You may have heard of “mHealth” or “digital medicine,” but have you heard of “MISST”? MISST is an acronym the Connected and Open Research Ethics (CORE) initiative research team uses to describe research that involves the use of mobile, imaging, pervasive-sensing, social media, and location-tracking strategies that can passively observe human behavior.
MISST data is often collected via wearable sensors and apps designed for research, and increasingly, via commercial products like Fitbit or MapMyRun. MISST tools and strategies offer amazing potential to collect granular personal health data. However, it is critical that researchers, clinicians, and regulators are aware of potential risks and risk management strategies to protect participants, some of whom are patients, from avoidable harms.
Several years ago we recognized that researchers and ethics review boards may benefit from access to a community with MISST expertise. In response, we built the web-based CORE platform. The project was recently featured in the Journal of Medical Internet Research in an article titled “Navigating Ethics in the Digital Age: Introducing Connected and Open Research Ethics (CORE): a Tool for Researchers and Institutional Review Boards.”
The CORE team collects and curates resources to assist researchers in designing and conducting ethical research, as well as assisting the IRBs evaluating these studies. The CORE now hosts a growing global network of over 300 individuals representing 10 countries, though the majority are within the United States. Network members bring expertise in privacy, technology, bioethics, research ethics, regulations, sciences, and engineering. What motivates these people to engage with the CORE project is a common interest in contributing to the ethical design and efficient and meaningful review of this research.
Using a participatory design process, the CORE features have been informed by stakeholders, including IRBs and researchers. The CORE currently hosts a Question & Answer Forum and a Resource Library. The Resource Library contains excerpts of IRB-approved language to describe study procedures in both research protocol and informed consent documents. All documents in the Resource Library have been uploaded by researchers conducting MISST research. We hope visiting the CORE will help researchers save time drafting IRB regulatory documents and application materials and improve the consistency with which IRBs evaluate and mitigate potential risks to research participants.
The CORE is a growing community where conversations about research ethics and technology are beginning. We seek to increase awareness of this resource and we invite IRBs and research stakeholders to get involved—specifically, we want to hear from the PRIM&R community! We invite you to join the conversation by signing up for the CORE Network and sharing your questions about how to do this research and/or your expertise and lessons learned. You can also follow CORE on Twitter and LinkedIn. Together we can learn from one another and begin to have an informed discussion developing an ethical framework for MISST.
The CORE initiative is supported by a grant from the Robert Wood Johnson Foundation and the University of California San Diego (UCSD) Chancellor’s Interdisciplinary Collaboratory Fellowship Program. Camille Nebeker, EdD, MS is the Principal Investigator of the CORE program, and an assistant professor in the UCSD Department of Family Medicine and Public Health with a primary appointment in Behavioral Medicine and a secondary appointment in Global Health. She is also an affiliated with the Scripps Translational Science Institute working with The Participant Center on the All of Us Research Program. She and Rubi Linares-Orozco, MAS, also of UCSD, contributed to this post.