Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05505058 |
| Other study ID # |
2019-01797 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University Hospital, Geneva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
