Building an Opt-Out Model for Service-Level Consent in the Context of New Data Regulations.

IF 1.4 3区 哲学 Q2 ETHICS Public Health Ethics Pub Date : 2022-07-01 DOI:10.1093/phe/phab030
A R Howarth, C S Estcourt, R E Ashcroft, J A Cassell
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引用次数: 2

Abstract

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual's right to withhold their data from trial analysis while routinely offering the same care to all patients.

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在新数据法规的背景下建立服务级同意的选择退出模型。
《通用数据保护条例》(GDPR)于2018年出台,旨在协调整个欧盟(EU)的数据隐私和安全法律。它适用于在欧盟收集个人数据的任何组织。迄今为止,服务水平的同意已被用作临床试验的比例方法,这些临床试验实施低风险、常规、全服务范围的干预措施,个人同意被认为是不合适的。在公共卫生研究的背景下,GDPR现在要求个人有权选择是否将其数据用于研究,这在临床服务而不是个人服务用户同意的情况下提出了挑战。我们在这里报告在英国性健康诊所的合作伙伴通知干预试验的背景下,这种同意悖论的务实选择退出解决方案的发展。我们的方法支持个人对试验分析保留数据的权利,同时为所有患者提供常规的相同护理。
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来源期刊
Public Health Ethics
Public Health Ethics PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-MEDICAL ETHICS
CiteScore
3.10
自引率
9.50%
发文量
28
审稿时长
>12 weeks
期刊介绍: Public Health Ethics invites submission of papers on any topic that is relevant for ethical reflection about public health practice and theory. Our aim is to publish readable papers of high scientific quality which will stimulate debate and discussion about ethical issues relating to all aspects of public health. Our main criteria for grading manuscripts include originality and potential impact, quality of philosophical analysis, and relevance to debates in public health ethics and practice. Manuscripts are accepted for publication on the understanding that they have been submitted solely to Public Health Ethics and that they have not been previously published either in whole or in part. Authors may not submit papers that are under consideration for publication elsewhere, and, if an author decides to offer a submitted paper to another journal, the paper must be withdrawn from Public Health Ethics before the new submission is made. The editorial office will make every effort to deal with submissions to the journal as quickly as possible. All papers will be acknowledged on receipt by email and will receive preliminary editorial review within 2 weeks. Papers of high interest will be sent out for external review. Authors will normally be notified of acceptance, rejection, or need for revision within 8 weeks of submission. Contributors will be provided with electronic access to their proof via email; corrections should be returned within 48 hours.
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