Improving informed consent processes for research in prisons
Testing a New Method to Improve Informed Consent in Prison Research
This study is testing a new way to help people in prison better understand the consent process for research so they can make informed choices about participating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 2 sites (Geneva, Canton of Geneva and 1 other locations) |
| Trial ID | NCT06378281 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the understanding of informed consent among incarcerated individuals by testing a modified 'teach-to-goal' approach compared to standard procedures. Recognizing the unique challenges faced by detained persons, such as limited education and cognitive impairments, the study seeks to improve ethical practices in research involving vulnerable populations. Conducted within a larger investigation on psychiatric outcomes, it will assess the effectiveness of this new method in ensuring that participants fully comprehend the consent process.
Who should consider this trial
Good fit: Ideal candidates for this study are incarcerated individuals aged 18 and older who have a good command of French and can provide written informed consent.
Not a fit: Patients with acute psychiatric disorders may not benefit from this study due to their compromised ability to understand the informed consent process.
Why it matters
Potential benefit: If successful, this study could lead to more ethical and effective research practices in prisons, ensuring that incarcerated individuals are better informed about their participation.
How similar studies have performed: While there is limited research specifically addressing informed consent in prison settings, studies in the general population have shown that simplified consent processes can improve understanding, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * inclusion in the parent-RCT * age ≥ 18 years * good command of French * absence of acute psychiatric disorder * providing written informed consent for study participation in the parent-RCT Exclusion Criteria: \- none.
Where this trial is running
Geneva, Canton of Geneva and 1 other locations
- Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (Not_yet_recruiting)
- Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Stéphanie Baggio, Prof.
- Email: stephanie.baggio@unil.ch
- Phone: +41216923238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.