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Financial Conflict of Interest Policy

For Investigators Receiving Public Health Service Funds

Executive Summary
The American Society for Tropical Medicine and Hygiene’s (ASTMH) programs and activities which are sponsored by the Public Health Service (PHS), including, but not limited to the National Institutes of Health (NIH), must be free of any financial or other conflict of interest from investigators. Investigators who apply to or receive funding from the PHS/NIH with or on behalf of ASTMH must comply with this Financial Conflict of Interest (FCOI) Policy. This FCOI Policy addresses federal regulations that require Investigators to disclose Significant Financial Interests (SFI), and institutions to identify, manage, and report potential FCOI in programs funded by specific government agencies. The existence of a SFI does not necessarily represent a FCOI, but it must be disclosed. Further, a FCO 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 NIH with regard to FCOIs. 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). If there are substantive differences between this policy and the regulations, the regulations shall take precedence.

Scope
This policy applies to all Investigators on ASTMH-led programs, activities or research who apply for or receive program or activity support from the PHS/NIH, and any other funder who incorporates PHS/NIH 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 sub-recipients on federal awards from these same agencies (see below).

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

Financial Conflict of Interest: exists when the Board’s Executive Committee (EC), alerted by the Chief Operating Officer (COO), reasonably determines that an Investigator’s SFI could directly and significantly affect the design, conduct, or reporting of the funded research.

Significant Financial Interest: a financial interest of the investigator (or spouse or dependent children) that is related to the investigator’s institutional responsibilities:
 
  • Regarding publicly traded entities, anything of monetary value related to the institutional responsibilities of an Investigator, which includes but is not limited to the following: any type of remuneration (e.g., salary, honoraria, consulting fees) received in the 12 months preceding the
  • disclosure and any equity interest in the entity (e.g., stock, stock option, ownership interest) as of the date of disclosure, when aggregated, which exceeds $5,000;
  •  
  • Regarding non-publicly traded entities, an SFI exists for anything of monetary value related to the institutional responsibilities of an Investigator, which includes but is not limited to the following: any type of remuneration (e.g., salary, honoraria, consulting fees, paid authorship) received in the 12 months preceding the disclosure when aggregated, exceeds $5,000 or any equity interest (e.g., stock, stock option, ownership interest), as of the date of disclosure; or
  •  
  • Receipt of any income from intellectual property rights and interests (e.g., patents, copyrights, royalties).

Any travel related to the investigator’s institutional responsibilities that is sponsored or reimbursed by someone or entity other than a government agency (federal, state or local), society, institution of higher education or research institute affiliated with such an institution (see 20 USC 100(a)), or academic teaching institution must be disclosed.

Any financial interests received from any foreign entity, including governments (e.g., national, provincial, local), educational institutions, commercial interests (whether publicly traded or not), or non-profit organizations.

SFI does not include such intellectual property rights or renumeration paid by ASTMH to the investigator if currently employed or appointed by ASTMH.

Sub-recipient: 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 NIH must participate in required training, provide required disclosures, and participate in the management of any identified FCOIs following procedures established by ASTMH. ASTMH will inform Investigators of this policy, impose this policy on sub-recipients, retain records, and follow reporting requirements. ASTMH 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 and submit information requested, including SFIs, sponsored travel, and/or foreign interests, for themselves and their spouse, domestic partner, and dependent children to the ASTMH COO for initial review. Disclosures must be current at the time of application for funding. Travel disclosures must include, at a minimum, purpose, identity of funder, destination and duration. 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 SFIs; and/or 4) within 30 days for Investigators joining the funded program, activity or research. 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/NIH funding are required to complete designated FCOI training prior to engaging in PHS/NIH funded research, programs or activities and to renew this training at least
every four years and/or immediately as required by the funding agency or ASTMH. The training module is available at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html.

Review: The ASTMH COO will review and make an initial determination on all submitted Disclosures. If the COO determines that a potential FCOI with the funded activity may exist, the COO will inform the Executive Committee (EC) and the EC will review. A FCOI exists when the EC reasonably determines that a SFI could directly or indirectly affect the design, conduct, or reporting of a funded program, activity, 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 COO 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 FCOIs; 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 COO must approve the plan in writing before any related activity 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 COO determines that a FCOI was not identified or managed in a timely manner, the COO 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. The COO will submit or update any reports required by the funding agency.

Administrative Actions or Sanctions: ASTMH reserves the right to impose sanctions on Investigators for failure to disclose SFIs or abide by this policy or related procedures.
Monitoring Sub-recipients: ASTMH is responsible for ensuring that all sub-recipients are compliant with federal

FCOI regulations. The Society will incorporate, as part of sub-recipient agreement(s), terms specifying whether the sub-recipient institution will follow ASTMH’s FCOI Policy or its own. This agreement will address designated disclosure and reporting requirements that allow both ASTMH and the sub-recipient to be compliant with federal regulations.

Reporting: The Society 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 any identified FCOIs to funding agencies and, in some cases, the public. Reporting requirements vary by funding agency. ASTMH 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 FCOI, and assurances that the FCOI 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: ASTMH 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.

Approval Date
September 12, 2022
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