Conflict of Interest in Research Policy
Effective date: 10/26/2019
Approved by the Brown University Corporation: 10/26/2019
POL #: 01.10.02
Conflict of Interest in Research Policy
1.0 Policy Purpose
2.0 To Whom the Policy Applies
3.0 Policy Statement
4.0 Definitions: See Appendix A for definitions as they relate to this Policy.
6.0 Consequences for Violating this Policy
7.0 Related Information
8.0 Policy Owner and Contact
9.0 Policy History
1.0 Policy Purpose
The purpose of Brown University’s Policy on Conflict of Interest in Research (COI Research Policy) is to maintain the integrity of Research conducted at or under the auspices of Brown University. This COI Research Policy establishes the University’s conflict of interest (COI) compliance framework for Research activities and educates researchers about regulatory and policy requirements related to conflict of interest in research. The COI Research Policy is compliant with applicable federal COI regulations, including 42 CFR 50 Subpart F and National Science Foundation (NSF) 2005 Conflict of Interest Policies (Chapter V – Grantee Standards).
Also, the COI Research Policy outlines Brown University’s approach to identifying, managing, reducing and, when needed, eliminating situations where Financial Interests, including Significant Financial Interests, of its researchers could interfere with or affect the objectivity of the Research, and to ensure transparency in relationships with Outside Entities as they relate to research activities.
The COI Research Policy applies to anyone who is an Investigator on Research administered through or otherwise appropriately conducted under the auspices of the Investigator’s Brown University affiliation, appointment or employment.
Investigators must also comply with the University’s Conflict of Interest and Commitment policy and subsidiary policies, as applicable.
Conflicts of interest in research may arise in situations where an Investigator’s personal, financial, or other interests could affect, or appear to affect, the conduct of their research activities. Having a conflict of interest does not imply improper conduct of research; rather, conflicts of interest must be identified and managed, reduced, or eliminated so that they do not threaten the integrity of scientific investigations and the public’s trust in academic research.
The Provost has final authority for compliance with this COI Research Policy. Consistent with this responsibility, the Provost has delegated authority to the Vice President for Research to serve as the University’s designated Institutional Official responsible for implementation and compliance with this COI Research Policy and all applicable COI laws, regulations, and external policies.
Investigators are required to report to the University Financial Interests, Outside Professional Activities, and any other interests, as requested, that could affect or appear to affect their Research, including their Significant Financial Interests that reasonably appear to be related to their professional expertise and Institutional Responsibilities. Conflict of Interest (COI) reporting is completed annually and at various transactional points, as outlined below.
Annual Reporting: Investigators must submit a COI Reporting Form annually in accordance with the University’s reporting procedures and time frames.
Transactional Reporting: In addition to the annual COI reporting requirement, Investigators must also comply with transactional COI reporting requirements throughout the calendar year, and in accordance with the University’s reporting procedures and time frames. Transactional COI reporting includes, but is not limited to, submitting a COI Reporting Form or certifying the accuracy of an existing COI Reporting Form when:
Participating as an Investigator on a new sponsored research proposal submission;
Participating as an Investigator on a new human subject research study or being added to a study via an amendment; and
Being added as a new Investigator to an ongoing Research project.
The University, acting through its designated institutional official and their designees, the COI Review Board, and the Office of Research Integrity, have the authority to and are responsible for:
Administering the COI Reporting Form submission and review process for Investigators;
Reviewing reported Financial Interests and Outside Activities, including Significant Financial Interests, that reasonably appear to be related to the Investigator’s Institutional Responsibilities;
Conducting COI reviews in accordance with standards set forth in the federal PHS COI regulations, 42 CFR 50 Subpart F, including
Determining whether any reported Significant Financial Interest is related to any of the Investigator’s, and
Determining whether any reported related Significant Financial Interest constitutes a Financial Conflict of Interest.
