Against Permitted Exploitation in Developing World Research Agreements

This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research sponsors and host communities benefit from the resulting agreements. I show that defenders of the claim that exploitation ought to be permitted rely on a mischaracterization of certain forms of interference as unjustly paternalistic and two dubious empirical assumptions about the results of regulation. The view I put forward is that by evaluating a system of constraints on international research agreements, rather than individual transaction‐level interference, we can better assess the alternatives to permitting exploitative research agreements.     

A Framework to Link International Clinical Research to the Promotion of Justice in Global Health

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high‐income countries owed to parties from low and middle‐income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post‐trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity.     

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.     

Research ethics guidelines and moral obligations to developing countries: Capacity‐building and benefits

This article outlines challenges to benefitting developing countries that are hosts of international research. In the context of existing guidance and frameworks for benefit‐sharing, it aims to provoke dialog about socioeconomic factors and other background conditions that influence what constitute benefits in a given host setting, and about the proportionality between benefits to hosts and benefits to sponsors and researchers. It argues that capacity‐building for critical thinking and negotiation in many developing country governments, institutions, and communities is a benefit because it can help to overcome background conditions that impinge on equitable international research negotiations, partnerships, and benefits. Enhancing the capacity for both critical thinking and negotiation can, like other targets of capacity‐building, nurture respectful and trusting partnerships that benefit all stakeholders in international research.     

Moral agency,moral worth and the question of double standards in medical research in developing countries

International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight-jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all. In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent(s) the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research.     

The benefit sharing vision of H3Africa

One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the “reasonable availability,” endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as “fair benefits,” which endorses other forms of benefits that host communities may deem as fair beyond those derived directly from the study's findings. This paper explores a third benefit model consistent with the writings of the Human Hereditary and Health in Africa (H3Africa) research initiative. The H3Africa—a North‐South collaborative initiative predicated by U.S. National Institutes of Health, the Wellcome Trust and the African Society of Human Genetics upholds a benefit model that endorses capacity building as the primary obligation of its research agenda. This is evident by the endorsement of mechanisms to strengthen capacity building in its research projects. While capacity building remains a plausible means of improving the expertise, quality and independence of research in Africa, sustainable measures are needed to realizing the full potential for African‐led research on the continent.     

Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low‐income South African communities on benefits in international clinical research. Twenty‐four individuals with and without experience of being involved in clinical research participated in in‐depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post‐trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.     

Benefit Sharing in a Global Context: Working Towards Solutions for Implementation

Due to the state of globalized clinical research, questions have been raised as to what, if any, benefits those who contribute to research should receive. One model for compensating research participants is “benefit sharing,” and the basic premise is that, as a matter of justice, those who contribute to scientific research should share in its benefits. While incorporated into several international documents for over two decades, benefit sharing has only been sparsely implemented. This analysis begins by addressing the concept of benefit sharing, its historical development, and how it has been applied in the context of virus sharing for influenza research. The second portion of this analysis presents recommendations for ensuring benefit sharing. These recommendations are threefold: 1) an emphasis on social pressure, 2) the revision of international documents as means to ensure benefit sharing, and 3) greater collaboration between sponsor IRB and host country IRB. Because clinical research is a globalized industry, a global model will be proposed in the second that focuses on collaboration between the sponsor and host country. This collaboration is vital in order to ensure that proper forms of benefit sharing are accomplished as a matter of justice.     

Clinical trials and SCID row: the ethics of phase 1 trials in the developing world

Relatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer's most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations' health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short-course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations.     

International research and just sharing of benefits in Mexico

International research enrolling human subjects has raised an ethical concern regarding the just distribution of benefits between the countries that design the research and the host communities. Although several universal declarations have expressed this concern, a gap between theory and practice continues to exist, as well as a significant divergence between the design of the research protocol and the social context where it will be implemented. Although institutional review boards have made a valuable effort to evaluate international research, their sensitivity to the just sharing of research benefits as well as their attention to the social context must be evaluated. This article analyzes the distribution of benefits in a review of international research in Mexico and produces an ethical reflection based on the results.     

Ethical review issues in collaborative research between us and low-middle income country partners: a case example

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country.     

What Are Fair Study Benefits in International Health Research? Consulting Community Members in Kenya

Background

Planning study benefits and payments for participants in international health research in low- income settings can be a difficult and controversial process, with particular challenges in balancing risks of undue inducement and exploitation and understanding how researchers should take account of background inequities. At an international health research programme in Kenya, this study aimed to map local residents'' informed and reasoned views on the effects of different levels of study benefits and payments to inform local policy and wider debates in international research.

