POLICY: INDIVIDUAL FINANCIAL CONFLICTS OF INTEREST IN RESEARCH
Effective August 24, 2012
The Federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take in order to promote objectivity in research. The regulations apply to all PHS funded grants, cooperative agreements, research contracts and subawards where the originating sponsor is PHS.
Investigators and staff of the Institute for Community Research (ICR) understand that their primary responsibility is to the ICR and to its mission. Integral to that mission is the pursuit of research excellence and the dissemination of knowledge that emerges from research.
PURPOSE, APPLICABILITY AND SCOPE:
This Policy on Individual Financial Conflicts of Interest in Research (hereinafter, the “Policy”) promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by any conflicting financial interest of an Investigator. ICR requires that all Investigators promptly and fully disclose, in writing, any significant financial interest (including those of a spouse or dependent child) that reasonably relates to the Investigator’s Institutional Responsibilities and, if applicable, comply with financial conflict of interest management or mitigation plans. This Policy applies to all investigators responsible for the design, conduct or reporting of research.
ICR institutional officials are obligated to identify and manage, reduce or eliminate any significant financial interest that could directly and significantly affect the design, conduct or reporting of research.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of funded research.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Human Subject (45 CFR Part 46) means a living individual about whom an Investigator conducting research obtains: 1.) Data through intervention or interaction with the individual, or 2.) Identifiable private information. See also 21 CFR 50.
Institution means any domestic or foreign, public or private, entity or organization that is applying for or that receives research funding.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution which may include research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Investigator means the Principal Investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research 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.
Public Health Service means the Public Health Service (PHS) of the U.S. Department of Health and Human Services (DHHS) and any components of PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH) and any other sponsor who requests application of the PHS FCOI regulation to the administration of their research awards.
PHS Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel on the grant application, progress report, or any other report submitted to the PHS by the Institution.
Research means a systematic investigation, study or experiment, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge, 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).
Significant Financial Interest (SFI) is defined as follows:
A. 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.
1. With regard to any publicly traded entity, an SFI 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. 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;
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 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); or
3. Intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests.
B. PHS-funded Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator), related to his/her institutional responsibilities, must be disclosed. The details of this disclosure will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an U.S. 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.
C. This Policy does not apply to PHS Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications/awards.
D. The term significant financial interest does not include the following types of financial interests:
1. Salary, royalties, or other remuneration paid by ICR to the Investigator if the Investigator is currently employed or otherwise appointed by ICR, including intellectual property rights assigned to ICR and agreements to share in royalties related to such rights;
2. 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;
3. 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
4. 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.
Sponsor means an entity or organization that funds research.
Prior to the submission of an application to the PHS Grantee for funding, the Principal Investigator and all other investigators/senior key personnel at ICR must have disclosed to ICR an up-to-date listing of their Significant Financial Interests (SFIs) and those of their spouse and dependent children, as defined above. Any new investigator, who, subsequent to the submission of an application to the PHS Grantee for funding, or during the course of the research project, plans to participate in the project, must similarly disclose their SFI to ICR’s designated COI official and prior to participation in the project.
Each investigator who is participating in research under a subaward where the prime award originates from PHS must submit an updated disclosure of SFI at least annually during the period of the award. Such disclosure must include any information that was not disclosed initially to ICR, pursuant to this Policy, or in a subsequent disclosure of SFI that was transferred from another institution, and must include updated information regarding any previously disclosed SFI (e.g. the updated value of a previously disclosed equity interest).
Each investigator who is participating in research under a subaward where the prime award originated from PHS must submit an updated disclosure of SFI (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
Sub-Recipient Investigators: If any portion of the funded research is performed by a sub-recipient, ICR will take reasonable steps to ensure that sub- recipient investigators comply with the sponsor’s applicable financial COI policy and regulations. ICR will establish by written agreement with the sub-recipient Institution or Investigator the applicable governing FCOI policy.
