ACIRB定义

不良事件: Any untoward or unfavorable medical occurrence in a human subject, 包括任何异常迹象, symptom or disease associated with the subject’s participation in the research/project, whether or not it is considered to be related to the subject’s participation in the study/project.

不遵守声明: 未经证实的不遵守声明.

孩子们: Persons who have not attained the legal age for consent to treatment or procedures involved in the project, as determined under the applicable law of jurisdiction in which the project will be conducted.

认知障碍: 患有影响认知或情感功能的精神障碍或发育障碍，以致判断和推理能力明显减弱的. 其他人, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative disease affecting the brain, terminally ill patients and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interest.

继续不遵守: 一种不遵守的模式，表明可能导致进一步不遵守的缺陷或调查员未能合作调查或纠正不遵守的情况.

指定审核人: IRB主席或管理员, or an experienced IRB Member designated by the IRB chair or administrator to conduct a non-committee review.
An IRB member is considered experienced if the member has served for three or more years.

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.

一个机构只要获得卫生与公众服务部(HHS)的直接奖励以支持此类研究，就自动被视为“从事”人类受试者研究. 在这种情况下, the awardee institution bears ultimate responsibility for protecting human subjects under the award.

欲知详情, including examples of situations where an institution may or may not be considered engaged, please refer to the guidance provided by the Office for Human Research Protections (OHRP) on this topic.

过期日期: 审批期限结束后的日期. The first date that the protocol is no longer approved.

不符合规定的裁定: 事实上不合规.

人类参与者(或受试者): 调查人员通过干预或与个人互动获得有关其数据或获得可识别的私人信息的活着的个人.

可识别的信息: 个人可识别的信息(i.e., 参与者的身份已经或可能很容易被调查人员确定或与信息相关). 这些信息通常是受保护的健康信息(PHI)，受1996年《澳门网上博彩下载》(HIPAA)法规的保护(参见 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, based upon adequate knowledge and understanding of relevant information, 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, subjects may not waive or appear to waive any of their legal rights, 或释放或似乎释放调查员, 赞助商, the institution or agents thereof from liability for negligence.

院校覆核委员会: 为保护被招募参加生物医学或行为研究或项目的人类受试者的福利，由一个实体设立或指定的特别组成的审查机构.

IRB批准: 审查委员会确定该研究或项目已经过审查，并可在审查委员会规定的限制以及其他机构和联邦要求的限制下在机构进行.

Note that there are several possible outcomes of an IRB review. 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. However, if a project is approved by an IRB, it may be overruled 由个人或实体.

交互: Communication or interpersonal contact between investigator and subject.

干预: 既包括收集数据的物理过程，也包括为研究或项目目的对参与者或参与者环境的操纵. Intervention includes communication or interpersonal contact between investigator and participant.

调查员: 被指定具有适当级别的权力和责任来指导研究项目和/或活动的个人.

首席研究员: The individual with primary responsibility for the design and conduct of a research or project.

主要人员: Individuals who contribute to the scientific development or execution of the project in a substantive, 可测量的方式, whether or not salaries are requested on the corresponding grant application/contract proposal. 主要人员包括首席研究员, 首席研究员, 监督与参与者或参与者数据有接触的教职员工和任何其他个人.

法定授权代表: 根据适用法律授权代表潜在受试者同意参与者参与研究或项目活动的个人或司法机构或其他机构.

有限数据集: 包含健康信息但不包括1996年《澳门网上博彩下载》(HIPAA)中概述的具体直接标识符的数据集. Limited data sets are considered identifiable even without the specific direct identifiers. 所有披露有限数据集的人都需要请求者与向其请求有限数据集的机构签署有限数据集数据使用协议. The Data Use Agreement ensures compliance with both the Privacy Act and HIPAA.

最小的风险: 在建议的研究/项目中所预期的危害或不适的可能性和程度不会更大的情况下，风险是最小的, 他们自己, 比在日常生活中或在进行常规身体或心理检查或测试时通常遇到的要多.

不符合: Failure to follow the regulations or the requirements or determinations of the IRB.

人类研究保护办公室(OHRP): 卫生与人类服务部(HHS)办公室，负责监督涉及人类研究参与者的研究的监管.

囚犯: An individual involuntarily confined in a penal institution, 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. (用于戒毒或治疗酗酒)根据提供刑事起诉或在刑事机构监禁的替代办法的法规或承诺程序.

私人信息: 包括在个体可以合理预期没有观察或记录发生的环境中发生的行为信息, 个人为特定目的而提供的信息，以及个人可以合理预期的信息，将不会被公开. 如果获得的信息构成了涉及人类参与者的研究，则私人信息必须是个人可识别的.

Protected 健康 Information (PHI or Identifiable Private Information): Name, address, elements of dates related to an individual (e.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. voice, fingerprints), full face photographs or comparable images.

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, or future payment for the provision of health care to an individual.

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, abstentions do not alter the quorum or change the number of votes required.

研究: 系统的调查, 包括研究开发, 测试, 和评估, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, 是否在其他目的的研究项目下进行或支持. 例如, 一些示范和服务项目可能包括研究活动，它们将包括在本研究的定义中.

限制: Applies to investigators or research staff members who are delinquent in meeting IRB requirements.

次要数据集: Data that can be used in research and comes from public or private documents, 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) is life-threatening (places the subject at immediate risk of death from the event as it occurred), (3) results in inpatient hospitalization or prolongation of existing hospitalization, (4) results in a persistent or significant disability/incapacity, (5)导致先天性异常/出生缺陷, (六)根据适当的医学判断, 可能危及受试者的健康，可能需要医疗或手术干预，以防止本定义中列出的其他结果之一.

严重的违规行为: Non-Compliance that affects the rights or welfare of participants.

标本: 样本(e).g., human tissue, blood, or urine) used for diagnostic or pathological analyses.

暂停审核: IRB暂时或永久撤销部分或全部研究程序的IRB批准的行动，但不包括终止IRB批准. Suspended studies remain open and are subject to continuing review.

IRB批准的终止: An action of the IRB to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review.

未预料到的问题: 涉及人类参与者或他人风险的未预料到的问题是(1)在其发生时无法预见的问题, and (2) indicates that participants or others are at an increased risk of harm.

弱势群体: Populations that may be used in research or projects, but that are considered vulnerable in some way. 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, and individuals in situations that place them in subordinate position to a person in power (e.g., faculty researcher-student relationships) may also be considered vulnerable populations.