1.1. The purpose of this document is to maintain an up-to-date, written, enforced Financial Conflict of Interest (FCOI) Policy by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of funded research, grants or cooperative agreements will be free from bias resulting from an Investigator’s FCOI.
1.2. Braincheck Inc., mentioned throughout the policy as the “Institution” has implemented this policy to comply with federal regulations required for receiving Public Health Service (PHS) grants.
2.1. This policy seeks to comply with the following federal regulations:
2.1.1. Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought
2.1.2. Title 45 Code of Federal Regulations (CFR), Part 94, Responsible Prospective Contractors
2.1.3. NIH Grants Policy Statement
3.1. FCOI means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct or reporting of research.
3.2. FCOI Official means the Institution official responsible for the implementation of this policy, including the solicitation and initial review of disclosures of SFI from research Investigators. The FCOI official has the discretion to consult other stakeholders to inform and document their decision-making as needed.
3.3. FCOI Management Plan means the written plan developed to manage conflicts by mitigating, reducing or eliminating FCOI(s) so that the design, conduct or reporting of research is free from bias or the appearance of bias.
3.4. Entity means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) from which an Investigator (and/or the Investigator’s spouse and/or dependent children) receives remuneration, or in which any person has an ownership or equity interest.
3.5. Equity Interests include any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
3.6. Financial Interest means anything of monetary value or potential monetary value held by the Investigator, the Investigator’s spouse and/or dependent children whether or not the value is readily ascertainable.
3.7. Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal Agency) that is applying for, or receives PHS research funding. Braincheck is considered an “Institution” for the purposes of this policy.
3.8. Institutional Official means the individual who is legally authorized to act for the Institution, and on behalf of the Institution.
3.9. Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution including, but not limited to, activities such as research, research consultation, teaching, professional/clinical practice, Institutional committee memberships, and service on panels such as Institutional Review Boards (IRB), Institutional Animal Care and Use Committees or Data and Safety Monitoring Boards, etc.
3.10. Investigator means the project director/principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposing of research, including persons who are subcontractors, collaborators or consultants. At the Institution this definition includes, but is not limited to, the following roles: Principal investigator, co-investigators, research coordinators, research associates, collaborators and consultants, and may include research assistants and students as identified by the Project Director/Principal Investigator depending on their specific roles and responsibilities.
3.11. FCOI Management means actions taken to address a FCOI, which can include reducing or eliminating the FCOI, and to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
3.12. Project Director/Principal Investigator (PD/PI) means the project director or principal investigator of a research project.
3.13. PHS Awarding Component means the organizational unit of the PHS that funds the research (e.g., National Institutes of Health)
3.14. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
3.15. Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research through which an investigator collects data through intervention or interaction with animal or human subjects, or from identifiable private information. The term encompasses basic and applied research and product development. The term also includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS or other statutory authority.
3.16. Senior/Key Personnel means the Project Director/Principal Investigator and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
3.17. SFI means
3.17.1. A financial interest consisting of one or more of the following interests of the Investigator (and/or of the Investigator’s spouse and/or dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities
188.8.131.52. 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 the disclosure, when aggregated, exceeds $5,000. See definition of Remuneration and Equity Interests.
184.108.40.206. 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 (and/or the Investigator’s spouse and/or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
220.127.116.11. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
18.104.22.168. Investigator/senior/key personnel also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator/senior/key personnel and not reimbursed to the investigator/senior/key personnel so that the exact monetary value may not be readily available) related to their responsibilities to the Institution; 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, medical center, or research institute that is affiliated with an Institution of higher education.
3.17.2. The term significant financial interest does not include the following types of financial interests:
22.214.171.124. Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution 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.
126.96.36.199. Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local agency, an academy of higher education, an academic teaching hospital, a medical center, or a research facility that is affiliated with an academy of higher education.
188.8.131.52. Income from service on advisory committees or review panels for a federal, state, or local government agency, an academy of higher education, an academic teaching hospital, a medical center, or a research facility that is affiliated with an academy of higher education.
184.108.40.206. Travel by a PHS-funded Investigator that is reimbursed or sponsored by a federal, state, or local government agency, an academy of higher education, an academic teaching hospital, a medical center, or a research facility that is affiliated with an academy of higher education.
3.18. Small Business Innovation Research (SBIR) Program – the extramural research program for small businesses established by the awarding components of certain Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. The term SBIR Program includes the Small Business Technology Transfer (STTR) Program, which was established by Public law 102-564.
