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BackgroundResearch ethics guidelines set a high bar for conducting research with vulnerable populations, often resulting in their exclusion from beneficial research. Our study aims to better characterise participants’ vulnerabilities, agency, resourcefulness and sources of support.MethodsWe undertook qualitative research around two clinical studies involving migrant women living along the Thai–Myanmar border. We conducted 32 in-depth interviews and 10 focus group discussions with research participants, families, researchers and key informants.ResultsWe found that being ‘undocumented’ is at the core of many structural vulnerabilities, reflecting political, economic, social and health needs. Although migrant women lead challenging lives, they have a support network that includes family, employers, community leaders, non-governmental organisations and research networks. Migrant women choose to participate in research to access quality healthcare, gain knowledge and obtain extra money. However, research has the potential to exacerbate existing vulnerabilities, such as the burdens of cross-border travel, foregoing work and being more visible as migrants.ConclusionsOur study confirms that research is important to provide evidence-based care and was viewed by participants as offering many benefits, but it also has hidden burdens. Migrant women exercised agency and resourcefulness when navigating challenges in their lives and research participation.

Background Child mortality rates during hospitalisation for acute illness and after discharge are unacceptably high in many under-resourced settings. Childhood vulnerability to recurrent illness, and death, is linked to their families’ situations and ability to make choices and act (their agency). We examined vulnerability and agency across treatment-seeking journeys for acutely ill children and considered the implications for policy and practice. Method A qualitative sub-study was embedded within the prospective CHAIN Network cohort study, which is investigating mechanisms of inpatient and post-hospital discharge mortality among acutely ill young children across a spectrum of nutritional status. Primary data were collected from household members of 20 purposively selected cohort children over 18 months through formal interviews (total n = 74), complemented by informal discussions and observations. Data were analysed using narrative and thematic approaches. Results Treatment-seeking pathways were often long and complex, particularly for children diagnosed as severely malnourished. Family members’ stories reveal that children’s carers, usually mothers, navigate diverse challenges related to intersecting vulnerabilities at individual, household and facility levels. Specific challenges include the costs of treatment-seeking, confusing and conflicting messaging on appropriate care and nutrition, and poor continuity of care. Strong power inequities were observed between family members and health staff, with many mothers feeling blamed for their child’s condition. Caregivers’ agency, as demonstrated in decision-making and actions, often drew on the social support of others but was significantly constrained by their situation and broader structural drivers. Conclusion To support children’s care and recovery, health systems must be more responsive to the needs of families facing multiple and interacting vulnerabilities. Reducing incurred treatment costs, improving interpersonal quality of care, and strengthening continuity of care across facilities is essential. Promising interventions need to be co-designed with community representatives and health providers and carefully tested for unintended negative consequences and potential for sustainable scale-up.

Health research in low-resource settings often involves individuals and populations defined as ‘vulnerable’. There is growing attention in the literature to the ethical dilemmas that frontline research staff face while conducting such research. However, there is little documented as to how research staff might support one another in identifying and handling these dilemmas in different contexts. Over the course of conducting empirical ethics research embedded in the Childhood Acute Illness & Nutrition Network, we developed an approach to examine and respond to the ethical issues and dilemmas faced by the study teams, particularly frontline staff. In this paper we describe the specific tools and approach we developed, which centred on regular cross-team ethics reflection sessions, and share lessons learnt. We suggest that all studies involving potentially vulnerable participants should incorporate activities and processes to support frontline staff in identifying, reflecting on and responding to ethical dilemmas, throughout studies. We outline the resources needed to do this and share piloted tools for further adaptation and evaluation. Such initiatives should complement and feed into—and certainly not in any way replace or substitute for—strong institutional ethics review, safeguarding and health and safety policies and processes, as well broader staff training and career support initiatives.

