Financial Conflict of Interest Policy
Purpose and Applicability
The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest (FCOI) in order to safeguard the integrity of the research of RevOpsis Therapeutics and to comply with federal regulations.
The 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50, Subpart F), was developed to establish standards to ensure the design, conduct, and reporting of research funded under grants provided by the National Institutes of Health (NIH) will be free from bias resulting from Investigator financial conflicts of interest.
Summary
RevOpsis Institutional Responsibilities:
1. Certify that the company has an up-to-date written and enforced process to identify and manage FCOI
2. Promote and enforce compliance by Investigators
3. Manage FCOI and provide initial and ongoing FCOI reports
4. Make FCOI and Significant Financial Interest (SFI) information publicly available
5. Fully comply with regulations
Investigator Responsibilities:
1) Complete FCOI training designed by the NIH and submit the certificate of completion to the FCOI Policy Administrator at regular intervals, including:
a) Prior to beginning of federally-funded research
b) At least every 3 years thereafter
c) When the Institution changes policy or in cases of non-compliance of an Investigator
2) Complete FCOI disclosure form annually, and/or when a SFI arises during the research. FCOI forms should be submitted to the FCOI Policy Administrator.
As required by the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50, Subpart F), RevOpsis Therapeutics requires Principal Investigators (PIs) and Key Personnel on all NIH funded research projects to disclose a listing of significant financial interests (and those of their spouse and dependent children) that could be reasonably expected to bias the design, conduct, or reporting of the project.
Definitions
| Institution | Any domestic or foreign entity, public or private (excluding a federal agency), applying for, or receiving NIH research funding. |
| Investigator | The project director (PD) or principal investigator (PI) 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 NIH, which may include collaborators or consultants. |
| 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 Animal Care and Use Committees, Institutional Review Boards or Data and Safety Monitoring Boards. |
| Financial Interest | Anything of monetary value, whether or not the value is readily ascertainable. |
| Financial conflict of interest (FCOI) | A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research. |
| 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. |
| 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 NIH by the Institution under the Regulations. |
| Significant Financial Interest (SFI) | (1) 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; (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) Upon receipt of income related to intellectual property rights and interests (e.g., patents, copyrights) that exceeds $5,000. (2) 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 excluded sources provided in the Regulations. For example, if the PI travels to a scientific seminar but does not pay or receive reimbursement from the Company directly (i.e., the travel was paid for by a third party/sponsor), the PI is required to disclose basic information to the Company relating to the trip, such as the purpose of the trip, identify of the payer/sponsor, destination and duration. The Company is required to determine if additional information is required (e.g., monetary value) and whether the travel constitutes an FCI with NIH-funded research. SFI Exclusions:Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution; Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights; Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; 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 Income from service on advisory committees or review panels for a federal, state or local government agency, Institution of higher education as defied 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 Disclosure Form (SFIDF) | Company form by which the required person provides an itemized disclosure statement about SFI categories. The form is submitted to the FCOI Policy Administrator upon assignment of work sponsored by a federal, state, or local government grant, yearly thereafter, and when any occurrences of a new SFI arise. |
Procedures
Training
The NIH Financial Conflict of Interest tutorial was designed by the NIH to provide education on what constitutes a financial conflict of interest. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of RevOpsis Therapeutics 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 submitted to the FCOI Policy Administrator. Investigators should retain a copy for his or her records.
This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by the Company due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or new to the Company. At a minimum, the FCOI training shall be taken every three (3) years.
Identification of Persons Required to Disclose a Significant Financial Interest
It shall be the responsibility of the research project’s PI to identify all Investigators who have an SFI requiring disclosure under this policy and to ensure that an SFI Disclosure Form is prepared and submitted. In addition, the PI shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed.
Submission and Review of Significant Financial Interest Disclosure Form
Every individual having a SFI requiring disclosure under this policy shall prepare a fully completed SFI Disclosure Form that shall be submitted to the FCOI Policy Administrator. An initial review of the SFI Disclosure Form will be conducted to determine whether a potential for conflict of interest exists. If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the SFI Disclosure Form. A management plan may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy. The management plan may require one or more of the following actions (but not limited to) to be taken to manage, reduce or eliminate any actual or potential FCOI:
- Public disclosure of significant financial interests;
- Review of research protocols by independent reviewers;
- Monitoring of research by independent reviewers;
- Modification of research plan;
- Disqualification from participation in all or a portion of the research funded;
- Divesture of significant financial interests;
- Severance of relationships that create actual or potential conflicts
Annual Reporting and After
All Investigators shall provide annual SFI Disclosure reports or more frequently if required by the management plan. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI Disclosure Form within 30 days of discovering or acquiring the new SFI. It is the PI’s responsibility to ensure that any newly acquired Investigator on a research project submits the required SFI report to the FCOI Policy Administrator.
Violations of Financial 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 a management plan, the FCOI Policy Administrator shall make recommendations to the CEO 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.
Within 120 days of the Institution’s determination of noncompliance, a complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project should be completed to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. The Institution shall document the retrospective review, including: the project number; project title; the PD/PI or contact PD/PI if a multiple PD/PI model is used; the name of the Investigator with the FCOI; the name of the entity with which the Investigator has a financial conflict of interest; the reason(s) for the retrospective review; the detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.); the findings of the review; and the conclusions of the review.
If bias is found, the Institution must notify NIH promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., 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, the Institution will submit FCOI reports annually as recommended above.
Record Keeping
Records of Investigator SFI Disclosure Forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by the FCOI Policy Administrator for three (3) years from the date the final expenditure report is submitted to the sponsoring agency, as required. This includes records of all Investigator disclosures of financial interests and the Institution’s review of and/or response to such disclosure, and all actions under the Institution’s policy or retrospective review.
Sub-recipient Requirements
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 an SFI is identified by the sub-award recipient, they must notify the FCOI Policy Administrator of the conflicting interest within 30 days of its identification. 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.
Federal Reporting
The FCOI Policy Administrator is responsible for the reporting disposition of matters involving disclosures of SFI in accordance with applicable federal requirements. The following reports are required by the NIH:
A) Initial report – prior to the Company’s expenditure of any funds under a NIH funded research project, the Company must provide to the NIH an FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation.
B) On-going reports – If it is determined that a new SFI exists during NIH-funded research projects, the Company shall submit an updated FCOI report. If an SFI was not disclosed timely, the Company shall submit a FCOI report to the NIH within 60 days of the discovery and complete a retrospective review within 120 days of discovery of noncompliance.
C) Annual FCOI report – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.