When a Financial Conflict of Interest is determined to exist, the University must develop and implement a management plan that specifies actions that have been taken and/or will be taken to manage the Financial Conflict of Interest.
A Financial Conflict of Interest may be managed through full and open disclosure of the Significant Financial Interest:
To all students and trainees who are directly supervised by the Investigator or who work in the Investigator’s lab;
In all publications and presentations of Research related to the Significant Financial Interest; and
To human subjects participating in a study, the results of which could affect the Investigator’s Significant Financial Interest, via a written statement in the informed consent or provided orally, as approved by the Institutional Review Board (IRB).
In addition, other actions that may be taken to manage an identified Financial Conflict of Interest include, but are not limited to, the following:
Periodic review of the Research, the Significant Financial Interest, and related activities in the lab by a neutral party or committee;
Disclosure of the Significant Financial Interest to the research team and provision of measures to protect vulnerable members of the research team (e.g., where a power dynamic may exist);
Modification of the research plan to ensure the integrity of the Research;
Independent oversight of the Research, including appointment of an independent monitor;
Involvement of an independent statistician to review research results, data analysis and interpretation;
Change of personnel responsibilities;
Prohibition to participate in the Research;
Divestiture of the Significant Financial Interest that creates the Financial Conflict of Interest; and
Severance of the relationship(s) that creates a Financial Conflict of Interest.
The University may also develop a management plan in situations that do not constitute Financial Conflicts of Interest, but where it is determined that there are other Conflict of Interest concerns and/or action is needed to preserve the integrity of the Research.
3.5.1 Conflict of Interest in Research Involving Human Subjects
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 the evaluation of a product or intellectual property from an Outside Entity in which the Investigator has a Significant Financial Interest.
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, including a list of compelling circumstances, and a proposal on how the conflict of interest could be effectively managed, for consideration by the COI Review Board and the University’s Institutional Review Board (IRB).
3.5.2 Conflict of Interest in Research Involving Funding and/or Products from a Privately-held Traded Entity
An Investigator wishing to conduct Research activities that involve sponsorship 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 create conflicts of interest that can potentially 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 may not participate in Research at Brown sponsored by a privately held Outside Entity, including a start-up, in which the Investigator has a Significant Financial Interest.
An Investigator may not participate in Research at Brown sponsored by a privately held Outside Entity, including a start-up, in which the Investigator’s current research assistants, trainees, or students have a Significant Financial Interest or otherwise hold a Fiduciary Role or executive-level position.
Exceptions may be made in compelling circumstances, which will depend in each case upon the nature of the science, the status of the company, 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 engage in a presumptively prohibited activity must present a written request for exception, including a list of compelling circumstances, for consideration by the COI Review Board.
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.
3.5.3 Self-Funded Research
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 and that involve research personnel, including graduate students.
Self-funded research blurs the boundary between funder and researcher, giving rise to concerns regarding appropriate oversight, accountability, and conflict of interest.
It is reasonable, and therefore not prohibited, for Investigators to use personal funds to occasionally supplement non-personnel expenses related to research, such as travel or to purchase research-related items.
Investigators 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.
The purpose of the federally funded Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs is to promote research by U.S. companies engaged in innovation and commercialization of technology.
Only small for-profit businesses are eligible to apply for these Federal awards. Many small businesses that receive SBIRs or STTRs collaborate with universities and other research institutions. For many faculty-owned start-up companies, SBIRs and STTRs, in particular, provide critical funding opportunities. When applying for SBIRs and STTRs, it is important to be aware that the Federal Government places certain restrictions and limits on subcontracting under SBIR and STTR awards.
3.6.1 SBIR Awards
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
3.6.2 STTR Awards
The principal investigator for an STTR award needs to be a full-time employee (at least 51%) of either the small business or the collaborating research institution, and must 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.
3.6.3 General Principles pertaining to SBIR/STTR Awards
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 the University sub-award must be separate individuals, and may not be a Family Member of either principal investigator.