4.1. Each year an investigator who conducts research through the Institution must disclose via the electronic system all SFIs that are relevant to an investigator’s Institutional Responsibilities or within 30 days after he/she becomes aware of new SFI or after a FCOI has been eliminated.
4.2. Investigators are required to complete the annual disclosure form even if they have no financial interest to report. Transactional disclosure by the PI is also required at the time a research proposal is submitted on behalf of the Institution in order to ensure compliance with federal disclosure and management requirements.
5.1. Investigator Responsibilities
5.1.1. Investigators are responsible for:
220.127.116.11. Disclosing all SFI(s).
18.104.22.168. Providing updates to disclosed information as needed.
22.214.171.124. If acting as the PD/PI, providing a list of individuals who meet the definition of “investigator” within the required disclosure timeline.
126.96.36.199. Completing all Institution assigned training and education.
188.8.131.52. Completing the annual disclosure form whilst having no financial interests to report.
184.108.40.206. Ensuring that an updated FCOI in Disclosure is on file at the time of IRB approval for any new research proposals.
5.2.1. An FCOI means an SFI that could directly and significantly affect the design, conduct or reporting of research. Examples include, but are not limited to, the following:
220.127.116.11. Investigator (and/or an Investigator’s spouse and/or dependent children) entering into a paid consultancy with an outside entity having an interest in the investigator’s, Institution-based research;
18.104.22.168. Investigator (and/or an investigator’s spouse and/or dependent children) receiving royalties or non-royalty payments related to ongoing research;
22.214.171.124. Investigator (and/or an investigator’s spouse and/or dependent children) having an equity interest (e.g., stocks, stock options, warrants) related to ongoing research;
5.2.2. This policy addresses individual FCOI; however, the Institution may also have conflicts of interest in research whenever the financial interests of the Institution, or of the Institution Official acting within his or her authority on behalf of the Institution, might affect—or reasonably appear to affect—the Institution processes for the conduct, review, or oversight of research. If Institution FCOI(s) are identified via the process described below, they will normally be addressed in a manner that is consistent with this policy.
5.3. Review of FCOIs
5.3.1. The designated FCOI Policy Compliance Manager (Designee) conducts an initial review of all disclosures. If necessary, the Designee obtains additional information from the investigator and other individuals to help determine whether the SFI disclosed is related to a proposed or existing sponsored project or program. The Designee then formally identifies cases that require further review to the FCOI Official. The FCOI Official will review the collected information to determine whether an FCOI exists by considering the following:
126.96.36.199. Impact on integrity of research data;
188.8.131.52. Risks to patient health information;
184.108.40.206. Risks to proprietary information and/or confidential data;
220.127.116.11. Risks to rights and safety of animal and/or human research subjects;
18.104.22.168. Risks to the rights of staff participating in research; and
22.214.171.124. Appearance of FCOI. If a FCOIis identified, the FCOI Official will determine whether the research can be undertaken with appropriate FCOI Management Plan.
5.4. Management of FCOI
5.4.1. For the case of an alleged FCOI, an FCOI Management Plan will be developed by the Designee and FCOI Official. The Management Plan will be developed collaboratively and examples of conditions or restrictions that may be employed to manage conflicts include:
126.96.36.199. Public disclosure of SFI(s) (e.g., when presenting or publishing the research), if appropriate;
188.8.131.52. Disclosure of SFI(s) directly to subjects involved in human research;
184.108.40.206. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of research;
220.127.116.11. Modification of research plan;
18.104.22.168. Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research;
22.214.171.124. Reduction or elimination of the financial interest (e.g., sale of an equity interest);
126.96.36.199. Severance of relationships and/or termination of contract;
188.8.131.52. If an acceptable Management Plan is not determined, appropriate funds will be returned to the agency.
5.4.2. A draft Management Plan will be provided to the Investigator for review and comment before it is finalized. The Investigator and their immediate supervisor must sign the final FCOI Official-approved plan to acknowledge their agreement to comply. If the Institution identifies an SFI that was not disclosed or reviewed in a timely manner it will initiate the review process and an interim management plan will be implemented when necessary.
Investigator compliance with Management Plans will be monitored by the Institution Officials. The frequency of monitoring will be dictated by agency requirements and Management Plan provisions.
