Minderjährige in klinischen Prüfungen: Ethische Abwägungen ihres Einbezugs am Beispiel der indizierten Prävention psychotischer Erkrankungen
Research output: Contribution to journal › Review article › Contributed › peer-review
Contributors
- Department of Psychiatry and Psychotherapy
- University Hospital Duesseldorf
- Universitas Airlangga
- University of Bern
- Heinrich Heine University Düsseldorf
- Heidelberg University
- University Hospital Tübingen
- Vivantes Hospital at Urban
- Charité – Universitätsmedizin Berlin
- German Center for Mental Health (DZPG)
- University of Cologne
- Otto von Guericke University Magdeburg
- LVR-Clinic Bonn
- University of Hamburg
- University Medical Center Mainz
- State Hospital Andernach - Reinhessen-Fachklinik Mainz
- State Hospital Andernach - Rheinhessen-Fachklinik Alzey
- Ludwig Maximilian University of Munich
- King's College London (KCL)
- Gemeinnützige
- University Hospital Schleswig-Holstein Campus Kiel
- University of Würzburg
- University of Münster
- Leipzig University
- University of Glasgow
- University of Bonn
- Zucker Hillside Hospital
- Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
- University Hospital Carl Gustav Carus Dresden
Abstract
As a vulnerable group, minors require special protection in studies. For this reason, researchers are often reluctant to initiate studies, and ethics committees are reluctant to authorize such studies. This often excludes minors from participating in clinical studies. This exclusion can lead to researchers and clinicians receiving only incomplete data or having to rely on adult-based findings in the treatment of minors. Using the example of the study “Computer-Assisted Risk Evaluation in the Early Detection of Psychotic Disorders” (CARE), which was conducted as an 'other clinical investigation' according to the Medical Device Regulation, we present a line of argumentation for the inclusion of minors which weighs the ethical principles of nonmaleficence (especially regarding possible stigmatization), beneficence, autonomy, and fairness. We show the necessity of including minors based on the development-specific differences in diagnostics and early intervention. Further, we present specific protective measures. This argumentation can also be transferred to other disorders with the onset in childhood and adolescence and thus help to avoid excluding minors from appropriate evidence-based care because of insufficient studies.
Translated title of the contribution | Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders |
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Details
Original language | German |
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Pages (from-to) | 261-289 |
Number of pages | 29 |
Journal | Zeitschrift fur Kinder- und Jugendpsychiatrie und Psychotherapie |
Volume | 52 |
Issue number | 5 |
Publication status | Published - 1 Sept 2024 |
Peer-reviewed | Yes |
External IDs
ORCID | /0000-0002-3415-5583/work/172572563 |
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ORCID | /0000-0002-0374-342X/work/172572599 |
ORCID | /0000-0002-2666-859X/work/172572653 |
ORCID | /0000-0001-5099-0274/work/172572661 |
Keywords
Sustainable Development Goals
ASJC Scopus subject areas
Keywords
- ethics, prevention, psychosis risk, research, vulnerable groups