Not surprisingly, over the past several decades, research studies designed to collect health data remotely from subjects via the Internet, using such platforms as personal computers, wearable devices, home monitoring equipment, smart phones, and other cellular devices, have proliferated.
As the Internet has grown in popularity, concerns about whether such research affects human subject protections have grown. In fact, work groups have been convened and codes of ethics have been developed to specifically address the obligations of researchers employing these new domains of electronic communication, interaction, and data collection made possible by these technologies.1–4
Although these as well as other ethical considerations of collecting health data remotely have been well articulated in the Internet research literature, little practical guidance is provided about how to establish data safety monitoring (DSM) procedures to ensure participant safety. In fact, a recent study found that although remote monitoring systems were designed to potentially recognize worrisome values and generate alerts, rarely explanations were provided about how to develop procedures to review these data in real time and intervene if needed.5
The authors suggested that researchers develop risk-monitoring procedures, defined as automatic surveillance procedures to detect critical data values for measured variables (e.g., blood pressure [BP] and glucose measures) that may indicate worsening of an individual's clinical condition and that the thresholds are specified apriori. Others note that systems used for research purposes and not clinical management must be capable of detecting changes, and procedures need to be established to perform ongoing surveillance and act in a timely manner to ensure subjects' safety.6
Typically published reports that involve monitoring physiological indicators clearly state that the studies were approved by International Review Boards (IRBs); however, few reports discussed how the researchers established DSM procedures and handled the unique DSM considerations and opportunities that arose in these trials.
Researchers who are on the front line receiving clinical data from participants have a responsibility to ensure participants' safety by setting up appropriate DSM protocols. They are not only required to monitor for potential adverse events, but researchers have additional responsibilities when the study data include electronic capture of health information that reflects a participant's condition in real time. Because of the electronic monitoring, researchers may be more proximal to the participant and may detect a problem before the participant, because the researcher has access to the most current information about the participant's clinical status (e.g., subclinical changes or trends), or before clinicians are likely to be communicating with their patients (e.g., between follow-up appointments). Because the researchers have access to these data, they are obligated to establish a plan for monitoring these data to ensure that participants in the study are safe while maintaining the integrity of the study by minimizing unnecessary intervention whenever possible. These safety concerns are particularly important when the researchers who are collecting remote health data are not responsible for managing the participant's clinical care.
Researchers involved in the collection of electronic data in real time need to establish systems to detect and deal with values that may indicate potential safety risks in a responsive and timely manner. This obligation is no different from other researchers who are collecting data in face-to-face or telephone interview formats. Data safety plans must include procedures to identify and evaluate the significance, accuracy, and possible explanations for critical values as well as protocols for how to appropriately respond and take actions. Fortunately, most studies that include remote data capture also have the technological capability to incorporate programs for DSM surveillance, alerts, and triage within the systems.
By testing the efficacy of Personal Assistant for Tracking Health (Pocket PATH®
), a mobile health application with customized data recording, trending, and decision-support programs to promote active involvement of patients in their care after lung transplantation,7
we recognized the importance of designing a comprehensive DSM plan for the Pocket PATH project that would extend beyond adverse event reporting to include monitoring remote health data to ensure participant safety. However, although the unique ethical considerations for remote health monitoring have been described in the literature, practical advice for how to develop and implement DSM plans are generally lacking. Therefore, we are now presenting the Pocket PATH project as an exemplar of how to develop effective DSM plans for research involving remote physiological health monitoring.