The need for compensation for RRIs in low-income and middle-income countries

Since the mid-1980s, researchers from high-income countries have increasingly sought to conduct research in low-income and middle-income countries (LMICs).17 Multiple factors might have contributed to this trend including: tightening of regulations in the West to protect vulnerable groups, such as prisoners;18 demands to develop research questions specific to ‘neglected diseases’ in LMICs such as HIV/AIDS, malaria and tuberculosis,19 and the possibility that drug companies incur significantly less costs for research and drug development work done in less developed countries.19 ,20

Although LMICs have been assuming more and more of the burden of health research, the ethical infrastructure has not progressed at the same pace. Nascent regulatory frameworks and ethics committees in Africa are just beginning to grapple with contentious ethical issues in research.19 ,21 ,22 The issue of compensation for RRIs reflects this general trend. For instance, there is no published empirical data on the extent of the occurrence of RRIs in LMICs, but isolated reports like the Pfizer scandal in Nigeria,23 indicate the problem exists. In India, for example, the rapid growth of a poorly regulated clinical trial industry has been associated with a considerable number of deaths of study participants. Most of the victims' families have not been compensated.24 These cases necessitated the introduction of national regulations in India to tackle RRIs, and sparked significant debate in India and beyond.4 ,5 ,25 ,26 It is, therefore, just a matter of time before African countries realise the magnitude of RRIs and the suffering of affected individuals who have no legal protection from researchers.

Towards a regional solution to compensation in Africa

If African countries are seeking ways to compensate those who sustain injuries as a result of participation in biomedical research, there is need to explore the social, moral and political receptivity of this practice, and also interrogate the ethical principles that shape African moral, social and political thought. Behrens et al, for example, implores African philosophers and ethicists to reclaim their dignity and reaffirm their identity, by appealing to their own culture, moral traditions and ethical values when reflecting on their ethical problems and dilemmas.27 This paper attempts to contextualise compensation for RRIs in Africa, through an approach grounded in the values of African people and the continent. It is our argument that litigation and tort approaches to compensation are unlikely to work in Africa, because most people enrolled in research are too poor to afford legal challenges through the courts, and populations with low literacy levels are unlikely to know their rights to compensation and how to claim them. Since the tort compensation system is adversarial, researchers are also less likely to facilitate compensation for illiterate participants, whereas these features may be less prominent in a more collaborative, less adversarial, no-fault based compensation system. As Pike observes, even in the USA where the tort system has been operational for a long time, this system does not adequately serve research participants.2 Below, we sketch a model for compensation that resonates with African social, moral and political values and practices, and one that may help foster greater consensus on compensation for RRIs in global research involving the African continent.

Dispute resolution in African cultures and traditions: how was compensation for harm handled?

Before proceeding, it is important to note that when discussing African culture, traditions and notions of ethics and morality, a number of generalisations will be made. This, however, does not mean that there is one homogeneous African culture or tradition. Indeed, differences do exist in, for instance, folktales, proverbs and the manner in which cultural practices are carried out, and it would be misleading to overlook such cultural differences. Similarly, it would be equally wrong not to recognise the common values and, at times, uniformity that exists within this diversity south of the Sahara.28

This being said, when it comes to conflict resolution in communities, including conflicts about harms to persons, questions of injury and appropriate compensation are likely as old as humanity and go far beyond the research context. There is compelling evidence from literature emanating from different regions of SSA that dispute resolution is traditionally based on what can be termed ‘collective responsibility without blame’, which functions around consensus building and long-lasting reconciliation and is aimed at providing appropriate compensation, restoring communal harmony and preventing of further disputes.29 ,30 The emphasis here was on restoration of harmony rather than the emphasis on who is right or wrong. Kabundi, a contemporary jurist and criminologist, observes that in traditional justice systems ‘… no attempt (was made) to prove wrongdoing on the part of the person who caused the damage, or to analyze the person’s psychological circumstances at the time of the deed’.30 Kabundi adds, ‘… once the debtor was identified, the people whose task it was to pronounce justice would not go to any more effort to condemn the person who caused the damage for his or her deviant, antisocial behaviour. Instead, the emphasis was placed on conciliation and on restoring understanding and harmony within the entire group. … In this judicial process, because of the collectivist nature of traditional African society, the victim was certain of obtaining compensation. The probable insolvency of the person who caused the damage was mitigated by the certain contribution of every member of the group. However, to avert gratuitous acts by individuals who might abuse this collective generosity, there was a provision that anyone found to be liable for any sort of damage would have to contribute to repairing the damage through levies on his or her own personal property’.30

The sentiments raised by Kabundi are echoed by views from other regions in Africa, notably the works by Louw on the African concept of Ubuntu and restorative justice in South Africa,31 Matavire from Zimbabwe,32 Wandibba from Kenya33 and several others.34 ,35 A modern day example of this justice system is the manner in which the South African Truth and Reconciliation Commission dealt with the perpetrators of violence and human rights violations committed under apartheid: individuals were encouraged to seek pardon and amnesty for crimes they committed rather than taking punitive measures to compensate for the injustices that many black Africans suffered under apartheid.28

