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Exploitation Risks in Collaborative International Research

  • Doris Schroeder
  • Kate Chatfield
  • Michelle Singh
  • Roger Chennells
  • Peter Herissone-Kelly
Open Access
Chapter
Part of the SpringerBriefs in Research and Innovation Governance book series (BRIEFSREINGO)

Abstract

Ethics dumping occurs in collaborative international research when people, communities, animals and/or environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power differentials between researchers from high-income countries and research stakeholders from low- and middle-income countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88 risks identified for collaborative international research, categorized according to four values: fairness, respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open call for case studies of exploitation. The findings of the exercise contributed to the development of the Global Code of Conduct for Research in Resource-Poor Settings.

Keywords

Exploitation Ethics dumping Collaborative research Vulnerability Research ethics Ethics codes 

Ethics dumping 1 occurs in collaborative international research when people, communities, animals and/or environments are exploited by researchers. In order to prevent ethics dumping, such exploitation needs to stop. This chapter describes our investigation into the risks of exploitation in low- and middle-income countries (LMICs), uncovering what makes exploitation more likely to occur due to vulnerabilities that can be exploited, either knowingly or unknowingly.

This undertaking was vital for the development of a Global Code of Conduct for Research in Resource-Poor Settings (GCC) that can address real-world risks for exploitation in research. Many such risks are not well described in the literature, and hence there was an empirical component to our activities. Furthermore, this process was necessary to ensure that the GCC was more than a compilation of existing codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.

The Nature of Exploitation

The potential to be exploited is part of the human condition. Exploiters take advantage of others’ vulnerabilities to promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of natural talents to create art, for example), the term is generally used to describe a moral failing. Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that distinguishes morally unacceptable exploitation from neutral exploitation?

Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has been coerced into enrolling (Annas and Grodin 1998). In this sense, exploitation occurs where one party takes advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there is no alternative. Others argue that exploitation is wrong because it treats human beings as means rather than ends (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong because it disadvantages the vulnerable (Macklin 2003).

Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretroviral drugs to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may decide not to exploit vulnerable research participants and offer the accepted standard of care to those in the control arm, rather than a placebo.

Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence, ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.

Our Method

The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional literature-based approach, or through investigation in a single geographical region. Many of these vulnerabilities are poorly represented in the literature, and they can differ between countries, cultures and types of research. For example, clinical trials, social science, animal experiments, environmental science and research in emergency settings may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach to data collection was needed to capture as many risks and vulnerabilities as possible.

In this regard it was very helpful that the interdisciplinary TRUST project consortium comprised multilevel ethics bodies, policy advisers and policymakers, civil society organizations, funding organizations, industry and academic scholars from a range of disciplines. With input from each of these perspectives, a broad-based consultative exercise4 was possible which included input from these collaborators as well as more than 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open call for case studies of exploitation in research in LMICs (Chapter  6).

For example, extensive input from members and chairs of ethics committees was sought in both India and Kenya. In India, the Forum for Ethics Review Committees in India (FERCI) hosted a two-day workshop in Mumbai on 11 and 12 March 2016. At this workshop, approximately 30 leading bioethicists from around India came together to share their experiences and discuss cases of exploitation in research. In Nairobi on 23 and 24 May 2016, three esteemed chairs of national ethics committees shared their experiences and opinions about the primary ethical challenges for LMIC-HIC collaborative research in Kenya. Findings from both events revealed multiple risks of exploitation that are characteristic of research in some LMIC settings. These included traditional requirements for appropriate community consultations and permissions, and specific cultural beliefs and customs that must be respected.

Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks for exploitation were undertaken. From Nairobi, Kenya, sex worker peer educators and, from South Africa, members of the San community shared their experiences of being the subjects of exploitation and their opinions about how they want to be treated in future. Among many other insights, both groups described a lack of benefits from research projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in which they were involved in the study.

12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter  6). From this data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each individual entry was based upon real-world experience rather than hypothetical suppositions. Our lists were compared with risks mentioned in the literature and, where necessary, additional information sought to address gaps.

Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”. Further thematic analysis resulted in distinctions between the various potential subjects of exploitation, or levels of risk for exploitation (persons, institutions,5 local communities, countries, animals and the environment). In the final stage of the analysis the vulnerabilities were grouped according to the four values of fairness, respect, care and honesty.

