Wearable Tech in Clinical Research Trials
Researchers are partnering with companies to facilitate clinical research trials that call for patients to use wearable tech, which raises multiple ethical concerns. “There is a lot of variability in how researchers are using wearable tech in clinical research trials,” notes Rebecca J. Bartlett Ellis, PhD, RN, ACNS-BC, FAAN, executive associate dean for academic affairs at Indiana University School of Nursing.
Some researchers are developing wearable tech on their own, some are co-designing with industry, and others are using commercially available consumer-based products off the shelf. “The extent to which researchers engage with tech companies is likely based on the wearable tech itself, how well it is established in the field, and how the tech is being used in each study,” Bartlett Ellis says.
Wearable tech allows for repeated collections of personal health data and behaviors that occur in the context of individuals’ daily lives. “Collecting these data is increasingly more accessible to researchers because of the variety of commercially available technologies, many of which are purchased by consumers for their own self-tracking and monitoring purposes,” Bartlett Ellis notes.
Such innovations could improve health. “However, there are ethical and regulatory concerns that researchers must account for in the selection and use of these technologies in research studies,” Bartlett Ellis cautions.
Investigators must consider informed consent, privacy protection, and risk assessment. Consumer-based products are not regulated for clinical research. Researchers must weigh the risks and benefits. “The nuances of individual technologies require researchers to be intimately familiar with all aspects of selected wearable tech and to consider these aspects related to their participants, study design, and purpose,” Bartlett Ellis says.
IRBs may lack expertise in wearable tech generally, or the specific technology used in individual studies. “It is imperative for the principal investigator and study team to assume greater due diligence in assessing potential risk associated with using the selected tech,” Bartlett Ellis stresses.
There are nuances in every technology and study, so careful risk assessment is important. First, the selected technology must be accessible for the target population. For example, if the wearable tech requires the participant to use a companion smartphone app with internet connection, the researcher must consider providing a phone as part of the study. The risk of using a personal smartphone means the participant might incur additional costs associated with the study, and should be made aware of that as part of the consent process.
Additionally, some apps are Android- or iOS-specific and may not work on all phones. That means some groups may be excluded from participating in studies, potentially creating health disparities.
Commercial product vendors might use or share individual data with third parties to further develop or refine their products. Understanding how data are used outside the research is important to protecting participants’ privacy. The informed consent process should be transparent on what the researcher knows about how the product vendor is protecting data, and about any areas that remain unknown. Fully vetting a product can facilitate this process.
“Potential harm might come from third parties using participants’ personal data in unintended ways, such as targeting them or discriminating against them in the future because of known personal health information,” Bartlett Ellis says.
As wearable devices are emerging as an important research tool, “so, too, emerge interesting and important ethical issues,” notes Kenneth W. Goodman, PhD, FACMI, FACE, director at the Institute for Bioethics and Health Policy at the University of Miami Miller School of Medicine.
These issues include the need to ensure adequate privacy protections, changes to study participant behavior, and the adequacy of software used to collect and analyze the large amounts of data that wearables generate. Goodman says to expertly review these study protocols, IRBs need better digital literacy.
One of the biggest concerns with any research that involves wearable technology is data privacy, according to Barbara DeCausey, MPH, MBA, director of the Human Research Protection Program at Virginia Tech. Researchers must consider potential security risks of the device that is used to collect the data, and who can access that information.
“This not only includes members of the research team, but also the manufacturer of the device and any third parties that may have access to the data,” DeCausey says.
In this regard, IRBs will ask several questions: What data does the device collect? Is the data collection continuous, or can the collection features be turned off or disabled? Can the manufacturer access the data? If yes, can the data be sold to a third party? Are the data encrypted when transmitted? Are the data stored in a secure location with limited access?
If the manufacturer can access the data, if the data could be sold to a third party, or if by using the device the participant is agreeing to receive notices from the manufacturer, the participants should be informed. “A research participant may not be aware that their data are subject to these agreements and policies. The researcher should make sure the participant is aware,” DeCausey stresses.
Researchers are partnering with companies to facilitate clinical research trials that call for patients to use wearable tech, which raises multiple ethical concerns.
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