利益冲突(COI)
RSCA (COIR)的财务利益冲突
Faculty who participate in RSCA may have to disclose additional information on Conflicts of Interest. 你必须完成的信息披露类型 是否必须披露取决于资金来源.
Regardless of the funding source, the information disclosed is reviewed by the Associate 研究副总裁或其指定人员. 因为如果……将会很困难 not impossible) to determine whether or not any particular financial relationship has caused bias in a project, this review seeks to identify the faculty member’s financial interest could directly and significantly affect the design, conduct, or reporting of the research, or that the outcome of the research could potentially impact the 教员的经济利益.
If the AVP determines that the potential for a Financial Conflict of Interest exists, they will recommend a plan to manage this potential and ensure that the RSCA activities 可以畅通无阻地进行. AVP将要求教师同意管理 与系主任和院长一起制定计划.
菠菜网lol正规平台将尽可能对所有披露的信息保密. However, it is important to remember that FCOI disclosure documents may be considered a public record and information from some federal disclosures may be requested under the Freedom of Information Act.
Resources
私人资助的RSCA
The State of California requires the Principal Investigator (the person with principal )在下列情况下，填写700-U表格:
- The research is funded or supported, in whole or in part by a contract or grant from
a nongovernmental entity; or
- The research funds from a nongovernmental entity have been earmarked by the donor
对于特定的研究项目或特定的研究人员.
请注意，一些非营利实体不受这些规定的约束. To find 如果你的非盈利赞助人是免税的，请退出 研究合规.
需要700-U披露的RSCA项目的一些例子如下:
- 私人公司赠送给单个研究人员的资金;
- 非免税非营利基金会的赠款;
- 研究经费由制药公司提供，用于进行临床试验.
Resources
§ 18755. 经济利益声明:某机构的个人或人员 以研究计划为主要责任的高等教育[pdf]
HR 2015-05 Attachment A: The California State University Conflict of Interest Policy 首席研究员
政府资助的RSCA
Each federal and state agency has different rules regarding what information needs to be disclosed. 所有调查人员(任何负责设计、实施或 reporting of the research) must complete the 菠菜网lol正规平台 Disclosure Form for Government Funded Research if your research is funded by any federal, state, or municipal agency.
常见问题- RSCA中的利益冲突
Training
Q: I was told that I 必须参加花旗COI培训吗 before my proposal can be submitted, 但我已经通过CSU Learn接受了COI培训. 为什么我的CSU Learn不是COI 足够的证书?
A: The COI training through CSU Learn focuses on California Regulations related to 利益冲突适用于所有政府雇员. 花旗COI培训，上 the other hand, covers federal regulations that are specific to conflicts of interest 在研究活动中. 这两门课程的范围非常不同，因此， we cannot accept the CSU Learn training certificate in place of the CITI COI certificate.
Q: Why do I have to take both the COI training through CSU Learn and the CITI COI training?
A: Any Principal Investigator who conducts privately-funded research will be required 通过CSU Learn完成COI培训. If you are an investigator (responsible for the design, conduct, or reporting) of government-funded 研究，你将被要求参加花旗COI培训. 如果你获奖了 无论是私人资源还是公共资源，你都必须两者兼得.
Q: I completed 负责任的研究行为 (RCR) training through CITI, and that 包括一个COI模块. 为什么我的RCR证书不够用?
A: While the RCR program contains important information on how to identify and mitigate conflicts of interest, the CITI “利益冲突” course is more rigorous and covers the federal regulations that apply to research activities in more detail. To obtain the CITI COI certificate, you must complete both modules of the course: “Overview, Investigator Responsibilities, and COI Rules” and “Institutional Responsibilities 因为它们会影响调查人员.你还必须通过每个模块结束时的测验 成绩不低于80%.
Q: My proposal will be submitted to a government agency, but it only includes training 活动，而不是RSCA. 为什么我还需要参加花旗COI培训?
A: Anyone who submits a proposal to a government agency through the 研究基金会 必须参加花旗COI培训吗. 我们目前没有区分培训 基于提案内容的需求.
Disclosure
问:我正在向公共机构提交提案. 谁必须披露自己的财务状况 interests?
A: All key personnel must complete the “Financial Conflict of Interest (FCOI) Disclosure Form for All Government Agencies” on behalf of themselves and their spouse/domestic 伴侣和/或受抚养子女.
问:我如何知道我应该披露哪些财务信息?
A: You should disclose any financial information that is related to your institutional responsibilities, that is, your professional actions on behalf of 菠菜网lol正规平台, which can include research, research consultation, professional practice, institutional committee 会员资格:小组、董事会或委员会的会员资格和服务.
也有一些例外. 以下财务利益不需要披露:
- Salary, royalties, or other remuneration paid to the investigator by their institution;
- 从其机构获得的特许权使用费或许可收入;
- 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;
- income from seminars, lectures or teaching engagement sponsored by a federal, state, 或当地政府机构或美国政府机构.S. 定义为高等教育机构 20 U.S.C. 100(a), an academic teaching hospital, a medical center, or a research institute 这是一个隶属于美国政府的机构.S. 高等教育机构.
问:我如何知道我是否需要披露我的报销或赞助旅行?
A: Reimbursed or sponsored travel will need to be disclosed if it meets three criteria:
- The travel was related to your institutional responsibilities, that is, any related 您以专业身份从事的任何活动;
- 这次旅行是由一个不是美国政府的实体赞助或报销的.S. Federal 州或地方政府机构.S. 美国高等教育机构.S. academic 大学教学医院.S. 医疗中心或附属的研究机构 with a U.S. 高等教育机构;
- The cost of the travel, when aggregated over 12 months, exceeds $5,000 (for example, a single trip per year costing $2,000 would not require disclosure but three trips 在一年的时间里，每个花费2000美元的数据需要被披露。).
Q: What if the travel expenses were paid on my behalf and I don’t know the actual amount?
A:请根据目前的市场价值估计一下这次旅行的费用.
问:我披露的信息怎么办?
A: Your disclosure is reviewed by the Associate Vice President for Research (AVP) 或其指定人员. 如果您报告的信息被确定为重要的 Financial Interest (based on the sponsor’s thresholds and 菠菜网lol正规平台 policy), the AVP will 确定是否存在潜在的财务利益冲突. The AVP will recommend a plan to manage this potential for conflict and ensure that the research can proceed. 这个计划也将得到你的学院主席和院长的批准.
问:这些信息是保密的吗?
答:上海外国语大学将尽最大可能对所有披露的信息保密. However, it is important to remember that FCOI disclosure documents may be considered a public 根据加州法典，政府法典第81008(a)条记录. 您的信息 disclosure may also be requested by members of the public under the California Public 记录法或信息自由法.
Resources
42 CFR第50部分，45 CFR第94部分(NIH) [pdf]
CIRM Grants Administration Policy for Discovery, Translation, and Education Projects [pdf]
