Carleigh Krubiner

Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration

Given that health systems research (HSR) involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board (IRB) and research ethics committee (REC) review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies.

Public participation in decision-making on the coverage of new antivirals for hepatitis C

Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public participation activities may be re-conceptualized as processes that illuminate policy problems relevant to a particular context, thereby promoting an agenda-setting role for the public. Originality/value - The paper offers an empirical analysis of public involvement in the case of sofosbuvir, where the relevant considerations that bear on priority-setting decisions have been particularly stark. The perspectives that emerge suggest that public participation contributes to raising attention to issues that need to be addressed by policymakers. Public participation activities can thus contribute to setting policy agendas, even if that is not their explicit purpose. However, the actualization of this contribution is contingent on the receptiveness of policymakers.

Advancing HIV research with pregnant women: navigating challenges and opportunities.

Objective:Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods:We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results:Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusion:Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

Universal health coverage, priority setting, and the human right to health

As health policy-makers around the world seek to make progress towards universal health coverage they must navigate between two important ethical imperatives: to set national spending priorities fairly and efficiently; and to safeguard the right to health. These imperatives can conflict, leading some to conclude that rights-based approaches present a disruptive influence on health policy, hindering states’ efforts to set priorities fairly and efficiently. Here, we challenge this perception. We argue first that these points of tension stem largely from inadequate interpretations of the aims of priority setting as well as the right to health. We then discuss various ways in which the right to health complements traditional concerns of priority setting and vice versa. Finally, we set out a three-step process by which policy-makers may navigate the ethical and legal considerations at play.

Barriers to and Facilitators of Stocking Healthy Food Options: Viewpoints of Baltimore City Small Storeowners

ABSTRACT Receptivity to strategies to improve the food environment by increasing access to healthier foods in small food stores is underexplored. We conducted 20 in-depth interviews with small storeowners of different ethnic backgrounds as part of a small-store intervention trial. Store owners perceived barriers and facilitators to purchase, stock, and promote healthy foods. Barriers mentioned included customer preferences for higher fat and sweeter taste and for lower prices; lower wholesaler availability of healthy food; and customers’ lack of interest in health. Most store owners thought positively of taste tests, free samples, and communication interventions. However, they varied in terms of their expectations of the effect of these strategies on customers’ healthy food purchases. The findings reported add to the limited data on motivating and working with small-store owners in low-income urban settings.

A bioethical framework for health systems activity: a conceptual exploration applying ‘systems thinking’

Recognizing that the health system is a complex and dynamic network of actors and activities, this paper seeks to push the field of bioethics to develop a more holistic approach from the health systems perspective. Expanding upon the work of existing public health frameworks and drawing upon concepts from related areas such as governance, human rights, and organizational ethics, our provisional list of ethical considerations for health systems fall under the following categories: Holism, Sustainability, Evidence & Effectiveness, Efficiency, Public Engagement & Transparency, Accountability & Feedback, Equity & Empowerment, Justice & Fairness, Responsiveness, Collaboration, and Quality. By outlining these key domains, we hope to stimulate global discussion and further development of an ethics framework that will help guide ongoing work to strengthen health systems. This will be particularly important for low- and middle-income countries where resources are highly constrained and health systems efforts have scaled-up dramatically in the past decade.

Which strings attached: ethical considerations for selecting appropriate conditionalities in conditional cash transfer programmes

Conditional cash transfers (CCTs) present a promising approach to simultaneously tackle chronic poverty and poor health. While these programmes clearly embody beneficent aims, questions remain regarding the ethical design of CCTs. Limited guidance exists for the ethical evaluation of the defining feature of these programmes: the conditionalities. Drawing upon prominent public health ethics frameworks and social justice theories, this paper outlines five categories of morally relevant considerations that CCT programme designers should consider when assessing which behaviours or outcomes they select as conditionalities for payment: (1) likelihood of yielding desired health outcomes, (2) risks and burdens, (3) receptivity, (4) attainability and (5) indirect impacts and externalities. When evaluating potential conditionalities across these five categories of considerations, it is important to recognise that not all beneficiaries or subgroups of beneficiaries will fare equally on each. Given that most CCTs aim to reduce inequities and promote long-term health and prosperity for the most disadvantaged, it is critical to apply these considerations with due attention to how different segments of the beneficiary population will be differentially affected. Taken on balance, with due reflection on distributional effects, these five categories represent a comprehensive set of considerations for the moral analysis of specific conditionalities and will help ensure that CCT designers structure programmes in a way that is both morally sound and effective in achieving their goals.

Ethical challenges in designing and implementing health systems research: Experiences from the field

ABSTRACT Background: Health systems research (HSR) seeks to generate knowledge to improve the mechanisms for delivering quality health services and improving population health outcomes. HSR covers a wide range of research questions, including health financing, service delivery, human resources for health, and quality improvement. Because HSR has its own definitions, methods, and analytic approaches, there is an increasing realization that these studies may raise ethical concerns that differ from other types of research. Despite the increasing interest and investment in HSR over the past several years, there is little empirical research examining the kinds of ethical challenges that arise in the design and implementation of these studies. A deeper understanding of the kinds of ethical issues encountered in various types of HSR could help researchers prepare for these challenges and better inform ethical review processes. Methods: Using semistructured qualitative interviews with 16 researchers involved in the Future Health Systems Consortium and Johns Hopkins–Fogarty African Bioethics Consortium, we conducted an exploratory study to identify some common or poignant ethical challenges in HSR. Results: Thematic analysis of interview transcripts using an inductive approach revealed ethics issues in HSR surrounding the following topics: privacy and confidentiality, associated harms, appropriate consent, institutional review board (IRB) review, appropriate controls, research ownership and control, responsiveness, posttrial issues, sustainability, and collaboration and competition. Conclusions: Though not exhaustive, this preliminary account highlights the nuanced and unique ethical challenges that can arise in HSR and underscores the need for different kinds of ethical guidance and oversight for HSR studies.