Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the (...) non-digital Informed Consent process. Methods We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia, non-interactive multimedia, and videos, and most studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures and clinical research. For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. (shrink)

Subjects of ectogenesis—human beings that are developing in artificial wombs (AWs)—share the same moral status as newborns. To demonstrate this, I defend two claims. First, subjects of partial ectogenesis—those that develop in utero for a time before being transferred to AWs—are newborns (in the full sense of the word). Second, subjects of complete ectogenesis—those who develop in AWs entirely—share the same moral status as newborns. To defend the first claim, I rely on Elizabeth Chloe Romanis’s distinctions between fetuses, newborns and (...) subjects of ectogenesis. For Romanis, the subject of partial ectogenesis ‘is neither a fetus nor a baby’ but is, instead, a ‘new product of human reproduction’. In this essay, I begin by, expanding upon Romanis’s argument that subjects of partial ectogenesis are not fetuses while arguing that those subjects are newborns. Next, I show that the distinction that Romanis draws between subjects of partial ectogenesis and newborns needs to be revised. The former is a kind of the latter. This leads us to an argument that shows why different moral statuses cannot be justifiably assigned to subjects of partial ectogenesis and subjects of complete ectogenesis, respectively. As subjects of partial ectogenesis share the same moral status as newborns, it follows that subjects of complete ectogenesis share the same moral status as newborns as well. I conclude by considering implications that this essay may have for the research and development of AW technology and conceptual links between a subject’s moral status and birth. (shrink)