5.6. Waiver for Research Involving Vulnerable Populations
5.6.1. Special consideration and scrutiny must be given to protect human subjects in research. Investigators with an identified FCOI or a SFI that could directly and significantly affect the design, conduct, or reporting of the research shall not ordinarily participate in any research involving human subjects. This presumption against the participation in human subjects’ research by financially interested individuals may be rebutted by compelling circumstances. Compelling justification may include factors such as unique investigator expertise, unique Institutional resources, unique access to particular patient populations, nature of the science, level of risk to human subjects and the degree to which the FCOI and the research are related.
5.6.2. The compelling justification and the degree of risk to human subjects must be presented and reviewed by the FCOI Official. If compelling circumstances justify a waiver of this policy, the research will be subject to the development and implementation of a management plan to ensure the safety of human subjects and the integrity of the research. The IRB must review the research with consideration given to the requirements of the management plan developed by the FCOI Official. The IRB may require additional safeguards to be implemented but may not determine less stringent FCOI Management requirements.
5.7.1. Investigators may appeal FCOI Official decisions in writing within 15 days of receipt of the finalized management plan or other decision. The written appeal should include details regarding circumstances which support the request for a proposed revision to the FCOI Official’s decision addressed to an Appeals Committee. An Appeals Committee will be formed for purposes of investigating the appeal and making a final decision. The Appeals Committee will be composed of the Research Designee, the CEO, the CFO, and one member of the Institution management to be determined at the time of the appeal. If the appealing Investigator is either the Research Designee or the CEO, they will recuse themselves from committee decision making. A meeting of the Appeals Committee will be convened to review the SFI information, the Management and Monitoring Plan, and previous meeting minutes to make a decision. The Investigator may be invited to describe reasons for the appeal and to address further questions. The appeals process will take no more than 60 days from the date requested by the Investigator. The decision of the Appeals Committee is final and binding.
5.8.1. Financial and other information disclosed in compliance with this policy will be kept confidential, maintained by the Institution Operations/Human Resources and disclosed only on a need-to-know basis as required to perform appropriate review and evaluation required by the policy, except in the case of required public accessibility of identified FCOI held by senior/key personnel.
5.9.1. Failure on the part of an Investigator to comply with this policy will result in disciplinary action and/or sanctions which may include formal reprimand, non-renewal/termination of appointment or affiliation, additional training requirements, additional supervision, closing existing research or denying future research by the Investigator, and/or any other enforcement action mandated by the applicable funding agency or the Institution.
5.9.2. If a senior/key personnel/investigator fails to comply with the Institution’s FCOI policy, within 120 days of awareness by the Institution, the Institution shall complete a retrospective review of the senior/key personnel/investigator’s activities to determine potential bias.
5.9.3. If a bias is found, the Institution shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias.
5.9.4. The Institution will work with the investigator/senior/key personnel to set up an FCOI management Plan to mitigate the situation.
5.9.5. The Institution is required to mandate that senior/key personnel/investigators disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the investigator/senior/key personnel may lose the right to work on the project.
5.10. Policy Revision
5.10.1. The Institution may modify this policy to conform to organizational changes and circumstances including revisions to federal or state law or regulations. The FCOI Official will have 5 business days to review and comment on any proposed revisions. The Institution’s Research Designee is responsible for granting approval of the policy to be ratified by the CEO. The CEO will review all proposed revisions, in collaboration with his/her staff, and will consider the FCOI Official’s feedback during the review process.
5.10.2. When necessary, procedures will be developed or modified to implement this policy.
5.11. Additional Requirements
The following additional requirements also apply to all research funded by the PHS of the U.S. Department of Health and Human Services and any PHS Awarding Component including the NIH.
184.108.40.206. As required by 42 CFR Part 50, Subpart F, the Institution shall file a report with the NIH providing information on every identified FCOI and the manner in which the FCOI is being or has been managed, reduced, or eliminated.
220.127.116.11. The Institution will provide to the PHS Awarding Component a FCOI report as outlined in the regulations:
18.104.22.168. Initial Report: Prior to expenditure of any funds under the NIH-funded research project, the Institution will provide a FCOI report regarding any SFI found to be a FCOI. The Institution will also provide a FCOI report within 60 calendar days from the date of a new SFI disclosure determined to be a FCOI, a new Investigator with an identified FCOI becomes engaged in the project or when the Institution identifies a FCOI not previously disclosed.
