Informed consent and its limitations
This study was designed to interrogate the normative ethical principle of respect for autonomy [3, 21], actualised during biomedical research and clinical practice through the doctrine of informed consent [16, 21, 22, 64]. We wanted to see if we could implement via the empirical bioethics approach in African communities dominated by a culture of communitarianism and relational autonomy; this involves combining normative ethical analysis with empirical data, to arrive at results that would not be possible otherwise [16, 57, 58, 64]. According to Mertz and others , ‘empirical ethics’ involves “normatively oriented medical ethical research that directly integrates empirical research” . In other words, empirical bioethics combines both empirical research with normative ethical analysis and tries to integrate both elements to produce new knowledge which might not have been possible otherwise [16, 57, 58, 64]. Here we used qualitative data derived from in-depth interviews with biomedical researchers working in Africa, with detailed analysis of the literature about principlism and respect for autonomy  as well as Ross's prima facie duties [34, 35], together with the African communitarian moral philosophy of Ubuntu or Ukama [10, 23, 29, 32, 37,38,39,40], to evaluate the practice of informed consent during biomedical research in South Africa.
This study supports the prevailing view that informed consent is the central defining feature of contemporary ethical biomedical research and clinical practice for researchers and clinicians, even in Africa, consistent with Manson and O'Neil's observation  that informed consent is a central concept in contemporary bioethics. It is widely seen as fundamental to ethical conduct of biomedical research in humans [22, 30].
Furthermore, we found that biomedical researchers working in South Africa perceived informed consent as a process that research participants and patients must follow to make research valid. The legal and ethical requirements for the informed consent process in South Africa stipulate that informed consent must involve full disclosure of information [16, 63, 64, 67]. There must be complete comprehension of the information disclosed to research participants or subjects. Further, this consent must be voluntary; that is, the individual must be free to agree or disagree on whether to participate in the research study. It also means that this has to occur in the absence of coercion or undue influence. Moreover, human subjects must not consent out of fear or any other reason whereby they cannot decide based on their own free will [16, 22, 64].
There must also be justice; if individuals have to spend their time and effort to get involved in a research study or project, they must be compensated. Even if they happen to drop out of the research study, vulnerable participants should be compensated for their time. One cannot use their time without their agreement, as that would be equivalent to exploitation. As a researcher, one must disclose all of the benefits that may accrue from participating in the research study; further, one must minimise the risks of research as much as possible. The rights to privacy of the individual participants also have to be protected [16, 22, 64, 67]. All these processes are supported by the South African Constitution , common law, the National Health Act 2003 , and international ethical guidelines like the Declaration of Helsinki .
Guidelines such as those promulgated by the Council of International Organizations of Medical Sciences (CIOMS, 2002) , the Nuffield Council on Bioethics (2002) , and the National Bioethics Advisory Commission (2001) , reinforce commitments that transcend cross-cultural differences, by mandating that the same standards should apply to research participants from both resource-poor and industrialised countries [30, 69,70,71,72,73]. For example, research participants in any cultural setting should provide individual voluntary consent, and studies that could not be conducted in an industrialised country should generally not be implemented in a developing country [72, 73]. These advocates applying the same ethical codes regarding informed consent and guidelines across all cultures [22, 30]. The purpose of such declarations was to reduce exploitation as much as possible, especially among vulnerable communities . Nevertheless, during this study, we discovered that balancing universal and local standards for ethical conduct in biomedical research is challenging, especially when investigators/researchers confront the practical constraints of implementing a study in areas where traditional customs may conflict with international ethical guidelines. This was perceived as a problem in research conducted in South Africa by the respondents in this study, and in studies conducted in other rural communities in Africa [74, 75]. In addition, some participants in this study revealed aspects of ethics of care and relational autonomy which could impact autonomy and the informed consent process in the African setting, as reported by other authors .
Furthermore, some respondents in this study highlighted the importance of language and education in informed consent and biomedical research in African communities. Language and education may present a barrier to understanding the informed consent process, as reported by previous studies from South Africa [16, 64, 76]. This consideration prompted the South African National Health Act  to require that HCPs obtaining informed consent in South Africa consider healthcare users' language and literacy levels [16, 64, 67, 76,77,78].
Africa is considered one of the impoverished continents and bears a disproportionate burden of disease morbidity and mortality due to a lack of adequate healthcare resources. It is also struggling to deal with the conflict between general ethical principles and traditional values and norms of behaviour [5, 24, 25, 28, 41, 42, 49]. It is challenging to accomplish the application of general ethical principles underlying guidelines for research conduct, without knowing the cultural context within which a study will occur. Since informed consent is the most important ethical principle for moral conduct of research, it cannot easily be globalised because it is culture dependent. Kuper (1999) states that "Anthropologists have described culture as a symbolic system representing ideas, values, cosmology, morality, and aesthetics, shared by individuals and groups" , and this definition goes against the idea of developing a general ethical principle, because 'culture' is particular to a group. Thus, the principles that guide the informed consent process must be flexible in order to fit in with every culture.
