Financial Conflict of Interest Policy
Warm Health Technology, Inc (WHT) is committed to protecting the integrity and objectivity of any research activities in which we participate 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.
WHT has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest.
I. PURPOSE AND SCOPE OF POLICY
The Public Health Service (PHS) regulations (42CFR Part 50 Subpart F) (the Regulations) on Promoting Objectivity in Research establish standards for institutions and Investigators to provide a reasonable expectation that the design, conduct and reporting of research funded under PHS grants will be free from bias resulting from investigator financial conflicts of interest. This Policy and the Regulations apply to WHT and Investigators who apply for or receive a prime grant or subaward of PHS funding.
The Regulations require investigators to disclose significant financial interests related to their institutional responsibilities before submitting applications for funding to PHS or to a PHS Grantee. PHS funding includes funding from the National Institutes of Health, the Centers for Disease Control and other organizations. This policy may also be used for subawards under a non-PHS sponsor which adopts the PHS Promoting Objectivity in Research regulations.
This policy establishes a process of disclosure and independent review when an investigator has a Significant Financial Interest (SFI). If WHT determines that such an interest might reasonably appear to affect the research directly and significantly, WHT will develop a mitigation plan to manage or eliminate the conflict.
This policy will be available at the WHT publicly accessible website: https://www.wht.care
II. DEFINITIONS
1. Financial Conflict of Interest
A Financial Conflict of Interest (FCOI) is a SFI that could directly and significantly affect the design, conduct or reporting of PHS funded research.
2. Investigator
The project director or principal Investigator and any other person who is responsible for the design, conduct, or reporting of PHS-funded research, or who applies for such funding, which may include, for example, collaborators or consultants.
3. COI Administrator
An official designated by WHT to solicit and review completed Disclosure Forms from each investigator who is planning to participate in, or who is participating in, PHS funded research and to determine whether any reported SFI is a FCOI. References to the COI Administrator in this document include his/her Delegate.
4. Institutional Responsibilities
Institutional Responsibilities means an investigator’s professional responsibilities performed on behalf of WHT.
5. PHS Awarding Component
PHS Awarding Component means the organizational unit of the PHS that funds the research.
6. Research
Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and socialsciences research. The term encompasses basic and applied research as well as product development (e.g., a diagnostic test or drug).
7. Senior/Key Staff
Senior/Key staff means the PI and any other person identified as Senior/Key staff by WHT in the grant application, proposal or any other report submitted to the PHS Awarding Component.
8. Significant Financial Interest
Significant Financial Interest (SFI) means either of the following:
a. Any interest of the investigator, his/her spouse, and dependent children that reasonably appears to be related to the investigator’s institutional responsibilities, including, but not limited to, one or more of the following:
• With regard to any publicly traded entity, a 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 disclosure, when aggregated, 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) and 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 regard to any non-publicly traded entity, a 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 (or the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest)
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
b. Investigators also must disclose the occurrence of 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 their 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.
Note: The term SFI does not include the following types of financial interests:
• salary, royalties, or other remuneration paid by WHT to the investigator if the investigator is currently employed or otherwise appointed by WHT, including intellectual property rights assigned to WHT and agreements to share in royalties related to such rights
• income from investment vehicles, such as mutual funds and retirement accounts, provided 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, a medical center, or a research institute that is affiliated with an Institution of higher education
• 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. DISCLOSURE REQUIREMENT
Each Investigator who is planning to participate in, or who is participating in, PHS Funded Research shall disclose any Significant Financial Interest (including those of the Investigator’s spouse and dependent children). Such Disclosures shall be made as part of the application submission process.
If no such Significant Financial Interest exists, the Investigator shall submit a “none” disclosure.
Disclosures of Significant Financial Interests or certifications that no such Significant Financial Interests exist shall be made by each Investigator as follows:
a. At or before the time of submission of an application for PHS Funded Research;
b. At least annually during the period of the PHS Funded Research award;
• The annual Disclosure shall include: (a) any new information that was not disclosed to WHT either initially or subsequently (e.g., any FCOI identified
on a PHS Funded Research project that was transferred from another institution); and (b) updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest);
• Annual updates shall be required of all Investigators participating in a PHS Funded Research project, regardless of whether or not a Significant Financial Interest was previously disclosed.
c. Within thirty (30) days of the discovery or acquisition (e.g., through purchase, marriage, or inheritance) of a new Significant Financial Interest.
The Disclosures shall include without limitation the following information:
a. The nature and amount of remuneration received from any entity in the twelve (12) months preceding the Disclosure;
b. The name and address of the entity;
c. If there is an equity interest in the entity, any value as of the date of Disclosure; and
d. With respect to reimbursed or reimbursable travel expenses that require Disclosure: the purpose of the trip; the identity of the sponsor/organizer; the destination; and the duration of the travel.
The COI Administrator shall notify the Investigator if further information is needed, including without limitation a determination or Disclosure of monetary value, in order to decide whether the disclosed Significant Financial Interest constitutes an FCOI with PHS Funded Research. The Investigator shall provide any such additional information, as requested.
