To qualify as PI on a human subjects research study, an individual must have the appropriate scientific or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving human subjects. The PI provides technical and administrative oversight of the research and makes important study-related decisions. The Human Research Protection Program (HRPP) and Institutional Review Board (IRB) recognize one qualified 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.

Research Personnel

Research personnel are individuals who have direct contact with participants, contribute to the research in a substantive way, have contact with a participant's identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva) or use a participant's personal information for research purposes.

PI Eligibility

Brown University’s IRB uses a two-tiered process for determining PI eligibility: Either PIs are deemed eligible according to Brown’s PI eligibility policies (i.e. “automatically” eligible to serve as PI) or they are approved to serve as PI by exception only, which requires an additional level of review.

Generally, PIs that fall into the designation of professor, associate professor, assistant professor, postdoctoral fellow, or have a “research” appointment or research scholar title are eligible. Additional details and exact eligibility information can be found in the PI Eligibility for Externally Sponsored Awards policy.

• Human Subjects Research PI Eligibility Policy
• PI Eligibility for Externally Sponsored Awards Policy

PI Qualifications

All PIs must demonstrate sufficient qualifications to oversee the design, conduct and 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).

Additional Personnel

Some human subjects research studies may require additional personnel 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.

Requesting an Exception to the PI Eligibility Policy

As noted in the official policy, faculty and staff who do not meet eligibility criteria may submit the Request for Approval to Serve as PI form to seek permission. The completed form, with the applicable signatures, must be included with the human subjects research application in order to be accepted for review. Please refer to the form for the list of required signatures. The IRB will review and determine the appropriateness of the request. 

If approved, the eligibility to serve as PI is only applicable to the study for which the request was submitted. For multi-study or longer-term approvals, please see the next section.

Requesting an Exception to the PI Eligibility Policy for Multiple Studies 

Brown University researchers who do not meet eligibility criteria may also request an exception to serve as PI on multiple studies or for a certain length of time. Such requests will be reviewed and approved by the Division of Research Institutional Official. Requests to serve as PI on multiple studies or for a specific time frame (e.g., one year, three years) for Brown researchers who do not automatically meet the PI eligibility criteria will be guided by the projected number of human subjects research studies a researcher is expected to submit to the HRPP/IRB per year.

Researchers who may meet this criteria or are interested in pursuing such a request should contact irb@brown.edu for more information.

A human subjects research (HSR) advisor is a Brown faculty or staff member who serves as an active mentor to a student PI and shares responsibility for the ethical conduct of research with the student. The HSR advisor should discuss with the student the general principles of research ethics prior to the initiation of any project involving human subjects.

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 Office of Research Integrity, the IRB, funding entities, sponsors and federal or state regulatory agencies;
• ensure that the research remains in compliance with Brown’s Data Management 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 team to close or transition the study if the student PI has not already done so before the student leaves Brown or in any other way becomes ineligible to serve as PI on the study.

• View Brown’s Data Management Policy
• Close an Award
• Managing PI Transitions