A full-time (at least 51%) employee of the University may not serve as the principal investigator for a small business’ SBIR prime award due to 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’ SBIR or STTR award, and concurrently perform Research under the small business’ 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 are 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.
3.7.2 Other Disclosure Obligations
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 their 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.
3.7.4 Office/Laboratory Space and other Resources
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 a for-profit company 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 a for-profit company 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.
3.7.5 Use of Students/Trainees
An Investigator should not involve any students and trainees whom they actively or directly supervise or advise in work at a privately owned Outside Entity in which the 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.
Should an Investigator wish to appeal a decision made by the COI Review Board (COIRB), the Investigator may present the appeal within 90 days of the COIRB’s decision in writing to the Vice President for Research (VPR). The VPR at their discretion, will consider the case with input from the COI Review Board and/or other offices as necessary. The Investigator may be asked to present their appeal in person to the VPR and/or the COIRB. The VPR will convey their decision in writing to the Investigator. The decision of the VPR shall be final.
Access to COI Reporting Forms submitted to the Office of Research Integrity is limited to authorized individuals in the conduct of their official University responsibilities. Information will not be shared with any individual, organization, or entity outside of the University except where required contractually or by law, such as in cases of federal audits or investigations, or when Financial Conflict of Interest notifications are sent to outside research sponsors. Investigators whose records will be shared with an individual, organization, or entity outside the University will be notified by the Office of Research Integrity.
The 2011 Public Health Service (PHS) regulations on “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought,” 42 C.F.R. Part 50, Subpart F, (“the PHS COI regulations”) overseen by the U.S. Department of Health and Human Services (HHS), impose special requirements on Investigators on research awards funded by PHS as well as on the institution administering such funded research.
Scope: The special requirements apply to researchers who are Investigators participating in PHS-Funded Research or research funded by a foundation that follows the PHS COI regulations.
3.10.1 Financial Conflict of Interest Training
Investigators must complete Financial Conflict of Interest training prior to engaging in PHS-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 regulations and/or the University's COI Research Policy.
Financial conflict of interest training is administered by the Office of Research Integrity.
3.10.2 Report new Significant Financial Interests within 30 days of acquisition or receipt
Investigators participating in PHS-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.
3.10.3 Report Sponsored or Reimbursed Travel
Investigators participating in PHS-Funded Research are required to report on their annual COI Reporting Form the occurrence of any Reportable Travel.
Investigators must provide information on the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
3.10.4 Institutional Reporting Requirements for PHS-Funded Research
For any Financial Conflict of Interest that the University identifies, prior to the expenditure of any funds under PHS-Funded Research, the University, acting through its designated institutional officials and COI Review Board shall:
Develop and ensure the implementation of a management plan that specifies how an identified Financial Conflict of Interest will be managed;
Ensure that any impermissible Financial Conflict of Interest is eliminated; and
Notify the PHS awarding agency of the existence of any Financial Conflict of Interest.
For any Financial Conflict of Interest that the University identifies after PHS funding for the research at the University has commenced, the University shall, within sixty (60) days of identification:
Ensure that any impermissible Financial Conflicts of Interest are eliminated;
Ensure that any other identified Financial Conflicts of Interest are managed and a management plan has been implemented, at least on an interim basis, and take any interim measures deemed necessary;
Notify the PHS awarding agency of the Financial Conflict of Interest.
3.10.5 Public Accessibility
Under 42 CFR 50 subpart F, 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-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-Funded Research is to be carried out through a subrecipient, the University will:
Establish, at the time of proposal submission, whether the subrecipient has a COI policy that is compliant with 42 CFR 50 Subpart F;
Establish, in cases where the subrecipient does not have a COI policy that is compliant with 42 CFR 50 Subpart F, 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-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.
3.10.7 Non-Compliance with the Special Requirements under 42 CFR 50 Subpart F
In the event of non-compliance with special requirements under 42 CFR 50 subpart F, the University must conduct a retrospective review of the Investigator’s activities and the PHS-Funded Research project to determine whether any PHS-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, submit a mitigation report to the PHS.
