Conflict of Interest for Funded Research Projects
|Conflict of Interest in Research
Policy Owner: Office of Research
|Effective: August 20, 2020
Last Revised: August 20, 2020
|T. Dwayne McCay, President|
1. Purpose and Application
The purpose of Florida Institute of Technology’s Conflict of Interest in Research Policy (COI Research Policy) is to maintain the objectivity and integrity of Research conducted at or under the auspices of Florida Institute of Technology (Florida Tech) and to ensure transparency in relationships with Outside Entities and individuals as they relate to the academic mission and research activities of Florida Tech. This COI Research Policy establishes Florida Tech’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).
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 Florida Tech affiliation, appointment or employment. Prior to participating in Research or licensing activities, Florida Tech personnel shall disclose the details of outside Financial Interests to the appropriate COI Reviewers. Investigators must also comply with Florida Tech’s Faculty Handbook 2.15.1 Conflict of Interest Policy, Human Resources 5.3 Conflict of Interest Policy, and subsidiary policies, as applicable.
2. Policy Statement
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 Executive Vice President of Academics (EVPA) has final authority for compliance with this COI Research Policy.
4. Conflict of Interest Reporting
Investigators are required to report Financial Interests, Outside Professional Activities, and any other interests requested, that could affect or appear to affect their Research, including their Significant Financial Interests (SFIs) that reasonably appear related to their professional expertise or Institutional Responsibilities. Investigators must submit a Disclosure Form annually, in accordance with Florida Tech’s reporting procedures and time frames. Additionally, Investigators may be required to complete a Disclosure Form, or certify the accuracy of an existing Disclosure Form, throughout the calendar year at the following points:
- Before application for funding and no later than the time of application or submission of a formal proposal, if applicable;
- When executing a contract with an entity where no application or proposal is required, prior to expending any funds;
- When participating as an Investigator on a new human subject Research study or being added to a study via an amendment;
- When added as a new Investigator to ongoing Research; and
- Upon discovery or acquisition of a new SFI, certain Investigators must submit a Disclosure Form within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) all new SFIs.
Investigators on Public Health Service (PHS) funded awards or foundations that follow PHS policy have additional reporting requirements, which are outlined in Section 12.
5. Conflict of Interest Review
SFIs are reviewed, by the appropriate academic office or committee, as determined by the Executive Vice President of Academics (COI Reviewers), in relation to each Research project on which an individual is an Investigator. Financial Conflict of Interest (FCOI) reviews are conducted in accordance with standards set forth in the federal PHS COI regulations, 42 CFR 50 Subpart F, including:
- Determining whether an SFI is related to any of the Investigator's Research (i.e. the SFI could be affected by the Research; or the SFI is in an entity whose financial interest could be affected by the Research); AND
- Determining whether a related SFI constitutes a Financial Conflict of Interest (i.e. the SFI could directly and significantly affect the design, conduct, or reporting of the Research)
6. Conflict of Interest Management
An FCOI may be managed through full and open disclosure of the SFI(s):
- 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 SFI; and
- To human subjects participating in a study, the results of which could affect the Investigator's SFI, 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 FCOI include, but are not limited to, the following:
- Periodic review of the Research, the SFI, and related activities in the lab by a neutral party or committee;
- Disclosure of the SFI 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 on participation in the Research;
- Divestiture of the SFI that creates the FCOI; and
- Severance of the relationship(s) that creates an FCOI.
Florida Tech may also develop a management plan in situations that do not constitute a Financial Conflict 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.
7. Presumptively Prohibited Activities
I. Conflict of Interest in Research Involving Human Subjects
To protect Research participants and preserve the integrity of the Research study and data, Florida Tech 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 an SFI.
- The human subject Research involves the evaluation of a product or intellectual property from an Outside Entity in which the Investigator has an SFI.
- 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 SFI, how closely the SFI 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 applicable COI Reviewers and Florida Tech’s Institutional Review Board (IRB).
II. Conflict of Interest in Research Involving Funding and/or Products from a Privately-held 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 Research has an SFI, 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 Florida Tech sponsored by a privately held Outside Entity, including a start-up, in which the Investigator has an SFI.
- An Investigator may not participate in Research at Florida Tech sponsored by a privately held Outside Entity, including a start-up, in which the Investigator's current research assistants, trainees, or students have an SFI 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 SFI, how closely the SFI 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 applicable COI Reviewers.
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 applicable COI Reviewers will normally recommend management of the FCOI that may arise with the Research conducted under Phase I SBIRs and STTRs.
III. 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 Florida Tech and that involve research personnel, including graduate students.
Investigators wishing to support Research projects at Florida Tech may donate in accordance with Florida Tech’s donation guidelines and policies. However, Investigators cannot donate to a research account over which they or someone they directly supervise has spending authority.
8. SBIR and STTR Awards
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.
I. 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
II. 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 Florida Tech, it can give rise to specific conflict of interest and conflict of commitment concerns. The following general principles have been adopted by Florida Tech to address these concerns.
III. 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 Officials, 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 Florida Tech 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 Florida Tech 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 Florida Tech’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 Florida Tech receives from a small business, and that involve an Investigator who has an SFI or a Fiduciary Role in the small business, must be reviewed by the applicable COI Reviewers.
9. Additional Obligations
I. 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.
II. Office/Laboratory Space and other ResourcesInvestigators may only use the facilities and resources of Florida Tech for Florida Tech business.
III. 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 an SFI or a Fiduciary Role. In exceptional circumstances, approval may be granted by the EVPA, with advice from the applicable Dean.
