What is a Principal Investigator?
A Principal Investigator is the individual who assumes full responsibility for a research project, including the supervision of any co-investigators, research assistants, house staff and students. The Institutional Review Board only recognizes one principal investigator per human subjects research study, no matter how many research sites may be involved. Other individuals may be named co-investigators. The principal investigator must possess the expertise, time and commitment to conduct and provide the necessary oversight for all aspects of the study, and must be willing to accept full responsibility for the study.
In multi-site studies for which Rutgers is the coordinating institution, the principal investigator assumes the responsibility for the conduct of the study at each performance site and by each site-specific principal investigator.
The following classes of individual may serve as Principal Investigator on human subjects studies conducted at Rutgers:
- Individuals with a paid faculty appointment at a Rutgers School, other than visiting and per-diem faculty, with the approval of the department chair; unpaid (volunteer) faculty at a Rutgers School by exception only, with written justification by the Department chair and research dean, and case-by-case approval by the University Institutional Official
- Individuals in permanent, non-faculty staff positions at Rutgers, with the approval of the department chair or pertinent vice president;
- students enrolled in a Rutgers School or Program which has procedures to ensure appropriate close-out of human subjects research on which the student is principal investigator. These procedures include as a requirement for graduation proof of study termination by the IRB. The student’s faculty advisor must be named a co-investigator on the study. Students whose school or program does not have close out procedures in place may only conduct human subjects research as a co-investigator under the supervision of a faculty advisor, who will be named the principal investigator and be held responsible for the conduct of the research and the work of the student.
*Rutgers Graduate students and PhD students may be Principal Investigators on eIRB submissions. This is providing that the graduate student has obtained a Rutgers full-time faculty advisor. The faculty advisor must be listed on the eIRB application (in eIRB under the Study Identification section, the advisor must be listed as the Co-Investigator).
**Students from Rutgers Biomedical and Health Sciences Schools may not serve as Principal Investigators. Students must check with their schools prior to submitting IRB applications to confirm whether they can serve as Principal Investigators on eIRB submissions.
Individuals who can not be a Rutgers Principal Investigator (PI):
Rutgers Biomedical Health Sciences (RBHS) Units:
- House staff (interns, residents and clinical fellows) and postdoctoral fellows may not be principal investigators on human subjects studies, but may be named co-investigator under a faculty advisor as principal investigator. The faculty advisor, as principal investigator, assumes all of the responsibilities for the conduct of the research and the work of the intern, resident, clinical fellow or postdoctoral fellow. Exceptions for individual house officers or postdoctoral fellows may be requested by the department chair to the IRB director if written procedures are in place to ensure appropriate closeout of the research when the individual leaves the university.
Other Rutgers Schools/Depts:
- Rutgers Part-Time Lecturer / Per Diem Instructor
- Rutgers adjunct professor
- Faculty member / student from another university or college
- Undergraduate student
- Former student who has graduated from Rutgers
*Undergraduate students cannot be Principal Investigators. On paper submissions and in eIRB, undergraduate students can work on an application with their Rutgers full-time faculty advisor is listed as Principal Investigator. The Principal Investigator is the only person allowed to submit the project to the IRB in paper or through eIRB.
Study Personnel are defined as all individuals, including students, who are responsible for the design or conduct of the study. Anyone who has contact with human subjects, with confidential data about human subjects, or data that was obtained from human subjects, for a research purpose is included.
For Study Personnel especially Non-Rutgers Key Personnel, the PI must provide their full contact information (Business Address, Job TItle, Study Role, etc) and Rutgers CITI Certification.
- Co-Investigators (Co-PIs): If your study contains two or more PIs, you must still select a PI to be the main contact for administrative purposes. The Co-PI should be listed as Key personnel on your eIRB application. A Co-PI can be from other universities but must be listed as Key personnel.
- Data Steward: A data steward is any individual who is responsible for creating, maintaining, or storing data files. Data Stewards are managers, researchers and others who oversee the capture, maintenance, and dissemination of data for a particular purpose. They are expected to know the specific types of data for which they are responsible, the appropriate uses of the data, and the applicable regulatory and policy requirements. Data Stewards are responsible for making security decisions regarding access to and protection of data under their charge. This includes developing and executing procedures for granting, maintaining and terminating access to the data for which they are responsible. These procedures should be developed taking into account the risks associated with the specific data and/or system being accessed, as well as the burdens associated with implementing the procedures. The data steward must be listed as study personnel on the protocol.
- Faculty Advisors: A Faculty Advisor's role is to assist the PI with their research project and act as a resource for following the research procedures as set by US Regulations and Rutgers University policy.
- Student Principal Investigators: Rutgers graduate and PhD students may be PIs but they are requested to have a faculty advisor who is a a fulltime faculty or staff. Undergraduate students can not be PIs.
- Postdoctoral Scholars: The IRB allows Post-Docs to apply for IRB approval of a human subjects project so long as there’s a supervising, full-time department faculty listed as Co-I. Therefore, their application will need to indicate their supervising faculty contact information and signature. All consent & debriefing statements must also contain their information.
- Visiting Scholars & Visiting Faculty: The IRB allows Visiting Scholars & Visiting Faculty to apply for IRB approval of a human subjects project so long as there’s a full-time department Rutgers faculty at listed as PI. Therefore, their application, will need to indicate the full-time Rutgers faculty contact information and signature and personnel, should be updated with the visiting faculty/scholar’s information. All consent & debriefing statements must also contain the full-time RU faculty with his/her name and contact information.