Qualifications of "Responsible" Principal Investigators
It is the policy of the University of Utah IRB that all human subjects research that is conducted by or under the direction of any employee, faculty, staff, student, or agent of the University of Utah in connection with his or her institutional responsibilities must be reviewed by the IRB.
What is a "Responsible" (RI) Investigator? How is it different from a "Principal" Investigator (PI)?
The RI is the person listed in the ERICA application as the individual who will be responsible for all ERICA tasks and requirements for the application they are listed on. This person holds the same responsibilities as a PI, but with the added understanding that they will be the primary ERICA contact for the study.
Who can be listed as the Responsible Investigator on an ERICA application?
The ERICA application requires you to select what the "position of the investigator" is under the Responsible Investigator section. Choices allowed by the application are:
- Faculty or Non-Academic Equivalent
- Student
- Staff
- Resident/Fellow
- Other; if "Other", describe
At the University of Utah, a person appointed as either regular or research faculty by his/her department head (with approval of the dean) may be designated as Principal Investigator (PI). The University Faculty shall consist of the president, vice presidents, deans, directors of libraries, professors (including distinguished professors, presidential professors and university professors), associate professors, assistant professors, instructors, librarians, associate librarians, assistant librarians, affiliate librarians, auxiliary faculty (research, clinical, lecturer, visiting, adjunct) and emeritus appointments.
For a more complete definition of University Faculty see the University of Utah Policy and Procedure Manual, Policy 6-300: University Faculty.
At the University of Utah, the IRB also acts as the ethical review board for University students, University Staff, and other person(s) who are not appointed as either regular or research faculty by his/her department head. In this instance, the University student, University staff member, and other person(s) may act as a Principal Investigator with the mandate a "Faculty Sponsor" is provided (see below to learn more about Faculty Sponsors).
The University of Utah IRB has been designated as the ethical review board for Primary Children's Hospital, Shriners Hospitals for Children Intermountain, and the Veteran Affairs Salt Lake City Health Care System. Person(s) with workforce privileges similar or equivalent to that of an appointed regular or research faculty at the University of Utah may be designated as a Principal Investigator by the institution's research or other administrative department(s) with the authority to pronounce such responsibility.
The University of Utah IRB also serves as the IRB for research conducted at locations external to the University of Utah and its affiliates listed in the previous paragraph. Because of this, the ERICA application will ask for the person designated as the Responsible Investigator and the Site Principal Investigator (Site PI). The Responsible Investigator should meet the equivalent qualifications of a Principal investigator.
Please review our other guidance on this and related topics on the IRB's Investigator Guidance Series (IGS). Topics of specific interest may include:
- Investigators and Key Study Personnel
- Investigator Responsiblities for Device Studies
- Investigator Responsiblities for Drug Studies
- Sponsor-Investigator Guidelines and Responsibilities
Frequently-Asked Questions
No, but there are some preliminary steps that must be completed before someone unaffiliated with the University of Utah can be listed as an RI on an ERICA application.
If you are the PI of a study that would like to use the University of Utah IRB as the single IRB (SIRB) for your study, but you are not affiliated with the University of Utah, begin by submitting a Reliance Consultation Request form so a member of the SIRB Reliance Team can get in touch with you.
If you need an ERICA account but you do not have a University ID number (UNID), please submit an ERICA Account Request Form. Once the form is submitted, the SIRB Reliance Team is notified and will begin reviewing your request.
A Faculty Sponsor is a current faculty member of the University of Utah who is willing to assist the RI in performing their role in the research. The Faculty Sponsor must be a person of appointment for either regular or research faculty by his/her department head (with the approval of the dean). Faculty sponsors should be experienced in the area of the research and oversee the research and the RI.
In addition to providing guidance, mentorship, and support to the RI, Faculty Sponsors are required to submit the ERICA application after the RI has submitted at initial submission of a New Study Application. The Faculty Sponsor should be well versed in how to use the ERICA system and available to provide support to the PI in navigating the system and addressing questions or revisions from the IRB and other HRPP committees.
If the position of the investigator is anything other than "Faculty or Non-Academic Equivalent", a Faculty Sponsor is required to submit an ERICA application.
If the PI of a study is a University of Utah student, staff member, or other person(s) who are not appointed as either regular or research faculty by his/her department head, a Faculty Sponsor must be listed in addition to the RI in order to submit the ERICA application.
Please contact the University of Utah IRB if you think you may qualify as a non-academic faculty equivalent and would like to submit an ERICA application without a Faculty Sponsor.
Principal Investigator (PI) Responsibilities
The Principal Investigator must certify that the information provided in applications submitted to the IRB is complete and accurate. By submitting an application via the ERICA online system, the Principal Investigator is providing a legally valid signature, equivalent to a paper signature submission. When submitting a new study application via the ERICA online system, the Investigator must agree to the Investigator's Statement of Assurance outlining the Principal Investigator's responsibilities.
The Principal Investigator has ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human participants, and strict adherence to the study protocol and any stipulations imposed by the University of Utah Institutional Review Board.
Should the Principal Investigator use the project described in the application as a basis for a proposal for funding (either intramural or extramural), it is his/her responsibility to ensure that the human participants' involvement as described in the funding proposal(s), is consistent in principle, to that contained in the application. The Principal Investigator will submit modifications and/or changes to the IRB as necessary, in the form of an amendment, to ensure these are consistent.
Principal Investigator Statement of Assurance
The Principal Investigator agrees to comply with all University of Utah policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human participants in research, including, but not limited to:
- Ensuring all investigators and key study personnel have completed the University of Utah IRB approved human subjects training program and declared all significant financial conflicts of interest;
- Ensuring the project is conducted with adequate resources to protect participants including but not limited to time, equipment, space, and by qualified personnel following the approved IRB application and study protocol;
- Implementing no changes in the approved IRB application, study protocol, or informed consent document without prior IRB approval in accordance with University of Utah IRB policy (except in an emergency, if necessary to safeguard the well-being of a human participant, and will report to the IRB within 5 days of such change);
- Obtaining the legally effective informed consent from human participants or their legally responsible representative, using only the currently approved date-stamped informed consent documents prior to that participant's involvement in the research, and providing a copy to the participant, if applicable;
- Promptly report to the IRB, Data Safety and Monitoring Boards, sponsors and appropriate federal agencies any adverse experiences and all unanticipated problems involving risks to human subjects or others that occur in the course of the research in accordance with University of Utah IRB Policies and Procedures;
- If unavailable to conduct this research personally, as when on sabbatical leave or vacation, the Principal Investigator will arrange for another investigator to assume direct responsibility for the study. Either this person is named as another investigator in this application, or the Principal Investigator will notify the IRB of such arrangements;
- Promptly and completely complying with an IRB decision to place an administrative hold, suspend or withdraw approval for the project;
- Obtaining Continuing Review approval prior to the date the approval for the study expires. If the Principal Investigator fails to apply for continuing review, IRB approval for the study will automatically expire, and all study activity must cease until IRB approval is granted;
- Maintaining accurate and complete research records, including, but not limited to, all informed consent documents indefinitely (if applicable);
- Maintaining any authorization documents to use or disclose PHI indefinitely from the date authorization is obtained; and
- Fully informing the University of Utah IRB of all locations in which human participants will be recruited for this project and being responsible for obtaining and maintaining current IRB approvals/letters of cooperation when applicable.