Concerns about privacy, confidentiality, and security and how to communicate about these issues to potential research participants is paramount to human basic and clinical research, implementation, and practice. Scientists and practitioners must seek optimal methods for informing and protecting the people that participate in their research programs or that receive treatment using digital therapeutics.
We have compiled resources (below) that can provide some guidance for how to navigate this sensitive research area of digital health and therapeutics research.
A) Examples of Consent Form Language from Research Projects conducted by CTBH Affiliates
B) Link to extensive online information and materials relevant to digital health research offered by Harvard Catalyst: The Harvard Clinical and Translational Science Center. This site provides advanced information and sample language to assist investigators in describing technologies used in research within the informed consent form.
1. Focus Groups Testing Digital Devices
Review / Feedback
Testing Device Accessories
Testing Passive Sensing Devices
2. Social Media Studies
3. Other Studies
Computer Program Intervention
Mobile App Intervention