APPLICABILITY: WHO MUST COMPLY WITH THE CONFLICT OF INTEREST POLICY
This Conflict of Interest Policy (COI Policy) applies to all individuals who fit the definition of Covered Individual in Section 4 below.
1. Conflict of Interest Committee (COI Committee) is an administrative committee composed of members of the administration and, in some cases, members of the faculty and/or others that will review the Covered Individual’s disclosures of Significant Financial Interests (SFIs), determine whether a Financial Conflict of Interest (FCOI) exists, and, if so, develop a Management Plan for the Covered Individual to manage, reduce, or eliminate the FCOI.
2. Financial Conflict of Interest (FCOI) will be deemed to exist when the Institute’s COI Committee reasonably determines that a Significant Financial Interest disclosed by the Covered Individual could directly and significantly affect the design, conduct, or reporting of Federally Funded Research, with the exception of Research funded through phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Note: Phase II SBIR and STTR programs are not exempt like phase I programs and are subject to this.
3. Federally Funded Research means any Research funded by a Public Health Service (PHS) awarding component, such as the National Institutes of Health (NIH), National Science Foundation (NSF), Department of Defense (DOD), Department of Energy (DOE), or other U.S. federal agency.
4. Covered Individual includes faculty, researchers, and senior administrative employees. Covered Individual also refers to the principal investigator or project director, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of Federally Funded Research or Research that is proposed for federal funding, which may include, for example, collaborators and consultants.
5. Covered Individual’s Institutional Responsibilities means professional activities taking place on behalf of the Institute, including, but not limited to, Research, Research consultation, teaching, institutional committee memberships, and service on committees or panels such as Institutional Review Boards or other monitoring boards.
6. Management of an FCOI means taking action to address the FCOI, including reducing or eliminating the conflict so that the Institute can reasonably expect that the Covered Individual’s design, conduct, and reporting of Research will be free from bias.
7. Management Plan is a written document approved by the COI Committee under which a Covered Individual with an identified FCOI must take steps and follow guidelines, conditions, and/or restrictions to reduce or eliminate the conflict.
8. Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health or agriculture, and it encompasses basic and applied Research. Research includes any activity for which research funding is available, regardless of the source, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
9. Significant Financial Interest (SFI) means anything of monetary, or potential monetary, value that was received from an entity in the twelve (12) months preceding the disclosure, whether or not the value is readily ascertainable, belonging to the Covered Individual, his or her spouse, and/or his or her dependent children, alone or in combination, that reasonably appears to be related to the Covered Individual’s Institutional Responsibilities.
10. Small Business Innovation Research (SBIR) is an award designed to support projects from small businesses having commercial viability.
11. Small Business Technology Transfer (STTR) is a program under the SBIR program designed to foster technology innovation through cooperative efforts between small businesses and research institutions.
12. Subrecipient refers to an individual or entity that receives federal funds from or through the Institute, as an awardee institution, where the subrecipient will be conducting a substantive portion of the Federally Funded Research and who will be accountable to the awardee institution for, e.g., programmatic outcomes and compliance matters.
The COI Policy implements and ensures compliance with the specific federal requirements set forth in the United States Department of Health and Human Services’ 2011 Objectivity in Research Regulations (COI Regulations), 42 CFR part 50 subpart F (grants) and 42 CFR part 94 (contracts). The COI Regulations establish new standards and clarify previously established standards to be followed by institutions that apply for or receive Research funding from the United States Public Health Service (PHS) Awarding Components, including the National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts.
Interactions between research institutions, government, the private sector, and industry help ensure the rapid application of scientific discoveries and the efficient translation of Research findings. Although such interactions are encouraged in many forms, they have become increasingly complex and can lead to relationships involving a Significant Financial Interest (SFI). A Financial Conflict of Interest (FCOI) exists when the Buck Institute for Research on Aging (the Institute), through procedures described in this COI Policy, reasonably determines that the Covered Individual’s SFI could affect the design, conduct, or reporting of the Covered Individual’s Research. An FCOI may arise even though no improper conduct or unethical behavior has occurred.
The Institute has the responsibility under the COI Regulations to manage Financial Conflicts of Interest between a Covered Individual’s (and his/her spouse’s and dependent children’s) personal financial interests and his/her Institutional Responsibilities. The Institute and its Covered Individuals must identify and then manage, reduce, or eliminate FCOIs to strengthen accountability and transparency, promote Research objectivity, maintain the integrity of Research findings, and ensure prudent stewardship of public funds.
