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Abstract

Bioethics expertise and infrastructure are available in most developed countries of the world but lacking or unevenly distributed in the developing or less developed ones. The gap between the developed and the developing countries will be addressed through a robust capacity-building process that targets all aspects of bioethics. Bridging this gap will not only lead to true globalization of bioethics but will also enhance the homogenization of bioethics knowledge, standard, and practice across the globe. Achieving this goal requires the fostering and nurturing of continuing partnership and collaboration with Western countries with established and functioning bioethics structures and practice. The development and sustainability of any capacity-building program must target the training of a critical core of bioethics personnel, with the provision of resources and establishment of infrastructure that will enable trainees to function. Moreover, support at institutional and national levels and the prospect of career opportunities and advancement for bioethics professionals will boost commitment and attract more entrants into the ﬁeld. Finally, effective capacity-building efforts should be directed at developing bioethics education programs, establishing and equipping ethics committees, providing legal and regulatory frameworks, acknowledging the role of the media, and harnessing the potential contributions of professional bioethics organizations in the development of the discipline.

Introduction

Bioethics, as a discipline, is relatively new. However, inquiries into many of the issues, which fall under the purview of bioethics, have existed from time immemorial. Modern bioethics rode to limelight on the back of research ethics, through which ethical issues, especially within the context of medicine, have undergone intense scholarship and discourse in recent times. However, unlike other subjects in biology and medicine, bioethics, in its truest sense and broadest perspective, rubs on almost all spheres of learning in medicine and human society. It is, for now, a discipline without a deﬁned boundary and a home to almost all issues relating to health and humanity.

Ethical issues are universal, although organized bioethics has its roots in the West. However, the knowledge of the principles governing inquiry and research in bioethics and the expertise and skills required for the practice of bioethics, as a ﬁeld of intellectual specialization, are not uniformly available across the globe. While the requisite expertise and infrastructure are available in most of the developed countries, they are lacking or unevenly distributed in the developing countries of the world. Commendably, the Anglo-Saxon West has invested huge resources to promote transcontinental bioethics studies and practices in many low and middle-income countries. This investment has yielded some dividends. For example, the international research ethics training program of the National Institute of Health, in the United States, has trained a core of foreign scholars to provide middle-level manpower and expertise in research ethics and bioethics in their different countries. There is, still yet, the need for robust capacity building to match the increasing demand and the necessity for bioethics expertise in the global community. It is imperative that all aspects of bioethics should be developed for true globalization of the discipline and to enhance the homogenization of its knowledge, standard, and practice across the world.

History And Development

Bioethics, as a discipline, signaled the beginning of an expanded body of knowledge and professionalism in medicine and the biomedical sciences, beyond the boundaries of traditional medical ethics. Bioethics provides the foundation for the application of moral philosophy to the practice of science and medicine. The scope of bioethics goes beyond the clinician-patient relationship and bedside ethics to involve “all of life” (Potter 1996). The origin of bioethics, as it is known and practiced today, has been traced partly to the convergence of three pivotal events, namely, the increasing disgust with unethical practices in biomedical research, advancement in medical technology, and the inroads, made mainly by the US-based civil rights movements, into the hitherto closed world of medical sciences (Jonsen 1993; Andre 2002). However, bioethics, with its multiple parentage and heritage – theology, philosophy, law, ethics, and sociology, among others – has grown to become a truly interdisciplinary discipline (Levitt and Williams 2003). Its scope seems limitless and its horizon keeps expanding and continuously directed by emerging trends and developments in the complex intermix of medicine with science, technology, and the society. Bioethics has emerged on the intellectual skyline as the long-awaited rallying point for human ﬂourishing. In the West, bioethics has enjoyed remarkable prominence, tremendous growth, and continuing recognition of its importance and inﬂuence on society. Unfortunately, however, the developing countries, especially those in the low-income bracket, lag far behind in all aspects of bioethics.