1. The sub-recipient will certify that its Institution’s FCOI policy complies with the respective sponsor’s regulations and, further, that the sub-recipient will report identified FCOIs for Investigators to ICR within thirty (30) days so that ICR has sufficient time to report those FCOIs to the sponsor.
2. Alternatively, if a sub-recipient lacks a sponsor-compliant FCOI policy, the sub-recipient Investigator will be governed by this Policy.
Training Requirements of Each Identified PHS Investigator
Each Investigator/key personnel must complete training on Institute for Community Research Conflict of Interest Policy Applicable to A Subaward Issued Under A Public Health Services Prime Award prior to engaging in research related to any PHS-funded subaward and at least every four years, and immediately (as defined below) when any of the following circumstances apply:
1) ICR revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators (training is to be completed within the timeframe specified in communications announcing such changes);
2) An Investigator is new to ICR research under a subaward issued under a PHS prime award (training is to be completed prior to his/her participation in the research); or
3) ICR finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the designated official).
In fulfillment of the training requirement, ICR requires its investigators to complete and sign ICR’s Individual Financial Conflict of Interest Training Module. Additionally, we ask each investigator to also complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
The Conflict of Interest designated official is responsible for overseeing the implementation and enforcement of this Policy. This policy is designed to identify actual or potential sources of individual significant financial conflicts of interest in research and to either eliminate, reduce or manage such conflicts.
The designated official will conduct reviews of disclosures. The designated official will review any SFI that has been identified in a disclosure; these interests will be compared to each research subaward funded under a PHS prime award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the award, and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that research subaward.
The designated official may request any other information he/she deems necessary to assist it in his/her determination. For review of disclosures of reimbursed or sponsored travel, the designated official may determine if further information is needed, including determination or disclosure of monetary value.
A financial conflict of interest exists when the designated official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
MANAGEMENT OF FCOI:
If the designated official determines that an FCOI exists, he/she will then determine and make a recommendation about what conditions or restrictions, if any, should be imposed by ICR to manage, mitigate, or eliminate such conflicts. The designated official will then report the conflict to the FCOI Committee to review the FCOI
An FCOI must be eliminated or a management plan agreed to before a related award will be accepted and fund account established. Neither the institution nor an Investigator may expend sponsor funds unless it has been determined that the FCOI has been eliminated or an FCOI management plan is in place. The designated official will adequately document his/her determinations, recommendations, FCOI management plans and retrospective reviews. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the subaward and relevant PHS regulations.
If a conflict of interest exists, the designated official will determine by what means – such as the individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee – the conflict should be avoided or managed in order to mitigate undue bias. In making those determinations, the designated official will be guided by the principles discussed in this Policy. The designated official will also take into consideration whether the Investigator’s ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications.
Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to:
- Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest);
- Severance of relationships that create financial conflicts;
- For research projects involving human subjects research, use of a data and safety monitoring board;
- Written disclosure of the conflict to all individuals working on the research project;
Annual reports on the research progress to the designated official.
If the designated official in conjunction with the FCOI committee determines that a conflict exists, he/she will communicate his/her determination and the means identified for eliminating or managing the conflict, in writing, to the individual, to the relevant Principal Investigator/Project Director, the appropriate direct supervisor, the Executive Director and the IRB if human subjects are involved. The designated official will keep a record of the disclosure and other relevant information for at least three years. If the designated official prescribes monitoring of the activity, he/she will describe what monitoring shall be performed and what records are to be kept.
The designated official will also notify and provide initial and on-going FCOI reports to sponsors, including FCOIs of sub-recipient Investigators or instances of non-compliance, in accordance with applicable sponsor regulations.
For PHS FCOI reports, the timing and content of such reports will be consistent with 40 CFR 50.604-606.
In situations where an Investigator disputes the decision of the designated official and the FCOI committee the Investigator may request that the FCOI Committee reconsider their determinations/recommendations as well as request permission to present his or her case in person. In the event the Investigator disagrees with the committee’s decision, the Investigator may appeal, in writing, to the Executive Director and the President of the Board of Directors, whose decision shall be final.
