Clinical Trials of Fetal Therapy With Continuing Neonatal Interventions: Legal Requirements and Customary Procedures Regarding Parental Consent. <i>The BOOSTB4 Trial as a Case Study</i>
While the pregnant woman's autonomy is paramount for prenatal trial participation, trials involving continuing neonatal interventions should adopt a two-step prenatal counseling approach. This approach allows a distinction between consent for fetal and neonatal procedures and allows researchers to comprehend parental perspectives without undermining the pregnant woman's individual rights.
Authors
- E. J. T. Verweij (ORCID: https://orcid.org/0000-0002-9343-9957)
- Martine C. de Vries (ORCID: https://orcid.org/0000-0002-3178-7470)
- Cecilia Götherström (ORCID: https://orcid.org/0000-0003-3782-0048)
- Esther J. Oldekamp
- Anna Louise David (ORCID: https://orcid.org/0000-0002-0199-6140)
- Magnus Westgren (ORCID: https://orcid.org/0000-0003-1174-2184)
- Oliver Semler (ORCID: https://orcid.org/0000-0003-0029-7556)
Institutions
- Leiden University (NL)
- University College Hospital (GB)
- University of Cologne (DE)
- Leiden University Medical Center (NL)
- Karolinska Institutet (SE)
- University Hospital Cologne (DE)
- University College London (GB)
Publication Details
- Journal
- Prenatal Diagnosis
- Published
- 2025-10-31
- DOI
- https://doi.org/10.1002/pd.70012
- Primary Topic
- Prenatal Screening and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Commission
- Lunds Universitet
- Vetenskapsrådet