PI Qualifications | Advisor QualificationsEligibility | Exceptions

The HRPP and Brown IRB recognize one Principal Investigator (PI) for each human subjects research study. While the PI may delegate certain responsibilities to other research personnel on a study, the PI retains ultimate responsibility for all aspects of the research and for compliance with all Brown policies and procedures, and federal and State requirements.

Brown University’s IRB uses a two-tiered process for determining PI eligibility. Those PIs deemed eligible by the Human Subjects Research Principal Investigator Eligibility Policy (i.e. “automatically” eligible to serve as PI) and those approved to serve as PI by exception only, which will require an additional level of review by the IRB/HRPP.


PI Qualifications

All PIs must demonstrate sufficient qualifications to conduct and/or oversee the design, conduct, and/or reporting of the research involving human subjects. Human subjects research studies that require skills beyond those held by the PI must be modified to meet the PI’s qualifications, or have one or more additional qualified research personnel act as co-investigator(s).

Some human subjects research studies may require additional personnel/staff with relevant qualifications in specific areas of research inquiry. For example, a licensed medical provider may be necessary if the PI intends to conduct activities that assess participant’ levels of significant emotional distress or self-harm. Additional personnel may also be needed if a study involves the administration of a drug or use a device for research purposes.

Advisor Qualifications

Advisors must be appropriately qualified by education, training, experience, and appointment type to accept joint responsibility with the student PI for the proper ethical conduct of the research and protection of participants.

Advisors must also:

  • Have sufficient time and resources to advise the student PI in the conduct of the research;
  • Cooperate with any post-approval monitoring or auditing of study activities and/or study records as requested or required by the Brown Office of Research Integrity, the Brown IRB, funding entities, sponsors, and/or federal or State regulatory agencies;
  • Ensure that the research remains in compliance with Brown’s Research Data and Research Materials Management, Sharing and Retention Policy;
  • Retain all study records and take measures to prevent accidental or premature destruction of these records if the student PI leaves Brown prior to three years following the end of the research, or for a longer length of time if specified in any applicable regulations or sponsor requirements; and
  • Work with the HRPP to close/transition the study if the student PI has not already done so before the student PI leaves Brown or in any other way becomes ineligible to serve as a student PI on the study.

Eligible PIs by Designation

  1. Faculty Appointments

  • Professor
  • Associate Professor
  • Assistant Professor
  • Postdoctoral Fellow
  • "Research" Appointments 
  • Faculty with a sponsored award through Brown
  1. In Accordance With the Office of Sponsored Projects “Brown University Policy on Principal Investigator Eligibility for Externally Sponsored Awards

Any faculty, student, or staff whose name appears in the Coeus grants management system as a PI or co-investigator on a submitted proposal and/or award.

  1. Hospital-based Faculty Conducting Educational Research

Human subjects research conducted by hospital-based faculty with a clinical appointment at The Warren Alpert Medical School (AMS) generally falls under the purview of that faculty’s affiliated hospital-based IRB. However, AMS faculty may submit human subjects research to Brown’s IRB if they are conducting research specifically in their role as an educator at Brown. AMS faculty must follow the instructions regarding the Request for Approval to Serve as a PI in the Exceptions section below. The IRB/HRPP will review and determine the applicability of the request.

AMS faculty requesting Brown's IRB to review a submission should contact their affiliated hospital-based IRB to determine the hospital IRB’s level of engagement and oversight.

  1. Graduate Students and The Warren Alpert Medical School (AMS) Students

Graduate and AMS students are eligible to serve as PIs, and must name their Advisor on the  IRB/HRPP Application.

The Advisor must complete and sign the Advisor Appendix, which must be included in the PI’s  IRB/HRPP Application.


Exceptions

Faculty and staff who do not meet eligibility criteria may use the Request for Approval to Serve as a PI form to seek permission to act as a PI for an individual study.  The completed form, with the applicable signature(s), must be included with the IRB/HRPP Application in order to be accepted for review. The IRB/HRPP will review and determine the applicability of the request. Requests for Approval to Serve as a PI approved by the IRB/HRPP are applicable only to the individual study for which it has been granted.

Required approval signatures for each appointment/employment type 

Hospital-based Faculty Holding a Clinical Appointment at Warren Alpert Medical School

  • Dean of Medicine and Biological Sciences

Emeritus faculty including Emeritus faculty with “Research” appointment:

  • Department Chairperson or

  • Dean/Center or Institute Director/University Librarian

Adjunct – Professorial, Lecturer, Instructor:

  • Department Chairperson or

  • Dean/Center Institute Director/University Librarian

Instructor, Senior Lecturer, Lecturer:

  • Department Chairperson or

  • Dean/Chair/Institute Director/University Librarian

Professor of the Practice (Assistant, Associate):

  • Department Chairperson or

  • Dean/Chair/Institute Director/University Librarian

Visiting – Professorial, Lecturer, Instructor:

  • Faculty Sponsor

  • Department Chairperson or

  • Dean/Chair/Institute Director/University Librarian

Research Staff (non-faculty) – Investigator, Senior Research Associate, Research Associate, Research Fellow:

  • Department Chairperson or

  • Dean/Chair/Institute Director/University Librarian

Exempt Staff including technical staff and administrative staff:

  • Department Chairperson or Direct Supervisor or

  • Dean/Chair/Institute Director/University Librarian

  • Vice President for Research

*Non-Exempt Staff are not eligible to conduct human subjects research at Brown University.