Ethical Development of Artificial Amniotic Sac and Placenta Technology: A Roadmap

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.

Interprofessional Consensus Regarding Design Requirements for Liquid-Based Perinatal Life Support (PLS) Technology

“…When designing PLS technology, the natural womb should as much as possible set the design requirements; and current advances in technology are encouraging. Application of PLS comes with ethical and societal responsibilities, as has been elaborated in a recently presented roadmap on the ethical development of PLS technology ( 16 ). Hence, even if all technical challenges would be met, ethical, legal and societal implications should be considered carefully, as the availability of PLS will highly influence societal values and perceptions regarding e.g., pregnancy, childbirth, women and (unborn) babies, but also the moral and legal status of the perinate.…”

“…Hence, even if all technical challenges would be met, ethical, legal and societal implications should be considered carefully, as the availability of PLS will highly influence societal values and perceptions regarding e.g., pregnancy, childbirth, women and (unborn) babies, but also the moral and legal status of the perinate. Therefore, we advocate stakeholder involvement and a value-sensitive design approach throughout the research and development process ( 16 ).…”

“…Human research ethics for PLS needs further study to address important aspects like patient selection and informed consent ( 16 ). Similarly to selecting appropriate patient groups for clinical trials ( 11 ), also once clinically implemented this mandates a head-to-head comparison with standard neonatal care.…”

“…As PLS technology is still developing, a vision on both co-creation of PLS technology and on clinical application of PLS is required, as this will determine design requirements, and also societal acceptance. Therefore, a value-sensitive design approach is preferred ( 15 , 16 ).…”

“…It is of the utmost importance that any development in this field is actively accompanied by socio-ethical debate, rather than that a fully developed technology is being introduced without ongoing debate. To this end, a roadmap on the ethical development of PLS technology has been recently presented by Verweij et al ( 16 ).…”