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我的研究项目涉及人类受试者吗？联邦法规将人类受试者定义为“进行研究的研究者通过干预或与个体互动获得(1)数据或(2)可识别的私人信息的活着的个体”（45 CFR 46）。 102 (f)(1),(2))。
人类被试
确定研究是否涉及人类作为研究对象的关键是以下定义：
What is a “living individual?”
- 样本/数据/信息必须来自活体受试者。 尸体，尸检标本，或来自非人类死亡受试者的标本/信息。
What does “about whom” mean?
- A human subject research project requires that the data received from the living individual is about the person—not about something else (such as a product or service).
What is an “intervention?”
- An intervention includes physical/psychological procedures, manipulations of the human subject, or manipulations of the subject’s environment for research purposes.
What is “interaction?”
- 互动包括研究者和受试者之间的交流。 这包括面对面、信件、电话、电子邮件以及任何其他的交流方式。
What is “identifiable private information?”
- Federal regulation defines identifiable private information as “information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place,” (such as a public restroom) 和 “information which has been provided for specific purposes by an individual 和 which the individual can reasonably expect will not be made public (such as a health care record)” (45 CFR 46. 102 (f)(2))。
What is “identifiable?”
- 可识别的意味着信息包含一个或多个数据元素，这些元素可以与其他信息组合以识别个人（例如社会安全号码）。
根据2019年1月21日生效的共同规则变更，以下活动不被视为涉及人类受试者的研究，不需要审查委员会的批准或监督：
- 学术和新闻活动，如口述历史、新闻学、传记、文学批评、法律研究、历史学术等，为法律或历史目的关注特定个人；
- Public health surveillance: the collection 和 testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority;
- 由刑事司法机构或为刑事司法机构收集和分析信息、生物标本或记录，仅为刑事司法或刑事调查目的而进行法院命令授权的活动；
- 支持情报、国土安全、国防或其他国家安全任务的授权业务活动（由各机构确定）；
- Program improvement activities – collection 和 analysis of data, including biospecimens, for the purpose of an institution’s internal evaluation, monitoring or program improvement; 和
- Quality assurance 和 quality improvement – the implementation of an accepted practice to improve the quality of care, or the analysis of data or biospecimens to evaluate the effectiveness of an accepted practice.
