Verbal consent in biomedical research: moving toward a future standard practice?

IF 2.8 3区 生物学 Q2 GENETICS & HEREDITY
Frontiers in Genetics Pub Date : 2025-02-28 eCollection Date: 2025-01-01 DOI:10.3389/fgene.2025.1472655
Alycia Noë, Emilie Vaillancourt, Ma'n H Zawati
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引用次数: 0

Abstract

Properly obtaining informed consent is a core obligation for research conducted using human subjects. The traditional informed consent process involves written forms and obtaining signatures. This process remains the standard, but in various research settings, such as COVID-19 and rare disease research, verbal consent has increasingly become the norm. Although verbal consent is used in these settings, its use is still a subject of debate. This article reviews in what medical settings verbal consent is commonly seen today, various advantages and disadvantages of verbal consent, and its legislative and policy ecosystem. In doing so, this review article asserts that it is time for the debate over verbal consent to come to an end and for legislator and policymakers to acknowledge its use and to formalize the process. This will allow verbal consent to be regulated in a similar manner to written consent and will give clinician-researchers guidance on how to better implement verbal consent in their studies to addressing ongoing concerns with the consenting process as a whole.

生物医学研究中的口头同意:向未来的标准做法迈进?
正确获得知情同意是使用人类受试者进行研究的核心义务。传统的知情同意程序包括书面表格和获取签名。这一过程仍然是标准,但在各种研究环境中,如COVID-19和罕见疾病研究,口头同意日益成为常态。虽然口头同意在这些情况下使用,但它的使用仍然是一个有争议的话题。本文回顾了在哪些医疗环境中口头同意是常见的,口头同意的各种优点和缺点,以及它的立法和政策生态系统。在这样做的过程中,这篇评论文章断言,现在是时候结束关于口头同意的辩论,让立法者和政策制定者承认口头同意的使用,并将这一过程正式化。这将允许口头同意以类似于书面同意的方式进行监管,并将为临床医生和研究人员提供指导,指导他们如何在研究中更好地实施口头同意,以解决整个同意过程中持续存在的问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Frontiers in Genetics
Frontiers in Genetics Biochemistry, Genetics and Molecular Biology-Molecular Medicine
CiteScore
5.50
自引率
8.10%
发文量
3491
审稿时长
14 weeks
期刊介绍: Frontiers in Genetics publishes rigorously peer-reviewed research on genes and genomes relating to all the domains of life, from humans to plants to livestock and other model organisms. Led by an outstanding Editorial Board of the world’s leading experts, this multidisciplinary, open-access journal is at the forefront of communicating cutting-edge research to researchers, academics, clinicians, policy makers and the public. The study of inheritance and the impact of the genome on various biological processes is well documented. However, the majority of discoveries are still to come. A new era is seeing major developments in the function and variability of the genome, the use of genetic and genomic tools and the analysis of the genetic basis of various biological phenomena.
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