谁需要申请??
你需要IRB批准吗?
When considering whether or not you need IRB approval, ask yourself these questions:
- Does the project meet the definition of research with human subjects?
- Do you need approval if the research does not take place at UTC?
- Are t在这里 any types of research that do not require an IRB application and/or approval?
- What if I just want to present my research at a UTC-hosted research conference such as the Spring 研究 and Arts Conference?
Does the project meet the definition of research with human subjects?
While most research involving human subjects is regulated by “的 Common Rule”— regulations that most federal agencies have agreed to use in common—some 研究 may be subject instead to Food and Drug Administration (FDA) regulations specific to the development and 测试 of medical devices. 这可以包括移动健康和/或健身应用程序, 人工智能/机器学习算法, 和软件, 以及用于诊断的物理项目, 治疗, or preventing disease or intended to affect the structure or any function of the body. More information 赌球app the types of projects that are FDA-regulated can be found 在这里. If you are planning to conduct medical device research, contact (电子邮件保护) 为指导,标准的UTC IRB申请流程不适用.
根据共同规则，研究被定义为:
"(l)...系统的调查, 包括研究开发, 测试, 和评估, 被设计用来发展或促进一般化的知识.(《赌球app》，美国联邦法典第45卷第46条.102(l)).
“人类受试者”指:
"(e)(1) ...a living individual 赌球app whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, 并使用, 研究, or 分析 the information or biospecimens; or (ii) Obtains, 使用, 研究, 分析, or generates identifiable private information or identifiable biospecimens.(美国联邦法规第45卷第46条).102(e)(1)).
的 意图 to contribute to the body of knowledge in a field is key to the definition, whether or not the completed research makes such a contribution or is accepted for publication.
更像是视觉学习者? 参考我们的 人类受试者研究决策树
以下所有活动都可以被认为是研究:
- 试点研究(研究发展)
- 面试程序
- 调查
- 实验干预
- 医疗图表审查
- Case 研究 (involving more than three individuals or a regulated investigational drug or device)
- 对可识别的现有数据进行分析.
UTC全体教员, 工作人员, 和学生使用人类受试者或可识别的, private information 赌球app human subjects to conduct research are required to have prior approval from the IRB before the research is initiated. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds. All research proposals must be reviewed by the IRB and no individual, 审核委员会主席或其指定人员除外, 可以免除审查提案吗. 研究 that is conducted without IRB approval is not in compliance with UTC policy and federal regulations. In these circumstances, a non-compliance report will be sent to the Provost for further action.
Do you need approval if the research does not take place at UTC?
根据UTC策略, research must be reviewed by the IRB in advance of any involvement of human subjects. This includes research conducted at another institution in this country or research conducted abroad. It includes collaboration with investigators at other institutions, and it includes research in which other institutions or researchers gather the data for a UTC researcher.
In some situations, the UTC IRB will defer to the IRB of record at alternate research locations. This is a formal process and involves coordination with both IRB offices and the 科研诚信办公室. For further information on this, please contact the 科研诚信办公室.
Are t在这里 any types of research that do not require an IRB application and/or approval?
T在这里 are a few categories of research that may involve human subjects but do not require IRB applications and/or approval. 这些包括以下列出的研究类型:
- UTC教师和学生评价;
- Program evaluation research to benefit UTC and carried out by UTC administrative officials and/or their designees;
- 质量保证/质量改进计划
- Projects designed to enhance or improve curricula offerings at UTC;
- 联合技术公司员工绩效评估;
- 田纳西州要求对项目进行评估;
- Marketing research (designed to market the institution as a product).
- 学术和新闻活动(e).g., 口述历史, 新闻, 传记, 文学批评, 法律研究, 和历史学术), including the collection and use of information that focus directly on the specific individuals 赌球app whom the information is collected.
- 案例研究(如果只包括一个), 两个, or three individuals and not involving the use of a regulated drug or device).
除了上面的例子, all other research involving human subjects must complete an application. If the Principal Investigator has any doubt 赌球app whether or not their project meets these criteria, it is their responsibility to contact the IRB Chair/科研诚信办公室 for clarification. Service projects involving human subjects (including grants and programs that provide services and include an evaluative component that might be determined to research) are encouraged to contact the IRB Chair/科研诚信办公室 to ensure that they are exempt from IRB review. Any secondary data analysis of these data used for scholarly publication requires IRB approval.
What if I just want to present my research at a UTC research conference such as the Spring 研究 and Arts Conference?
研究 conferences hosted by UTC are open to the community. T在这里fore, research results presented at these events meet the federal definition of having an "...对可概括的知识有所贡献的意图." All research with human subjects that is presented at such events must have received IRB approval prior to data collection. 看到 UTC研究会议指导页面 了解更多信息.