IV. REVIEW OF DISCLOSURES AND MANAGEMENT OF FCOIs
1. Review Requirement
Prior to WHT’s expenditure of any funds under a PHS funded research project, the WHT COI Administrator will review all Disclosure Forms with SFIs to determine whether the SFIs relate to the PHS funded research and whether a FCOI exists. If a FCOI exists, the WHT COI Administrator will develop and implement a management plan that specifies the actions that have been, and will be, taken to manage such FCOI.
2. Disclosure/Identification of SFI
Whenever, in the course of an ongoing PHS funded research project, (1) an investigator who is new to participating in the research project discloses a SFI; (2) an existing investigator discloses a new SFI; or (3) WHT identifies a SFI that was not disclosed timely by an investigator or was not previously reviewed by WHT during an ongoing PHS funded research project, the WHT COI Administrator within sixty days of the disclosure will review the SFI to determine whether it is related to PHS funded research and whether a FCOI exists. If a FCOI exists, the WHT COI Administrator will develop and implement, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage such FCOI. Depending on the nature of the SFI, WHT may determine that additional interim measures are necessary with regard to the investigator’s participation in the PHS funded research project between the date of disclosure and the completion of WHT’s review.
3. Public Accessibility
WHT shall make FCOI details available by written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:
a. The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;
b. The Institution determines that the significant financial interest is related to the PHS-funded research; and
c. The Institution determines that the significant financial interest is a financial conflict of interest.
The following information regarding the FCOI must be provided.
a. Project number
b. Name of the investigator with the FCOI, title, and role with respect to the research project
c. Name of the entity with which the investigator has a FCOI
d. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
e. Value of the financial interest (dollar ranges are permissible: $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 readily be determined through reference to public prices or other reasonable measures of fair market value; this information must be updated at least annually as well as within 60 days of the following events:
• WHT’s receipt or identification of information concerning any additional SFI of the senior/key staff for the PHS funded research project that was not previously disclosed; or
• upon disclosure of any SFI of senior/key Staff new to the PHS funded research project and meeting the disclosure criteria. The website shall note that the information is current as of the date shown and is subject to the required updates. Any SFI posted to the website shall remain available for at least three years from the date that the information was most recently updated by WHT.
4. Management of FCOI
Examples of conditions or restrictions that may be imposed to manage a FCOI include, but are not limited to the follow actions:
a. Public disclosure of the FCOI (e.g. when presenting or publishing research)
b. For research projects involving human subjects, disclosure of the FCOI directly to participants
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 FCOI
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
g. Severance of relationships that create financial conflicts
5. Retrospective Reviews
Whenever a FCOI is not identified, disclosed, or managed in a timely manner or an investigator fails to comply with a FCOI management plan, WHT has additional review and reporting obligations. If in these situations WHT determines that a SFI constitutes a FCOI, WHT’s COI Administrator will, within 120 days of WHT’s determination of noncompliance, complete a retrospective review of the investigator’s activities and the PHS funded research project to determine whether any PHS funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. WHT is required to document the retrospective review. Documentation shall include all of the following key elements:
• Project number
• Project title
• PI or contact PI if a multiple PI model is used
• Name of the investigator with the FCOI
• Name of the entity with which the investigator has a FCOI
• 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)
• Findings of the review
• Conclusions of the review.
As necessary, based on the results of the retrospective review, WHT will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, WHT will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. Minimally, the mitigation report must include the key elements documented in the retrospective review, a description of the impact of the bias on the research project, and WHT’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; 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, WHT will submit FCOI reports annually. Depending on the nature of the
FCOI, WHT may determine that additional interim measures are necessary with regard to the Investigator’s participation in the
PHS funded research project between the date that the FCOI or the investigator’s noncompliance is determined and the completion of WHT’s retrospective review.
6. Monitoring
Whenever WHT implements a management plan, WHT will monitor investigator compliance with the management plan on an ongoing basis until the completion of the PHS funded research project.
V. REPORTING OF FINANCIAL CONFLICTS OF INTEREST
1. Initial FCOI Report
Prior to WHT’s expenditure of any funds under a PHS funded research project, WHT will provide to the PHS Awarding Component a FCOI report regarding any investigator’s SFI found by WHT to be a FCOI. Additionally, WHT will ensure that it has implemented a management plan in accordance with Section IV of this policy. In situations in which WHT identifies a FCOI and eliminates it prior to the expenditure of PHS awarded funds, WHT is not required to submit a FCOI report to the PHS awarding Component.
2. Subsequent FCOI Reports
For any SFI that WHT identifies as a FCOI after WHT’s initial report during an ongoing PHS funded research project, WHT will provide to the PHS Awarding Component a FCOI report regarding the FCOI within 60 days of identification of the FCOI. Additionally, WHT will ensure that it has implemented a management plan in accordance with Section IV of this policy and, if required, complete a retrospective review and a mitigation report according to Section IV of this policy.
