There is a long history of women being underrepresented in biomedical and health research. Specific women’s health needs have been, and in some cases still are, comparatively neglected areas of study. Concerns about the health and social impacts of such bias and exclusion have resulted in inclusion policies from governments, research funders, and the scientific establishment since the 1990s. Contemporary understandings of foregrounding sex and gender issues within biomedical research range from women’s rights to inclusion, to links between human rights, (...) women’s health and sustainable development, and the increasing scientific and funding expectation for studies to consider the sex and gender implications of research design, results and impact. However, there are also exploitation issues to consider when foregrounding the inclusion of women as research participants, especially for research ethics committees and institutional review boards. A hidden risk is that exploitative research designs and practices may be missed, particularly by reviewers who may not have a nuanced understanding of gender-based harm. Utilizing contemporary case studies of ethics dumping, this paper highlights some of the concerns, and makes recommendations for IRBs/research ethics reviewers to help ensure that essential research is undertaken to the highest ethical standards. (shrink)

A 78-year-old Chinese woman joined a clinical trial sponsored by a Pharmaceutical companies. Unfortunately a serious Serious Adverse Event occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. According Good (...) Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide Insurance to those human subjects who participate in clinical trials, cover the cost of Treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial”. The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the Patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The Litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of Risks of Exploitation when a major, international Pharmaceutical companies sponsors clinical research in a country with an immature legal system and where Research participants have limited resources. (shrink)

Mobile cellular subscriptions had reached 87% of the world’s population by 2011. Notably, Africa has “the fastest mobile phone growth rate in the world and … a proliferation of social media users”. Mobile phones that can run software applications are increasingly used in health settings, for example, to improve diagnosis and personalize health care :67, 2012). This fast-paced development saw the number of “mHealthMHealth apps reach 97,000 as of March 2013.

In 2010 an international genomic research project entitled “Complete Khoisan and Bantu genomes from southern Southern Africa was published in Nature amidst wide publicity. The research aimed to examine the genetic structure of “indigenous Hunter gatherers peoples” selected from Namibia, and to compare the results with “Bantu from southern 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 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. 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/Ethics committee review boards in three countries, and that they had complied with all the relevant requirements. The San leadership wrote to Nature, expressing their anger at the inherent insult and lack of Respect displayed by the process. This case study details the most serious aspects of the perceived Exploitative nature of the research, and the San response. (shrink)

The use of non-human primates in biomedical research is a contentious issue that raises serious ethical and practical concerns. In the European UnionEuropean 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. There is evidence that researchers from high-income countries, (...) 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 standardsEthical standards in animal research, regardless of location, is necessary to avoid this exploitationExploitation. (shrink)

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely (...) variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping. (shrink)

Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are diverted for (...) clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research. (shrink)

This open access book offers insights into the development of the ground-breaking Global Code of Conduct for Research in Resource-Poor Settings (GCC) and the San Code of Research Ethics. Using a new, intuitive moral framework predicated on fairness, respect, care and honesty, both codes target ethics dumping – the export of unethical research practices from a high-income setting to a lower- or middle-income setting. The book is a rich resource of information and argument for any research stakeholder who opposes double (...) standards in research. It will be indispensable for applicants to European Union framework programmes, as the GCC is now a mandatory reference document for EU funding. (shrink)

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 Benefit fairly. Subsequent investigations by American and Chinese media and authorities showed that the US research institute, its research personnel and a Pharmaceutical companies (...) 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: the exploitation of local individual citizens as human research participantsthe exploitation of the local scientific Community in Chinathe exploitation of the country’s national interestIn 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 Science & Technology cooperation. (shrink)

The issue of the protection of communities in clinical research first arose 10 years ago in studies conducted in technologically developing countries by scientists from technologically developed nations. The question was, which ethical standards ought to apply, those of the Western investigators or local standards?

This case study is written as a personal story by an outside support worker starting to engage with sex workers, a vulnerableVulnerable and stigmatizedStigmatized population in a NairobiNairobislumSlum. 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 exploitationExploitation, despite sex work being illegalIllegal in KenyaKenya.

