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  1. Adding Dynamic Consent to a Longitudinal Cohort Study: A Qualitative Study of EXCEED Participant Perspectives.Susan E. Wallace & José Miola - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions (...)
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  • Health Data Research on Sudden Cardiac Arrest: Perspectives of Survivors and Their Next-of-Kin.Dick L. Willems, Hanno L. Tan, Marieke T. Blom, Rens Veeken & Marieke A. R. Bak - 2021 - BMC Medical Ethics 22 (1):1-15.
    BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...)
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  • Taking It to the Bank: The Ethical Management of Individual Findings Arising in Secondary Research.Mackenzie Graham, Nina Hallowell, Berge Solberg, Ari Haukkala, Joanne Holliday, Angeliki Kerasidou, Thomas Littlejohns, Elizabeth Ormondroyd, John-Arne Skolbekken & Marleena Vornanen - forthcoming - Journal of Medical Ethics:medethics-2020-106941.
    A rapidly growing proportion of health research uses ‘secondary data’: data used for purposes other than those for which it was originally collected. Do researchers using secondary data have an obligation to disclose individual research findings to participants? While the importance of this question has been duly recognised in the context of primary research, it remains largely unexamined in the context of research using secondary data. In this paper, we critically examine the arguments for a moral obligation to disclose individual (...)
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  • From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository.Elizabeth Bromley, Alexandra Mendoza-Graf, Sandra Berry, Camille Nebeker & Dmitry Khodyakov - 2020 - Journal of Law, Medicine and Ethics 48 (1):172-182.
    The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is (...)
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  • Genomic Data-Sharing Practices.Angela G. Villanueva, Robert Cook-Deegan, Jill O. Robinson, Amy L. McGuire & Mary A. Majumder - 2019 - Journal of Law, Medicine and Ethics 47 (1):31-40.
    Making data broadly accessible is essential to creating a medical information commons. Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency.
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  • Physicians’ Communication Patterns for Motivating Rectal Cancer Patients to Biomarker Research: Empirical Insights and Ethical Issues.Sabine Wöhlke, Julia Perry & Silke Schicktanz - 2018 - Clinical Ethics 13 (4):175-188.
    In clinical research – whether pharmaceutical, genetic or biomarker research – it is important to protect research participants’ autonomy and to ensure or strengthen their control over health-related decisions. Empirical–ethical studies have argued that both the ethical concept and the current legalistic practice of informed consent should be adapted to the complexity of the clinical environment. For this, a better understanding of recruitment, for which also the physician–patient relationship plays an important role, is needed. Our aim is to ethically reflect (...)
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  • The Role and Nature of Consent in Government Administrative Data.Alexandra Eveleigh, Oliver Duke-Williams, Elizabeth Shepherd & Anna Sexton - 2018 - Big Data and Society 5 (2).
    This article draws on research undertaken by the authors as part of the Administrative Data Research Centre in England. Between 2014 and 2017, we conducted four case studies on government administrative data for education, transport, energy and health. The purpose of the research was to examine stakeholder perspectives about the sharing, linking and re-use of government administrative data. In relation to the role and nature of consent given by data subjects for re-use, our study revealed significant variations in data provider (...)
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  • Biomedical Big Data: New Models of Control Over Access, Use and Governance.Alessandro Blasimme & Effy Vayena - 2017 - Journal of Bioethical Inquiry 14 (4):501-513.
    Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated (...)
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  • Demonstrating ‘Respect for Persons’ in Clinical Research: Findings From Qualitative Interviews with Diverse Genomics Research Participants.Stephanie A. Kraft, Erin Rothwell, Seema K. Shah, Devan M. Duenas, Hannah Lewis, Kristin Muessig, Douglas J. Opel, Katrina A. B. Goddard & Benjamin S. Wilfond - forthcoming - Journal of Medical Ethics:medethics-2020-106440.
    The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...)
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  • Public Interest in Health Data Research: Laying Out the Conceptual Groundwork.Angela Ballantyne & G. Owen Schaefer - 2020 - Journal of Medical Ethics 46 (9):610-616.
    The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...)
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  • Biobanking for Human Microbiome Research: Promise, Risks, and Ethics.Yonghui Ma, Hua Chen, Ruipeng Lei & Jianlin Ren - 2017 - Asian Bioethics Review 9 (4):311-324.
    With the advancement of human microbiome research, it is inevitable that a growing number of biobanks will include a collection of microbiota specimens to characterize the microbial communities that inhabit the human body and explore the relationships between the microbiota and their human hosts. Biobanks of human microbiota and their associated genetic information may become a valuable health resource. But, this area of research also presents ethical and social problems, some of which are distinct from those faced by biobanks that (...)
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  • Towards Rawlsian ‘Property-Owning Democracy’ Through Personal Data Platform Cooperatives.Michele Loi, Paul-Olivier Dehaye & Ernst Hafen - forthcoming - Critical Review of International Social and Political Philosophy:1-19.
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  • Authority and the Future of Consent in Population-Level Biomedical Research.Mark Sheehan, Rachel Thompson, Jon Fistein, Jim Davies, Michael Dunn, Michael Parker, Julian Savulescu & Kerrie Woods - forthcoming - Public Health Ethics.
    Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of (...)
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  • Participatory Improvement of a Template for Informed Consent Documents in Biobank Research - Study Results and Methodological Reflections.Bossert Sabine, Kahrass Hannes, Heinemeyer Ulrike, Prokein Jana & Strech Daniel - 2017 - BMC Medical Ethics 18 (1):78.
    For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers’ understanding and reactions. We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with (...)
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  • Challenges Arising When Seeking Broad Consent for Health Research Data Sharing: A Qualitative Study of Perspectives in Thailand.Phaik Yeong Cheah, Nattapat Jatupornpimol, Borimas Hanboonkunupakarn, Napat Khirikoekkong, Podjanee Jittamala, Sasithon Pukrittayakamee, Nicholas P. J. Day, Michael Parker & Susan Bull - 2018 - BMC Medical Ethics 19 (1):86.
    Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...)
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  • Broad Consent for Biobanks is Best – Provided It is Also Deep.Rasmus Bjerregaard Mikkelsen, Mickey Gjerris, Gunhild Waldemar & Peter Sandøe - 2019 - BMC Medical Ethics 20 (1):1-12.
    As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a (...)
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