Purpose
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 Carina Medical LLC (the "Company") research and to comply with federal regulations.
This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR Part 50, Subpart F). This regulation 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. An electronic version of the regulation is found at gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.
Summary of process
Significant Financial Interests (SFI), as defined below, shall be disclosed on the Significant Financial Interest Disclosure Form (Exhibit 1) by an Investigator requesting government-sponsored or company-sponsored funds for a research project, or by an Investigator when a Significant Financial Interest arises during the course of research. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFI Disclosure Form annually.
It is the Principal Investigator's responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal or application for human-subjects approval.
The Significant Financial Disclosure Form and supporting materials are forwarded to the Chief Financial Officer (CFO) for review. The Finance Department will be responsible for evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy.
Advance approval by the President or CFO is required prior to engaging in government-sponsored research. A SFI review must be completed before any expenses are incurred under an award.
Annual updates are required of all Investigators and key personnel participating in research. Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately to the CFO.
Training
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, including all Investigators, consultants, and employees of the Company engaged in NIH-funded research or its compliance. The course is accessible at grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion, a certificate of completion must be turned in to the CFO; retain a copy for your records. This training is required prior to engaging in research relating to any NIH-funded grant, or as deemed necessary by the Company. At a minimum, FCOI training shall be taken every three (3) years.
Key definitions
A complete list of official definitions can be found at 42 CFR 50.603. Key definitions:
- Institution
- Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for, or receiving NIH research funding.
- 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 NIH, which may include collaborators or consultants.
- Institutional responsibilities
- An Investigator's professional responsibilities on behalf of the Institution, including 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.
- 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, including reducing or eliminating it, to ensure 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.
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).
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities, with limited exceptions for excluded sources defined in the regulation.
(3) Significant financial interest does NOT include:
- Salary, royalties, or other remuneration paid by the Institution to the Investigator if currently employed or otherwise appointed by the Institution;
- Intellectual property rights assigned to the Institution and agreements to share in royalties;
- Any ownership interest in the Institution held by the Investigator if the Institution is a commercial or for-profit organization;
- Income from investment vehicles (mutual funds, retirement accounts) where the Investigator does not directly control investment decisions;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or an affiliated research institute;
- Income from service on advisory committees or review panels for the entities listed above.
Procedures
A. Identification of persons required to disclose
The Principal Investigator of a Research project is responsible for identifying all Investigators who have a SFI requiring disclosure under this policy, ensuring a SFI Disclosure Form is prepared and submitted, and ensuring annual updates and disclosures of new or increased financial interests.
B. Submission and review
Every individual having a SFI requiring disclosure under this policy shall prepare a fully completed SFI Disclosure Form and submit it to the CFO. An initial review will determine whether a potential conflict of interest exists. If so, steps will be taken to determine appropriate measures, which may include a management plan with one or more of the following:
- Public disclosure of significant financial interests;
- Review of research protocols by independent reviewers;
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification from participation in all or a portion of the research funded;
- Divestiture of significant financial interests;
- Severance of relationships that create actual or potential conflicts.
All management plans are signed by the Investigator and CFO. Compliance is monitored by the Finance Department.
C. Annual reporting and after-acquired SFIs
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.
D. Violations
Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, the CFO shall make recommendations to the President regarding the imposition of sanctions or disciplinary proceedings. The Company shall follow Federal regulations regarding notification of the sponsoring agency in the event of noncompliance.
E. 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 Finance Department 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).
F. Sub-recipient requirements
Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with 42 CFR Part 50, Subpart F. If a SFI is identified by the sub-award recipient, they must notify the CFO within 30 days of the identification of the interest, and certify that any reported conflicting interest has been managed, reduced, or eliminated in accordance with federal regulations.
G. Federal reporting
The Finance Department is responsible for the reporting of disclosures of SFI in accordance with applicable federal requirements. NIH reports required:
- Initial report — prior to the Company's expenditure of any funds under a NIH-funded research project, the Company must provide to NIH an FCOI report regarding any Investigator SFI found to be a financial conflict of interest in accordance with the regulation.
- During on-going NIH-funded research projects — the Company shall submit an FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, the Company shall submit an FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance.
- 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.
For NIH-funded subaward agreements, contact [email protected].