Clinical trials of fetal therapy with continuing neonatal interventions: legal requirements and customary procedures regarding parental consent. The BOOSTB4 trial as a case study

Oldekamp, E.J.; Vries, M.C. de; David, A.L.; Semler, O.; Westgren, M.; Götherström, C.; Verweij, E.J.T.

doi:doi:10.1002/pd.70012

Objective: To analyze the legal consent requirements and customary procedures in clinical trials of fetal therapy with continuing neonatal interventions across four European countries using the BOOSTB4 trial as a case study. Methods: The study of country-specific legal consent requirements and the actual consent procedures in the BOOSTB4 trial, incorporating surveys with the trial's principal investigators. Results: Prenatal consent was obtained solely from the pregnant women in all participating countries, in line with legal requirements. However, in all countries both prospective parents were engaged in prenatal counseling. In Sweden, the Netherlands and Germany obtaining consent from both parents for continuing neonatal interventions is mandatory. In the United Kingdom, officially only the consent of one parent is required. Nevertheless, researchers there are cautious of including pregnant women or neonates if parents disagree to trial participation, a concern echoed by Dutch,...Show moreObjective: To analyze the legal consent requirements and customary procedures in clinical trials of fetal therapy with continuing neonatal interventions across four European countries using the BOOSTB4 trial as a case study. Methods: The study of country-specific legal consent requirements and the actual consent procedures in the BOOSTB4 trial, incorporating surveys with the trial's principal investigators. Results: Prenatal consent was obtained solely from the pregnant women in all participating countries, in line with legal requirements. However, in all countries both prospective parents were engaged in prenatal counseling. In Sweden, the Netherlands and Germany obtaining consent from both parents for continuing neonatal interventions is mandatory. In the United Kingdom, officially only the consent of one parent is required. Nevertheless, researchers there are cautious of including pregnant women or neonates if parents disagree to trial participation, a concern echoed by Dutch, German and Swedish researchers. Conclusion: 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.Show less

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Clinical trials of fetal therapy with continuing neonatal interventions: legal requirements and customary procedures regarding parental consent. The BOOSTB4 trial as a case study