Defending secular clinical ethics expertise from an Engelhardt-inspired sense of theoretical crisis

Theoretical Medicine and Bioethics - The national standards for clinical ethics consultation set forth by the American Society for Bioethics and Humanities (ASBH) endorse an “ethics...     

The Pakistan Experience

This article featuring Pakistan constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream programme funded by the Fogarty International Center for Advanced Study in the Health Sciences (FIC). Research ethics in Pakistan is an emerging field seeking to articulate best ethical standards for research practices. It is best understood as the initiation of a dialogue. Still, there are weak mechanisms for research ethics and there is an absence of mechanisms for monitoring ongoing research, particularly for assessing compliance with the recommendations of ethics review committees. Further, there are few qualified individuals in research ethics in both the private and public sectors. There are multiple challenges associated with research ethics, many of them stemming from issues around development and democratization, which cannot be addressed by guidelines and regulatory processes alone.     

The Ghana Experience

This article featuring Ghana constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream programme funded by the Fogarty International Center for Advanced Study in the Health Sciences (FIC). Although there are no national ethical guidelines in Ghana, eight research ethics committees have been established in the country, with a number of them obtaining Federal Wide Assurances (FWA) from the United States Office for Human Research Protections (OHRP).However, the existing ethics committees cannot match the volume of work to be done, especially in light of the increase of research activities in the country. This calls for the need to train more people in research ethics to fill that gap and provide continuing education to members of research ethics committees in the country.     

UNESCO’s Activities in Ethics

UNESCO is an intergovernmental organization with 193 Member States. It is concerned with a broad range of issues regarding education, science and culture. It is the only UN organisation with a mandate in science. Since 1993 it is addressing ethics of science and technology, with special emphasis on bioethics. One major objective of the ethics programme is the development of international normative standards. This is particularly important since many Member States only have a limited infrastructure in bioethics, lacking expertise, educational programs, bioethics committees and legal frameworks. UNESCO has recently adopted the Universal Declaration on Bioethics and Human Rights. The focus of current activities is now on implementation of this Declaration. Three activities are discussed that aim at improving and reinforcing the ethics infrastructure in relation to science and technology: the Global Ethics Observatory, the Ethics Education Programme and the Assisting Bioethics Committees project.     

Introduction

Clinical research is now a global enterprise. However, research ethics capacity has lagged behind the growth and expansion of clinical research in low and middle income countries. To address this mismatch, the Fogarty International Center of the National Institutes of Health has created a program to fund education in research ethics. This series of articles describes the experiences of graduates from 5 nations of the University of Toronto’s Joint Centre for Bioethics International Masters of Health Science Program. The program has graduated 32 students to return to their institutions to build research ethics capacity.     

The Nigeria Experience

This article featuring Nigeria constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream programme funded by the Fogarty International Center for Advanced Study in the Health Sciences (FIC). The first National Health Research Ethics Committee was inaugurated in 2006. Since then, more institutional health research ethics committees continue to be formed. However, research ethics challenges in Nigeria are systemic and require a systems approach to address them effectively. Nigeria requires capacity-building for authentic acculturation of health systems as well as for health research, education, and advocacy within the research community and the general public. Further, it requires relevant legislation and effective regulatory measures.     

The practice of medical ethics: A structuralistic approach

Theoretical Medicine and Bioethics - Structuralist ethics is an alternative to utilitarianism and deontology. But it also incorporates these ethical approaches in a larger frame. Rule...     

The India Experience

This article featuring India constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream program funded by the Fogarty International Center for Advanced Study in the Health Sciences. Research ethics is a growing area of work and interest in India. Ethics review remains the weakest component in the mechanism of good clinical practice, and there is a severe dearth of professionals trained in ethics who can provide leadership. Although the Indian Good Clinical Practice Guidelines, the Indian Medical Council Act, and the Drugs and Cosmetics Act require that the Indian Council of Medical Research’s ethical guidelines be followed as a mandatory requirement for physicians who conduct research, there is a pervasive lack of awareness of basic requirements guiding the ethical conduct of research. There is a great need to strengthen India’s research ethics capacity and regulatory framework for research.     

