Informed ConsentNCT05505058
One-time Informed Consent for Research in Prison
A study testing Audio-visual material in people with Informed Consent, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent
- What is being tested?
- Audio-visual material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- presence of an acute psychiatric problem preventing the person from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Informed Consent
- Being tested
- Audio-visual material
- Keywords
- Prison, Research ethics, Audio-visual intervention, Bioethics, Human rights
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-visual materialBehavioural
Also called Paper-based conventional 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Audio-visual material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance to sign the informed consent
Binary outcome, legal Swiss document
Measured: Assessed immediately after intervention
Secondary outcomes (3)
Understanding of the informed consent
Eight self-developed questions assessed as true/false and combined in a 0-8 points score
Measured: Assessed immediately after intervention
Evaluation of the informed consent
Nine self-developed question assessed on a six-point Likert scale and averaged
Measured: Assessed immediately after intervention
Time to read/watch
Time in minutes for reading the booklet (the video has a unique duration of 4 min)
Measured: Assessed immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Sep 2019
- Primary completion30 Sep 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional study with parallel randomized design (allocation 1:1)
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphanie Baggio, University Hospital, Geneva
- Investigators
- Hans Wolff, MD, Study chair, Division of Prison Health, Geneva University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505058
- Sponsor's protocol ID
- 2019-01797
- Other IDs
- 2019
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets are not publicly available due their sensitive nature (detained persons) but are available from the corresponding author on reasonable request.
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.
PubMed 36219446
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-time Informed Consent for Research in Prison: A Randomized Comparison Between Audio-visual and Written Materials
- ClinicalTrials.gov ID
- NCT05505058
- Acronym / sponsor ID
- 2019-01797
- Conditions
- Informed Consent
- Keywords
- Prison, Research ethics, Audio-visual intervention, Bioethics, Human rights
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional study with parallel randomized design (allocation 1:1)
| Arm | Type | Receives |
|---|---|---|
| Audio-visual material | Experimental | Behavioral: Audio-visual materialThe video for informed consent was developed by a science filmmaker (https://www.lostlikebeesinrain.comhttps://betomation.space/) for the project's purposes. |
| Paper-based conventional material | Active comparator | Behavioral: Audio-visual materialThe 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- presence of an acute psychiatric problem preventing the person from participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-visual materialAlso: Paper-based conventional materialParticipants 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. | Behavioural | Audio-visual material, Paper-based conventional material |
Primary outcome
Acceptance to sign the informed consent
Time frame: Assessed immediately after intervention
Binary outcome, legal Swiss document
3 secondary outcomes
Understanding of the informed consent
Time frame: Assessed immediately after intervention
Evaluation of the informed consent
Time frame: Assessed immediately after intervention
Time to read/watch
Time frame: Assessed immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 36219446Baggio 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.
- Individual participant dataSharing planned: No. The datasets are not publicly available due their sensitive nature (detained persons) but are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Wolff, MD study chair
Division of Prison Health, Geneva University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-visual material in people with Informed Consent, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance to sign the informed consent (time frame: Assessed immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.