One-time Informed Consent for Research in Prison

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Informed Consent

Intervention / Treatment
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* Behavioral: Audio-visual material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: to be18 years old or more in the adult prison and 14 years old or more in the juvenile detention center to be able to communicate in one of the languages of the study material to agree to participate in this study. Exclusion Criteria: presence of an acute psychiatric problem preventing the person from participating in the study

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cross-sectional study with parallel randomized design (allocation 1:1)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audio-visual material<br>The video for informed consent was developed by a science filmmaker (https://www.lostlikebeesinrain.comhttps://betomation.space/) for the project's purposes. | Behavioral: Audio-visual material<br>* 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.<br>* Other names: Paper-based conventional material;|
| Active Comparator: Paper-based conventional material<br>The written material for informed consent was developed by the Swiss Association of Research Ethic Committees and the booklet was designed by the Clinical Research Center of the Geneva University Hospitals. | Behavioral: Audio-visual material<br>* 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.<br>* Other names: Paper-based conventional material;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance to sign the informed consent | Binary outcome, legal Swiss document | Assessed immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding of the informed consent | Eight self-developed questions assessed as true/false and combined in a 0-8 points score | Assessed immediately after intervention | 
| Evaluation of the informed consent | Nine self-developed question assessed on a six-point Likert scale and averaged | Assessed immediately after intervention | 
| Time to read/watch | Time in minutes for reading the booklet (the video has a unique duration of 4 min) | Assessed immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prison, Research ethics, Audio-visual intervention, Bioethics, Human rights