Some IRBs have begun to review studies that use medical devices with tracking technology. These types of mobile devices raise some ethical and regulatory questions.
“The bigger question is whether the regulatory agencies will provide further guidance on the use of these features in medical devices and how their use will fit into current regulations,” says Linda Reuter, MS, CIP, director of Biomedical Research Alliance of New York (BRANY) IRB in Lake Success, NY.
Reuter was among those involved in CITI committees that reviewed the use of such devices and their data security, data management, access, and monitoring.
“We were asked to go and represent the IRB perspective as a small piece of a larger question about the research use of mobile technology,” Reuter says.
Mobile devices include any wearable medical technology, including EKG monitors, accelerometers like Fitbits, and glucometers. They collect real-time data about patients, and the information can be seen by clinicians and researchers.
Another issue that makes reviewing this new technology challenging for IRBs is that traditional clinical trials usually do not provide real-time data. Under the traditional model, the research participant will come in for visits in a controlled environment. Mobile device technology involves transmitting data in new ways and possibly giving participants access to data without the benefit of having someone there to help them interpret what it means.
“The role of the IRB is to protect the rights and welfare of subjects, so we’re not concerned so much with the technical aspects of the device, as we are concerned with whether they pose any risk to the participants in the study, and exactly how they will be impacted,” Reuter says.
Also, there’s the question of data integrity and whether participants are even wearing the device as expected.
The following are some of the questions an IRB might ask about these devices in a trial:
- Is there any risk to the subject, physical or psychological, in wearing the device?
- How do investigators know whether the research participant is wearing the device and not someone else?
- Are there any benefits to wearing the device?
- If the device produces specific information, is it visible to the subject?
- Could the subject ask for information about what the data mean, or not?
- What will be done with any incidental findings?
- Are data transmitted by the device secure, private, and safe?
- What are subjects being told about how the information will be used?
- What do subjects need to do for their own safety when wearing the device?
- If a subject’s mobile device alarm sounds, indicating a potential health crisis, where is this reported?
- How does wearing this device affect the participant’s safety and welfare?
- Does the informed consent document properly inform research participants of these issues?
The BRANY IRB is working on making sure its informed consent language is clear about what type of data are collected with the device, how the data are used, and which data are available to subjects. The IRB also wants the informed consent to be clear about how subjects should report any information that’s collected and what should be done with that information, Reuter notes.
“We have seen one study for epilepsy or a seizure disorder where they used a portable device to detect changes in physiological measures to predict when the seizure would occur,” she says. “That study was establishing a baseline.”
Most of the IRB’s questions were related to what sort of information would be given to subjects in the consent form. There were no clinical decisions made in the study, as it was a feasibility study to see if standard data matched data from the portable device, Reuter explains.
“As guidance comes out on how manufacturers can frame their studies, more device manufacturers will want to do studies and get their technology approved,” she says. “If they submit to the FDA for approval, they’ll want to make sure the data is valid and will support an application for approval. Therefore, it is very important that the study designs are valid.”
The IRB is concerned with the subject’s rights and welfare in wearing the device and handling data.
“We’re concerned with how to handle safety signals and, also, whether a particular device can pick up incidental findings,” Reuter says.
“In traditional studies, there have been situations where we discover information we were not necessarily looking for, such as picking up a tumor on an MRI when this was not the intent of the study,” she continues. “Mobile technology may also present us with incidental findings. We need to plan ahead for what we will do with that information if it is discovered.”
Another data integrity issue involves what happens to the real-time data as they are securely transmitted.
“Biostatisticians are weighing in on how this data needs to be transmitted and transformed,” Reuter says. “We need to make sure it’s not altered while being transmitted securely.”
There also is the possibility of research participants being lulled into believing their health is fine since the mobile device is collecting real-time data and they haven’t heard from their physician.
“It’s a false sense of security,” Reuter says. “They might be lightheaded and not call the doctor because they’re wearing the device and feel like someone would call them if something was wrong.”
Federal regulations must catch up with these kinds of technological changes, she says. The FDA hasn’t made any major changes to their regulations in several years, but will issue guidance to reflect changes and help IRBs apply the regulations to emerging research issues. In the case of mobile technology, there was a very helpful guidance document about mobile medical applications issued in February 2015, Reuter says.
“Additional guidance will be needed as this technology moves forward,” she adds.