Co‐creation of information materials within the assent process
From theory to practice
Bibliographic Data
| ID | 19507848 |
|---|---|
| Authors | Jaime Fons‐Martinez (0000-0002-8319-3658, Vaccine Research Area Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO Valencia Spain, corresponding author), Cristina Ferrer‐Albero (0000-0001-8904-0532, Facultad de Medicina y Ciencias de la Salud Universidad Católica de Valencia San Vicente Mártir Valencia Spain), Javier Díez‐Domingo (0000-0003-1008-3922, Vaccine Research Area Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO Valencia Spain) |
| Year | 2023 |
| Volume | 26 |
| Issue | 1 |
| Pages | 429-439 |
| Publication date | 2023-02-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Health Expectations (JOURNAL) |
| Journal identifiers | ISSN: 1369-6513 • E-ISSN: 1369-7625 |
| Publisher | Wiley (PUBLISHER • GB) |
| DOI | 10.1111/hex.13675 |
| PMID | 36416386 |
| OpenAlex | W4309790040 |
| Language | EN |
| Citations received | 2 |
| References cited | 29 |
INTRODUCTION: The informed consent process is key to safeguarding the autonomy of the participant in medical research. For this process to be valid, the information presented to the potential participant should meet their needs and be understood by them. The i-CONSENT project has developed 'Guidelines for adapting the informed consent process in clinical trials' which aim to improve informed consent so that they are easier to understand and better adapted to the needs and preferences of the target population. The best way to tailor information to the characteristics and preferences of the target population is to involve the community itself. METHODS: Following guidelines developed by i-CONSENT, assent materials were co-created for a mock clinical trial of the human papillomavirus vaccine in adolescents. During the process, two design thinking sessions were conducted involving a total of 10 children and 5 parents. The objectives of the sessions were to find out the children's opinion of the informed consent (assent in their case) process in clinical trials, identify the parts that were most difficult to understand and alternatives for their presentation and wording, identify the preferred formats for receiving the information and the main characteristics of these formats, design a video explaining the clinical trial and evaluate a tool for assessing comprehension. RESULTS: Assent materials were co-created in three formats: a web-based material following a layered approach; a video in story format; a pdf document with an innovative way of presenting information compared to traditional assent documents. In addition, the Comprehension of Assent Questionnaire was co-designed, based on the Quality of Informed Consent questionnaire. CONCLUSION: The design thinking methodology has proven to be an easy and useful tool for involving children in designing information tailored to their needs and preferences. PATIENT OR PUBLIC CONTRIBUTION: A sample of the target population participated in the design and piloting of the materials created using design thinking methodology. In addition, patient representatives participated in the design and evaluation of the guidelines developed by the i-CONSENT project that were followed for the development of the materials in this study
Alternative medicine · Autonomy · Clinical trial · Comprehension · Family medicine · Informed consent · Medical education · Population · Safeguarding · Computer Science · Ethics in Clinical Research · Focus Groups and Qualitative Methods · Medicine · Mental Health and Patient Involvement · Nursing · Psychology
| Citations per year | 0.67 |
|---|---|
| Citation span | 2023 - 2026 (4) |
| Highly cited | No |