研究
研究是指系统的调查, 包括研究开发, 测试, 和评估, 被设计用来发展或促进一般化的知识. 符合这一定义的活动构成本条例所指的研究, 他们是否在被认为是其他目的的研究项目下得到支持或资助. 例如,一些示范和服务项目可能包括研究活动.(45 CFR 46.102 d).
人类的主题
Human subject means a living individual about whom an investigator (whether professional or 学生) conducting research obtains data through intervention or interaction with the individual; 和/or identifiable private information (45 CFR 46.102f).
弱势群体
弱势群体包括未成年人, 孕妇, 人类胎儿, 人类的新生儿, 囚犯(在押人员, 假释犯人), 制度化的人, 智障人士或残障人士.
最小的风险
最小风险是日常生活中通常遇到的身体或心理伤害的概率和程度, 或者在日常医疗中, 牙科, 或对健康人进行心理检查. 这是, the probability 和 magnitude of harm or discomfort anticipated in the research are not greater in 和 of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102 (i) 和 46.303 (d)
IRB批准
IRB approval means the determination of the 十大菠菜靠谱老平台 院校检讨委员会 that the research that has been proposed 和 reviewed may be conducted at the institution or within the proposed venue external to 十大菠菜靠谱老平台 as described in the proposal (as subject to the approval of the usage of the proposed external venue by the external venue’s governing body) within the constraints set forth by the 十大菠菜靠谱老平台 院校检讨委员会 和 by other institutional or federal, 状态, 或当地法规或要求,因为它们与被审查的研究具体相关.
全体委员会审查
A full committee review is a procedure for research that does not qualify for an expedited review (见 definition) that occurs during convened 院校检讨委员会 meetings at which the majority of IRB members (a quorum) are present, 包括至少一名主要关注非科学领域的成员. 为了让这项研究得到批准, 它将得到出席会议的大多数成员的同意. (45 CFR 46.108 a-b)
快速审核定义
An expedited review is a procedure for certain kinds of research involving no more than minimal risk to subjects that participate in the research study or project under scrutiny. 加速审查程序用于审查以下一种或两种类型的研究或类似活动:
- Minor changes in previously approved research during the period (of one year or less) for which approval is authorized (an IRB Addendum or research 修改 must be submitted); or
- Some or all of the research appearing on the US Department of Health 和 Human 服务 Federal Register list of categories of research that may be reviewed by the IRB through an expedited review procedure.