Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family – usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.
Keywords: Interculturalism, Informed Consent, Autonomy, Clinical ResearchEthics is defined as “the branch of philosophy dealing with values relating to human conduct, with respect to the rightness or wrongness of certain actions and to the goodness and badness of the motives and ends of such actions” (Ethics, n.d.). Scientists and philosophers have given deep thought to the origins of human values and ethical behaviors. Human instincts, personal cognitive capacities, and gender are among the most discussed subjects in this regard. Kohlberg, for example, focused on the intellectual development of the child and stated that moral development “represents the transformations that occur in a person’s form or structure of thought” rather than simply representing increasing knowledge of cultural values (Kohlberg & Hersch, 1977). Kohlberg’s view of morality is based on impartiality, justice, rationality, and universality. His work provided the basis for Carol Gilligan’s work, in which she disagreed with Kohlberg about the impartiality and universality of ethical values and advocated “a different voice” that speaks for the personal relationships, care, and particularity of the agent (Blum, 1988). Gilligan contends with gender differences in moral reasoning by stating that women are centered on the responsibility, interdependence, and ethics of care, whereas men tend to prioritize rights and justice (Fox, 2001). However, gender and cognitive development as well as intellectual capacity are not enough to explain the morality of humans. Global ethics requires us to look deeply into the effect of cultural values, norms, and religious beliefs to understand the roots of ethical values and reasoning in various populations. The medical community has encountered cultural variations through multicenter/multicountry clinical trials on human subjects. The number and scope of such trials have continued to rise over the last two decades. As of April 2017, in the US alone, there are 43,688 multicenter clinical trials, out of which only 38% are recruiting human subjects. This increase attracted attention towards the intercultural competence of researchers. The number of articles and book chapters on the subject of culture and counseling rose from 25 in 1976 to more than 15,000 books, chapters, conference presentations, and journal articles in 2008 (Deardoff, 2001).
Unfortunately the attention of the medical ethics community towards this issue was provoked by tragic events in recent history. The Pfizer Trovan study, which was conducted in Tudun Wada in Kano State, Nigeria, during a meningitis outbreak among children, is one such paradigmatic case. The drug company recruited 200 children in two study arms, one arm receiving chloramphenicol or ceftriaxone and the other arm receiving the test drug. The study was concluded within three weeks; however, ethical discussions are still ongoing. The researchers did not obtain informed consent before recruiting the subjects and they did not disclose that this was a research and that the drug was still being tested. Moreover, most of the recruited children were from poor, illiterate families desperate to save their children from the outbreak. The company left the town after conducting the study without a second thought about the ongoing meningitis outbreak (Okonta, 2014).
The Havasupai Tribe Type II Diabetes Project was another case that caught the attention of the medical ethics community for ignoring communal values and informed consent. The aim of the project was to reveal a genetic link to type II diabetes. The prevalence of type II diabetes was significantly high in the Havasupai Tribe in a remote part of Grand Canyon, which made the tribes people excellent prospective research subjects. DNA samples were collected from tribe members. However, researchers failed to prove this genetic link and later decided to use the collected samples in unrelated studies for which no informed consent was obtained. Research on schizophrenia, migration, and inbreeding, all taboo concepts for this particular tribe, was conducted using their genetic samples. In 2004, the tribe filed a lawsuit against the researchers for failing to obtain informed consent, violating civil rights by mishandling blood samples, using unapproved personal data, and breaching confidential medical data (Ekmekci, 2017; Havasupai Tribe and the lawsuit settlement aftermath, n.d.).
Ever since the Nuremberg Code was drafted in 1947 (The Nuremberg Code. n.d.), all scientists have been bound by universal ethical codes and norms while conducting trials on humans. The Declaration of Helsinki, which was updated for thirteenth time in 2013, is the ultimate code for ethics in clinical trials (World Medical Association(2013).
However, instances from recent history urge us to think beyond these universal codes and develop a more comprehensive perspective embracing the cultural, social, religious, and ethnic variations among communities. Looking deeper into dissimilarities between non-Western ethics and right-based liberal individualism would expand social consciousness in this regard.
