One-time Informed Consent for Research in Prison

NCT05505058 | Completed

• 1 other identifier: 2019-01797
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Informed Consent

Keywords

Prison; Research ethics; Audio-visual intervention; Bioethics; Human rights

Outcome Measures

Primary Outcomes (1)

• Acceptance to sign the informed consent

  Binary outcome, legal Swiss document

  Assessed immediately after intervention

Secondary Outcomes (3)

• Understanding of the informed consent

  Assessed immediately after intervention

• Evaluation of the informed consent

  Assessed immediately after intervention

• Time to read/watch

  Assessed immediately after intervention

Study Arms (2)

Audio-visual material

EXPERIMENTAL

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

Paper-based conventional material

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Paper-based conventional material

Audio-visual material; Paper-based conventional material

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of an acute psychiatric problem preventing the person from participating in the study

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Division of prison health

Geneva, 126, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36219446 DERIVED

Study Officials

• Hans Wolff, MD

  Division of Prison Health, Geneva University Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Model Details: Cross-sectional study with parallel randomized design (allocation 1:1)

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: June 30, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)