The Ethics of Ethics Reviews in Global Health Research: Case Studies Applying a New Paradigm

With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs.We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies that researchers ought to consider. We present case studies in which Canadian health professional students conducted a health promotion project in a community in Honduras; a research capacity-building program in South Africa, in which Canadian students also worked alongside LMIC partners; and a community-university partnered research capacity-building program in which Ecuadorean graduate students, some working alongside Canadian students, conducted community-based health research projects in Ecuadorean communities.We examine each case, identifying ethical issues that emerged and how new ethical paradigms being promoted could be concretely applied.We conclude that research ethics boards should focus not only on protecting individual integrity and human dignity in health studies but also on beneficence and non-maleficence at the community level, explicitly considering social justice issues and local capacity-building imperatives.We conclude that researchers from HICs interested in global health research must work with LMIC partners to implement collaborative processes for assuring ethical research that respects local knowledge, cultural factors, the social determination of health, community participation and partnership, and making social accountability a paramount concern.

The Ethics of Ethics Reviews in Global Health Research: Case Studies Applying a New Paradigm

With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs.We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies that researchers ought to consider. We present case studies in which Canadian health professional students conducted a health promotion project in a community in Honduras; a research capacity-building program in South Africa, in which Canadian students also worked alongside LMIC partners; and a community-university partnered research capacity-building program in which Ecuadorean graduate students, some working alongside Canadian students, conducted community-based health research projects in Ecuadorean communities.We examine each case, identifying ethical issues that emerged and how new ethical paradigms being promoted could be concretely applied.We conclude that research ethics boards should focus not only on protecting individual integrity and human dignity in health studies but also on beneficence and non-maleficence at the community level, explicitly considering social justice issues and local capacity-building imperatives.We conclude that researchers from HICs interested in global health research must work with LMIC partners to implement collaborative processes for assuring ethical research that respects local knowledge, cultural factors, the social determination of health, community participation and partnership, and making social accountability a paramount concern.

Ethical Considerations of Dissemination and Restitution of Findings in Global Health Research

Étude de cas / Case study

Ethical issues of human genetic databases : a challenge to classical health research ethics?

[Contents] - Introduction - Selected existing genetic database : distinctive features, ethical problems and the public debate - The ethical debate : principles, values and interests : the ethical foundations of guidelines - Selected issues of consensus and of controversy - Ethical issues of human genetic databases and the future This book compares the new area of biobanking with the tradition of ethically accepted classical research and highlights the distinctive features of existing databases and guidelines

The role of NGOs in global health research for development

Affiliation: Hélène Delisle: Département de nutrition, Faculté de médecine, Université de Montréal

Nutrigenomics for Global Health: Ethical Challenges for Underserved Populations

Nutrigenomics covers disparate fields of nutrition science and has been defined in many different ways. In fact, this emerging field of science has multiple facets, many of which do not generate the same ethical issues. In particular, different ethical issues emerge concerning the extent to which nutrigenomics may actually improve global health, i.e., in terms of worldwide improvement of health, reduction of disparities, and protection against global threats that disregard national borders. Nutrigenomics raises many hopes and expectations on that score. However it remains unclear and controversial whether nutrigenomics studies and their actual or potential applications will actually benefit developing countries and their populations. Different forces may drive the choice of research priorities and shape the claims that are made when communicating the goals or the results of nutrigenomics studies and applications. This article proposes to assess expectations and claims in nutrigenomics, with respect to their respective potential impact on global health and the ethical issues they raise. Nutrigenomics is and should be more than premature claims and much debated promises about personalized nutritional interventions on individuals. Beyond questionable commercial claims, nutrigenomics is also knowledge about and recognition of the considerable impacts of underfeeding and malnutrition on the genome (and epigenome) integrity and stability. As such, nutrigenomics research is a valuable opportunity to revive and give strength to the debate about the unacceptable consequences of hunger and malnutrition worldwide, and to support a newly and potentially significant convergence in research priorities that could benefit both developed and developing countries.

The need for adequate ethical guidelines for qualitative health research

O artigo discute a adequação de aplicar a Resolução 196/961 do Conselho Nacional de Saúde - CNS, às pesquisas qualitativas em saúde, que se baseiam em paradigmas não positivistas. Nestas pesquisas, freqüentemente as decisões sobre a pesquisa são tomadas conjuntamente com a comunidade em estudo. Há a preocupação de favorecer a justiça e a mudança social. E, uma vez que a subjetividade pode ser considerada seu instrumento privilegiado, busca-se o balanço entre objetividade e subjetividade, e discute-se como superar a visão do pesquisador. Estudamos o âmbito de aplicação e a concepção de pesquisa presentes nas diretrizes éticas internacionais e brasileiras. Verificamos que elas adotam uma concepção positivista de pesquisa, que prevê: teste de hipótese, definição prévia de todos os procedimentos pelo pesquisador e neutralidade do pesquisador e do conhecimento produzido. Serão apresentadas algumas características das pesquisas qualitativas, as implicações éticas da maneira como a pesquisa qualitativa é concebida nos paradigmas não positivistas e um breve histórico dos documentos sobre ética em pesquisa. Concluímos que não é adequado analisar estas pesquisas com base nestes documentos e sugerimos a elaboração de diretrizes específicas

Free-trade agreements: challenges for global health

In this study new free-trade agreements are discussed, which are based on the breaking down of tariff and technical barriers and normally exclude most of the poorest countries in the world. Considering the current context of economic globalization and its health impacts, seven controversial points of these treaties and their possible implications for global public health are presented, mainly regarding health equity and other health determinants. Finally, this research proposes a greater social and health professionals participation in the formulation and discussion of these treaties, and a deeper insertion of Brazil in this important international agenda.

Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries

BACKGROUND: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries. METHODS AND FINDINGS: Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%-52.4%, I2 = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%-65.9%, I2 = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2-3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6-2.5). The probability of publication within two years after study completion ranged from 7% to 30%. CONCLUSIONS: A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.

IPH response to EU Commission consultation on EU role in global health

The European Commission launced a public consultation iin October 2009 on stakeholder views regarding the rationale, scope and strategic objectives for an EU role in global health. The Institute of Public Health in Ireland (IPH) aims to improve health on the island of Ireland by working to combat health inequalities and influence public policies in favour of health.  The Institute promotes cooperation between Northern Ireland and the Republic of Ireland in public health research, training and policy advice. IPH also contributes to a number of European networks and projects and is a member of the International Association of National Public Health Institutes (IANPHI). IPH welcomes the opportunity to respond to the European Commission consultation on the role of the EU in global health.

Research Ethics Committee Activity in Northern Ireland (PDF 23 KB)

Research Ethics Committee Activity in Northern Ireland

The Swiss regulatory framework for pædiatric health research

Medical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.

Variance in Bioethics Services: Challenges and Opportunities in Canada with a Focus on In-house vs. Outsourced Health Care Ethics Consultations

Étude de cas / Case study