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  1.  2
    Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations.Laurie J. Bauman, Claude Ann Mellins & Robert Klitzman - 2020 - Journal of Law, Medicine and Ethics 48 (1):188-201.
    Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...)
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  2.  1
    Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary.Laura M. Beskow, Catherine M. Hammack-Aviran, Kathleen M. Brelsford & P. Pearl O'Rourke - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):138-146.
    In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.
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  3.  3
    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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  4.  2
    Online Pediatric Research: Addressing Consent, Assent, and Parental Permission.Kyle B. Brothers, Ellen Wright Clayton & Aaron J. Goldenberg - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):129-137.
    This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.
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  5. Diversity and Inclusion in Unregulated mHealth Research: Addressing the Risks.Shawneequa Callier & Stephanie M. Fullerton - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):115-121.
    mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research — misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms — may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation (...)
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  6.  2
    Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions.Fook Yee Cheung, Lauren Clatch, Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2020 - Journal of Law, Medicine and Ethics 48 (1):87-104.
    The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to (...)
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  7.  2
    What Should We Be Asking of Informed Consent?Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):185-187.
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  8.  1
    Cop to Cop: Negotiating Privacy and Security in the Examining Room.Sondra S. Crosby & George J. Annas - 2020 - Journal of Law, Medicine and Ethics 48 (1):169-171.
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  9.  1
    Who Are the People in Your Neighborhood? Personas Populating Unregulated mHealth Research.Megan Doerr & Christi Guerrini - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):37-48.
    A key feature of unregulated mHealth research is the diversity of participants in this space. Applying an approach drawn from user experience design, we describe a set of archetypal unregulated mHealth researcher “personas,” which range from individuals who seek empowerment or have philanthropic objectives to those who are primarily motivated by financial gain or have misanthropic objectives. These descriptions are useful for evaluating policies applicable to mHealth to understand how they will impact various stakeholders.
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  10.  1
    To What Extent Does the EU General Data Protection Regulation (GDPR) Apply to Citizen Scientist-Led Health Research with Mobile Devices?Edward S. Dove & Jiahong Chen - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):187-195.
    In this article, we consider the possible application of the European General Data Protection Regulation to “citizen scientist”-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for lex specialis that would provide greater clarity and certainty regarding the processing of health data by for research purposes, including these non-traditional researchers.
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  11. The Streetlight Effect: Regulating Genomics Where the Light Is.Barbara J. Evans - 2020 - Journal of Law, Medicine and Ethics 48 (1):105-118.
    Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.
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  12. The Perils of Parity: Should Citizen Science and Traditional Research Follow the Same Ethical and Privacy Principles?Barbara J. Evans - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):74-81.
    The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how (...)
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  13.  1
    How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?Barbara J. Evans, Gail Javitt, Ralph Hall, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan & Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):44-68.
    Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
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  14. Entwined Processes: Rescripting Consent and Strengthening Governance in Genomics Research with Indigenous Communities.Nanibaa’ A. Garrison, Stephanie Russo Carroll & Maui Hudson - 2020 - Journal of Law, Medicine and Ethics 48 (1):218-220.
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  15.  1
    The Future of DTC Genomics and the Law.Henry T. Greely - 2020 - Journal of Law, Medicine and Ethics 48 (1):151-160.
    Direct-to-Consumer genomics has been a controversial topic for over a decade. Much work has been done on the legal issues it raises. This article asks a different question: What will DTC genomics and its legal issues look like in ten to twenty years? After discussing the five current uses of DTC genomics, it describes three current legal issues: medical uses, privacy of genomic information, and privacy in collection and analysis of human DNA. It then suggests that changes in human genomics (...)
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  16.  2
    A Right to Privacy and Confidentiality: Ethical Medical Care for Patients in United States Immigration Detention.Amanda M. Gutierrez, Jacob D. Hofstetter, Emma L. Dishner, Elizabeth Chiao, Dilreet Rai & Amy L. McGuire - 2020 - Journal of Law, Medicine and Ethics 48 (1):161-168.
    Recently, John Doe, an undocumented immigrant who was detained by United States Immigration and Customs Enforcement, was admitted to a hospital off-site from a detention facility. Custodial officers accompanied Mr. Doe into the exam room and refused to leave as physicians examined him. In this analysis, we examine the ethical dilemmas this case brings to light concerning the treatment of patients in immigration detention and their rights to privacy. We analyze what US law and immigration detention standards allow regarding immigration (...)
