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Viewing benefit sharing in global health research through the lens of Aristotelian justice
  1. Bege Dauda,
  2. Kris Dierickx
  1. Correspondence to Professor Kris Dierickx, Department of Public Health and Primary Care, Centre for Biomedical Ethics and Law, 35, Kapucijnenvoer box 7001, Leuven 3000, Belgium; kris.dierickx{at}med.kuleuven.be

Abstract

The ethics of benefit sharing has been a topical issue in global health research in resource-limited countries. It pertains to the distribution of goods, benefits and advantages to the research participants, communities and countries that are involved in research. One of the nuances in benefit sharing is the ethical justification on which the concept should be based. Extensive literature outlining the different principles underlying benefit sharing is available. The purpose of this paper is to examine the proposed principles using Aristotelian principles of justice. The paper assesses the central idea of Aristotelian justice and applies and evaluates this idea to benefit sharing in research, especially when commercial research sponsors conduct research in resource-limited countries. Two categories of Aristotelian justice—universal and particular—were examined and their contribution to the benefit-sharing discourse assessed. On the one hand, benefit sharing in accordance with universal justice requires that for-profit research sponsors obey the legal regulations and international standards set for benefit sharing. On the other hand, benefit sharing in accordance with particular justice transcends obeying legal requirements and standards to a realm of acting in an ethically accepted manner. Accordingly, the paper further examines three perspectives of particular justice and develops ethical justification for benefit sharing in global health research. As Aristotelian justice is still relevant to the contemporary discourse on justice, this paper broadens the ethical justifications of benefit sharing in global health research.

  • International Affairs
  • Philosophical Ethics
  • Research Ethics
  • Public Health Ethics

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Introduction

Participation in global health research is considered altruistic, as research participation is viewed as an individual's contribution to the advancement of medicine and service to other patients.1 ,2 While this altruistic notion is still important in medical research, there is a growing emphasis on the need for research participants and communities to accrue some benefits for participating in research. The emphasis on conferring benefits to research participants is especially relevant considering the proliferation of for-profit research sponsors that outsource research in developing countries.3 Studies show that participants are more motivated to participate in research because of perceived benefits to themselves, particularly information and clinical care, than an appeal to altruism.4 The ethics of sharing a portion of the gains with research participants and, by extension, research communities is contained within the concept of benefit sharing. It is a concept that deals with the fair allocation of the profits and fruits of the research by the sponsors with the participants and communities. There is a consensus within the ethics community that individuals and communities that participate in a research study ought to have some benefits from it, especially when the study is on commercial products that generate profits for the sponsors and is conducted in resource-limited countries where there are many healthcare challenges.5

Furthermore, assuming that for-profit research sponsors would gain surplus profit from a proven medication after a trial in a resource-limited country, it would be ethically right to allocate benefits to the participants and communities that have contributed to the trial.6 However, if benefits are not allocated, we would presuppose a case of exploitation and the sponsor would be regarded as having taken undue advantage of the participants and communities.6 Exploitation raises a concern for justice, and justice seeks to restore fairness to the participants and their communities by determining what they ought to accrue for their contribution to the research activity.7 There are different perspectives of justice and each of these perspectives presents different rationales as to what fair benefits in research interaction ought to be. For example, from the perspective of commutative justice, benefit sharing is an instrument of exchange. From this perspective, benefit allocation in a given research interaction is considered fair only when there is an equivalent exchange of benefit between the research sponsors and the researched community.8 Commutative justice does not consider the inequality between the sponsors and communities; rather, it only considers whether the resources to be exchanged between the sponsors and host communities can be equated fairly. In contrast with commutative justice, the distributive justice perspective considers the inequality between the sponsors and the participants in the allocation of research benefits. In other words, distributive justice emphasises that equals should be treated equally and unequals should be treated unequally.8 ,9

This paper examines the Aristotelian concept of justice and how it applies to the concept of benefit sharing. Aristotelian justice encompasses the notions of distributive, commutative and corrective justice, and represents an important framework for contemporary justice reasoning among scholars.10 The impetus for this paper stems from the fact that, in most of the literature, the concept of benefit sharing is associated with the Aristotelian notion of commutative justice.11 ,12 We deem it necessary to take a step further by assessing how the concept of Aristotelian justice applies to benefit sharing. The paper starts from a comprehensive overview of the Aristotelian concept of justice and then provides an analysis of the concept as it applies to benefit sharing.

