BMC Medical Ethics

Poverty and social deprivation have adverse effects on health outcomes and place a significant burden on healthcare systems. There are some actions that can be taken to tackle them from within healthcare institutions, but clinicians who seek to make frontline services more responsive to the social determinants of health and the social context of people’s lives can face a range of ethical challenges. We summarise and consider a case in which clinicians introduced a poverty screening initiative (PSI) into paediatric practice using the discourse and methodology of healthcare quality improvement (QI). Whilst suggesting that interventions like the PSI are a potentially valuable extension of clinical roles, which take advantage of the unique affordances of clinical settings, we argue that there is a tendency for such settings to continuously reproduce a narrower set of norms. We illustrate how the framing of an initiative as QI can help legitimate and secure funding for practical efforts to help address social ends from within clinical service, but also how it can constrain and disguise the value of this work. A combination of methodological emphases within QI and managerialism within healthcare institutions leads to the prioritisation, often implicitly, of a limited set of aims and governing values for healthcare. This can act as an obstacle to a genuine broadening of the clinical agenda, reinforcing norms of clinical practice that effectively push poverty ‘off limits.’ We set out the ethical dilemmas facing clinicians who seek to navigate this landscape in order to address poverty and the social determinants of health. We suggest that reclaiming QI as a more deliberative tool that is sensitive to these ethical dilemmas can enable managers, clinicians and patients to pursue health-related values and ends, broadly conceived, as part of an expansive range of social and personal goods.

Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment (REA) to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial. This REA was conducted in two purposively selected Woredas/Districts and Worabe Town administration of Silti Zone. Data were collected using in-depth interviews and focus group discussions. Purposive and convenient sampling techniques were used to select respondents. Five in-depth interviews and 15 Focus Group Discussions were conducted in the Amharic language. The collected data was transcribed, translated, and analyzed using a thematic approach. Most of the community members never heard about research and therapeutic misconception was common. In the area, the permission of people working in the formal and informal community administration is essential before approaching individuals. The male head of the household should also be involved in the decision before individual household members participate in research. Furthermore, sensitizing the community using public and religious gatherings was suggested before individual recruitment. In the consent process, delivering selected information particularly the purpose and benefits of the research was emphasized and the tendency of preferring verbal consent was documented despite the willingness of the individuals to sign on the consent form. Local health workers were identified as appropriate personnel to communicate information and the procedures of the research were found to be acceptable. However, the value of small incentives was suggested to motivate potential participants. Finally, involving all concerned stakeholders and respecting the cultural norm of the community was emphasized. Through REA, we understand the research awareness of the community, their expectation, and the cultural norms relevant to the ethical conduct of research. It enabled us to devise culturally sensitive and scientifically sound strategies to secure authentic informed consent. The process of conducting REA was found to be feasible, quick, and efficient.

When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT’s through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk (as they are already dying). Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy.

The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.

In gender-affirming medical care (GAMC), ethical challenges in decision-making are ubiquitous. These challenges are becoming more pressing due to exponentially increasing referrals, politico-legal contestation, and divergent normative views regarding decisional roles and models. Little is known, however, about what ethical challenges related to decision-making healthcare professionals (HCPs) themselves face in their daily work in GAMC and how these relate to, for example, the subjective nature of Gender Incongruence (GI), the multidisciplinary character of GAMC and the role HCPs play in assessing GI and eligibility for interventions. Given the relevance and urgency of these questions, we conducted a qualitative study among HCPs providing GAMC to transgender adults in the Netherlands. In this qualitative research, we conducted 11 semi-structured interviews between May 2020 and February 2021 with HCPs (six mental health professionals, two HCPs in endocrinology, two in plastic surgery, and one in nursing) working in two distinct GAMC settings. We purposively sampled for professional background and years of experience in GAMC. We analyzed our interview data using thematic analysis. As some respondents were more inclined to speak about what should or ought to be done to arrive at good or right decision-making, we identified both ethical challenges and norms. Furthermore, in our analysis, we differentiated between respondents’ explicit and implicit ethical challenges and norms and ascertained the specific context in which these challenges emerged. Respondents’ ethical challenges and norms centered on (1) dividing and defining decisional roles and bounds, (2) negotiating decision-making in a (multidisciplinary) team, and (3) navigating various decision-making temporalities. These themes arose in the context of uncertainties regarding (1) GAMC’s guidelines, evidence, and outcomes, as well as (2) the boundaries and assessment of GI. This interview study provides detailed empirical insight into both the explicit and implicit ethical challenges that HCPs experience and their ethical norms regarding decision-making. It also describes how uncertainties and (implicit) normativities concerning GAMC and GI pre-structure the moral environment in which these challenges and norms manifest. We provide normative reflections and recommendations on handling these ethical challenges in a way that is sensitive to the context in which they arise.

