Layered vulnerability and researchers' responsibilities: learning from research involving Kenyan adolescents living with perinatal HIV infection.

BACKGROUND: Carefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/AIDS, without increasing burdens. Such studies, however, must navigate a 'vulnerability paradox', since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/AIDS (ALH) in Kenya, we develop an account of researchers' responsibilities towards young people, incorporating concepts of vulnerability, resilience, and agency as 'interacting layers'. METHODS: Using a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders' perspectives on vulnerability and resilience of young people living with HIV/AIDS, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna's layered account of vulnerability. RESULTS: ALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences. CONCLUSIONS: The most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers' responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities.

Respecting relational agency in the context of vulnerability: What can research ethics learn from the social sciences?

Despite advances in theory, often driven by feminist ethicists, research ethics struggles in practice to adequately account for and respond to the agency and autonomy of people considered vulnerable in the research context. We argue that shifts within feminist research ethics scholarship to better characterise and respond to autonomy and agency can be bolstered by further grounding in discourses from the social sciences, in work that confirms the complex nature of human agency in contexts of structural and other sources of vulnerability. We discuss some of the core concepts and critiques emerging from the literature on women and children's agency in under-resourced settings, highlighting calls to move from individualistic to relational models of agency, and to recognise the ambiguous, value-laden, and heterogeneous nature of the concept. We then draw out what these conceptual shifts might mean for research ethics obligations and guidance, illustrating our analysis using a case vignette based on research ethics work conducted in South Africa. We conclude that if research practices are to be supportive of agency, it will be crucial to scrutinise the moral judgements which underpin accounts of agency, derive more situated definitions of and responses to agency, and enable people and participants to influence these based on their own experiences and self-perceptions.

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study.

BACKGROUND: Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research. METHOD: We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted. RESULTS: Our analysis identified four interrelated themes surrounding participants' ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations. CONCLUSIONS: Participant's agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.

Grandparent caregiving in Cambodian skip-generation households: Roles and impact on child nutrition.

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.

Vulnerability and agency across treatment-seeking journeys for acutely ill children: how family members navigate complex healthcare before, during and after hospitalisation in a rural Kenyan setting.

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.

Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women.

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.

Evaluation of the impact of the ARC program on national nursing and midwifery regulations, leadership, and organizational capacity in East, Central, and Southern Africa.

BACKGROUND: The African Health Professions Regulatory Collaborative (ARC) was launched in 2011 to support countries in East, Central, and Southern Africa to safely and sustainably expand HIV service delivery by nurses and midwives. While the World Health Organization recommended nurse initiated and managed antiretroviral therapy, many countries in this region had not updated their national regulations to ensure nurses and midwives were authorized and trained to provide essential HIV services. For four years, ARC awarded annual grants, convened regional meetings, and provided technical assistance to country teams of nursing and midwifery leaders to improve national regulations related to safe HIV service delivery. We examined the impact of the program on national regulations and the leadership and organizational capacity of country teams. METHODS: Data was collected to quantify the level of participation in ARC by each country (number of grants received, number of regional meetings attended, and amount of technical assistance received). The level of participation was analyzed according to two primary outcome measures: 1) changes in national regulations and 2) improvements in leadership and organizational capacity of country teams. Changes in national regulations were defined as advancement of one "stage" on a capability maturity model; nursing and midwifery leadership and organizational capacity was measured by a group survey at the end of the program. RESULTS: Seventeen countries participated in ARC between 2012 and 2016. Thirty-three grants were awarded; the majority addressed continuing professional development (20; 61%) and scopes of practice (6; 18%). Fourteen countries (representing approximately two-thirds of grants) progressed at least one stage on the capability maturity model. There were significant increases in all five domains of leadership and organizational capacity (p < 0.01). The number of grants (Kendall's tau = 0.56, p = 0.02), duration of technical assistance (Kendall's tau = 0.50, p = 0.03), and number of learning sessions attended (Kendall's tau = 0.46, p = 0.04) were significantly associated with improvements in in-country collaboration between nursing and midwifery organizations. CONCLUSIONS: The ARC program improved national nursing regulations in participating countries and increased reported leadership, organizational capacity, and collaboration among national nursing and midwifery organizations. These changes help ensure national policies and professional regulations underpin nurse initiated and managed treatment for people living with HIV.

Cross-sectional description of nursing and midwifery pre-service education accreditation in east, central, and southern Africa in 2013.

