Co-creation of information materials within the assent process: From theory to practice.

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.

Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.

BACKGROUND: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders. METHODS: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting. RESULTS: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms. CONCLUSIONS: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.