Ethical Dimensions

Capacity Building In Bioethics In Developing Countries

Effective capacity building in bioethics in developing countries requires partnership and collaboration with countries of the West, which have established functioning bioethics structures. Capacity building involves the development of strategies, activities, and mechanisms that build or strengthen individual, corporate, or institutional abilities or processes for improved and sustainable performance and output (Department for International Development 2010). In capacity building, higher benchmarks are often established and new skills and capabilities acquired. The acquisition of these skills and capabilities will enable personnel to perform new tasks and to function in new roles competently and effectively. It also will enhance acquisition, internalization, and ownership of abilities and proﬁciencies hitherto unavailable locally (United Nations Environment Program 2014). Achieving these goals requires a comprehensive, multipronged approach, which will target all subdivisions of bioethics, as a discipline. The reason for this is that bioethics, as an entity, encompasses a variety of activities. As an area of intellectual specialization, bioethics is extensive and multidisciplinary, attracting inputs from many subjects and ﬁelds of learning. In practice, bioethics knowledge and principles are applied and utilized in bioethics education programs, within the ambits of ethics committees and in the formulation of regulatory documents and guidelines. In many Western countries, for instance, there are people who pursue careers as full-time bioethics professionals in academic centers and research organizations and as members of ethics committees. In many developing countries, bioethics expertise and prospects are inadequate or grossly negligible. This situation needs to be addressed as a matter of universal urgency. Bioethics is a discipline where the transfer of knowledge and expertise between the developed countries and the underdeveloped countries need not be unduly costly. Gaps need not widen or exist between the rich and the not-so-rich nations as currently exists in other areas of human health and development.

Sustaining Capacity Building In Bioethics In Developing Countries

Training Of Personnel

Personnel development is central to any capacity building program. In this context, personnel development, within bioethics, involves a process of training that is directed at equipping individuals with the requisite information, knowledge, understanding, attitude, skills, and aptitude to enable them to function as bioethics experts. For many ﬁrst-generation trainees in bioethics from many developing countries, interest in bioethics was aroused at research ethics awareness workshops or through involvement in research activities in academic centers or research institutes. Some others, especially those from nonclinical backgrounds, were drawn into the ﬁeld either by prior exposure to ethics or through some afﬁliations to ethics committees. These early trainees received training in bioethics from Europe and North America. Some training programs were wholly foreign-based while others were split between local and foreign institutions. The training spanned variable lengths of time, for instance, from 3 months to 12 months, with such trainings leading to the awarding of certiﬁcates, diplomas, or full academic degrees. The trainees were mostly middle-level professionals who became the torch bearers of the bioethics light in their home institutions and countries. Some of these people have established indigenous, culturally sensitive training programs at home. These programs are either fully home based or in partnership with foreign training institutions. The home-grown programs utilize multimodality approaches to training and developing bioethics capacity, including face-to-face teaching and online programs. Their methodology also includes organizing short-term courses, conferences, and workshops to expand and consolidate their reach and inﬂuence.

Resources And Infrastructure

For capacity building in bioethics to be maintained and sustained, the personnel, trained in bioethics, require institutional resources and infrastructure to function effectively and efﬁciently. Trainees from places where bioethics programs or activities have existed prior to their training theoretically have a base to return and be integrated after training. However, in many countries, outside of Europe and North America, bioethics does not exist as a formal discipline or subject, and there are no bioethics activities to return to. Trainees in such circumstances face the risk of becoming redundant and unable to initiate or facilitate productive bioethics activities. The challenge becomes more profound as those who have been trained are left to grapple with conﬂicting and highly demanding primary duties and responsibilities. For trainees to be productive and fulﬁlled, there must be platforms for them to utilize their training and maximize the potentials that their exposures have afforded them. In recent times, the National Institutes of Health’s International Fogarty Center has funded programs in Latin America, West Africa, South Africa, and India, among others, which have provided the structure and platform for trainees to network and function (Millum et al. 2013; Ndebele et al. 2014; Silverman et al. 2013; Saenz et al. 2014; Strosberg et al. 2013; Pratt et al. 2014).

