Abstract
In this paper we present an initial roadmap for the ethical development and eventual implementation of artificial amniotic sac and placenta technology in clinical practice. We consider four elements of attention: (1) framing and societal dialogue; (2) value sensitive design, (3) research ethics and (4) ethical and legal research resulting in the development of an adequate moral and legal framework. Attention to all elements is a necessary requirement for ethically responsible development of this technology. The first element concerns the importance of framing and societal dialogue. This should involve all relevant stakeholders as well as the general public. We also identify the need to consider carefully the use of terminology and how this influences the understanding of the technology. Second, we elaborate on value sensitive design: the technology should be designed based upon the principles and values that emerge in the first step: societal dialogue. Third, research ethics deserves attention: for proceeding with first-in-human research with the technology, the process of recruiting and counseling eventual study participants and assuring their informed consent deserves careful attention. Fourth, ethical and legal research should concern the status of the subject in the AAPT. An eventual robust moral and legal framework for developing and implementing the technology in a research setting should combine all previous elements. With this roadmap, we emphasize the importance of stakeholder engagement throughout the process of developing and implementing the technology; this will contribute to ethically and responsibly innovating health care.
Highlights
Worldwide, extreme prematurity at the limit of fetal viability is a main cause for perinatal mortality and morbidity [1, 2]
Not every pregnant person who is in a situation of extremely premature birth must automatically qualify as a study participant; certain requirements for study participants can be formulated so that the recruitment and inclusion process is ethically responsible
We propose the following inclusion criteria for a woman: (a) they have enough time to decide whether or not to participate in the study, (b) their decision is supported by high-quality counseling and they are able to understand and weigh the pros and cons of participating in the study; they are as much as possible aware of the uncertainties involved; (c) they are in a situation in which a cesarean is per se clinically indicated; and (d) they are in a situation in which for the mothers health it is much better to be no longer be pregnant
Summary
Extreme prematurity at the limit of fetal viability is a main cause for perinatal mortality and morbidity [1, 2]. Not every pregnant person who is in a situation of (threatening) extremely premature birth must automatically qualify as a study participant; certain requirements for study participants can be formulated so that the recruitment and inclusion process is ethically responsible To this end, we propose the following inclusion criteria for a woman (and her partner): (a) they have enough time to decide whether or not to participate in the study, (b) their decision is supported by high-quality counseling and they are able to understand and weigh the pros and cons of participating in the study; they are as much as possible aware of the uncertainties involved; (c) they are in a situation in which a cesarean is per se clinically indicated; and (d) they are in a situation in which for the mothers health it is much better to be no longer be pregnant (for example maternal complications like pre-eclampsia). The discussed elements—societal dialogue with stakeholders, value sensitive design, research ethics, and the moral and legal status of the subject in the AAPT—should be integrated in a robust ethical and legal framework to guide socially acceptable ethical development of AAPT
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