财务利益冲突

Conflicts of interest in research may occur when outside financial interests compromise, 或者表现出妥协的样子, the professional judgment of a researcher when designing, 进行, 或者报告研究.

一个的 重大财务利益披露政策 seeks to maintain the appropriate balance among all competing interests that have the potential to produce bias in the design, 行为, 或者研究报告 or distort technology transfer transactions.

2011年，公共卫生服务(PHS)发布 revised financial conflict of interest (FCOI) regulations (42 CFR 50) that apply to any institution receiving funds from a PHS entity. 一个的 revised FCOI policy went into effect in August 24, 2012, 符合联邦法规.

本FCOI网页的目的是提供:

• Up-to-date and adequate information on the new requirements.
• A location to display that UNE has an FCOI policy in compliance with regulatory requirements.
• 连结至 强制性的培训, 完整的政策, and essential details on processes that investigators must follow to meet these new requirements.

政策变化

UNE’s revised FCOI policy reflects the following changes:

所有UNE调查员

• Lower Monetary Threshold: The minimum monetary threshold for reporting an SFI is lowered from $10,000 to $5,000, with a $0 threshold for disclosure of equity in a non-publicly traded company. 有效的11月, 2020, the policy has been clarified to also require disclose of all financial interests received from a foreign Institution of higher education or the government of another country (which includes local, 省, 或其他国家的同等政府).  看到 http://grants.国家卫生Research院.gov/grants/guide/notice-files/NOT-OD-18-160.html
• 一个新的 信息披露形式 已经发展到反映新政策.
• 新粉红单(UNE提案传送表) 已经发展到反映新政策 and should be used for all new submissions.

Only for Investigators engaged in Public 健康 Service (PHS) Funded research

• 强制性培训要求
  All PHS-funded "Investigators" must complete online FCOI training (provided by UNE through 花旗集团的培训) prior to the expenditure of funds on any newly-funded projects, 包括非竞争性延续奖. 培训 must be completed at least every four years. Current PHS awards (pre-8/2012) are not subject to these new requirements until the noncompeting continuation award. However, we encourage investigators to take the FCOI training to fulfill this mandatory requirement. The definition of an "investigator" includes the Principal Investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, 行为, 或者研究报告. While this online training is required for PHS-funded investigators, it is encouraged for all non-PHS-funded investigators as well.
• Disclosure of all externally-funded travel reimbursements
  PHS-funded investigators must disclose all travel reimbursements that are either sponsored by (that is paid by an outside entity directly to the investigator) or reimbursed directly to the investigator from an outside entity for travel, 除了一些例外. Exceptions include: travel reimbursements from an institution of higher education, 联邦/州/地方政府, 学术型教学医院, 医疗中心, or a research institute affiliated with an institution of higher education. This disclosure requirement does not apply to funding provided to the investigator via the institution (for example as part of sponsored research projects, 由部门酌情拨款或捐赠基金支付). Travel disclosures are to be made via the UNE FCOI Disclosure Form, 部分F, 旅行完成后30天内.
• New requirements for FCOI information made accessible to the public
  The new regulations require public transparency of investigators’ FCOI management plans either by a publicly-accessible website or by a written response within five business days to a request for an institution’s financial conflict of interest policy. This includes providing certain information regarding any key personnel whose significant financial interests are related to PHS-funded research. UNE will provide written response to any request submitted to the Director of 研究 Administration within five days.

培训

All PHS-funded investigators must complete mandatory online training prior to engaging in PHS-funded research. 培训 completions will be recorded automatically. Completion records will be made available to the Office for Sponsored Programs (OSP) for verification of Investigator compliance with the 强制性的培训 requirement.

接受培训

资源

• 大学的FCOI披露政策(PDF)
• UNE的FCOI披露表格(PDF)
• 公共卫生服务条例
  • 主要修订摘要(PDF)
  • 最终规则全文(PDF)
  • 小灵通规例全文
• 美国国立卫生研究院 财务利益冲突常见问题