One-time Informed Consent for Research in Prison

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

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.

Study Overview

• Status: Completed
• Conditions: Informed Consent
• Intervention / Treatment: Behavioral: Audio-visual material

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 126
    • Division of prison health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Audio-visual material; 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; 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
ACTIVE_COMPARATOR: Paper-based conventional material; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Study Chair: Hans Wolff, MD, Division of Prison Health, Geneva University Hospitals

Publications and helpful links

General Publications

• Baggio S, Getaz L, Giraudier L, Tirode L, Urrutxi M, Carboni S, Britan A, Price RL, Wolff H, Heller P. Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2235888. doi: 10.1001/jamanetworkopen.2022.35888.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Prison; Research ethics; Audio-visual intervention; Bioethics; Human rights
• Other Study ID Numbers: 2019-01797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets are not publicly available due their sensitive nature (detained persons) but are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No