Ethics and Data Protection
Cross-source consensus on Ethics and Data Protection from 2 sources and 10 claims.
2 sources · 10 claims
Preparation
Risks & contraindications
Background
Other
Other
Other
Highlighted claims
- All participants must read and sign a consent form before enrolment. — A double-blind, crossover, non-inferiority randomised controlled trial where primary care providers and patients compare human-generated and AI-generated digital health messages: the AI-CARE study protocol
- The study received ethics approval from Istanbul Medipol University's Non-Interventional Clinical Research Ethics Committee on 17 September 2025. — Development and investigation of the efficacy of an interactive, web-based game exercise system (ApnoeaTheraPlay) for individuals with obstructive sleep apnoea syndrome: study protocol for a randomised, single-blind, controlled trial
- The Hôpital Montfort Research Ethics Board approved the protocol and study documents in December 2024. — A double-blind, crossover, non-inferiority randomised controlled trial where primary care providers and patients compare human-generated and AI-generated digital health messages: the AI-CARE study protocol
- Participant names and initials are anonymised and replaced with provider or patient codes. — A double-blind, crossover, non-inferiority randomised controlled trial where primary care providers and patients compare human-generated and AI-generated digital health messages: the AI-CARE study protocol
- Identifiable data are stored on a Hôpital Montfort server, while anonymised data are stored on a Hôpital Montfort SharePoint site. — A double-blind, crossover, non-inferiority randomised controlled trial where primary care providers and patients compare human-generated and AI-generated digital health messages: the AI-CARE study protocol
- Anonymised data may be used for future research only with Research Ethics Board approval. — A double-blind, crossover, non-inferiority randomised controlled trial where primary care providers and patients compare human-generated and AI-generated digital health messages: the AI-CARE study protocol
- Digital data collection and privacy measures will follow Turkey's Personal Data Protection Law No. 6698. — Development and investigation of the efficacy of an interactive, web-based game exercise system (ApnoeaTheraPlay) for individuals with obstructive sleep apnoea syndrome: study protocol for a randomised, single-blind, controlled trial
- Participants will receive verbal and written study information and provide written informed consent under the Declaration of Helsinki 2013. — Development and investigation of the efficacy of an interactive, web-based game exercise system (ApnoeaTheraPlay) for individuals with obstructive sleep apnoea syndrome: study protocol for a randomised, single-blind, controlled trial
- No identifiable or individual participant data will be publicly shared. — Development and investigation of the efficacy of an interactive, web-based game exercise system (ApnoeaTheraPlay) for individuals with obstructive sleep apnoea syndrome: study protocol for a randomised, single-blind, controlled trial
- The intervention is considered low risk, so no independent Data Monitoring Committee was established. — Development and investigation of the efficacy of an interactive, web-based game exercise system (ApnoeaTheraPlay) for individuals with obstructive sleep apnoea syndrome: study protocol for a randomised, single-blind, controlled trial