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临床试验/NCT05505058
NCT05505058已完成不适用

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

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2019年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stéphanie Baggio

PD Dr.

University Hospital, Geneva

研究点 (2)

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