我需要IRB审查吗?

The information below will assist you in determining if your research requires IRB Review.

IRB决策树

指导教师进行研究作为课程或班级项目的一部分

教师教学/研究及相关活动

This section is intended to provide guidance to faculty regarding course activities that are research-related and present issues regarding whether or not the course activities fall under the jurisdiction of the Institutional 审查委员会 (IRB). 接下来是指导 只有.

Review by the IRB should be sought if a project uses methods designed to develop or contribute to generalizable knowledge, 涉及人类参与者, 以下任何一项都适用:

1. 1. 学生打算将结果传播到课堂之外.g., presentations at local, regional, and national conferences; publications; blogs and websites). 在高级会议或荣誉日发布, 在校园, does not necessitate IRB review unless one or more of the conditions described in points 2 through 5 below apply.
  2. 该项目涉及的风险大于最小风险, meaning the probability and magnitude of physical or psychological harm is greater than what is normally encountered in the daily lives of the participants.
  3. The project collects sensitive information that is recorded in such a way that the respondent can be linked with their responses (either through collected identifiers or demographic data). 敏感信息可能包括有关药物使用的信息, 性取向, 家庭暴力, 类似的话题.
  4. The project collects data from people unable to provide informed consent due to their age, 监禁, 或者说心智能力有限.
  5. 这项研究涉及欺骗.

Class and Course Research Exceptions to Review Requirements and Research Requiring Review

教师 are encouraged to consult with the IRB Chair or committee members if they have questions. 联邦政府对研究的定义是“系统的调查(i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge" is the key concept defining IRB jurisdiction. The following three categories illustrate how applying the concept to activities combining teaching and research may or may not require IRB review.

1. 1. 示威活动
    
    以教授学生研究为主要目的的课堂项目, 为了说明科学原理, 或者进行统计分析, 并且不是为了传播给老师和班上的其他学生, do not constitute human subjects research because they are not designed to develop or contribute to generalizable knowledge. The following sections provide additional guidance regarding circumstances where classroom projects do or do not require review by the IRB.
    
    Data are collected from students enrolled in a course for the purpose of demonstrating principles of science and/or behavior firsthand or to provide data for learning statistical analysis. 这样的演示仅在类的上下文中是公开的, 众所周知，风险很小, and students are able to choose not to participate and are provided alternate means of earning participation credit. The data are not collected for publication in scholarly journals or disseminated outside the course. There are no restrictions about how long the demonstration lasts (one or more class periods), 数据最初是在哪里收集的(上课期间或课外时间), 或者被证明的原理有多“广为人知”. 这些类型的课堂活动的主要组成部分是 risk of harm to students is minimal and gathering and dissemination of the data is confined within the class setting. 如果教师在课堂上进行的活动如本节所述, 不需要IRB审查.
  2. 学生在课堂上学习研究或如何做研究
    
    This category differs from the first in that students may be asked to be participants in research projects as a credit earning class activity, 但这项研究并不局限于一个班级. An example is joining a participant pool of students enrolled in introductory social science classes or students conducting human participant research as a component of a research methods class.
    
    如果学生注册了一门课程, 作为课程的一部分, 他们有机会作为研究对象参与研究, 这一点应在课程大纲中明确说明. 教师 teaching courses where credit is offered for participating in research should seek a single, global informed consent for participation from the students (or students' parents or legal guardians if they are under 19 years of age) for all participation opportunities throughout the term. Researchers should then obtain assent from the subject pool participants for each project in which an opportunity to participate is offered.
    
    In other cases students may be enrolled in classes designed to develop research capacity and skill. Students in these classes may individually or jointly conduct several research projects in one term. 教师 instructing these classes should request IRB approval for all projects to be conducted in the class at the beginning of the term. The faculty member must stipulate that none of the projects will be disseminated beyond the classroom or 365英国上市官网 campus setting, 风险大于最小, collect sensitive information that is recorded in such a way that the respondent can be linked with their responses, 或者从无法提供知情同意的人那里收集数据.
    
    When students are asked to serve as researchers with non-class participants serving as subjects, 然后这些非阶级成员的利益优先. 项目是否符合IRB的豁免类别, 那么教授可能会提前寻求IRB的“全面”批准, based on a generic description of topics and/or methods that the professor will subsequently allow students to pursue. 否则，项目应按照IRB标准程序提交.
  3. 在教师指导下做研究的学生
    
    在教师指导下进行个人或小组研究的学生.g.、高级项目、自主学习、荣誉项目等.)不进行课堂项目，可能需要也可能不需要IRB审查. 建议向内部审核委员会咨询.

批准用于教学目的的研究地位的变化

If the original project is primarily for instructional purposes but researchers wish to disseminate the results publicly at a later time, the researchers or course instructor may file for IRB review of the archival data analysis at that time. 类似的, if the investigator finds that demonstration or instructional research conducted and/or approved under the principle of minimal risk of harm to participants poses a greater than minimal risk of harm the research must stop. 在研究可以继续之前，需要完整的IRB审查和批准.