Information and informed consent in a longitudinal screening involving children: a questionnaire survey

Area of Science:

• Pediatric Research
• Medical Ethics
• Public Health

Background:

• Longitudinal studies involving children require robust participant understanding.
• The All Babies In Southeast Sweden (ABIS) study screens 17,005 children for Type 1 diabetes and multifactorial diseases.
• Effective communication is crucial for informed consent in long-term research.

Purpose of the Study:

• To explore mothers' perceptions of information and understanding regarding their involvement and their children's involvement in the ABIS Study.
• To identify gaps in knowledge about the study's aims and methods among participants.
• To inform strategies for enhancing information and informed consent in longitudinal child research.

Main Methods:

• An anonymous questionnaire was administered to a random selection of 293 mothers from the ABIS study.
• The questionnaire assessed participant satisfaction with and understanding of study information.
• A response rate of 73.3% was achieved.

Main Results:

• A significant discrepancy exists between reported satisfaction with information and actual knowledge of study objectives, including high-risk identification, prevention strategies, and future data collection.
• Mothers demonstrated a lack of understanding regarding specific aims and methods of the ABIS screening.
• Participant understanding varied concerning the identification of at-risk children and the purpose of subsequent questionnaires.

Conclusions:

• There is a critical need to re-evaluate and enhance information dissemination and informed consent processes in longitudinal studies involving children.
• Ethical considerations regarding participant understanding must be prioritized in the design and analysis of long-term research.
• Further discussion is required on how to effectively communicate complex study details to ensure sustained, informed consent.