Application of the traditional African dispute resolution system to compensation for RRIs

Two principles can be drawn from the dispute resolution process described above. Foremost, that there was no attribution of blame to the offender and, second, that there was a collective responsibility through contributions from members of the community to ensure that the injured one gets compensated. By attaching no blame to the offender, the traditional African judicial system was essentially applying what has now come to be known as a ‘no-fault’ policy. With the no-fault system, when a research participant is injured during participation in the research, the research team only needs to establish that it is the participation in the research that has resulted in the injury ‘causality’ regardless of who was to blame or was responsible for the injury ‘fault’.36 Despite a few challenges (like deciding what sort of injuries qualify for compensation and to what extent14), no-fault compensation is the model currently being advocated by some ethicists as probably the most equitable compensation policy, and argue that it should be adopted by the US government as a federal regulation.1 ,2 ,9 This system is enshrined in the ABPI guidelines and a lot of countries in Europe have a no-fault compensation policy as a legal requirement before approval of any clinical trial.

The second tenet in the traditional African dispute resolution system, collective responsibility for mobilisation of resources for compensation, addresses the pertinent question on mechanisms for funding the no-fault compensation system. As observed above, in the traditional African system, the community acted as surety that whoever was harmed would be compensated. If this tradition of solidarity were to be applied to the research setting, then, all the stakeholders in the research enterprise: the local research organisation, research sponsors, researched communities and the host governments, would contribute to the compensation mechanism in one way or another, not necessarily only financial compensation or support. Such a system would work in tandem with a no-fault compensation system whereby both the study sponsors and the host institution or country contribute to an insurance fund or pool.

Just as the first principle of not attaching blame translates to no-fault compensation in modern research ethics discourse, the concept of contributory collective responsibility also finds some support in contemporary ethical guidelines for conduct of international research as outlined by Emanuel et al, where the authors advocate both for ‘…collaborative partnership between researchers and sponsors in developed countries and researchers, policy makers, and communities in developing countries’ and also for the research to be valuable to the society in which it is conducted.37 Thus, if these ethical principles by Emanuel et al are followed, only research that is beneficial to the community in which the research is conducted will be carried out, and it then follows that the burden of compensation for RRIs does not fall on sponsors alone but rather, the host communities and countries should also contribute since they are also beneficiaries of the research enterprise. In the event that the research being carried out offers little or no benefit to the studied community, the local research ethics committee should ensure that the researchers and their sponsors take full responsibility for any injuries that may result from such an exercise.

Analogous to traditional African systems, there could be a mechanism to prevent unscrupulous researchers who might abuse the collective solidarity of the compensation system. Such preventative measures could require sponsors of research with a considerably higher risk for harm, or where the sponsor benefits much more than the researched community (as cautioned above), to contribute more, or entirely, to the compensation mechanism.

The principles of collective responsibility, solidarity and compensatory justice with regard to contributions to the compensation mechanism also have the potential to mitigate overly restrictive regulations. The new regulations on RRI in India have been described as such by some commentators.25 ,38 However, if host countries and regulators themselves share the responsibility for the provision of compensation, this may inhibit countries creating overly demanding rules about compensation for RRIs.

We isolate the elements of the traditional African dispute resolution system and relate them to our proposed research injury compensation mechanism in table 1.

The moral justification for no-fault compensation and collaborative responsibility drive for RRIs in Africa

We have so far made a number of observations: that injuries to research participants in Africa is an ongoing risk for as long as research keeps being conducted on the continent; that different regions in the world have put in place mechanisms for compensation of such injuries; that such mechanisms are not uniform across the developed world; and that the continent of Africa needs to define its own compensation model and regulate it. We have also established that in the traditional African dispute resolution a no-fault model was used with collective responsibility from all stakeholders. However, all these conclusions would come to no effect if there were no moral justification to rally the people of Africa behind any proposed model. Henry clearly articulates that the tension among ethical principles has led to moral gridlock that has prevented the USA from moving forward on this issue of compensation.39 Different ethical principles including reparative justice, humanitarianism, professional beneficence and compensatory justice, have been invoked by different committees assembled to address the question of compensation in the USA, and each has generated a unique moral obligation to compensate injured subjects, whose application results in distinct compensation schemes.39

We consider the Bantu ethic of Ubuntu, promoted by some prominent African ethicists, as the spirit behind the no-fault traditional judicial system and its associated collective responsibility for compensation, described by Kabundi and other authors of SSA judicial history.30–35

Ubuntu ‘refers to a practical humanist disposition towards the world’, a notion that emphasises the interconnectedness and relatedness of individuals within the community, thereby encouraging virtues such as fairness, compassion, justice, respect and dignity for humankind. The ethic of Ubuntu stems from the understanding that an individual is not an atomic entity, but one that is socially constituted. Hence, Ubuntu expects individuals not to engage in pursuits that are detrimental to the well-being of the community. In the context of the judicial system where one member of the community has been harmed by another, the practice of not attaching blame to the offense respects the notion that the one who has offended is a ‘brother’ to the one that has been offended, and in order to enhance social coherence, the whole community shares the blame and responsibility for compensation.