Where more stringent requirements and regulations relating to conflict of interest of any funding agency or sponsor conflict with the Institute’s COI Policy, the requirements and regulations of that funding agency or sponsor will take precedence.
All Covered Individuals must be informed of the Institute’s COI Policy as well as their disclosure responsibilities and other requirements of the COI Regulations. The COI Regulations require all Covered Individuals to complete a COI training tutorial prior to engaging in Federally Funded Research and at least every four years thereafter. In addition, training is required immediately under the following circumstances:
- The Institute’s COI Policy changes in a manner that affects Covered Individual requirements;
- The Covered Individual is a new Institute employee; and
- The Covered Individual is non-compliant with the Institute’s COI Policy or Management Plan.
The Institute offers the required training as a web-based tutorial through the Collaborative Institutional Training Initiative (CITI Program).
An SFI is a financial interest consisting of one or more of the following interests of the Covered Individual (and those of the Covered Individual’s spouse and/or dependent children) that reasonably appears to be related to the Covered Individual’s Institutional Responsibilities.
- With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve (12) 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.
Remuneration includes salary and any payment for services not otherwise identified as salary, such as consulting fees, honoraria, and paid authorship.
Equity interests include stocks, stock options, or other ownership interests, as determined through reference to public prices or other reasonable measures of fair market value.
2. With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve (12) months preceding the disclosure, when aggregated, exceeds $5,000, or when the Covered Individual or the Covered Individual’s spouse and/or dependent children holds any equity interest.
3. Equity interests include stocks, stock options, or other ownership interests, including any equity in a non-publicly traded company.
The Covered Individual must fully describe the nature of the equity interest, including the number of shares owned, voting rights, etc., if at the time of disclosure there is no reasonable basis for assessing the fair market value or percentage interest in the non-publicly traded entity.
4. Remuneration from intellectual property rights such as patents, copyrights, royalties from such rights, and agreements to share royalties related to intellectual property rights and interests not received from the Institute.
5. Travel. Covered Individuals must disclose any reimbursed or sponsored travel (i.e., i.e., that which is paid on behalf and not reimbursed to the investigator), when aggregated during the past twelve months, exceeds $5,000 per individual entity and that is related to their Institutional Responsibilities. This disclosure requirement does not apply to travel that is reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education as defined at 20 U.S.C 1001 (a), an academic teaching hospital, a medical center, or another research institute that is affiliated with an institution of higher education including the Institute. All travel sponsored or reimbursed by a foreign entity, regardless of the type of organization, must be disclosed. The disclosure must include the following details:
- The purpose of the trip
- The identity of the sponsor/organizer
- The destination of the trip
- The time duration of the trip
The Institute will then determine if any travel requires further investigation, including determination or disclosure of the monetary value in order to determine whether the travel constitutes a FCOI.
An SFI does not include the following types of financial interests:
- Salary, royalties, or other remuneration received from the Institute if the Covered Individual is currently employed or appointed by the Institute.
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency; an institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.
- Income from service on advisory committees or review panels for a federal, state, or local government agency; an institution of higher education; an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.
- Travel expenses that are reimbursed or sponsored by the Institute or a federal, state, or local government agency; an institution of higher education; an academic teaching hospital; a medical center; or another research institute that is affiliated with an institution of higher education.
- An equity interest that, when aggregated for the Covered Individual and his or her immediate family, meets the following tests:
- Does not exceed $5,000 in value, as determined through reference to public prices or other reasonable measures of fair market value.
- Does not represent more than a five (5) percent ownership interest in any single entity.
- Salary, royalties, or other payments that, when aggregated for the Covered Individual and his or her immediate family over the next twelve (12) months, are not expected to exceed $5,000.
- Intellectual property rights assigned to the Institute and unlicensed intellectual property that does not generate income.
- Agreements with the Institute to share in royalties related to such rights.
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Individual does not directly control the investment decisions made in these vehicles.
Many scientific journals have implemented policies that require authors to declare competing financial interests in relation to work published in those journals. Such requirements of third parties, including how financial interests are defined, are distinct from the requirements in this policy relating to Federally Funded Research and should not be used as guidance for the information a Covered Individual must disclose under this policy.