The increase in the volume of health-related research in AfricaAfrica has not everywhere been accompanied by improvements in research oversight systems related to biomedical and health services research, including the strengthening of institutional review boards Institutional Review Boards and national regulatory oversight institutions. Critical to such oversight are not only competencies in ethics for the review of clinical trialsClinical trial, but also competencies in diverse research methods, statistical analyses and project implementation. In LiberiaLiberia, there are recognized weaknesses in the existing (...) infrastructure and capacity to regulate and monitor clinical research based on ethical institutional regulations and guidance for the protection of human research participantsResearch participants. During the height of the Ebola virus disease surge in Liberia in 2014, there was a fragile national regulatoryRegulatory approval framework to oversee research. Some researchers took undue advantage of this gap to conduct unethical research. (shrink)

The Ebola epidemic that broke out inWest Africa West AfricaAfrica 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 Phase I/II clinical trial of a candidate Ebola virus vaccine in 2015 in a sub-Saharan AfricanSub-Saharan Africa country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized double-blinded trialRandomized double blinded trial. (...) It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companiesPharmaceutical companies. The protocol received ethics clearance from the relevantNational Ethics Committee national ethics committeeEthics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratoryDiagnostic laboratory and a laboratory of a local regional hospital. The overall study was a multi-countryMulti-country, multi-siteMulti-site trial aimed at recruiting a total of 3,000 research participantsResearch participants across four or five sub-Saharan African countries. For this country, the recruitmentRecruitment sites were two big cities, each aiming to recruit 200 participants: adults at the first site and childrenChildren at the second. The target sampleSample size was almost achieved at the first site but, before the study commenced at the second site, some members of raised the alarm that the governmentGovernment was carelessly risking the health, safetySafety 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 trustTrust, 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 CanadaCanada in 2014. (shrink)

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. (...) Although the Standard of care for testing of the disease in India has been Cytology screening (or Pap 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 Risks 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 trial in India. It is imperative that Ethical standards for research be applied equally across nations to prevent “ethics Ethics dumping and protect the rights of human Research participants in research, no matter where they are located on the globe. (shrink)

This case study looks into recent developments with regard to the CRISPR/Cas9CRISPR/Cas9 and other novel genome editing technologies that are becoming widely available thanks to their low costs and modest technological requirements.

This case study about research in an emergency setting depicts how unexpected findings created conflicts of conscience for non-governmental Non-Governmental Organisations 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. (shrink)

Patients participate in clinical trials for a variety of reasons, the first of which is often the prospect of direct health Benefit 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, 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. (shrink)

This case study is about a study entitled “Comparable randomized double-blindRandomized double blinded trial investigation of safetySafety and immunogenicity of vaccineVaccine against Hepatitis B in healthy adult subjects” proposed in RussiaRussia with an international sponsorSponsor. There were indications of elements of exploitationExploitation, which consisted of inadequacies in the study’s design compared with its announced purpose, and the indirect inclusion of womenWomen research subjects in the clinical trialClinical trial without their informed consentInformed consent. On the basis of noncomplianceNon-compliance with the applicable (...) regulatoryRegulatory approval and ethical requirements the study was not approved by the local ethics committee Local Ethics Committee. (shrink)

Collaborations in global health research are on the rise because they enhance productivity, facilitate capacity building, accelerate output and make tackling big, multifactorial research questions possible. In this paper, I examine the concepts of trust and reliance in scientific collaborations in general, but also in the particular context of collaborations in global health research between high‐income countries and low‐and‐middle income countries (LMIC). I propose and defend the argument that given the particular characteristics of collaborations and demands of trust relationships, reliance (...) is a better relational mode for successful collaborations. Although reliance can be difficult to establish in situations where asymmetry of power exists, trust should not be the only relational mode available to LMIC researchers because of the type of vulnerability it introduces to the relationship. I conclude that the promotion of good collaborations requires addressing the power imbalances between partners, and establishing an even playing field in global health research. (shrink)

Drawing on 171 in-depth interviews with physicists at universities in the United States and the UK, this study examines the narratives of 48 physicists to explain the concept of ethical ambiguity: the border where legitimate and illegitimate conduct is blurred. Researchers generally assume that scientists agree on what constitutes both egregious and more routine forms of misconduct in science. The results of this study show that scientists perceive many scenarios as ethically gray, rather than black and white. Three orientations to (...) ethical ambiguity are considered—altruism, inconsequential outcomes, and preserving the status quo—that allow possibly questionable behavior to persist unchallenged. Each discursive strategy is rationalized as promoting the collective interest of science rather than addressing what is ethically correct or incorrect. The results of this study suggest that ethics training in science should focus not only on fabrication, falsification, and plagiarism and more routine forms of misconduct, but also on strategies for resolving ethically ambiguous scenarios where appropriate action may not be clear. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)