3. Contents of a FCOI Report
Any FCOI report required under Section V will include sufficient information to enable the PHS awarding component to understand the nature and extent of the FCOI and to assess the appropriateness of WHT’s management plan. The FCOI report will include the following minimum Information:
a. Project number
b. PI or contact PI if a multiple PI model is used
c. Name of the investigator with the FCOI
d. Name of the entity with which the investigator has a FCOI
e. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
f. Value of the financial interest (dollar ranges are permissible: $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 readily be determined through reference to public prices or other reasonable measures of fair market value
g. A description of how the financial interest relates to the PHS funded research and the basis for WHT’s determination that the financial interest conflicts with such research
h. A description of the key elements of WHT’s management plan including the following minimum information:
• Role and principal duties of the conflicted investigator in the research project
• Conditions of the management plan
• Explanation of how the management plan is designed to safeguard objectivity in the research project
• Confirmation of the investigator’s agreement to the management plan
• Explanation of how the management plan will be monitored to ensure investigator Compliance.
4. Annual FCOI Report
For any FCOI previously reported by WHT regarding an ongoing PHS funded research project, WHT will provide to the PHS awarding component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS funded research project.
The annual FCOI report will specify whether the FCOI is still being managed or explain why the FCOI no longer exists. WHT will provide annual FCOI reports to the PHS awarding component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS awarding component.
VI. SUBCONTRACTORS/CONSULTANTS
Subcontractors/consultants who perform services within the definition of an investigator must maintain a policy that complies with the aforementioned regulatory requirements or comply with this policy. All applicable subcontract/consulting agreements must contain a clause that requires compliance with the applicable federal regulations either through a policy maintained by the subcontractor/consultant or this policy. Examples of appropriate clauses are shown below.
Financial Conflicts of interest – Compliance with Subcontractor’s Policy
Subcontractor agrees to comply with any and all requirements relating to Public Health Service funded projects. Without limiting the generality of the foregoing, Subcontractor, its employees, and agents agree to comply with the applicable requirements of 42 CFR Part 50 or 45 CFR Part 94.
Subcontractor certifies that it maintains a policy that requires compliance with these requirements. Subcontractor shall report all identified financial conflicts of interests to WHT immediately and submit a mitigation plan for WHT’s review and approval. WHT is under no obligation to approve a mitigation plan. WHT reserves the right to terminate this Agreement or request removal of subcontractor’s employee or lower-tier subcontractor as a result of subcontractor, its employee, or lower tier subcontractor’s financial conflict of interest. Subcontractor must include this clause in its agreements with any applicable lower-tier subcontractors or consultants. Failure to comply with these requirements is a material breach of this Agreement.
Financial Conflicts of interest – Compliance with WHT’s Policy
Subcontractor agrees to comply with any and all requirements relating to Public Health Servicefunded projects. Without limiting the generality of the foregoing, subcontractor, its employees and agents agree to comply with the applicable requirements of 42 CFR Part 50 or 45 CFR Part 94. Subcontractor agrees to comply with WHT’s Policy on Financial Conflicts of Interest in Public Health Service.
Subcontractor shall report all identified financial conflicts of interests to WHT immediately and submit a mitigation plan for WHT’s review and approval. WHT is under no obligation to approve a mitigation plan. WHT reserves the right to terminate this Agreement or request removal of subcontractor’s employee or lower-tier subcontractor as a result of subcontractor, its employee, or lower-tier subcontractor’s financial conflict of interest. Subcontractor must include this clause in its agreements with any applicable lower-tier subcontractors or consultants. Failure to comply with these requirements is a material breach of this Agreement.
VII. NON-COMPLIANCE
If the failure of an investigator to comply with this Policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS funded research, WHT is required to promptly notify the PHS awarding component of the corrective action taken or to be taken by WHT. The PHS awarding component will consider the situation and, as necessary, take appropriate action, or refer the matter to WHT for further action, which may include directions to WHT on how to maintain appropriate objectivity in the PHS funded research project. Sponsors may impose special award conditions or may suspend or terminate the award and/or debar an investigator from receiving future awards in the event of failure to comply with applicable federal regulations on disclosure, review, and management of SFI related to federally sponsored projects.
Failure by WHT staff to comply with this policy may be grounds for disciplinary action.
VIII. RECORD RETENTION
Records regarding Disclosure Forms, determinations made by WHT’s COI Administrator, and WHT’s actions regarding management of a FCOI will be retained by WHT for three years beyond the date of the final expenditure report submitted to the PHS Awarding Component under an award or, where applicable, from other dates specified in 45 CFR 74.53(b) and 45 CFR 92.42(b).
IX. TRAINING
Each investigator must complete training prior to engaging in PHS funded research. Acceptable forms of training include, but are not limited to, the NIH Office of Extramural Research FCOI online tutorial (available here: grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm), the Collaborative Institutional Training Initiative (CITI) FCOI course, or other accredited training courses.
Additionally, investigators must complete training at least every four years and must immediately complete training under the following circumstances:
• WHT’s FCOI policy changes in a manner that affects investigator requirements
• An investigator is new to WHT
• WHT determines that an investigator is not in compliance with WHT’s FCOI policy or management plan.
X. POINT OF CONTACT
If you have a conflict of interest or if you have a question to discuss, contact the WHT COI Administrator.