Should an Investigator wish to appeal a decision made by the COI Reviewers, the Investigator may present the appeal within 90 days of the applicable COI Reviewers’ decision in writing to the EVPA. The EVPA at their discretion, will consider the case with input from the applicable COI Reviewers and/or other offices as necessary. The Investigator may be asked to present their appeal to the EVPA and/or the applicable COI Reviewers. The decision of the EVPA shall be final.
Access to Disclosure Forms 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 Florida Tech except where required contractually or by law, such as in cases of federal audits or investigations, or when FCOI notifications are sent to outside research sponsors.
12. Specific Requirements for Research Awards funded by the Public Health Service (PHS)
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 specific requirements apply to researchers who are Investigators participating in PHS-Funded Research or research funded by a foundation that follows the PHS COI regulations.
I. Financial Conflict of Interest (FCOI) Training
Investigators must complete FCOI training prior to engaging in PHS-Funded Research. Investigators must be re-trained every four years and whenever there is a substantive change to Florida Tech’s COI Research Policy. Florida Tech must also re-train any Investigator who has been found to be non-compliant with the regulations and/or this COI Research Policy.
II. Report new Significant Financial Interests within 30 days of acquisition or receipt
Investigators participating in PHS-Funded Research are required to submit an updated Disclosure Form to Florida Tech in accordance with Florida Tech’s conflict of interest procedures within thirty (30) days of discovering or acquiring a new SFI.
III. Report Sponsored or Reimbursed Travel
Investigators must provide information on the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
IV. Institutional Reporting Requirements for PHS-Funded Research
For any FCOI that Florida Tech identifies, prior to the expenditure of any funds under PHS- Funded Research, Florida Tech, acting through its designated Institutional Officials and applicable COI Reviewers shall:
- Develop and ensure the implementation of a management plan that specifies how an identified FCOI will be managed;
- Ensure that any impermissible FCOI is eliminated; and
- Notify the PHS awarding agency of the existence of any FCOI.
For any FCOI that Florida Tech identifies after PHS funding for the Research, at Florida Tech, has commenced, Florida Tech shall, within sixty (60) days of identification:
V. Public Accessibility
Under 42 CFR 50 subpart F, Florida Tech is required to make available to the public, upon request, specific information regarding FCOIs identified for senior and key personnel on PHS-Funded Research, as defined in 42 CFR 50 subpart F. Florida Tech is required to provide specific information relative to such public requests within five business days of the request.
VI. SubrecipientsWhen proposed PHS-Funded Research is to be carried out through a subrecipient, Florida Tech 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 Florida Tech’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 Florida Tech’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 FCOI reports.
VII. 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, Florida Tech 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. The retrospective review must be completed within 120 days of the determination of noncompliance. If bias is found in the course of the retrospective review, Florida Tech must promptly notify PHS and submit a mitigation report that addresses the impact of the bias on the PHS-Funded Research and Florida Tech’s plan of action to eliminate or mitigate the effect of the bias. Non-compliance with special requirements includes the following:
- An Investigator failed to report a new SFI within the required time frame or Florida Tech failed to review a new SFI within the required time frame, and that SFI, upon review by Florida Tech, is then determined to create an FCOI with a PHS-Funded Research project;
- An FCOI is not identified or managed in a timely manner; and
- An Investigators fails to comply with an FCOI management plan.
All individuals to whom this COI Research Policy applies are responsible for becoming familiar with and following this COI Research Policy. University supervisors are responsible for promoting the understanding of this COI Research Policy and for taking appropriate steps to help ensure compliance with it.
- Compliance with the COI Research Policy: All Investigators are responsible for becoming familiar with and adhering to this COI Research Policy.
- External Reporting Obligations: In accordance with applicable regulations and research sponsors’ policies and guidelines, Florida Tech may be obligated to report identified FCOIs to the sponsor of Research that could be affected by the presence of the FCOI. Additional special reporting and accessibility requirements apply to PHS-Funded Research.
- Report Violations: All Investigators have a responsibility to report violations of this COI Research Policy to the institution.
14. Consequences for Violating this COI Research Policy
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 Florida Tech, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.
15. Related Information
- NSF Grantee Standards (Chapter V–510 COI)
- 42 CFR Part 50 Subpart F (“Promoting Objectivity in Research”)
For purposes of this COI Research Policy, the terms below have the following definitions:
Disclosure Form: a reporting form that is collected annually and at various transaction points from Investigators who are subject to this COI Research Policy. It requires Investigators to report Financial Interests, Outside Professional Activities, and any other interests that could affect or appear to affect their Research, including reporting their SFIs that reasonably appear to be related to their professional expertise and Institutional Responsibilities. The SFIs and Outside Professional Activities of an Investigator's spouse and dependent children must also be reported if they are related to the Investigator'sInstitutional Responsibilities.
COI Reviewers: are responsible for reviewing submitted Disclosure 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 applicable COI Reviewers determine whether an FCOI needs to be managed, reduced, or eliminated.
Family Member: are 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 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 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 Interest: generally refers to any monetary 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.
Institutional Official: is an official of Florida Tech who is authorized to speak for and legally commit Florida Tech to compliance with the requirements of the federal regulations or grants and contracts.
Institutional Responsibilities: means an Investigator's professional responsibilities on behalf of Florida Tech, including Research, education, clinical care, administrative, and other Florida Tech activities and services.
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: means any for profit or non-profit corporation, foundation, or other organization, including any governmental entity that is not a Florida Tech-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: 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: means travel that is either reimbursed or sponsored by a non-Florida Tech 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 Florida Tech, 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 Florida Tech’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: 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.
Significant Financial Interest (SFI): means the receipt by an Investigators, Investigator's spouse, or 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 Florida Tech 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