Testing a New Method to Improve Informed Consent in Prison Research

According to ethical requirements of Swiss Human Research Act, the interviewer will explain the nature of the study, its purposes, duration, the potential risks and benefits it entails, and study procedures. He will inform that study participation is voluntary and that participants may withdraw at any time. He will also explain that the study is independent from the prison authorities. Participants will then be given time to read the informed consent, or, if they are not able to read, it will be read to them by the interviewer. The interviewer will answer all questions.

The standard process will first be used. After that, the interviewer will ask participants to summarize the content of the informed consent. The interviewer will correct not-well understood components and ask questions about forgotten components. In case of misconceptions, the participant will be asked to summarize again the corresponding components. A list of key components to be addressed will be developed by study team members, including experts in prison research and ethics, based on components listed in Art. 16 of the Swiss Human Research Act. The material of the informed consent of the parent-randomized controlled trial will be used.