This study aims to understand nutrition‐related roles, responsibilities and ethical issues of grandparents caring for their grandchildren in skip‐generation households in rural Cambodia. Over the past decade, Cambodia has experienced a rise in economic migration of working age populations. This has resulted in increasing numbers of ‘skip‐generation’ households, in which grandparents and grandchildren co‐reside without parents, reflecting potential household vulnerability. This qualitative study involved in‐depth interviews and focus group discussions with Cambodian grandparents who were primary caregivers to grandchildren for six months or longer. A total of 39 grandparents were recruited at two sites in north‐west Cambodia. Interviews and focus group discussions were conducted in Khmer and were recorded, transcribed and translated into English. Data were analysed using thematic analysis. Grandparents in this study looked after an average of three children, aged between two months and 18 years old. Overall, 40% were sole caregivers. Analysis showed that grandparents, particularly grandmothers, played a central role in their grandchildren's health and nutrition. Although grandchildren's health and nutrition were a major priority to grandparents, they reported facing significant challenges to safeguard their grandchildren's and their own nutritional needs. As a result, grandparents frequently faced difficult ethical trade‐offs and prioritised their grandchildren's health and nutrition over their own. This study highlights that in order to improve child nutrition, policies and interventions need to be designed in ways that support and enable grandparent caregivers to meet their grandchildren's health and nutritional needs without neglecting their own.

To optimize scale-up of pre-exposure prophylaxis (PrEP) for pregnant women at risk of HIV in high HIV burden settings, implementation strategies must be developed that account for perceptions of PrEP in this unique population. Semistructured focus group discussions were conducted with 68 HIV-uninfected Kenyan pregnant and postpartum women without prior PrEP knowledge or experience. A qualitative descriptive analysis was performed, using a constant comparison approach, to identify key themes related to the values and rationale impacting potential PrEP use in pregnancy. Median age was 19.5 years and participants were either pregnant or had 1–2 children. Almost all (96%) were married or had a steady partner. Women felt pregnancy was a time of high HIV risk because they desired sex less frequently, which may lead their partners to have outside partnerships. This made PrEP an attractive HIV prevention option for themselves and their infants. Although women believed male partner behaviors influenced their HIV risk, many women perceived that male partners would react negatively, including becoming physically violent, if they discovered that women used PrEP. Clinicians were identified as potential facilitators of PrEP use who could explain PrEP to male partners on behalf of pregnant women. Women said that community-level stigma against HIV and potential for conflating PrEP with antiretroviral therapy (ART) would necessitate that PrEP use be discreet. Our results indicate the importance of addressing risk perception of women, concerns of male partners, HIV stigma, and benefits of PrEP for HIV prevention as programs are developed for pregnant women.

Background We describe the findings from a research ethics case study, linked with a team evaluating a package of intervention services to prevent HIV infection in adolescent girls and young women (AGYW) living in a rural and poor setting of KwaZulu-Natal, South Africa. Methods We conducted qualitative interviews (n=77) with members of the linked research team evaluating the intervention programme, programme implementing staff, AGYW enrolled in the intervention programme, caregivers, ethics committee members, Public Engagement officers, community advisory board members and community stakeholders. Data were analysed iteratively using thematic framework analysis. Themes were determined by the study aims combined with an inductive development of codes emerging from the data. Results The findings show that the burden of providing ancillary care fell primarily on the shoulders of frontline researchers and programme staff. Dilemmas around responding to gender-based violence illustrated the limits of ‘referral to services’ as a solution for meeting ancillary care obligations in contexts with barriers to basic health and social services. Conclusion Our findings show important gaps in meeting ancillary care needs. Participants’ needs required social and economic support which frontline researchers and implementing partners were not able to meet, causing moral distress.

Pediatric clinical research in low-resourced countries involves individuals defined as “vulnerable” in research ethics guidance. Insights from research participants can strengthen the design and oversight of studies. We share family members' perspectives and experiences of an observational clinical study conducted in one Kenyan hospital as part of an integrated empirical ethics study. Employing qualitative methods, we explored how research encounters featured in family members' care-seeking journeys. Our data reveals that children's vulnerability is intricately interwoven with that of their families, and that research processes and procedures can inadvertently add to hidden burdens for families. In research, the potential for layered and intersecting situational and structural vulnerability should be considered, and participants' agency in constrained research contexts actively recognized and protected.