BACKGROUND: In 2013, the World Health Organization issued guidelines, Transforming and Scaling Up Health Professional Education and Training, to improve the quality and relevance of health professional pre-service education. Central to these guidelines was establishing and strengthening education accreditation systems. To establish what current accreditation systems were for nursing and midwifery education and highlight areas for strengthening these systems, a study was undertaken to document the pre-service accreditation policies, approaches, and practices in 16 African countries relative to the 2013 WHO guidelines. METHODS: This study utilized a cross-sectional group survey with a standardized questionnaire administered to a convenience sample of approximately 70 nursing and midwifery leaders from 16 countries in east, central, and southern Africa. Each national delegation completed one survey together, representing the responses for their country. RESULTS: Almost all countries in this study (15; 94%) mandated pre-service nursing education accreditation However, there was wide variation in who was responsible for accrediting programs. The percent of active programs accredited decreased by program level from 80% for doctorate programs to 62% for masters nursing to 50% for degree nursing to 35% for diploma nursing programs. The majority of countries indicated that accreditation processes were transparent (i.e., included stakeholder engagement (81%), self-assessment (100%), evaluation feedback (94%), and public disclosure (63%)) and that the processes were evaluated on a routine basis (69%). Over half of the countries (nine; 56%) reported limited financial resources as a barrier to increasing accreditation activities, and seven countries (44%) noted limited materials and technical expertise. CONCLUSION: In line with the 2013 WHO guidelines, there was a strong legal mandate for nursing education accreditation as compared to the global average of 50%. Accreditation levels were low in the programs that produce the majority of the nurses in this region and were higher in public programs than non-public programs. WHO guidelines for transparency and routine review were met more so than standards-based and independent accreditation processes. The new global strategy, Workforce 2030, has renewed the focus on accreditation and provides an opportunity to strengthen pre-service accreditation and ensure the production of a qualified and relevant nursing workforce.

The role of male partners in women's participation in research during pregnancy: a case study from the partners demonstration project.

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.

A comparison of institutional review board professionals' and patients' views on consent for research on medical practices.

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.

Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.

BACKGROUND: The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. OBJECTIVE: To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. DESIGN: Cross-sectional survey conducted in August 2014. SETTING: Web-based questionnaire. PATIENTS: 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). MEASUREMENTS: Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. RESULTS: 97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). LIMITATION: Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. CONCLUSION: Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. PRIMARY FUNDING SOURCE: National Center for Advancing Translational Sciences at the National Institutes of Health.

Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making.

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.

Nursing and midwifery regulatory reform in east, central, and southern Africa: a survey of key stakeholders.

BACKGROUND: In sub-Saharan Africa, nurses and midwives provide expanded HIV services previously seen as the sole purview of physicians. Delegation of these functions often occurs informally by shifting or sharing of tasks and responsibilities. Normalizing these arrangements through regulatory and educational reform is crucial for the attainment of global health goals and the protection of practitioners and those whom they serve. Enacting appropriate changes in both regulation and education requires engagement of national regulatory bodies, but also key stakeholders such as government chief nursing officers (CNO), professional associations, and educators. The purpose of this research is to describe the perspectives and engagement of these stakeholders in advancing critical regulatory and educational reform in east, central, and southern Africa (ECSA). METHODS: We surveyed individuals from these three stakeholder groups with regard to task shifting and the challenges related to practice and education regulation reform. The survey used a convenience sample of nursing and midwifery leaders from countries in ECSA who convened on 28 February 2011, for a meeting of the African Health Profession Regulatory Collaborative. RESULTS: A total of 32 stakeholders from 13 ECSA countries participated in the survey. The majority (72%) reported task shifting is practiced in their countries; however only 57% reported their national regulations had been revised to incorporate additional professional roles and responsibilities. Stakeholders also reported different roles and levels of involvement with regard to nursing and midwifery regulation. The most frequently cited challenge impacting nursing and midwifery regulatory reform was the absence of capacity and resources needed to implement change. DISCUSSION: While guidelines on task shifting and recommendations on transforming health professional education exist, this study provides new evidence that countries in the ECSA region face obstacles to adapting their practice and education regulations accordingly. Stakeholders such as CNOs, nursing associations, and academicians have varied and complementary roles with regard to reforming professional practice and education regulation. CONCLUSION: This study provides information for effectively engaging leaders in regulatory reform by clarifying their roles, responsibilities, and activities regarding regulation overall as well as their specific perspectives on task shifting and pre-service reform.

Biodefence and the production of knowledge: rethinking the problem.

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.

Triage in the Tower of Babel: interpreter services for children in the prehospital setting.

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.

Vulnerability and agency in research participants' daily lives and the research encounter: A qualitative case study of participants taking part in scrub typhus research in northern Thailand.

BACKGROUND: Researchers have a responsibility to protect all participants, especially vulnerable participants, from harm. Vulnerability is increasingly understood to be context specific, yet limited guidance is available regarding the vulnerability and agency of research participants in different cultural settings. This study aims to explore research participants' daily vulnerability and agency, and how these interact with participants' research experiences in their own words. Researchers' views and responses were also explored. METHODS: A qualitative study was conducted around two scrub typhus research studies in northern Thailand. A thematic analysis was carried out on 42 semi-structured interviews with research participants, their families, researchers and key informants. RESULTS: The majority of the research participants belonged to a hill tribe ethnic minority group. Common challenges were related to Thai language barriers, travel difficulties, uncertain legal status, unstable employment, lack of education and healthcare. We did not identify new vulnerabilities but we found that the extent of these vulnerabilities might be underestimated or even hidden from researchers in some cases. Despite these challenges people demonstrated agency in their daily lives and were often motivated and supported in this by family members. The majority of perceived research benefits were related to healthcare and gaining knowledge, while attending follow-up visits could be a burden for some. CONCLUSIONS: Our approach to research in culturally and socioeconomically diverse settings should be more responsive to participants' specific vulnerabilities and abilities evidenced in their daily life, rather than attributing vulnerability on the basis of membership of pre-defined 'vulnerable groups'. Researchers need to be aware and responsive towards the challenges participants face locally in order to minimise the burdens of research participation whilst allowing participants to benefit from research.