Our Findings

The remainder of this chapter is devoted to presenting and explaining our findings. For each value, an exploitation risk table details the main risks for persons, institutions, local communities, countries, animals and the environment. Each entry on the tables describes a vulnerability that could lead to exploitation (deliberate or unintentional) in LMIC-HIC research collaborations and all are grounded in real-world experience. Additionally, for each value, certain examples are described in more detail to further illustrate the risks.

It has to be noted that some entries could have been linked to more than one value. For instance, if a research participant suffered from a therapeutic misconception, the researcher might not have taken enough care to explain that research is different from treatment because s/he was not aware that this might be problematic in some settings, or otherwise because s/he deliberately and dishonestly wanted to avoid explaining the difference, in which case the value of honesty would have been violated. To avoid overburdening the tables, we made a decision to prioritize one value in each case.

Fairness

Our data revealed many risks for exploitation that might be categorized as issues of fairness (or unfairness) that are varied in nature and pertain to different aspects of fairness. Philosophers commonly distinguish between different types of justice or fairness (Pogge 2006) (Chapter  3), but the most relevant fairness concepts for global research ethics are fairness in exchange and corrective fairness.

Fairness in exchange concerns the equity of transactions that occur between parties. In collaborative research, ventures should aim to be mutually beneficial. Where the collaboration is between HIC and LMIC partners, typical fairness in exchange issues might include:
  • The relevance of the research to local needs

  • Whether reasonable benefit sharing is taking place

  • Whether LMIC researchers are involved in meaningful ways

Table 5.1 shows the primary risks related to fairness in exchange for persons, institutions, communities, countries and the environment.
Table 5.1

Primary risks for fairness in exchange

Level of risk

Nature of risk

Personal

• In medical research:

 - Multiple trial enrolment

 - No post-study access to treatment

• In all research:

 - Undue inducement

 - No access to results or benefits of research

Researcher/ institutional

• Research priorities driven by HIC partners:

 - Mismatch to local research needs

• Poor representation of LMIC (host) partners on research teams:

 - Responsible for menial tasks only

 - Not acknowledged or represented appropriately in publications

• “Helicopter research” by HIC partners:

 - No knowledge transfer or capacity building/strengthening

Community

• Research priorities driven by HIC partners:

 - Mismatch to local research needs

• Little or no input from marginalized communities into research

• Undue inducement

• No benefit sharing or feedback

• Support for foreign-sponsored research drains local system of staff

Country

• No universal access to health care for population:

 - Differences in standards of “usual” care

• Placebo-controlled trials approved

• Support for foreign-sponsored research drains local systems and resources

• Medical science research shaped by the “para state”

Animal

 

Environmental

• Study leads to reduction of natural resources

• Lack of benefit sharing for the environment

A primary risk in the exploitation of individuals and communities is that they may not have access to the results or benefits of research. This occurs when the research is designed to benefit people in other countries or settings and the individuals who contributed to the study never get a chance to benefit from it. This happened with a clinical study of the hepatitis B vaccine in Kenya. Although the research was undertaken in Kenya, for many years afterwards people in Kenya could not afford to purchase the vaccine and therefore could not benefit (Bhatt 2016). When research aims are driven by, and in the interests of, high-income researchers or institutions with no real benefit to the local community or participants, we must ask why it is being conducted there.

Local LMIC researchers are exploited when used only for tasks such as data collection, or when, having participated in a research project, they are then not properly represented, or not represented at all, in subsequent publications. Local environments are exploited when environmental studies fail to benefit them. Research agreements focused on the use of biodiversity and traditional knowledge typically ignore the environmental component, and the common approaches to benefit sharing from research activities include only humans (Stone 2010).

