1. OBJECTIVE
1.1. 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 to promote objectivity in PHS-funded research. The regulations apply to all PHS funded grants, including from the National Institutes of Health (NIH), cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is PHS.
2. SCOPE
2.1. This policy applies to all research team members working on PHS funded programs and/or projects.
3. RESPONSIBILITY
3.1. Program Director/Principal Investigator
3.1.1. Prior to the submission of an application to the NIH Grantee for funding, the Principal Investigator and all other Investigators must have disclosed to the designated official an up-to-date listing of their Significant Financial Interests [SFIs] (and those of their spouse and dependent children), as defined in section 4. Any new Investigator, who, after the submission of an application to NIH for funding from NIH, or during the research project, plans to participate in the project, must similarly disclose their SFI to the designated official promptly and prior to participation in the project.
3.1.2. Each Investigator who is participating in research under an NIH award 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 pursuant to this Policy, or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on a NIH funded project directly as a NIH Grantee and/or indirectly through a subaward) 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).
3.1.3. Each Investigator who is participating in research under an award from NIH 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.
3.1.3.1. Regarding 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 for the investigator, investigator’s spouse and dependent children, 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;
3.1.3.2. Regarding 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); or
3.1.3.3. Regarding 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.
3.1.4. The term significant financial interest does NOT include the following types of financial interests:
3.1.4.1. Salary, royalties, or other remuneration paid by DCP to the Investigator if the Investigator is currently employed or otherwise appointed by DCP, including intellectual property rights assigned to DCP and agreements to share in royalties related to such rights;
3.1.4.2. 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;
3.1.4.3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States (U.S.), a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. Institution of higher education; or
3.1.4.4. Income from service on advisory committees or review panels for a federal, state, or local government agency
located in the U.S., a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a
research institute that is affiliated with a U.S. Institution of higher education.
3.1.4.5. Investigators must disclose the occurrence of any foreign or domestic reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities. 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. The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
3.2. 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 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 award.
1. Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes; or
2. Whether the degree of replication and verification of research results is such that immediate commercialization or
clinical application is not likely; or
3. Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention); or
4. Where the research involves human subjects, whether there are double blind conditions or the involvement of a data and safety monitoring board; or
5. Where the SFI is in a privately held company, whether the researcher’s SFI could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and STTRs); or
6. The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or
7. Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser’s technology, the amount of commercialization payments received by the Investigator from that technology, both currently or in the future; or
8. The number and nature of relationships an Investigator has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts; or
9. Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the SFI; or
10. Whether other scientific groups are independently pursuing similar questions; or
11. Whether sufficient external review of the research conducted, and the reporting of research results exist to mitigate undue bias; or
12. Whether the goal of the project is a comparative evaluation of a technology in which an Investigator has a SFI; or
13. Whether the project involves a subaward to an entity in which the Investigator has an SFI.
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 non-affected research team member – 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.
Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to:
a). Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to research personnel working on the study, to the Institution Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.);
b). For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants in the informed consent document;
c). 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;
d). Modification of the research plan;
e). Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
f). Reduction or elimination of the financial interest (e.g., sale of an equity interest);
g). Severance of relationships that create financial conflicts;
h). For research projects involving human subjects research, use of a data and safety monitoring board;
i). Double-blind conditions;
j). Provisions to conduct the work simultaneously at multiple sites;
k). Written disclosure of the conflict to all individuals working on the research project;
l). Annual reports on the research progress to the designated official.
m). Disclosure at any presentation of information related to the FCOI.
3.4. No expenditures on a NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the Conflict of Interest. The designated official will communicate, in writing, with the NIH Grantee to notify it of the existence and the nature of a Financial Conflict of Interest and whether the conflict has been managed, reduced, or eliminated. No expenditures can be incurred until the NIH Grantee has reported the FCOI to NIH.
3.5. The designated official will keep a record of Investigator disclosures of financial interests and the designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations.
3.6. Prior to the expenditure of any funds under a NIH award, public accessibility, by written response to any requestor within five business days of a request of information concerning any SFI disclosed that meets the following three criteria:
3.6.1. The SFI was disclosed and is still held by the senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel by the PD/PI in the award application, progress report or any other report submitted to the NIH Grantee;
3.6.2. the SFI is related to the research funded through an award; and
3.6.3. SFI is a financial conflict of interest.
3.6.4. The information available via a publicly accessible web site or in a written response to any requestor within five days of request will include, at a minimum, the following: the investigator’s name, title and role with respect to the research project; the name of the entity in which the SFI is held, the nature of the SFI and the approximate dollar value of the SFI in the following ranges: $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 the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
3.7. Training Requirements – Each Investigator must complete training on DCP’s Financial Conflict of Interest Policy Applicable to an Award Issued by Public Health Services prior to engaging in research related to any NIH award and at least every four years, and immediately (as defined below) when any of the following circumstances apply: 1) changes to this policy, 2) when a new investigator is added to the research program, 3) when an investigator is found NOT to be in compliance. To fulfill the training requirement, the investigator will complete the NIH FCOI tutorial located at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html.
