研究合规
NJIT is committed to conducting research in compliance with established federal, 国家和地区法规, 政策和程序.
The 研究合规 unit in the central office helps to ensure that all research activities undertaken by faculty, 工作人员, 申博太阳城的学生都遵守道德规范和联邦法规, 状态, 当地的, 制定法规和政策. It also serves as a resource for the NJIT research community for regulatory analysis and interpretation, 政策发展, 培训和教育. 本股监督和负责下列领域:
- 负责任的研究行为
- 人类受试者研究通过IRB
- Biosafety:重组DNA, BSL-3病原体, 选择代理, 生物危害, 放射性物质, Radiation-Producing设备, 激光
- 研究中动物的护理和使用 (through Rutgers University-Newark Institutional Animal Care and Use Committee)
- 研究中的出口管制
- 研究中的利益冲突与外部活动
- 研究不当行为
- 联邦信息安全管理法
所有申博太阳城的员工,包括学生, 工作人员, 博士后, 研究协会, faculty and collaborators are expected to be in compliance with NJIT and federal requirements with respect to responsible conduct of research. 此培训可通过 合作机构培训计划.
人类被试 or associated data can only be used for research purposes after required review and institutional approval in compliance with federal requirements. Under a Federal wide Assurance with the United States Department of 健康 and Human Services, 所有涉及人类受试者的研究都由申博太阳城的教职员工进行, 工作人员, 无论是在校学生还是校外学生, 包括在其他机构, 必须在启动之前由新泽西理工学院审查和批准吗 院校覆核委员会.
一个完整的审查和批准,从 机构Biosafety委员会 is required for all research activities and protocols dealing with live cells, 组织, 任何基因工程生物的环境释放, 人类基因治疗, 以及任何在实验室或温室里进行的实验. The IBC also has the responsibility of reviewing a variety of experimentation that involves hazardous biological materials (e.g., human bodily fluids, cell lines, infectious agents) and other potentially hazardous agents (e.g.致癌物质). The IBC is a federally mandated review body established under the NIH Guidelines for 研究 Involving Recombinant DNA Molecules to provide 当地的 review and oversight of nearly all forms of research utilizing recombinant DNA.
申博太阳城依赖于 Rutgers-Newark IACUC 供审批 脊椎动物研究 conducted by NJIT researchers in order to ensure compliance with all regulations, 保护动物福利的政策和标准. NJIT researchers contemplating the use of animals in their research or in the early stages of preparing to use animals in their research should contact Dr. 拉朱·塔莫特(拉.k.tamot@申博太阳城.edu),研究合规与诚信助理主任. 埃里克·赫瑟林顿(erich@申博太阳城.edu), NJIT研究办公室执行主任.
Export Control 法规是管理出口的联邦法律, 装运, 传输, 转移, 或者与美国分享.S. 到国外去, 人, 或者技术实体, 技术数据, 技术援助, 项目或材料. 美国.S. 美国国务院和美国.S. Department of Commerce each administers different export control regulations. 此外,你.S. 政府制裁限制前往, 以及金融交易, 某些国家, 个人, 和组织, 包括一些国外的大学和研究机构. NJIT致力于遵守适用的美国法律.S. 有关物品出口的法律法规, services and technology by or on behalf of the University and the Office of 研究 collaborates with other university offices, 比如总法律顾问办公室, to identify and manage export risks for national security and foreign policy reasons.
研究中的利益冲突与外部活动
NJIT遵循了几个联邦, 状态, University guidelines that govern the disclosure of an outside activity, 的关系, 或利益, the management of personal conflict of interest (COI) and conflict of commitments (COC) in research. The Committee on Conflict of Interest is charged with identifying and addressing any potential, 实际, apparent conflicts of interest in research that result from related external interests. The Office of 研究 supports the Committee while working collaboratively with the NJIT community to manage, 减少, 或消除任何已识别的潜能, 实际, 或者察觉到利益冲突. 每位NJIT研究人员必须通过Streamlyne进行披露和认证, all professional activities outside of NJIT and any financial interests in outside entities that the researcher, his/her immediate family members may have that are related or have the appearance of affecting, the researcher's professional judgment in exercising any university duty or responsibility.
研究不当行为
研究不端行为被定义为捏造, 伪造, 或者是求婚中的抄袭, 执行, 或者回顾研究, 或者报告研究结果. All 个人 affiliated with NJIT have an ethical responsibility to foster an environment that promotes intellectual honesty and integrity as well as act if they suspect research misconduct has occurred.
Many 研究合规 training courses including RCR training for required certification can be accessed online through the 合作机构培训计划 software programs.
申博太阳城教师, 学生, 博士后, associates and 工作人员 can access the CITI software programs and courses through the website www.citiprogram.org.
请通过网站在线注册 www.citiprogram.org 然后选择“New Jersey Institute of Technology”来设置您的帐户. 一旦您的帐户注册, you will be able to select and go through the specific courses in 研究合规.
简化研究合规
研究办公室正在开发 Streamlyne, 一个电子研究管理软件, to serve as a dynamic content management system that will aid in the oversight of NJIT’s compliance related needs. 截至2020年7月,流线型用于IRB和COI管理.
FISMA -联邦信息安全管理法
什么是FISMA:
美国nited States 联邦信息安全管理法 (FISMA) defines a framework, 标准, guidelines to protect United States Government (USG) sensitive information. FISMA适用于大学研究界, 国家机构, entities and service providers including those who use data provided by the federal government. Universities that have contracts with the US government need to comply with FISMA if the data is regulated. 任何违规行为都可能减少联邦资金或招致其他处罚.
FISMA合规:
FISMA defines roles and responsibilities for all agencies and related entities to protect sensitive information from compromise and ensure that compliance requirements of the federal government are met. 具体地说, FISMA requires entities and program officials to perform annual reviews of information security programs. FISMA compliance follows the guidelines and best practices laid out by the National Standards for Information Technology (NIST) 标准.
资源:
- NJIT’s Office of 研究 provides institutional support and services to the research community. 这包括 pre-award服务, post-award管理, 研究合规. The Office of 研究 has experience with FISMA compliance and can provide assistance accordingly. It is the researchers’ responsibility to be aware of FISMA requirements and seek assistance and guidance.
- FISMA由国土安全部管理. 更改和更新可在 http://www.国土Safety部.gov/fisma.
- Questions about FISMA should be directed to the assistant director of 研究合规 and integrity. http://research.gharsocho.com/contact.
监管参考联邦信息处理标准: