研究 Integrity and Human Subjects Protection
Any 威尼斯安卓版 (CCC) employee, 部门, 子公司, or associated party who wishes to conduct research on behalf of CCC must first communicate its intent to the Office of 制度研究 for review and coordination using the Intent to 研究 Application Form below. 这包括(a)研究, (b)有关研究的活动, and (c) training projects that have a research component.
If you are unsure about whether or not a project qualifies as research involving living human subjects meeting the criteria below, submit the 研究意向表格 and 制度研究 will follow up with you.
Guidelines for Institutional Review Board (IRB) projects
According to federal regulations (specific所有y, 45 CFR 46), Institutional Review Boards have the responsibility of overseeing the ethical standards in research involving human subjects. This responsibility is broken down in more detail below to clarify what projects should and what projects should not be reviewed by the IRB.
什么是研究?
研究, 在联邦监管的意义上, is “a systematic investigation that is designed to develop or contribute to generalizable knowledge.“这包括研究开发, 测试, and evaluation that contributes to generalizable knowledge.
In order to determine if a proposed project qualifies as research, the IRB must know the intent of the researcher. Will findings be published or presented to external audiences? 研究结果如何, whether in the form of data analysis or methodological advances or anything else, be reported as a means to disseminate knowledge and advance the field? These possibilities should be considered when deciding if your project needs to be reviewed by the IRB.
- Projects done in fulfillment of a course or “class project” and that will be presented to the class are not considered to contribute to generalizable knowledge.
- Program evaluation projects in which the findings are reported to an oversight agency or other interested party or used to develop a quality improvement plan also are not considered to contribute to generalizable knowledge.
什么是人类实验对象?
The federal regulations define a human subject as a “living individual about whom an investigator conducting research obtains:
- data through intervention or interaction with the individual
- 可识别的私人信息”
研究 involving records from deceased individuals, 比如在历史研究中, 不需要经审核委员会审核. Projects in which information about a thing, 比如一个过程, 是从个人身上收集的, but personal identifiers or any information about the informant is not collected, also do not need to be reviewed by an IRB. 研究 collecting private information must be reviewed by the IRB. Private information is information that can cause the identity of the participant to be associated with the information provided or 所有ow the participant’s identity to be readily ascertained by the researcher.
Projects that meet the criteria described under both of the questions above require review by an IRB. 也就是说，项目必须同时:
- 研究，如上所述
- 涉及活的人类受试者
Student projects that are solely classroom directed exercises do not require IRB review if they meet 所有 下列标准之一:
- the primary purpose is a learning experience in the methods and procedures of research; AND
- there is uniformity in the research methods conducted by 所有 students (i.e., 所有 students will use the same instruments or methods (surveys, 调查问卷, 面试指导), to collect the data and/or consent procedures); AND
- 涉及 no more than minimal risk; AND
- the project does not include sensitive topics or vulnerable populations, such as children or prisoners; AND
- the data must be recorded anonymously by the students (i.e., 没有名字, 社会安全号码, or any other codes that can be linked to a list of names, or the recorded data will not identify the subjects through their behavior); AND
- where and whenever possible, the research takes place in a 公共场合 向公众开放, 例如:教室, 部门, 宿舍, 或者其他校园环境, 购物中心, 公园, or street; AND
- the data will not be used beyond the classroom environment (i.e., the data is only used for instructional purposes, which can include a course paper or oral class presentation only. The data cannot be published or presented at a conference, 讨论会, 部门 讨论会 or poster presentation and cannot be used in further research by the student, other class members and/or the instructor).