ACIRB定义

不良事件: 在人类受试者身上发生的任何不幸或不利的医疗事件, 包括任何异常迹象, 与受试者参与研究/项目相关的症状或疾病, 是否被认为与受试者参与研究/项目有关.

不遵守声明: 未经证实的不遵守声明.

孩子们: 未达到同意该项目的治疗或程序的法定年龄的人士, 根据项目实施所在司法管辖区的适用法律确定.

认知障碍: Having either a psychiatric disorder or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. 其他人, 包括受毒品或酒精影响或依赖毒品或酒精的人, 患有影响大脑的退行性疾病的人, 身患绝症的病人和身体有严重残疾的人, 也可能会损害他们为自己的最大利益做出决定的能力.

继续不遵守: A pattern of non-compliance that indicates a deficiency likely to result in further non-compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting non-compliance.

指定审核人: IRB主席或管理员, 或由IRB主席或管理员指定的有经验的IRB成员进行非委员会审查.
如果IRB成员任职三年或以上，则被认为是有经验的成员.

从事研究: An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes.

An institution is automatically considered to be "engaged" in human subjects research whenever it receives a direct 健康 and Human 服务s (HHS) award to support such research. 在这种情况下, 获奖机构对保护该奖项下的人类受试者负有最终责任.

欲知详情, 包括一个机构可能被认为参与或不被认为参与的情况的例子, 请参阅人类研究保护办公室(OHRP)就此主题提供的指导.

过期日期: 审批期限结束后的日期. 协议不再被批准的第一个日期.

不符合规定的裁定: 事实上不合规.

人类参与者(或受试者): A living individual about whom an investigator obtains data through intervention or interaction with the individual or obtains identifiable private information.

可识别的信息: 个人可识别的信息(i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information). This information often is Protected 健康 Information (PHI) that is subject to protection by the 健康 Insurance Portability and Accountability Act of 1996 (HIPAA) regulation (see http://www.美国卫生和公众Service部.gov/hipaa/index.html).

直系亲属: Spouse, domestic partner; and dependent children or an individual designated by the court.

知情同意: 一个人的自愿协议, 基于对相关信息的充分了解和理解, 参与:参与研究或项目, 或者接受诊断, 治疗或预防程序. 在给予知情同意时, 受试者不得放弃或表现出放弃其任何合法权利, 或释放或似乎释放调查员, 赞助商, 机构或其代理人免于过失责任.

院校覆核委员会: A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research or projects.

IRB批准: The determination of the IRB that the research or project has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

请注意，IRB审查有几种可能的结果. 包括批准, 附带条件的批准, 修改后的批准, 嵌合, 要求在批准前提供更多信息, 和反对. 请注意，如果一个项目不被IRB批准, 它不能被推翻, 根据联邦指导方针, 由个人或实体. 然而，如果一个项目被IRB批准，它可能会被个人或实体推翻.

交互: 研究者与受试者之间的交流或人际接触.

干预: Includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research or project purposes. 干预包括研究者和参与者之间的沟通或人际接触.

调查员: The individual(s) designated to have the appropriate level of authority and responsibility to direct the research project and/or activity.

首席研究员: 对研究或项目的设计和实施负有主要责任的个人.

主要人员: 对科学发展或项目实施作出实质性贡献的个人, 可测量的方式, 是否在相应的拨款申请/合约建议书上要求薪金. 主要人员包括首席研究员, 首席研究员, supervising faculty members and any other individuals who will have contact with the participants or the participants' data.

法定授权代表: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the participant’s participation in the research or project activities.

有限数据集: Data sets that contain health information but exclude specific direct identifiers as outlined in the 健康 Insurance Portability and Accountability Act of 1996 (HIPAA). 即使没有特定的直接标识符，有限的数据集也被认为是可识别的. All disclosers of the limited data set require a signed Limited Data Set Data Use Agreement between the requester and the institution from which the limited data set is requested. 数据使用协议确保遵守隐私法和HIPAA.

最小的风险: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research/project are not greater, 他们自己, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

不符合: 不遵守内部审查委员会的规定或要求或决定.

人类研究保护办公室(OHRP): The 健康 and Human 服务s (HHS) office that oversees the regulation of research involving human research participants.

囚犯: 被非自愿地关在刑事机构的人, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, 试验, or sentencing; and (3) detained in other facilities (e.g. for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.

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 not be made public. Private information must be individually identifiable if obtaining the information constitutes research involving human participants.

受保护的健康信息(PHI或可识别的私人信息): 姓名、地址、与个人有关的日期元素(如.g., 出生年月日), 电子邮件地址, numbers; telephone, 传真, 社会保障, 医疗记录, 健康受益人/健康保险, 证书或执照号码, 车辆, 账号, 特征或代码(e.g., 全球定位系统(GPS)读数, Web url, Internet协议(IO)地址, 生物识别标识(如.g. 声音，指纹)，全脸照片或类似的图像.

PHI包括任何信息, 无论是口头的还是以任何形式或媒介记录的, 由医疗保健提供者创建或接收, 健康计划, 公共卫生当局, 雇主, 人寿保险公司, 学校或大学, 或者医疗保健信息交换所, 和过去有关, 现在, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, 现在, 或者将来支付给个人的医疗保健费用.

法定人数: 法定人数为简单多数.g.(超过50%)的IRB投票成员. 出于利益冲突以外的原因, 弃权不改变法定人数或改变所需的票数.

研究: 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政策的研究, whether or not they are conducted or supported under a program which is considered research for other purposes. 例如, some demonstration and service programs may include research activities and they would be included in this definition of Research.

限制: 适用于不符合IRB要求的调查人员或研究人员.

次要数据集: 可用于研究的数据，来自公共或私人文件, 包括医疗记录, 警方报告, 生命统计记录, 学生记录.

严重不良事件: (1)导致死亡的任何不良事件, (2)危及生命(使受试者在事件发生时处于立即死亡的危险中), (3)导致住院或延长现有住院时间, (4)导致持续或严重的残疾/丧失工作能力, (5)导致先天性异常/出生缺陷, (六)根据适当的医学判断, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

严重的违规行为: 影响参与者权利或福利的不服从行为.

标本: 样本(e).g.(人体组织、血液或尿液)用于诊断或病理分析.

暂停审核: An action of the IRB to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. 暂停的课程仍然开放，并将继续接受审查.

IRB批准的终止: 内部审查委员会永久撤销对所有研究程序的批准的行动. 终止的研究永久关闭，不再需要继续审查.

未预料到的问题: An unanticipated problem involving risk to human participants or others is one that (1) was unforeseen at the time of its occurrence, (2)表示参与者或其他人受到伤害的风险增加.

弱势群体: 可用于研究或项目的种群，但在某些方面被认为是脆弱的. 弱势群体包括儿童, 囚犯, 孕妇和胎儿, 决策障碍个体(如.g.、智障人士、痴呆症患者). 另外, 那些教育程度低或收入低的人, 以及处于处于权力人物的从属地位的个人(例如.g.(如教师研究人员与学生的关系)也可能被认为是弱势群体.