The team will evaluate the information materials created following the project guidelines
The project validation starts today in Spain and will be followed by a validation in UK and Romania. This validation allows to present the materials elaborated following the project guidelines (websites, videos and infographics) to the end-users and evaluate them.
The validation is based on the presentation and assessment of the understanding of the information disposed on the materials. The tool used for the assessment is an adaptation by the consortium for studies with vaccines of the “QuIC” Questionnaire. This tool has been coined by i-CONSENT as Comprehension and Quality of Informed Consent Questionnaire (c-QuIC).
The populations selected for the validation have been adults, pregnant women and children from the 3 mentioned countries. This represents 3 cultural and linguistically different settings. This allocation offers the possibility to test if an adaption of the materials elaborated for the Spanish end-users, can be extrapolated to other European countries (UK and Romania).
“The validation of the materials imply an indirect validation of the project guidelines, as the materias were created following the recommendations described on them”, explains Jaime Fons, technical project coordinator.
i-CONSENT will present the specific materials elaborated for pregnant women, adolescents and adults in following posts.
Where can I get guidelines related to IC in pregnant women?
Hi Mariana, thanks for your message! Our guidelines are still under revision but will be available very soon. In the meantime, check the CIOMS guidelines which include a section on the ethical aspects to take into account in studies with pregnant women (“CIOMS GUIDELINE 19: PREGNANT AND BREASTFEEDING WOMEN AS RESEARCH PARTICIPANTS”). Additionally, we published an article entitled “Gender and Informed Consent in Clinical Research: Beyond Ethical Challenges”, that may also be of interest to you. Please find it here! http://rivista.biodiritto.org/ojs/index.php?journal=biolaw&page=article&op=view&path%5B%5D=401 Thanks again for showing interest in our project! More information will be released soon!