Input on New Sample Informed Consent Language for Digital Health Needed

A trans-NIH working group (which includes NCI) wants your input on sample language that fellow researchers can use as they develop and review informed consent for studies involving digital health technologies (e.g., wearable devices, sensor technologies, and mobile software applications). For example, proposed language would specify the type of data collected, whom the data will be shared with, and possible risks for sharing the data on such digital technology.

See the Request for Information (RFI) for further details, sample language, and guidance on how to submit a response. The RFI is open, and the deadline for comments is December 12, 2023.

If you are a research investigator, institutional review board member, study participant, or member of the public interested in informed consent and digital health technologies, your feedback is welcome. NIH is also looking for input from professional organizations and associations with a focus on research oversight.

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