If location data is not going to be erased in a study, how should IRBs explain the risks in informed consent communications? Delivering a meaningful consent process in this area can be challenging, so researchers developed a list of key points for IRBs to consider.
“These are some elements of informed consent for IRBs to think about. We think these are some of the considerations, almost as a checklist,” says Daniel Goldenholz, MD, PhD, lead author of the paper1 and an epilepsy researcher and clinician at Beth Israel Deaconess Medical Center in Boston.
“Any location data carry reidentification potential to various degrees and should be assessed on a case-by-case basis,” the researchers recommend. “Occasionally, additional support for the IRB may be needed from a data scientist to act as a subject expert.”
The following are some of the suggestions for informed consent with studies involving GPS tracking:
• state the frequency of location data collection;
• state the nature and the type of data collected, with examples;
• when applicable, remind participants that they may forget they are being tracked, and that the device may record their visits to private locations;
• when applicable, remind participants that evidence suggesting illegal activities may be uncovered by location data. If so, disclosure may not be protected by the research institution’s confidentiality policy and could be potentially discoverable by law enforcement;
• provide a statement explaining that individuals will not be identified in any research publication or presentation dissemination without explicit participant consent;
• provide a statement explaining that identifiable data will not be shared with other researchers without the subject’s consent, but that deidentified data may be shared;
• when applicable, remind participants that they can disable or temporarily pause location tracking whenever they wish, unless doing so would compromise the study;
• provide a list of who will have access to the location data that is linked to identifiers;
• assess risk that participants will be reidentified from location data;
• assess risk for possibility of harm if location data were inadvertently reidentified including, when relevant, financial loss, psychological harm, and/or physical harm.
REFERENCE
1. Goldenholz DM, Goldenholz SR, Krishnamurthy KB, et al. Using mobile location data in biomedical research while preserving privacy. Journal of the American Medical Informatics Association, ocy071, https://doi.org/10.1093/jamia/ocy071.
If location data will not be erased in a study, how should IRBs explain the risks in informed consent communications?
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