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-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.
All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure compliance with it.
Compliance with the Policy: All Investigators are responsible for becoming familiar with and adhering to this policy.
External Reporting Obligations: In accordance with applicable regulations and research sponsors’ policies and guidelines, the University may be obligated to report identified Financial Conflicts of Interest to the sponsor of research that could be affected by the presence of the Financial Conflict of Interest. Additional special reporting and accessibility requirements apply to PHS-Funded Research (see Section 3.10).
Report Violations: All Investigators have a responsibility to report violations of this policy to the institution.
Failure to comply with this and related policies is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.
Brown University is a community in which employees are encouraged to share workplace concerns with University leadership. Additionally, Brown’s Ethics and Compliance Reporting System allows anonymous and confidential reporting on matters of concern through the EthicsPoint platform.
The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.
7.1 Related Policies:
7.2 Related Procedures: N/A
7.3 Related Forms: N/A
7.4 Frequently Asked Questions (FAQs):
7.5 Related Information:
8.1 Policy Owners: The Vice President for Research
8.2 Policy Approved by: The Corporation of Brown University
8.3 Contact Information: Associate Director of Research Operations, Juliane Blyth
Email: [email protected]
9.1 Policy Effective Date: October 26, 2019
9.2 Policy Last Reviewed: October 26, 2019
9.3 Policy Update/Review Summary: Policy content revised to reflect changes in COI reporting and review process, and the overall University’s Conflict of Interest and Commitment Policy. Formatted to comply with new University Policy Template.
For purposes of this policy, the terms below have the following definitions:
COI Reporting Form: The COI Reporting Form is a conflict of interest reporting form that is collected electronically annually and at various transaction points from Investigators who are subject to this Policy. It requires Investigators to report to the University Financial Interests, Outside Professional Activities, and any other interests that could affect or appear to affect their research, including reporting their Significant Financial Interests that reasonably appear to be related to their professional expertise and Institutional Responsibilities. The Significant Financial Interests and Outside Professional Activities of an Investigator’s spouse and dependent children must also be reported if they are related to the Investigator’s institutional responsibilities.
Conflict of Interest Review Board (COI Review Board): The COI Review Board is a Brown faculty committee that is appointed by the Vice President for Research and that is responsible for reviewing submitted COI Reporting Forms and for conducting COI reviews in accordance with standards set forth in the federal PHS COI regulations: 42 CFR 50 Subpart F. For all identified Financial Conflicts of Interest, the COI Review Board determines whether the Financial Conflict of Interest needs to be managed, reduced, or eliminated.
Family Member: Family Member means the spouse, domestic partner, parent, child, sibling, grandparent, grandchild, (as well as in-laws and step parent, child, sibling, grandchild), guardian and ward or member of one's household.
Family Trust: A Family Trust is a trust created to benefit persons who are related to one another by blood, affinity, or law. A Family Trust can be established by a family member for the benefit of the members of the family group.
Fiduciary Role: A Fiduciary Role is a position in which one has a legal responsibility of care for the assets or rights of another entity or person. Fiduciary roles include serving as a member of a company’s board of directors, or a position such as an officer or executive of a company (e.g., Chief Executive Officer, Chief Operating Officer) which requires high-level responsibility for the day-to-day management of the business.
Financial Conflict of Interest (FCOI): Financial Conflict of Interest means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Research.
Financial Interest: Financial Interest generally refers to any pecuniary interests in and from Outside Entities. The term includes salary, honoraria, or other payments for services, equity and ownership interests like stocks and stock options, as well as intellectual property rights and royalty payments.
Gifts: Gifts are contributions received for either restricted or unrestricted purposes in support of the university’s mission for which the institution has made no commitment of resources or services other than, possibly, committing to use the gifts as the donor specifies.