Corrective fairness presupposes the availability of legal instruments and access to mechanisms for righting wrongs (e.g. a complaints procedure , a court or an ethics committee). For instance, if no research ethics structure exists in the host country, corrective fairness is limited to the research ethics structure in the HIC country, which may not have the capacity to make culturally sensitive decisions. Table 5.2 shows the primary risks related to corrective fairness for persons, institutions, communities, countries, animals and the environment.
Table 5.2

Primary risks for corrective fairness

Level of risk

Nature of risk

Personal

• Difficult or no access to legal system or legal aid

• Human rights violations not taken up by civil society

Researcher/institutional

• Lack of protection of IPR for LMIC institutions

• Lack of clear standards for operating systems and timelines for RECs

• No capacity/procedures for study oversight to ensure compliance with REC decisions

Community

• Lack of protection of IPR or traditional knowledge for local communities

• Human rights violations not taken up by civil society

• Absence of systems for community approvals

Country

• No relevant legal instruments for ethics committees

• Poor research governance frameworks to ensure adherence to ethical standards

• No cross-border legal recourse in cases of exploitation

• Discriminatory laws that may create stigmatized minorities

Animal

• Variations in regulatory standards for animal experimentation

• Inadequate systems to ensure compliance with animal welfare standards

Environmental

• Variations in governance of natural resources

• Variations in procedural rights

• Environmental protection not well policed by civil society

Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially problematic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance through the entire research process and where the home institutions in HICs do not ensure that their employees comply with requirements.

Respect

Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one disagrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However, respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not create conflicts of conscience. For instance, HIC researchers should not insist that LMIC ethics committees accept the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities, countries, animals and the environment.
Table 5.3

Primary risks for respect

Level of risk

Nature of risk

Personal

• Unequal power relations

• Tendency to defer to authorities

• Individual spiritual and religious priorities incompatible with or ignored by HIC partners

• Researchers and/or ethics committees deciding “what is best”

Researcher/

institutional

• Research protocol and papers imported from HIC partners and not tailored to local needs

• Ethical approval sought only from HIC partner

Community

• Diverse interpretations of important values

• Local requirements for effective community engagement ignored

• Diverse ethical priorities for matters such as:

 - gender equality

 - sexual relations

• Particular spiritual and religious priorities incompatible with or ignored by Northern partners

• Localized social effects from research team presence

• Local customs that may violate laws of the country and/or human rights

Country

• Research protocols and practices which fail to take account of national traditions and legislation

Animal

• Variations in customs, norms and attitudes regarding animal welfare and inhumane practices

Environmental

• Variations in customs, norms and attitudes regarding the environment

Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound impact that needs to be acknowledged and addressed in a manner that is sensitive to the wishes of the local community. A liberal interpretation of autonomy, i.e. individual autonomy, prevails in HICs but may not be easily transferred to LMIC settings where “community” or “group autonomy” is also highly valued. Furthermore, in some settings it might be deemed rude for a research participant to say “no” or to ask questions about the research. In other situations, people may be too afraid or unconfident to do so. Either way, the power imbalance between researcher and research participant can impact upon the consent process.

Animals and environments are also at risk of exploitation because of variations in customs and norms. What is considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures. Additionally, some animals are awarded greater protection in certain cultures than others, for example, dogs and cats in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different partners in collaborative research may have different philosophies related to the environment. Environmental protection is sometimes regarded as a colonial construct that has negative impacts on local communities in LMICs, and research agendas likewise. There may therefore be a philosophical or paradigmatic difference between research partners that needs to be identified and addressed.

Care

Researchers who take good care in their research combine two elements: they care about research participants, in the sense that they are important to them, and they feel responsible for the welfare of those who contribute to their research, or might suffer as a result of it. In work with vulnerable communities, this might, for example, entail the tailoring of informed consent procedures to local requirements (language, literacy, education levels) to achieve genuine understanding. Table 5.4 shows the primary risks related to care for persons, institutions, communities, countries, animals and the environment.
Table 5.4

Primary risks for care

Level of risk

Nature of risk

Personal

• In medical research: therapeutic misconception

• Misunderstanding of research aims

• Procedures for informed consent not tailored to individual

• Lack of possible actions to address adverse effects of participation

• Direct risks, such as physical side effects

• Indirect risks, such as stigmatization

Researcher/

institutional

• No host country research ethics structures or inappropriate match with requirements

• No capacity in existing REC

• REC members are poorly trained and lack specialized expertise to review ALL types of research protocols

• REC meetings are either too few or too sporadic

• REC does not have local or national government or ministry support to conduct its activities

Community

• Localized physical effects from research team presence

Country

• Insufficient data security measures

• Insufficient safeguarding protocols

• Lack of risk management approaches to biosafety

• Lack of risk management approaches to biosecurity

Animal

• Animal research centres established in countries where regulation is less stringent

• Lack of resources for humane animal care

Environmental

• Inadequate consideration of unintended consequences for biodiversity and the environment

• Inadequate consideration of local environmental contexts

• Disregard for long-term effects upon local environment

• Lack of resources for environmental protection

• Insufficient information for assessment of environmental effects

At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are just some of the issues that can lead to exploitation. The number of different ways in which individuals can suffer harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and services, and form relationships with local people.