Aristotelian concept of justice

In his seminal work, the Nichomechean ethics, Aristotle distinguishes between two types of justice: universal and particular.13 ,14 Universal justice, otherwise known as general justice, is related to the moral uprightness of a person to lawful conduct. Lawful conduct would demand that a person act in accordance with the law and in ways that would not injure others in society. Lawful conduct, according to Aristotle can encourage the development of virtues in a person. For example, the law can encourage or force a soldier to remain at the war front and thus ignite the virtue of courage.15 As such, a person acting in accordance with the laws of universal justice would develop virtues by simply abiding by the prescribed laws. Justice in a universal sense is therefore a special virtue because it encompasses all other virtues and it involves one's relationship with others. A just person is one who acts according to the law in an honest, modest, courageous, moderate and wise way. It goes without saying, according to Aristotle, that to be dishonest or to act cowardly is to act unjustly.13

Aristotle recognises that the practice of lawful conduct as dictated by justice in the universal sense would not necessarily lead to the fullest development of virtues in a just man. In other words, obeying a prescribed law in a given society does not entirely define a person as a just person in that society, as societies vary considerably from one another.16 For example, what might be considered lawful or virtuous conduct in an oligarchy might be regarded as unlawful and a vice in a democracy. Aristotle recognises this tenet and proposes justice in the particular sense. He describes particular justice as that which concerns itself with the fairness and equality on which things have to be shared by deserving members of the society.17 Particular justice takes note of those acts that might be unjust and are not recounted in the prescriptions of the law. In other words, justice in the particular sense transcends an individual's compliance and non-compliance with the prescribed law to a domain where everyone is apportioned a just proportion of property.18

Aristotle grouped particular justice into three categories: distribution of goods (distributive justice), correction of private transactions that have gone wrong (corrective justice) and the reciprocity in exchange of goods and services (commutative justice). These categories of particular justice are very relevant in the current discourse on justice and benefit sharing.

Aristotelian concept of justice and benefit sharing

Hitherto, we have noted that benefit sharing is essential in global health research especially when for-profit research sponsors conduct research in resource-limited countries. We have also distinguished between the Aristotelian concepts of universal and particular justice. In accordance with universal justice, for-profit research sponsors are expected to act justly by obeying the set laws and regulations of benefit sharing. For example, commercial biotechnological companies that want to obtain a non-human genetic resource for their research have to act in accordance with the Nagoya Protocol on Access and Benefit Sharing.19 This is because the Nagoya Protocol represents an important binding regulation on benefit sharing. As such, for-profit research organisations within the non-human genetic research community that act in accordance with the legal guidelines of the Nagoya Protocol would be acting justly and in line with Aristotle's universal justice. In the same vein, pharmaceutical companies that conduct global health research would act justly and in accordance with the principle of universal justice if they abide by benefit-sharing provisions as specified in international ethics guidelines such as the World Medical Association guideline (Helsinki Declaration), Council for International Organizations on Medical Sciences (CIOMS) guideline, etc. For example, the Helsinki Declaration states that ‘at the conclusion of the study, patients entered into the study are entitled […] to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits’.20 This position has been slightly adjusted in the new version of the Declaration of Helsinki.21 Also, Ravinetto et al 22 state in reference to the CIOMS guidelines that any product developed in a research programme should be made available to the population involved in that research. If there are reasons to believe that these requirements cannot or will not be met, the guidelines deem it unethical and exploitative to conduct research in that country. The statements in the Helsinki Declaration and CIOMS guidelines are guiding principles, which research sponsors are expected to abide by in order to act morally in the conduct of their research. Assuming that these principles are legally binding regulations that must be implemented at all times, then research sponsors that abide by them to ensure good access to proven medication to the host communities after trials are acting in accordance with universal justice.

However, because most regulations on benefit sharing are not formulated as legally binding regulations, it is unrealistic to rely on universal justice in justifying benefit sharing. Apart from the Nagoya Protocol on Access and Benefit Sharing in research involving non-human genetic resources, which is a binding document on benefit sharing, other regulations on benefit sharing in global health research involving human subjects are mostly in the form of non-binding international ethics guidelines. Moreover, some of the regulations in the international ethics guidelines are vague and ambiguous.23 Consequently, the concept of universal justice is not suitable as a rationale for the ethics of benefit sharing, especially in research involving human subjects. However, Aristotelian particular justice, which focuses on just proportions of properties and transcends acting in accordance with the law, can justify benefit sharing when it is not formulated as a legal framework.

