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对同意程序和同意书的修订后的《通用规则》变更

Revised Common Rule Changes to the Consent Process and Consent Form.

作者信息

LeCompte Leah L, Young Sylvia J

机构信息

Department of Rehabilitation Services, Ochsner Clinic Foundation, New Orleans, LA.

Human Research Protection Program, Ochsner Clinic Foundation, New Orleans, LA.

出版信息

Ochsner J. 2020 Spring;20(1):62-75. doi: 10.31486/toj.19.0055.

Abstract

The Federal Policy for the Protection of Human Subjects-the Common Rule-was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process. We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non-federally funded studies. Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects' understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation. The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.

摘要

《联邦保护人类受试者政策——通用规则》于2017年进行了修订,以减轻低风险研究的行政负担,同时加强对参与高于最小风险试验的人类受试者的保护。这些强化保护措施涉及同意程序的变更。我们审查了适用于同意程序的一般要求,以及通用规则修订案规定的同意的其他要素。这些规定适用于联邦资助的研究,对于非联邦资助的研究则为可选规定。为了提高潜在受试者对研究的理解,并促进研究人员与潜在受试者之间的信息交流,新增了两项同意程序的一般要求、一项同意书的基本必填要素以及三项同意书的可选附加要素。有关研究的重要信息应提炼成一个简洁的关键信息部分,以帮助潜在受试者就是否参与做出明智的决定。通用规则的修订旨在通过在同意程序中以易懂的形式提供更多信息来加强对人类受试者的保护。新的同意要素旨在提高透明度并有助于提高清晰度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9184/7122264/5337c4a84660/toj-19-0055-figure1.jpg

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