Ubuntu is defined as the African worldview or perspective of life; it is an indigenous concept rooted in the culture, religion, and collective consciousness of Africans (Coetzee & Roux, 2001). Ubuntu ethics conceptualizes fundamental human rights in the context of communal rights. According to its philosophy, inalienable human rights can only gain meaning in the context of the society in which the individual is living. Chuwa remarks that Ubuntu ethics have strong implications with regard to “the subordinate position of individual rights in front of basic communal interests and well-being,” meaning that the community takes precedence over the individual and that the communion of people takes priority over individual inalienable rights including self-autonomy (Chuwa, 2010).
Ubuntu ethics considers moral maturity as “understanding the normative principle for responsible decision making and action for oneself and for the good of the community.” Therefore, any person with moral maturity has to consider both community rights and her rights respectfully during the ethical decision making process. A decision that does not consider communal good and well-being would be unethical. This perception of Ubuntu ethics is rooted in its ontological discourse. It defines innate personhood as only “a potential,” which is realized through human relationships in the medium of the community. In other words, being individual means being with others (Chuwa, 2010).
This argument of Ubuntu ethics has some consequentialist implications regarding the reciprocity of care. Every individual has an irreplaceable role in the sustenance and integrity of the community. An individual receives help from others because of her service to the community. In this respect, solidarity is the key attitude for sustaining the community, and it can be achieved by developing Ujamaa, a particular state of mind needed to ensure that people care for each other’s well-being. In this context, marriage and procreation are considered crucial for every member of the community to participate in, and anyone who refuses to take her place in the chain of procreation is a rebel, a curse, a law breaker, and under-human (Chuwa, 2010).
Liberal individualism, which is a rights-based ethical theory, has been advocating a free space for individuals in which they can pursue their own prospects of life. This perspective has been present since Thomas Hobbes and has evolved through history in accordance with the democratic realization of human rights in Anglo-American legal tradition. Liberal individualistic theory opposes the pressure of the binding rules and norms of status quo, established by societies’ religions, customs, or traditions to promote the civil, political, and legal rights of the individual. This means that individual rights and freedom take precedence over communal well-being and societal norms (Beauchamp & Childress, 2001). Ubuntu ethics’ perception of individual rights and communal precedence seems oppositional to the rights-based liberal individualism of Western culture’s understanding, which gives priority to individual rights over any other set of rights and considers human rights fundamental. Rights-based liberal ethics regards the autonomy, privacy, and confidentiality of personal information among the primary human rights, whereas Ubuntu ethics take these as relative and circumstantial.
The main implications of the differences between the two perspectives becomes manifest in decision making processes during medical interventions. The liberal individualistic perspective, which dominates international guidelines and ethical codes, promotes individual autonomy, and voluntariness of the individual, by overriding communal interests and well-being. In fact, giving counsel to the individual during the decision making process to consider the opinions of community leaders or family members, or to give priority to the well-being of the community prior to herself, would be considered coercive. Respect for an autonomous individual requires acknowledging her “right to make choices, hold views and take actions based on her personal values and beliefs.” (Beauchamp & Childress, 2001).
The liberal individualistic view regards family as “a social construct, created through particular arrangements of its participants, with no independent reality of its own.” Therefore it is plausible to highlight the individual as the exclusive decision making authority, independent of social connections such as family. Family members may only be welcome in the decision making process if they are explicitly invited by the individual (Ruiping, 2015).
On the other hand, Ubuntu ethics and Asian cultures in general state that understanding the interdependency between the well-being of the community and the individual and balancing good for others and self is the outcome of the moral maturity of the individual. Anyone who cannot develop these abilities is considered to be morally immature and faces the risk of losing the benefits she has gained through reciprocity of care. Decision making with regard to medical interventions is conceived to be a collective process rather than an individualistic one.
It is plausible to say that these two perceptions embody significant variations in clinical practice and informed consent procedures. For example, according to Ubuntu philosophy, disclosing information to the patient about how advanced her cancer is, instead of telling the relatives, would be considered offensive and rude behavior that could impact the patient’s willingness to survive, while in Western culture, it would be regarded as showing respect to the autonomy of the patient. Similarly, asking a believer of the Ubuntu philosophy for informed consent to participate in a clinical trial without informing other members of the community in advance would be considered unethical. On the contrary, in Western culture, a patient would call it “violation of privacy and confidentiality” if her participation in a clinical trial was disclosed to her kin without her approval.
