Is the UN receiving ethical approval for its research with human participants?

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors' experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight?

Advance Care Planning and Parent-Reported End-of-Life Outcomes in the Neonatal Intensive Care Unit.

OBJECTIVE: This study aimed to evaluate the impact of advance care planning (ACP) on parent-reported end-of-life (EOL) outcomes in the neonatal intensive care unit (NICU). STUDY DESIGN: Single-center, cross-sectional mixed-methods survey study of bereaved parents who experienced the death of a child in the Boston Children's Hospital NICU between 2010 and 2021. Logistic regression, chi-square test, Fisher's exact test, and Wilcoxon rank-sum test were used to evaluate the relationship between ACP and parent-reported EOL outcomes. Qualitative content was analyzed through inductive coding. RESULTS: A total of 40/146 (27%) of eligible parents responded to our survey. There was a significant association between ACP and improved EOL care processes and parental satisfaction with communication. Parents with ACP were more likely to report goal-concordant care and higher levels of perceived shared decision-making. Qualitatively, emerging themes in parents' descriptions of goal-concordant care included misaligned expectations and communication. Emerging themes for parental preparedness included infant symptoms, logistical aspects, impact on parents, and degrees of preparedness. For decisional regret, the primary theme was reevaluating supports. CONCLUSION: ACP is associated with improved EOL care outcomes and parents qualitatively conceptualize goal-concordant care, preparedness for their child's death, and decisional regret in nuanced ways. Families should have the opportunity to participate in ACP discussions that meet their unique communication and decision-making needs. KEY POINTS: · ACP is associated with improved parent-reported end-of-life outcomes.. · Parents conceptualize end-of-life care outcomes in nuanced ways.. · Families should have the opportunity to participate in ACP discussions that meet their unique needs..

Parent Preferences and Experiences in Advance Care Planning in the Neonatal Intensive Care Unit.

OBJECTIVE: Our objective was to evaluate the preferences and experiences of bereaved parents around advance care planning (ACP) in the neonatal intensive care unit (NICU). STUDY DESIGN: Single-center cross-sectional survey of bereaved parents who experienced the death of a child in the Boston Children's Hospital NICU between 2010 and 2021 was carried out. Chi-square, Fisher's exact, Fisher Freeman Halton, and Wilcoxin rank sum tests were used to evaluate differences between parents who did and did not receive ACP. RESULTS: Out of eligible parents, 40 out of 146 (27%) responded to our survey. Most parents (31 out of 33, 94%) rated ACP as being very important and 27 out of 33 (82%) reported having ACP discussions during their child's admission. Parents preferred initial ACP discussions to occur early in their child's illness trajectory with members of the primary NICU team, with most parents' experiences aligning with these preferences. CONCLUSION: Parents value ACP discussions suggesting a further role for ACP in the NICU. KEY POINTS: · NICU parents value and participate in advance care planning discussions. · Parents prefer advance care planning with members of the primary NICU, specialty, and palliative care teams. · Parents prefer advance care planning early in their child's illness trajectory.

Overcoming Ethical Challenges to Engaging Men Who Have Sex with Women in HIV Research.

Men who have sex with women are understudied in HIV research despite the extent to which they experience HIV-related mortality and contribute to the epidemic among women. During our experience of developing and piloting an HIV prevention intervention for men living with HIV in South Africa, and planning to have a child with an HIV-negative woman, ethical questions were posed regarding implementation of a male-centered intervention that did not require female partner participation. Two overarching ethical issues were the potential for (1) compromising women's reproductive and sexual autonomy and (2) increasing HIV-acquisition risks for the woman because the intervention efficacy was unknown. We describe here how these concerns were addressed to facilitate development of a male-centered HIV-prevention intervention. We hope this process manuscript will support researchers, clinicians, and reviewers to engage men who have sex with women in HIV prevention and care.

Parental manual ventilation in resource-limited settings: an ethical controversy.