All Covered Individuals must submit an Annual Disclosure Form at the beginning of their time at the Institute and each subsequent year thereafter. All Covered Individuals are required to complete a current, accurate Annual Disclosure Form that identifies and describes both existing and new SFIs. All Covered Individuals will be prompted annually and sent a link to a private portal for the submission of their Annual Disclosure Form. In addition, Covered Individuals have an ongoing obligation to promptly update their Annual Disclosure Forms to accurately reflect any significant change in their external activities, SFIs, and internal responsibilities as follows:
- No later than at the time of application for Federally Funded Research;
- Within thirty (30) days of discovering or acquiring a new SFI (including through purchase, marriage, or inheritance); and
- At least annually.
The Institute (i) may not submit any new grant applications to a federal agency for Research projects, and (ii) may not spend any federal funds in connection with Notices of Award for new or continuing Federally Funded Research projects until all Covered Individuals identified to work on such projects have completed the training and submitted their disclosures as required by COI Regulations and this policy.
Annual Disclosure Form review by the Conflict of Interest Committee
The Institute’s COI Coordinator will initially review the Annual Disclosure Forms and may request further information or clarification about an SFI. Prior to the expenditure of any federal funds, the COI Coordinator will review all disclosures of SFIs and make a preliminary determination whether any SFI appears to relate to the Research. If so, the matter will be immediately referred to the COI Committee for further review. The COI Committee will be comprised of approximately 3 or 4 Institute administrators and the faculty chair and may include additional Institute faculty. One member of the Institute’s Office of Technology Development will serve on the COI Committee. One member of the Institute’s Grants Administration or Research Development department will serve on the COI Committee. One member of the COI Committee will be an Institute Vice President.
The administrative members of the COI Committee will initially review all disclosed SFIs to determine whether any are related to the Covered Individual’s Research and, if so, whether the SFI may be an FCOI. The Committee reviews and analyzes the specific circumstances of an SFI by taking into account such factors as the nature of the Covered Individual’s relationship to an outside entity, the dollar value of that relationship, and the degree and nature of any overlap between that relationship and the Covered Individual’s Research. The administrative members of the COI Committee may, if warranted, involve the faculty chair, the Covered Individual, and/or other faculty members or advisors in determining whether an SFI is related to the Research in question. An FCOI will be deemed to exist when the full COI Committee reasonably determines that an SFI disclosed by the Covered Individual could directly and significantly affect the design, conduct, or reporting of the Covered Individual’s Research. Any COI Committee member involved or otherwise conflicted with an SFI will be recused from said review.
The steps set forth in this Section 7 must be completed promptly following disclosure of an SFI in order to enable any FCOIs to be reported to the federal funding agency within the sixty (60) day deadline set forth in the COI Regulations and Section 10 of this policy.
Where a documented SFI is deemed by the COI Committee not to constitute a current FCOI, the COI Committee nevertheless may decide to manage the SFI and may institute guidelines for the Covered Individual to follow as an interim measure.
Managing, reducing, or eliminating a Financial Conflict of Interest
If an SFI is identified by the COI Committee as an FCOI, the COI Committee will develop a Management Plan to manage, reduce, or eliminate the conflict. The Management Plan will be set forth in a written document and may require the Covered Individual to take certain steps and follow guidelines approved by the COI Committee. Conditions or restrictions that might be imposed to manage the FCOI include, but are not limited to, the following:
- Disclosure of the FCOI to lab personnel and collaborators
- Disclosure of the FCOI in publications, journals, posters, etc.
- Disclosure of the FCOI to audiences at conferences and seminars
- Monitoring of Research, proposals, and data by independent peer reviews
- Modification of Research plan
- Removal of an affected Covered Individual from participation in all or the portion of the Research which is funded by the entity that would be affected by a SFI
- Divestiture of an SFI by the affected Covered Individual
- Limiting the dollar value of fees received and/or stock ownership
- Severing of the relationship(s) that created the conflict
As appropriate, the COI Committee may meet with the Covered Individual and/or appoint an Institute official to meet with the Covered Individual during the design and development of a Management Plan that will include mechanisms appropriate for the specific situation. The COI Committee may, as necessary, query other Institute committees and/or personnel to solicit alternate ideas for Management of the conflict.
A copy of the Management Plan will be sent by the COI Coordinator to the Covered Individual and to the Institute’s President/CEO, who will have final authority to determine whether an FCOI exists and the appropriate plan for managing the FCOI. The Covered Individual may appeal the COI Committee’s proposed Management Plan or the findings on which the plan is based to the President/CEO within ten (10) calendar days of the date of the plan. The President/CEO and/or the COI Committee may consult with members of the Institute’s Board of Trustees as needed regarding the FCOI and its Management. After the Management Plan and its implementation schedule have been finalized, the COI Coordinator will forward the final version to the Covered Individual. The Covered Individual will then review and sign the plan to acknowledge his or her commitment to compliance.
