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Achieving equity in international research is a pressing concern. Exploitation in any scenario, whether of human research participants, institutions, local communities, animals or the environment, raises the overarching question of how to avoid such exploitation. Agreed principles can be universally applied to research in any discipline or geographical area, whatever methodologies are employed. This chapter introduces a collection of case studies, presenting a range of up-to-date examples of exploitation in North-South research collaborations, in order to raise awareness of ethics dumping.

This case study about research in an emergency setting depicts how unexpected findings created conflicts of conscience for non-governmental organization (NGO) workers and exposed research participants and their community to retribution and compromised the local social structure. The community felt betrayed when unexpected findings from research about health seeking behaviours revealing illegalfemale genital mutilation were shared publicly and contributed to stigmatizing their culture. In addition, the NGO involved performed a dual role – that of assistance provider as well as researcher – which endangered the neutrality of the data collection and, in the end, the acceptability of the NGO as assistance provider.

In 2010 an international genomic research project entitled “Complete Khoisan and Bantu genomes from southern Africa” was published in amidst wide publicity (Schuster et al ). The research aimed to examine the genetic structure of “indigenous hunter-gatherer peoples” selected from Namibia, and to compare the results with “Bantu from southern Africa” , including Nobel peace prize winner Archbishop Desmond Tutu. Four San individuals, the eldest in their respective communities, were chosen for genome sequencing, and the published article analysed many aspects of the correlations, differences and relationships found in the single-nucleotide polymorphisms (SNPs) (A single-nucleotide polymorphism is a variation in a single nucleotide that occurs at a specific position in a genome, where each variation is present to some appreciable degree within a population) within the sequenced genomes. A supplementary document published with the paper contained numerous conclusions and details that the San regarded as private, pejorative, discriminatory and inappropriate. The San leadership met with the authors in Namibia soon after publication, asking why they as leaders had not been approached for permission in advance, and enquiring about the informed consent process. The authors refused to provide details about the informed consent process, apart from stating that they had received video-recorded consents in each case (Hayes ). They defended their denial of the right of the San leadership to further information on the grounds that the research project had been fully approved by ethics committees/institutional review boards in three countries, (names of committees given to editors of this book) and that they had complied with all the relevant requirements. The San leadership wrote to , expressing their anger at the inherent insult and lack of respect displayed by the process (Ngakaeaja ). This case study details the most serious aspects of the perceived exploitative nature of the research, and the San response.

This case study is written as a personal story by an outside support worker starting to engage with sex workers, a vulnerable and stigmatized population in a Nairobislum. We hope the shared experiences will give better insight into the difficulties faced by members of this key population as they eke out a living. It is also a positive case study, not one of exploitation, despite sex work being illegal in Kenya.

Three clinical trials took place in India between 1998 and 2015 in urban and rural areas of Mumbai, Osmanabad and Dindigul. The trials aimed to determine whether trained health care workers could conduct cervical cancer screening in a community using cheap methods of testing – primarily visual inspection with acetic acid – to reduce the incidence and mortality rate of cervical cancer. The clinical trials were conducted on approximately 374,000 women, of whom about 141,000 were placed in the control arm (no screening). Although the standard of care for testing of the disease in India has been cytology screening (or Pap smear) since the 1970s, screening for cervical cancer was not available universally under a government programme, and for the study purposes the standard of care was therefore misconstrued to be no screening. Known and effective methods of screening for cervical cancer were therefore withheld from 141,000 women in areas where it was known to be of high incidence and prevalence. This placed them at a known risk of developing invasive cervical cancer, and dying from it, because it was not detected and treated in time. Two hundred and fifty-four women in the no-screening arm died due to cervical cancer as per the latest published reports on the three trials. A no-screening control arm would not have been allowed in the USA, but was accepted by the US funders for clinical trials in India. It is imperative that ethical standards for research be applied equally across nations to prevent “ethics dumping” and protect the rights of human research participants in research, no matter where they are located on the globe.

The Ebola epidemic that broke out in West Africa towards the end of 2013 had been brought under reasonable control by 2015. The epidemic had severely affected three countries. This case study is about a phase I/II clinical trial (testing for safety and immunogenicity) of a candidate Ebola virus vaccine in 2015 in a sub-Saharan African country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized double-blinded trial. It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companies. The protocol received ethics clearance from the relevant national ethics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratory and a laboratory of a local regional hospital. The overall study was a multi-country, multi-site trial aimed at recruiting a total of 3,000 research participants across four or five sub-Saharan African countries. For this country, the recruitment sites were two big cities, each aiming to recruit 200 participants: adults at the first site and children at the second. The target sample size was almost achieved at the first site but, before the study commenced at the second site, some members of (the public) raised the alarm that the government was carelessly risking the health, safety and lives of citizens in the cause of an unproven vaccine that could precipitate a public health disaster. The trial was immediately suspended. A commentary on this case, and on the importance of trust, is provided by Katharine Browne and Doris Schroeder at the end of this chapter. It highlights differences between this case and a phase I Ebola vaccine trial in Canada in 2014.

This case study is about a study entitled “Comparable randomized double-blind investigation of safety and immunogenicity of vaccine against Hepatitis B in healthy adult subjects” proposed in Russia with an international sponsor. There were indications of elements of exploitation, which consisted of inadequacies in the study’s design compared with its announced purpose, and the indirect inclusion of women research subjects in the clinical trial without their informed consent. On the basis of noncompliance with the applicable regulatory and ethical requirements the study was not approved by the local ethics committee (LEC).

Patients participate in clinical trials for a variety of reasons, the first of which is often the prospect of direct health benefits for themselves. Healthy volunteers, by definition, cannot expect such benefits. In resource-limited settings, healthy volunteers are most often poor people with low literacy levels who might not understand the risks they may be taking and are in no position to refuse financial incentives. For many of them, participation in clinical trials is a critical source of income. An added complication is that some participants covertly enrol in several studies simultaneously, in order to increase their income. This exposes the volunteers to medical risks (e.g. drug-drug interactions), and also potentially biases study data. Our recommendations are that specific efforts are made to ensure proper informed consent of this vulnerable population and that compulsory national databases be established to ensure that healthy volunteers do not participate simultaneously in several studies.

In 1995, a research team from a renowned US university started collecting blood samples from villagers living in Anhui province, China, with the cooperation of local research institutes and the Chinese government. In 2000, the US university team was accused of violating research ethics principles by not adequately informing the participants about the research and not sharing benefits fairly. Subsequent investigations by American and Chinese media and authorities showed that the US research institute, its research personnel and a pharmaceutical company involved were benefiting substantially from the project, while the Chinese research participants and the government were not. Three levels of exploitation can be distinguished in this case: In order to avoid such exploitation, high-income countries as well as low- and middle-income countries should strengthen their institutional arrangements and improve their cooperation mechanisms, in order to ensure that both sides benefit equally from international science and technology cooperation.

The use of non-human primates in biomedical research is a contentious issue that raises serious ethical and practical concerns. In the European Union, where regulations on their use are very tight, the number of non-human primates used in research has been in decline over the past decade. However, this decline has been paralleled by an increase in numbers used elsewhere in the world, with less regard for some of the ethical issues (e.g. genetic manipulations). There is evidence that researchers from high-income countries (HICs), where regulations on the use of non-human primates are strict, may be tempted to conduct some of their experiments in countries where regulation is less strict, through new collaborative efforts. In collaborative ventures, equivalence in the application of ethical standards in animal research, regardless of location, is necessary to avoid this exploitation.