One-time Informed Consent for Research in Prison: A Randomized Comparison Between Audio-visual and Written Materials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Acceptance to sign the informed consent
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •presence of an acute psychiatric problem preventing the person from participating in the study
结局指标
主要结局
Acceptance to sign the informed consent
时间窗: Assessed immediately after intervention
Binary outcome, legal Swiss document
次要结局
- Time to read/watch(Assessed immediately after intervention)
- Evaluation of the informed consent(Assessed immediately after intervention)
- Understanding of the informed consent(Assessed immediately after intervention)
研究者
Stéphanie Baggio
PD Dr.
University Hospital, Geneva
