What is a Principal Investigator?
The Principal Investigator (PI) (or project director) is the individual who has ultimate responsibility for the design, execution, and management of a sponsored project:
- Write and submit the sponsored proposal
- Ensure that the proposal is ethically and scientifically meritorious
- Execute the scientific and technical aspects of a project
- Oversee the day-to-day management of the project
- Ensure completion of the programmatic work
- Comply with all government, sponsor, and University policies and regulations
- Maintain fiscal stewardship of sponsored funds
- Disseminate results from project
- Manage all administrative requirements of the project
Serving in the role of Principal Investigator on a sponsored project is a privilege granted to certain people associated with the University of Arizona. This role carries with it important responsibilities. With the oversight responsibility implicit in the University's acceptance of outside funds for a project, the University must be in a position of authority over the Principal Investigator's actions. Therefore, an individual's participation in University of Arizona research is dependent upon that individual's relationship with the institution. Research, Discovery & Innovation has set out guidelines that must be met for the consideration of granting status as a Principal Investigator to any individual.
The prospective PI must be:
- An individual to whom the University has issued and the individual has signed an annual Notice of Appointment or Notice of Reappointment, including Emeriti Appointments, or
- An individual employed by a Federal agency with which the University has an ongoing relationship, pursuant to other formal agreements such as cooperative agreements, or
- A University of Arizona student who has provided proof of satisfactory completion of all pertinent research training as well as formal approval by a supervising faculty member who meets the criteria set out above, or
- A visiting professor who has a formal relationship with a University department
If involved in clinical research, as determined by the Institutional Review Board (IRB), the PI is either:
- An employee of the University and, if a physician, is a member of University Physicians, Inc., or a Campus Health Services' Physician; or
- A clinical practitioner employed by the Southern Arizona VA Health Care System and whose research is conducted in the College in which his/her protocols would be conducted most appropriately, as determined by the University; or
- A physician appointed as an affiliate or associate by the College of Medicine Phoenix, performing clinical work in the Phoenix Metro Area and covered under institutional affiliation agreements that cover such relationships
Visiting Professors with a formal relationship with a University Department and Investigators involved in research as defined by the IRB shall:
- Have a signed agreement with the University agreeing to:
- Comply with all applicable ABOR/University policies and procedures, including, but not limited to, Human Subjects' Protection, Conflict of Interest and Commitment and Intellectual Property
- Assume responsibility for the defense of all claims, litigation and/or investigations arising out of the research activities;
- Accept no payment from University for participation in the grant
- Provide proof of professional liability insurance
- Advise the University of any change in status of licensure, credentialing, privileging, status of relationship with the University or any pertinent information initially provided by the researcher.
- In addition, if conducting clinical research, they must agree to:
- Limit research to those studies approved by University IRB
- Assume sole responsibility for all activities involved in the securing of subjects' consent for research participation including, but not limited to, use of University's IRB template
- Provide immediate notification to University IRB of any unanticipated occurrences, such as adverse events, protocol deviations/violations/amendments, etc.
- Provide to the IRB written notification of the close of the research project and provide to the University a copy of the Study Closure Letter
Some research projects have multiple Principal Investigators (PI’s). These PI’s can be at more than one institution. Each must have a leadership role, defined in the proposal, and have responsibility for technical aspects of the project.
The National Institutes of Health (NIH) Multiple Principal Investigator/Project Director (PI/PD) model accommodates team-based science and recognizes the contributions of team members for projects that do not fit the traditional single PI/PD model. The Multiple PI model does not replace the traditional single PI/PD model. Under the model, one investigator is named as the Contact Principal Investigator. The NIH specifically states that being named Contact PI does not imply any particular role within the leadership team other than being responsible for communication. The University of Arizona will treat the Contact PI as the communication lead, and the responsible person on for the project.