Genetic Control in Historical Perspective: The Legacy of India's Genetic Control of Mosquitoes Unit.

In the early 1970s, a World Health Organization-initiated and United States-funded project released lab-reared mosquitoes outside New Delhi in the first large-scale field trials of the genetic control of mosquitoes. Despite partnering with the Indian Council of Medical Research and investing significantly in outreach to local communities at the release sites, the project was embroiled in controversy and became an object of vehement debate within the Indian parliament and diplomatic contretemps between the United States and India. This early episode of genetic control research demonstrates how a scientific collaboration was entangled in geopolitics and shaped by the legacy of colonialism. This historical case study has implications for public deliberation in the present, pointing to the challenges of shared decision-making in the context of structural inequality, the way that a backdrop of military interest in a technology can impede trust, and the long-term consequences of projects that foster mistrust.

The global forum on bioethics in research meeting, "ethics of alternative clinical trial designs and methods in low- and middle-income country research": emerging themes and outputs.

Alternative clinical trial designs and methods are increasingly being used in place of the conventional individually randomised controlled trial (RCT) in high-income and in low-income and middle-income country (LMIC) research. These approaches - including adaptive, cluster-randomised and stepped-wedge designs and controlled human infection models - offer a number of potential advantages, including being more efficient and making the clinical trial process more socially acceptable. However, these designs and methods are generally not familiar to researchers, research ethics committees and regulators and their ethical implications have not received sufficient international attention from the bioethics, research, and policymaking communities working together. The ethics of alternative clinical trial designs and methods in LMIC research was chosen as a topic for the 2017 Global Forum on Bioethics in Research (GFBR). The meeting opened a global dialogue about this emerging issue in research ethics and gave voice to the LMIC perspective. It identified the need to take a multidisciplinary approach and to develop capacity amongst researchers and research ethics committees and regulators to propose, review and regulate these novel designs and methods. Building skills and infrastructure will empower researchers to choose from a broad range of designs and methods and adopt the most scientifically suitable, efficient, ethical and context-appropriate of these. The need for capacity development is most pressing from the LMIC perspective, where limited resources create an urgency to seek the most efficient trial design and method. The aim of this paper is to encourage broad debate about this complex area of research. By opening up this debate, GFBR aims to promote the appropriate and ethical use of novel designs and methods so their full potential to address the health needs in LMICs can be realised.

Should Social Value Obligations be Local or Global?

According to prominent bioethics scholars and international guidelines, researchers and sponsors have obligations to ensure that the products of their research are reasonably available to research participants and their communities. In other words, the claim is that research is unethical unless it has local social value. In this article, we argue that the existing conception of reasonable availability should be replaced with a social value obligation that extends to the global poor (and not just research participants and host communities). To the extent the social value requirement has been understood as geographically constrained to the communities that host research and the countries that can afford the products of research, it has neglected to include the global poor as members of the relevant society. We argue that a new conception of social value obligations is needed for two reasons. First, duties of global beneficence give reason for researchers, sponsors, and institutions to take steps to make their products more widely accessible. Second, public commitments made by many institutions acknowledge and engender responsibilities to make the products of research more accessible to the global poor. Future research is needed to help researchers and sponsors discharge these obligations in ways that unlock their full potential.

The global forum on bioethics in research meeting, "ethics of research in pregnancy": emerging consensus themes and outputs.

Research during pregnancy is affected by multiple ethical challenges which have not received sufficient international attention and consideration from the bioethics, clinical, and policymaking communities working together. Unresolved ethical questions about research in pregnancy have significant detrimental impacts on maternal and newborn health, in part because they inhibit an evidence base being developed on the efficacy and safety of medicines and health interventions for pregnant women. These problems are compounded in low- and middle-income country (LMIC) settings due to variability in regulatory provisions, the burden of maternal morbidity and mortality, and many social and cultural conventions that impact on pregnant women's ability to participate in research. Research in pregnancy was chosen as a topic for the 2016 Global Forum on Bioethics in Research (GFBR) meeting, and its timeliness was all the more apparent given the 2016 Zika outbreak, which has deeply affected the Latin American region. The meeting's emerging consensus themes and outputs epitomized the core aims of the GFBR-to give voice to LMIC perspectives as a priority in dialogue about global health research ethics and to promote collaboration. In this instance, the GFBR meeting catalyzed a strong, unified drive to push researchers and policymakers to include pregnant women in research by default: given the complex nature of the topic, this is a significant achievement in addressing an important question of social justice.

Ethical challenges in research with orphans and vulnerable children: a qualitative study of researcher experiences.