The Sudan Experience

This article featuring Sudan constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream programme funded by the Fogarty International Center for Advanced Study in the Health Sciences (FIC). Research ethics is a relatively new area of practice in Sudan. In 2008, the National Health Research Council (NHRC) and health research ethics were clearly stated in the Public Health Act, marking the first legislation rendering research misconduct as a legal offense. It also clearly stated that the NHRC is the focal body of health research in Sudan. Despite the difficulty in following the pace of newly-formed institutions and academies in Sudan, the NHRC’s Research Directorate assisted in the establishment of eight Research Ethics Committees (RECs) in two state ministries of health, two federal hospitals, the Sudan Medical Specialization Board (SMSB), and three universities.     

A Code of Ethics for Health Care Ethics Consultants: Journey to the Present and Implications for the Field

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, the American Society for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here.     

The healing relationship: Edmund Pellegrino’s philosophy of the physician–patient encounter

Theoretical Medicine and Bioethics - In this paper I briefly summarize Pellegrino’s phenomenological analysis of the ethics of the physician–patient relationship. In delineating the...     

The design and use of the Bioethics Consultation Form

The emergence of the ethics consultation as a means to resolve moral crises in clinical medicine has revealed the need for a worksheet that would facilitate intake and analysis. The author developed the Bioethics Consultation Form as an attempt to remedy this need. The form is arranged in an outline format and is a useful asset to ethics committee discussions and record keeping. The first section covers basic intake data concerning the patient's medical and personal information, advance directives, and values, as well as the values of the physician and family. After the intake section is completed with the above data, the ethics consultant then turns to the analysis section. This second section allows for (1) the discussion of conflicting values, (2) the identification of priorities, and (3) the elucidation of ethical norms relevant to the case.The Bioethics Consultation Form was adopted by the Patient Care Advisory committee of the Franklin Square Hospital Center in Baltimore, Maryland in 1986. The methodology in the use of the form will be discussed. Further, the potential spectrum of consultative cases that can be analyzed using the form will be highlighted.     

Some methodological aspects of ethics committees’ expertise: The Ukrainian example

Today local, national and international ethics committees have become an effective means of social regulation in many European countries. Science itself is an important precondition for the development of bioethical knowledge and ethics expertise. Cultural, social, historical and religious preconditions can facilitate different forms and methods of ethics expertise in each country. Ukrainian ethics expertise has some methodological problems connected with its socio-cultural, historical, science and philosophy development particularities. In this context, clarification of some common legitimacies or methodological approaches to ethics committee (EC) phenomena such as globalization, scientization and the prioritization of an ethics paradigm are very important. On the other hand, elaborate study and critical analysis of international experience by Ukraine and other Eastern European countries will provide the integration of their local and national ethics expertises into a world bioethics ethos. An earlier version of this paper was presented at the 6th International Bioethics Conference entitled ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

Medical ethics in France: The latest great political debate

The American term Bioethics has been adopted over the last ten years and the development of Bioethics committees on the American model testifies this influence, even before the official appointment of a National Committee in 1983. This phenomenon acknowledged as the “emergence of French bioethics” is in fact the final outcome of a long-lasting crisis in the medical profession, in quest for a new style of ethics, breaking with the traditional professional ethics (French Déontologie, through the Ordre des Médecins). Among other factors of conceptual and institutional change, the increase of biomedical research comes first: a major consequence is the sharing of moral responsibilities in decision-making with outsider scientists and finally the involvement of the whole population as potential moral subjects. The designation of these events as the emergence of French bioethics is hardly appropriate for an account of this dramatic shift in ethical norms and roles in medicine. This paper attempts to review the intellectual roots of the recent evolution and to summarize present and prospective trends.     

The protection of patients’ rights in clinical trials

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. The author is Chairman, Bioethics Committee of the Warsaw Regional Chamber of Physicians and Dentists.     

Institutional identity, integrity, and conscience

Bioethics has focused on the areas of individual ethical choices -- patient care -- or public policy and law. There are however, important arenas for ethical choices that have been overlooked. Health care is populated with intermediate arenas such as hospitals, nursing homes, hospices, and health care systems. This essay argues that bioethics needs to develop a language and concepts for institutional ethics. A first step in this direction is to think about institutional conscience.     

James Drane's More Humane Medicine: a new foundation for twenty-first century bioethics?

