Conflicts of interest in Research involving human subjects require enhanced considerations beyond preserving the integrity of the Research, to include risks to the rights and welfare of participants. 

To protect research participants and preserve the integrity of the research study and data, the University has a presumptive prohibition against participation in human subject research by an Investigator in the following situations:

• The human subject research is funded by an Outside Entity in which the Investigator has a Significant Financial Interest;
• The human subject research involves a product or intellectual property from an Outside Entity in which the Investigator has a Significant Financial Interest; and
• The human subject research is funded by an Outside Entity for which the Investigator serves in a Fiduciary Role (e.g., Board of Directors, Chief Executive Officer).

Exceptions to the presumptively prohibited activities may be made in compelling circumstances on a study-by-study basis. Compelling circumstances could include the nature of the Research, the risk level of the study (minimal risk vs. more than minimal risk, as defined at 45CFR 46.102(j)), the nature of the Significant Financial Interest, how closely the Significant Financial Interest is related to the proposed Research, and the degree to which the interest may be affected by the proposed Research.

Investigators wishing to participate in a presumptively prohibited human subject research activity must present a written request for an exception to the COI Review Board and the University’s Institutional Review Board (IRB). This request must include a list of compelling circumstances, and a proposal on how the conflict of interest could be effectively managed. 

An Investigator wishing to conduct Research activities that involve sponsorship, including but not limited to funding or in-kind support, or products/intellectual property from a privately held Outside Entity, including a start-up, in which the Investigator has a Significant Financial Interest, should be aware that these situations may create conflicts of interest that can impact the scientific integrity of the Research.  

The following activities/situations are presumptively prohibited as they create, in almost all circumstances, conflicts of interest that cannot be effectively managed.

• An Investigator’s Research at Brown is sponsored by 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.
• An Investigator’s Research at Brown is sponsored by 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.

The COI Review Board may make exceptions in compelling circumstances, which will depend in each case upon the nature of the Research, the status of the Outside Entity, the nature of the Significant Financial Interest, how closely the Significant Financial Interest is related to the proposed Research, and the degree to which the interest may be affected by the proposed Research.  The COIRB may, within its discretion, consult other offices as necessary and appropriate in its evaluation of the compelling circumstances or it may refer a case to University leadership for adjudication.

Investigators wishing to engage in a presumptively prohibited activity must present a written request for exception to the COI Review Board. This request must include a list of compelling circumstances, and a proposal on how the conflict of interest could be effectively managed. 

Phase I of the Small Business Innovation Research (SBIRs) and Small Business Technology Transfer (STTRs) programs are exceptions to this presumption and the compelling circumstance requirement; in such cases, however, the COI Review Board will normally recommend management of the Financial Conflict of Interest 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.

As an exception to this presumptive prohibition, an Investigator may, in the normal course of conducting research, use personal funds to purchase low-cost, routine research-related items or to supplement travel.  Review and prior approval by the Office of the Vice President for Research is required if an Investigator wishes to use personal funds to purchase major or capital research items or equipment. 

Investigators and their Family Members wishing to support research projects at the University may donate in accordance with the University’s donation guidelines and policies. However, Investigators cannot donate to a research account over which they or someone they directly supervise has spending authority.

Under SBIR awards, the principal investigator for the small business must be a full-time employee (at least 51%) of the small business. Small businesses receiving SBIR grants are not required to collaborate with universities or research institutions. However, the SBIR program permits and encourages research partnerships. For Phase I SBIR awards, no more than thirty-three percent (33%) of the SBIR award can be performed by any collaborating research institution. For Phase II awards, no more than fifty percent (50%) can be performed by any collaborating research institution.

The principal investigator for an STTR award needs to be (1) a full-time employee (at least 51%) of the small business or (2) a full-time employee of the collaborating research institution and have a formal relationship with the small business.

Small businesses receiving STTR awards must collaborate with a non-profit research institution, like a university. STTR awards require that the collaborating research institution perform at least thirty percent (30%) of the award. At least forty percent (40%) must be performed by the small business. The remaining thirty percent (30%) of an STTR award may be performed by the small business, the research institution, or third parties.

While small business-related research is encouraged at the University, it can give rise to specific conflict of interest and conflict of commitment concerns. The following general principles have been adopted by the University to address these concerns.

• All work performed for, or in connection with, SBIR- or STTR-funded Research that makes use of University facilities, equipment, materials, employees, or students, must be performed under a fully negotiated agreement (e.g., sponsored research agreement or facilities use agreement) executed by the appropriate Institutional Official, in compliance with all applicable University policies related to the use of facilities and resources.
• The principal investigator for a small business and the principal investigator for a University sub-award must be separate individuals, and neither may be a Family Member of the other.
• A full-time (at least 51%) employee of the University may not serve as the principal investigator for a small business’s SBIR prime award due to likely Conflict of Commitment issues.
• No University student, staff member, visiting researcher, or visiting scientist may perform Research under the University’s portion of a small business’s SBIR or STTR award, and concurrently perform Research under the small business’s portion of the award at or on behalf of the small business.
• All SBIR or STTR subcontracts that the University receives from a small business, and that involve an Investigator who has a Significant Financial Interest or a Fiduciary Role in the small business, must be reviewed by the COI Review Board.

