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New Project to Create mHealth Ethics for Clinical Trials

The CORE project, launched by the University of California-San Diego, will establish an ethical framework for the use of digital tools and platforms in research

- What happens when a clinical research project that collects iPhone images unwittingly accesses inappropriate or private content? How about a study that gathers GPS data, or one that pulls in personal data from wearable devices?

Clinical studies that make use of mHealth devices and platforms are more and more venturing into uncharted ethical territory, and neither the researchers nor the Institutional Research Boards that have to OK these studies are on firm footing.

A new project launched at the University of California’s San Diego campus aims to create a code of ethics for mHealth-related clinical trials. Backed by the Robert Wood Johnson Foundation, the Connected and Open Research Ethics (CORE) project will create a tool by which to measure proposed clinical trials against federal regulations for human research.

The tool will be designed to help researchers and IRBs work with mobile imaging, pervasive sensing (such as wearables and even tattoos), social media and location-tracking (MISST) technologies. And judging by the popularity and growth of Apple’s ResearchKit platform, it’s coming at just the right time.

“There are an estimated 6,000 IRBs out there, and they all will need to think about how the existing regulations apply to 21st Century research tools and methods” Camille Nebeker, EdD, MS, the project’s principal investigator, said in a story prepared by the California Institute for Telecommunications and Information Technology. “At the same time, IRBs frequently lack the expertise or resources necessary for making informed decisions about studies involving MISST methods, so researchers are engaging independently with them - which means they’re often duplicating efforts.”

According to the CORE website, the guidelines will address bidirectional and dynamic models of informed consent, data management protocols, risk identification and management strategies, and requirements for deploying a web-based ethical learning and support system.

Nebeker, an assistant professor at the UCSD School of Medicine’s Department of Family Medicine and Public Health and a member of the Qualcomm Institute, said CORE “will work toward developing ethical best practices so that participants in such studies can be confident that the studies have been vetted and are safe, while also ensuring that this important research continues to advance.”

As an example of an ethically tricky project, she noted the Qualcomm Institute’s Center for Wireless and Population Health Studies, which recently sent researchers out to measure sedentary behavior and physical activity with a variety of cameras, sensors and GPS devices. Some of the data collected, she said, included images of people encountered by the researchers but who were not part of the study, raising questions about their right to privacy.

“Instruments like CORE that help Institutional Review Boards and researchers more quickly and ethically conduct research using personal health data will be a game changer for the field,” Deborah Bae, senior program officer at the Robert Wood Johnson Foundation, told the California Institute for Telecommunications and Information Technology. “These tools will encourage broad participation and allow researchers to discover new insights and solutions to today’s pressing health problems.”

Nebeker said the CORE committee will be looking for input from healthcare providers, IRBs, mHealth vendors, researchers, even potential study participants. And once the guidelines are established, she anticipates interest from a wide variety of research fields, including genomics. 

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