- With regard to a new Federally Funded Research award, the COI Coordinator will disclose through the eRA Commons FCOI Module required information about the identified FCOI before the Institute spends any awarded funds. If the FCOI is eliminated prior to spending any funds, then no FCOI report is required. In addition, the Institute may be required to submit an FCOI report for FCOIs identified for subrecipient investigators, if applicable under Section 16 of this policy.
- With regard to an ongoing Federally Funded Research award, the COI Coordinator will disclose through the eRA Commons FCOI Module information about the identified FCOI within sixty (60) days of the identification of the FCOI. For any SFI that is identified as an FCOI subsequent to the Institute’s initial FCOI report during an ongoing Federally Funded Research project, the Institute shall implement, within sixty (60) days, on at least an interim basis, a Management Plan that shall specify the actions that have been and will be taken to manage the FCOI.
- With regard to a period of non-compliance during an ongoing Federally Funded Research project, the Institute will, within sixty (60) days of the Covered Individual’s delayed disclosure of an SFI, determine if the SFI constitutes an FCOI. If the FCOI exists, the Institute will implement, on at least an interim basis, a Management Plan that shall specify the actions that have been and/or will be taken to reduce or eliminate the FCOI, and the COI Coordinator will submit the FCOI report through the eRA Commons FCOI Module. In addition to the FCOI report, the Institute will, within one hundred twenty (120) days of its determination of non-compliance, complete a retrospective review of the Covered Individual’s activities and the Research project to determine whether part or all of the Research conducted during the period of non-compliance was biased in the design, conduct, or reporting of such Research. Based on the results of the retrospective review, if appropriate, the COI Coordinator will update the previously submitted FCOI report, specifying the actions that will be taken to reduce or eliminate the FCOI.
- With regard to a new, non-federal award entity, the Institute may, if warranted, disclose to such entity (e.g., corporation, educational institution, nonprofit entity, private foundation, trust, or individual donor) information about an identified FCOI before dispersing or spending any funds and/or during the duration of the award.
- Annual FCOI follow-up reports will be provided by the COI Coordinator to the funding agency for any FCOI previously reported by the Institute. The annual FCOI report will specify whether the FCOI is still being managed, describe any changes to the Management Plan, or explain why the FCOI no longer exists. The Institute will provide annual FCOI reports to the funding agency for the duration of the project period, including extensions with or without funds, at the same time as the Institute’s Grants Administration department submits the annual progress report or at the time of project extension.
Information submitted to a federal funding agency about the identified FCOI shall include the following:
- Grant/contract number
- Name of the Principal Investigator or Project Director
- Name of the Covered Individual with the FCOI
- The name of the entity with which the Covered Individual has a FCOI
- Statement about whether the FCOI was managed, reduced, or eliminated
- The nature of the FCOI, i.e., equity, consulting fees, travel reimbursement, honoraria
- The value of the financial interest, as determined by dollar range from $0–$4,999, $5,000–$9,999, $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that a value cannot be readily determined through reference to public prices or reasonable measures of fair market value
A description of the key elements of the Institute’s Management Plan must also be submitted to the funding agency, including the following information:
- Role and principal duties of the conflicted Covered Individual in the Research project
- Conditions of the Management Plan
- How the Management Plan is designed to safeguard objectivity in the Research project
- Confirmation of the Covered Individual’s agreement to the Management Plan
- How the Management Plan will be monitored to facilitate the Covered Individual’s compliance
- Other information as needed.
Public accessibility to the Institute’s Conflict of Interest Policy and identified Financial Conflicts of Interest
The Institute’s COI Policy will be publicly accessible on its website (www.buckinstitute.org). In addition, in compliance with the COI Regulations, the Institute will make the following information about identified FCOIs available by written response within five (5) days of a request:
- The name of the Covered Individual
- The title and role of the Covered Individual with respect to the Research project
- Name of the entity in which the SFI is held
- The nature of the SFI
- Approximate value of the SFI, as determined by dollar range from $0–$4,999, $5,000–$9,999, $10,000–$19,000; amounts between $20,000–$100,00 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that a value cannot be readily determined through reference to public prices or reasonable measures of fair market value
The Institute will monitor the FCOI and the Covered Individual’s compliance with the FCOI Management Plan until the completion of the Research project. As necessary, the COI Committee may require and develop a project-specific monitoring process, which may include appointing an Institute-designated official to assist with monitoring the FCOI and the Covered Individual’s compliance. The COI Committee may modify a Covered Individual’s Management Plan at any time.
