The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of DeepHealth, Inc. (Company) research and to comply with federal regulations. The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). This policy was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
Disclosure of significant financial interests – an Investigator’s disclosure of significant financial interests to an Institution.
Financial conflict of interest (FCOI) – a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report – an Institution’s report of a financial conflict of interest to a PHS Awarding Component.
Financial interest – anything of monetary value, whether or not the value is readily ascertainable.
HHS – the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institution – any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for or receiving NIH research funding. In this policy more specifically: DeepHealth, Inc.
Institutional responsibilities – an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Investigator – the project director or principal Investigator and any other person, regardless of title or position, who is or will be 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.
Manage – taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PD/PI – a project director or principal Investigator of a PHS-funded research project.
PHS – the Public Health Service of the U.S. 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 (NIH).
PHS Awarding Component – the organizational unit of the PHS that funds the research that is subject to this subpart.
Public Health Service Act or PHS Act – the statute codified at 42 U.S.C. 201 et seq.
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. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this policy, the term 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 Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Senior/key personnel – the PD/PI 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.
Significant financial interest –
A. A financial interest consisting of 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:
i. 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 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); 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;
ii. 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 (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
iii. 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. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
C. The term significant financial interest does not include the following types of financial interests:
i. salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;
ii. intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
iii. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;
iv. 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;
v. 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 enter, or a research institute that is affiliated with an Institution of higher education;
vi. 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. 001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
It is DeepHealth’s highest priority to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS-funded grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest (FCOI). It is also DeepHealth’s responsibility to establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance.
Disclosure and Reporting
Each Investigator who is planning to participate in a PHS-funded research must complete a FCOI Disclosure Statement and submit it to the Head of Research and Development (R&D) no later than the time of application for PHS-funded research. Post Award: An investigator or subrecipient must file an FCOI Disclosure statement within 30 days of acquiring or discovering that an FCOI exists for an ongoing project. Annual Disclosure: All investigators and subrecipients working on PHS-funded projects will be required to review DeepHealth’s FCOI policy and fill out an annual FCOI Disclosure Statement.
New award: Prior to DeepHealth’s expenditure of any funds under a PHS-funded research project, DeepHealth shall provide to the PHS Awarding Component an FCOI report regarding any Investigator’s significant financial interest found by DeepHealth to be conflicting and ensure that DeepHealth has implemented a management plan in accordance with regulations. In cases in which DeepHealth identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit an FCOI report to the PHS Awarding Component.
Ongoing Research Project: Requirements for submission of Initial FCOI reports during an Ongoing NIH-funded Research Project.
A. The Institution must submit an FCOI report within sixty (60) days after its determination that an FCOI exists for an Investigator who is newly participating in the project or for an existing Investigator who discloses a new Significant Financial Interest to DeepHealth during the period of award. Although the Institution has up to sixty days to report the identified FCOI to NIH, reports should be submitted during the ongoing project and not after the project period end date.
B. Whenever an Investigator does not disclose timely a previously existing Significant Financial Interest or DeepHealth fails to review a previously existing Significant Financial Interest during an ongoing NIH-funded project, DeepHealth’s designated official(s) shall, within sixty (60) days: review the Significant Financial Interest; determine whether it is related to the NIH-funded research; determine whether a Financial Conflict of Interest exists. If so, DeepHealth will implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage such Financial Conflict of Interest going forward and submit an FCOI report to the NIH.
Annual FCOI Report to NIH:
For any Financial Conflict of Interest previously reported by DeepHealth to NIH, DeepHealth shall provide an annual FCOI report that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports shall specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists.
These Annual FCOI Reports must be submitted to the NIH (e.g., through the eRA Commons for grants and cooperative agreements) for the duration of the project period (including extensions with or without funds) at the same time as DeepHealth is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension (e.g., submission of an extension notification in the eRA Commons or submission of a NIH prior approval request, whichever is applicable.)
In cases in which DeepHealth identifies a Financial Conflict of Interest and eliminates it prior to the expenditure of NIH-awarded funds, DeepHealth shall not submit an FCOI report to the NIH.
Annual FCOI reports are not required as part of the grant closeout requirements. The last submitted Annual Report will be required prior to the issuance of the last year noncompeting award within the project’s competitive segment unless the grant is extended via the Commons or through the issuance of a revised Notice of Award.