From the perspective of particular justice, research sponsors are expected to share research benefits with host communities not because of any law stipulating the same, but because it is ethically good to do that. We elaborate on particular justice and show how it relates to benefit sharing in global health research.

Distribution of goods and benefit sharing

Just distribution of social goods can be achieved in a society if the principle of equality among deserving members complies with geometrical proportion.18 According to geometrical proportion, equality is applied when the concern is for a just distribution of goods between persons. Geometric proportion prioritises the evaluation of persons rather than shares, and assumes that persons are unequal. It requires consideration of such questions as: is this person ‘equal to’ or worthy of the share that they will receive? Such questions result in equal shares being distributed to equals, and unequal shares to unequals.24 In other words, equals are treated equally and unequals unequally.25 For example, a government can decide to distribute radio sets to school pupils in order to encourage the practice of listening to the news. It will be unjust to distribute radio sets to both pupils with normal hearing and pupils with impaired hearing because they are unequal in their hearing abilities. Justice demands that hearing-impaired pupils should receive additional adapted support that helps transcend their hearing problem—say, sets of hearing aids (assuming that the use of hearing aids will enable them to listen to radio). This type of distribution of goods is in accordance with the principle of distributive justice. It is vital in distributive justice to determine the criterion on which the distribution of goods should be based. Set criteria could be based on the rights, needs, status or contribution of the beneficiaries.26 In the example of distribution of radio sets to school pupils, the hearing-impaired pupils deserve adapted complementary benefits (hearing aids in addition to the radio sets) based on the criterion of need.

For-profit research sponsors are expected to comply with the principle of geometric proportion in the distribution of research benefits to communities in resource-limited countries. Many communities in resource-limited countries live in poverty and have compromised healthcare systems with dilapidated or non-existent infrastructures. These bad conditions create the criterion of need for distributive justice whereby for-profit research sponsors should share benefits with the communities in which the research is conducted. However, it must be stated that there are no obligations based on distributive justice that specify that research sponsors must provide benefits because they have conducted research in resource-limited countries. These responsibilities are borne out of a moral duty to do so.23 ,27

It is important to note here that distributive justice in accordance with geometric proportion may be exceedingly difficult to apply in practice in so far as there is a lack of a common platform on which to compare the worth of agents and the distributable goods.14 Furthermore, the principle of distributive justice is centred on just distribution of benefits among individuals or groups within a nation state.28 As such, a platform on which benefit sharing can be extended to citizens outside the geographical boundaries of a state is needed. A global distributive justice argument fits well for such a platform. While distributive justice underscores just distribution of goods among individuals and groups within a state, global distributive justice extends and fortifies such just distribution of benefits to other people that are not within a national boundary or a state. By this reasoning, for-profit research sponsors are expected to uphold benefit sharing in global health research as a means of distributing health goods and services to resource-limited countries in order to improve their healthcare systems.

Similarly, because clinical trials are continually conducted on a global scale across many countries,29 it is important that the accompanying ethical considerations and principles should also have a global approach. Global distributive justice in health research has been advocated through benefit sharing. For example, the Human Genome Organization (HUGO) Ethics Committee—a committee set to deliberate on benefit sharing and other ethical issues in genetic research—has suggested that companies involved in international health research should set aside 1–3% of their profits for charitable work to improve the healthcare of populations in poor countries (HUGO Ethics Committee, 2000). Also, Ballantyne expresses the view that commercial research industries outsource research in developing countries because they enjoin surplus profits that they would otherwise not realise if the research were conducted within an industrialised country. She then proposes that a global research tax should be paid by commercial research industries from the surplus profits, which are meant for developmental projects in resource-poor countries. This global research tax could be used to generate revenue for local health-related capacity building.5

