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  1. Return of Results in Participant-Driven Research: Learning from Transformative Research Models.Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (S1):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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  • The Rise of Citizen Science in Health and Biomedical Research.Andrea Wiggins & John Wilbanks - 2019 - American Journal of Bioethics 19 (8):3-14.
    Citizen science models of public participation in scientific research represent a growing area of opportunity for health and biomedical research, as well as new impetus for more collaborative forms of engagement in large-scale research. However, this also surfaces a variety of ethical issues that both fall outside of and build upon the standard human subjects concerns in bioethics. This article provides background on citizen science, examples of current projects in the field, and discussion of established and emerging ethical issues for (...)
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  • Characterizing the Biomedical Data-Sharing Landscape.Angela G. Villanueva, Robert Cook-Deegan, Barbara A. Koenig, Patricia A. Deverka, Erika Versalovic, Amy L. McGuire & Mary A. Majumder - 2019 - Journal of Law, Medicine and Ethics 47 (1):21-30.
    Advances in technologies and biomedical informatics have expanded capacity to generate and share biomedical data. With a lens on genomic data, we present a typology characterizing the data-sharing landscape in biomedical research to advance understanding of the key stakeholders and existing data-sharing practices. The typology highlights the diversity of data-sharing efforts and facilitators and reveals how novel data-sharing efforts are challenging existing norms regarding the role of individuals whom the data describe.
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  • Privacy and Security Issues with Mobile Health Research Applications.Stacey A. Tovino - 2020 - Journal of Law, Medicine and Ethics 48 (S1):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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  • 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 (S1):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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  • Beyond Belmont—and Beyond Regulations.Lisa M. Rasmussen - 2019 - American Journal of Bioethics 19 (8):19-21.
    The ethical (and philosophical) issues arising in citizen science are fascinating, challenging, and potentially pathbreaking in that they force us to reconsider the conceptual and regulatory catego...
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  • 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 (S1):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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  • Ethical Use of Social Media Data: Beyond the Clinical Context.Catherine M. Hammack - 2019 - Hastings Center Report 49 (1):40-42.
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  • 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 (S1):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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  • Biomedical Citizen Science or Something Else? Reflections on Terms and Definitions.Christi J. Guerrini, Anna Wexler, Patricia J. Zettler & Amy L. McGuire - 2019 - American Journal of Bioethics 19 (8):17-19.
    In their article “The Rise of Citizen Science in Health and Biomedical Research,” Wiggins and Wilbanks (2019) present a new typology for understanding the complex landscape of health and biomedical...
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  • 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 (S1):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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  • 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 (S1):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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  • Who Are the People in Your Neighborhood? Personas Populating Unregulated mHealth Research.Megan Doerr & Christi Guerrini - 2020 - Journal of Law, Medicine and Ethics 48 (S1):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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