Disclosure is a method for ensuring open and transparent communication regarding financial and other interests that could affect or appear to affect research activities, and for informing collaborators, trainees, and the scientific community more generally of interests that may have interfered with objectivity and could create a potential for bias. Investigators should disclose any relevant financial and other interests, but must disclose relevant Significant Financial Interests and Fiduciary Roles: 

• to students and trainees who are under active mentorship and who work on projects and Research related to the Significant Financial Interest or Fiduciary Role; and 
• in publications and presentations presenting results or data that are related to the Significant Financial Interest or Fiduciary Role.

Investigators are also required to comply with any reporting requirements set forth in their funding instruments or established by external sponsors and agencies.

Gifts, including equipment, given to an Investigator or the Investigator’s lab for research purposes must be reported on the Investigator’s COI Reporting Form. Investigators must also comply with University policy on the solicitation and acceptance of Gifts, as outlined in the University’s Policy on Conflict of Interest and Commitment.

In accordance with the University’s Policy on Conflict of Interest and Conflict of Commitment, Investigators may only use the facilities and resources of the University for University business.

Use of University space for Research by an Outside Entity is permissible under special conditions and only with an agreement formally signed in accordance with the Delegations of Signature Authority for Contracts. Use of University space for research by an Outside Entity in which an Investigator has a Significant Financial Interest or Fiduciary Role, must be reviewed, in advance, by the COI Review Board to determine if it is allowable and, if allowable, what management, if any, should be implemented.

Any students, trainees, or other personnel whom an Investigator actively or directly supervises or advises cannot be involved in work at a privately owned Outside Entity in which that Investigator has a Significant Financial Interest or a Fiduciary Role. In exceptional circumstances, approval may be granted by the Vice President for Research, in coordination with the Graduate School, the Dean, and the Investigator’s Department Chair.

Investigators must complete Financial Conflict of Interest training prior to engaging in PHS- or DoE-Funded Research. Investigators must be re-trained every four years and whenever there is a substantive change to the University’s COI Research Policy.  The University must also re-train any Investigator who has been found to be non-compliant with the PHS COI regulations or the DoE interim COI Policy and/or the University's COI Research Policy.

Financial conflict of interest training is administered by the Office of Research Integrity.

Investigators participating in PHS- or DoE-Funded Research are required to submit an updated COI Reporting Form to the University in accordance with the University’s COI procedures within thirty (30) days of discovering or acquiring a new Significant Financial Interest.

Investigators participating in PHS- or DoE-Funded Research are required to report on their annual COI Reporting Form the occurrence of any Reportable Travel.

At Brown, the internal threshold for reporting and reviewing travel is $5,000 for any 12-month period. Exceptions to this reporting requirement are set forth in PHS COI regulation and the DoE interim COI Policy, and include when travel is reimbursed or sponsored by (1) a federal, state, or local government agency; (2) an institution of higher education as defined at 20 U.S.C. 1001 (a); (3) an academic teaching hospital; (4) a medical center; or (5) a research institution that is affiliated with an institution of higher education.

Investigators must provide information on the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

Under PHS COI regulations and the DoE interim COI policy, the University is required to make available to the public, upon request, specific information regarding Financial Conflicts of Interest identified for senior and key personnel on PHS- or DoE-Funded Research. The University is required to provide specific information relative to such public requests within five business days of the request.

When proposed PHS- or DoE-Funded Research is to be carried out through a subrecipient, the University will: 

• Establish, at the time of proposal submission, whether the subrecipient on PHS-funded Research has a COI policy that is compliant with 42 CFR 50 Subpart F or whether the subrecipient on DoE-funded Research has a COI policy that is compliant with the DoE interim COI Policy;
• Establish, in cases where the subrecipient does not have a COI policy that is compliant with 42 CFR 50 Subpart F or the DoE interim COI Policy, whichever is applicable, whether the subrecipient will implement a compliant policy prior to accepting funding or follow the University’s COI Research Policy for the duration of the PHS- or DoE-Funded Research activity (if the latter, subrecipient’s Investigators must adhere to procedures and time frames outlined in the University’s internal COI procedures document); and
• In cases where the subrecipient has a compliant COI policy, incorporate terms into the subrecipient agreement that establish obligations of the subrecipient relative to conflict of interest, including specific time periods for providing Financial Conflict of Interest reports.