National And Institutional Support

Capacity building in bioethics has assumed a national priority and, hence, has blossomed in many developed countries. The effect is that those countries have experienced tremendous growth in bioethics education, bioethics professional development, and bioethics service. To a very large extent, government’s support for bioethics programs and activities has been a major driving force in those countries. The National Research Act of the United States in 1974 gave executive and legal backing to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission, in the Belmont Report, enunciated the US government Policy for the Protection of Human Subjects, which was later incorporated into the US Code of Federal Regulations. This high-level government involvement in bioethics continues till today and has helped to enhance its progress in the United States. Bioethics is still in infancy or relatively unknown in many developing countries of the world. Capacity building in such countries will beneﬁt from support from governments, from academic and research centers, and from corporate institutions. Governments should promote bioethics activities by establishing national bioethics advisory committees, promulgate national research ethics codes, create bioethics centers, and provide funds and the mandate for academic institutions to establish bioethics training programs at diploma or degree level. Country support for international agencies like UNESCO to establish national bioethics committees and host international or regional conferences on bioethics will further enhance such initiative. Modules on research ethics, organizational ethics, and other relevant bioethics topics should be incorporated into the periodic retreats and update courses for senior functionaries of government and government establishments. Corporate establishments, industries, pharmaceutical companies, and donor agencies in developing countries should embrace capacity building in bioethics as an important social responsibility (Samba 2014). This can be fulﬁlled by supporting and sponsoring short-term courses in bioethics and through ﬁnancing of bioethics programs and endowing bioethics chairs and fellowships in academic institutions.

Career Opportunities And Advancement

Career opportunities abound for experts interested in bioethics. Experts in bioethics can serve on institutional review boards and clinical ethics committees or ﬁnd positions at government agencies, regulatory bodies, and medical associations (Turner 2004). The academically inclined can pursue careers as professors at universities or researchers at independent research institutes. For beginners and junior professionals with interest in pursuing a career path in bioethics, educational training is usually the right way to begin. A diploma certiﬁcate, an MA, or MSc degree in bioethics can be most appropriate. However, tenure-track faculty positions will require higher or advanced degrees. Of course, many individuals who pursue graduate studies in bioethics are motivated more by intellectual interests than the prospect of future employment opportunities.

For most scholars in developing countries, bioethics is an ancillary calling, not their primary profession. The majority of practitioners combine bioethics activities with their primary academic and/or professional duties. One major challenge that the ﬁrst generation of foreign bioethics trainees face is integrating their training and new role as bioethicists into their routine work and schedule. Without local recognition and appreciation of their new skills and without appropriate avenues to utilize their skills and be rewarded appropriately, some are at the risk of wasting away. As mid-career staff, which many of them are, with full-time primary appointments and with no protected or ofﬁcially designated time for bioethics-related activities, their ﬁrst and due allegiance and loyalty is to their primary employment. Most of them engage in issues relating to bioethics on the sideline. In such settings, a paradigm shift that embraces the emerging global trend of bioethics as a stand-alone discipline is advocated. A new work structure is required that will recognize bioethics training in the employment organogram, create new career paths, or adopt promotion guidelines or reward systems that factor in bioethics training and activities. Moreover, it is gratifying that a new set of bioethics practitioners is emerging, to whom bioethics is a home and a career choice.

Focus Of Capacity-Building Programs In Developing Countries

Bioethics Education/Research Ethics Training

Formal academic programs are fundamental to building lasting and ever-increasing capacity in all branches and uses of bioethics. The end of the twentieth century witnessed the expansion of many existing bioethics programs in North America and Europe and the springing up of new bioethics training programs in South America, Southeast Asia, and Africa. Most of the new programs in the developing world received foreign funding to establish culturally sensitive bioethics training programs with focus on research ethics. In the year 2000, the Fogarty International Center, a unit of the US National Institute of Health, launched the International Research Ethics Education and Curriculum Development Awards to fund special training programs, focusing on Africa and Asia. To date, that initiative funds master’s level, lower degrees (diploma and certificate), and nondegree programs in Africa, South and East Asia, East and Central Europe, Latin America, as well as the Caribbean (Millum et al. 2013; Ndebele et al. 2014; Silverman et al. 2013; Saenz et al. 2014; Strosberg et al. 2013; Pratt et al. 2014). The European and Developing Countries Clinical Trials Partnership (EDCTP) funds bioethics education programs and establishes ethics committees in Africa. In 2002, the Wellcome Trust in the United Kingdom has been launched and has hitherto provided multiple grants for bioethics research in many developing countries. Moreover, a collaboration between the US Naval Medical Center Detachment,

University of Washington, and the NIH’s Department of Clinical Bioethics funds research ethics training in Peru.

