Do I Need IRB Review?

以下信息将帮助您确定您的研究是否需要IRB审查.

IRB Decision Tree

Guidance for Faculty Conducting Research as Part of a Course or Class Project

Faculty Teaching/Research and Related Activities

本节旨在就与研究相关的课程活动以及有关课程活动是否属于机构审查委员会(IRB)管辖范围的问题向教师提供指导。. What follows is guidance only.

如果一个项目使用的方法旨在开发或有助于推广知识，则应寻求内部审查委员会的审查, involves human participants, and any of the following apply:

1. 1. The student intends to disseminate the results beyond the classroom (e.g., presentations at local, regional, and national conferences; publications; blogs and websites). Dissemination at Senior Conference or Honors Day, on campus, 除非符合以下第2点至第5点所述的一个或多个条件，否则不需要IRB审查.
  2. The project involves greater than minimal risk, 这意味着身体或心理伤害的概率和程度比参与者在日常生活中通常遇到的要大.
  3. 该项目收集敏感信息，这些信息以这样一种方式记录，即受访者可以与他们的回答联系起来(通过收集的标识符或人口统计数据)。. Sensitive information may include information about drug use, sexual preferences, family violence, and similar topics.
  4. 该项目从由于年龄原因无法提供知情同意的人群中收集数据, incarceration, or limited mental capacity.
  5. The research involves deception.

班级和课程研究例外审查要求和研究要求审查

如果有疑问，鼓励教师向IRB主席或委员会成员咨询. The federal definition of research as "a systematic investigation (i.e. (收集和分析信息)旨在发展或有助于普遍化的知识”是定义IRB管辖权的关键概念. 以下三个类别说明了如何将概念应用于结合教学和研究的活动中，可能需要或不需要IRB审查.

1. 1. Demonstrations
    
    Classroom projects that are for the primary purpose of teaching a student about research, to illustrate scientific principles, or to conduct statistical analysis, and are not for dissemination beyond the instructor and other students in the class, 不构成人类受试者研究，因为它们不是为了发展或促进可推广的知识而设计的. 以下部分提供了关于课堂项目需要或不需要IRB审查的情况的额外指导.
    
    数据是从参加课程的学生中收集的，目的是展示科学和/或行为的第一手原理，或为学习统计分析提供数据. Such demonstrations are public only within the context of the class, the risks are known to be minimal, 学生可以选择不参加，也可以通过其他方式获得参与学分. 收集的数据不会在学术期刊上发表，也不会在课程之外传播. 演示持续时间没有限制(一个或多个课时), where the data are initially collected (during or outside class time), or how "well-known" the principle being demonstrated is. The primary components of these types of class activities are that the 对学生造成伤害的风险最小，数据的收集和传播仅限于课堂环境. If the activities in a class conducted by faculty are as described in this section, IRB review is not required.
  2. Students Learning About Research or How to Do Research in a Class
    
    这一类别与第一种不同之处在于，学生可能会被要求参与研究项目，作为一项获得学分的课堂活动, but the research is not confined to one just one class. 一个例子是加入参加社会科学入门课程的学生，或者作为研究方法课程的组成部分进行人类参与者研究的学生.
    
    If students are enrolled in a course where, as a component of the course, they are offered the opportunity to participate in research as subjects, this should be clearly stated in the course syllabus. 教授参与研究可获得学分的课程的教师应寻求单个学分, 学生(或学生的父母或法定监护人，如果他们未满19岁)在整个学期的所有参与机会的全面知情同意. 然后，研究人员应该获得每个有机会参与的项目的受试者池参与者的同意.
    
    在其他情况下，学生可以参加旨在培养研究能力和技能的课程. 这些课程的学生可以在一个学期内单独或联合进行几个研究项目. 指导这些课程的教师应在学期开始时要求IRB批准所有在课堂上进行的项目. 教师必须规定，任何项目都不会传播到课堂或平衡计分卡校园环境之外, involve greater than minimal risk, 收集敏感信息，这些信息记录的方式可以将被访者与其回答联系起来, or collect data from people unable to provide informed consent.
    
    当学生被要求作为研究人员，而非课堂参与者作为研究对象时, then the interests of these non-class members takes precedence. If the project would readily fit under the exemption categories of the IRB, then the professor may seek "blanket" IRB approval in advance, 基于主题和/或方法的一般描述，教授随后将允许学生进行研究. Otherwise, the project should be submitted under standard IRB procedures.
  3. Students Doing Research under Faculty Guidance
    
    Students doing individual or group research under faculty guidance (e.g., senior project, independent study, Honors projects, etc.) are not conducting classroom projects and may or may not require IRB review. Consultation with the IRB is recommended.

Change in Status of Research Approved for Instructional Purposes

如果最初的项目主要是为了教学目的，但研究人员希望在以后的时间公开传播结果, 研究人员或课程讲师可以申请IRB审查档案数据分析. Similarly, 如果研究者发现在最小伤害风险原则下进行和/或批准的示范或指导性研究对参与者造成的伤害风险大于最小伤害风险，则研究必须停止. Full IRB review and approval is required before the research may continue.