At a national and international level, the rapid emergence of high-risk applications of technologies such as genome editing7 challenges not only safety risk assessments but also existing governance tools. This creates an environment where risky experiments might be carried out in countries with an inadequate legal framework, or in countries where although legal frameworks exist, their effective implementation is prevented by limited resources.

Most LMICs have processes in place for ethical approval of research, but they are hindered by resource issues. Even where research ethics committees are well established, they may have limited capacity and expertise. For effective governance, the wide-ranging and dynamic nature of research requires extensive and cutting-edge expertise from research ethics committees. This can be particularly difficult in resource-poor areas.

Inadequate environmental information in LMICs means that research decisions and directions may be developed in a vacuum and result in long-term harm. For example, research programmes may introduce exotic species that deplete water resources, displace traditional varieties − thereby impacting upon agricultural biodiversity or “escape” and become invasive, thus threatening biodiversity.

Honesty

In all cultures and nations, “do not lie” is a basic rule of ethical human interaction. However, the value of honesty has a broader scope in the context of global research ethics. Lying is only one possible contravention. In research ethics it is equally unacceptable, for instance, to omit important information from an informed consent process: that is, to fail to be transparent. The duties of honesty also include, most prominently, research integrity, which entails practices such as giving due credit for contributions and refraining from the manipulation of data and the misappropriation of research funds. In this section, we distinguish between these two forms of honesty and divide the risks into those that are mainly related to transparency and those that are more readily aligned with integrity. Table 5.5 sets out the primary risks to honesty through transparency for persons, institutions, communities, countries and the environment.
Table 5.5

Primary risks for honesty through transparency

Level of risk

Nature of risk

Personal

• Inability of participant to provide fully informed individual consent :

 - Incomplete information provided

 - Information provided in an inappropriate format

• Potential effects of participation not fully explained

• Dual roles of researcher

Researcher/

institutional

• REC not fully independent

• Cryptic research procedures

Community

Inability to provide fully informed community consent:

 - Incomplete information provided

 - Information provided in inappropriate format

• Potential effects of participation not fully explained

• Dual roles of researcher

Country

• Lack of data sharing

Animal

 

Environmental

• Incomplete information about potential risks or harm to the environment

There are many ways in which the informed consent process can be inadequate. For example, where there are omissions and/or inappropriate or misleading language for the context in which consent is being sought; when potential participants (some of whom may be illiterate) are not taken through any kind of suitable consent process but are, instead, provided with written information sheets to take home and told to come back with a signed consent form; or when information does not fully explain the potential (possibly harmful) consequences of participation. Misunderstanding can lead to a violation of trust: for example, where the researchers are also aid workers or health care providers, potential participants may believe that they have to participate in order to receive the aid or treatment.

A lack of transparency concerning research processes can make it very difficult to hold anyone accountable when things go wrong. For example, where numerous bodies are engaged in collaborative research and their separate activities and responsibilities are not clear, then it may be impossible to say where things have gone wrong and who is responsible.

Honesty is also the foundation of research integrity. Honesty is essential in all aspects of research, including

in the presentation of research goals, intentions and findings; in reporting on research methods and procedures; in gathering data; in using and acknowledging the work of other researchers; and in conveying valid interpretations and making justifiable claims based on research findings (Universities UK 2015).

Table 5.6 shows the primary risks for honesty through integrity for persons, institutions, communities, countries, animals and the environment.
Table 5.6

Primary risks for honesty through integrity

Level of risk

Nature of risk

Personal

• Personal data protection breaches

• Unauthorized secondary use of samples

• Use of samples for commercial purposes without consent

• Deliberate withholding of information

• Deliberate obfuscation of research aims

Researcher/

institutional

• Bribery in existing REC

• Ingrained institutional unethical practices or institutional culture of disregard for legal requirements

