Personal View: An ethicist’s thoughts on the Termination of Pregnancy Bill debate in Malawi

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Proposing the LEGS framework to complement the WHO building blocks for strengthening health systems: One needs a LEG to run an ethical, resilient system for implementing health rights

The aim of this paper is to present a new framework to design and run a responsive and resilient health system. It can be used by both private and public, profit and non-profit organizations in order to translate strategic goals of an organization into desirable and intended best practice, and results. This includes the health sector. The framework is based on the four pillars of leadership, ethics, governance and systems, hence called LEGS framework. It can complement the six World Health Organization building blocks that guide inputs to help a health system achieve the intended goals. Despite all the strengths of the World Health Organization building blocks for health systems strengthening, it is important to highlight a few challenges: Ethics is assumed but is not explicitly stated as part of any building block. Furthermore, the World Health Organization framework lacks the flexibility to accommodate other important factors which may differ in various settings and contexts. Hence, the World Health Organization building blocks are either difficult to apply or insufficient in certain contexts, especially in countries with rampant corruption, weak rule of law and systems. This paper explores areas to strengthen the existing framework so as to achieve the intended results efficiently in different contexts. The authors propose LEGS (Leadership, Ethics, Governance and Systems Framework). This framework is very flexible, simple to use, easy to remember, accommodates the existing six WHO building blocks and can better guide different health systems and actors to achieve intended goals by taking into consideration the contextual factors like deficits in moral capital, rule of law or socioeconomic determinants of health

Survival rights for children : what are the national and global barriers?

Most children die in low and middle-income countries as a result of structural injustice, and while it may not be possible to prove causality between economic policies and breaches of rights, it is possible to audit policy and practices through the lens of human rights. Child health advocates need to highlight the fact that technical interventions, in the absence of action on structural injustice, cannot address the fundamental causes of poor health. It could even be said that we collude in the fallacy that injustices can be solved with technical solutions. The determinants of health, water, food, shelter, primary education and health care are minimum core human rights, are the rights required for survival and today should be available to every child (and their families) in all countries. However, there are national and global limitations on the ability of countries to determine policy and generate the revenue required for core human rights. The authors conducted a review of the literature on the main leakages from government revenues in low and middle-income countries to identify obstacles to children enjoying their right to survival. Based on the review the authors suggest a framework for an upstream audit that can be carried out, country by country, to identify barriers in terms of policies and the generation, allocation and utilisation of revenues. This audit involves systematically screening the policies and practices of the main actors: national governments, high-income country partners, multinational enterprises, and international organisations, for possible influence on the realisation of human rights. Human rights advocates and child health associations could lead or commission an upstream audit on behalf of children in their countries in order to identify the fundamental causes and real remedies.Publisher PDFPeer reviewe

Operationalising a real-time research ethics approach: supporting ethical mindfulness in agriculture-nutrition-health research in Malawi

BACKGROUND: There have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of 'ethics in practice' by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel 'real-time research ethics approach' (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the 'Addressing Hidden Hunger with Agronomy'. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation. RESULTS: The RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants' 'lived research experience'. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants' (TPs) perspectives and experiences. CONCLUSIONS: The use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers 'ethical mindfulness' which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels

Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi

National policy-makers speak out: are researchers giving them what they need?

The objective of this empirical study was to understand the perspectives and attitudes of policy-makers towards the use and impact of research in the health sector in low- and middle-income countries. The study used data from 83 semi-structured, in-depth interviews conducted with purposively selected policy-makers at the national level in Argentina, Egypt, Iran, Malawi, Oman and Singapore. The interviews were structured around an interview guide developed based on existing literature and in consultation with all six country investigators. Transcripts were processed using a thematic-analysis approach. Policy-makers interviewed for this study were unequivocal in their support for health research and the high value they attribute to it. However, they stated that there were structural and informal barriers to research contributing to policy processes, to the contribution research makes to knowledge generally, and to the use of research in health decision-making specifically. Major findings regarding barriers to evidence-based policy-making included poor communication and dissemination, lack of technical capacity in policy processes, as well as the influence of the political context. Policy-makers had a variable understanding of economic analysis, equity and burden of disease measures, and were vague in terms of their use in national decisions. Policy-maker recommendations regarding strategies for facilitating the uptake of research into policy included improving the technical capacity of policy-makers, better packaging of research results, use of social networks, and establishment of fora and clearinghouse functions to help assist in evidence-based policy-makin

Strengthening ethical community engagement in contemporary Malawi.

Although community engagement is increasingly promoted in global health research to improve ethical research practice, there is sometimes a disconnect between the broader moral ambitions for community engagement in the literature and guidelines on the one hand and its rather narrower practical application in health research on the other. In practice, less attention is paid to engaging communities for the 'intrinsic' value of showing respect and ensuring inclusive participation of community partners in research design. Rather, more attention is paid to the use of community engagement for 'instrumental' purposes to improve community understanding of research and ensure successful study implementation. Against this backdrop, we reviewed the literature and engaged various research stakeholders at a workshop to discuss ways of strengthening ethical engagement of communities and to develop context-relevant guidelines for community engagement in health research in Malawi

Socio-demographic factors associated with early antenatal care visits among pregnant women in Malawi : 2004-2016

