Pediatric research · 2025
Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals' and parental perspectives.
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de Boer Angret, Krom André, Kalaai Rania, de Vries Marieke, Hogeveen Marije, Obermann-Borst Sylvia A, Vermeulen Marijn, van Haren Juliette S, Andriessen Peter, de Vries Martine C, Verweij E J T, Geurtzen Rosa
Аннотация
BACKGROUND: The Artificial Amnion and Placenta Technology (AAPT) is developed to improve outcomes of extremely premature birth, with first in-human trials expected in the coming years. Empirical research with key stakeholders is essential for responsibly designing these trials. This study aims to discuss considerations for counselling and informed consent for the first in-human trials of the AAPT, discussing legal and ethical considerations.
METHODS: A qualitative study using both individual and focus group interviews with healthcare professionals (HCPs) and parents was performed. Interviews were thematically analysed.
RESULTS: Fifteen parents and 46 HCPs were interviewed. The results are represented into key themes reflecting participants' perspectives on: (I) the moral and legal status of the subject treated in AAPT trials, (II) the first participant: the pregnant person, and (III) the terminology used to describe the technology. Furthermore, considerations around the informed consent process and counselling, including parental hope, are described. The findings suggest these factors are interconnected, as the moral and legal context surrounding AAPT trials influences the approach to counselling and informed consent.
CONCLUSION: Resolving key ethical and legal issues important for counselling and informed consent is essential for establishing parental right and the development of a responsible, ethically sound informed consent process.
IMPACT: Addressing ethical and legal issues surrounding counseling and informed consent is essential to safeguard a responsible and ethically sound consent process for future human artificial amnion and placenta technology (AAPT)-trials. This is the first study exploring stakeholder perspectives on the AAPT, highlighting the complexities in counselling and informed consent, such as the moral status of participants and the rights of all parties, which must be carefully navigated before trial designs can progress. The article underscores the importance of establishing consensus and maintaining open dialogue among all stakeholders to create a robust, ethically grounded framework for informed consent in future trials.
METHODS: A qualitative study using both individual and focus group interviews with healthcare professionals (HCPs) and parents was performed. Interviews were thematically analysed.
RESULTS: Fifteen parents and 46 HCPs were interviewed. The results are represented into key themes reflecting participants' perspectives on: (I) the moral and legal status of the subject treated in AAPT trials, (II) the first participant: the pregnant person, and (III) the terminology used to describe the technology. Furthermore, considerations around the informed consent process and counselling, including parental hope, are described. The findings suggest these factors are interconnected, as the moral and legal context surrounding AAPT trials influences the approach to counselling and informed consent.
CONCLUSION: Resolving key ethical and legal issues important for counselling and informed consent is essential for establishing parental right and the development of a responsible, ethically sound informed consent process.
IMPACT: Addressing ethical and legal issues surrounding counseling and informed consent is essential to safeguard a responsible and ethically sound consent process for future human artificial amnion and placenta technology (AAPT)-trials. This is the first study exploring stakeholder perspectives on the AAPT, highlighting the complexities in counselling and informed consent, such as the moral status of participants and the rights of all parties, which must be carefully navigated before trial designs can progress. The article underscores the importance of establishing consensus and maintaining open dialogue among all stakeholders to create a robust, ethically grounded framework for informed consent in future trials.