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Article

Retrieval-Augmented Generation Enhanced GPT-4.1 to Support Clinical Trial Informed Consent Review for Data Reuse

2026-03-04

Abstract excerpt

<h4>Background: </h4> Regulatory frameworks such as the Belmont Report, the Common Rule, and the Declaration of Helsinki require informed consent to ensure participants understand a study’s purpose and can make voluntary decisions about their involvement. Regulations including the General Data Protection Regulation (Regulation (EU) 2016/679) further emphasise that consent must be freely given and revocable without...

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Literature Corpus work
65cf78bb-7040-504a-8f57-06d04ecc1238
DOI
10.20944/preprints202603.0380.v1
Open publication

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