知情同意指引
All protocols submitted to the IRB must utilize an appropriate (and approved) recruitment 同意程序与所涉及的风险相一致. 这是责任 of the PI and research staff to ensure that proper informed consent has been obtained 来自所有研究参与者. 必须征得未成年人的同意. 同意形式 are typically much briefer than consent forms, and the language must be appropriate 参与者的年龄.
同意指南:
Unless a waiver of documentation of informed consent is requested (see below), all research projects involving human subjects require a consent form signed by both the 研究者和研究对象.
The human subjects in your project must participate willingly, having been adequately 了解研究情况. 如果你项目中的人类受试者是脆弱的 人口(我.e. prisoners, cognitively impaired individuals, or minors), special 需要保护措施. 请联系IRB办公室了解更多信息.
Except where noted, written informed consent must contain all sections described in 的模板.
The consent form should be able to be read easily (5th to 8th grade level) and should be formatted to separate required elements of the informed consent process (i.e. 风险 & 研究的好处、解释等). 例如,创建节标题 to guide the reader or use topic sentences to highlight pertinent information in each 新部分. Please do not include a copy of this consent form template with your application; only include the consent form you plan to use.
这 网站 is useful for gauging the approximate reading level of a document.
Each section includes instructions for preparation and provides suggested text of 要包含的信息. 请自定义建议的文本,以充分 描述研究项目.
If informed consent will be obtained in a language other than English, please include a copy of the consent document in that language, as well as a copy of the English 版本.
We have provided a number of informed consent templates that fit various kinds of 研究. 这些表单的链接在本页的底部.
放弃同意文件
Under certain circumstances the IRB may waive the need for a signed consent from a 研究参与者. 本同意文件的豁免可在 下列情形:
请注意: The absence of a signed consent document DOES NOT release the researcher from obtaining 受试者同意参加本研究. 参与者应注意 that they are in a research study, who is conducting the study and for what reason, 他们的参与是自愿的. 一种方法是附加一个同意类型 document with the pertinent information (“elements 的同意”), and indicate that 完成调查即表示同意参与. 个人也可以给予 要随身携带的研究信息. 在知情同意的情况下 must be obtained verbally, oral instructions and the script detailing exactly what 会不会对参与者说很重要.
A waiver of documentation 的同意 may be requested by checking the appropriate box in the IRB initial application, and explaining why the request is being made, i.e. which of the above criteria applies, and how subjects will be provided the elements 的同意.
Protocols granted a waiver of documentation of informed consent must employ an information 登记受试者时填写. 所有资料表应包括以下内容:
使用受保护的健康信息和HIPAA隐私规则
Some healthcare data (Protected Health Information or PHI) is protected by the HIPAA 隐私规则.
欲了解更多信息,请访问http://www.美国卫生和公众服务部.gov / ocr /隐私/ hipaa /理解/特殊/研究/索引.html
Any investigator using Protected Health Information must complete the Responsible Conduct of 研究 (RCR) module on Information Privacy and Security - Health Privacy 模块.
样本知情同意模板
Note that these templates all meet the New Common Rule guidelines which went into 地点2019年1月21日.