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. (shrink)

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. (shrink)

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. (shrink)

Next SectionBiodefence, 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. (shrink)

BackgroundCarefully 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’.MethodsUsing 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.ResultsALH 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.ConclusionsThe 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. (shrink)

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. (shrink)

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...

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.

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. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Invisible ChildrenMaureen KelleyИсчезаю в весне,в толпе,в лужах,в синеве.И не ищите.Мне так хорошо...I fade into spring,or into a crowd,or into a puddle,sometimes into the blue.There's no sense in looking for me.I feel fine...—¾"Absentee" by Arvo Mets"You have to go through Lesha to get to Danil," Alexandra told me. Lesha was a small but unmoving dog with matted hair and a fierce growl. The dog was pressed against the little (...) boy, who looked no more than three or four years old. Alexandra later told me he was eight. Danil was wearing a Spider Man shirt that was four sizes too big and came down to his feet and mismatched sandals. He was huddled against his dog not only for security but warmth. His tiny arm circled Lesha's neck and he looked at me with a mix of curiosity and caution. I knelt and put my hand out for Lesha to smell me. Apparently I didn't pass the smell test. The dog didn't budge from his post. We stood like that for a long time, at the base of the steps to the shelter. I tried the few Russian words I had learned while visiting as a volunteer. The dog didn't understand my broken Russian, or pretended not to, but I managed to get a shy smile from Danil.Alexandra, a nurse volunteer at the shelter, eventually mediated the standoff by giving Lesha, the dog, a cookie. I introduced myself to the little boy. And just like that, he leaned up against me and put both arms around my legs. It didn't matter that I was a stranger, and a stranger who spoke terrible Russian. "Spidey" was an affectionate little guy. He gripped my hand while Alexandra led us up the steps and Lesha followed close behind. Inside was a small room, warm and full of color. One wall was covered in kids' drawings. Another had public health posters in Russian, some with instructions for condom use, others on literacy. There were about fifteen kids in the shelter that afternoon. The young ones were drawing pictures at a low table. Two teenage boys were hunched over a small TV playing a video game. There was only one teenage girl, Irina. She was cooing at the little kid's drawings, showing one girl how to draw a princess. Alexandra said quietly to me, "Most of the teenage girls are only here in the morning. The rest are back at work right now." I found out later "back at work" meant on the streets as sex workers. This city was frequented by businessmen and itinerant workers heading to the factories or lumber mills in the North. The best money for homeless girls was in prostitution. Danil unwrapped himself from me and ran over to the two older boys playing video games. One put his controller down long enough to pull Danil into his lap. The three boys stared intently as Super Mario hopped from mushroom to magic cloud, golden coins spinning above his cartoon head.To the right of the main room was a closet-sized office for the shelter director, Anya, a pediatrician who donated her time to running the shelter for homeless and orphaned youth living on the streets. Alexandra and I stood in the doorway waiting for Anya to finish a phone conversation. Her desk was covered in papers. Behind her were photos of the kids who had "graduated" from the streets. There were cards and letters pinned to a cork board. When [End Page E4] she finished, Anya greeted us with bear hugs and showed us to the clinic area. Next to her office was a small bathroom with a shower and tub. She explained that bath days were on Wednesdays. Around back, with a separate entrance was the small clinic space. The outside metal door had a sliding window that you see at some nightclubs. They ran a needle exchange program out of that door. It was funded for street youth, but from time to time they would get adult addicts. Anya was adamant that this side of the clinic remain separate from the central space for the children. In reality the distance... (shrink)

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. (shrink)

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% agree...