N I H F C O I P O L I C Y
COMPANY-WIDE POLICY: GRANT FUNDING FINANCIAL CONFLICT OF INTEREST DISCLOSURES
SCOPE: Company Wide. Immunophotonics, Inc. (“Immunophotonics”) is advancing breakthrough drug discoveries to develop first-in-class therapies in the field of Interventional Immuno-Oncology™, in order to make a real difference for patients, their families, and the global healthcare system. Immunophotonics is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. Immunophotonics has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest. The Government Awards Compliance Program (Program) covers all projects conducted with government funds in Immunophotonics and is applicable to all employees, sub recipients, consultants, or any other covered organizations or persons involved in governmental awards.
PURPOSE: Under this policy, Immunophotonics strives to ensure that all work performed under Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could harm patients, the reputation of Immunophotonics, the governmental agency providing the funding, and/or external partners. As Immunophotonics must comply with government regulations when making expenditures with Government Awards, this policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in Governmental Awards. It is intended to comply with the requirements of federal regulations, including, but not limited to, the conflict-of-interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”). These regulations require that all individuals who participate in the design, conduct, or reporting of Research funded by the PHS complete training on financial conflicts and disclose personal financial interests that could give rise to an actual conflict of interest or the appearance of a conflict.
Conflict Management Plan: the document specifying the actions to be taken to manage a Financial Conflict of Interest.
Designated Official: the individual designated by Immunophotonics to oversee the financial conflicts-of-interest process, including solicitation and review of disclosures of significant financial interests.
External Partner: a consultant, subcontractor, or sub-recipient performing work under a Government Award who is not employed by Immunophotonics.
Government Award: government grants and cost reimbursement contracts including research grants or contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan guarantees, property, donated supplies, and direct appropriations) that Immunophotonics receives directly from government agencies or indirectly from pass through entities. (At Immunophotonics, Government Awards are commonly referred to as “Sponsored Projects.”) Government Awards do not include procurement contracts, payments for health care services provided under government health care programs (e.g., Medicare, Medicaid) or Medical Education and Research Costs (MERC).
Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of a research study or other government funded project as determined by Immunophotonics through the Designated Official.
Immediate Family Member: a spouse, domestic partner, child or stepchild, parent or step-parent, or sibling or step-sibling.
- For PHS-funded research: 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 the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
- For other Government Awards: project staff directly involved in management of the project or who hold key responsibilities on the Government Award. Typically, these would be individuals specifically named to a Government Award or whose participation is key to the success of the project.
Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Immunophotonics, which may include, but is not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Public Health Service (PHS): a division of the Department of Health and Human Services, consisting of the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).
Research: 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.
Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships).
Significant Financial Interest (SFI):
- A financial interest consisting of one or more of the following interests of the Investigator or their Immediate Family Member that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
- the value of any remuneration received from a publicly traded 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; or
- the value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. The disclosure will include, at a minimum, the following details: (i) the purpose of the trip; (ii) the identity of the sponsor/organizer; (iii) the destination; and (iv) the trip duration. (This disclosure requirement does not apply to travel that is reimbursed or 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.)
- A significant financial interest does not include the following:
- Salary, royalties, or other remuneration paid by Immunophotonics to the Investigator if the Investigator is currently employed or otherwise appointed by Immunophotonics;
- Intellectual property rights assigned to Immunophotonics and agreements to share in royalties related to such rights;
- 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 in 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; and
- Income from service on advisory committees or review panels for a federal, state, or local government agency, or 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.
It is the policy of Immunophotonics to comply with the Financial Conflict of Interest Rules (“FCOI Rules”) to ensure that the work performed under Government Awards is carried out in a manner that is free from any bias which may result from financial conflicts of interest. All Investigators for Government Awards must disclose any Significant Financial Interests (SFI) to Immunophotonics. Investigators must complete or update a disclosure survey at least annually during the period of the award and must disclose any new SFI’s within 30 days of discovering or acquiring the SFI. Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for a Government Award.
If Immunophotonics determines that a SFI constitutes a Financial Conflict of Interest (“FCOI”), Immunophotonics will establish and monitor a Conflict Management Plan (“CMP”) to manage or eliminate the conflict of interest. The Designated Official will be the conflict-of-interest official responsible for managing the conflict-of-interest process for Government Awards. No Government Award funds may be expended unless the Designated Official has determined that no FCOI exists or that any FCOI is manageable in accordance with the terms of a CMP that has been adopted and implemented in accordance with the procedures set forth in this policy.