The federal agency will evaluate the FCOI information received through the eRA Commons FCOI Module to determine if the Institute’s actions are sufficient to reduce or eliminate the identified FCOI. The federal agency may request and review additional information before implementing, if needed, further corrective actions to ensure research objectivity. If the federal agency decides that the particular FCOI will bias the objectivity of the funded Research to such an extent that further corrective action is needed or that the Institute has not managed the FCOI in accordance with the regulation, it may impose special award conditions, suspend funding, or enforce other actions until the matter is sufficiently resolved.
The Institute is required to establish adequate enforcement mechanisms and provide for employee sanctions and/or other administrative action, where appropriate, to address any failure by the Covered Individual to comply with the COI Policy or a Management Plan. Violations of this policy may result in progressive disciplinary action.
A Covered Individual is non-compliant and in violation of the COI Policy if the Covered Individual fails to:
- Submit an Annual Disclosure Form or provide an update to the Annual Disclosure Form by the deadlines established for such submissions;
- Provide the COI Coordinator with written acknowledgement of a Management Plan; or
- Provide the COI Coordinator and/or COI Committee with requested documentation regarding compliance with a Management Plan.
If a Covered Individual fails to comply with the Institute’s COI Policy or Management Plan, the Institute must complete, within one hundred twenty (120) days of determining non-compliance, a retrospective review of the Covered Individual’s activities and Research projects and then document the Institute’s determination as to whether the Federally Funded Research or any portion thereof conducted prior to the identification and Management of the FCOI was biased in the design, conduct, or reporting of such Research.
If bias is found, the Institute must submit a mitigation report addressing the impact of the bias on the Research project, including the extent of the harm done and any qualitative and quantitative data to support any actual or future harm, an analysis of whether the project is salvageable, and the actions the Institute has taken, or will take, to eliminate or mitigate the effect of the bias. Depending on the nature of the FCOI, the Institute may determine that additional interim measures are necessary with regard to the Covered Individual’s participation in the Research project between the date the FCOI is identified and the completion of the Institute’s retrospective review.
Each Principal Investigator, Project Director, or individual identified as Key Personnel involved with a federal funding submission must submit an Outside Activities and Financial Disclosure Form (OAFD) to the Grants Administration department upon submission of a new or continuing project. Information needed to complete the OAFD includes:
- Name of Principal Investigator/Project Director (or other Key Personnel)
- Funding entity or agency
- Project title
- Grant number (if available)
If the Institute carries out Research through a subrecipient, the Institute, as the awardee institution, will take reasonable steps to ensure that any subrecipient Investigator complies with the federal FCOI regulations. The Institute will incorporate, as part of a written agreement with the subrecipient, terms that establish whether the COI Policy of the Institute or that of the subrecipient will apply to the subrecipient Investigators.
If the subrecipient’s COI Policy applies to the subrecipient Investigators, the subrecipient will certify as part of the agreement that they are in compliance with federal regulations and that their portion of the project is in compliance with their institutional policies on conflict of interest. If the subrecipient cannot provide the certification, the agreement shall state that the subrecipient Investigators are subject to the Institute’s COI Policy for disclosing SFIs that are directly related to the subrecipient’s work for the Institute. The Institute will, if applicable, submit an FCOI report through the eRA Commons FCOI Module for any FCOIs identified for the subrecipient Investigators.
If the subrecipient’s COI Policy applies to the subrecipient Investigators, the agreement shall specify the time period(s) for the subrecipient to report all identified FCOIs to the Institute. Such time period(s) must be sufficient to enable the Institute to provide timely FCOI reports, as necessary, through the eRA Commons FCOI Module.
If the Institute’s COI Policy applies to the subrecipient Investigators, the agreement shall specify the time period(s) for the subrecipient to submit all Investigator disclosures of SFIs to the Institute. Such time period(s) shall be sufficient to enable the Institute to comply with its review, Management, and reporting obligations under the COI Regulations. The Institute’s Grants Administration department will submit any FCOI reports for the subrecipient Investigators through the eRA Commons FCOI Module.