Qualifications | Eligibility | 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.

Qualifications

All PIs and Advisors 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).

Advisors must be appropriately qualified by education, training and experience to assume responsibility for the proper conduct of the research, must be able to directly supervise the research (or delegate that direct supervision to another appropriately qualified member of the research team), and have sufficient time and resources to properly supervise the research.

Human subjects research studies that involve the administration of a drug or use of a device for research purposes must include a licensed medical provider as the PI or as a co-investigator. This licensed medical provider must have relevant qualifications in the area of research inquiry.

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.