ABSTRACT
The article covers electronic informed consent (eIC) 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.
Subject(s)
Confidentiality , Consent Forms/standards , Informed Consent/legislation & jurisprudence , Mobile Applications , Software/standards , User-Computer Interface , HumansABSTRACT
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 research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.
Subject(s)
Biomedical Research/legislation & jurisprudence , Computers, Handheld , Ethics, Research , Mobile Applications , Policy , Telemedicine , Biomedical Research/trends , Guidelines as Topic , Humans , Research Personnel/classification , United StatesABSTRACT
Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC). We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
Subject(s)
Community Participation , Information Dissemination , Medical Informatics/standards , Stakeholder Participation , Humans , TrustSubject(s)
Confidentiality/legislation & jurisprudence , Data Mining/economics , Electronic Health Records/legislation & jurisprudence , Electronic Health Records/statistics & numerical data , Government Regulation , Information Dissemination/legislation & jurisprudence , Patient Access to Records/legislation & jurisprudence , Algorithms , Civil Rights/legislation & jurisprudence , Data Mining/legislation & jurisprudence , Electronic Health Records/economics , European Union , Humans , Monitoring, Physiologic/instrumentation , Monitoring, Physiologic/methods , Patient Access to Records/economics , Patient Advocacy , United StatesABSTRACT
The prospect of newly-emerging, technology-enabled, unregulated citizen science health research poses a substantial challenge for traditional research ethics. Unquestionably, a significant amount of research ethics study is needed to prepare for the inevitable, widespread introduction of citizen science health research. Using the case study of mobile health (mHealth) research, this article provides an ethical, legal, and social implications (ELSI) research agenda for citizen science health research conducted outside conventional research institutions. The issues for detailed analysis include the role of IRBs, recruitment, inclusion and exclusion criteria, informed consent, confidentiality and security, vulnerable participants, incidental findings, and publication and data sharing.