3.8. Failure to Comply with DCP’s Conflict of Interest Policy Applicable to Public Health Service Funded Award – When a FCOI is not identified or managed in a timely manner, including, failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a FCOI; failure by the Institution to review or manage such a FCOI; and failure by the Investigator to comply with a management plan; then DCP will within 120 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 at 42 CFR 50.605(a)(3)(ii)(B);
c) Document DCP’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;
d) If bias is found, DCP shall notify NIH promptly and submit a mitigation report to NIH via the eRA Commons FCOI Module that shall address the following
a. Impact of the bias on the research project and the action or actions taken to eliminate or mitigate the effect of the bias.
b. Thereafter, FCOI reports will be submitted annually to NIH, in accordance with the regulation and terms and conditions of the award agreement. Depending on the nature of the Financial Conflict of Interest, 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 an independent retrospective review.
3.9. Clinical Research – If HHS determines that one of its funded clinical research projects 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 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.
3.10. Subrecipient FCOI Compliance – A subrecipient relationship is established when federal funds flow down from or through the awardee to an individual or entity and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to DCP for programmatic outcomes and compliance matters. Subrecipients, who include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors and subawardees, are subject to terms and conditions, and as such, will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the federal FCOI regulation.
3.10.1. Tris Pharma will incorporate, as part of a written agreement with the subrecipient, terms that establish whether DCP’s FCOI Policy or that of the subrecipient’s institution will apply to the subrecipient Investigator.
3.10.2. If the subrecipient’s FCOI policy applies to the subrecipient Investigator, the subrecipient institution will certify as part of the agreement with Tris Pharma that it is in compliance with the federal FCOI regulation and that the institution’s portion of the project is in compliance with the FCOI policy. If the subrecipient cannot provide the certification, the agreement shall state that the subrecipient Investigator is subject to Tris Pharma’s FCOI Policy for disclosing SFI that are directly related to the subrecipient’s work. Tris Pharma will, if applicable, submit a FCOI report to the NIH through the eRA Commons FCOI Module for any FCOIs identified for a subrecipient Investigator.
3.10.3. If the subrecipient’s conflict of interest policy applies to the subrecipient Investigator, the agreement shall specify the time period for the subrecipient to report all identified FCOIs. Such time period must be sufficient to enable DCP to provide timely FCOI reports to the NIH as necessary, through the eRA Commons FCOI Module.
3.11. Maintenance of Records – Records of financial disclosures and any resulting action will be maintained by the Institution for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations. Tris Pharma will retain records for each competitive segment as provided in the regulation.
3.12. Failure to Comply with This Policy – When a FCOI is not identified or managed in a timely manner, including, failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a FCOI; failure by the Institution to review or manage such a FCOI; and failure by the Investigator to comply with a management plan; then DCP will within 120 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 at 42 CFR 50.605(a)(3)(ii)(B);
c) Document DCP’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;
d) If bias is found, DCP shall notify NIH promptly and submit a mitigation report to NIH via the eRA Commons FCOI Module that shall address the following:
• Impact of the bias on the research project and
• DCP’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, DCP shall submit FCOI reports annually to NIH, in accordance with the regulation and terms and conditions of the award agreement. Depending on the nature of the Financial Conflict of Interest, DCP 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 DCP’s independent retrospective review.
3.13. No expenditures of funds on an award supported by NIH 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.
4. DEFINITIONS
4.1. Financial conflict of interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
4.2. HHS: the Department of Health and Human Services.
4.3. PD/PI/Investigator: 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 award, or proposed for such funding, which may include, for example, collaborators or consultants. Tris Pharma’s Principal Investigator/Project Director, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.
4.4. PHS: 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).
4.5. NIH: the biomedical research agency of the PHS.
4.6. 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 appear to be related to the Investigator’s institutional responsibilities on behalf of DCP.
5. REFERENCES
5.1. 42 CFR Part 50 Subpart F
5.2. 45 C.F.R. 75.361
5.3. 45 CFR Part 94
5.4. https://grants.nih.gov/grants/policy/coi/index.htm
6. HISTORY
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