In the event of non-compliance with special requirements under 42 CFR 50 subpart F or the DoE interim COI Policy, the University must conduct a retrospective review of the Investigator’s activities on the PHS-or DoE-Funded Research project to determine whether any PHS- or DoE-funded research, or portion thereof, conducted during the time of non-compliance, was biased in the design, conduct, or reporting. Furthermore, the University must, to the extent required by federal regulations or policy, submit a mitigation report to the PHS or to DoE. 

Non-compliance with special requirements includes the following:

• An Investigator failed to report a new Significant Financial Interest within the required time frame or the University failed to review a new Significant Financial Interest within the required time frame, and that Significant Financial Interest, upon review by the University, is then determined to create a Financial Conflict of Interest with a PHS- or DoE-funded research project;
• A Financial Conflict of Interest is not identified or managed in a timely manner; and
• An Investigator fails to comply with a Financial Conflict of Interest management plan.

Brown Investigators who are funded by either NSF or NASA must also report any Venture or other Capital Financing.

When the University engages a subrecipient on NSF- or NASA-Funded Research, the University will: 

• At the time of proposal submission, confirm the subrecipient’s COI policy complies with the relevant sponsor’s (i.e., NSF or NASA) COI Policy,  
• In cases where the subrecipient does not have a COI policy that is compliant with the relevant sponsor’s COI Policy, confirm that the subrecipient will implement a compliant policy prior to accepting funding or that it will follow the University’s COI Research Policy for purposes and the duration of the NSF- or NASA-Funded Research activity
  • If the subrecipient will follow the University’s COI in Research Policy, Investigators on the subaward must adhere to procedures and time frames established by the University, including any set forth in the University’s internal COI procedures; and
• In cases where the subrecipient has a compliant COI policy, incorporate terms into the subrecipient agreement that establish obligations of the subrecipient relative to conflict of interest, including specific time periods for providing Financial Conflict of Interest reports to the University.

For any Financial Conflict of Interest that the University identifies and that involves an award funded by PHS, prior to the expenditure of any funds under the award, the University, acting through its designated Institutional Officials and COI Review Board will:

• Confirm that the Financial Conflict of Interest is managed or eliminated.
• For Financial Conflicts of Interest that will be managed, develop and implement a management plan that specifies how the identified Financial Conflict of Interest will be managed.
• Notify the PHS awarding agency of the existence of any Financial Conflict of Interest in accordance with PHS requirements.

For any SFI that the Institution identifies as creating a conflict or potential conflict subsequent to the Institution's initial FCOI report that is related to ongoing PHS-funded research, the University shall provide PHS, within sixty days, an FCOI report regarding the SFI and implement a management plan in accordance with institutional policies.

For any Financial Conflict of Interest that the University identifies and that involves an award funded by DoE, prior to the expenditure of any funds under the award, the University, acting through its designated Institutional Officials and COI Review Board will:

• Confirm that the Financial Conflict of Interest is managed or eliminated.
• For Financial Conflicts of Interest that will be managed, develop and implement a management plan that specifies how the identified Financial Conflict of Interest will be managed.
• Notify the DoE program officer listed on the related award(s) in writing of any Financial Conflict of Interest that cannot be satisfactorily managed, reduced, or eliminated in accordance with Brown’s COI policy.
• Follow any other FCOI related reporting requirements specified in the terms and conditions of the award.

For any Financial Conflict of Interest that the University identifies and that involves an award funded by NSF, prior to the expenditure of any funds under the award, the University, acting through its designated Institutional Officials and COI Review Board will:

• Confirm that the Financial Conflict of Interest is managed or eliminated.
• For Financial Conflicts of Interest that will be managed, develop and implement a management plan that specifies how the identified Financial Conflict of Interest will be managed.
• Notify the NSF Office of the General Counsel in writing of any Financial Conflict of Interest that cannot be satisfactorily managed, reduced, or eliminated in accordance with Brown’s COI policy.

For any Financial Conflict of Interest that the University identifies and that involves an award funded by NASA, prior to the expenditure of any funds under the award, the University, acting through its designated Institutional Officials and COI Review Board will:

• Confirm that the Financial Conflict of Interest is managed or eliminated.
• For Financial Conflicts of Interest that will be managed, develop and implement a management plan that specifies how the identified Financial Conflict of Interest will be managed.
• Notify the NASA Grant Officer(s) listed on the related award(s) in writing of any Financial Conflict of Interest that cannot be satisfactorily managed, reduced, or eliminated in accordance with Brown’s COI policy.

After the expenditure of award funds, notify NASA within 60 days of any FCOI that the University identifies FCOI that cannot be managed, reduced, or eliminated.

For any Financial Conflict of Interest that the University identifies and that involves an award funded by external sponsors other than PHS, DoE, NSF and NASA, the University will follow any FCOI related reporting requirements specified in the terms and conditions of the award.