Lower respiratory tract infections are a leading cause of paediatric morbidity and mortality worldwide. Children in low-income countries are disproportionately affected. This is in large part due to limitations in healthcare resources and medical technologies. Mechanical ventilation can be a life-saving therapy for many children with acute respiratory failure. The scarcity of functioning ventilators in low-income countries results in countless preventable deaths. Some hospitals have attempted to adapt to this scarcity by using hand-bag ventilation, as either a bridge to a mechanical ventilator, or until clinical improvement occurs rendering mechanical ventilation no longer necessary. In instances of hand-bag ventilation, an endotracheal tube is first placed. Family members are then asked to play the role of a ventilator, manually compressing a bag repeatedly to inflate the child's lungs. This approach is fraught with numerous ethical challenges. A careful examination of the data and a nuanced approach to the ethical considerations are imperative. Ethical arguments in support of and in opposition to allowing parental hand-bag ventilation are explored, including the best interests of the child, the child's right to an open future, beneficence and parental protection, legitimising substandard care, and finally, contextual concerns. An algorithmic, potentially ethically permissible approach to parental participation in manual ventilation is proposed.

Does professional orientation predict ethical sensitivities? Attitudes of paediatric and obstetric specialists toward fetuses, pregnant women and pregnancy termination.

BACKGROUND: To determine (1) whether fetal care paediatric (FCP) and maternal-fetal medicine (MFM) specialists harbour differing attitudes about pregnancy termination for congenital fetal conditions, their perceived responsibilities to pregnant women and fetuses, and the fetus as a patient and (2) whether self-perceived primary responsibilities to fetuses and women and views about the fetus as a patient are associated with attitudes about clinical care. METHODS: Mail survey of 434 MFM and FCP specialists (response rates 60.9% and 54.2%, respectively). RESULTS: MFMs were more likely than FCPs to disagree with these statements (all p values<0.005): (1) 'the presence of a fetal abnormality is not an appropriate reason for a couple to consider pregnancy termination' (MFM : FCP-78.4% vs 63.5%); (2) 'the effects that a child born with disabilities might have on marital and family relationships is not an appropriate reason for a couple to consider pregnancy termination' (MFM : FCP-80.5% vs 70.2%); and (3) 'the cost of healthcare for the future child is not an appropriate reason for a couple to consider pregnancy termination' (MFM : FCP-73.5% vs 55.9%). 65% MFMs versus 47% FCPs disagreed that their professional responsibility is to focus primarily on fetal well-being (p<0.01). Specialists did not differ regarding the fetus as a separate patient. Responses about self-perceived responsibility to focus on fetal well-being were associated with clinical practice attitudes. CONCLUSIONS: Independent of demographic and sociopolitical characteristics, FCPs and MFMs possess divergent ethical sensitivities regarding pregnancy termination, pregnant women and fetuses, which may influence clinical care.

A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19.

With disparate rates of morbidity and mortality among minoritized communities, COVID-19 illuminated the need for equity-informed practices in public health. Pacia et al posit FQHCs as entities that addressed inequity when others failed. This commentary further situates how FQHCs address the public health crisis of institutional racism and related health inequities every day and presents a FQHC-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with FQHCs.

Establishing a neonatology consultation program: extending care beyond the neonatal intensive care unit.

Neonates can be cared for in neonatal, pediatric, or cardiac intensive care units, and general and subspecialty pediatric units. Disposition is based on phase of care, gestational and postnatal age, birth weight, specific cardiac or surgical diagnoses, and co-existing medical morbidities. In addition, neonates may transfer between the neonatal intensive care unit (NICU) and other units several times throughout their hospitalization. As such, care for high-risk infants with ongoing neonatal morbidities (often related to prematurity or congenital anomalies) is provided in units with varying neonatal expertise. In this perspective, we provide a framework for the design and implementation of a neonatology consultation service for infants cared for in clinical units outside the NICU. We describe the core principles of effective neonatology consultation and focus on understanding hospital/unit workflow, team composition, patient selection, billing and compliance, and offer suggestions for research initiatives and educational opportunities.

A Sierra Leone 2021 Midwifery Clinical Training Needs Assessment: A Call to Action to Augment Clinical Precepting.

Objective: Sierra Leone has one of the highest maternal mortality and infant mortality rates globally. We share findings from a Midwifery Clinical Training Needs Assessment, conducted in 2021 as a collaboration between the Government of Sierra Leone and Seed Global Health. The assessment identified existing needs and gaps in midwifery clinical training at health facilities in Sierra Leone from various stakeholders' perspectives. Methods: The descriptive needs assessment utilized mixed methods, including surveys, focus group discussions (FGDs), interviews, and reviews of maternal medical records. Results: The following showed needs and gaps in labor and delivery management; record keeping; triage processes; clinical education for students, recent graduates, and preceptors; and lack of infrastructure and resources. Conclusion: The knowledge gained from this needs assessment can further the development of midwifery clinical training programs in Sierra Leone and other low-income countries facing similar challenges. We discuss the implication of our findings.

