Informed Consent Guidelines
提交给IRB的所有协议必须使用适当的(和批准的)招聘 and consent process(es) consonant with the risks involved. It is the responsibility ,以确保获得适当的知情同意 from all research participants. Assent must be obtained from minors. Assent forms 通常比同意书要简短得多,而且语言必须合适 for the age of the participant.
Consent Guidelines:
除非要求放弃知情同意文件(见下文),否则所有 涉及人类受试者的研究项目需要双方签署的同意书 researcher and the subject.
在你的项目中的人类受试者必须自愿参与,已经充分 informed about the research. If the human subjects in your project are part of a vulnerable population (i.e. 囚犯、认知障碍者或未成年人),特殊的 protections are required. Contact the IRB Office for more information.
除特别注明外,书面知情同意书必须包含 the templates.
同意书应易于阅读(5至8年级水平),并应 格式化,以分离知情同意过程的必要要素(如.e. Risks & Benefits, Explanation of the Research Study, etc). For example, create section headings 引导读者或使用主题句来突出每篇文章中的相关信息 new section. 请不要在您的文件中附上此同意书模板的副本 application; only include the consent form you plan to use.
This website 是否有助于衡量文件的大致阅读水平.
每个部分包括准备说明,并提供建议的文本 the information to be included. Please customize the suggested text to adequately describe the research project.
如果将以英语以外的语言获得知情同意书,请包括 一份该语文的同意书副本,以及一份英文同意书副本 version.
我们已经提供了一些适合各种类型的知情同意模板 research studies. The links to these forms are at the bottom of this page.
Waiver of Documentation of Consent
在某些情况下,本局可豁免申请人签署同意书 research participant. This waiver of documentation of consent may be requested in the following circumstances:
PLEASE NOTE:没有签署的同意文件并不意味着研究者可以获得 research subjects’ consent to participate in the study. Participants should be aware 他们正在进行一项研究,谁在进行这项研究,出于什么原因, and that their participation is voluntary. One approach is to attach a consent -type 提供相关信息的文件(“同意要素”),并注明 completing the survey indicates consent to participate. Individuals may also be given information on the study to take with them. In circumstances when informed consent 必须获得口头、口头指示和脚本的具体细节是什么 will be said to the participant are very important.
可通过检查相应的同意文件要求放弃 ,并解释提出申请的原因; i.e. 上述哪一项标准适用?如何向科目提供这些要素 of consent.
授予放弃知情同意文件的协议必须采用一种信息 sheet when enrolling subjects. All information sheets should include the following:
Use of Protected Health Information and HIPAA Privacy Rule
某些医疗保健数据(受保护的健康信息或PHI)受HIPAA保护 Privacy Rule.
For more information, please see http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/index.html
任何使用受保护健康信息的调查人员都必须填写责任表 研究行为(RCR)模块的信息隐私和安全-健康隐私 Modules.
Sample Informed Consent Templates
请注意,这些模板都符合新通用规则的指导方针 place January 21, 2019.