In the case when DeepHealth identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by DeepHealth during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a sub recipient), the designated official(s) shall, within 120 days: review the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so:
A. Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
B. a) In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by DeepHealth to constitute a financial conflict of interest; failure by DeepHealth to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, DeepHealth shall, within 120 days of DeepHealth’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.
b) DeepHealth will document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:
- 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);
- Findings of the review; and
- Conclusions of the review.
Revised FCOI: Based on the results of the retrospective review, if appropriate, DeepHealth shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. When bias is not found following the completion of a Retrospective Review, the Institution should not submit a “Revised” FCOI report.
The Institution must submit a new FCOI report if any of the following elements of a previously submitted FCOI report changes:
- Project Number
- Name of Investigator with the FCOI
- Name of the entity
- Nature of the Significant Financial Interest
If the value of a reported SFI changes during the year, the Investigator should disclose the change to the Institution in their annual disclosure. Changes in the value of an SFI do not constitute a “new” FCOI report. The annual FCOI report will provide the status of the existing FCOI and any changes to the management plan that may result due to the increase in value.
Designated Official Responsibilities
DeepHealth has designated the Head of Research and Development, as the official, to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research. It is the official’s responsibility to solicit and review financial disclosure statements from each Investigator who is planning to participate in PHS-funded research.
Upon receipt of any FCOI Disclosure Statement, the DeepHealth official shall:
A. Review all Investigator disclosures of significant financial interests.
B. Determine whether any significant financial interests relate to PHS-funded research as
defined in the glossary of terms above.
C. Determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.
These requirements shall be conducted:
A. When required for an Investigator who is new to participating in the research project or for an existing Investigator who discloses a new SFI; or
B. Within sixty days whenever DeepHealth identifies an SFI that was not disclosed timely by an Investigator or not previously reviewed by DeepHealth.
Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies. If a SFI is identified by the sub-award recipient, they are required to notify DeepHealth of the existence of the conflicting interest within 30 days of the identification of the interest. In addition, the sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations.
Violations of Conflict of Interest Policy
Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of the management plan, DeepHealth’s management shall make recommendations regarding the impositions of sanctions or disciplinary proceedings against the violating individual. In addition, the Company shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The federal agency may take its own action as it deems appropriate, including the suspension of the funding for the Investigator until the matter is resolved.
If the failure of an Investigator to comply with DeepHealth’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, DeepHealth shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken.
Each Investigator, including sub recipient Investigator(s), must complete training prior to engaging in NIH-funded research and at least every four years, and immediately under the designated circumstances:
A. DeepHealth’s Financial Conflict of Interest policies change in a manner that affects Investigator requirements.
B. An Investigator is new at DeepHealth.
C. DeepHealth finds that an Investigator is not in compliance with this policy or
The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes financial conflict of interest. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of DeepHealth engaged in NIH-funded research or its compliance.
The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the training, a certificate of completion must be turned into DeepHealth’s management team. Investigators should retain a copy for their records. This tutorial is related to the Financial Conflict of Interest (FCOI) regulation provided at 42 CFR Part 50 Subpart F on Promoting Objectivity in Research.
Prior to DeepHealth’s expenditure of any funds under a PHS-funded research project, DeepHealth shall ensure public accessibility, via a publicly accessible website or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to DeepHealth that meets the following three criteria:
A. The significant financial interest was disclosed and is still held by the senior/key personnel;
B. DeepHealth determines that the significant financial interest is related to the PHS- funded research; and
C. DeepHealth determines that the significant financial interest is a financial conflict of interest.
The information that DeepHealth makes available via a publicly accessible website or written response to any requestor within five business days of a request, shall include, at a minimum, the following:
a) the Investigator’s name;
b) the Investigator’s title and role with respect to the research project;
c) the name of the entity in which the significant financial interest is held;
d) the nature of the significant financial interest; and
e) the approximate dollar value of the significant 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 be readily determined through reference to public prices or other reasonable measures of fair market value.
The information that DeepHealth posts shall be updated at least annually on DeepHealth’s publicly accessible website. In addition, DeepHealth shall update the website within sixty days of DeepHealth’s receipt or identification of information concerning any additional significant financial interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a significant financial interest of senior/key personnel new to the PHS-funded research project, if DeepHealth determines that the significant financial interest is related to the PHS-funded research and is a financial conflict of interest.
Information concerning the significant financial interests of an individual subject to this section shall remain available, for responses to written requests or for posting via DeepHealth’s publicly accessible website for at least three years from the date that the information was most recently updated.
Records of Investigator FCOI Disclosure forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by DeepHealth for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 74.53(b) and 92.42(b) for different situations.