知情同意

知情同意Template

新的普通规则关键信息示例：

To assist investigators in developing the key information section of the consent form we are posting a few examples. These examples would be placed at the beginning of the consent form document. Currently there is no federal guidance defining exactly what “key information” is required in the concise and focused introduction. This is due in part to the fact that the application of this new requirement will depend upon the nature of the specific research study. The “key information” that a subject will need to decide whether to enroll in a Phase II Clinical Trial will be different from the “key information” needed to decide whether or not to enroll in a longitudinal or observational research study involving not greater than minimal risk. For some minimal risk studies, the concise introduction may require only a few paragraphs. For more complex research trials key information should never be longer than 2 pages and most should fit on one page.

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

英语知情同意模板（2021年10月的新数据共享信息版本）
Concise Summary Example – Greater Than Minimal Risk Study
简明摘要示例 - 最小风险研究
Concise Summary Example – Repository

Individual Patient Expanded Access Consent Template(only for use with protocols using the “Individual Patient Expanded Access” submission type in CHeRP).
Individual Patient Expanded Access Consent Template

知情同意库

BCH知情同意图书馆（ICLibrary）为调查人员及其员工提供了访问当前批准的知情同意书的能力。拥有儿童医院网络帐户的任何人都可以访问该网站。指示学习人员直接从iClibrary网站获得其同意书。该iClibrary仅通过内部访问获得，可以通过Cherp IRB网站找到。

Use of the Short Form Consent

The IRB provides short consent document translations in several commonly understood languages. This abbreviated translation or “short form” (which attests that the elements of consent have been presented orally) may be used to document informed consent in writing for individuals who do not speak English in limited situations. There are specific regulatory requirements that need to be met in order to use this form. Please reviewIRB Policy 6.4 "Informed Consent with Non-English Speakers"before using a short form.

当使用简短的表格并带有主题中的解释器时，我们提供了一个清单来帮助您完成此过程。

Due to the increasing numbers of non-English speaking patients, interpreter services have contracted with remote interpreters to provide assistance as needed. This process is facilitated through the use of iPads dedicated for this purpose. If a short form is used and a REMOTE interpreter (VRI iPad Technology) is utilized there is a checklist that must be completed and filed with the short form to assure compliance.

简短的翻译

阿尔巴尼亚人
阿姆哈拉语
阿拉伯
波斯尼亚
保加利亚语
Cape Verdean Creole
Chinese
Czech
丹麦语
荷兰
英文版（以供参考）
波斯语
French
German
希腊语
Haitian Creole
Hebrew
印地语
意大利人
Japanese
Khmer
Korean
老挝
Maay Maay
Nepali
抛光
葡萄牙语
俄语
索马里
西班牙语
Tamil
泰国
Telugu
Turkish
Urdu
Vietnamese

Informed Assent Template

All assent documents must be reviewed and approved by the IRB. The assent template below was developed to provide guidance to investigators as to what information to include in an assent form. Please feel free to use this sample in the development of assent 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.

Informed Assent Template

信息表模板

该模板仅适用于指示知情同意/同意/授权的调查人员将通过C部分中的书面文档以外的其他方法获得，并计划开发信息表。所有信息表文档必须由IRB审查。下面的信息表模板是为了向调查人员提供有关在信息表中包含哪些信息的指导。请随时在信息表文档的开发中使用此示例。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。信息表将不会上传到iClibrary网站。
信息表模板

简化医学术语

知情同意文件应在6年级阅读级别写，并应避免使用复杂的医学术语。请咨询以下链接以进行常见的医学术语描述。
Stanford University Glossary of Lay Terms
University of Michiganplain language medical dictionary