Some Asian countries like Japan follow an approach similar to Ubuntu philosophy. The professional ethics guidelines for physicians, published by the Japan Medical Association in 2008, state:
“Many families in Japan have strong ties among members, and the patient and his/her family support each other. In such cases, it is necessary to give detailed explanation of the disease name and condition to family members as well. (…) If the family objects to the disease name and condition being disclosed to the patient, the physician should try to persuade the family to understand the need for explanation to the patient, unless the physician considers such disclosure is detrimental to the patient.” (Japan Medical Association, 2009)
This perspective depends on the “family-facilitated” approach to decision making. A liberal individualist might criticize the Japan Medical Association claiming that they overlook the right to self-determination of the individual or at least trivialize it with regard to communal decisions.
Self-construal in Asian and Ubuntu cultures is the key to understanding their decision making perspective. Asian and Ubuntu ethics encourage interdependent self-construal, while liberal ethics are built upon independent self-construal. Family-facilitated and collective decision making processes are consistent with the interdependent self-construal that identifies the individual as an amalgamation of her relationships with family and society. The view of the self and personhood is created through interaction with others (Akabayashi & Slingsby 2006). In this regard being a member of the community is the fundamental inalienable determinant of the individual; hence, collective decision making becomes a neutral consequence of this social structure.
Some actions are being taken in response to recent tragic instances that involved controversial research decisions and the ethical discussions that followed. The lack of sensitivity of researchers to the differences in the decision making process between Western and Asian cultures and to the ethical, value-based roots of these differences has caused an increase in distrust and skepticism towards Western researches in non-Western communities. Community members have developed more intolerant and suspicious attitudes that have led them to constitute local ethical frameworks and guidelines for clinical research. Four ethical dimensions are highlighted in these documents: intercultural perspectives to assess the risks and benefits of the research, culturally appropriate and respectful informed consent procedures, confidentiality and disclosure policies, and community and participant consultation (Deardoff, 2001).
The H3Africa Consortium in collaboration with some stakeholders released The Ethics and Governance Framework for Best Practice in Genomic Research and Biobanking in Africa, which is expected to help countries develop or review their existing research ethics guidelines to address ethical issues in genomic research and biobanking (H3Africa Working Group on Ethics (2017). This document aims to unite the communal solidarity–based view of African countries with that of the rights-based view of Western ethics. The key values of this document are reciprocity, consultation, and accountability. The four core principles are listed as follows:
Research should be sensitive to and respectful of African values and cultures;Research should be for the benefit of African people recognizing that it likely also yields benefits to the global population;
Research and the dissemination of data in publications should take place with genuine and active intellectual participation of African investigators and other African stakeholders;
Research should promote ways of relating typified by respect for individuals and communities, fairness, equity, and reciprocity.
These core principles are explicitly diverse from what we see in ethics documents originating in Western countries. The Belmont Report, which was published in the US in 1979, for example, is centered on respect for persons, beneficence, and justice. The Declaration of Helsinki, which is considered to be the universal gold standard for research ethics, barely mentions community under the headline of vulnerable groups and post-trial provisions. The main emphasis is on individual rights, such as autonomy in decision making, voluntariness, beneficence, safety, privacy, and confidentiality. Only these core principles can shed some light on the differences between cultures in understanding the principle values of moral life.
In the H3Africa policy framework, there is a comprehensive section on community engagement that requires researchers to develop an inclusive perspective on the basis of the argument that genomic research has implications not solely for individuals but also for families and communities. Therefore researchers are steered to ask, inform, consult, and actively involve relevant communities to realize “its’ legitimate interest in the research.”
