Conflict of Interest Policy: Preamble
The Preamble provides the institutional official’s contact information and lays out the authority, applicability and purpose for promoting objectivity in research. Definitions are listed to clarify the meanings of conflict of interest terms and provide examples of reportable activities.
Please contact the FCOI Team at email@example.com if you have any questions or concerns about financial conflict of interest
Authority – Public Health Service (PHS) regulation at 42 CFR 50, Subpart F is designed to promote objectivity in PHS-funded research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grant awards is not biased by any conflicting financial interests of an Investigator. PHS issued a final rule in the Federal Register, August 2011, that amended the 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). This policy became effective as of August 24, 2012.
- 42 U.S.C. 216, 289b–1, 299c–4; Sec. 219, Tit. II, Div. D, Pub. L. 111–117, 123 Stat. 3034.
- FDA 21 CFR 54
- VA:VHA Handbook 1200
Source: 76 FR 53283, August 25, 2011, unless otherwise noted. NIH financial conflict of interest policy: http://grants.nih.gov/grants/policy/coi/.
National Science Foundation (NSF) encourages the increased involvement of academic researchers and educators with industry and private entrepreneurial ventures, but recognizes that such interactions carry with them an increased risk of conflict of interests. The NSF Awards and Administration Guide, AAG Chapter IV.A contains NSF’s policy on conflict of interest.
Although the PHS/National Institutes of Health (NIH) and NSF have formal policies, it is Tufts’ policy to apply these standards to all sponsors, except where there are specific PHS requirements that cannot be applied to a non-PHS sponsor. Examples of some requirements are PHS reporting requirements and the definition of significant financial interest.
A conflict of commitment occurs when the commitment to an individual’s external activities may adversely affect his or her capacity to meet University responsibilities. This form of conflict involves a perceptible reduction of the individual’s time and energy devoted to University activities. The University recognizes, however, that the contributions and activities of an individual to the University may extend beyond the work done directly for the University. The University also understands the desire of an individual, within the constraints set forth below, to earn and accept outside income for activities that do not create a conflict of interest. Under University policy, a full-time faculty member may spend up to one day in a calendar week (20% of his or her full-time weekly effort) on consulting or other external activities, subject to individual School policies on outside activities. No individual, including faculty members and other employees, may accept salaried employment at another institution while employed full-time by the University. Part-time faculty and staff may not engage in consulting or other external activities during the time they have committed to the University.
It is important to recognize that each individual’s obligations move beyond the letter of these requirements to their spirit. The University requires that its faculty meet their teaching, administrative and clinical obligations, and remain productively involved in their research and other scholarly pursuits. External activities that compromise or diminish an individual’s capacity to meet these obligations represent a conflict of commitment, regardless of how much time an individual devotes to these activities.
This Policy applies to all Tufts University faculty members and other individuals — such as medical staff, researchers, students, postdoctoral fellows and visiting researchers — who are responsible for the design, conduct or reporting of research at Tufts on federally funded grants and cooperative agreements, to include proposals. “Investigator” in this Policy refers to such faculty members and other individuals.
Additionally, this policy applies to Investigators participating in federal research, as defined by the PHS regulation, including subgrantee/contractor/collaborating Investigators, but excluding applications for Phase I support under the SBIR and Small Business Technology Transfer (STTR) programs.
This policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under federal grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
In describing the requirements, the regulations use a number of definitions. Accurate understanding of the requirements depends upon an accurate understanding of each term’s meaning.
Disclosure of Significant Financial Interests means an Investigator’s disclosure of significant financial interests to the University.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI Report means the University’s report of a financial conflict of interest to a PHS Awarding Component.
Federally Funded means any funding i.e., grant, cooperative grant, contract, received from any United States government agency, department or entity.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of Tufts University. That is, all activities that derive or descend from the investigator’s standing or expertise and are tied to those responsibilities and activities the investigator was hired to perform and for which the investigator is paid by the University. Some examples are, research, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
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 funded by a sponsor, or proposed for such funding, which may include, for example, collaborators or consultants.
Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this policy.
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this policy.
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a federal Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by Tufts in the grant application, progress report, or any other report submitted to the federal sponsor by Tufts under this policy.
Significant Financial Interest (SFI)
A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
- With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.
- With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
For purposes of this definition, remuneration includes:
- salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship);
- equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Disclosure of travel applies only to federal sponsors
For federal sponsors, Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities. For example, costs that were paid on your behalf and not reimbursed to you so that the exact monetary value may not be readily available provided, however, this disclosure requirement does not apply to travel that is reimbursed or sponsored by:
- Federal, state, or local government agency;
- Institution of higher education as defined at 20 U.S.C. 1001(a); and
- Academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
- The details of this disclosure will include, at a minimum:
- dollar amount or value,
- purpose of the trip,
- identity of the sponsor/organizer,
- destination, and
- The Chair of the CCIR will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
- The term “significant financial interest” does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by Tufts to the Investigator if the Investigator is currently employed or otherwise appointed by Tufts, including intellectual property rights assigned to Tufts and agreements to share in royalties related to such rights;
- Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization i.e., for STIR and SBIR Phase I;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
- Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
- Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97–219, the Small Business Innovation Development Act, as amended. The term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102–564.
Activities of the types described in the following examples must be disclosed, and in most circumstances will be subject to oversight as a potential conflict of interest:
- An individual participates in clinical research on a technology that was developed by the individual or his or her spouse or dependent child, but which is owned by or licensed to a business in which the individual, the spouse or dependent child, has a consulting relationship, a management position or a significant financial interest.
- An individual or his or her spouse or dependent child serves on the board of directors or scientific advisory board of a business from which the individual receives sponsored research support or with which Tufts has a contractual relationship known to the individual.
- An individual publishes the results of research which could have an impact on a significant financial interest of his or her spouse, provided that the individual discloses his or her significant financial interest in the publication.
The following examples represent types of activities presumed to constitute major conflicts of interest. Such activities must be disclosed, are not permitted without express authorization of the University, and usually will be prohibited, or permitted only with continuing oversight:
- An individual receives sponsored research support (whether in dollars or in kind) for research from a business in which he or she or his or her spouse or dependent child holds a significant financial interest.
- An individual participates in clinical research on a technology owned by or licensed to a business in which the individual, or his/her spouse or dependent child, has a significant financial interest.
- An individual makes patient referrals to a diagnostic company in which he or she or his or her spouse or dependent child has a significant financial interest.
- An individual directs the purchase of supplies for Tufts to a business in which he or she or his or her spouse or dependent child has a significant financial interest.
- An individual conducts research externally that could be conducted within the University.
- An individual assigns a student, fellow or other trainee to a project in which the individual has a significant financial interest.
- An individual assumes an executive position in an outside entity engaged in commercial or research activities related to the individual’s field.
For Federal sponsors each Investigator is required to complete training regarding financial conflicts of interest prior to engaging in research related to any federally funded grant and at least every four years, and immediately when any of the following circumstances apply:
- The University revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
- An Investigator is new to Tufts; or
- The University finds that an Investigator is not in compliance with this financial conflict of interest policy or management plan.
A Conflict of Interest course is available to take through the Collaborative Institutional Training Initiative (CITI). Click here for instructions on how to register and take the course.