Safe access to the most effective treatment options for Plasmodium vivax malaria are limited by the absence of accurate point-of-care testing to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency, the most common human genetic disorder. G6PD-deficient patients are at risk of life-threatening hemolysis when exposed to 8-aminoquinolines, the only class of drugs efficacious against P. vivax hypnozoites. Until recently, only qualitative tests were available in most settings. These accurately identify patients with severe G6PD deficiency (mostly male) but not patients with intermediate G6PD deficiency (always female). This has led to and reinforced a gap in awareness in clinical practice of the risks and implications of G6PD deficiency in females—who, unlike males, can have a heterozygous genotype for G6PD. Increasing recognition of the need for radical cure of P. vivax, first for patients’ health and then for malaria elimination, is driving the development of new point-of-care tests for G6PD deficiency and their accessibility to populations in low-resource settings. The availability of simple, affordable, and accurate point-of-care diagnostics for the precise classification of the three G6PD phenotypes can reduce sex-linked disparities by ensuring safe and effective malaria treatment, providing opportunities to develop supportive counseling to enhance understanding of genetic test results, and improving the detection of all G6PD deficiency phenotypes in newborns and their family members.

Background: Pregnant and postpartum women in high HIV prevalent regions are at increased HIV risk. Oral pre-exposure prophylaxis (PrEP) can decrease HIV incidence reducing infant HIV infections. Understanding healthcare worker (HCW) beliefs about PrEP prior to national roll-out is critical to supporting PrEP scale-up. Methods: We conducted 45 semi-structured interviews among a range of HCW cadres with and without PrEP provision experience purposively recruited from four clinics in Kenya to compare their views on prescribing PrEP during pregnancy and postpartum. Interviews were analysed using a conventional content analysis approach to identify key influences on PrEP acceptability and feasibility. Results: All HCWs perceived PrEP as an acceptable and feasible HIV prevention strategy for pregnant and postpartum women. They believed PrEP meets women’s needs as an on-demand, female-controlled prevention strategy that empowers women to take control of their HIV risk. HCWs highlighted their role in PrEP delivery success while acknowledging how their knowledge gaps, concerns and perceived PrEP implementation challenges may hinder optimal PrEP delivery. Conclusion: HCWs supported PrEP provision to pregnant and postpartum women. However, counseling tools to address risk perceptions in this population and strategies to reduce HCW knowledge gaps, concerns and perceived implementation barriers are required.

Background Noncommunicable diseases including cancer are widespread amongst the 5.6 million Syrian refugees currently hosted in the Middle East. Given its prevalence as the third leading cause of death in Syria, cancer is likely to be an important health burden among Syrian refugees. Against this background, our aim was to describe the clinical, ethical and policy decision-making experiences of health actors working within the current refugee cancer care system; the impact of refugee cancer care health policies on health care providers and policy makers in this context; and provide suggestions for the way delivery of care should be optimised in a sustained emergency situation. Methods From April-July 2016, we conducted in-depth interviews with 12 purposively sampled health officials and health care workers from the Jordanian Ministry of Health, multilateral donors and international non-governmental organisations. Data were analysed using a framework analysis approach to identify systemic, practical and ethical challenges to optimising care for refugees, through author agreement on issues emerging from the data and those linked more directly to areas of questioning. Results As has been previously reported, central challenges for policy makers and health providers were the lack of quality cancer prevalence data to inform programming and care delivery for this refugee population, and insufficient health resource allocation to support services. In addition, limited access to international funding for the host country, the absence of long-term funding schemes, and barriers to coordination between institutions and frontline clinicians were seen as key barriers. In this context where economic priorities inevitably drive decision-making on public health policy and individual care provision, frontline healthcare workers and policy makers experienced significant moral distress where duties of care and humanitarian values were often impossible to uphold. Conclusions Our findings confirm and expand understanding of the challenges involved in resource allocation decisions for cancer care in refugee populations, and highlight these for the particular situation of long term Syrian refugees in Jordan. The insights offered by frontline clinicians and policy makers in this context reveal the unintended personal and moral impact of resource allocation decisions. With many countries facing similar challenges in the provision of cancer care for refugees, the lessons learned from Jordan suggest key areas for policy revision and international investment in developing cancer care policies for refugees internationally.