Novel arguments emerged suggesting that the presumed divergence between Western and non-Western cultures may not be as deep as we think. The most prominent one claimed that the reasons for the skepticism of Asian particularisms and Ubuntu ethics against individualism, freedom, and liberty were grounded in the generally accepted idea that the primacy of democracy, freedom, and individual human rights are rooted in Western culture. This argument is supported by historic evidence of the perceptions of Greco-Roman and Christian communities about the value of personal freedom, equality of freedom, and tolerance of diversities. However, Amartya Sen argues that we can detect similar perspectives in the norms of ancient Asian communities. For example, ancient Mandarins and Brahmins valued freedom consonant with ancient Greek conceptions, as an advantage for the privileged, non-slave men. Sen remarks that we can find more evidence on the importance given to freedom and tolerance in various ancient writings of Asian origin such as those on Akbar and the Mughals, Kautilya, and Emperor Ashoka. Hence, so-called Asian, African, or any other non-Western values undermining individual rights and freedoms are “made into these cultures by the mere force of rhetoric” and the grand contrast between non-Western and Western values is not real, but the result of “over simple generalizations.” (Sen, 1997). From this perspective, it is plausible to say that the discourse built upon the primacy of communal values and underrepresentation of individual rights in non-Western cultures and the central position of individual autonomy and ignored values of communal norms in Western cultures seem to be over simplistic.
Albert Jonsen agrees with Sen’s over simplistic generalizations argument and remarks that the central position of individual rights and autonomy in Western ethics also needs to be questioned carefully to avoid misconceptions. He argues that American individualism is tightly connected to communal cooperation and mutual understanding. He states: “We dimly recognize that American individualism was the product of having to make a world from scratch but that it was an individualism that could not have succeeded without cooperation. There are many contradicting yet mutually reinforcing themes hidden beneath the surface of the American ethos.” (Jonsen, 2000).
Some other authors criticize the overemphasis of the exclusive role of the individual in decision making processes in the Western world and suggest the need to involve “others” in these processes. They argue that individuals might have a chance to recognize their internal weaknesses, psychological impediments, or irrational preferences if they are in dialogue with others during decision making. The “other” acts as a mirror to the individual enhancing her self-consciousness to make rational decisions in coherence with her life plans, beliefs, and values. Since the individual develops her identity in and through community memberships, starting with family, it is plausible to think that the involvement of family members in the decision making procedure would help the individual make more reasonable choices (Ruiping, 2015). This line of thinking leads to revising the exclusive authority of the individual in informed consent procedures and giving more thought to empowering family-facilitated decision making in the context of dependency and communal values.
Erich Loewy says that one of the greatest dangers of the global development of bioethics is ethical imperialism, which becomes manifest with the tendency “to regard itself as the proper standard for ethical norms and disregards cultural differences and condescend nations whose culture and ethical norms are different.” (Loewy, 2002).
Bioethics is a young discipline that has mainly flourished in the Western world. The first few international guidelines such as the Nuremberg Code and the Belmont Report were published in the US. The World Medical Association, which published the Declaration of Helsinki, is dominated by scientists from Western countries. Not surprisingly, we can see that the ethical perspective in these documents is coherent with Western humanist tradition and is focused on individual rights. UNESCO, which falls under the umbrella of the United Nations and therefore might be expected to have a more pluralistic view, says, “The interests and welfare of the individual should have priority over the sole interest of science or society” in article 3 of the Universal Declaration on Bioethics and Human Rights (The United Nations Educational, Scientific and Cultural Organization [UNESCO], 2005). The monolithic language in these documents is criticized for turning a blind eye to non-Western countries that happen to constitute the majority of the world’s population (Chattopadhyay & De Vries, 2008).
The developments in bioethics, and particularly in research ethics, have occurred as a result of the emerging demands of new circumstances. The increase in the number of multicounty clinical trials is a challenge for the bioethics community to test itself on the existing implications of ethical imperialism in research ethics, particularly in the informed consent procedure. We do not think that the Western dominance in bioethics is the result of a bad intention to support the cultural imperialism of “oriental cultures.” On the contrary, the overemphasis of individual rights and personal autonomy should be considered a reaction to human rights violations, negligence of individual autonomy, and sacrificing the individual for the good of the society. Humanity has witnessed violations of individual rights not only during the Second World War, before the international consensus on ethical norms for research ethics, but also after the declaration of some of the international agreements mentioned earlier. The radioactivity tests, the Willow brook State School experiments, and the well-known Tuskegee Syphilis research took place not too long ago. One of the common features in all of these unfortunate cases was the lack of respect for the autonomy of human subjects and the rights of individuals to determine their own fates. Hence it is plausible to say that the emphasis on individual rights and respect for autonomy is never enough when talking about research on human subjects.