Prenatally diagnosed fetal conditions in the age of fetal care: does who counsels matter?

OBJECTIVE: We sought to characterize practices and attitudes of maternal-fetal medicine (MFM) and fetal care pediatric (FCP) specialists regarding fetal abnormalities. STUDY DESIGN: This was a self-administered survey of 434 MFMs and FCPs (response rate: MFM 60.9%; FCP 54.2%). RESULTS: For Down syndrome (DS), congenital diaphragmatic hernia (CDH), spina bifida: MFMs were more likely than FCPs to support termination (DS 52% vs 35%, P < .001; CDH 49% vs 36%, P < .001; spina bifida 54% vs 35%, P < .001), and consider offering termination options as highly important (DS 90% vs 70%, P < .001; CDH 88% vs 69%, P < .001; spina bifida 88% vs 70%, P < .001). For DS only, MFMs were less likely than FCPs to think that pediatric specialist consultation should be offered prior to a decision regarding termination (54% vs 75%, P < .001). MFMs reported report higher termination rates among patients only for DS (DS 51% vs 21%, P < .001). CONCLUSION: MFM and FCP specialists' counseling attitudes differ for fetal abnormalities.

The Case for Advance Care Planning in the NICU.

Many NICUs have reached an inflection point where infant deaths following limitation of life-sustaining treatments outnumber those following unsuccessful resuscitations, and many infants who survive continue to require intensive supports. Families of such infants with serious illness may benefit from a standardized, process-oriented approach in decisional-support. Advance care planning (ACP), or communication that supports patients, or their surrogate decision-makers, in sharing values, goals, and preferences for future medical care, is recognized as a valuable strategy in supporting adults with serious and chronic illness. Although the role of ACP in older children and adolescents is evolving, its utility has not been systematically explored in the perinatal context. This article builds a case for formalizing a role for ACP in the NICU by defining ACP and appraising recent outcomes research, reviewing the current state of parental needs for decisional support and serious illness in the NICU, and describing how ACP may address current limitations in primary and specialty pediatric palliative care and challenges for decision-making in the newborn period.

Partnering to Build Human Resources for Health Capacity in Africa: A Descriptive Review of the Global Health Service Partnership's Innovative Model for Health Professional Education and Training From 2013-2018.

Several Sustainable Development Goals (SDGs) (3, 16, 17) point to the need to systematically address massive shortages of human resources for health (HRH), build capacity and leverage partnerships to reduce the burden of global illness. Addressing these complex needs remain challenging, as simple increases in absolute numbers of healthcare providers trained is insufficient; substantial investment into long-term high-quality training programs is needed, as are incentives to retain qualified professionals within local systems of care delivery. We describe a novel HRH initiative, the Global Health Service Partnership (GHSP), involving collaboration between the US government (President's Emergency Plan for AIDS Relief [PEPFAR], Peace Corps), 5 African countries, and a US-based non-profit, Seed Global Health. GHSP was formed to enlist US health professionals to assist in strengthening teaching and training capacity and focused on pre-and in-service medical and nursing education in Malawi, Tanzania, Uganda, Eswatini and Liberia. From 2013-2018, GHSP sent 186 US health professionals to 27 institutions in 5 countries, helping to train 16 280 unique trainees of all levels. Qualitative impacts included cultivating a supportive classroom learning environment, providing a pedagogical bridge to clinical service, and fostering a supportive clinical learning and practice environment through role modeling, mentorship and personalized learning at the bedside. GHSP represented a novel, multilateral, public-private collaboration to help address HRH needs in Africa. It offers a plausible, structured template for engagement and partnership in the field.

Resiliency, Stress, and Culture Shock: Findings from a Global Health Service Partnership Educator Cohort.