This study explored how multinational HIV experts weigh clinical, evidential, and ethical considerations regarding pre-exposure prophylaxis in pregnant/breastfeeding women. Semi-structured interviews were conducted with experts in HIV policy, research, treatment, and implementation from three global regions. A constant comparative approach identified major themes. Experts noted that exclusion of pregnant women from research limits evidence regarding risks/benefits, emphasizing that underinclusion of pregnant women in RCTs shifts the onus of evidence-building to clinical care. Experts discussed approaches for weighing evidence to make decisions, including triangulating evidence from sources other than RCTs. Likelihood and severity of disease strongly influenced decisions. Less effective interventions with limited fetal risk were preferred over interventions of uncertain safety, unless the disease was serious. Experts resisted the dichotomous choice between protecting maternal and fetal interests, arguing that these interests are intertwined and that more holistic approaches to maternal–fetal balance support greater inclusion of pregnant women in research. Electronic supplementary material The online version of this article (10.1007/s10461-018-2361-5) contains supplementary material, which is available to authorized users.

The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women’s access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women’s continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman’s decision; however, many reported that they deferred to their male partner’s opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner’s permission, while a few men believed participation was ultimately a woman’s decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women’s autonomy while accommodating partner engagement.

We conducted focus groups to assess patient attitudes towards research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency and partnership.

Should informed consent for participants in research that compares the effectiveness of standard medical practices include notification of the potential risks of those practices? This survey of 109...

We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership.

Optimal pediatric HIV disclosure impacts illness and developmental experiences while improving access to timely treatment. However, disclosure rates in high HIV prevalence countries remain low and there are limited data on best practices. We conducted a qualitative study of disclosure practices and interviewed healthcare providers from five pediatric HIV clinics in Kenya. We identified themes central to disclosure practices, rationale for approaches, barriers to implementing disclosure, and creative strategies to overcome challenges. We used these insights to develop a practice-based framework for disclosure that is sensitive to practical challenges. Overall, providers had limited training but extensive experience in disclosure, endorsed individualized disclosure practices, invested substantial time on disclosure despite clinical burden, and noted adverse outcomes associated with unplanned or abrupt disclosure. Providers advocated for an approach to disclosure that is child-centered but respects caregiver fears and values. Caregiver support was provided to enable caregivers to be the person who ultimately disclosed HIV status to children. Unplanned or abrupt disclosure to children was reported to have severe and persistent adverse impact and was a stimulus to accelerate disclosure in scenarios when providers believed children may be suspecting their diagnosis. Based on these expert insights, the framework we developed incorporates concurrent evaluation of child and caregiver readiness, identifies cues to prompt disclosure discussions, includes caregiver education and support, and utilizes a gradual approach of unveiling HIV diagnosis to the child.

Three recently diagnosed cases of caregiver-fabricated illness in a child at Seattle Children's Hospital shed light on a new manifestation of their caretakers' attention seeking. The patients' mothers were actively blogging about their children's reputed illnesses. Although it is not uncommon for parents of chronically ill children to blog about their child's medical course, specific themes in these blogs of parents suspected of medically abusing their children were noted. In particular, gross distortions of the information parents had received from medical providers were presented online, describing an escalation of the severity of their children's illnesses. The mothers reported contacting palliative care teams and Wish organizations, independently from their medical providers' recommendations. They sought on-line donations for their children's health needs. We believe these blogs provide additional direct evidence of the suspected caregivers' fabrications. Although we have not performed formal content analysis, blogs might also provide insight into the caretakers' motivations. Protective Services and/or police investigators could consider querying the internet for blogs related to children at risk for caregiver-fabricated illness in a child. These blogs, if viewed in parallel with the children's medical records, could assist medical diagnosis and legal documentation of medical fabrication and assist in protective planning for the affected children. Language: en

Background/aims: In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards’ interpretations and applications of research regulations align with patients’ values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices. Methods: We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. Results: A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. Conclusion: Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.