We should ask if emphasizing individual rights and autonomy demand one particular type of decision making. Is family-facilitated decision making contrary to individual autonomy? Or is it an unavoidable feature of the decision making process, since human beings are social beings? Does involving people within the social network of the individual breach individual rights?
It is plausible to say that the decision making process can be diversified through the different communal norms and values of various populations. Respecting the communal decision making procedure, ensuring reciprocity of care and interpersonal dependency in communities, and revising the informed consent procedure to embrace these values would guarantee the universality of the process and silence critics harping about the ethical imperialism of Western norms. Including local scientists in research and development, consulting with community leaders before approaching the community members, and respecting cultural and religious norms, particularly those that may require privacy and confidentiality, can be regarded among the most sensible ethical considerations. This respectful manner would facilitate the involvement of various populations in clinical trials and improve their representation in research studies.
From this point of view, amending international codes and guidelines to meet this end would be plausible. However, doing so runs the risk of overlooking some fundamental human rights for the sake of preserving communal values.
The tolerance for the involvement of the community in an individual’s consent process presents the concrete risk of breaching the fundamental human rights of subjects, especially women, minors, elders, or people with various vulnerabilities who have limited power of autonomy and can easily be coerced by the pressure of communal norms and values. Amending international guidelines to empower communities in the informed consent process or taking community values for granted without questioning their possible impacts on human rights violations and individual autonomy, would be legitimizing the dominance of community leaders or heads of families – who are men in most cases – and debilitating the rights of the vulnerable with regard to the voluntary and free consent of the individual. Moreover, this manner would feed the conservative communities’ adherence to values that are not in compliance with fundamental human rights, especially in radical religious communities.
To avoid any individual rights violations one could argue that the approval of the individual for the involvement of others in the decision making process is sine qua non. However the practicability of this proposal is contentious, since disapproval would require an environment in which the individual is free to express her autonomous decision.
The short history of research ethics has clearly shown us that human subjects of various backgrounds and diverse cultural norms and ethical values will be involved in clinical research over time and researchers have to learn to work with and respect such diversity. This requires developing a set of academic and interpersonal skills that allows individuals to increase their understanding and appreciation of cultural differences and similarities within, among, and between groups – a concept called cultural competence (Orlandi, Weston & Epstein, 1992). This competence would foster establishing interculturally sensitive research, which requires developing and implementing informed consent procedures that are respectful of cultural values and engaging in community and participant consultation.
Developing a comprehensive understanding with regard to the origins of norms and values of communities would prevent the dominance of over simplistic paradigms and help us see the real content of the issue. As the work of Sen suggests, the divergences between Western and non-Western values regarding individual rights are not as deep as we think. Individual freedom and autonomy are respected in ancient Asian writings, while solidarity, interdependency, and interpersonal networks are regarded as valuable in Western culture. A compromise needs to be made between these Western and non-Western values by developing an atmosphere of mutual understanding. Including a more pluralistic perspective to the existing monolithic Western language of international guidelines would be considered an appropriate step in this regard. On the other hand, we should always keep an eye on vulnerable, impoverished groups and individuals and be very cautious not to fortify conduct that breaches fundamental human rights, even if communal values and norms inform us otherwise.
Cultivating intercultural communication would develop pluralistic perspective on basic concepts of research ethics among scientists. This would help to amend the monolithic Western language of international guidelines to embrace various cultural differences.
Novel training programs regarding cultural academic and interpersonal skills increase researchers’ understanding and appreciation of cultural differences and similarities are to be developed.
Additional research should evaluate how intercultural variations are manifested in informed consent and decision making procedures proceed. In addition the researchers’ perceptions about intercultural variations of norms and values should be investigated. More research is required to understand how to avoid endorsing the disadvantages of vulnerable groups’ and breaching their fundamental human rights, while looking for ways to respect communal values and norms.
This work was supported in part by FIC/NIH R25TW009248, KM Munir (PI)
Perihan Elif Ekmekci, Department of History of Medicine and Ethics, Faculty of Medicine, TOBB University of Economics and Technology, Söğütözü, Söğütözü Cd. 43, Ankara, Turkey.
Berna Arda, Department of History of Medicine and Ethics, Faculty of Medicine, Ankara University, Emniyet Mahallesi, Dögol Cd. 6A, Yenimahalle/Ankara, Turkey.