Reciprocity in exchange of goods and benefit sharing

Aristotle further describes another type of particular justice whereby persons (or groups) freely exchange equal proportions of goods. The goods to be exchanged have to be proportionately equal and the parties freely agree to a reciprocal exchange of such goods in the transaction.14 In Aristotle's example: ‘let A be a builder, B a shoemaker, C a house, D a shoe. The builder, then, must get from the shoemaker the latter's work, and must himself give him in return his own. If, then, first there is proportionate equality of goods, and then second reciprocal action takes place, [then a just exchange is said to occur]. If not, the bargain is not equal, and does not hold; for there is nothing to prevent the work of the one being better than that of the other; they must therefore be equated’.13 ,17 The idea here is that, if individuals or groups voluntarily transact and exchange their goods and services with one another, for such a transaction to be considered just, the goods to be exchanged must be proportionally equal. This Aristotelian notion of exchange is also known as commutative justice or justice in exchange.30 Commutative justice is not concerned with the equality of the individuals or groups involved in the transaction, rather it is concerned with the proportionate reciprocation of the goods to be exchanged.18

However, in practical terms it is difficult to establish two things that are proportionately equal, as not all goods are easily comparable. For example, it may be difficult to correctly establish the number of pairs of shoes that are proportionately equivalent to a house. Aristotle points out that money can help in solving such proportional difficulties—because money is an intermediate that serves as a measure for all things. Money serves as a surety to get some goods that one needs, and the amount one pays serves as the proportionate equality to the goods one needs.17 This means that an exchange in a transaction that leaves one party with too little money than the right amount is unjust; the party with too little money is said to be treated unjustly and the party with too much money is said to have acted unjustly.

Commutative justice as applied to benefit sharing fits well with non-human genetic research such as research involving the use of plant genetic resources as delineated in the Convention on Biological Diversity (CBD). The CBD regulation has granted property rights to the custodians of genetic resources.31 In other words the custodians of genetic resources have a sovereign right over the biological diversity (goods) within their geographical boundaries. In accordance with Aristotle's commutative justice, transaction between local communities and commercial research sponsors can only be just when plant genetic resources that the research sponsors obtain are proportionately exchanged with benefits to the local communities.9 The research sponsors can provide proportionate exchange of goods that the communities might need such as social infrastructures, technological transfer to the communities, etc. According to Aristotle, money would be the appropriate medium that can measure the worth of biological resources. However, the use of money as incentives is highly discouraged in research—as such, we advocate that research sponsors should endeavour to improve health and infrastructure in communities in exchange for the biological resources they obtain from the communities.

The commutative justice argument for benefit sharing does not hold for benefit sharing in global health research involving human subjects, because human subjects do not have property rights over their body to the extent that they can freely exchange their organs or tissues with other goods. As such, because the body cannot be seen as a property,32 it is difficult to talk about commutative justice where researchers offer money or other goods to research participants in exchange for body materials for research. Moreover, human genetic resources have been removed from the legal framework of the CBD.33

Correction of private transactions that have gone wrong and benefit sharing

Aristotle states that private transactions among individuals or groups can sometimes go wrong, with one party suffering harm and, as such, an injustice. Such transactions can be either involuntary or voluntary.13 In the case of an involuntary transaction, the consent of one of the parties in the transaction is absent; as such, the party that did not consent has been coerced or forced into the transaction. Involuntary transactions are carried out either in secret, such as theft or poisoning, or in violent ways, such as robbery, assault and insult. In a voluntary transaction, the parties involved in the transaction have voluntarily agreed to exchange goods and services. For example, voluntary transactions are seen in trade transactions such as buying, lending at interest, pledging and letting for hire. Transactions in which one party has suffered an injustice need to be addressed through corrective justice or restorative justice.

Corrective justice is mainly aimed at restoring equality between the injured party and the perpetrator of the injury. Corrective justice focuses on an arithmetic proportion in restoring equality to the injured party. This implies that parties involved in the transaction are considered equal entities—what matters is whether the compensations to the injured party are proportionate to the degree of injustice suffered.18 ,25 Research activities between participants and communities on the one hand and research sponsors on the other take the form of a voluntary transaction because the groups have voluntarily consented to interact (although in the past some research participants were coerced to participate in research, eg, the Nazi experiments).34 Sometimes such research transactions can go wrong and the communities and participants suffer varying degrees of harm. The harm could be the result of an unintentional occurrence or wrong ethical conduct by the research sponsors. For example, an unintentional occurrence could be that the intervention to be tested in the research has severe adverse effects on the participants. Wrong ethical conduct could be sponsors' overutilisation of the existing local health facilities of the community for their research, or the sponsors' total reliance on the local health staff for their research, thereby curtailing adequate provision of integrated health services to the population.35 Another ethically wrongful conduct could be not making a new, innovative drug available in a country where clinical trials of it were conducted, or making it unaffordable to those in need in that country. These conducts constitute forms of harm to the research communities and participants and requires some form of restoration.