In precision medicine biomarkers stratify patients into groups that are offered different treatments, but this may conflict with the principle of equal treatment. While some patient characteristics are seen as relevant for unequal treatment and others not, it is known that they all may influence treatment decisions. How biomarkers influence these decisions is not known, nor is their ethical relevance well discussed. We distributed an email survey designed to elicit treatment preferences from Norwegian doctors working with cancer patients. In a forced-choice conjoint analysis pairs of hypothetical patients were presented, and we calculated the average marginal component effect of seven individual patient characteristics, to estimate how each of them influence doctors’ priority-setting decisions. A positive biomarker status increased the probability of being allocated the new drug, while older age, severe comorbidity and reduced physical function reduced the probability. Importantly, sex, education level and smoking status had no significant influence on the decision. Biomarker status is perceived as relevant for priority setting decisions, alongside more well-known patient characteristics like age, physical function and comorbidity. Based on our results, we discuss a framework that can help clarify whether biomarker status should be seen as an ethically acceptable factor for providing unequal treatment to patients with the same disease.

Fetal alcohol spectrum disorders (FASD) is an umbrella term covering several conditions for which alcohol consumption during pregnancy is taken to play a causal role. The benefit of individuals being identified with a condition within FASD remains controversial. The objective of the present study was to identify ethical aspects and consequences of diagnostics, interventions, and family support in relation to FASD. Ethical aspects relating to diagnostics, interventions, and family support regarding FASD were compiled and discussed, drawing on a series of discussions with experts in the field, published literature, and medical ethicists. Several advantages and disadvantages in regards of obtaining a diagnosis or description of the condition were identified. For instance, it provides an explanation and potential preparedness for not yet encountered difficulties, which may play an essential role in acquiring much needed help and support from health care, school, and the social services. There are no interventions specifically evaluated for FASD conditions, but training programs and family support for conditions with symptoms overlapping with FASD, e.g. ADHD, autism, and intellectual disability, are likely to be relevant. Stigmatization, blame, and guilt are potential downsides. There might also be unfortunate prioritization if individuals with equal needs are treated differently depending on whether or not they meet the criteria for a specific condition. The value for the concerned individuals of obtaining a FASD-related description of their condition – for instance, in terms of wellbeing – is not established. Nor is it established that allocating resources based on whether individuals fulfil FASD-related criteria is justified, compared to allocations directed to the most prominent specific needs.

With the increased use of implanted medical devices follows a large number of explantations. Implants are removed for a wide range of reasons, including manufacturing defects, recovery making the device unnecessary, battery depletion, availability of new and better models, and patients asking for a removal. Explantation gives rise to a wide range of ethical issues, but the discussion of these problems is scattered over many clinical disciplines. Information from multiple clinical disciplines was synthesized and analysed in order to provide a comprehensive approach to the ethical issues involved in the explantation of medical implants. Discussions and recommendations are offered on pre-implantation information about a possible future explantation, risk–benefit assessments of explantation, elective explantations demanded by the patient, explantation of implants inserted for a clinical trial, patient registers, quality assurance, routines for investigating explanted implants, and demands on manufacturers to prioritize increased service time in battery-driven implants and to market fewer but more thoroughly tested models of implants. Special emphasis is given to the issue of control or ownership over implants, which underlies many of the ethical problems concerning explantation. It is proposed that just like transplants, implants that fulfil functions normally carried out by biological organs should be counted as supplemented body parts. This means that the patient has a strong and inalienable right to the implant, but upon explantation it loses that status.