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WHO guidance for human genome data collection, access, use and sharing: why granularity maximisation in informed consent should be reconsidered.

作者信息

Thaldar Donrich, Edgcumbe Aliki

机构信息

School of Law, University of KwaZulu-Natal, Durban, South Africa

School of Law, University of KwaZulu-Natal, Durban, South Africa.

出版信息

BMJ Glob Health. 2025 Jul 20;10(7):e018494. doi: 10.1136/bmjgh-2024-018494.

DOI:10.1136/bmjgh-2024-018494
PMID:40685159
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12278145/
Abstract
摘要

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本文引用的文献

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Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices.为何过多的临床研究知情同意书无效：对现行做法的批判性分析。
BMJ Open. 2022 Mar 4;12(3):e050543. doi: 10.1136/bmjopen-2021-050543.
2
Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document.过于冗长和详细：知情同意书的健康素养属性评估。
J Racial Ethn Health Disparities. 2020 Apr;7(2):327-335. doi: 10.1007/s40615-019-00661-1. Epub 2019 Dec 10.
3
The Reasonable Person Standard for Research Disclosure: A Reasonable Addition to the Common Rule.研究披露的合理人标准：对普通规则的合理补充。
J Law Med Ethics. 2019 Jun;47(2):194-202. doi: 10.1177/1073110519857275.
4
The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm.不堪重负患者的知情同意权限制：临床医生在保护患者及防止其不堪重负方面的作用
AMA J Ethics. 2016 Sep 1;18(9):869-86. doi: 10.1001/journalofethics.2016.18.9.peer2-1609.
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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言：涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
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OECD guidelines on human biobanks and genetic research databases.
Eur J Health Law. 2010 Mar;17(2):191-204.
7
Universal Declaration on Bioethics & Human Rights.《生物伦理与人类权利世界宣言》
Bull Med Ethics. 2005 Oct-Nov(211):11-5.
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Castell v. De Greef.卡斯特尔诉德格里夫
S Afr Law Rep. 1994 Feb 17;1994(4):408-41.