Duty to Cooperate:
If the conflict-of-interest official requests additional information from an Investigator to assess whether a SFI constitutes a Financial Conflict of Interest (including but not limited to documents relating to the SFI), the Investigator must cooperate with the request. If a CMP is implemented in connection with a SFI, the Investigator must comply with the CMP. Compliance with the requirements of this policy is a condition of employment with Immunophotonics for employed Investigators and a condition of participating in Government Award projects as an External Partner. Failure to comply may result in appropriate sanctions.
If the Department of Health and Human Services (HHS) determines that an FCOI was not managed or reported as required by the regulation, the Investigator involved must disclose the FCOI in each public presentation of the results of the research and request an addendum to previously published presentations. If there are problems in obtaining SFI Disclosure Forms, additional information as requested, or the Investigator refuses to follow the policies and procedures, the Designated Official may suspend enrollment privileges to NIH clinical trials. If an Investigator fails to comply with the Financial Conflict of Interest policy or the Management Plan, the Designated Official shall within 120 days:
- complete a retrospective review of the Investigator’s activities and the NIH-funded research project to determine any bias in the design, conduct, or reporting of research;
- document the retrospective review consistent with the regulation;
- document the Institution’s determination as to whether any NIH-funded research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with Immunophotonics’s FCOI Policy or an FCOI management plan, was biased in the design, conduct, or reporting of such research.
Non-compliance will result initially in re-training, then in disciplinary action if there are further occurrences.
Retrospective Review and Mitigation Report:
A retrospective review will be conducted within 120 days when there is:
- a failure by the Investigator to disclose a Significant Financial Interest that is determined by the Designated Official to constitute an FCOI;
- a failure by the Designated Official to review or manage such an FCOI; or
- a failure by the Investigator to comply with a Conflict Management Plan (CMP).
The retrospective review must include the following:
- Project number.
- Project title.
- PD/PI or contact PD/PI if a multiple PD/PI model is used.
- Name of the Investigator with the FCOI.
- Name of the entity with which the Investigator has a financial conflict of interest.
- Reason(s) for the retrospective review.
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.).
- Findings of the review.
- Conclusions of the review.
If bias is found during the review, the Designated Official shall notify the NIH promptly and submit a mitigation report, which must include the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and Immunophotonics’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project; the extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, Immunophotonics will submit FCOI reports annually as prescribed by the regulation.
Investigators must complete training regarding this policy and the applicable regulations at the following times: (i) upon becoming an Investigator for Immunophotonics; (ii) before performing work under a Government Award; (iii) when this policy is revised in a manner that affects Investigator requirements; (iv) when Immunophotonics finds that an investigator is not in compliance with this FCOI Policy or a CMP; and (v) and at least every four years.
Public Posting of Policy:
This policy will be posted on a publicly accessible Internet site for Immunophotonics.
Reporting of Financial Conflicts of Interest for PHS-Funded Projects:
Before the expenditure of any funds under a PHS-funded project and within sixty days of subsequently identifying a Financial Conflict of Interest, the Designated Official will report all Financial Conflicts of Interest that have not been eliminated to the PHS awarding component and will ensure that an appropriate Conflict Management Plan has been implemented. The report will include the elements required under the PHS FCOI Rules. For subsequently identified FCOI’s, the Designated Official will conduct a retrospective review to determine whether the PHS-funded project was affected by the financial conflict of interest, and if bias is found, will submit a mitigation report to the PHS awarding component. The Designated Official also will provide an annual FCOI report that addresses the status of any previously reported FCOI’s and CMP’s related to an ongoing PHS-funded project.
Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to Immunophotonics on a PHS-funded award must either: (1) have a FCOI policy that meets the requirements of the PHS FCOI Rules or (2) follow this policy.
- Organizations with their own policy will certify that the policy meets the requirements of the PHS FCOI Rules by submitting an External Partner Financial Conflict of Interest Disclosure form or registering with the FDP Clearinghouse before submission of the Government Award. The Designated Official will verify registration with the FDP Clearinghouse before submission. The contract with Immunophotonics will contain language requiring compliance with the organization’s FCOI Policy.
