DeNovX, LLC Financial Conflict of Interest Policy
This policy documents the requirements and responsibilities associated with identifying and managing a financial conflict of interest (FCOI) to safeguard the integrity of DeNovX, LLC (Company) research and to comply with federal regulations. This policy has been developed to address and to comply with the specific federal agency requirements as defined in the FCOI Regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F and any revisions). These regulations and this policy 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.
The following key definitions are provided to promote an understanding of the federal regulations of FCOIs. A complete list of definitions can be found at 42 CFR 50.603.
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 (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 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 (as defined below) that could directly and significantly affect the design, conduct, or reporting of NIH funded research.
Manage: action taken to address an FCOI, which can include reducing or eliminating the FCOI, 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 regulation.
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, an SFI exists if the value of any remuneration received from the publicly traded entity in the 12 months preceding the disclosure and the value of any equity interest in the publicly traded entity as of the date of disclosure, when aggregated, exceeds $5,000.00;
(ii) With regard to any nonpublicly traded entity, an SFI exists if the value of any remuneration received from the nonpublicly traded entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000.00, 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 or copyrights)
(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 reimbursed or sponsored by sources excluded from this regulation. For example, if the PI travels to a scientific seminar but does not pay or receive direct reimbursement from the Company (i.e., the travel costs were paid by a third party), the PI is required to disclose basic information to the Company relating to the trip; for example, purpose of the trip, the identity of the payer/sponsor, the destination, and the duration of the trip. The Company is required to determine if additional information is required (e.g., monetary value) and whether the travel constitutes an FCOI with NIH funded research.
(3) The term SFI 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 any 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 in 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
(vi) Income from service on advisory committees or review panels for a federal, state or local government agency; institution of higher education as defined in 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.
SUMMARY OF PROCESS
An SFI shall be disclosed on the SFI Disclosure Form by an Investigator requesting federal funds for a research project or by an Investigator when an SFI arises during the course of research. Regardless of whether an SFI exists, all Investigators and key personnel are required to submit an SFI Disclosure Form annually. Any Investigator or key personnel who has acquired a new or increased financial interest during the course of a research project shall report it immediately using the SFI Disclosure Form.
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 SFI Disclosure Form and supporting materials are forwarded to the Chief Operating Officer or the Chief Executive Officer, who are 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 Chief Operating Officer or the Chief Executive Officer is needed prior to engaging in, and seeking reimbursement of expenses in any government sponsored research under a grant award.
The NIH Financial Conflict of Interest Tutorial (alternately available at the following URL: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm) was designed by the National Institutes of Health (NIH) to provide education and training on what constitutes a FCOI and the various responsibilities of Investigators and institutions. This course is required for anyone participating in an NIH funded research project, including Investigators, consultants, and employees of DeNovX, LLC engaged in NIH funded research or compliance activities. Upon completion of the training, a certificate of completion must be turned into the Chief Operating Officer, and individuals may retain a copy for their own records. This training is required prior to engaging in research relating to any NIH funded grant or as deemed necessary by DeNovX, LLC due to changes in the FCOI policy, noncompliance of an Investigator, key personnel, or employee new to the Company. At a minimum, this FCOI training shall be completed once every four (4) years.
Identification of persons required to disclose an SFI: It shall be the responsibility of the PD/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 PD/PI shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed.
Submission and review of SFI Disclosure Form: Every individual having an SFI requiring disclosure under this policy shall complete an SFI Disclosure Form that shall be submitted to the Chief Operating Officer or the Chief Executive Officer. After an initial review of the SFI Disclosure Form by the Chief Operating Officer or the Chief Executive Officer, as the case may be, a determination will be made as to whether a potential FCOI exists. If it is determined that there is a potential FCOI, then the measures needed to address the SFI identified in the SFI Disclosure Form will be determined. A management plan may be needed to outline the terms, conditions, and restrictions, if any, needed to ensure compliance with the FCOI policies. The management plan may include, but will not be limited to, any of the following measures in order to manage, reduce, or eliminate any actual or potential FCOI: public disclosure of SFIs, review of research protocols by independent third parties, monitoring of research by independent reviewers, modification of the research plan, disqualification of an Investigator from participation in all or a portion of the funded research, divestiture of SFIs, or severance of relationships that create actual or potential FCOIs. All management plans are required to be signed by the Investigator, the Chief Operating Officer, and the Chief Executive Officer. Compliance of the management plan shall be monitored by the Chief Operating Officer and the Chief Executive Officer.
Annual reporting and after-acquired SFIs: All Investigators shall provide SFI Disclosure reports on an annual basis, or more frequently if required by a management plan. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI Disclosure Form within thirty (30) days of discovering or acquiring the new SFI. It is the PD/PI’s responsibility to ensure that any Investigators new to the Company or project complete the required SFI Disclosure Form.
Violations of FCOI Policy: Investigators are expected to comply fully and promptly with this FCOI 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 Chief Operating Office or the Chief Executive Officer shall make recommendations that target compliance, which may include sanctions or disciplinary actions against the violating individual. 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.
Record keeping: Records of Investigator SFI Disclosure Forms, and of actions taken to manage actual or potential FCOIs, shall be retained by the Company for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 75.361, depending on the situation.
Subrecipient requirements: Subaward recipients must comply with this policy or will provide evidence that their organization is in compliance with the FCOI Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F, and any revisions) and that their portion of the research project, as detailed in their subaward agreement is in compliance with their institutional policies. If an SFI is identified by the subaward recipient, they are required to notify the PD/PI of the existence of the conflicting interest within thirty (30) days of the identification of the SFI. In addition, the subaward recipient must certify and assure that any reported conflicting interest has been managed, reduced, or eliminated in accordance with federal regulations.
Federal Reporting: The Chief Operating Officer and Chief Executive Officer are responsible for reporting SFI disclosures in accordance with applicable federal requirements. The following reports are required by the NIH:
1. Initial report: prior to the Company’s expenditure of any funds under an NIH funded research project, the Company must provide to the NIH an FCOI report for any Investigator with an SFI found to be an FCOI in accordance with the regulation.
2. Ongoing NIH funded research projects: the Company shall submit an FCOI report within 60 days after its determination that an FCOI exists. If an FCOI was not disclosed timely, the Company shall submit an FCOI report to the NIH within sixty (60) days of the discovery and will complete a retrospective review within four (4) months of any discovery of noncompliance.
3. 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.