The expectation is that these programs will leverage on the available funding opportunities to establish the necessary framework and institutional structure required for continuity and sustainability after cessation of funding. One critique of these programs is that the current focus of bioethics scholarship and research is skewed toward research ethics, and this trend is currently replicated in almost all internationally sponsored capacity-building programs in bioethics. Most trainees have acquired signiﬁcant and valuable knowledge and expertise, which have equipped them to function effectively in research ethics matters. However, their knowledge and expertise do not necessarily extend to all areas of bioethics in its broadest sense. Additional training, perhaps more broad based, may be required to fully engage them in all aspects of bioethics. Another raging controversy is that the proliferation of research ethics training programs and the number of trainees from such programs that function in different aspects of research – from research concept, through ethics committee’s review of research protocols, to research implementation in the clinic or on the ﬁeld – may not necessarily translate to or guarantee ethical research. For now, empirical data are not available to support this argument. Moreover, these training programs seem to be a step in the right direction toward achieving that goal of ethical research.

Ethics Committees

One of the earliest provisions of the international regulatory guidelines, on the conduct of research involving human persons, is the need for the establishment of institutional review committees (IRCs) or research ethics committees (REC). The REC is an independent body of people from multiple backgrounds that arbitrate the conduct of research between researchers and research participants. Their primary role is to protect research participants from harm. This, they do through reviews of research protocols for scientiﬁc validity and ethical soundness among others. Most ethics training programs feature modules on ethics committees and with a focus on their setup, composition, roles, organization, and the process of review of protocols, among others. One of the most visible manifestations of capacity building in research ethics, in the developing countries, is the establishment and training of local RECs with funding mostly from donor countries and agencies. Moreover, trainees from the programs mentioned above are the fulcrum of many of these committees in their countries, and many of them have established programs of training and re-training of committee members through both local and foreign sponsorships. Apart from the RECs, other bioethics committees such as clinical ethics committees, animal ethics committees, and ethics committee for stem cell research represent an emerging trend in bioethics in many developing countries.

Legal Provisions And Regulations

The road to modern bioethics is strewn with the milestones of the development and formulation of research regulatory instruments starting with the Nuremberg Code in 1949. Since then, many international guidelines for health research ethics have been developed for regulating the conduct of research in humans. These include the Declaration of Helsinki by the World Medical Association (revised seven times to date since 1964) and the International Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) (1993, revised in 2002). There are many other special ethics publications, which provide ethical framework for research and other ethics-related issues. Among such are the Nufﬁeld Council on Bioethics’ “The Ethics of Research Related to Healthcare in Developing Countries” (2002), UNESCO’s “Universal Declaration on the Human Genome and Human Rights” (1997) and the “Universal Declaration on Bioethics and Human Rights” (2006), as well as the WHO’s “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants” (2011).

National codes are operational within national boundaries. They apply to research and to researchers within the jurisdiction of each country. The requirements of such guidelines are usually binding on both local and foreign investigators that conduct research within each national boundary. The Belmont Report’s “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is one of such guidelines. The report was published in 1979. Since then, many national governments have established codes of ethics to provide guidance for research involving human participants in their territories. Some of the guidelines and codes have legal power of enforcement, whereas most are merely instructional and persuasive documents that do not have any legal weight or controlling power over people. Over the years, these documents have been and continue to be a rich resource for the teaching and learning of research ethics. They have also provided the ground for training and development of bioethicists in the developed and developing countries by stimulating analytical reasoning, discussions, and debates.

The Role Of The Media

The nature of bioethics and that of capacity building makes it inevitable that the media should play a very major role in capacity building in bioethics. A valid capacity building in bioethics will involve the fostering of views, broad values, goals, strategies, methods, and means (including international agreements, national constitutions, enactment and enforcement of laws, policies, guidelines, and regulations) that are congenial to bioethics. It also involves the development and enhancement of an individual’s intellectual, emotional, volitional, and social capabilities, which facilitate the ability to reﬁne and enrich bioethical concepts, discussions, and individual capabilities to realize such dynamic bioethical concepts and resolutions. Bioethics capacity building therefore involves the creation of general awareness, advocacy, education, training, public debates, and political actions of varying depths and signiﬁcance. The need for information exchange, preservation, and dissemination in such an undertaking cannot be overemphasized in an attempt to create general societal awareness and the facilitation of improved expertise of professionals whose activities directly impinge on bioethics. The media used include the electronic media such as radio, television, and, much more signiﬁcantly, the Internet as well as the print media, which include newspapers and magazines. Other outlets for dissemination of news about bioethics are brochures, textbooks, monographs, and academic journals of various degrees of specialization in bioethics. Many publications have both paper and electronic digital versions. Sustained availability and accessibility to such media have always been important to the growth and impact of bioethics.

