我的研究需要IRB审查吗?
《火博体育官网》
Federal regulations require that research projects involving human subjects be reviewed 由院校覆核委员会. The IRB must approve or determine the project to be exempt prior to the start of any research activities. IRB无法提供 approval or determinations for research that has already been concluded. 在光 of the mission to protect human subjects, and the potential regulatory consequences of 不 obtaining IRB review and approval, the investigator should choose to err on the side of caution and consult the IRB when s/he is uncertain whether the study is 人类受试者研究与否.
IRB review and approval is required for projects that:
1. meet the federal definition of research; and
2. 涉及人类受试者
什么是研究?
研究的定义是 a 系统的调查, including research development, testing, and evaluation, designed to develop or 导致 可概括的知识.
A 系统的调查 follows a predetermined plan for studying a specific topic, testing a hypothesis or research question, or developing a new theory. 系统调查:
- Attempts to answer one or more research questions
- Collects data or information in an organized and consistent way
- Analyzes data or information in some way (quantitative, qualitative)
- 从结果中得出结论
Examples of conducting a 系统的调查 包括:
- 管理调查和问卷
- 进行访谈和焦点小组讨论
- Analyzing existing data or biological specimens
- 评估社会或教育项目
- 进行医疗图表检讨
导致 可概括的知识 means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being 研究了. 可概括的知识 适用于下列研究项目:
- Publication, presentation, or other distribution of the results outside the College is intended to inform or 导致 general knowledge in the field
- Results are expected to be generalized to a larger population beyond the population 研究了
- Results are intended to be replicated in other settings or by other researchers
- The primary beneficiaries of the research are other researchers, scholars and practitioners 在研究领域
研究 不 包括:
- 学术和新闻活动(e).g.、口述历史、新闻、传记、 literary criticism, legal research, and historical scholarship) that focus directly on the specific individuals about whom information are collected
- Public health surveillance activities (collecting, analyzing, and using data to target 公共卫生和疾病预防)
- Data collection and analysis that enables the conduct of certain activities carried 作为刑事司法系统的一部分
- Authorized operations in support of national security
- Studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies or contracted-for 服务
如果项目 做 不 满足研究的定义(i.e. is 不 a 系统的调查 or 不 导致 可概括的知识), as described above, then the project 做 不 require IRB review, and an IRB application is 不 required.
是否涉及人类受试者?
Human subjects is defined as "a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through 干预 or 交互 with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) obtains, uses, studies, analyzes, or generates 可识别的私人信息 or 可识别biospecimens."
干预 includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment 是为了研究目的而进行的.
交互 includes communication or interpersonal contact between investigator and subject.
私人信息 includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will 不 be made public (e.g.医疗记录).
可识别的私人信息 is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
可识别的生物标本 is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
If your project meets the definition of research but 不 涉及人类受试者 as defined in the regulations, then the project 做 不 require IRB review, and an IRB application is 不 required.