However, the principles advocated by most general ethical guidelines are not very flexible, as they are dependent on the Western-European libertarian tradition. Therefore, they emphasise individual autonomy and privacy, which is likely to fail if applied without cultural modifications to traditional societies like those in Africa. This observation is consistent with the arguments of other researchers working on informed consent in Africa . However, one cannot speak about African culture as if it is a homogenous phenomenon. While affirming the diversity among African cultures and its ability to respond to contemporary social and political realities, this study supports Peter Kasenene's position that "despite variety, there is a common ‘Africanness’ about the culture and worldview of Africans" . Some commonalities are shared by indigenous African societies, such as a belief in ancestors, understanding an individual as communally constituted, and a relational worldview [5, 23,24,25,26,27, 81]. One may argue that these commonalities should be the foundational basis for a discourse on African bioethics . Along this line of thought, Akin Makinde argues that:
Theories and practices of medicine have a cultural basis, and it is because of this notion of social embeddedness that African medical practices are inextricable from African culture and belief systems: From this point of view, the concept of illness, diagnosis, treatment, life, and death, must also have a cultural dimension 
Makinde's argument has also been echoed by Sindiga, Nyaigotti-Chacha, and Kanunah, who pointed out that:
Each cultural group handles its medical problems in a particular way and has its worldview, traditions, values, and institutions, which have developed over time to address disease and illness. Each culture has its disease etiologies, medical terminologies, classifications, medical practitioners, and a whole range of pharmacopeia. 
Sindiga et al.’s observations imply that one cannot postulate, with logical impunity, healthcare practice or ethical methodology as engendering eternal truths that are applicable everywhere, regardless of cultural context. These authors’ analysis established the dichotomy between the Western practice of medicine and biomedical research. Western medicine tends to see disease in terms of the functioning of the body, while Africans may understand diseases in terms of a causal relationship between the "visible" and "invisible world" . In the same vein, Gloria Waite has suggested that an "African understanding of disease should be seen as a medico-religious in contrast to a biotechnical medical system" . Shutte further argues that "a healthcare practice that is purely scientific in its conceptualization and treatment of disease would inevitably fail to embrace the spiritual dimension of human sickness" . Within the traditional African context, such healthcare practice is construed as an exercise in dehumanisation. With its strong emphasis on the idea of the human body's dignity, African bioethics may view Western medical practices as problematic because the human body is treated in such a manner as to regard the person as insentient. In an African cultural context, where a human being is viewed holistically, healthcare practice that emphasises merely repairing human organs is inadequate, because it cannot view disease and causation comprehensively. From this perspective, Janzen states that:
One could argue that this is because of the African holistic view of healing; that is partly why many Africans have resorted to complement Western medicine with that which is provided by African traditional medicine. 
One could argue that the practice of complementing Western medicine with African traditional medicine creates room for the implementation of everything, including informed consent processes, which are ontologically Western. However, none of the participants in our study fully agreed with the above arguments. Some point out that with exposure to Western forms of education one may begin to think individually, which creates room for understanding informed consent in an individualistic way . However, with the whole movement towards decolonialization in Africa, it is arguable that Africa's educational systems are beginning to take into consideration key traditional and African cultural values. Therefore, education may not fully resolve the existing conflict between informed consent and conventional African cultural values and behavioural norms [24, 26, 27, 77]. This ever-growing ethical or moral dilemma has led to the emergence of indigenous populations developing their own codes of ethics, such as the San people of Southern Africa [1, 2, 87, 88].
An alternative approach
This study suggests the need for an alternative approach to the application of informed consent in Southern Africa. The arguments below will combine the findings from the empirical research with existing normative ethics to argue for introducing ethical pluralism in bioethics, while suggesting an alternative approach to ethical decision-making in Africa. Current decision making in bioethics seems to adopt a bottom-up approach to moral reasoning [43, 44]. Since the traditional monistic ethical theories, like consequentialism, utilitarianism, and deontological ethics, appeal to an abstract universal notion of personhood, they could be used as a means of intellectual and cultural imperialism [52, 89, 90].
However, bioethics deals with real people in particular situations: specific persons in specific contexts or contextualized persons. Bioethics is also arguably rooted in culture because there might be no bioethics if there were no cultural practices and way of life [13, 28, 49,50,51,52]. Thus, the four assumed globally accepted ethical principles—respect for autonomy, beneficence, non-maleficence, and justice, formally postulated by Beauchamp and Childress since 1989 —address biomedical issues from a Western-European moral and intellectual perspective, and one can posit that the Western-European worldview is different from the African worldview [3,4,5,6,7,8,9, 24,25,26,27,28,29]. In reality, biomedical ethics is assumed to be culture-free and applicable across cultures, despite obvious evidence that its elements and principles are derived from a specific culture and moral tradition [13, 28].