INTRODUCTION: In 2016, the WHO published recommendations increasing the number of recommended antenatal care (ANC) visits per pregnancy from four to eight. Prior to the implementation of this policy, coverage of four ANC visits has been suboptimal in many low-income settings. In this study we explore socio-demographic factors associated with early initiation of first ANC contact and attending at least four ANC visits ("ANC4+") in Malawi using the Malawi Demographic and Health Survey (MDHS) data collected between 2004 and 2016, prior to the implementation of new recommendations. METHODS: We combined data from the 2004-5, 2010 and 2015-16 MDHS using Stata version 16. Participants included all women surveyed between the ages of 15-49 who had given birth in the five years preceding the survey. We conducted weighted univariate, bivariate and multivariable logistic regression analysis of the effects of each of the predictor variables on the binary endpoint of the woman attending at least four ANC visits and having the first ANC attendance within or before the four months of pregnancy (ANC4+). To determine whether a factor was included in the model, the likelihood ratio test was used with a statistical significance of P< 0.05 as the threshold. RESULTS: We evaluated data collected in surveys in 2004/5, 2010 and 2015/6 from 26386 women who had given birth in the five years before being surveyed. The median gestational age, in months, at the time of presenting for the first ANC visit was 5 (inter quartile range: 4-6). The proportion of women initiating ANC4+ increased from 21.3% in 2004-5 to 38.8% in 2015-16. From multivariate analysis, there was increasing trend in ANC4+ from women aged 20-24 years (adjusted odds ratio (aOR) = 1.27, 95%CI:1.05-1.53, P = 0.01) to women aged 45-49 years (aOR = 1.91, 95%CI:1.18-3.09, P = 0.008) compared to those aged 15-19 years. Women from richest socio-economic position ((aOR = 1.32, 95%CI:1.12-1.58, P<0.001) were more likely to demonstrate ANC4+ than those from low socio-economic position. Additionally, women who had completed secondary (aOR = 1.24, 95%CI:1.02-1.51, P = 0.03) and tertiary (aOR = 2.64, 95%CI:1.65-4.22, P<0.001) education were more likely to report having ANC4+ than those with no formal education. Conversely increasing parity was associated with a reduction in likelihood of ANC4+ with women who had previously delivered 2-3 (aOR = 0.74, 95%CI:0.63-0.86, P<0.001), 4-5 (aOR = 0.65, 95%CI:0.53-0.80, P<0.001) or greater than 6 (aOR = 0.61, 95%CI: 0.47-0.79, <0.001) children being less likely to demonstrate ANC4+. CONCLUSION: The proportion of women reporting ANC4+ and of key ANC interventions in Malawi have increased significantly since 2004. However, we found that most women did not access the recommended number of ANC visits in Malawi, prior to the 2016 WHO policy change which may mean that women are less likely to undertake the 2016 WHO recommendation of 8 contacts per pregnancy. Additionally, our results highlighted significant variation in coverage according to key socio-demographic variables which should be considered when devising national strategies to ensure that all women access the appropriate frequency of ANC visits during their pregnancy

Assessing the potential of HTA to inform resource allocation decisions in low-income settings : The case of Malawi

Health technology assessment (HTA) offers a set of analytical tools to support health systems' decisions about resource allocation. Although there is increasing interest in these tools across the world, including in some middle-income countries, they remain rarely used in low-income countries (LICs). In general, the focus of HTA is narrow, mostly limited to assessments of efficacy and cost-effectiveness. However, the principles of HTA can be used to support a broader series of decisions regarding new health technologies. We examine the potential for this broad use of HTA in LICs, with a focus on Malawi. We develop a framework to classify the main decisions on health technologies within health systems. The framework covers decisions on identifying and prioritizing technologies for detailed assessment, deciding whether to adopt an intervention, assessing alternative investments for implementation and scale-up, and undertaking further research activities. We consider the relevance of the framework to policymakers in Malawi and we use two health technologies as examples to investigate the main barriers and enablers to the use of HTA methods. Although the scarcity of local data, expertise, and other resources could risk limiting the operationalisation of HTA in LICs, we argue that even in highly resource constrained health systems, such as in Malawi, the use of HTA to support a broad range of decisions is feasible and desirable

Potential impact of intervention strategies on COVID-19 transmission in Malawi : a mathematical modelling study

BACKGROUND: COVID-19 mitigation strategies have been challenging to implement in resource-limited settings due to the potential for widespread disruption to social and economic well-being. Here we predict the clinical severity of COVID-19 in Malawi, quantifying the potential impact of intervention strategies and increases in health system capacity. METHODS: The infection fatality ratios (IFR) were predicted by adjusting reported IFR for China, accounting for demography, the current prevalence of comorbidities and health system capacity. These estimates were input into an age-structured deterministic model, which simulated the epidemic trajectory with non-pharmaceutical interventions and increases in health system capacity. FINDINGS: The predicted population-level IFR in Malawi, adjusted for age and comorbidity prevalence, is lower than that estimated for China (0.26%, 95% uncertainty interval (UI) 0.12%-0.69%, compared with 0.60%, 95% CI 0.4% to 1.3% in China); however, the health system constraints increase the predicted IFR to 0.83%, 95% UI 0.49%-1.39%. The interventions implemented in January 2021 could potentially avert 54 400 deaths (95% UI 26 900-97 300) over the course of the epidemic compared with an unmitigated outbreak. Enhanced shielding of people aged ≥60 years could avert 40 200 further deaths (95% UI 25 300-69 700) and halve intensive care unit admissions at the peak of the outbreak. A novel therapeutic agent which reduces mortality by 0.65 and 0.8 for severe and critical cases, respectively, in combination with increasing hospital capacity, could reduce projected mortality to 2.5 deaths per 1000 population (95% UI 1.9-3.6). CONCLUSION: We find the interventions currently used in Malawi are unlikely to effectively prevent SARS-CoV-2 transmission but will have a significant impact on mortality. Increases in health system capacity and the introduction of novel therapeutics are likely to further reduce the projected numbers of deaths