Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives

Angret de Boer; André Krom; Rania Kalaai; Marieke de Vries; Marije Hogeveen; Sylvia A. Obermann-Borst; Marijn Vermeulen; Juliette S. van Haren; Peter Andriessen; Martine C. de Vries; E.J.T. Verweij; Rosa Geurtzen

doi:10.1038/s41390-025-04051-8

Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives

Angret de Boer
, André Krom
, Rania Kalaai
, Marieke de Vries
, Marije Hogeveen
, Sylvia A. Obermann-Borst
, Marijn Vermeulen
, Juliette S. van Haren
, Peter Andriessen
, Martine C. de Vries
, E.J.T. Verweij
, Rosa Geurtzen (Corresponding author)

Onderzoeksoutput: Bijdrage aan tijdschrift › Tijdschriftartikel › Academic › peer review

1 Citaat (Scopus)

Samenvatting

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.

Originele taal-2	Engels
Pagina's (van-tot)	2385-2393
Aantal pagina's	9
Tijdschrift	Pediatric Research
Volume	98
Nummer van het tijdschrift	6
Vroegere onlinedatum	16 apr. 2025
DOI's	https://doi.org/10.1038/s41390-025-04051-8
Status	Gepubliceerd - dec. 2025

Financiering

We would like to extend our sincere thanks to all the participants of this study for their time, insights and contributions. We are especially grateful to Leonie Lof and Heidi Theeuwen, who took the time to read the last version of the manuscript and refine the results, and to Lien De Proost, who executed the study. Furthermore, we would like to express our gratitude to the Dutch neonatal patient organization Care4Neo for their valuable support in revising our research protocol, their assistance in recruiting participants for this study, and writing this manuscript. Care4Neo aims to increase knowledge, awareness, and understanding for parents who have a baby that needs to be placed in an incubator and the infant itself. This work was supported by a research grant from the European Society for Pediatric Research (ESPR) provided to R. Geurtzen (RGP2022-EPDRG-04/04). EJTV was funded by the ZonMw Clinical Fellow program (90719039). The other authors received no additional funding. The funders had no role in the study design, data collection and analysis, preparation of the manuscript, or decision to publish.

Duurzame ontwikkelingsdoelstellingen van de VN

Deze output draagt bij aan de volgende duurzame ontwikkelingsdoelstelling(en)

SDG 3 – Goede gezondheid en welzijn

Toegang tot document

10.1038/s41390-025-04051-8

Andere bestanden en links

Link naar publicatie in Scopus

Perinatal Medicine
van der Hout-van der Jagt, B. (Content manager) & Delvaux, E. (Content manager)
Impact: Research Topic/Theme (at group level)

Citeer dit

de Boer, A., Krom, A., Kalaai, R., de Vries, M., Hogeveen, M., Obermann-Borst, S. A., Vermeulen, M., van Haren, J. S., Andriessen, P., de Vries, M. C., Verweij, E. J. T., & Geurtzen, R. (2025). Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives. Pediatric Research, 98(6), 2385-2393. https://doi.org/10.1038/s41390-025-04051-8

@article{d1d6234a75d44c5791d169879dd4b366,

title = "Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals{\textquoteright} and parental perspectives",

abstract = "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{\textquoteright} 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.",

author = "\{de Boer\}, Angret and Andr{\'e} Krom and Rania Kalaai and \{de Vries\}, Marieke and Marije Hogeveen and Obermann-Borst, \{Sylvia A.\} and Marijn Vermeulen and \{van Haren\}, \{Juliette S.\} and Peter Andriessen and \{de Vries\}, \{Martine C.\} and E.J.T. Verweij and Rosa Geurtzen",

year = "2025",

month = dec,

doi = "10.1038/s41390-025-04051-8",

language = "English",

volume = "98",

pages = "2385--2393",

journal = "Pediatric Research",

issn = "0031-3998",

publisher = "Springer Nature",

number = "6",

}

de Boer, A, Krom, A, Kalaai, R, de Vries, M, Hogeveen, M, Obermann-Borst, SA, Vermeulen, M, van Haren, JS , Andriessen, P, de Vries, MC, Verweij, EJT & Geurtzen, R 2025, 'Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives', Pediatric Research, vol. 98, nr. 6, blz. 2385-2393. https://doi.org/10.1038/s41390-025-04051-8

TY - JOUR

T1 - Human artificial placenta technology-trials

T2 - counselling and informed consent using healthcare professionals’ and parental perspectives

AU - de Boer, Angret

AU - Krom, André

AU - Kalaai, Rania

AU - de Vries, Marieke

AU - Hogeveen, Marije

AU - Obermann-Borst, Sylvia A.

AU - Vermeulen, Marijn

AU - van Haren, Juliette S.

AU - Andriessen, Peter

AU - de Vries, Martine C.

AU - Verweij, E.J.T.

AU - Geurtzen, Rosa

PY - 2025/12

Y1 - 2025/12

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/105005075573

U2 - 10.1038/s41390-025-04051-8

DO - 10.1038/s41390-025-04051-8

M3 - Article

C2 - 40240874

SN - 0031-3998

VL - 98

SP - 2385

EP - 2393

JO - Pediatric Research

JF - Pediatric Research

IS - 6

ER -

Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives

Samenvatting

Financiering

Duurzame ontwikkelingsdoelstellingen van de VN

Toegang tot document

Andere bestanden en links

Vingerafdruk

Impact

Perinatal Medicine

Citeer dit