James Drane's More Humane Medicine: A Liberal Catholic Bioethics is an outstanding contribution to the study of bioethics in our day. Catholics and others who are interested in the issues discussed here will benefit from this masterful treatment. The author opens with a set of definitions, starting with what he means by a "more humane medicine." Drane contends that a more humane medicine has become necessary and desired, but not because the traditional medical ethic as "a self-declared and self-imposed ethic, outlining what noble service to others entails" is no longer valid. Rather he defines it as an advance on the traditional ethic; a "new foundation" based on a "lived set of obligations derived from a felt commitment to other persons ... an ethics based on the relationship between doctors and patients and essentially an ethics of virtue." Drane's work is a "liberal Catholic Bioethics" in which he challenges his own faith tradition, the Roman Catholic Church, on such topics as sexuality, birth control, abortion, cloning, stem cell research, aging and dying, and euthanasia and physician-assisted suicide. The present article is a critical essay that analyzes the author's statements and conclusions.     

The origins and evolution of bioethics: some personal reflections

Bioethics was officially baptized in 1972, but its birth took place a decade or so before that date. Since its birth, what is known today as bioethics has undergone a complex conceptual metamorphosis. This essay loosely divides that metamorphosis into three stages: an educational, an ethical, and a global stage. In the educational era, bioethics focused on a perceived "dehumanization" of medicine by the rising power of science and technology. Remedies were sought by introducing humanities, ethics, and human "values" into the medical curriculum. Ethics was one among the humanistic disciplines, but not the dominant one. In the second era, ethics assumed a dominant role as ever more complex dilemmas emerged from the rapid pace of biological research. As such dilemmas were applied to medical practice, the need for a more rigorous and more formal analysis of their moral status was clear. Philosophically-trained ethicists had an obvious role. They began to teach, write, and profoundly influence medical education and practice. In the third -- and present -- period, the breadth of problems has become so broad that ethicists must, themselves, draw on disciplines well beyond their expertise -- e.g., law, religion, anthropology, economics, political science, psychology, and the like. The era of bioethics as a global enterprise is upon us. The original hope for humanizing medicine has not been overtly successful; however, much has been accomplished of value to patients, the profession, and society. Medical morality has been transformed into a formal, systematic study of a whole range of issues of the greatest significance to humanity. Now the major challenge is one of identity, or inter-relationships and connections between the theoretical and the practical. Bioethics has outgrown its beginnings.     

The activities of UNESCO in the area of ethics

The member states of the United Nations Educational, Scientific and Cultural Organization (UNESCO) decided in 2002 that ethics is one of the five priority areas of the organization. This article describes three categories of past and current activities in the ethics of science and technology, in particular bioethics. The first category is the global standard setting with the Universal Declaration on Bioethics and Human Rights as the most recently adopted normative instrument. The second category focuses on capacity building in order to enable member states to apply the provisions of the declarations, through, for example, the establishment of national bioethics committees, the introduction of ethics teaching programs, and drafting of legislation and guidelines. The final category of activities is awareness raising through publications, events, and conferences. The challenges and difficulties UNESCO may face in its various activities are highlighted.     

Medical Ethics,Bioethics and Research Ethics Education Perspectives in South East Europe in Graduate Medical Education

Ethics has an established place within the medical curriculum. However notable differences exist in the programme characteristics of different schools of medicine. This paper addresses the main differences in the curricula of medical schools in South East Europe regarding education in medical ethics and bioethics, with a special emphasis on research ethics, and proposes a model curriculum which incorporates significant topics in all three fields. Teaching curricula of Medical Schools in Bulgaria, Bosnia and Herzegovina, Croatia, Serbia, Macedonia and Montenegro were acquired and a total of 14 were analyzed. Teaching hours for medical ethics and/or bioethics and year of study in which the course is taught were also analyzed. The average number of teaching hours in medical ethics and bioethics is 27.1 h per year. The highest national average number of teaching hours was in Croatia (47.5 h per year), and the lowest was in Serbia (14.8). In the countries of the European Union the mean number of hours given to ethics teaching throughout the complete curriculum was 44. In South East Europe, the maximum number of teaching hours is 60, while the minimum number is 10 teaching hours. Research ethics topics also show a considerable variance within the regional medical schools. Approaches to teaching research ethics vary, even within the same country. The proposed model for education in this area is based on the United Nations Educational, Scientific and Cultural Organization Bioethics Core Curriculum. The model curriculum consists of topics in medical ethics, bioethics and research ethics, as a single course, over 30 teaching hours.