Digital health technologies are becoming increasingly important in medical research, making it essential for participants to fully understand what they consent to when joining these studies. The National Institutes of Health (NIH) has provided a comprehensive resource to help researchers and Institutional Review Boards (IRBs) create precise and effective informed consent documents for such studies. Here are the main points you need to know:
Purpose of the NIH Resource
- Guidance for Researchers: Offers best practices for obtaining informed consent when using digital health technologies in research.
- Transparency and Understanding: Aims to help participants understand the use of these technologies in research, enhancing transparency.
General Considerations
- Readability: Consent documents should be easy to read, ideally not exceeding an 8th-grade reading level.
- Data Management: Ensure data management and sharing plans align with the consent language.
- Technology Specifics: Address the unique considerations for each digital health technology used in the study.
- Future Data Use: NIH provides additional resources for consent language concerning the future use of collected data.
Key Components of Sample Language
Introduction:
- Explain the digital health technology and its role in the study.
- Clarify whether the technology is mandatory or optional for participation.
- Disclose any relationships between the researchers and the technology providers.
Procedures:
- Describe how and when the technology will be used and the type of data collected.
- Inform participants about required interactions with the technology.
- Provide instructions on installing and using the technology.
Potential Risks:
- Outline potential privacy, security, and physical risks associated with the technology.
- Inform participants about possible changes in software or privacy policies.
- Highlight risks for non-participants who might be indirectly affected.
Potential Benefits:
- Clearly state any direct benefits to participants.
- If no direct benefits are known, explain that participation may benefit others in the future.
Costs:
- Specify who covers the costs related to the digital health technology, including any subscriptions or maintenance.
- Clarify any costs participants might incur if they use their own devices.
Withdrawal:
- Explain what happens to the data if a participant withdraws.
- Provide instructions for uninstalling technology and stopping data collection.
- Detail the process for participants who do not adhere to study requirements.
Ethical and Practical Considerations
- Data Privacy: Ensure participants understand who has access to their data and how it is protected.
- Participant Responsibility: Highlight participants’ role in safeguarding their privacy, for example, by using secure passwords.
- Risk Management: Choose technologies that minimize risks while meeting the study’s needs.
By adhering to these guidelines, researchers can ensure that participants are well-informed and comfortable with their involvement in studies using digital health technologies. This approach upholds ethical standards and fosters trust and cooperation between researchers and participants.
For further guidance, refer to the complete NIH resource on informed consent for digital health technologies.