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  17.  1
    Ethical Considerations in the Conduct of Unregulated mHealth Research: Expert Perspectives.Catherine M. Hammack-Aviran, Kathleen M. Brelsford & Laura M. Beskow - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):9-36.
    To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.
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  18.  1
    Revisiting Legal Foundations of Crisis Standards of Care.James G. Hodge - 2020 - Journal of Law, Medicine and Ethics 48 (1):221-224.
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  19. Letter From The Editor.Ted Hutchinson - 2020 - Journal of Law, Medicine and Ethics 48 (1):1-2.
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  20.  1
    The Implementation Chasm Hindering Genome-Informed Health Care.Kevin B. Johnson, Ellen Wright Clayton, Justin Starren & Josh Peterson - 2020 - Journal of Law, Medicine and Ethics 48 (1):119-125.
    The promises of precision medicine are often heralded in the medical and lay literature, but routine integration of genomics in clinical practice is still limited. While the “last mile’ infrastructure to bring genomics to the bedside has been demonstrated in some healthcare settings, a number of challenges remain — both in the receptivity of today's health system and in its technical and educational readiness to respond to this evolution in care. To improve the impact of genomics on health and disease (...)
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  21. Letter to the Editor.Bryan Kibbe & Jordan Potter - 2020 - Journal of Law, Medicine and Ethics 48 (1):232-232.
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  22.  1
    International mHealth Research: Old Tools and New Challenges.Michael Lang, Bartha Maria Knoppers & Ma’N. H. Zawati - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):178-186.
    In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.
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  23.  1
    Data Sharing in the Context of Health-Related Citizen Science.Mary A. Majumder & Amy L. McGuire - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):167-177.
    As citizen science expands, questions arise regarding the applicability of norms and policies created in the context of conventional science. This article focuses on data sharing in the conduct of health-related citizen science, asking whether citizen scientists have obligations to share data and publish findings on par with the obligations of professional scientists. We conclude that there are good reasons for supporting citizen scientists in sharing data and publishing findings, and we applaud recent efforts to facilitate data sharing. At the (...)
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  24. From Genetics to Genomics: Facing the Liability Implications in Clinical Care.Gary Marchant, Mark Barnes, James P. Evans, Bonnie LeRoy & Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (1):11-43.
    Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...)
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  25. Letter From The Editor.Courtney McClellan - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):1-1.
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  26. General-Purpose Privacy Regulation and Translational Genomics.William McGeveran & Caroline Schmitz - 2020 - Journal of Law, Medicine and Ethics 48 (1):142-150.
    At one time, specialized health privacy laws represented the bulk of the rules regulating genetic privacy, Today, however, as both the field of genomics and the content of privacy law change rapidly, a new generation of general-purpose privacy laws may impose new restrictions on collection, storage, and disclosure of genetic data. This article surveys these laws and considers implications.
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  27.  1
    There Oughta Be a Law: When Does(N’T) the U.S. Common Rule Apply?Michelle N. Meyer - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):60-73.
    Using mobile health research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that the Common Rule does or does not “apply,” the extent to which these different meanings of “apply” matter, and, when the Common Rule does apply, how it applies.
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  28. Navigating the Regulatory Framework for HIV Prevention Research in Adolescents.Quianta Moore & Zeinab Bakhiet - 2020 - Journal of Law, Medicine and Ethics 48 (1):202-204.
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  29.  1
    Australian Aboriginal and Torres Strait Islander Collections of Genetic Heritage: The Legal, Ethical and Practical Considerations of a Dynamic Consent Approach to Decision Making.Megan Prictor, Sharon Huebner, Harriet J. A. Teare, Luke Burchill & Jane Kaye - 2020 - Journal of Law, Medicine and Ethics 48 (1):205-217.
    Dynamic Consent is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time. The DC model enables individuals to know and to decide how personal research information is being used and provides a way in which to exercise legal rights provided in privacy and data protection law. The DC tool is flexible and responsive, enabling legal and ethical requirements in research data sharing to be met and for online health (...)
