Consent to research participation: understanding and motivation among German pupils

BMC Medical Ethics

Jana Reetz¹  Christine Glinicke²  Gesine Richter³  Alena Buyx⁴  Christoph Borzikowsky⁵  Stephanie Darabaneanu⁶ 

[1] Diakonissenkrankenhaus, Department of Paediatrics, Knuthstraße 1, 24939, Flensburg, Germany;Ethics Commission, University Hospital Schleswig-Holstein, Arnold-Heller-Straße 3; Haus U 27, 24105, Kiel, Germany;Institute of Experimental Medicine, Division of Biomedical Ethics, Kiel University, University Hospital Schleswig-Holstein, UKSH, Campus KielArnold-Heller-Str. 3, Haus U35, 24105, Kiel, Germany;Institute of History and Ethics in Medicine, Technical University of Munich, Ismaninger Str. 22, 81675, München, Germany;Institute of Medical Informatics and Statistics, Kiel University, University Hospital Schleswig-Holstein, Brunswiker Str. 10, 24105, Kiel, Germany;Institute of Medical Psychology and Medical Sociology, Kiel University, University Hospital Schleswig-Holstein Kiel, Preußerstrasse 1-9, 24105, Kiel, Germany;

关键词: Paediatric consent;    Medical research;    Informed consent;    Understanding;    Data protection;    Therapeutic-misconception;   

DOI  :  10.1186/s12910-021-00661-z

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodThis 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.ResultsA majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents’ decision-making process.ConclusionBearing in mind adolescents’ generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample.

【 授权许可】

CC BY