Aristotelian corrective justice or restorative justice is closely related to compensatory justice in the contemporary discourse of justice.36 Compensatory justice, in turn, is linked to benefit sharing and is aimed at ensuring fair recompense to research participants and communities in return for their contribution.37 An advantage of the compensatory justice approach to benefit sharing is that sharing of research benefits is not necessarily confined to participants and communities in resource-poor countries only but is also applicable in industrialised countries. In general, participants in developing countries would be eager to participate in research because of perceived therapeutic gains and poor regulatory oversight compared with participants in industrialised countries. However, in terms of the risks incurred during research, all participants irrespective of their context are prone to similar burdens. As such, because participants in industrialised countries can be subjected to similar risks and burdens to their counterparts in developing countries, they should equally be compensated for their risks in participation. Ndebele et al 38 argue this, stating that: ‘research participants from both industrialized nations and those from limited resource settings should be compensated equally since they suffer the same burdens and equally contribute towards the study by contributing the same product data’.

Conclusion

While many publications on benefit sharing only mention the link between benefit sharing and Aristotelian commutative justice, this paper applies the broader concept of Aristotelian justice to benefit sharing in global health research. The paper has critically analysed benefit sharing in the framework of Aristotelian universal justice and has provided insight that benefit sharing within it would mean obeying the set rules and legal frameworks on benefit sharing. We have also broadened the analysis by evaluating benefit sharing within the three perspectives of Aristotelian particular justice. Among these three perspectives, we have demonstrated that distributive justice and compensatory justice offer a good justification for benefit sharing in global health research. Commutative justice is not as suitable for benefit sharing in global health research involving human subjects because of the restriction on commodification of the human body. Nonetheless, the commutative justice approach is well suited in research involving non-human genetic resources.

Accordingly, commercial research sponsors must endeavour to contribute to the development of healthcare systems in resource-limited countries. In accordance with universal justice, the research sponsors must abide by the international standards and legal frameworks on benefit sharing. However, because there are no legal frameworks on benefit sharing in global health research, and international guidelines are not well elaborated on the aspect of benefit sharing, universal justice is not enough to strengthen benefit sharing in health research. We need Aristotelian particular justice, which consists of the three ethical justifications of distributive justice, commutative justice and corrective justice. As such, it is important for commercial research sponsors to think of benefit sharing outside the box of legal frameworks. As Aristotelian justice is still relevant to the contemporary discourse on justice, this paper has broadened the ethical justifications of benefit sharing within the justice framework in global health research.

Finally, as stated at the beginning of this paper, benefit sharing is widely accepted among research stakeholders as an ethically sound concept. Nonetheless, because there is no legal framework on the concept, it is rather difficult to enforce it in practice. We recommend as a starting point that international ethics and Good Clinical Practice guidelines for medical research and clinical trials should have explicit statements on benefit sharing. Such statements should include what benefit sharing is, how it can be achieved in research and whose responsibility it is to provide benefits. We must point out that the emphasis on benefit sharing by for-profit research sponsors does not necessarily exempt non-profit research organisations from the requirements of benefit sharing. The emphasis is prompted by the high possibility of self-interest and exploitation of host communities in research by for-profit research sponsors39 ,40 compared with the non-profit sponsors. Nonetheless, non-profit research organisations should also uphold responsible research practices that are tailored to the health needs of resource-limited countries. They can also work towards building capacities of local researchers by providing training, academic research sponsorship of staff to study abroad, etc. This is considered to be a form of benefit sharing.

References

Footnotes

  • Contributors The article was developed at various stages of the drafted manuscript. BD and KD contributed equally to the first draft. BD elaborated the various stages of the manuscript with thorough revision, editing and mentoring from KD during the pre-publication process. Both authors read and approved the final version of the manuscript.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.