A community developed conceptual model for reducing long-term health problems in children with intellectual disability in India.

Children with intellectual disability (ID) have a higher risk of long-term health problems in adulthood. India has the highest prevalence of ID of any country with 1.6 million under-five children living with the condition. Despite this, compared with other children, this neglected population is excluded from mainstream disease prevention and health promotion programmes. Our objective was to develop an evidence-based conceptual framework for a needs-based inclusive intervention to reduce the risk of communicable and non-communicable diseases among children with ID in India. From April through to July 2020 we undertook community engagement and involvement activities in ten States in India using a community-based participatory approach, guided by the bio-psycho-social model. We adapted the five steps recommended for the design and evaluation of a public participation process for the health sector. Seventy stakeholders from ten States contributed to the project: 44 parents and 26 professionals who work with people with ID. We mapped the outputs from two rounds of stakeholder consultations with evidence from systematic reviews to develop a conceptual framework that underpins an approach to develop a cross-sectoral family-centred needs-based inclusive intervention to improve health outcomes for children with ID. A working Theory of Change model delineates a pathway that reflected the priorities of the target population. We discussed the models during a third round of consultations to identify limitations, relevance of the concepts, structural and social barriers that could influence acceptability and adherence, success criteria, and integration with existing health system and service delivery. There are currently no health promotion programmes focusing on children with ID in India despite the population being at a higher risk of developing comorbid health problems. Therefore, an urgent next step is to test the conceptual model to determine acceptance and effectiveness within the context of socio-economic challenges faced by the children and their families in the country.

Culturally responsive research ethics: How the socio-ethical norms of Arr-nar/Kreng-jai inform research participation at the Thai-Myanmar border.

Despite advances, international research ethics guidelines still tend to consist of high-level ethical principles reflecting residual influence from North American and European traditions of ethics. Local ethics committees and community advisory boards can offer more culturally-sensitive approaches to training but most institutions lack substantive practical ethics guidance to engage rich moral understandings in day-to-day research practice in diverse cultural contexts. To address this gap, we conducted an international series of qualitative research ethics case studies, linked prospectively to active research programs in diverse settings. Here, we share findings from two case studies with a research team working on malaria and hepatitis B prevention with pregnant women in clinics serving migrants along the Thai-Myanmar border. In this sociocultural ethical analysis, we consider how core ethical requirements of voluntary participation, provision of fair benefits, and understandings of research risks and burdens are shaped, enriched, and in some instances challenged, by deep-seated and widespread Burmese, Karen and Thai cultural norms known as Arr-nar (in Burmese and Karen) or Kreng-jai (in Thai), encompassing multiple meanings including consideration for others and graciousness. We offer a model illustrating how one might map ethically significant sociocultural influences across the research practice pathway and close with lessons for developing a more culturally responsive research ethics practice in other international settings.

Transition from hospital to home care for preterm babies: A qualitative study of the experiences of caregivers in Uganda.

Improving care for preterm babies could significantly increase child survival in low-and middle income countries. However, attention has mainly focused on facility-based care with little emphasis on transition from hospital to home after discharge. Our aim was to understand the experiences of the transition process among caregivers of preterm infants in Uganda in order to improve support systems. A qualitative study among caregivers of preterm infants in Iganga and Jinja districts in eastern Uganda was conducted in June 2019 through February 2020, involving seven focus group discussions and five in-depth interviews. We used thematic-content analysis to identify emergent themes related to the transition process. We included 56 caregivers, mainly mothers and fathers, from a range of socio-demographic backgrounds. Four themes emerged: caregivers' experiences through the transition process from preparation in the hospital to providing care at home; appropriate communication; unmet information needs; and managing community expectations and perceptions. In addition, caregivers' views on 'peer-support' was explored. Caregivers' experiences, and their confidence and ability to provide care were related to preparation in the hospital after birth and until discharge, the information they received and the manner in which healthcare providers communicated. Healthcare workers were a trusted source of information while in the hospital, but there was no continuity of care after discharge which increased their fears and worries about the survival of their infant. They often felt confused, anxious and discouraged by the negative perceptions and expectations from the community. Fathers felt left-out as there was very little communication between them and the healthcare providers. Peer-support could enable a smooth transition from hospital to home care. Interventions to advance preterm care beyond the health facility through a well-supported transition from facility to home care are urgently required to improve health and survival of preterm infants in Uganda and other similar settings.