Background Orphans and vulnerable children (OVCs) represent a significant population worldwide, enduring poor health and living conditions. Evidence-based interventions are needed. However, without parents, ethical concerns about including OVCs in research persist. The aim of our study was to better understand the ethical challenges facing researchers who work with OVCs. Methods We conducted semi-structured interviews with 12 international pediatric researchers working with OVCs in seven countries. We used descriptive content analysis to characterize the ethical rationale for inclusion and associated challenges. Results Researchers believed research was justified as a necessary means for informing evidence-based interventions to benefit OVCs directly or as a population. Ethical challenges included difficulty identifying OVCs given variation among children living without parents; difficulty identifying guardians among a range of caregivers; concerns about meaningfulness of guardian consent; difficulty assessing risk; and responding to children's many needs. Conclusions A range of caregivers bear responsibility to protect OVC's interests in place of parents in research but are often not prepared to do so. This places greater burden on researchers to assess risks and respond to children's needs. Findings suggest that we should improve support and rethink the roles of guardians, researchers and older children in research participation and protection.

Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research.We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments.Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship.Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.

Patients who undergo bone marrow transplant (BMT) must adhere to a complex follow-up regimen. Nonadherence may lead to graft failure and death. Serious psychological disorders that interfere with the recovery process may be a contraindication to BMT. This issue’s “Ethics Rounds” raises issues about whether psychosocial issues should ever disqualify a child from receiving a transplant. Respondents are Maureen Kelley, PhD, a philosopher and bioethicist at the University of Washington School of Medicine and Seattle Children's Hospital; Yoram Unguru, MD, MS, MA, a pediatric hematologist/oncologist and bioethicist at the Herman & Walter Samuelson Children's Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics; and G. Douglas Myers, MD, a hematopoietic stem cell transplant (HSCT) physician at Children's Mercy Hospital. ### Case Presentation B.K. is an 8-year-old boy with relapsed acute myelogenous leukemia (AML) and multiple social and psychiatric problems. B.K. has been a ward of the state since 3 years of age when his single mother lost parental rights due to substance abuse. The father is not known. B.K. has been in and out of 3 foster homes, including a medical group home during his first treatment of AML at age 5 years. He was diagnosed by a psychiatrist as having attachment disorder. He is currently in the inpatient psychiatry unit given behavioral difficulties exhibited when on the oncology ward, including aggression and temper fits. B.K. is very intelligent and often asks direct questions about his illness. He has become very close to 1 of the psychiatry nurses, who has considered offering temporary medical foster care for B.K. He has no relatives other than his mother. A court-appointed guardian ad litem and a state case worker are charged with making medical decisions on his behalf. They report that there is no immediate prospect for foster placement for B.K. given his medical and … Address correspondence to John D. Lantos, MD, Children’s Mercy Hospital, 2401 Gillham Rd, Kansas City, MO 64105. E-mail: jlantos{at}cmh.edu

The speed and effectiveness of current approaches to research translation are widely viewed as disappointing given small gains in real population health outcomes despite huge investments in basic and translational science. We identify critical value questions—ethical, social, economic, and cultural—that arise at moments throughout the research pathway. By making these questions visible, and promoting discussion of them with diverse stakeholders, we can facilitate handoffs along the translational pathway and increase uptake of effective interventions. Who is involved with those discussions will determine which research projects, populations, and methods get prioritized. We argue that some upfront investment in community and interdisciplinary engagement, shaped by familiar questions in ethics, social justice, and cultural knowledge, can save time and resources in the long run because interventions and strategies will be aimed in the right direction, that is, toward health improvements for all. Clin Trans Sci 2012; Volume 5: 445–451

Minority pediatric populations have higher rates of emergency medical services use than the general pediatric population, and prior studies have documented that limited-English proficiency patients are more likely to undergo invasive procedures, require more resources, and be admitted once they arrive in the emergency department. Furthermore, limited-English proficiency patients may be particularly vulnerable because of immigration or political concerns. In this case report, we describe an infant with breath-holding spells for whom a language barrier in the prehospital setting resulted in an escalation of care to the highest level of trauma team activation. This infant underwent unnecessary, costly, and harmful interventions because of a lack of interpreter services. In a discussion of the legal, ethical, and medical implications of this case, we conclude that further investigation into prehospital strategies for overcoming language barriers is required to provide optimal prehospital care for pediatric patients.

