Human Subjects Research Advisors (HSR Advisors) must be Brown faculty with appropriate qualifications to accept joint responsibility with the student PI for the proper ethical conduct of the research and protection of participants.
HSR Advisors must also:
- Have previous experience conducting human subjects research
- Have completed human subjects research education requirements
- 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.
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.
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 participants’ 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 of a medical device for research purposes.
- Associate Professor
- Assistant Professor
- Postdoctoral Fellow
- "Research" Appointment / Research Scholar Title
In Accordance With the Office of Sponsored Projects “Brown University Policy on Principal Investigator Eligibility for Externally Sponsored Awards”
Any faculty, student, or staff with a sponsored award through Brown as a PI or Co-Investigator on an approved proposal and/or award.
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 IRB’s review of a submission should also contact their affiliated hospital-based IRB to determine the hospital IRB’s level of engagement and oversight.
Graduate Students and The Warren Alpert Medical School (AMS) Students
Graduate and AMS students are eligible to serve as PIs with an HSR Advisor named on the Human Subjects Research Application. The Advisor must complete and sign the Appendix I: HSR Advisor which must be included in the PI’s submission to the HRPP.
Student research being conducted in a clinic or practice may require a reliance agreement. Please refer to the Collaborative Research webpage or contact the HRPP for questions.
Information Futures Fellows (IF Fellows)
IF Fellows are eligible to serve as PIs. Due to the small window allotted to IF Fellows to develop, conduct, and complete research, these submissions will always be prioritized in the review queue. To request a priority review, please note in the e-mail submission “Priority Protocol: Time Sensitive” when submitting the Human Subjects Research Application and associated research materials.
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 Human Subjects Research submission in order to be accepted for review. The IRB/HRPP will review and determine the appropriateness of the request. Requests for Approval to Serve as a PI 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 The Warren Alpert Medical School
Emeritus Faculty including Emeritus Faculty with “Research” Appointment:
Adjunct – Lecturer, Instructor, Assistant Professor, Associate Professor, Professor:
Instructor, Lecturer, Senior Lecturer, Distinguished Senior Lecturer:
Professor of the Practice, including Assistant and Associate ranks:
Visiting – Lecturer, Instructor, Assistant Professor, Associate Professor, Professor:
Officer of Research and/or Instruction:
Exempt Staff including Technical Staff and Administrative Staff:
*Non-Exempt Staff are not eligible to conduct human subjects research at Brown University.