Financial Conflict of Interest Policy

Overview

No research or sponsored program activities occurring at Lewis & Clark College shall be adversely affected by an Investigator’s financial interests. Investigators who apply to or receive funding from the designated external funders below must comply with both the College’s Code of Ethics Policy and this more stringent Financial Conflict of Interest (FCOI) Policy. This FCOI Policy addresses federal regulations that require Investigators to disclose Significant Financial Interests (SFI), and institutions of higher education to identify, manage, and report potential Financial Conflicts of Interest (FCOI) in research funded by specific government agencies. The existence of a Significant Financial Interest does not necessarily represent a Financial Conflict of Interest, but it must be disclosed. Further, a Conflict of Interest is not prohibited in and of itself, but it must be managed appropriately and in accordance with the funder’s requirements and applicable regulations.

Purpose

This policy fulfills the requirements of the National Science Foundation and Public Health Service (PHS) agencies, including the National Institutes of Health, with regard to Financial Conflicts of Interest. NIH requires recipient institutions and investigators to comply with the requirements of 42 CFR 50 Subpart F (grants and cooperative agreements) and 45 CFR Part 94 (contracts). The Public Health Service (PHS) regulations promote objectivity in research and provide a reasonable expectation to funders that the design, conduct, or reporting of research will be free from bias by any conflicting financial interest of an Investigator. If there are substantive differences between this policy and the regulations, the regulations shall take precedence.

Scope

This policy applies to all Investigators at Lewis & Clark College who apply for or receive research support from the National Science Foundation, agencies of the Public Health Service (including but not limited to NIH, CDC, SAMHSA), and any other funder who incorporates PHS regulations into their policies. Investigators are subject to funder-specific requirements, which may include mandatory training, disclosures and related updates, and reporting of foreign interests and travel reimbursed or sponsored by other organizations. This policy also applies to subrecipients on federal awards from these same agencies (see below).

Definitions

Investigator: personnel responsible for the design, conduct, or reporting of research under the terms of a federal grant or contract, or the sub award to a federal grant or contract.

Financial Conflict of Interest (FCOI): exists when the Institutional Official (IO) reasonably determines that an Investigator’s Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the funded research.

Significant Financial Interest (SFI): anything of monetary value related to the institutional responsibilities of an Investigator, which includes but is not limited to the following: 1) remuneration received in the 12 months prior to disclosure that exceeds $5,000 when aggregated; 2) equity interest exceeding $5,000; 3) gains from intellectual property rights (e.g., patents, copyrights, royalties); or 4) travel paid for or reimbursed by someone or entity other than a government agency, college or university, or academic medical institution.

Subrecipient: an entity that receives a sub award from the prime recipient and is accountable to the prime recipient for the use of the Federal funds provided by the sub award

Policy Statement

All Investigators who apply for or receive research funding from the agencies identified above must participate in required training, provide required disclosures, and participate in the management of any identified FCOIs following procedures established by the Sponsored Projects and Research Compliance (SPARC) Office. SPARC will inform Investigators of this policy, impose this policy on subrecipients, retain records, and follow reporting requirements. While managed by the SPARC Office, the Institutional Official (IO) is responsible for ensuring implementation of this policy, reviewing disclosures to determine if an FCOI exists, and managing any potential conflict. The IO may suspend all relevant activities until they are satisfied that the potential FCOI is resolved or other appropriate action is implemented.

Disclosures: Each Investigator must disclose information requested, including SFIs, Sponsored Travel, and/or Foreign Interests, for themselves and their spouse, domestic partner, and/or dependent children to the College. Disclosures must be current at the time of application for funding. At a minimum, forms must be completed 1) prior to proposal submission; 2) annually for Investigators with active grants, commensurate with the funded project period; 3) within 30 days of acquiring or discovering any new reportable significant financial interests; and/or 4) within 30 days for Investigators joining the College. Principal Investigators must ensure that required disclosures have been submitted by all other co-investigators and Senior/Key Personnel on their funded project.

Training: Investigators with PHS funding, including NIH, are required to complete designated Conflict of Interest training prior to engaging in PHS funded research, and to renew this training at least every four years and/or immediately as required by the funding agency or Institutional Official (IO). Investigators applying for funding from the National Science Foundation or any other funding agency are strongly encouraged to complete COI training. Lewis & Clark reserves the right to require that any Investigator complete relevant training.

Review: The SPARC Office will review and make an initial determination on all submitted Disclosures. If SPARC determines that a potential conflict of interest with the funded research may exist, SPARC will inform the Institutional Official (IO) and the IO will review. A conflict of interest exists when the IO reasonably determines that a Significant Financial Interest could directly or indirectly affect the design, conduct, or reporting of funded research, teaching, or mentoring. If a potential FCOI is identified, the Investigator will be informed how the determination was made and the FCOI’s relationship to the sponsored research will be documented and shared with the federal sponsor as required.

Management of FCOIs: If an FCOI is identified, the Institutional Official (IO) or designee will work with the Investigator to prepare and implement a written plan to manage the conflict and monitor ongoing compliance. Written plans are designed to manage, reduce, or eliminate any Financial Conflict(s) of Interest; plans must meet applicable legal requirements, facilitate the local resolution or management of any conflict, and protect the sensitivity of disclosed information. Both the Investigator and the IO must approve the plan in writing before any related research begins. Investigators must participate in and comply with any FCOI management plan, including any retrospective review, mitigation plan, and ongoing compliance monitoring.

Retrospective Review: If the IO determines that a Financial Conflict of Interest was not identified or managed in a timely manner, the IO or designee will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research. This review may occur, for example, if an Investigator fails to disclose an SFI that is determined to be a FCOI, or an Investigator fails to comply with an FCOI management plan. SPARC will submit or update any reports required by the funding agency.

Administrative Actions or Sanctions: Lewis & Clark reserves the right to impose sanctions on Investigators for failure to disclose SFIs or abide by this Policy or related procedures.

Monitoring Subrecipients: Lewis & Clark College is responsible for ensuring that all subrecipients are compliant with federal Financial Conflict of Interest regulations. The College will incorporate, as part of subrecipient agreement(s), terms specifying whether the subrecipient institution will follow Lewis & Clark’s FCOI Policy or its own. This agreement will address designated disclosure and reporting requirements that allow both Lewis & Clark and the subrecipient to be compliant with federal regulations.

Reporting: The College will endeavor to keep financial disclosures, management plans, and related information confidential to the extent permitted by law. However, federal regulations require that institutions report information about Investigators’ potential and identified conflicts of interest to funding agencies and, in some cases, the public: reporting requirements vary by funding agency. The SPARC Office will prepare and submit all reports in accordance with applicable regulations and/or official funding agency policy within the specified period(s) and as required, and notify the Investigator of such disclosures. Required reports may include, but are not limited to the following:

• the existence of real or potential conflicts of interest, and assurances that the COI has been managed, reduced, or eliminated
• initial and ongoing/annual FCOI reports to the funding agency
• information relating to any Investigator’s disclosure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of an FCOI
• certain information concerning identified FCOI via a publicly accessible Web site or by a written response to any requestor, and updates to such information as specified

Record Retention: The SPARC Office will retain all financial disclosures, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the funding agency.