Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language

Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language
National Institute of Health, May 2024
Key Points

• This resource provides points to consider and sample language for informed consent of research studies which plan to use digital health technologies. The use of this resource is completely voluntary.
• The considerations and sample language provided in this resource may not apply to all studies or cover all potential contexts of use. Users of this resource should apply relevant considerations/sample language as applicable to their study. Points to consider and sample language below are included in the most relevant sections, although they may be relevant to multiple sections.
• This resource does not take the place of an informed consent document. The considerations and sample language included in this resource are specific to the inclusion of digital health technologies in a study; other general and population-specific informed consent considerations and language still apply. The sample language provided in this resource should be tailored for individual studies and may need further revision or clarification when used in an informed consent.
• The sample language provided in this resource does not alone satisfy the regulatory requirements for informed consent as described in the 2018 revised Common Rule at 45 CFR46.116 or the FDA’s regulations governing the protection of human participants (i.e., 21 CFR parts 50 and 56).
• Within this resource, the term digital health technology refers to wearable devices, sensor technologies, and mobile software applications (“apps”) most often used with tablets, watches, or phones. The resource does not address considerations for implantable devices, artificial intelligence, or other types of digital health technologies.
• This consent resource does not address future use of data collected from digital health technologies, which may have additional considerations when developing or reviewing informed consent.