Methods and Findings

Using a relatively novel two-stage process community consultation approach, five participatory workshops involving 90 local residents from diverse constituencies were followed by 15 small group discussions, with components of information-sharing, deliberation and reflection to situate normative reasoning within debates. Framework Analysis drew inductively and deductively on voice- recorded discussions and field notes supported by Nvivo 10 software, and the international research ethics literature. Community members'' views on study benefits and payments were diverse, with complex contextual influences and interplay between risks of giving ‘too many’ and ‘too few’ benefits, including the role of cash. While recognising important risks for free choice, research relationships and community values in giving ‘too many’, the greatest concerns were risks of unfairness in giving ‘too few’ benefits, given difficulties in assessing indirect costs of participation and the serious consequences for families of underestimation, related to perceptions of researchers'' responsibilities.

Conclusions

Providing benefits and payments to participants in international research in low-income settings is an essential means by which researchers meet individual-level and structural forms of ethical responsibilities, but understanding how this can be achieved requires a careful account of social realities and local judgment. Concerns about undue inducement in low-income communities may often be misplaced; we argue that greater attention should be placed on avoiding unfairness, particularly for the most-poor.     

A human rights approach to an international code of conduct for genomic and clinical data sharing

Fostering data sharing is a scientific and ethical imperative. Health gains can be achieved more comprehensively and quickly by combining large, information-rich datasets from across conventionally siloed disciplines and geographic areas. While collaboration for data sharing is increasingly embraced by policymakers and the international biomedical community, we lack a common ethical and legal framework to connect regulators, funders, consortia, and research projects so as to facilitate genomic and clinical data linkage, global science collaboration, and responsible research conduct. Governance tools can be used to responsibly steer the sharing of data for proper stewardship of research discovery, genomics research resources, and their clinical applications. In this article, we propose that an international code of conduct be designed to enable global genomic and clinical data sharing for biomedical research. To give this proposed code universal application and accountability, however, we propose to position it within a human rights framework. This proposition is not without precedent: international treaties have long recognized that everyone has a right to the benefits of scientific progress and its applications, and a right to the protection of the moral and material interests resulting from scientific productions. It is time to apply these twin rights to internationally collaborative genomic and clinical data sharing.     

Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature,Legislation, and International Guidelines

There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post‐trial access and participants and community members. Given that clinical trials conducted in low‐income countries will likely continue, there is an urgent need for consideration of post‐trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.     

Sharing the Knowledge: Sharing Aggregate Genomic Findings with Research Participants in Developing Countries

Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and benefits of attempting such an exercise are identified, and suggestions on ways to avoid some of the challenges are proposed. I argue that disseminating the findings of genomic research to participating communities should be seen as sharing knowledge rather than returning results. Calling the dissemination of aggregate, population level information returning results can be confusing and misleading as participants might expect to receive individual level information. Talking about sharing knowledge is a more appropriate way of expressing and communicating the outcome of population genomic research. Considering the knowledge produced by genomics research a worthwhile output that should be shared with the participants and approaching the exercise as a ‘sharing of knowledge’, could help mitigate the risks of unrealistic expectations and misunderstanding of findings, whilst promoting trusting and long lasting relationships with the participating communities.     

Judging the social value of controlled human infection studies

In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost-effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in practice. Yet depending on the pathogen, CHI studies can involve significant risks or burdens for participants, pose risks to individuals or communities not involved in the research, and lead to public controversy. It is therefore essential to ensure that the risks of CHI studies are justified by their social value—that is, their potential to generate benefits for society—and that public trust can be maintained. In this paper, we aim to clarify how research sponsors, research ethics committees and other reviewers should judge the social value of CHI studies. We develop a list of relevant considerations for making social value judgments based on the standard view of social value. We then use this list to discuss the example of potentially conducting dengue virus CHI studies in endemic settings. We argue that dengue virus CHI studies in endemic settings would fall on the higher end of the spectrum of social value, mostly because of their potential to redirect all fields of future dengue research. Drawing on this discussion, we derive several general recommendations for how reviewers should judge the social value of CHI studies.     

Research Ethics: Beyond the Guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold the guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, vary in different settings.     

From Private Performance to the Public Stage: Reconsidering ‘Staged Authenticity’ and ‘Traditional’ Performances at the Pasifika Festival

Over the past 60 years, the phenomenal growth of international tourism has been paralleled by the phenomenal growth in festivals held across the world and the increasing academic attention given to understanding them. Performances of culture in tourist settings are often viewed as inauthentic, staged purely for the benefit of tourists. This article contests this enduring perspective, best known through the notion of ‘staged authenticity’. Drawing on research conducted in the diasporic Pacific festival space in New Zealand, this article focuses on how those from within Pacific communities view their performances. Giving agency to the actors allows them to define performances and festivals from an emic perspective, and this challenges the notion of staged authenticity. Rather than material performed purely for the festival and its cultural tourists, performances instead represent a movement of material from largely homogenous community contexts into the multicultural public sphere. Furthermore, the notion of nonlinear temporal relations shows how these performance traditions function contemporaneously, as an important component of the community repertoires from which they come. This in particular challenges the idea that touristic performances represent ‘staged authenticity’. Rather, traditional musics represent one way in which diasporic Pacific communities authentically stage themselves.     

Ethics committees. Research ethics: beyond the guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold their guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, very in different settings.