The debate over how to best guide HIV-infected mothers in resource-poor settings on infant feeding is more than two decades old. Globally, breastfeeding is responsible for approximately 300,000 HIV infections per year, while at the same time, UNICEF estimates that not breastfeeding (formula feeding with contaminated water) is responsible for 1.5 million child deaths per year. The largest burden of these infections and deaths occur in Sub-Saharan Africa. Using this region as an example of the burden faced more generally in other resource-poor settings, we contrast the evolution of the clinical standard of care for infant feeding with HIV-infected mothers in high-income countries to the current international clinical guidelines for HIV-infected mothers and infant feeding in resource-poor settings. While the international guidelines of exclusive breastfeeding for a 6-month period seem to offer the least-worst strategy for reducing mother-to-child transmission of HIV during infancy while conferring some immunity through breastfeeding post-6 months, we argue that the impact of the policy on mothers and healthcare workers on the ground is not well understood. The harm reduction approach on the level of health policy translates into a complicated, painful moral dilemma for HIV-positive mothers and those offering them guidance on infant feeding. We argue that the underlying socio-economic disparities that continue to fuel the need for a harm reduction policy on infant feeding and the harm to women and children justify: (1) that higher priority be given to solving the infant feeding dilemma with improved data on safe feeding alternatives, and (2) support of innovative, community-driven solutions that address the particular economic and cultural challenges that continue to result in HIV-transmission to children within these communities.

The medical profession and medical ethics currently place a greater emphasis on physician responsibility than patient responsibility. This imbalance is not due to accident or a mistake but, rather is motivated by strong moral reasons. As we debate the nature and extent of patient responsibility it is important to keep in mind the reasons for giving a relatively minimal role to patient responsibility in medical ethics. It is argued that the medical profession ought to be characterized by two moral asymmetries: (1) Even if some degree of responsible behavior from patients is called for, placing the dominant emphasis on professional responsibility over patient responsibility is largely correct. The value of protecting the right to refuse treatment and arguments against paternalism block a more expansive account of patient responsibility and support a strong notion of professional responsibility. (2) Insofar as we do want to encourage an increase in patient responsibility, we have good reasons to emphasize prospective rather than retrospective notions of responsibility in clinical practice. Concerns about patient vulnerability along with the determined factors in disease leave little room for blame at the bedside. These two asymmetries generate normative limits on any positive account of patient responsibility.

Most of professional ethics is grounded on the assumption that we can speak meaningfully about particular, insulated professions with aims and goals, that conceptually there exists a clear "inside and outside" to any given profession. Professional ethics has also inherited the two-part assumption from mainstream moral philosophy that we can speak meaningfully about agent-relative versus agent-neutral moral perspectives, and further, that it is only from the agent-neutral perspective that we can truly evaluate our professional moral aims, rules, and practices. Several important changes that have occurred, or are currently taking place, in the structure of the health care professions, challenge those assumptions and signal the need for teachers of professional ethics to rethink the content of what we teach as well as our teaching methods. The changes include: influences and critique from other professions and from those who are served by the health professions, and influences and critique from professionals themselves, including increased activism and dissent from within the professions. The discussion focuses on changes that have occurred in the health-related fields, but insofar as similar changes are occurring in other professions such as law and business, these arguments will have broader conceptual implications for the way we ought to think about professional ethics more generally.

