知情同意模板
New Common Rule Key Information Examples:
为了协助研究人员制定同意书的关键信息部分，我们正在发布一些示例。这些示例将放置在同意表格文档的开头。当前，没有联邦指导准确地定义简洁和重点介绍中需要什么“关键信息”。这部分是由于这一新要求的应用将取决于特定研究的性质。受试者将需要决定是否参加II期临床试验的“关键信息”与决定是否参加纵向或观察性研究所需的“关键信息”会不同风险。对于一些最小的风险研究，简洁的介绍可能只需要几段。对于更复杂的研究试验，关键信息不应超过2页，并且大多数应该适合一页。
It is important to note that the concise and focused introduction should include a summary of why an individual may want to participate, but should also include information about why an individual may not want to participate in the research, such as the fact that participation involves significant time commitments or risks. While the introductory section should not list every foreseeable risk of participation, it should describe those risks that occur with significant frequency or are of significant severity. The total time commitment may also be an important factor. Investigators know their participant population best; therefore they are in the best position to determine the key information that should be provided at the start of the consent to meet this new requirement. Some key information examples are provided below
- English Informed Consent Template（2022年2月的新版本）
- 简明的摘要示例 - 大于最小风险研究
- Concise Summary Example – Minimal Risk Study
- Concise Summary Example – Repository
- 个人患者扩大访问同意模板（仅用于使用“单个患者扩展访问”提交类型的协议中）。
- 个人患者扩大访问同意模板
知情同意Library
The BCH Informed Consent Library (ICLibrary) provides investigators and their staff the ability to access the currently approved versions of their informed consent(s). The site is accessible to anyone with a Children's Hospital web account. Study staff are instructed to obtain their consent forms directly from the ICLibrary website. This ICLibrary is available through internal access only and may be found through the切普IRB website.
Use of the Short Form Consent
IRB提供了几种通常理解的语言的简短同意文档翻译。这种缩写的翻译或“简短形式”（证明已口服同意的要素）可用于记录在有限情况下不会说英语的个人的书面书面同意书。为了使用此形式，需要满足特定的监管要求。请查阅IRB政策6.4“与非英语演讲者的知情同意”before using a short form.
When a short form is used and the interpreter is present in the room with the subject we have provided a checklist to help you through this process.
由于越来越多的非英语患者数量，口译服务与远程口译员签约，以根据需要提供帮助。通过用于此目的的iPad使用iPad来促进此过程。如果使用了简短的表格，并且使用了远程解释器（VRI iPad技术），则必须完成一个清单，必须完整并用简短表格提交以确保合规性。
- 短形式清单，可与远程解释器一起使用,REQUIREDfor both OPI (over the phone interpretation) and VRI (video remote interpreting)
简式翻译
Albanian
Amharic
阿拉伯
Bosnian
Bulgarian
佛得角克里奥尔角
中国人
Czech
Danish
Dutch
English Version（以供参考）
波斯语
French
德语
Greek
海地克里奥尔
希伯来语
Hindi
Italian
日本人
高棉
韩国人
Laotian
Maay Maay
尼泊尔
Polish
Portuguese
Russian
索马里
西班牙语
Tamil
泰国
泰卢固语
Turkish
Urdu
越南人
知情的同意模板
所有同意文件必须由IRB审查和批准。下面的同意模板是为了向调查人员提供指导，以了解哪些信息以同意形式包括在内。请随时在开发同意文件中使用此样本。模板中的语言和信息应根据受试者的年龄和认知水平，适合于每个协议。
Information Sheet Template
This template only applies to investigators who indicate that informed consent/assent/authorization will be obtained through a method other than a written document in Part C and plan to develop an information sheet. All information sheet documents must be reviewed by the IRB. The information sheet template below was developed to provide guidance to investigators as to what information to include in an information sheet. Please feel free to use this sample in the development of information sheet documents. The language and information in the template should be modified as appropriate for each protocol depending on the age and cognitive level of the subject population. Information sheets will not be uploaded to the ICLibrary website.
Information Sheet Template
Simplifying Medical Terms
Informed consent documents should be written at a 6th grade reading level and should avoid the use of complex medical terminology. Please consult the links below for lay descriptions of common medical terms.
Stanford University Glossary of Lay Terms
University of Michiganplain language medical dictionary