利益冲突常见问题
Federal regulations require that all persons who are involved in the design, conduct, 或者研究报告必须如此 完成年度COI披露. Federal regulations requirements also mandate that faculty, staff and students who are key personnel on research protocols involving the use of human subjects, animals, or biohazardous materials in research also be screened for potential COIs, NJIT requires the completion of this information each time a research proposal is submitted for external funding.
You must report all personal financial interests from external sources, including travel. This would include any interest in a company, business, foundation or other organization that:
- Provides products or services in your academic, clinical, or research discipline or area of study. An example would be a manufacturer that has products in your professional discipline, 临床实践区, 或研究领域;
- Will likely make use of your scholarly work or research – either directly or indirectly. 例如, 公司能不能, foundation or organization use your scholarly work or research in its own product line, 或者它会被竞争对手使用?
- 是一个行业的成员吗, trade, advocacy group or professional association that funds scholarly work, research or is an advocate for funding in your professional discipline or area of study or expertise;
- Has some other relationship not described above that could reasonably appear to impact your research or other obligations to the University;
- You receive royalties directly from intellectual property that you have licensed to an external entity.
A "financial interest" is any monetary value that belongs to you, 你的配偶或伴侣, 或者你受抚养的孩子. The financial interest becomes "significant" if it meets ANY of the following conditions:
- All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, 结合时, exceeds $10,000 or represents more than 5% ownership interest in any single entity. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
- ANY equity interest held in a non-publicly traded entity, 或者超过10美元,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
- Income from intellectual property rights and interests received from an entity other than NJIT that exceeds $10,在披露之前的12个月里,他总共获得了5000美元.
请注意,美国.S. Public Health Service (PHS) and its agencies define a "significant" financial interest (SFI) at a lower level than do other federal agencies, 比如国家科学基金会, 以及该大学长期以来的10美元水平,000以上所述.
具体地说, if you have worked on PHS funded research in the past year, 或希望在今年从事公共卫生服务资助的项目, a financial interest becomes “significant” if it meets ANY of the following conditions:
- All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, 结合时, exceeds $5,000. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
- ANY equity interest held in a non-publicly traded entity, 或者超过5美元,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
- Income from intellectual property rights and interests received from an entity other than NJIT that exceeded $5,在披露之前的12个月里,他总共获得了5000美元.
PHS agencies include the National Institutes of Health (NIH), 美国食品和药物管理局, 美国疾病控制与预防中心, 印第安人保健服务, 卫生资源和服务管理局, Substance Abuse and Mental Health Services 政府 (SAMHSA), 医疗保健研究和质量局(AHRQ), 医疗保险中心 & 医疗补助服务(CMS), 儿童及家庭署, 或安老管理(AOA).
Federal regulations and university policy do not require you to disclose the following types of financial interests:
- 报销或支付由十大网赌平台支付的差旅费, or covered by a sponsored program agreement managed through the Office of Research;
- Royalties received from NJIT for intellectual property owned by the university;
- Royalties resulting from traditional academic publishing activities such as the publication of text books or other educational materials;
- NJIT支付给您的任何工资或其他报酬.
Faculty, staff, and students are required to disclose the occurrence of any reimbursed or sponsored travel paid for directly or reimbursed by an external entity.
However, this disclosure requirement does not apply to:
- 任何由美国政府报销、赞助或支付的旅行.S. 美国政府机构.S. 高等教育机构,美国.S. 学术教学医院、医疗中心或美国医疗机构.S. 隶属于美国科学研究所的研究机构.S. higher education institution; and
- Any travel reimbursement or payment of travel made by NJIT, 大学学院, 部门或单位, or travel covered by a sponsored program agreement managed through the Office of Research.
为了研究目的, if it is determined that a significant financial conflict of interest exists that may directly and significantly affect the design, 进行或报告一项特定的研究项目, then the case will be reviewed by the Vice Provost for Research.
Financial conflicts of interest disclosures made for research purposes will be reviewed by the Executive Director, 赞助研究项目管理, 以符合适用的法规. Determination that a conflict exists will require the PI to work with the Chair and Dean to provide a mitigation plan that will be reviewed and approved by the Executive Director, 赞助研究项目管理.