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No closure in sight for the 10/90 health-research gap

Scholarly discussion around the governance of human genome editing (HGE) recognizes that development and application of HGE techniques could result in unexpected societal outcomes. However, it contains few to no methodological models for how to anticipate, prepare for, or shape such outcomes. This article presents early-stage results from research guided by anticipatory governance, a framework for broad expert and public consideration of innovation processes and purposes. We present and discuss key themes emerging from a set of future-oriented interviews with genome editing practitioners and experts, designed to inform broadly scoped deliberations about plausible futures of HGE. We articulate our results as seven “open questions,” the answers to which will be important components of HGE’s eventual shape and outcomes. Some themes are perennial in studies of science and society, and others are more novel to HGE. Each helps to reframe HGE beyond a simple comparison of risk and benefit. Such reframing opens up new and important terrain for discussion among policymakers, academics, scientists, and publics. We suggest that discussion framed around broad and reflexive questions like those presented here will help governance efforts to better acknowledge and flexibly respond to the uncertainty and complexities of HGE developments.

Global health actors use economic evaluations, including cost-effectiveness analyses, to estimate the effect of different interventions they might fund. However, producing reliable cost-effectiveness estimates is difficult, meaning organisations must often choose between funding interventions for which reliable predictions of efficacy exist and those for which they do not. In practice, many organisations appear to be risk-averse, favouring more certain interventions simply because they are more certain. We argue that this practice is not justifiable. Prioritising projects backed by greater evidence might often produce greater health benefits. However, a general tendency to prefer more certain interventions will cause global health actors to overlook opportunities to help less well-studied populations, support promising but complex interventions, address the upstream causes of illness, and conduct the most important impact evaluations. We argue that global health actors should instead adopt nuanced attitudes towards uncertainty and be willing to fund highly uncertain interventions in some cases. We further describe the considerations they should take into account in rendering these judgements.

Over the last few hundred years, best practice in some fields of human action—e.g. the treatment of heart disease, the transportation of persons, goods, and messages, and destruction of landscapes, structures, and lives—has become dramatically more effective. At the same time, best practice in other fields, e.g. the amelioration of poverty or the teaching of reading, writing, or math, has improved more slowly, if at all. As Richard Nelson and colleagues have argued, it seems that practice and technology (“know-how”) can only improve rapidly under rather special conditions: that, at any given point in time, some fields are more “progressible” than others. Drawing on Nelson's work and studies in the history, sociology, and economics of technology and innovation, I offer a conceptual framework articulating several characteristics of practice in a field that may facilitate rapid progress. These characteristics, while not fixed, tend to remain fairly stable for long periods of time. I argue that know-how can improve more quickly 1) when “vicarious trial” of variations in practice is feasible and useful; 2) when practice is formal and standardized; 3) when practice is in significant part performed by artifacts rather than by humans; 4) when outcomes of variations in practice may be rapidly evaluated; 5) when valued performance dimensions are consistently agreed upon; 6) when contexts and objects of practice may be treated as, or have been made, consistent for the purposes of intervention; and 7) when labor is finely divided. Thus, analysis of these features may inform judgments about the plausibility of rapid advance within a field, absent disruptive change in methods or problem formulation. The argument may also shed light on which varieties of innovative effort may and may not foreseeably contribute to improving practice in a given field.

This themed issue on global health research has come at an opportune time in the middle of the ongoing global public health crisis arising from the coronavirus disease (COVID-19) pandemic which has claimed nearly 756,000 lives in 210 countries and territories around the world as of August 15, 2020. The public health crisis underscores the importance of global health research partnerships and collaborations to develop and evaluate the requisite health technologies to assist in containing COVID-19, other diseases, and health-related concerns that defy national borders. The 17 Sustainable Development Goals (SDGs), adopted by the member countries of the United Nations in September 2015, provide a framework for global development efforts including global health research. SDG3, which promotes health and well-being for the world populations across the age spectrum, highlights disease areas for special focus which can be adapted in specific global health research programs to serve local health needs. SDG17 promotes partnerships between high income (HIC) and low and middle-income countries (LMIC) for sustainable and equitable global development. However, given the wide disparities in fiscal and overall capacity for research between researchers in HIC and their counterparts in LMIC as well as the greater vulnerabilities of the LMIC communities when serving as research locations, a spotlight on the nature of such global health research partnerships in the context of the SDGs is desirable. This is to ensure that they are meaningful and mutually-beneficial partnerships which address local health concerns and promote long-term value for the communities involved.

The objective of this commentary is, therefore, to provide a brief overview of the SDGs by way of context; explore the power differences at play when researchers from HIC are seeking research opportunities in LMIC; examine the social determinants of health and the disproportionate burden of global diseases carried by populations in LMIC to establish their vulnerability; discuss global research partnerships; and attempt to make a case for why community-based participatory research may be the preferred type of global health research partnership in the context of the SDGs.

The increasing conduct of clinical research in low- and middle-income countries (LMIC) is motivated by the desire to promote host country access to biomedical research, to enhance LMIC access to modern clinical care, and opportunities to conduct research with simpler regulatory requirements and at lower cost. Yet clinical research in LMIC is associated with ethical risks beyond those of clinical research conducted in high-income countries (HIC). Ethical challenges particular to clinical research in LMIC include the conduct of placebo-controlled clinical trials in LMIC despite HIC availability of effective comparator interventions, obtaining informed consent despite power inequities, and the obligation of HIC researchers to redress health disparities in LMIC. This chapter covers these and additional ethical challenges of clinical research in LMIC, and proposes ways to navigate these challenges through awareness, regulatory oversight, consultation, and collaboration with LMIC investigators and community representatives. With its ethical challenges properly managed, clinical research in LMIC provides historic opportunities to bring biomedical research and better healthcare infrastructure to countries previously left behind in the modern rush to biomedical innovation.