Introduction
In recent years, digital health technologies have revolutionized biomedical and behavioral research, offering new possibilities for scientific discovery and improved health outcomes. As these technologies become integral to research, it is essential to ensure that informed consent documents effectively communicate their potential benefits and risks to study participants. The National Institutes of Health (NIH) has developed sample language and considerations for use in informed consent documents for research involving digital health technologies to aid in this effort.
NIH seeks input from various stakeholders, including research investigators, IRB members, study participants, and organizations focused on research oversight. This feedback will help refine and improve the sample language and considerations, ensuring that informed consent in digital health research remains practical and straightforward.
Points to Consider
- Voluntary Resource: The use of the sample language and considerations is entirely voluntary. They are designed to serve as a helpful resource for investigators and Institutional Review Boards (IRBs) as they tailor informed consent language to their specific research studies.
- Scope of Digital Health Technologies: The resource addresses wearable devices, sensor technologies, and mobile apps primarily used on tablets, watches, or phones. It does not cover implantable devices, artificial intelligence, or other digital health technologies.
- Research-Grade and Commercial Technologies: Considerations are included for both research-grade and commercial digital health technologies, ensuring broad applicability.
- Regulatory Compliance: It’s important to note that the language provided in this resource may only partially satisfy regulatory requirements for informed consent. Researchers should be aware of the 2018 revised Common Rule (45 CFR46.116) and the FDA’s regulations governing human participant protection (21 CFR parts 50 and 56).
- Flexibility and Adaptability: Researchers may need to revise or clarify the sample language in an informed consent document. Digital health technology evolves rapidly, and new resources may be developed to address unique considerations in research.
Links to the Draft Request and Comment Form
