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      Investigating the Extent to Which Patients Should Control Access to Patient Records for Research: A Deliberative Process Using Citizens’ Juries

      research-article
      , BSc (Hons), MSc, PhD, FRPharmS, FFRPS 1 , 2 , , , MTS 3 , , BSc, PhD 4 , , BSc (Hons), MA 5 , , BSc (Hons), MPhil, PhD 1 , , BSc (Hons), PGDip 1 , , BA (Econ), MA, PhD 6 , 7 , , PhD 1 , 8
      (Reviewer), (Reviewer), (Reviewer), (Reviewer)
      Journal of Medical Internet Research
      JMIR Publications
      public participation, patient engagement, public opinion, medical research, confidentiality, privacy, national health services, data linkage, public policy, decision making, organizational

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          Abstract

          Background

          The secondary use of health data for research raises complex questions of privacy and governance. Such questions are ill-suited to opinion polling where citizens must choose quickly between multiple-choice answers based on little information.

          Objective

          The aim of this project was to extend knowledge about what control informed citizens would seek over the use of health records for research after participating in a deliberative process using citizens’ juries.

          Methods

          Two 3-day citizens’ juries, of 17 citizens each, were convened to reflect UK national demographics from 355 eligible applicants. Each jury addressed the mission “To what extent should patients control access to patient records for secondary use?” Jurors heard from and questioned 5 expert witnesses (chosen either to inform the jury, or to argue for and against the secondary use of data), interspersed with structured opportunities to deliberate among themselves, including discussion and role-play. Jurors voted on a series of questions associated with the jury mission, giving their rationale. Individual views were polled using questionnaires at the beginning and at end of the process.

          Results

          At the end of the process, 33 out of 34 jurors voted in support of the secondary use of data for research, with 24 wanting individuals to be able to opt out, 6 favoring opt in, and 3 voting that all records should be available without any consent process. When considering who should get access to data, both juries had very similar rationales. Both thought that public benefit was a key justification for access. Jury 1 was more strongly supportive of sharing patient records for public benefit, whereas jury 2 was more cautious and sought to give patients more control. Many jurors changed their opinion about who should get access to health records: 17 people became more willing to support wider information sharing of health data for public benefit, whereas 2 moved toward more patient control over patient records.

          Conclusions

          The findings highlight that, when informed of both risks and opportunities associated with data sharing, citizens believe an individual’s right to privacy should not prevent research that can benefit the general public. The juries also concluded that patients should be notified of any such scheme and have the right to opt out if they so choose. Many jurors changed their minds about this complex policy question when they became more informed. Many, but not all, jurors became less skeptical about health data sharing, as they became better informed of its benefits and risks.

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          Most cited references23

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          Written informed consent and selection bias in observational studies using medical records: systematic review

          Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. Design Systematic review. Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161?604 eligible patients, 66.9% consented to use of data from their medical records. Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.
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            The use of citizens' juries in health policy decision-making: a systematic review.

            Deliberative inclusive approaches, such as citizen juries, have been used to engage citizens on a range of issues in health care and public health. Researchers engaging with the public to inform policy and practice have adapted the citizen jury method in a variety of ways. The nature and impact of these adaptations has not been evaluated. We systematically searched Medline (PubMED), CINAHL and Scopus databases to identify deliberative inclusive methods, particularly citizens' juries and their adaptations, deployed in health research. Identified studies were evaluated focussing on principles associated with deliberative democracy: inclusivity, deliberation and active citizenship. We examined overall process, recruitment, evidence presentation, documentation and outputs in empirical studies, and the relationship of these elements to theoretical explications of deliberative inclusive methods. The search yielded 37 papers describing 66 citizens' juries. The review demonstrated that the citizens' jury model has been extensively adapted. Inclusivity has been operationalised with sampling strategies that aim to recruit representative juries, although these efforts have produced mixed results. Deliberation has been supported through use of steering committees and facilitators to promote fair interaction between jurors. Many juries were shorter duration than originally recommended, limiting opportunity for constructive dialogue. With respect to citizenship, few juries' rulings were considered by decision-making bodies thereby limiting transfer into policy and practice. Constraints in public policy process may preclude use of the 'ideal' citizens' jury with potential loss of an effective method for informed community engagement. Adapted citizens' jury models provide an alternative: however, this review demonstrates that special attention should be paid to recruitment, independent oversight, jury duration and moderation. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
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              “Let’s get the best quality research we can”: public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study

