| Summary: | This is a Comment on the Department of Health and Human Services (HHS) Proposed Rule: Federal Policy for the Protection of Human Subjects. We recognize the exciting research opportunities enabled by new data sources and technologies for collecting, analyzing, and sharing data about individuals. With the ability to collect and analyze massive quantities of data related to human characteristics, behaviors, and interactions, researchers are increasingly able to explore phenomena in finer detail and with greater confidence. At the same time, a 2 major challenge for realizing the full potential of these recent advances will be protecting the privacy of human subjects. Approaches to privacy protection in common use in both research and industry contexts often provide limited real-world privacy protection. We believe institutional review boards (IRBs) and investigators require new guidance to inform their selection and implementation of appropriate measures for privacy protection in human subjects research.
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