财务利益冲突 in Research 政策

负责人: 教务长办公室
相关法律 & 政策: 42 CFR第50部分，F子部分

目的

To promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, 行为, or reporting of sponsored research will be biased by any conflicting financial interest of an investigator.

联邦法规(42 CFR Part 50), Subpart F) require investigators to disclose any financial interest that may present an actual or potential conflict of interest in relationship to externally sponsored projects prior to the submission of a proposal for funding. Institutions must develop specific mechanisms by which conflicts of interest will be satisfactorily managed, 减少或取消 prior to the expenditure of any funds on an award. Should a new reportable significant conflict of interest arise at any time, 调查人员必须表明这种兴趣.

政策

首席研究员, 项目总监, 首席调查人员, and any other person 行为ing research at 威尼斯游戏大厅 who is responsible for the design, 行为, or reporting of research that is being funded or proposed for funding by an external sponsor must disclose whether they (including their spouse, 国内合作伙伴, 孩子们, and dependents) have significant financial interests related to the work being 行为ed under the sponsored project.
〇经济利益 Anything of monetary value received within the preceding 12 months, including but not limited to:

薪金或其他服务付款(例如.g., consulting fees or honoraria) received from for-profit entities
股权权益(e).g. 股票, 股票期权或其他所有权权益, excluding mutual funds or other retirement accounts*) or
知识产权(e.g. patents, copyrights, trademarks, licensing agreements, and royalties from such rights)

*For a complete description of exclusions, see 42 CFR第50部分，F子部分

过程

At the time a grant application is made and submitted to the Director of Grant 项目, the principal investigator is required to fill out the “Disclosure of Financial Interests Related to Sponsored Research Proposals” form. The PI is responsible for ensuring that all appropriate personnel complete the document and return it to the Director of Grant 项目. If a conflict of interest should arise during the course of the project, the investigator must immediately disclose the interest to the 业务办公室.

If the investigator indicates that a financial interest exists, the Director of Grant 项目 will notify the 业务办公室 for further review. If the 业务办公室 determines that there is a potential conflict of interest, the CFO and Provost will 行为 additional evaluation of the information. If it is determined there is a financial conflict of interest, the 业务办公室 will work with the investigator to develop a resolution to manage, 减少或消除冲突. The resolution will be incorporated into a management plan. This document will be executed prior to the expenditure of funds and kept on file in the 业务办公室.

根据42 CFR§50.604(2), “Prior to the institution’s expenditure of any funds under the award, the institution will report to the PHS Awarding Component, the existence of a conflicting interest (but not the nature of the interest or other details) found by the institution and assure that the interest has been managed, 减少或取消 in accordance with this subpart; and, for any interest that the institution identifies as conflicting subsequent to the institution’s initial report under the award, the report will be made and the conflicting interest managed, 减少, 或取消, 至少暂时是这样, 在确认后60天内.”

要求, 威尼斯游戏大厅 agrees to make information available to the sponsoring agency regarding all conflicting interests and how these interests have been managed, 减少, 或取消.

When the project is submitted to the 业务办公室 for annual renewal, the investigators will be required to update their financial disclosures.
所有机构外的调查人员, 是否通过分包, 咨询协议, 等. will also be required to submit financial disclosures to 威尼斯游戏大厅 on an annual basis as required by federal regulation.
Records of all financial disclosures and all actions taken by the institution will be maintained for three years from the date of submission of the final expenditure report.

公共可访问性

Information concerning identified financial conflict of interests held by senior/key personnel will be provided within five business days upon written request to the 业务办公室.

培训

Each investigator will complete either in-person FCOI training with the Post-Award Administrator, or complete individual training via an online computerized module prior to engaging in research related to any government 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
这个机构新来了一名调查员
The institution finds an investigator noncompliant with Carroll’s FCOI policy or management plan.

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