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
- Feedback on Using Mobile Messaging App for Positive Health Behaviors
- Information for Parents of Teens Participating in Focus Group about Stress
- Mobile App Survey about Teen Health
- Physician Feedback on Opioid-Treated Chronic Pain Patients with Aberrant Behavior Undergoing Web-Based CBT
- Reviewing Mobile App for Helping Stay on Job
- Reviewing Mobile App for Smoking Cessation
- Reviewing Web-Based Cbt for Opioid-Treated Chronic Pain Patients
Parental Permission
Testing Device Accessories
Testing Passive Sensing Devices
- Biometrics Measurements
- Device Usage and Interaction Monitoring
- Mobile Blood Pressure Monitoring
- Mobile Health Screening Kit
- Testing Biosensors and Giving Online Feedback by Teens
- Wearable Activity Monitors
- Wearable Sensors to Measure Stress Response
2. Social Media Studies
Surveys
- Cannabis and Related Processes Survey Consent
- Consent to Participate in a Cannabis Survey (Participants Recruited On Social Media)
- Diabetes Device Usage Survey
3. Other Studies
Computer Program Intervention
- Computer Program for Teen Substance Use Computer Psychosocial Intervention for Individuals in Methadone Maintenance Treatment Gaming for Smoking Cessation
- Computer Psychosocial Intervention for Individuals in Methadone Maintenance Treatment
- Gaming for Smoking Cessation
- Parental Permission: Parental Consent to Computer Program for Teen Substance Use
Mobile App Intervention
- Mobile Phone Based Prospective Survey Mobile Phone Delivered Intervention for Methadone Maintenance Patients
- Mobile Phone Delivered Intervention for Methadone Maintenance Patients