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Question:

eConsent有没有监管单位发布对应Guideline? 国外是否已有eConsent 的实例?

Answer:

国外已有eConsent 应用,针对eConsent的现有监管指南和IEC/IRB审查/批准要求都有限。不同国家和地区对eConsent的多媒体组件(如数字签名)的接受程度可能有所不同,均影响着其在全球范围内的发展。eConsent新技术可能会让人望而生畏,但有 "改进的空间",在某些情况下,新技术需要高额的初始投资和资源。

 

参考以下Guidance

1FDA 2016):Use of Electronic Informed Consent in Clinical Investigations Questions and Answers

linkhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers

2MHRA 2018):Joint statement on seeking consent by electronic methods

linkhttps://www.hra.nhs.uk/documents/1588/hra-mhra-econsent-statement-sept-18.pdf

3Transcelertae 也有关于e-Consent的相关章节

link https://transceleratebiopharmainc.com/econsent/what-is-econsent/"