Significant Financial Interests (SFI) threshold
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De minimis threshold of $10,000 for disclosure generally applies to payments or equity interests
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De minimis threshold of $5,000 for disclosure generally applies to payments for services and equity interests. Includes any equity interest in non-publicly traded entities.
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This topic is consistent with current UNF policy # 4.0170R, Conflicts of Interest and Outside Employment / Activity.
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Which SFIs need to be disclosed (once the threshold is met)
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Only those SFI the Investigator deems related to the PHS-funded research.
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All SFI related to the Investigator’s institutional responsibilities.
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PHS-potentially supported and supported Investigators will complete a PHS FCOI Disclosure Form in accordance with ORSP and AA’s PHS FCOI Disclosure Standard Operating Procedures.
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Excluded from disclosure requirement
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Income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities
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Income from seminars, lectures, or teaching engagements sponsored by and service on advisory 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.
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This topic is consistent with current UNF policy # 4.0170R, Conflicts of Interest and Outside Employment / Activity.
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Types of SFI excluded
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All forms of remuneration are included – specific questions such as mutual funds and blind trusts are addressed in FAQ on the NIH website.
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Excludes 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.
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This topic is consistent with current UNF policy # 4.0170R, Conflicts of Interest and Outside Employment / Activity.
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Travel reimbursements and sponsored travel
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Travel reimbursement is not mentioned explicitly in the regulations but is not excluded from the SFI definition.
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Disclose the occurrence of any reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration). NOT required to disclose 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 will determine if any travel requires further investigation, including determination or disclosure of the monetary value.
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Financial Conflicts of Interest related to travel reimbursements and sponsored travel will be addressed with adequate accommodation for the requirements of the Final Rule.
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Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to the PHS Awarding Component
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- Grant/Contract number
- Project Director/Principal Investigator (PD/PI) or Contact PD/PI
- Name of Investigator with FCOI
- Whether FCOI was managed, reduced, or eliminated
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INITIAL REPORT
Requirements in 1995 reg, plus:
- Name of the entity with which the Investigator has a FCOI
- Nature of FCOI, e.g., equity, consulting fees, travel reimbursement, honoraria
- Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amts between $20K-$100K by increments of $20K; amts above $100K by increments of $50K or statement that a value cannot be readily determined.
- A description how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
- Key elements of the Institution’s management plan
ANNUAL REPORT
- Status of the FCOI
- Changes to the management plan
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Financial Conflicts of Interest will be disclosed to the PHS Awarding Component consistent with ORSP and AA’s proposed PHS FCOI Disclosure Standard Operating Procedures.
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Subrecipient Institutions/Investigators and Reporting of identified FCOIs
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Institutions must take reasonable steps to ensure that Investigators working for subs comply with the regs by requiring those Investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with the regs
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- Incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and include time periods to meet disclosure and/or FCOI reporting requirements
- Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to the awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the PHS Awarding Component (e.g., NIH through the eRA Commons FCOI Module) to meet reporting obligations.
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Financial Conflicts of Interest contract provisions will be included in contractual documents to subrecipients and managed in accordance with ORSP and AA’s PHS FCOI Disclosure Standard Operating Procedures.
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Public Accessibility
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No requirement
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Make certain information available concerning identified FCOIs held by senior/key personnel via a publicly accessible Web site or by a written response to any requestor within five business days of a request, and update such information as specified in the rule.
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Financial Conflicts of Interest will be made available to requestor within five business days of request.
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FCOI training
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No requirement
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Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements
- An Investigator is new to an Institution
- An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan.
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Financial Conflicts of Interest training is offered through CITI and valid for four years: www.citiprogram.org
Financial Conflicts of Interest will be disclosed to the PHS Awarding Component consistent with ORSP and AA’s proposed PHS FCOI Disclosure Standard Operating Procedures.
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Retrospective Review (“Mitigation plan,” discussed in NPRM)
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Not mentioned
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Institution is required to conduct a retrospective review in those cases of non-compliance with the regulation but is not required to report the review to the PHS Awarding Component. The Institution will be required to notify the PHS Awarding Component promptly and submit a report to the PHS Awarding Component only in cases where bias is found. The report will address the impact of the bias on the research project and the actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias.
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ORSP and AA will conduct a retrospective review of issues of non-compliance and report to PHS Awarding Component in accordance with Federal Regulations.
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