According to the Ubuntu philosophy, ‘an injury to one is an injury to all’ and ‘an injury by one is an injury by all’. Such solidarity expresses the essence of humanity and expresses the spirit of communalism. It should come as no surprise then, that this traditional ethical thinking would seem to provide a natural home for no-fault compensation for RRIs. The African ethic of Ubuntu, it can be argued, is both at the heart of the traditional African judicial system and shares affinities with no-fault compensation schemes, and as such should find acceptance as the moral justification for compensation on a no-fault basis contributed by all stakeholders of the research enterprise.

One may argue that the proposed Ubuntu philosophy if implemented might also lead to conflicts with the principles of respect for autonomy and distributive justice. Hypothetical situations may arise whereby one African individual volunteering to participate in research sustains an RRI. If the Ubuntu philosophy is applied in the strictest sense, this injury will be classified as injury or loss to the entire community in the spirit of ‘Ubuntu’, thereby necessitating that any compensation for the RRI be distributed to the entire community and not to that individual alone. Such a situation where the compensation is distributed among the various stakeholders within the community would mean that the individual, who originally volunteered for the benefit of society, ends up receiving less of the monetary or other compensation.

Indeed such a scenario would bring confusion and probably be unjust to the individual who initially volunteered in the research. It is known that traditional African society is based on both the community and the individual person with the community coming first and the individual, second.29 Balma observes that although the group takes priority over the individual, it must do so without harming him and must allow him to prosper as a person.29 This principle would therefore mitigate the hypothesised situation raised above. In the narrative by Kabundi, individuals were still recognised as individuals, owning personal property, unlike in a socialist setting.30 Through no-fault systems, the injured person receives less compensation as they would upon successful contention in tort, and this could count as the benefit to the community and stakeholders in that the pool of resources for compensation is conserved, therefore, reducing community contributions to the fund.

The need for regional regulation to guide compensation for research injuries

Experience has shown that, however, well-intentioned ethical guidance may be, in the absence of a legal framework to regulate the guidelines, such claims are not enforceable in a court of law. The case of Abdullahi v Pfizer brought by Nigerian litigants in 2005 comes to mind on this aspect when the trial judge in the New York Circuit court opined that ‘while this court may disapprove of Pfizer's actions … it must apply established law, not some normative or moral idea’.40 In South Africa, where the ABPI mechanism was listed as one of the guidelines for compensation of RRI by the Medical Research Council in South Africa for over 15 years, no patients or human research participant injured during biomedical research in South Africa have been compensated using this mechanism due to lack of enforcement. Mamotte et al decry the non-commitment of US sponsored researchers in South Africa, particularly the National Institute for Health's HIV/AIDS clinical trials, to provide compensation for the treatment of RRIs for trial participants, and the refusal to allow grant funds to be used for appropriate insurance despite the South African Medical Research Council (2003) and South African Good Clinical Practice Guidelines (2006) recommendations for compensation.41

It is therefore important that any resolution made by African governments, be passed as a law by a regional body, to ensure that all researchers coming into the region to conduct research, abide by the provisions of such a law and are held accountable. We therefore echo Chima's appeal made as early as 2006 that ‘it is ethically imperative for the African Union to develop regulations and directives for biomedical research in Africa which would be binding on but adaptable to the laws of individual states’.21 This approach seems to be working in the EU where a common legal framework for the insurance of subjects participating in clinical research was instituted through the EU Directive 2001/2020 which became effective in 2004.16 With this directive, research ethics committees in EU member countries are mandated by law to authorise a clinical trial only if ‘provision has been made for insurance or indemnity cover the liability of the investigator and sponsor’. Similarly in Japan, the guidelines by the Japan Pharmaceutical Industry Legal Affairs Association, developed in 1999 and revised in 2009, mandate research sponsors to contribute to the cost of treatment for clinical trial RRI as a part of compensation and also monetary compensation for death or disability to be provided by the sponsor.42 Through this legally enforced system, Japan boasts of probably the highest rate of compensation for clinical trial-related injuries; 99% of all injuries were compensated according to one report.42 Such success stories from legislation of compensation policies should act as an example for African countries.

Although the principle of Ubuntu, which underpins our proposed compensation mechanism, is more largely accepted among the Bantu people of SSA, for the sake of unity and uniformity, we recommend that the African Union (AU) should move to legislate insurance-based no-fault compensation for RRIs, based on the ethic of Ubuntu.