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  30.  1
    Introduction: Unregulated Health Research Using Mobile Devices.Mark A. Rothstein & John T. Wilbanks - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):7-8.
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  31.  2
    Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.Mark A. Rothstein, John T. Wilbanks, Laura M. Beskow, Kathleen M. Brelsford, Kyle B. Brothers, Megan Doerr, Barbara J. Evans, Catherine M. Hammack-Aviran, Michelle L. McGowan & Stacey A. Tovino - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):196-226.
    Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...)
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  32.  1
    Development of a National Public Pharmaceutical Research and Development Institute.Ameet Sarpatwari, Dana Brown & Aaron S. Kesselheim - 2020 - Journal of Law, Medicine and Ethics 48 (1):225-227.
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  33.  1
    Dimensions of Research-Participant Interaction: Engagement is Not a Replacement for Consent.Emily Shearer, Nicole Martinez & David Magnus - 2020 - Journal of Law, Medicine and Ethics 48 (1):183-184.
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  34.  1
    Assessing the Thin Regulation of Consumer-Facing Health Technologies.Nicolas P. Terry - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):94-102.
    This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and suggests (...)
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  35.  1
    Privacy and Security Issues with Mobile Health Research Applications.Stacey A. Tovino - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):154-158.
    This article examines the privacy and security issues associated with mobile application-mediated health research, concentrating in particular on research conducted or participated in by independent scientists, citizen scientists, and patient researchers. Building on other articles in this issue that examine state research laws and state data protection laws as possible sources of privacy and security protections for mobile research participants, this article focuses on the lack of application of federal standards to mobile application-mediated health research. As discussed in more detail (...)
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  36.  1
    Lost in Anonymization — A Data Anonymization Reference Classification Merging Legal and Technical Considerations.Kerstin N. Vokinger, Daniel J. Stekhoven & Michael Krauthammer - 2020 - Journal of Law, Medicine and Ethics 48 (1):228-231.
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  37. The Federal Trade Commission and Consumer Protections for Mobile Health Apps.Jennifer K. Wagner - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):103-114.
    The Federal Trade Commission has an important role to play in the governmental oversight of mobile health apps, ensuring consumer protections from unfair and deceptive trade practices and curtailing anti-competitive methods. The FTC’s consumer protection structure and authority is outlined before reviewing the recent FTC enforcement activities taken on behalf of consumers and against developers of mhealth apps. The article concludes with identification of some challenges for the FTC and modest recommendations for strengthening the consumer protections it provides.
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  38. Electronic Informed Consent in Mobile Applications Research.John T. Wilbanks - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):147-153.
    The article covers electronic informed consent from different dimensions so that practitioners might understand the history, regulation, and current status of eIC. It covers the transition of informed consent to electronic screens and the implications of that transition in terms of design, costs, and data analysis. The article explores the limits of regulation mandating eIC for mobile application research, and addresses some of the broader social context around eIC.
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  39. Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law.Leslie E. Wolf, Catherine M. Hammack, Erin Fuse Brown, Kathleen M. Brelsford & Laura M. Beskow - 2020 - Journal of Law, Medicine and Ethics 48 (1):126-141.
    Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.
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  40. Return of Results in Participant-Driven Research: Learning From Transformative Research Models.Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):159-166.
    Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.
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  41. Introduction: The Crucial Role of Law in Supporting Successful Translation of Genomics Into Clinical Care.Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2020 - Journal of Law, Medicine and Ethics 48 (1):7-10.
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  42.  1
    Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.Susan M. Wolf, Pilar N. Ossorio, Susan A. Berry, Henry T. Greely, Amy L. McGuire, Michelle A. Penny & Sharon F. Terry - 2020 - Journal of Law, Medicine and Ethics 48 (1):69-86.
    Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
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  43. Do Groups Have Moral Standing in Unregulated mHealth Research?Joon-Ho Yu & Eric Juengst - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):122-128.
    Biomedical research using data from participants’ mobile devices borrows heavily from the ethos of the “citizen science” movement, by delegating data collection and transmission to its volunteer subjects. This engagement gives volunteers the opportunity to feel like partners in the research and retain a reassuring sense of control over their participation. These virtues, in turn, give both grass-roots citizen science initiatives and institutionally sponsored mHealth studies appealing features to flag in recruiting participants from the public. But while grass-roots citizen science (...)
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