Ethical challenges in first-in-human trials of the artificial placenta and artificial womb: not all technologies are created equally, ethically.

Artificial placenta and artificial womb technologies to support extremely premature neonates are advancing toward clinical testing in humans. Currently, no recommendations exist comparing these approaches to guide study design and optimal enrollment eligibility adhering to principles of research ethics. In this paper, we will explore how scientific differences between the artificial placenta and artificial womb approaches create unique ethical challenges to designing first-in-human trials of safety and provide recommendations to guide ethical study design for initial human translation.

The physiology, assessment, and treatment of neonatal pain.

Studies have clearly shown that development of pain receptors starts as early as 20-weeks' gestation. Despite contrary belief, the human fetus develops a similar number of receptive pain fibers as seen in adults. These receptors' maturation is based on response to sensory stimuli received after birth which makes the NICU a critical place for developing central nervous system's pain perception.

Ethical implications of economic compensation for voluntary medical male circumcision for HIV prevention and epidemic control.

Despite tremendous efforts in fighting HIV over the last decades, the estimated annual number of new infections is still a staggering 1.5 million. There is evidence that voluntary medical male circumcision (VMMC) provides protection against men's heterosexual acquisition of HIV-1 infection.

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees.

Background: The COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for a significant duration of the COVID-19 pandemic.

Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi.

Background: Pragmatic clinical trials generally rely on real world data and have the potential to generate real world evidence. This approach arose from concerns that many trial results did not adequately inform real world practice. However, maintaining the real world setting during the conduct of a trial and ensuring adequate protection for research participants can be challenging.

Donors' experiences and attitudes of fecal microbiota transplantation: An empirical bioethics study from China.

Donor participation is a critical part of ensuring the development of human microbiome research and the clinical application of fecal microbiota transplantation (FMT). Most FMT donors are still not sufficiently aware of the risks associated with the act of donating gut microbiota, especially the risk of data privacy disclosure. Enhanced awareness of the moral responsibility of the researchers and ethical oversight by ethics committees are needed.

Bioethics for Neonatal Cardiac Care.

Background: Clinicians caring for neonates with congenital heart disease encounter challenges with ethical implications in daily practice and must have some basic fluency in ethical principles and practical applications.

Methods: Good ethical practice begins with a thorough understanding of the details and narrative of each individual case, examination via classic principles of bioethics, and further framing of that translation into practice.

Results: We explore some of these issues and expand awareness through the lens of a case presentation beginning with fetal considerations through end-of-life discussions.

Re-membering Gun Violence.

Re-membering is the combination of remembering and bringing something back into membership. Addressing spiritual care for gun-violence requires us to remember our past while allowing the remnants of violence to remake us-our social norms around violence. With collective ownership of our shared context of violence we can reframe our obligation: care is for the community and the social milieu not just for the individual victim or victimizer.

Caring for Ourselves, Supporting Anti-Racist Programming in Medicine.

Healthcare disparities and racism are finally being addressed in medical education. Medical schools are working to implement anti-racist programming; however, this can have a negative impact on the mental health of doctors and medical students of color. Continually hearing about people of one's racial group suffering from inequity can have a negative personal and performance impact.

Psychosocial Considerations for the Child with Rare Disease: A Review with Recommendations and Calls to Action.

Rare diseases (RD) affect children, adolescents, and their families infrequently, but with a significant impact. The diagnostic odyssey undertaken as part of having a child with RD is immense and carries with it practical, emotional, relational, and contextual issues that are not well understood. Children with RD often have chronic and complex medical conditions requiring a complicated milieu of care by numerous clinical caregivers.

Perceptions of HIV cure and willingness to participate in HIV cure-related trials among people enrolled in the Netherlands cohort study on acute HIV infection.

Background: People who initiate antiretroviral therapy (ART) during acute HIV infection are potential candidates for HIV cure-related clinical trials, as early ART reduces the size of the HIV reservoir. These trials, which may include ART interruption (ATI), might involve potential risks. We explored knowledge and perception of HIV cure and willingness to participate in cure-related trials among participants of the Netherlands Cohort Study on Acute HIV infection (NOVA study), who started antiretroviral therapy immediately after diagnosis of acute HIV infection.

Current controversies in neonatal resuscitation.

The goal of neonatal bioethics is to help clinicians navigate difficult decisions that arise every day in the care of critically ill newborns. Over the last few decades, there have been vigorous discussions of numerous ethical issues. For some, we have worked out a tentative societal agreement for appropriate responses.

Ethics Roundtable: How Much is Too Much?

How should the medical team approach care for a very preterm infant with a significant painful and life-limiting condition when the parents wish to pursue all life-sustaining therapies? Here, we discuss a case of an infant born at 28 weeks' gestation with a diagnosis of Carmi syndrome (junctional epidermolysis bullosa and pyloric atresia). While the medical team felt that a do-not-resuscitate order and redirection to comfort care were appropriate, the family held on to hope for recovery and wished to continue with full intensive care measures.

Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups.

Parental request for non-resuscitation in fetal myelomeningocele repair: an analysis of the novel ethical tensions in fetal intervention.

As the field of fetal intervention grows, novel ethical tensions will arise. We present a case of Fetal myelomeningocele repair involving a 25-week fetus where parents requested that if emergent delivery was necessary during the open uterine procedure, that the medical team did not perform resuscitation. This question brings forward an important discussion around the complicated space of maternal autonomy, child rights, and clinician obligations that exists in fetal intervention.

Trauma-informed care and ethics consultation in the NICU.

Trauma-informed care responds to our current understanding of the ways in which people's traumatic life experiences influence both their health and their interactions with the health care system. Many ethics consults arise because those past traumatic life experiences are not recognized and addressed. In this paper, we present a NICU case that led to an ethics consultation about end-of-life decisions for a dying baby.

An ethical rationale for perinatal palliative care.

Perinatal palliative care has grown out of both an historical necessity in attending to babies in the NICU that face difficult odds of survival, the increasing technology that may avail life-extending, yet technology-dependent, care, and the growth of fetal diagnostic and treatment centers. This review looks ta the history and ethical rationale for making available services from Pediatric and Perinatal Palliative Care to families in the prenatal and postnatal periods caring for a loved one with life-limiting circumstances.