Are you in the planning phases for a study involving digital health methods? Wondering about what you need to think about as you design your study and plan your IRB submission? Don't know who to contact about your work with outside entities or vendors? Join us for this interactive workshop with Melissa Abraham, PhD, Director of the Research Ethics Consultation Unit within the Division of Clinical Research, Michael Canova, JD, Agreement Associate Team Lead, Clinical Trials Office, and Kathleen Rossi-Roh, MEd, Mobile Application Process Coordinator.
You are encouraged to bring a study idea, study summary, or a protocol summary with you to discuss with the group.
Learn about:
- Overview of Institutional reviews needed at Partners for studies involving mobile apps, wearables and connected devices
- Points to consider when planning a digital health project, who to contact, why and when
- Technical issues to consider (e.g. data security, technical specifications, ensuring appropriate/acceptable use of technologies)
- CTO review process for digital health protocols
- Contractual issues (e.g. Terms of Use, Privacy Policy, End-User License Agreement) and solutions to common issues
- Ethical and privacy issues to consider in your design and IRB application (e.g. consent processes, clinical uses of data, return of findings, ethics consultation)
Lunch will be served. Space will be limited to facilitate discussion.
Contact Tiereny Rohlfs with any questions.