- Individuals and organizations without their own FCOI policy are required to follow this policy. The contract with Immunophotonics will contain language requiring compliance with Immunophotonics’s Government Awards FCOI Policy.
This procedure is for use by Immunophotonics employees and External Partners that do not have their own FCOI policy.
- Before the expenditure of funds under a Government Award, Investigators must complete the training on Immunophotonics’s Government Awards FCOI Policy. All external investigators must complete FCOI training required under the policy. Training can either be completed using the NIH FCOI tutorial found at:https://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or CITI COI training found at: https://about.citiprogram.org/en/homepage/. Immunophotonics will provide additional training in house when a training requirement is triggered or upon request.
- Training must be documented by submitting the Government Award FCOI Training Certification form to Immunophotonics Sponsored Projects Administration. The required training is valid for four years; however, Investigators are required to certify annually that they understand and have complied with their responsibilities under Immunophotonics’s Government Awards FCOI Policy.
- After the training is completed, the Investigator will complete the Government Award FCOI Questionnaire. This survey must be completed no later than the time of application for a Government Award and before any funds are expended. It also must be updated as required by the policy.
- The principal investigator or project director will complete the Government Award Approval form, which requires verification that those meeting the definition of Investigator and External Partners have been informed of the requirement to comply with this policy.
- The Investigator must report and update their Government Award FCOI Questionnaire when he or she is a recipient of sponsored travel. The Investigator will disclose: the purpose of the trip; the name of the entity that paid for the travel; the travel destination; the duration of the trip; the dates of the travel; and if known, the approximate value of the Sponsored Travel.
- If the Designated Official determines a FCOI exists, he or she will create a draft and implement a CMP.
- The Designated Official will ensure that CMP’s are properly implemented and will monitor compliance with CMP’s on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:
- Disclosure to research participants or the public of significant financial interests (e.g., when presenting or publishing the research);
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification of staff from participation in all or a portion of the research;
- Reduction or divestiture of a financial interest; or
- Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, Immunophotonics may require the management of conflicting financial interests in other ways as it deems appropriate.
- Each Investigator under a CMP must comply fully and promptly with the CMP, and each person identified in the CMP as having responsibility for monitoring compliance with the CMP must carefully and fully monitor that compliance.
- For PHS-funded projects, Designated Official will disclose the FCOI and CMP to the PHS awarding component before the expenditure of any federal funds.
- For PHS-funded projects, Immunophotonics will be make FCOI information available to authorized PHS officials who submit a request by sending an email to or by writing the Designated Official at the address below. Responses will be sent within five business days.
- Immunophotonics will keep records related to FCOI and the related CMP for the longer of at least three years after:
- the date of creation;
- the date of termination or completion of the Government Award and submission of the final expenditure report for the Government Award identified in the disclosure statement;
- the date of final resolution of any investigation, audit, or similar action involving the records; or
- the date required to be in compliance with Immunophotonics’s Record Retention policies.
- The Designated Official will regularly evaluate compliance with this policy and will review the effectiveness of any CMPs, including a review of the implementation and effectiveness of these procedures.
Procedure for External Partners with Their Own PHS Rule Policy:
- The principal investigator or project director will complete the Government Award Approval form, which requires them to inform any External Partner if they need to comply with FCOI Rules.
- Prior to any application submitted by Immunophotonics for a Government Award, the Designated Official must receive confirmation the External Partner has a FCOI policy that meets the PHS FCOI Rules.
- The External Partner will have two options to verify they have a FCOI:
- Register with the FDP Clearinghouse, https://fdpclearinghouse.org/. At this time, this website is acting as a central registration location for many colleges. Immunophotonics will accept this method of verification. Registration is free and you may contact the Designated Official if you have questions.
- Submit the External Partner Financial Conflict of Interest Disclosure.
Special Provisions for Clinical Research:
In any case in which the HHS determines that an NIH-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 conflicting interest that was not managed or reported by the Institution as required by the regulation, Immunophotonics requires that the Investigator(s) involved disclose the FCOI in each public presentation of the results of the research and request an addendum to previously published presentations.
Point of Contact:
If you have a conflict of interest or if you have a question to discuss, contact the Immunophotonics Administrator via the Immunophotonics Contact Us page at Contact Us - Immunophotonics.