Ethical Considerations of Wearable Technologies in Human Research

Abstract

Wearable technologies hold great promise for disease diagnosis and patient care. Despite the flourishing research activities in this field, only a handful of wearable devices are commercialized and cleared for medical usage. The successful translation of current proof‐of‐concept prototypes requires extensive in‐human testing. There is a lag between current standards and operation protocols to guide the responsible and ethical conduct of researchers in such in‐human studies and the rapid development of the field. This essay presents relevant ethical concerns in early‐stage human research from a researcher's perspective.

Wearable Bioelectronics for Chronic Wound Management

“…Last but not least, considering that most effort has been invested in the technology development and evaluation at the bench side or on animal models, the validation and utility of the wearable bioelectronic devices on human subjects need to be carefully investigated following proper ethical guidelines. [ 191 ] Future devices envision to be capable of providing off‐the‐shelf solutions for emergent conditions such as wounded troops on the battlefield as well as affordable in‐home wound therapy for patients in rural areas. In the foreseeable future, highly integrated wound management systems with outstanding wearability, diverse functionality, and excellent longevity will be developed and facilitated by AI to revolutionize personalized wound care.…”

Electronic Textile Sensors for Decoding Vital Body Signals: State‐of‐the‐Art Review on Characterizations and Recommendations

“…Further, for the wearable sensor to be relevant in a medical context, the sensor data must exhibit a certain degree of accuracy, repeatability, and sensitivity throughout its life. Several studies discuss the considerations for testing and standardization of wearable sensors in the context of the medical device market, including quality control and ethics [20,170,171] The study by Leenen et al attempts to set limits of agreement (LoA) and accuracy constraints for the various physiological sensing modalities: 10 AE 10 beats per minute for HR, 3 AE 3 breaths per minute for RR, 0.5 AE 1.0 C for temperature, 10 AE 20 mmHg for systolic BP, and 3 AE 5% for SpO 2 . [115] While this cannot be vetted as an industrial standard, it sets a reasonable guideline for researchers as they characterize sensor performance across a range of physiologically relevant temperatures as well as standard strains associated with day-to-day movement and motions such as walking and stretching.…”

Wearable Self‐Powered Electrochemical Devices for Continuous Health Management

“…Therefore, extensive in-human testing needs to be performed while keeping the high standards in medical trials. [122] Unfortunately, few investigations are showing the clinical relevance of such biofluids which hinders the acceptance by the medical community. In consequence, it is time that high-performance WEDs correlate their values with blood levels and/or physiological status through new analytical methods to ensure the usefulness of WEDs for health applications.…”

“…In this direction, proper human trials must be fulfilled by carrying out massive in-human testing while keeping the medical standards and operation protocols. [122] This information will gain the confidence of physicians and coaches to rely on the information of WeSPEDs and provide on-track meaningful decisions. If a correlation is not attained due to the regional use of the WeSPED, another possibility is to perform clinical studies showing the relationship between biomarkers levels in noninvasive biofluids with the physiological condition of the wearer.…”