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 project, 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.

Effective May 21, 2020, Brown University’s IRB began following 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.

Eligible PI by Faculty Appointment

  • Professor
  • Associate Professor
  • Assistant Professor
  • Postdoctoral Fellow
  • "Research" Appointments 
  • Faculty with a sponsored award through Brown

Eligible PI 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.

Graduate Students and Alpert Medical School Students

Graduate students and Alpert Medical School students are eligible to serve as PIs on human subjects research applications but must name an Advisor on the human subjects research application. The Advisor must complete the Advisor Appendix and the completed and signed form must be included in the PI’s submission of a human subjects research application.

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 faculty act as co-investigator(s).

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.

Exceptions

Individuals that do not meet eligibility criteria must request written permission and acquire the applicable signature(s) for an exception to serve as PI. Such requests must use the PI Eligibility Form. The completed and signed form must be included in the PI’s submission of a human subjects research application. 

 

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.