ABSTRACTThe objective of this module is to inform you on issues of concern for Research Ethics Committee members and investigators during the review process. The many guidelines on research ethics, including those from the South African Department of Health and the World Health Organisation, will be referred to extensively to educate you on the requirements of Research Ethics Committees. The evolution of the review process in South Africa will be detailed.

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when (...) consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations. (shrink)

There is a need to increase the number of practicing medical doctors in South Africa. We examine the ethical implications of patients’ rights being affected in medical education in a South African context.The South African legal framework advocates public healthcare access. Yet, the State’s ethical obligations when it comes to guaranteeing public healthcare access, conflict with its utilitarian policy, that allows for medical education to help achieve the State’s public healthcare commitments, at the cost of eroding patients’ rights, and accepts (...) that certain actions are imperative, in line with Ubuntu, which is tenable yet nuanced. A patient treated by a licenced doctor today, benefits because other patients have allowed themselves to be used as hands-on learning material for medical students yesterday.Healthcare institutions need to take cognisance of the numbers of medical students that patients can reasonably be expected to endure. There is a need for the Health Professions Council of South Africa and medical schools to adopt guidelines on reasonable levels of medical student-patient interaction, and medical student-to-patient ratios in healthcare delivery. (shrink)

Informed consent for anesthesia is an ethical and legal requirement. A patient must have adequate decision-making capacity (DMC) as a prerequisite to informed consent. In determining whether a patient has sufficient DMC, anesthesiologists must draw on their knowledge of DMC. Knowledge gaps regarding DMC may result in incorrect assessments of patients’ capacity. This could translate to an informed consent process that is ethically and legally unsound. This study examined the DMC-related knowledge of anesthesiologists in a group of four university-affiliated hospitals. (...) The findings suggest that anesthesiologists have several areas of knowledge deficiency regarding DMC and DMC assessment. These findings could inform the development of undergraduate and postgraduate curricula. (shrink)

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South (...) African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations. (shrink)

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs (...) for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

The most pressing issues of the twenty-first century—climate change and persistent hunger in a world of food surpluses, to name only two—are not problems that can be solved from within individual disciplines, nation-states, or cultural perspectives. They are predicaments that can only be resolved by generating sustained and globally robust coordination across value systems. The scale of the problems and necessity for coordinated global solutions signal a world historical transit as momentous as the Industrial Revolution: a transition from the predominance (...) of technical knowledge to that of ethical deliberation. This volume brings together leading thinkers from around the world to deliberate on how best to correlate worth (value) with what is worthwhile (values), pairing human prosperity with personal, environmental, and spiritual flourishing in a world of differing visions of what constitutes a moral life. Especially in the aftermath of what is now being called the Great Recession, awareness has mounted of the imperative to question the modern divorce of economics from ethics. While the domains of economics and ethics were from antiquity through at least the eighteenth century understood in many cultures to be coterminous and mutually entailing, the modern assumption has been that the goal of maximizing human prosperity and the aim of justly enhancing our lives as persons and as communities were functionally and practically distinct. Working from a wide array of perspectives, the contributors to this volume offer a set of challenges to the assumed independence of the quantitative and qualitative dimensions of human and planetary well-being. Reflecting on the complex interrelationship among economics, justice, and equity, the book resists "one size fits all" approaches and struggles to revitalize the marriage of economics and ethics by activating cultural differences as the basis of mutual contribution to shared human flourishing. The publication of this important collection will stimulate or extend critical debates among scholars and students working in a number of disciplines in the social sciences and humanities, including philosophy, history, environmental studies, economics, and law. Contributors: Roger T. Ames, James Behuniak Jr., Steve Bein, Nalini Bhushan, Purushottama Bilimoria, Steven Burik, Amita Chatterjee, Baoyan Cheng, Gordon Davis, Jay L. Garfield, Steven F. Geisz, Peter D. Hershock, Larry A. Hickman, Kathleen M. Higgins, Heidi M. Hurd, Thomas P. Kasulis, Workineh Kelbessa, Lori Keleher, Oliver Leaman, James McRae, Jin Y. Park, James Peterman, Naoko Saito, May Sim, Robert Smid, Paul Standish, Kenneth W. Stikkers, Karsten J. Struhl, Meera Sushila Viswanathan, Wu Shiu- Ching, Xu Di, T. Yamauchi, Yang Liuxin. (shrink)

Composed more than 2,000 years ago during a turbulent period of Chinese history, the Dao de jing set forth an alternative vision of reality in a world torn apart by violence and betrayal. Daoism, as this subtle but enduring philosophy came to be known, offers a comprehensive view of experience grounded in a full understanding of the wonders hidden in the ordinary. Now in this luminous new translation, based on the recently discovered ancient bamboo scrolls, China scholars Roger T. (...) class='Hi'>Ames and David L. Hall bring the timeless wisdom of the Dao de jing into our contemporary world. Though attributed to Laozi, “the Old Master,” the Dao de jing is, in fact, of unknown authorship and may well have originated in an oral tradition four hundred years before the time of Christ. Eschewing philosophical dogma, the Dao de jing set forth a series of maxims that outlined a new perspective on reality and invited readers to embark on a regimen of self-cultivation. In the Daoist world view, each particular element in our experience sends out an endless series of ripples throughout the cosmos. The unstated goal of the Dao de jing is self-transformation–the attainment of personal excellence that flows from the world and back into it. Responding to the teachings of Confucius, the Dao de jing revitalizes moral behavior by recommending a spontaneity made possible by the cultivated “habits” of the individual. In this elegant volume, Ames and Hall feature the original Chinese texts of the Dao de jing and translate them into crisp, chiseled English that reads like poetry. Each of the eighty-one brief chapters is followed by clear, thought-provoking commentary exploring the layers of meaning in the text. The book’s extensive introduction is a model of accessible scholarship in which Ames and Hall consider the origin of the text, place the emergence of Daoist philosophy in its historical and political context, and outline its central tenets. The Dao de jing is a work of timeless wisdom and beauty, as vital today as it was in ancient China. This new version will stand as both a compelling introduction to the complexities of Daoist thought and as the classic modern English translation. (shrink)

Uses a comparative hermeneutical method to explain the most important terms in the classical Confucian philosophical texts, in an effort to allow the tradition to speak on its own terms.

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the REC (...) of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the (...) REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Ames shows that Zen has been present in America all along, though not by the name.

The problems of environmental ethics are so basic that the exploration of an alternative metaphysics or attendant ethical theory is not a sufficiently radical solution. In fact, the assumptions entailed in adefinition of systematic philosophy that gives us a tradition of metaphysics might themselves be the source of the current crisis. We might need to revision the responsibilities of the philosopher and think in terms of the artist rather than the “scientific of first principles.” Taoism proceeds from art rather than (...) science, and produces an ars contextualis: generalizations drawn from human experience in the most basic processes of making aperson, making a community and making a world. This idea of an “aesthetic cosmology” is one basis for redefining the nature of the relatedness that obtains between particular and world-between tao and te. (shrink)

Philosophers on Education offers us the most comprehensive available history of philosopher's views and impacts on the directions of education. As Amelie Rorty explains, in describing a history of education, we are essentially describing and gaining the clearest understanding of the issues that presently concern and divide us. The essays in this stellar collection are written by some of the finest comtemporary philosophers. Those interested in history of philosophy, epistemology, moral psychology and education, and political theory will find Philosophers on (...) Education to be both an engaging and fascinating read. (shrink)

Argues that the only way to understand the Confucian vision of the consummate moral life is to take the tradition on its own terms.