NCT05505058

One-time Informed Consent for Research in Prison

One-time Informed Consent for Research in Prison: A Randomized Comparison Between Audio-visual and Written Materials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

Ethical research on detained persons remains limited, including research on informed consent. This study aimed to fill in this research gap and compared audio-visual and paper-based materials for a one-time general informed consent for research in prison, using a randomized design. The primary outcome was whether participants sign the inform consent. Secondary outcomes included understanding, evaluation, and time to read/watch the informed consent.

Detailed description

Detained persons constitute a very vulnerable and perhaps reluctant to share their medical data. In particular, it is crucial to ensure that these persons, deprived of their liberty, understand that their consent is voluntary and that a refusal will not have any consequence on their treatment or care. In other words, it is necessary to ensure that consent is informed. In a historical context of non-ethical research using detained persons, this is a crucial issue. However, while detained persons are now protected from various forms of abuse, this may have had the consequence of reducing research involving them, to the detriment of understanding their characteristics and vulnerabilities. A general consent for research will encourage research on prison populations by facilitating access to their medical data in order to study and reduce health disparities, for this population with multiple somatic and psychiatric comorbidities. Our main questions are: Q1. What is the acceptability rate of general consent for research in detained persons? Q2. What are the characteristics (socio-demographic and medical) of detained person who refuse to give their consent? Q3. Which material (paper-based or video) is more effective? To answer these research question, we will use an exploratory randomized cross-sectional trial, conducted in an adult pre-trial prison and a juvenile detention center. Participants will be randomly assigned to read or watch information about informed consent, stratified on the prison. In both prisons, the study will take place in the prison medical unit. This project is aimed to improve general consent, which contributes to reducing inequalities in documentation on health status, and ultimately, health inequalities.

Conditions

• Informed Consent

Interventions

Type	Name	Description
BEHAVIORAL	Audio-visual material	Participants were randomized to receive a paper-based conventional material or to watch a 4-min video. Materials both included legal information required by the Swiss Federal Act on Research involving Human Beings.

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-09-30
• Completion: 2022-06-30
• First posted: 2022-08-17
• Last updated: 2022-08-17

Locations

1 site across 1 country: Switzerland