Community

• Dishonoured commitments

Country

• Data sharing without consent because of lack of strict privacy arrangements

Animal

• Deliberate obfuscation of experimental conditions

Environmental

• Results from HIC research inappropriately applied in LMIC context

Research misconduct can happen anywhere; it is not unique to collaborative ventures in LMICs. However, variations in customs and a lack of facilities to ensure oversight of compliance with research ethics might encourage unscrupulous behaviour. In our investigation we found that people can be put at risk if sensitive personal data is not sufficiently protected or exploited; when, for example, blood samples or data are sold for profit without the knowledge or consent of the participants. In some institutions, certain unethical practices may become the norm, and even those workers who object may feel pressurized to comply. Additionally, researchers may break promises routinely; where, for example, the researchers have promised to return with feedback about the research and then fail to do so. A lack of integrity can also threaten animal welfare. Where standards of animal housing and care are not high, obfuscation about the conditions in which the animals are kept may occur for two main reasons: first, to ease the process of gaining ethical approval from the HIC partner, and secondly, so as not to jeopardize publication of the experimental results.8

Conclusion

Our findings revealed 88 separate risks for exploitation but in this conclusion, we draw attention to three factors that underpin many of the individual risks, namely:
  • Extreme differentials in available income, i.e. serious poverty

  • Extreme differentials in power

  • Past history of colonialism

Serious Poverty

The most obvious risk of exploitation in LMIC-HIC collaborative research is the extreme divergence in levels of affluence across the world. Many of the individual points in the risk table have their origins in extreme poverty. Researchers cannot solve this problem, but they can show heightened awareness of it and try their best to promote local improvements, for example by equitably involving local researchers, by focusing their research on local research needs and by obtaining input from local populations.

Extreme Differentials in Power

The relationship between wealth and power, and the differentials in power between those who are wealthy and those who live in poverty, is a topic that has filled books, halls and television programmes. However, other factors also play a part in maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United Nations member states have never been members of the Security Council and hence have never even had voting rights, let alone veto power.

Past History of Colonialism

Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how “indigenous peoples had to challenge, understand and have a shared language for talking about ... colonialism” (Smith 2012).

We close this chapter with a comment from the TRUST gender adviser, Prof. Fatima Alvarez-Castillo (2016):

A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that unschooled women have more expertise about their own situation than the experts. This ushered in a new research philosophy that valorizes poor women’s stories and their own versions of their realities.

Footnotes

  1. 1.

    The export of unethical research from a high-income setting to a resource-poor setting with weaker compliance structures or legal governance mechanisms.

  2. 2.

    A placebo-controlled trial involves some participants being given a medicine with active ingredients, for instance a new drug against malaria, while others, the control group, are given a substance that should have no effect (the placebo), so that the outcomes can be compared.

  3. 3.

    One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the “standard of care” debate.

  4. 4.

    This type of consultative exercise is of proven value in the development of ethical codes that are broadly representative and can have wide-ranging impact. For example, the principles of the “Three Rs”, which are globally accepted as a reasonable measure for ethical conduct in animal research, arose from a broad consultation with stakeholders undertaken by Russell and Burch in the 1950s. See Russell et al. (1959).

  5. 5.

    “Institutions” includes local researchers as well as their organizations.

  6. 6.

    For instance, if a researcher learns that female genital mutilation is being used as a “cure” for diarrhoea in female babies, respecting this approach to health care is likely to be the wrong decision, particularly as the practice is likely illegal. At the very least such a decision would leave the researcher with a serious conflict of conscience (Luc and Altare 2018).

  7. 7.

    For example, applying genome editing technologies to human embryonic stem cells.

  8. 8.

    Many academic journals that publish results from animal experimentation stipulate requirements that the studies have been conducted in a manner that is consistent with high ethical standards such as EU Directive 2010/63 (EU 2010).

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Authors and Affiliations

  • Doris Schroeder
    • 1
  • Kate Chatfield
    • 1
  • Michelle Singh
    • 2
  • Roger Chennells
    • 3
  • Peter Herissone-Kelly
    • 4
  1. 1.Centre for Professional EthicsUniversity of Central LancashirePrestonUK
  2. 2.Africa OfficeEuropean & Developing Countries Clinical Trials PartnershipCape TownSouth Africa
  3. 3.Chennells Albertyn AttorneysStellenboschSouth Africa
  4. 4.School of Humanities and Social SciencesUniversity of Central LancashirePrestonUK

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