In the target article, McGuire and colleagues (2009) found that 54% of social networkers would consider using direct-to-consumer personal genome testing (DTC PGT) for their child and that 63% agreed that parents should be able to have their children tested with DTC PGT (McGuire et al. 2009). These results suggest that the use of DTC PGT may significantly broaden the scope of pediatric genetic testing. Currently, some DTC PGT companies seem to simultaneously promote and discourage use of their services for children. For example, 23andMe suggests on its website that, its services are not “designed or intended to attract children under the age of 13” (23andMe 2009a), yet suggests that consumers can, “Add some excitement to your family reunion by comparing the DNA of children with other relatives” (23andMe 2009b). What are the ethical considerations of DTC PGT in children and how should they be addressed? Genetic testing in children is not a new challenge. Guidelines by the American Society of Human Genetics/American College of Medical Genetics (1995) and by the American Academy of Pediatrics (2001) address the use of genetic tests in children. These guidelines are based on a medical model of genetic testing that presumes the involvement of a clinician who has certain obligations to parents and children. The clinician acts as a gatekeeper, informing decisions about risk and benefit and determining whether testing is appropriate. The guidelines acknowledge that the risk-benefit ratio of much genetic information is unclear, and that in the absence of information, providers “may be obligated to avoid the possibility of harm, rather than to provide unclear benefits” (American Society of Human Genetics 1995, 1238). In contrast, the direct-to-consumer model, by definition, bypasses the medical gatekeeper and their guidance. As consumers of DTC PGT services, parents may not prioritize consideration of medical benefit to their children in the same way as parents of patients. Users of DTC PGT may include families who are not likely or able to obtain genetic testing under the traditional medical model, including families not at risk for any rare genetic diseases. For these reasons, in a DTC PGT model, considerations of medical benefit may be either absent or minimal. Outside a medical model of benefit, the key question becomes: what harms are associated with DTC PGT in children and do they differ from harms associated with medical genetic testing in children? Wilfond and Ross (2008) have suggested that genetic testing in children should be guided by parental-decision making “unless empirical social and behavioral data indicate that genetic testing is highly likely to cause serious harms to children” (1). Unfortunately, there are no empirical data on the harms of DTC PGT in children, including whether they differ from harms in a medical delivery model or whether they differ across populations and reasons for obtaining the service. Because DTC PGT shifts genetic testing from a physician-parent relationship to an institution-consumer relationship, it may be unclear who is responsible for minimizing harms. While the DTC PGT companies act as providers of the service, they do not assume the same kinds of obligations as a medical provider. Assent of the child is not required, and there appears to be no provision of information about the possible risks of genetic information to children or consideration of risk-benefit ratios. Furthermore, the scope of obligation to provide benefit is as yet unclear. We will illustrate some of the concerns raised by DTC PGT in children through two scenarios, using the services offered by 23andme as an example. These scenarios demonstrate the challenges in applying current guidelines on genetic testing in children and suggest the need to develop guidelines specific to the DTC PGT arena.

We face significant challenges in the translation of basic biomedical research into meaningful improvements in patients' health, moving research from “bench to bedside.” The federal government's ne...

In this chapter we will offer a way of framing the ethical balance of competing considerations in pain treatment in infants and children, distinguishing between analyses of harms and benefits, from other more pragmatic, contextual, and cultural considerations. We begin with the ethical foundations behind good pain management for any patient, and especially children: the ethical duty to prevent harm by alleviating pain or suffering, and the importance of assuring equal access to pain treatment. Historically, the driving ethical concern in paediatric pain has been the pervasive undertreatment of pain in children. In the second and main section of the chapter, we offer a detailed analysis of the practical ethical challenges involved in weighing the harms and benefits of pain relief against untreated or undertreated pain. In the third section, we will discuss the more specific concerns of socioeconomic and cultural determinants to paediatric pain treatment. Finally, in the last section, we will address concerns in conducting research on pain interventions in infants and children, as clearly many of the modal methodologies traditionally used for clinical trials in adults (e.g. placebo control designs) pose unjustifiable risk to younger individuals. We will also discuss the importance of considering local context as it impacts standards of care to guide ethical paediatric pain research.