Background: Global health field assignments for medical and nursing professionals include a wide variety of opportunities. Many placements often involve individuals practicing in settings very different from their home environments, relying on their professional experience to help bridge cultural and clinical divides. Objectives: There is limited information about the individual factors that might lead to successful longer-term global health experiences in non-disaster settings. In this paper, we report on one cohort of health professionals' experiences of culture shock, stress, and resiliency as volunteers within the Global Health Service Partnership (GHSP), a public-private collaboration between Seed Global Health, the US Peace Corps, and the US Presidents Plan for Emergency Aids Relief (PEPFAR) that placed American medical and nursing educators in five African countries facing a shortage of health professionals. Methods: Using the tools of Project PRIME (Psychosocial Response to International Medical Electives) as a basis, we created the GHSP Educator Support Survey to measure resiliency, stress, and culture shock levels in a cohort of GHSP volunteers during their year of service. Findings: In our sample, participants were likely to experience lower levels of resiliency during initial quarters of global health placements compared to later timepoints. However, they were likely to experience similar stress and culture shock levels across quarters. Levels of preparedness and resources available, and medical needs in the community where the volunteer was placed played a role in the levels of resiliency, stress, and culture shock reported throughout the year. Conclusion: The GHSP Educator Support Survey represented a novel attempt to evaluate the longitudinal mental well-being of medical and nursing volunteers engaged in intense, long-term global health placements in high acuity, low resource clinical and teaching settings. Our findings highlight the need for additional research in this critical area of global health.

Community-Institutional Partnerships to Strengthen Maternal Health Care: Case Study of the First Obstetrics and Gynecology Specialty Training Program in Liberia.

Despite major setbacks to its health infrastructure and health workforce capacity, Liberia began its first post-graduate training program for physicians in 2013. Specialty training in Internal Medicine, Pediatrics, General Surgery and Obstetrics and Gynecology were the four inaugural Residency programs that recruited graduates from the country's only medical school, A.M. Dogliotti College of Medicine. The Obstetrics and Gynecology residency program was designed to combat the rising maternal mortality and strengthen health systems to improve maternal care. The program adapted in the face of challenges posed by limited financial support, lack of specialist-faculty and general physician shortages and the Ebola virus outbreak. The manuscript discusses the challenges and successes of the program and demonstrates how the shortage of teaching faculty was addressed by developing a collaboration between local government and educational communities, a United States (US) academic institution and volunteers from the Global Health Service Partnership.

Research and Responsibility in Global Health: An Analysis of the Joining Forces Study in Ghana.

We explore conceptions of responsibility and integrity in global health research and practice as it is being carried out in the academic setting. Our specific motivation derives from the recent publication of a study by a clinical research team involving the delivery of mental health care services in a Ghanaian prayer camp. The study was controversial on account of the prayer camp's history of human rights abuses and therefore was met with several high-profile critiques. We offer a more charitable evaluation of the Joining Forces study. Our analysis has three primary goals. First, we respond to criticism suggesting that the Joining Forces research team needed to maintain some form of morally "clean hands" in relation to the human rights abuses at Mount Horeb prayer camp. We argue that, for academic global health practitioners working under severe resource constraints, what is reasonable and responsible to pursue is a complex proposition without a one-size-fits-all ethical answer. Second, we offer an explanation for why the Joining Forces study team designed the project as they did in spite of their obvious vulnerability to ethical concern. We argue that the Joining Forces study was a morally risky, but ethically earnest effort to reach a neglected patient population and promote behavior change in prayer camp staff. Third, we identify an open ethical question born of the researchers' commitment to pragmatism that, to our knowledge, has not been previously addressed in published discussion of the Joining Forces project. Namely, was the incomplete disclosure of information to prayer camp staff defensible? We close with a broader reflection on the notion of moral integrity in the pursuit of the salutary aims of global health.

Institutionalising global health: a call for ethical reflection.

We describe a global health course and pedagogy that highlights the moral ambiguity and many ethical compromises that have emerged as the discipline has increasingly become institutionalised. We encourage students to reflect on how the oft-declared aspiration for global health equity still remains seriously contested as a normative and political matter, especially in settings like the USA. We further encourage students to reflect on how authentic concern for social justice, health equity and human rights are consistently undermined by unconscious and/or intentional fealty to standard operating procedures within hierarchical structures and systems. Lastly, we encourage students to openly question and critique the dominant socioeconomic and institutional paradigms that influence practitioner ways of thinking about global health. Our aim is to provide a learning space for students to at least imagine, if not demand, more daring modes of engagement. We also encourage our colleagues in the global health education community to be forthright that the process of institutionalising global health reliably favours our own interests more than those we claim to be most concerned about. If the ideal of global health is to build a bridge to human solidarity, we see substantial risk that current popularised approaches might never yield a structural tipping point.