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UC Comments NIH's RFI on Developing Consent Language for Research Using Digital Health Technologies (NOT-OD-24-002)
Abstract
This comment letter responds to the National Institutes of Health (NIH)'s Request for Information on developing consent language for research using Digital Health Technologies. UC expresses concern that NIH’s sample consent language is too long, too complex, duplicative, and includes issues beyond informed consent, such as DHT terms of use, data ownership, and third-party sharing. UC recommends shortening and simplifying the language, removing technical or out-of-scope content, aligning consent with data management and IRB materials, and offering guidance without a template.