In this study we opted out of a monistic approach in preference of a pluralistic one due to its compatibility with the idea of multiculturalism. As Kevin and Wildes argue, culture has a deep relationship with morality . The concept of multiculturalism links directly to why morality should be pluralistic and account for a diversity of beliefs and value systems [4,5,6,7,8,9, 50,51,52]. One can assert that morality encompasses moral practice, which is embedded in culture, which we see as a way of life. Ethics seeks to examine those practices and ethical systems that are embedded in cultural practices; advocating for a multicultural society will be synonymous with supporting a morally pluralistic society . As seen from the above report, there are conflicts and ongoing ethical and moral dilemmas. The differences in cultural and moral values and seemingly intractable problems within the traditional ethical theories indicate the need to look for a principled alternative approach, which is vital to this study. Adopting Ross's model of moral reasoning as a lens, one may argue that it is possible to develop suitable methods to deal with potential conflicts that arise when applying informed consent in Africa, taking into consideration African cultural beliefs and norms of behavior, without undermining traditional African values and belief systems. The central notion of this alternative approach uses Ross's prima facie duties [34, 35], which are different from absolute duties which apply in all circumstances or conditional duties as illustrated by Beauchamp and Childress . We preferred Ross's model because the prima facie duties  stem from relationships. Based on the analogy previously illustrated in this article, it is clear that the African notion of personhood is relational. Although Ross's model is Western in origin, it gives credit to relationships, obligations, and responsibility, like the African notion of Ubuntu/Botho, which advocates for just relationships, mutual interdependence, and humanity [32, 39, 40]. As aptly demonstrated by a landmark judgment of the South African Constitutional Court in Dikoko v Mokhatla 2006 , where a claimant sought reparations in the form of substantial monetary damages from a defendant in a defamation case, the Court argued that Ubuntu emphasises restorative justice rather than retributive justice, because restorative justice concentrates more on healing the victims. In her judgment, Justice Mogkoro contended that South African courts should focus on rebuilding relationships between parties, rather than punishing a defendant by awarding heavy fines when deciding defamation cases, since this results in the breakdown of interpersonal relationships. The Court argued that “the primary purpose of a compensatory measure is to restore the plaintiff's dignity who has suffered the damage and not to punish a defendant” [39, 40]. Justice Mokgoro further opined that:
In our constitutional democracy the basic constitutional value of human dignity relates closely to Ubuntu or Botho, an idea based on deep respect for the humanity of another […] A remedy based on the idea of Ubuntu or Botho could go much further in restoring human dignity than an imposed monetary award in which the size of the victory is measured by the quantum ordered and the parties are further estranged rather than brought together by the legal process. It could indeed give better appreciation and sensitise a defendant as to the hurtful impact of his or her unlawful actions, similar to the emerging idea of restorative justice in our sentencing laws. The focus on monetary compensation diverts attention from two considerations that should be basic to defamation law. The first is that the reparation sought is essentially for injury to one’s honour, dignity, and reputation, and not to one’s pocket. The second is that courts should attempt, wherever feasible, to re-establish a dignified and respectful relationship between the parties. Because an apology serves to recognise the human dignity of the plaintiff, thus acknowledging, in the true sense of Ubuntu, his or her inner humanity, the resultant harmony would serve the good of both the plaintiff and the defendant […] The goal should be to knit together shattered relationships in the community and encourage across-the-board respect for the basic norms of human and social interdependence. (Dikoko v Mokhatla 2006, paras 68–69) .
It is also important to note that Ross's model is not limited to a micro-sociological level; it also calls for issues such as reparations, which can translate to restorative justice at the societal, legal, and policy levels, similar to the Ubuntu philosophy, as argued by other commentators [23, 39].
Therefore, based on the above arguments, we suggest that Ross's model seems to be a more suitable model to follow in the African context, because of its emphasis on interpersonal relationships and restorative justice, such as reparations, which appear to be more consistent with the African philosophy of Ubuntu. Thus, it may be necessary for political and legal institutions in Africa to undertake reforms to make it possible to apply forms of consent and respect for autonomy that are adapted to Africa's socio-cultural and philosophical contexts. This would include involving family or community members in the consent process during biomedical research [74, 75], or applying the African ethic of Ubuntu/Botho, which emphasizes harmony and dignity in human interactions [32, 37,38,39,40].
Furthermore, similar to previous reports [16, 64, 76,77,78], this study noted that the poor educational background in African communities plays a part in comprehending the informed consent process, especially if not administered in a language that the participants understand. Thus, we recommend that African bioethics and biomedical research conducted within African communities consider group consent that aligns with people's literacy, cultural values, and interpersonal relationships.