from the approved protocol without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subject(s).
- Report to the IRB all required reports within the required reporting timeframe.
- Submit an updated disclosure of financial interests for you and your key research staff within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
- Do not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”)
- Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment (“bonus payments.”)
- Follow applicable federal department or agency requirements when conducting human subject research funded or supported by that department or agency.
Every project needs a principal investigator who accepts the responsibilities of leadership, ethical engagement in research, research integrity, and overall study oversight. A change of principal investigator can be necessary because of a change of employment, retirement, reallocation of professional duties, or other reasons. The new PI or Co-PI must be eligible to serve under HRP-103 (Investigator Manual) and have current certifications. An amendment/modification submission is required to change a PI or Co-PI, and the submission must be reviewed and approved by the IRB prior to implementation.
Amendment/modification submission to the IRB must include:
- Form HRP-213 Modification Form signed by the PI or Co-PI relinquishing his or her role. If the current PI or Co-PI is unavailable because s/he has left the University, the Department Chair may sign.
- Marked (tracked changes) versions of study documents updating the PI or Co-PI information, where applicable
- Clean (changes accepted) version of study documents updating the PI or Co-PI information, where applicable
- HRP 226 Administrative Approvals documenting review and approval of the new PI or Co-PI’s qualifications.
- Updated IRBNet Project Overview and online document.
- New PI or Co-PI must have “Full” access to the project in IRBNet.
- New PI or Co-PI’s electronic signature using the IRBNet “Sign this Package” feature.