Safeguards against dual-use risk need to be developed without unduly restricting infectious disease research aimed at the public good. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Background In the United States, an estimated 70 stillbirths occur each day, on average 25,000 each year. Research into the prevalence and causes of stillbirth is ongoing, but meanwhile, many parents suffer this devastating loss, largely in silence, due to persistent stigma and taboo; and many health providers report feeling ill equipped to support grieving parents. Interventions to address bereavement after neonatal death are increasingly common in U.S. hospitals, and there is growing data on the nature of parent bereavement after a stillbirth. However, further research is needed to evaluate supportive interventions and to investigate the parent-clinician encounter during hospitalization following a stillbirth. Qualitative inquiry offers opportunities to better understand the lived experience of parents against the backdrop of clinicians’ beliefs, intentions, and well-meaning efforts to support grieving parents. Methods We present a secondary qualitative analysis of transcript data from 3 semi-structured focus groups conducted with parents who had experienced a stillbirth and delivered in a hospital, and 2 focus groups with obstetrician-gynecologists. Participants were drawn from the greater Seattle region in Washington State. We examine parents’ and physicians’ experiences and beliefs surrounding stillbirth during the clinical encounter using iterative discourse analysis. Results Women reported that the cheery, bustling environment of the labor and delivery setting was a painful place for parents who had had a stillbirth, and that the well-meaning attempts of physicians to offer comfort often had the opposite effect. Parents also reported that their grief is deeply felt but not socially recognized. While physicians recognized patients’ grief, they did not grasp its depth or duration. Physicians viewed stillbirth as an unexpected clinical tragedy, though several considered stillbirth less traumatic than the death of a neonate. In the months and years following a stillbirth, these parents continue to memorialize their children as part of their family. Conclusions Hospitals need to examine the physical environment for deliveries and, wherever possible, offer designated private areas with staff trained in stillbirth care. Training programs in obstetrics need to better address the bereavement needs of parents following a stillbirth, and research is needed to evaluate effective bereavement interventions, accounting for cultural variation. Critical improvements are also needed for mental health support beyond hospitalization. Finally, medical professionals and parents can play an important role in reversing the stigma that surrounds stillbirth.

Biodefence, broadly understood as efforts to prevent or mitigate the damage of a bioterrorist attack, raises a number of ethical issues, from the allocation of scarce biomedical research and public health funds, to the use of coercion in quarantine and other containment measures in the event of an outbreak. In response to the US bioterrorist attacks following September 11, significant US policy decisions were made to spur scientific enquiry in the name of biodefence. These decisions led to a number of critical institutional changes within the US federal government agencies governing scientific research. Subsequent science policy discussions have focused largely on ‘the dual use problem’: how to preserve the openness of scientific research while preventing research undertaken for the prevention or mitigation of biological threats from third parties. We join others in shifting the ethical debate over biodefence away from a simple framing of the problem as one of dual use, by demonstrating how a dual use framing distorts the debate about bioterrorism and truncates discussion of the moral issues. We offer an alternative framing rooted in social epistemology and institutional design theory, arguing that the ethical and policy debates regarding ‘dual use’ biomedical research ought to be reframed as a larger optimisation problem across a plurality of values including, among others: (1) the production of scientific knowledge; (2) the protection of human and animal subjects; (3) the promotion and protection of public health (national and global); (4) freedom of scientific enquiry; and (5) the constraint of government power.

Preterm birth is the leading cause of neonatal mortality and perinatal morbidity. The etiology of preterm is multi-factorial and still unclear. As evidence increases for a genetic contribution to PTB, so does the need to explore genomics, transcriptomics, proteomics and metabolomics in its study. This review suggests research guidelines for the conduct of high throughput systems biology investigations into preterm birth with the expectation that this will facilitate the sharing of samples and data internationally through consortia, generating the power needed to study preterm birth using integrated "-omics" technologies. The issues to be addressed include: (1) integrated "-omics" approaches, (2) phenotyping, (3) sample collection, (4) data management-integrative databases, (5) international consortia and (6) translational feasibility. This manuscript is the product of discussions initiated by the "-Omics" Working Group at the Preterm Birth International Collaborative Meeting held at the World Health Organization, Geneva, Switzerland in April 2009.

Stillbirths are largely excluded from international measures of mortality and morbidity. Zeshan Qureshi and colleagues argue that stillbirth should be higher on the global health agenda.