PUBLIC ACCESSIBILITY for PHS-funded Research:
ICR will make information on FCOIs of PHS senior/key personnel publicly accessible upon request within five (5) business days after the request is received by the designated FCOI Official. Such disclosures shall be made in accordance with 42 CFR Part 50.605 (5)(i) and updated upon request.
MONITORING COMPLIANCE WITH THE POLICY AND MITIGATION:
The designated official will monitor the following:.
1. Failure to timely disclose an SFI: The designated official will monitor to assure that SFIs are timely disclosed.
2. Retrospective Review – Failure to timely disclose an SFI that is determined to be an FCOI and/or Failure to comply with a management plan: If it is learned that a FCOI was not timely identified or managed, or if an Investigator fails to comply with a FCOI management plan the designated official shall take the following actions:
a. PHS-funded Research: Consistent with 42 CFR 50.605, a retrospective review shall be conducted and will cover key elements as specified by federal regulations, 40 CFR 50.605 (3) (B), and may result in updating the Individual Financial Disclosure Form, notifying the PHS and/or submitting/implementing a Mitigation Plan or other corrective actions, pursuant to 42 CFR 50.606.
b. Non-PHS Funded Research: The designated official may, in accordance with the sponsor’s regulations or, if no sponsor regulations exist, at its discretion conduct retrospective reviews of non-PHS funded research.
3. Enforcement: ICR will comply with applicable sponsor’s regulations regarding enforcement of this Policy.
J. Sanctions: Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the designated official and the FCOI committee in consultation with the Executive Director and the Board President. Sanctions include, but are not restricted to: letter of reprimand; reassignment of duties; notification to professional and/or scientific societies, funding agencies and/or professional journals; termination of grant support; adjustment of salary; suspension or dismissal.
K. PHS Remedies: If the failure of an Investigator to comply with this Policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of research, ICR shall promptly notify PHS of the corrective action taken or to be taken. Consistent with 42 CFR 50.606, PHS and/or the U.S. Department of Health and Human Services (HHS) may impose additional corrective or enforcement actions. In any case in which HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by ICR as required by 42 CFR 50 Subpart F, ICR shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
L. Maintenance of Records: The designated official shall maintain all records related to Investigator disclosures of SFIs and related documentation and the review of and response to such disclosures (whether or not a disclosure resulted in the determination of a FCOI) and all actions under this Policy, or retrospective review, if applicable for at least three (3) years following the date the project terminates, the date the final expenditure report is submitted to the governmental sponsor or until the resolution of any federal action involving those records, whichever is longer.
Failure to Comply with ICR’ s Conflict of Interest Policy Applicable to Public Health Service Funded Subaward
When a FCOI is not identified or managed in a timely manner, including, for example, because the underlying Significant Financial Interest is not disclosed timely by an Investigator or, because a FCOI was not timely reviewed or reported by a second tier subrecipient or by ICR, or because an investigator failed to comply with a management plan; then ICR will within 90 days:
a) Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research;
b) Document the retrospective review consistent with the regulation;
c) Document ICR’s determination as to whether any research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with this Policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research; and
d) Notify the PHS Grantee in writing.
If bias is found, ICR shall notify the PHS Grantee promptly and submit a mitigation report to the PHS Grantee that shall address the following:
– Impact of the bias on the research project and
-ICR’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, ICR shall submit FCOI reports annually to the PHS Grantee, in accordance with the regulation and terms and conditions of the subaward agreement. Depending on the nature of the Financial Conflict of Interest, ICR may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the Financial Conflict of Interest is identified and the completion of ICR’s independent retrospective review.
Failure to Comply with This Policy
No expenditures of funds on a subaward supported by a PHS prime award will be permitted unless the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any designated official-approved FCOI management plan.
Any failure by an individual to adhere to this Policy may be cause for disciplinary action, including, in severe cases, termination, and termination of the subaward by the PHS Grantee.