Institutional Official: The Institutional Official (IO) is an individual who is legally authorized by Brown University to act for the University and, on behalf of the University, obligates the University to the Terms of the Assurance.
Institutional Responsibilities: Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of Brown, including research, education, clinical care, administrative, and other Brown activities and services.
Investigator: Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of Research, which may include, for example, collaborators and consultants. “Design, conduct, or reporting” includes, but is not limited to:
- Designing, conducting, and/or directing Research
- Enrolling research subjects (including obtaining informed consent, if applicable) or making decisions related to eligibility for enrollment
- Analyzing, reporting, presenting, or publishing research data
Outside Entity: Outside Entity means any for profit or non-profit corporation, foundation, or other organization, including any governmental entity that is not a Brown-affiliated institution. The term includes the entity itself and entities that own or control, are owned or controlled by, or are under common ownership or control with the entity, with ownership and control defined as a 50% or greater direct or indirect interest.
Outside Professional Activity: An Outside Professional Activity is generally an engagement in specific work or services for an entity that is not part of, or affiliated with, the University. Outside Professional Activities can be compensated or uncompensated, and are generally related to the professional expertise of the faculty member. Outside Professional Activities may include private consulting activities, service on non-University advisory boards, and engaging in entrepreneurial activity. Activities for which an authorized University official has signed a contract or agreement are not considered Outside Professional Activities.
Reportable Travel: Reportable Travel means travel that is either reimbursed or sponsored by a non-Brown entity, and that is related to the investigator’s institutional responsibilities. Reimbursed travel is travel for which the investigator is directly reimbursed by the sponsoring entity. Sponsored travel is travel that is paid directly by the sponsoring entity and is not reimbursed to the investigator.
The institution can establish internal thresholds for reporting and reviewing travel. At Brown, the threshold has been set to $5,000 for any 12-month period. The $5,000 threshold does not mean that an investigator cannot have sponsored or reimbursed travel of more than $5,000. Rather, it means that any travel that exceeds this threshold must be reported in accordance with Brown’s internal reporting procedures and time frames.
Exceptions to this reporting requirement 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.
Research: Research means any systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge, including basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test, drug or device), and non-research projects such as training, clinical services, educational conferences, exhibitions, performances, archives, workshops, and library projects for which external funding is received.
Research also includes any such activity for which a proposal is submitted for funding from external sources through a grant, contract or agreement, including, but not limited to, research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects and research resources awards. Research also includes projects which are internally funded, as well as research for which approval of an IRB (or IRB exemption) or Institutional Animal Care and Use Committee (IACUC) is required.
PHS-Funded Research: PHS-Funded Research means Research funded by the Public Health Service and any other foundation or organization that has adopted to follow PHS’ COI regulations 42 CFR 50 Subpart F.
Significant Financial Interest (SFI): A Significant Financial Interest (SFI) means the receipt by an Investigator or an Investigator’s spouse and dependent children of any of the following, provided that they appear to be reasonably related to the Investigator’s Institutional Responsibilities:
- Income that exceeds $5,000 from any Outside Entity, measured on a 12‐month basis. This may be one payment from a particular company of more than $5,000, or multiple payments from the same company that, in the aggregate, exceed $5,000;
- Acquisition of equity in a public company that exceeds $5,000 in value;
- Aggregated income and equity/ownership interest from a public company that exceeds $5,000, as measured on a 12‐month basis;
- Any equity/ownership interest in a privately‐held company; and
- Any income received from rights in intellectual property, as measured on a 12‐month basis.
Excluded from this definition are payments (including travel) received from or through Brown and income from investment vehicles over which the Investigator or Investigator’s spouse and dependent children do not exercise control, such as mutual funds and retirement accounts. Also excluded from this definition are payments received from any of the following entities, provided these payments are received for teaching engagements, lectures, seminars, or service on advisory committees or review panels:
- Government agencies
- U.S. institutions of higher education and research institutes affiliated with them
- Academic teaching hospitals
- Medical centers