IRB资源
IRB的演讲
外部资源
- 临床试验教材(NCI)
- 人力学科保障培训
- Do Current Federal Regulations Protect People Who Participate in Medical Research?
- 人类研究保护办公室(OHRP)
- 与人类受试者研究相关的OHRP视频
- 贝尔蒙特报告
术语表
匿名: Subjects are not identifiable to anyone, including the researcher. “匿名” and “confidentiality” do not have the same meaning and are not interchangeable.
委员会审查: Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. All applications that are not granted exempt or expedited status must receive board review.
儿童/未成年人(18岁以下): Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
保密: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. 如果研究对象承诺保密, 研究人员可以识别它们, but the researcher promises not to identify them publicly. "保密" and "anonymity" do not have the same meaning and are not interchangeable.
同意:见知情同意.
免除只有IRB可以决定一项研究是否获得豁免. Certain types of research may qualify for exemption according to federal regulations contained in 45CFR46. Once the IRB determines that a study is exempt, informed consent is not required. All applications that are not granted exempt status must receive expedited review or board review.
加快审查: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
全面审查: 全面审查 of proposed research is conducted at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. All proposals that are not granted exempt or expedited review and all projects which involve “vulnerable groups” (i.e., 儿童/未成年人, 制度化的人, 孕妇, cognitively impaired individuals) require a full board review. Other projects that may involve more than minimal risk (e.g., sensitive questions, unusual interventions) to the subject also must have full board review.
人类研究参与者:见人体受试者.
人类的主题: Means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, 或(2)可识别的私人信息.
知情同意一个人的自愿协议, based upon adequate knowledge and understanding of relevant information, 参与研究或接受诊断, 治疗, 或者预防程序. 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.
知情同意书给被试者的一封信，概述同意的要素, informing them about the research and explaining exactly what their participation, 如果他们选择参与, 由. A consent form contains investigator contact information and is signed by the subject.
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.
干预: Includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
交互: includes communication or interpersonal contact between investigator and subject.
最小的风险: Probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or 心理 examinations or tests.
首席研究员: The scientist or scholar with primary responsibility for the design and conduct of a research project.
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 (for example, 医疗记录). 私人信息必须是可单独识别的(例如.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
报酬:参与研究的报酬.
风险伤害或伤害(身体上的)的可能性, 心理, social or economic) occurring as a result of participation in a research study. 在IRB审查中, probability and severity of possible pain or discomfort should be included in the concept of risk.
自愿的:不受胁迫, duress or undue inducement; used in a research context to refer to a subject's decision to participate (or continue to participate) in a research activity.
弱势群体:孕妇, 人类胎儿, 生存能力不确定的新生儿, 或者无法存活的新生儿, 怀孕的动物, institutionalized persons and minors (children under the age of 18 years old).