Throughout the world, the struggles, growth, modiﬁcations, and impact of bioethics still involve ideological, political, economic, and legal frictions at institutional, local, national, international, and global levels. The ever-increasing need for advanced bioethics capacity building in these contexts will continue to require the capability to effectively and efﬁciently utilize information media. The pursuit of science and the development of technology have always raised issues of ethics in the advanced world and become contentious issues, especially when various media leak, intensify, and spread information about unethical practices.

Various issues in bioethics are usually of public concern, leading to public debates. The example of human stem cells in research is an example of such controversial issues, which became later clariﬁed and deﬁned. Questionable research involving less privileged nations and persons abound till present days. Clinical decisions could get into public debate and may even involve the law courts, such as we have in the cases of Baby Doe and Terri Schiavo. Issues of the environment are another such example. In all such areas, all media available, with various degrees of specialization and rigor, get involved in the debate. In America, science and technology have enabled humans to selectively and signiﬁcantly modify human biology and life. It was inevitable, therefore, that discussions, as such, would later foster bioethics and would ensue considering the fact that there is a previously little acknowledged intersection between medicine, philosophy, religion, sociology, and law.

The Internet has become a prominent medium for fostering views and values about bioethics, including the various “social media.” The Internet is a medium that serves as a formidable and robust instrument of information, through all modes including blogs, but also through various courses and research methods in bioethics and its different aspects. Most signiﬁcantly, it has offered all faiths and regions in the world to contribute to the ever dynamic challenges and solutions in bioethics. Media is and will always remain important to capacity building in bioethics in the developing world, and it is important to practitioners, especially those in the less impactful groups and regions, to utilize it more. Reassuringly, the emerging developing world of bioethicists has recognized this and has bought into it.

Professional Organizations

There has been an increase in the number of national and international professional organizations in and for bioethics all over the world. The goals of these organizations are, among other things, to provide information and promote and enhance understanding among persons concerned with bioethics. They also seek to promote collaboration and communication among bioethics experts. The methods by which these organizations carry out their goals are through professional conferences among experts or trainings and workshops aimed at increasing professional capacity in bioethics and research ethics. These organizations, among other things, seek to promote the exchange of ideas and foster multidisciplinary, interdisciplinary, and inter-professional scholarship, research, teaching, policy development, professional development, and collegiality among people engaged in clinical and academic bioethics as well as the medical humanities. In the Western world where bioethics is a highly developed profession, conferences and workshop are held on a regular basis. In developing or resource-poor countries like in Africa, bioethics will ﬂourish with more of such conferences and workshops taking place at national and regional levels.

Conclusion

The ﬁeld of knowledge known as bioethics is both expansive and wide in its scope and content. The origin of bioethics is usually traced to the history of unethical practices in research involving humans, to advancements in medical technology, and to the civil rights groups’ peering into the insular world of medicine. The depth of bioethics as a discipline has proven to be boundless because of the application and utilization of its principles to emerging trends and development in medical sciences and other life disciplines. It is however important to reiterate here that while bioethical expertise and infrastructure are highly developed in advanced parts of the world, these are either completely lacking or unevenly distributed in the developing or resource-poor countries of the world. Proper training and the investment of resources will yield dividends as they will help to enhance bioethics knowledge and expertise in the developing world.

More importantly, bioethics expertise and prospects have been found to have been grossly trivialized in many developing countries, owing to lack of information and understanding about the discipline. To this extent, effective capacity building is seen as a veritable tool for addressing the problems that arise from neglecting the concerns and expertise of bioethics. Effective capacity building in this way will entail extensive personnel development as well as the formation of regulatory documents and guidelines for biomedical research. The whole gamut of personnel development encapsulates personnel training, establishment of resources and infrastructure which will serve as national and institutional support for bioethics, the creation of career opportunities, and the incorporation of the media as a means of creating awareness for bioethical concerns and biomedical research both locally and internationally.

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