22.214.171.124. This report will include the following information:
126.96.36.199.1. Grant/Contract Number.
188.8.131.52.2. Name of Project Director/Principal Investigator (PD/PI).
184.108.40.206.3. Name of Investigator with the FCOI.
220.127.116.11.4. Nature of the FCOI (e.g., equity, consulting fees, travel reimbursement or honoraria).
18.104.22.168.5. Value of the financial interest 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.
22.214.171.124.6. Description of how FCOI relates to PHS-funded research and the basis for the determination that the financial interest conflicts with such research.
126.96.36.199.7. Key elements of the Management Plan.
188.8.131.52. Annual updates to this report will be submitted to the PHS Awarding Component for the duration of the research project. The annual report will include:
184.108.40.206.1. Status of the FCOI.
220.127.116.11.2. Changes to the Management Plan.
18.104.22.168.3. Justification if FCOI no longer exists.
22.214.171.124. For PHS-funded research that involves subcontractors, subgrantees or subawardees (collectively subrecipients) of other entities, the Institution will require a written agreement that includes terms that establish whether the FCOI policy of the awardee entity or that of the subrecipient entity will apply to subrecipient Investigators. This agreement will specifically address time periods to meet disclosure and/or FCOI reporting requirements.
126.96.36.199. Subrecipient entities who rely on their FCOI must report identified FCOI to the awardee entity in sufficient time to allow the Institution to report the FCOI to the PHS Awarding component.
188.8.131.52. Subrecipients who do not have a policy for FCOI will be required to follow the Institution’s FCOI policy.
184.108.40.206. A subrecipient’s failure to promptly comply with the Institution’s FCOI policy will be considered grounds for immediate termination by the Institution of any applicable subcontract or subaward. The written agreement terms required by the Institution will contain a provision that subrecipients will report to the Institution as the awardee entity, any identified FCOI in sufficient time to allow the Institution to report and manage the FCOI to meet the reporting obligations.
5.11.3. Travel Disclosure
220.127.116.11. PHS-funded Investigators must disclose the occurrence of travel related to their company Institutional Responsibilities that is sponsored or reimbursed by an external organization, regardless of the value. At a minimum the travel disclosure must include:
18.104.22.168.1. Purpose of the trip
22.214.171.124.2. Identity of the sponsor/organizer
126.96.36.199.5. Monetary value, if known
188.8.131.52. The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
184.108.40.206.1. a federal, state, or local government agency
220.127.116.11.2. an academy of higher education as defined at 20 U.S.C. 1001(a)
18.104.22.168.3. an academic teaching hospital
22.214.171.124.4. a medical center, or
126.96.36.199.5. a research facility that is affiliated with an academy of higher education
188.8.131.52. Travel disclosures will be reviewed by the FCOI Official as appropriate, to determine if the travel represents a FCOI with PHS-funded research. Additional information may be requested at the time of review. Disclosure of travel must occur no more than 30 days after the last day of the trip.
5.11.4. Public Accessibility
184.108.40.206. This policy will be posted on the Institution’s public website.
220.127.116.11.1. If the Institution does not have any current presence on a publicly accessible website (and only in those cases), the Institution shall make its written policy available to any requestor within 5 business days of a request received.
18.104.22.168.2. In addition, information concerning identified FCOIs held by senior/key personnel will be available to any requestor within 5 business days. .
22.214.171.124.3. This information may be requested by calling the Institution, at (888)-416-0004 or emailing firstname.lastname@example.org. The written response will include:
126.96.36.199.3.1. Senior/key personnel name.
188.8.131.52.3.2. Senior/key personnel’s role in the research project.
184.108.40.206.3.3. Name of the entity in which the FCOI is held.
220.127.116.11.3.4. Nature of the FCOI.
18.104.22.168.3.5. Approximate dollar value of the FCOI or a statement that the value cannot be readily determined.
22.214.171.124. This information will remain available for three years from the date the information was most recently updated.
5.11.5. Training Requirements
126.96.36.199. PHS-funded Investigators must complete FCOI training and any other relevant training prior to engaging in research related to any PHS-funded grant or contract, and every 4 years thereafter.
188.8.131.52. Training must also be completed as soon as reasonably possible under the following circumstances:
184.108.40.206.1. When relevant training is available.
220.127.116.11.2. This policy changes in a manner that affects Investigator requirements.
18.104.22.168.3. An Investigator is new to the Institution and will be working on PHS funded research.
22.214.171.124.4. An Investigator is found to be noncompliant with this policy or their approved Management Plan.
Investigators participating in, or planning to participate in the design, conduct, or reporting of research including PHS funded research at the Institution have the authority and responsibility for the activities in this policy.