Ontology highlight
ABSTRACT: Background
The EU's 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children's rights.Method
This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany.Results
A majority of participants showed a general good
SUBMITTER: Reetz J
PROVIDER: S-EPMC8283995 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature