FINANCIAL CONFLICT OF INTEREST IN RESEARCH POLICY
Employees, officers, staff, volunteers, investigators, subrecipients and all others representing or acting on behalf of NextGen Jane, Inc. (“COMPANY”) should avoid conflicts of interest or the appearance of conflicts of interest. All decisions and actions considered or made by such individuals should be based solely on the best interests of the COMPANY and in accordance with applicable federal, state, and local laws and regulations. Personal considerations should not be a factor in any action or decision made on behalf of the COMPANY. The confidence that members of the profession and the public have depends on the integrity of those who represent the COMPANY.
Conflict of Financial Interest in Research
As a recipient of National Institutes of Health (NIH) grant funds, COMPANY is subject to 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research.” In the handling of all such grant funds, the COMPANY will take steps to ensure that Investigators and any other persons responsible for the design, conduct or reporting of all research funded by the Public Health Service (PHS), or proposed for such funding will not be biased by any conflicting “significant financial interest.” For purposes of this policy, “Investigator” means a study Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research funded by PHS and includes the individual’s spouse and dependent children. This policy applies to all persons representing or acting on behalf of the COMPANY.
What Constitutes a Financial Conflict of Interest (FCOI)?
A “significant financial interest” required to be disclosed under this policy is one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
- With respect to a 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 $5000. “Remuneration” includes salary and any payment for services other than salary, such as 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.
- With respect to a 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
- Any equity interest (such as stock, stock option or other ownership interest) held by the Investigator or the Investigator’s spouse, or dependent children
- Intellectual property rights and interests (such as patents or copyrights) upon receipt of income related to those rights and interests.
- Investigators must also disclose the occurrence of any reimbursed or sponsored travel (i.e. that which is paid on behalf of the investigator) including the purpose of the trip, sponsor/organizer, destination, and duration, when related to their institutional responsibilities.
Investigators do not have to disclose travel that is reimbursed 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.
Disclosures related to reimbursed or sponsored travel must include:
- The purpose of the trip
- The identity of the sponsor/organizer
- The destination
- The duration
- Any additional information requested by COMPANY, including the monetary value of the travel, as necessary for COMPANY to determine whether the travel constitutes a FCOI with PHS-funded research.
- The term “significant financial interest” does not include the following:
- Salary, royalties or other remuneration paid by the COMPANY to the Investigator if the Investigator is employed by COMPANY, including intellectual property rights assigned to COMPANY and agreements to share in royalties related to such rights
- Ownership interest in the COMPANY held by the Investigator
- Income from investment vehicles, such as mutual funds or retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles
- Income from seminars, lectures or teaching engagements sponsored by a Federal, state or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, medical center or research institute affiliated with an Institution of higher education or income from service on advisory committees or review panels for a Federal, state or local government agency, an Institution of higher education as defined at 20 U.S.C 1001(a), an academic teaching hospital, medical center or research institute affiliated with an Institution of higher education
Disclosure of Significant Financial Interest
Disclosures of significant financial interests is required annually and when an Investigator makes application to participate in research supported by NIH funds and/or prior to the expenditure of such funds. Investigators should use the disclosure forms at the end of this policy. The disclosure requirement is considered an “on-going” obligation of the Investigator, requiring an updated submission within 30 days of discovering or acquiring a new significant financial interest. At a minimum, the Investigator is required to complete and submit to the COMPANY a new financial disclosure form annually.
All financial disclosure forms will be reviewed by the Company’s Conflict of Interest Coordinator with guidance, as needed, from COMPANY’s legal counsel. Any identified FCOI will be reviewed with the affected Investigator and reported to NIH within 60 days of its discovery by the COMPANY. Actions that are necessary to manage, reduce or eliminate the FCOI will be taken by the Conflict of Interest Coordinator with advice from legal counsel and included in the report to NIH. Management of an identified FCOI will include the development and implementation of a management plan and, if necessary, a retrospective review and mitigation report, submitted to NIH. All financial disclosure forms and any actions taken by the COMPANY to resolve a FCOI will be recorded and kept on file in accordance with applicable law.
Institutions through which investigators provide services to the COMPANY shall provide COMPANY with written “certification” that the Institution is compliant with the financial conflict of interest requirements of 42 CFR 50, Part F. Institutions must also notify COMPANY of any identified FCOI and if an Institution has identified an Investigator as failing to comply with the Institution’s conflict of interest policy and such failure has biased the design, conduct or reporting of PHS-funded research, the Institution must promptly notify COMPANY of any corrective action taken or to be taken.
Such notification to COMPANY is necessary so that COMPANY can consider the situation, comply with its reporting obligations to NIH, take appropriate action or refer the matter back to the Institution for further action, including instructions to the Institution on how to maintain appropriate objectivity for the funded project.
FCOI training is required for all Investigators prior to participating in PHS funded research and at least every four years. Training must also be completed under the following circumstances:
- COMPANY’s Financial Conflicts of Interest Policy changes in a material manner
- When a new Investigator joins Company
- Following a finding that an Investigator is out of compliance with COMPANY’s Financial Conflicts of Interest policy or a FCOI management plan.
In order to complete annual training, Investigators must review the following presentation: Financial Conflict of Interest (FCOI) – What You Need to Know – YouTube and certify the date and time of completion. The COMPANY may require additional training on specific topics as circumstances warrant.
Management and Enforcement
Management and enforcement of this policy is the responsibility of the Conflict of Interest Coordinator with the support of COMPANY counsel and senior management. In the case of reported FCOI such actions to manage, reduce or eliminate the conflict of interest may include, but are not limited to, public disclosure of the FCOI, disclosure of the FCOI directly to participants, appointment of an independent monitor, modification of the research plan, change of personnel or personnel responsibilities, or disqualification of personnel from participation in the research, or severance of relationships that create financial conflicts.
Any significant financial conflict of interest not reported but discovered during the course of a research activity will be immediately investigated by the Conflict of Interest Coordinator with assistance from COMPANY legal counsel. Reporting to NIH will be in accordance with applicable law. Depending upon the nature of the FCOI and the facts surrounding the failure of reporting corrective action to reduce, or eliminate the conflict of interest will at a minimum include consideration of those actions described above. In addition, COMPANY may take disciplinary action such as elimination of the Investigator and/or the Institution involved from further participation in COMPANY research activities and other discipline, up to and including termination.
COMPANY will make certain information available concerning identified FCOI held by investigators via a publicly accessible Web site and update such information in accordance with 42 CFR 50.605.
Notice: All institutions and individuals providing or engaged in research activities for the COMPANY will be provided with a copy of this policy.