A R Howarth, C S Estcourt, R E Ashcroft, J A Cassell
{"title":"Building an Opt-Out Model for Service-Level Consent in the Context of New Data Regulations.","authors":"A R Howarth, C S Estcourt, R E Ashcroft, J A Cassell","doi":"10.1093/phe/phab030","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":49136,"journal":{"name":"Public Health Ethics","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9719338/pdf/","citationCount":"2","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Public Health Ethics","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1093/phe/phab030","RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
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.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