BACKGROUND: Orphans and vulnerable children (OVCs) represent a significant population worldwide, enduring poor health and living conditions. Evidence-based interventions are needed. However, without parents, ethical concerns about including OVCs in research persist. The aim of our study was to better understand the ethical challenges facing researchers who work with OVCs. METHODS: We conducted semi-structured interviews with 12 international pediatric researchers working with OVCs in seven countries. We used descriptive content analysis to characterize the ethical rationale for inclusion and associated challenges. RESULTS: Researchers believed research was justified as a necessary means for informing evidence-based interventions to benefit OVCs directly or as a population. Ethical challenges included difficulty identifying OVCs given variation among children living without parents; difficulty identifying guardians among a range of caregivers; concerns about meaningfulness of guardian consent; difficulty assessing risk; and responding to children's many needs. CONCLUSIONS: A range of caregivers bear responsibility to protect OVC's interests in place of parents in research but are often not prepared to do so. This places greater burden on researchers to assess risks and respond to children's needs. Findings suggest that we should improve support and rethink the roles of guardians, researchers and older children in research participation and protection.

Conducting research with human subjects in international settings: ethical considerations.

Biomedical research in international settings is undergoing expansive growth and may potentially result in far-reaching benefits, such as direction of research resources toward solving basic health care needs of world populations. However, key ethical concerns surround this expansion and must be carefully considered by international researchers. International research is impacted by differences in language, culture, regulatory structures, financial resources, and possibly ethical standards. Local community leadership involvement in the planning stages of research is imperative. Especially in resource-poor countries, the research agenda must be designed to address local needs and provide local benefit. Capacity strengthening efforts, aimed at improving institutional support for ethical conduct of human subjects research, must continue to be supported by wealthier nations.

¿Ética de la investigación internacional como ética cívica transnacional?: Análisis de las posibilidades de aplicación de la propuesta de Adela Cortina / Ética da pesquisa internacional como ética cívica transnacional?: análise das possibilidades de aplicação da proposta de adela cortina / International research ethics as transnational civic ethics?: analysis of the possibilities of applying the adela cortina proposal

En este trabajo pretendo analizar si la "ética cívica transnacional", propuesta por la filósofa española Adela Cortina, constituye una propuesta susceptible de ser aplicada para el análisis y construcción de una ética de la investigación internacional. No se trata, por tanto, de analizar los fundamentos filosóficos de la propuesta. Se trata de analizar sus planteamientos a la luz del desarrollo de la ética de la investigación y los principales problemas que continúan siendo materia de discusión, conflicto y desacuerdo. El trabajo está divido en tres partes: La primera parte describe el planteamiento de Adela Cortina sobre "ética cívica transnacional". La segunda analiza dichos planteamientos, a la luz de la evidencia reciente sobre el desarrollo de la ética de la investigación y su práctica. Por último, la tercera parte, resume las principales conclusiones, enfatizando que las condiciones en que se desarrolla la ética de la investigación internacional están lejos de permitir la construcción de una ética cívica transnacional. Las aspiraciones de la deliberación racional ignoran la influencia de la realidad social y sus conflictos, enmascarando las transacciones sociales, las negociaciones estratégicas o las concertaciones, bajo la forma de "acuerdos" o "consensos" que se sustentarían sobre principios universales atemporales...

In this work I aim to analyze whether the "transnational civic ethics", proposed by the Spanish philosopher Adela Cortina, constitutes a proposal susceptible to be applied for analyzing and developing an international research ethics. This is not about, therefore, an analysis of the philosophical fundaments of the proposal. It is about of analyzing the approach in the light of the research ethics development and, the main problems that continue being matter of discussion, conflict and disagreement. The article is divided in three sections. The first section describes the Adela Cortina approach on "transnational civic ethics". The second section analyzes such approach in the light of recent evidence on research ethics development and practice. Lastly, the third section resumes the main conclusions, emphasizing that the conditions under international research ethics develops are far away to allow the construction of a transnational civic ethics. The aspiration of rational deliberation is unaware of the influence of the social reality and its conflicts, hiding the social transactions or strategic negotiations, under the form of "agreements" or "consensus" that would be supported by timeless universal principles...

Neste trabalho pretendo analisar se a "ética cívica transnacional", proposta pela filósofa espanhola Adela Cortina, constitui uma proposta suscetível de ser aplicada para a análise e construção de uma ética da pesquisa internacional. Não se trata, portanto, de analisar os fundamentos filosóficos da proposta. Trata-se de analisar suas propostas à luz do desenvolvimento da ética da pesquisa e dos principais problemas que continuam sendo matéria de discussão, conflito e desacordo. O trabalho está dividido em três partes. A primeira parte descreve a proposta de Adela Cortina sobre "ética cívica transnacional". A segunda analisa tais proposições à luz da evidência recente sobre o desenvolvimento da ética da pesquisa e sua prática. Por último, a terceira parte resume as principais conclusões, enfatizando que as condições, nas quais se desenvolve a ética da pesquisa internacional, estão longe de permitir a construção de uma ética cívica transnacional. As aspirações da deliberação racional ignoram a influência da realidade social e seus conflitos, mascarando as transações sociais, as negociações estratégicas ou as conciliações, sob a forma de "acordos" ou "consensos" que seriam sustentados sobre princípios universais atemporais...