Conflict of Interest Policy for PHS-Funded Research at SfN, Lecture notes of Neuroscience

Download Conflict of Interest Policy for PHS-Funded Research at SfN and more Lecture notes Neuroscience in PDF only on Docsity! 1 SfN FCOI Policy 5/13/2021 SOCIETY FOR NEUROSCIENCE (SfN) Financial Conflict of Interest Policy (FCOI) for Public Health Service (PHS)-Supported Funding Purpose of Policy This Financial Conflict of Interest (FCOI) policy provides guidelines for identifying, disclosing, and managing significant financial conflicts of interest related to Public Health Service (PHS)- funded SfN programs. This policy is intended to meet or exceed requirements under the 2011 Revised Financial Conflict of Interest regulation, 42 CFR Part 50 Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.” This policy applies to each Investigator, as defined by the regulation, who is planning to participate in or is participating in PHS-funded SfN activities, including serving as a Principal Investigator (PI) or Co-Principal Investigator (Co-PI) on NIH-supported SfN grants. This policy outlines the administrative process for identifying FCOIs, promoting and enforcing Investigator compliance with the regulation, managing FCOIs, providing initial and ongoing FCOI reports, and making FCOI and Significant Financial Interest (SFI) information available to HHS. SfN’s Signing Official (SO) for PHS-supported activities serves as the Institutional Official for this policy and is responsible for ensuring the implementation of this policy. This policy operates in addition to other SfN Conflict of Interest policies by which SfN employees, Council, committee members, and other volunteers must abide. Training (42 CFR 50.604(b)) For each new Investigator for any planned or actual PHS-funded SFN projects, the SfN Institutional Official will inform the Investigator of this FCOI policy, the federal regulation, and the Investigator’s disclosure responsibilities. The Institutional Official will provide each Investigator with a copy of this policy and a FCOI Disclosure Form to complete, sign, and return to SfN. Each PHS-supported Investigator will be required to complete training on this FCOI policy: (1) prior to engaging in research related to any PHS-funded grant; (2) at least every four years; and (3) immediately, if SfN revises its FCOI policy in such a way that affects Investigator requirements, if an Investigator is new to the SfN project, and/or if an Investigator is not in compliance with the policy or management plan. Disclosure (42 CFR 50.603, 42 CFR 50.604) The Institutional Official will provide a SfN FCOI Disclosure Form to each Investigator. This Disclosure Form must be completed and signed by the Investigator: (1) no later than at the time of application for PHS-funded research, (2) at least annually during the period of the award; and (3) within 30 days of discovering or acquiring a new SFI. Each Investigator must disclose any SFI, and those of the Investigator’s spouse and dependent children, related to the Investigator’s institutional responsibilities that meets or exceeds the regulatory definition of SFI outlined in 42 CFR 50.604(e)(1)-(3): (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, 2 SfN FCOI Policy 5/13/2021 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. (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 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. (3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including 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, 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. Review (42 CFR 50.604(d)(f)(g), 42 CFR 50.605(a)(1-4)) The Institutional Official or his/her designee will review all Investigator SFI disclosures and determine: (1) whether an Investigator’s SFI is related to PHS-funded research; and (2) if so related, whether the SFI is an FCOI (i.e., a SFI that could directly and significantly affect the design, conduct, or reporting of the PHS-funded research). If the Institutional Official determines the FCOI can be managed, the Institutional Official will develop and implement a written management plan, intended to reduce or eliminate the conflict, as appropriate, within 60 days. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before participating or continuing participation in any related PHS-sponsored activity. The Institutional Official will monitor