MindLight, LLC
Financial Conflict of Interest Policy
I. Purpose
This Financial Conflict of Interest Policy provides guidelines to promote objectivity in research. The Policy establishes standards to ensure that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from a financial conflict of interest. This policy is implemented in accordance with 42 CFR Part 50, Subpart F – “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought” and 45 CFR Part 94- “Responsible Prospective Contractors”, as well as other relevant policies of federal funding and oversight agencies.
II. Definitions
Designated Official is the individual designated by MindLight to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS- funded research.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Institution means MindLight, LLC.
Investigator means the project director/principal investigator and any other person who is responsible for the design, conduct, or reporting of the research or proposed research.
PHS Awarding Component means the organizational division of the US 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.
Significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and/or the Investigator’s spouse and/or dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities, including:
· A financial interest consisting of one or more of the following interests of the Investigator (and/or of the Investigator’s that reasonably appears to be related to the Investigator’s institutional responsibilities:
o With regard to 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 (and/or the Investigator’s spouse and/or dependent children) holds any equity interest. 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 interests includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; (e.g., stock, stock option, or other ownership interest);
o With regard to 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 the disclosure, when aggregated, exceeds $5,000; or
o Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
· Significant financial interests also include any 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, provided, however, that 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 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.
· Significant financial interest does not includethe following types of financial interests:
o Salary, royalties, or other remuneration paid by MindLight to the Investigator if the Investigator is currently employed or otherwise appointed by MindLight, including intellectual property rights assigned to MindLight and agreements to share in royalties related to such rights;
o Any ownership interest in MindLight held by the Investigator if MindLight is a commercial or for-profit organization;
o 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;
o 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
o 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.
III. Procedures
A. Training. Each Investigator shall complete training regarding disclosure of financial interests prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply:
· MindLight revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
· An Investigator is new to MindLight; or
· MindLight finds that an Investigator is not in compliance with its financial conflict of interest policy or management plan.
The training module and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH FCOI page: https://grants.nih.gov/grants/policy/coi/index.htm.
B. Disclosure.
· Each Investigator who is planning to participate in PHS-funded research is required by regulation to complete a Significant Financial Interest Disclosure and submit the Disclosure to MindLight’s Designated Official. Research should not be undertaken where a Significant Financial Interest is present until a determination and approval has been made pursuant to this policy.
· This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research.
· Disclosure forms will be provided to Investigators in conjunction with the annual training and will be otherwise made available.
· Disclosure Frequency: Disclosure must be made annually. If no Significant Financial Interest is present a Disclosure must still be submitted that states “none”. In addition to the annual Disclosure, a new or updated Disclosure must be completed in a timely manner whenever a new or potential Significant Financial Interest arises or when a significant change occurs concerning an existing Disclosure. In any event, Disclosure must be made within thirty (30) days of discovery or acquiring a new Significant Financial Interest. Newly hired Investigators should make a Disclosure as part of their new hire employment process.
C. Management of Financial Conflicts of Interest.
· Upon receipt of a completed Disclosure, the Designated Official shall determine whether an Investigator’s significant financial interest is related to the subject research and, if so, whether the interest constitutes a financial conflict of interest under this policy and any applicable regulations. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
· If the Designated Official determines that a financial conflict of interest exists, a financial conflicts of interest management plan will be implemented and monitored 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:
o Disclosure to research participants or the public of significant financial interests (e.g., when presenting or publishing the research);
o Monitoring of research by independent reviewers;
o Modification of the research plan;
o Change of personnel or disqualification from participation in all or a portion of the research;
o Reduction or divestiture of a financial interest; or
o Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, MindLight may require the management of conflicting financial interests in other ways as it deems appropriate.
D. Responsibilities of MindLight’s Designated Official.
· The Designated Official shall be responsible for the following:
o Informing MindLight Investigators of their obligations under this policy and any related regulations;
o Reviewing disclosures of significant financial interest with MindLight’s Designated Official to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest;
o Screening and managing potential financial conflicts of interest;
o Maintaining all records relating to disclosures of financial interests, MindLight’s review of and response to such disclosures, and any related actions under this policy;
o Ensuring inclusion of any required certifications in applications for funding or contract proposals; and
o Reporting and disclosure as required under this policy and applicable regulations.
· For PHS-funded research, the Designated Official shall also have the following responsibility:
o Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide MindLight with sufficient assurances to enable MindLight’s compliance with all applicable laws or regulations. To this end, the written agreement between MindLight and the subrecipient will specify whether MindLight’s or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
§ Obtain certification from the subrecipient that its policy complies with MindLight’s policy and the applicable regulations (absent such certification, MindLight’s policy will apply to the subrecipient’s Investigators, and
§ Establish time periods for subrecipient reporting of financial conflicts of interest to MindLight that enable MindLight to report such conflicts in a timely manner, as required under its policy and the applicable regulations.
· If MindLight’s policy will apply to the subrecipient Investigators, MindLight will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.
E. External Reporting Requirements. MindLight will disclose financial conflicts of interest as required by applicable laws or regulations.
· Before expending any funds under a PHS award, MindLight will ensure public accessibility by posting financial conflicts of interest information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations.
· The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any financial conflict of interest that has not been eliminated and will ensure that MindLight has implemented a plan to manage the conflict.
· If a financial conflict of interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, MindLight will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant financial interest that was not disclosed by an Investigator or not previously reviewed or managed by MindLight (e.g., not reviewed or reported by a subrecipient in a timely manner), MindLight will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, MindLight will promptly notify the PHS Awarding Component and submit a mitigation report. Upon request, MindLight will provide HHS with information relating to any Investigator disclosure of significant financial interests; MindLight’s review of, and response to, such disclosure; and whether the disclosure resulted in MindLight’s determination of a financial conflict of interest.
F. Confidentiality. MindLight will, to the extent possible, protect the confidentiality of disclosures. In every instance, MindLight will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to MindLight staff only on a need-to-know basis and will not be disclosed outside of MindLight unless necessary to comply with contractual, legal, or regulatory requirements.
G. Noncompliance.
· If MindLight discovers that an Investigator has failed to comply with this policy (e.g., fails to identify an actual or potential financial conflict of interest or fails to disclose within the timelines set forth in this policy), MindLight shall remedy such noncompliance and conduct a retrospective review and may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research.
· In addition, for PHS-funded research, failure to comply with this policy or the applicable regulations shall result in the following:
o If an Investigator’s failure to comply with this policy or a financial conflicts of interest management plan has biased the design, conduct, or reporting of the PHS-funded research, MindLight shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken;
o MindLight will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts; and
o If HHS determines that a clinical PHS-funded research project 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 neither disclosed nor managed, MindLight shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if necessary.
H. Retention of Records. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by MindLight with respect to each financial conflict of interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 74.53(b) or 48 CFR Part 4, Subpart 4.7.