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. (shrink)
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. 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.
Beginning in the 20th century, scientific research came to be dominated by a growing class of credentialed, professional scientists who overwhelmingly displaced the learned amateurs of an earlier time. By the end of the century, however, the exclusive realm of professional scientists conducting research was joined, to a degree, by “citizen scientists.” The term originally encompassed non-professionals assisting professional scientists by contributing observations and measurements to ongoing research enterprises. These collaborations were especially common in the environmental sciences, where citizen scientists (...) participated in counting wildlife and measuring environmental conditions. Later, patient groups began to play a more active role in supporting clinical trials and collecting health records from affected individuals. (shrink)
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.
Advancements in technology are shifting the ways that biomedical data are collected, managed, and used. The pervasiveness of connected devices is expanding the types of information that are defined as ‘health data.’ Additionally, cloud-based mechanisms for data collection and distribution are shifting biomedical research away from traditional infrastructure towards a more distributed and interconnected ecosystem. This shift provides an opportunity for us to reimagine the roles of scientists and participants in health research, with the potential to more meaningfully engage in (...) partnership across the research process. At the same time, these emerging practices present a potential to expose research participants to unanticipated and unintended consequences. Social norms and policy can help to mitigate these risks, but their development is often slow relative to the pace of technological advances and, as such, they can become reactive rather than prospective. As an alternative, the integrated development of data governance structures within technological advancements, supports their effective implementation, evaluation and evolution in a manner that can balance the benefits and risks of biomedical researcher in a decentralized ecosystem. (shrink)