Ethical Concerns if Study Participants Use Electronic Wearables
Researchers are considering ethical implications of study participants using third-party wearable technologies in clinical trials.1 “IRBs should be looking at the use of wearables and asking questions about potential risks and harms posed to potential research participants,” according to Jessica Macha, director of the IRB at Spectrum Health.
Wearable technology allows researchers to collect vast amounts of data with ease. “This can be concerning if the data are not secure,” Macha says.
Study participants might be reassured if they learn identifiers (e.g., names and contact information) are removed. However, privacy concerns are more complex than that, Macha explains. Wearables can collect location data, health data, and bodily movements. “It is critical for researchers to know how data are collected, who has access to it, and what possible risks to privacy might exist if the data are shared with researchers or other parties,” Macha says.
Additional ethical concerns with wearables include accessibility, tech literacy, and equity. “Applications and wearables may seem simple to one group and complex to another,” Macha says. Off-the-shelf wearable technology is not always sufficiently designed to accommodate disabilities or the neurodiversity of potential research participants. Some wearables require access to high-speed internet or a personal smartphone. “This may limit the ability to have a diverse population in the study,” Macha observes.
IRBs should require researchers to minimize risks related to the wearables. “During the research design process, investigators can address these problems early on through thoughtful preparation,” Macha says.
To assist researchers in this process, IRB members can update policies and procedures to place guardrails on the use of wearables and address ethical questions. “IRBs can provide guidance on what practices can enhance data security, and how to craft consent forms to inform participants of the known and unknown limits of privacy and confidentiality of the collected study data,” Macha says.
Stacey Page, PhD, chair of the Conjoint Health Research Ethics Board at the University of Calgary Cumming School of Medicine, says there are important ethical questions for researchers to consider when designing study protocols involving wearables:
• Are there any physical discomforts or possibilities of harms (e.g., skin rash, irritation, shocks, burns, chemical exposure, or movement restriction)?
• What information is the wearable collecting? Is it identifiable or de-identified? Is it continuous or for fixed periods?
• Where will the collected data reside? With whom will it be shared, how will it be shared, and in what form (identifiable or de-identified)?
• Are all possible uses of the data defined up front, or is it possible the data will be kept for unspecified future use?
• Can participants request withdrawal of their data?
• If the wearable is providing data the participant can see, how valid are those data? Could participants be harmed if they see inaccurate data (e.g., a glucose monitor providing inaccurate blood sugar readings)?
• If the wearable requires an app, is there a provision made to include participants who might not have the technology, or if devices might need to be updated? “Otherwise, those who don’t have, or can’t support, the tech will miss out on the opportunity to take part in the research,” Page notes.
• Can third parties use any of the data (e.g., if a pharmaceutical company who sponsors the trial and uses data for product development that is not part of the clinical trial)?
“Researchers should be sure the answers to these questions are articulated clearly and accessibly in the participant consent forms,” Page adds.
There are significant ethical concerns surrounding data ownership and control, especially when commercial devices are used, says Wei Gao, PhD, assistant professor of medical engineering at the California Institute of Technology. Gao says study participants should clearly understand who owns the data collected and how they can exercise control over its use. Participants should know privacy will be maintained when researchers share data with third parties or when publishing research findings.
Further, participants should understand data security concerns that arise from the large amount of data collected by many wearable sensors. Finally, researchers should explain additional risks associated with wearable device data (e.g., potential re-identification or unintended disclosure of sensitive information).
Gao suggests IRBs ask these questions when reviewing study protocols for electronic wearables:
• What measures are in place to ensure participants’ privacy when collecting, storing, and transmitting the data from the wearable devices?
• Have appropriate de-identification or anonymization techniques been implemented to minimize the risk of re-identification or unintended disclosure?
• How will participant privacy be maintained when sharing data with third parties, or when publishing research findings?
• Are there any additional risks associated with wearable device data, such as potential re-identification or unintended disclosure of sensitive information?
• Is the informed consent process clear and comprehensive? Does the process appropriately address using wearable devices, data collection, and potential risks and benefits?
• Are participants provided with sufficient information about the potential privacy implications, data security measures, and any known limitations or discomfort associated with wearing the devices?
• What challenges are anticipated with participant compliance, especially for long-term studies? “Investigators should consider methods to enhance adherence, such as regular monitoring, reminders, or incentives,” Gao advises.
Researchers should bear in mind the risk of data breach is significant when electronic wearables are used in clinical trials. “Scientists need to ensure that only the minimum amount of health data needed for the study are being gathered and transmitted,” warns Maria Silveira, MD, MA, MPH, FAAHPM, associate director of research at the University of Michigan Palliative Care Program.
Scientists can mitigate risks by asking device manufacturers to transmit data directly to research servers. “However, most device manufacturers require the data to be transmitted to their own commercial server before being delivered to scientists through an online portal or app,” notes Silveira, a clinician scientist at the Ann Arbor Veterans Administration Geriatric Research Education and Clinical Center.
The data safety agreement between the researcher and the vendor should be given to the IRB for review before the study can commence, Silveira adds.
Risks involving electronic wearables are complex, and possibly are outside of the expertise of IRB members. One solution is for institutions to require that separate committees review the data safety and privacy aspects of the studies. “This is not a bad idea, since typical IRB members are not experts in information technology,” Silveira notes.
REFERENCE
1. Sui A, Sui W, Liu S, Rhodes R. Ethical considerations for the use of consumer wearables in health research. Digit Health 2023 Feb 1;9:20552076231153740. doi: 10.1177/20552076231153740. eCollection 2023 Jan-Dec.
Study participants should clearly understand who owns the data collected and how they can exercise control over its use. Participants should know privacy will be maintained when researchers share data with third parties or when publishing research findings.
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