COI Review, Management and Prohibited Conflicts at Brown University
Brown University’s Office of Research Integrity (ORI) administers and manages the COI review process for faculty and researchers. ORI, in collaboration with the University's Conflict of Interest Review Board (COIRB):
- Reviews all COI Reporting Forms that are submitted through the University's electronic COI disclosure system.
- Conducts a COI review for any Investigator on a research project that is administered through Brown.
- Conducts a COI review of related financial interests identified via a protocol submission to the IRB and provides a recommendation to the IRB regarding disclosures to human research participants.
- Refers Conflicts of Interest that are unrelated to research and Conflicts of Commitment to the appropriate Dean's office.
The COIRB meets monthly during the academic year to identify financial conflicts of interests (FCOIs) with research, teaching, and other scholarly activities. The COIRB makes recommendations to the Vice President for Research regarding the elimination, reduction, or management of identified FCOIs, and monitors implementation of any management plan. The COI Review Board is comprised of faculty from a broad range of departments.
In cases where the COIRB recommends that the FCOI be managed, ORI, with guidance from the COIRB and the Vice President for Research, will develop and implement a FCOI management plan. The management plan lists required and recommended management measures that are designed to mitigate the conflict of interest and reduce the potential for bias to affect the design, conduct, or reporting of the research. Possible measures include, but are not limited to:
disclosure of the financial interest in publications/presentations;
disclosure of the financial interest to all collaborators on the research project;
disclosure of the financial interest to students/trainees;
disclosure to any study participants, if applicable.
The management plan is signed by the Investigator and is subject to annual review and/or periodic audits.
Prohibited Research Activities at Brown
To preserve the integrity of the research study and data, and to protect research participants, the University has a presumptive prohibition against participation in research by an Investigator in the following situations, as they create in almost all instances unmanageable conflicts of interest.
The Investigator wants to participate in human subject research that is funded by an Outside Entity in which the Investigator has a Significant Financial Interest or serves in a Fiduciary role (e.g., Board of Directors,Chief Executive Officer);
The Investigator wants to participate in human subject research that involves a product or intellectual property from an Outside Entity in which the Investigator has a Significant Financial Interest or serves in a Fiduciary role (e.g., Board of Directors, Chief Executive Officer);
The Investigator wants to receive sponsored research from a privately held Outside Entity, including a start-up, in which the Investigator has a Significant Financial Interest or otherwise holds a Fiduciary Role or executive-level position.
The Investigator’s wants to receive sponsored research from a privately held Outside Entity, including a start-up, in which the Investigator’s current research assistants, trainees, students, [or others over which the Investigator has supervisory authority] have a Significant Financial Interest or otherwise hold a Fiduciary Role or executive-level position.
Investigators wishing to engage in a presumptively prohibited activity must present a written request for exception to the COIRB. This request must include a list of compelling circumstances, and a proposal on how the conflict of interest could be effectively managed. Please contact the COI Administrator in the Office of Research Integrity (ORI) for assistance.
Note that Phase I of the Small Business Innovation Research (SBIRs) and Small Business Technology Transfer (STTRs) programs are exceptions to the presumptive prohibition and the compelling circumstance requirement; in such cases, however, the COIRB will normally recommend management of the FCOI that may arise with the research conducted under Phase I SBIRs and STTRs.
Investigators are presumptively prohibited from using their own personal funds or receiving funding from a Family Member or a Family Trust to support research efforts they are directing or conducting under the auspices of the University, including efforts that involve research personnel such as, but not limited to, graduate students.
Self-funded research can blur the boundary between funder and researcher, and may give rise to concerns regarding appropriate oversight, accountability, and conflict of interest.
Exceptions to this presumptive prohibition include using personal funds to purchase low-cost, routine research-related items or to supplement travel. For information about self-funded research, please contact the COI Administrator.