              Background Opt-in consent is usually required for research, but is known to introduce selection bias. This is a particular problem for large scale epidemiological studies using only pre-collected health data. Most previous studies have shown that members of the public value opt-in consent and can perceive research without consent as an invasion of privacy. Past research has suggested that people are generally unaware of research processes and existing safeguards, and that education may increase the acceptability of research without prior informed consent, but this recommendation has not been formally evaluated. Our objectives were to determine the range of public opinion about the use of existing medical data for research and to explore views about consent to a secondary review of medical records for research. We also investigated the effect of the provision of detailed information about the potential effect of selection bias on public acceptability of the use of data for research. Methods We carried out a systematic review of existing literature on public attitudes to secondary use of existing health records identified by searching PubMed (1966-present), Embase (1974-present) and reference lists of identified studies to provide a general overview, followed by a qualitative focus group study with 19 older men recruited from rural and suburban primary care practices in the UK to explore key issues in detail. Results The systematic review identified twenty-seven relevant papers and the findings suggested that males and older people were more likely to consent to a review of their medical data. Many studies noted participants’ lack of knowledge about research processes and existing safeguards and this was reflected in the focus groups. Focus group participants became more accepting of the use of pre-collected medical data without consent after being given information about selection bias and research processes. All participants were keen to contribute to NHS-related research but some were concerned about data-sharing for commercial gain and the potential misuse of information. Conclusions Increasing public education about research and specific targeted information provision could promote trust in research processes and safeguards, which in turn could increase the acceptability of research without specific consent where the need for consent would lead to biased findings and impede research necessary to improve public health.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                March 2018
                28 March 2018
                : 20
                : 3
                : e112
                Affiliations
                [1] 1 Health E-Research Centre, Division of Imaging, Informatics and Data Sciences School of Health Sciences, Faculty of Biology, Medicine and Health The University of Manchester, Manchester Academic Health Science Centre Manchester United Kingdom
                [2] 2 Division of Pharmacy and Optometry School of Health Sciences, Faculty of Biology, Medicine and Health The University of Manchester, Manchester Academic Health Science Centre Manchester United Kingdom
                [3] 3 Jefferson Center Saint Paul, MN United States
                [4] 4 Department of Geography and Planning School of Environmental Sciences University of Liverpool Liverpool United Kingdom
                [5] 5 Health Research Authority London United Kingdom
                [6] 6 School of Law Faculty of Humanities The University of Manchester Manchester United Kingdom
                [7] 7 Citizens Juries Community Interest Company Manchester United Kingdom
                [8] 8 Greater Manchester Patient Safety Translational Research Centre Division of Population Health, Health Services Research and Primary Care, School of Health Sciences The University of Manchester, Manchester Academic Health Science Centre Manchester United Kingdom
                Author notes
                Corresponding Author: Mary P Tully mary.p.tully@ 123456manchester.ac.uk
                Author information
                http://orcid.org/0000-0003-2100-3983
                http://orcid.org/0000-0001-7671-3881
                http://orcid.org/0000-0002-5422-622X
                http://orcid.org/0000-0003-2156-7279
                http://orcid.org/0000-0002-5888-422X
                http://orcid.org/0000-0003-2353-6265
                http://orcid.org/0000-0001-9197-7973
                http://orcid.org/0000-0002-6393-9969
                Article
                v20i3e112
                10.2196/jmir.7763
                5895919
                29592847
                55bf832f-8273-49da-99fd-d11e7dcd6f9d
                ©Mary P Tully, Kyle Bozentko, Sarah Clement, Amanda Hunn, Lamiece Hassan, Ruth Norris, Malcolm Oswald, Niels Peek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.03.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 28 March 2017
                : 12 July 2017
                : 2 November 2017
                : 16 November 2017
                Categories
                Original Paper
                Original Paper

                Medicine
                public participation,patient engagement,public opinion,medical research,confidentiality,privacy,national health services,data linkage,public policy, decision making, organizational

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