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Completed

NCT Number: NCT05505058

One-time Informed Consent for Research in Prison

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.

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Key information

Conditions

Informed Consent

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of prison health

Geneva, 126, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio-visual material

Behavioral

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.

Other names: Paper-based conventional material

Primary outcomes

  1. Acceptance to sign the informed consent

    Time frame: Assessed immediately after intervention

    Binary outcome, legal Swiss document

Secondary outcomes

  1. Understanding of the informed consent

    Time frame: Assessed immediately after intervention

    Eight self-developed questions assessed as true/false and combined in a 0-8 points score

  2. Evaluation of the informed consent

    Time frame: Assessed immediately after intervention

    Nine self-developed question assessed on a six-point Likert scale and averaged

  3. Time to read/watch

    Time frame: Assessed immediately after intervention

    Time in minutes for reading the booklet (the video has a unique duration of 4 min)

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 17, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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