SUNScholar - Browsing by Author "Moodley, Keymanthri"

Browsing by Author "Moodley, Keymanthri"

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Advancing research ethics training in Southern Africa (ARESA)
(Health and Medical Publishing Group (HMPG), 2012-12) Moodley, Keymanthri; Rennie, Stuart
Southern Africa is a research-rich environment in which research ethics review is critical. The research ethics review system is well established but considerable variability in capacity and training exists among the various research ethics committees (RECs) in the region. The ARESA programme comprises a Postgraduate Diploma in Health Research Ethics, an annual seminar, a newsletter and an association of REC members. The programme has been developed to promote health in the region via capacity development in the field of research ethics.
Allocation of scarce resources in Africa during COVID‐19 : utility and justice for the bottom of the pyramid?
(John Wiley & Sons, 2020-08-26) Moodley, Keymanthri; Rennie, Stuart; Behets, Frieda; Obasa, Adetayo Emmanuel; Yemesi, Robert; Ravez, Laurent; Kayembe, Patrick; Makindu, Darius; Mwinga, Alwyn; Jaoko, Walter
The COVID‐19 pandemic has raised important universal public health challenges. Conceiving ethical responses to these challenges is a public health imperative but must take context into account. This is particularly important in sub‐Saharan Africa (SSA). In this paper, we examine how some of the ethical recommendations offered so far in high‐income countries might appear from a SSA perspective. We also reflect on some of the key ethical challenges raised by the COVID‐19 pandemic in low‐income countries suffering from chronic shortages in health care resources, and chronic high morbidity and mortality from non‐COVID‐19 causes. A parallel is drawn between the distribution of severity of COVID‐19 disease and the classic “Fortune at the bottom of the pyramid” model that is relevant in SSA. Focusing allocation of resources during COVID‐19 on the ‘thick’ part of the pyramid in Low‐to‐Middle Income Countries (LMICs) could be ethically justified on utilitarian and social justice grounds, since it prioritizes a large number of persons who have been economically and socially marginalized. During the pandemic, importing allocation frameworks focused on the apex of the pyramid from the global north may therefore not always be appropriate. In a post‐COVID‐19 world, we need to think strategically about how health care systems can be financed and structured to ensure broad access to adequate health care for all who need it. The root problems underlying health inequity, exposed by COVID‐19, must be addressed, not just to prepare for the next pandemic, but to care for people in resource poor settings in non‐pandemic times.
An Investigators perspective on litigation in clinical trial research.
(2008) Moodley, Keymanthri
ASSAf consensus study on the ethical, legal and social implications of genetics and genomics in South Africa
(Academy of Science of South Africa, 2018) Pepper, Michael S.; Dandara, Collet; De Vries, Jantina; Dhai, Amaboo; Labuschaigne, Melodie; Mnyongani, Freddy; Moodley, Keymanthri; Olckers, Antonel; Pope, Anne; Ramesar, Raj; Ramsay, Michele; Soodyall, Himla; Towers, Wayne
No abstract available.
Autonomy of the child in the South African context : is a 12 year old of sufficient maturity to consent to medical treatment?
(BioMed Central, 2016-11-02) Ganya, Wandile; Kling, Sharon; Moodley, Keymanthri
Background: A child is a developing person with evolving capacities that include autonomy, mental (decisional) capacity and capacity to assume responsibility. Hence, children are entitled to participatory (autonomy) rights in South Africa as observed in the Children’s Act 38 of 2005. According to section 129 of the Act a child may consent to his or her own medical treatment provided that he or she is over the age of 12 years and is of sufficient maturity and decisional capacity to understand the various implications of the treatment including the risks and benefits thereof. However, the Act does not provide a definition for what qualifies as ‘sufficient maturity’ nor does it stipulate how health professionals ought to assess the decisional capacity of a child. In addition, South Africa is a culturally diverse country. The Western liberal notion of autonomy may not necessarily find equal prominence in the mores of people with a different worldview. Hence we demonstrate a few salient comparisons between legal liberal moral theory and African communitarianism as pertinent to the autonomy of the child. Discussion: Children are rights-holders by virtue of their humanity. Their dignity as individual human persons affords them the entitlement to human rights as contemplated under the Constitution of the Republic of South Africa. However, contrary to the traditional Western notion of individual autonomous persons African societies hold a communalistic notion of person hence there is less regard for individual autonomy and rights with more emphasis on the communal good and maintaining the continuity of relationships and interdependencies shared within a community. A child considered in this view is not regarded as a full person. This implies that decisions concerning the child, including consent to medical treatment are discussed and determined by the community to which the child belongs. Lastly, in this article, we draw on the notion of capacity for responsibility to produce a pragmatic definition of sufficient maturity. Conclusion: It seems reasonable to suggest a move away from a general legal age of consent for medical treatment toward more individualised, context-specific approaches in determining the maturity of a child patient to consent to medical treatment. Perhaps, decision-making with respect to consent to the medical treatment of a child belonging to a traditional African community where the notion of a person is embedded in communitarianism ought to involve the child’s parents/guardians/caregivers where possible provided that the best interests of the child are awarded priority.
Challenges in biobank governance in Sub-Saharan Africa
(BioMed Central, 2013-09) Staunton, Ciara; Moodley, Keymanthri
Background: Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples. Methods: A literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found. Results: It was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples. Conclusion: Collaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.
Clinical Ethics Committees in Africa : lost in the shadow of RECs/IRBs?
(BioMed Central, 2020) Moodley, Keymanthri; Kabanda, Siti Mukaumbya; Soldaat, Leza; Kleinsmidt, Anita; Obasa, Adetayo Emmanuel; Kling, Sharon
Background: Clinical Ethics Committees (CECs) are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services (CESs) on the continent. Methods: A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data were subjected to descriptive analysis and Fischer’s exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results: In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics (p = 0.005). All participants were familiar with Research Ethics Committees (RECs), and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants (81.7%) were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions: This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. Keywords: Clinical ethics committees, Clinical ethics consultation service, Africa, Developing countries, Ethics, Clinical ethics, Dilemma
Consent for critical care research after death from COVID-19 : arguments for a waiver
(Health & Medical Publishing Group, 2020-05-26) Moodley, Keymanthri; Allwood, Brian W.; Rossouw, T. M.
Pandemics challenge clinicians and scientists in many ways, especially when the virus is novel and disease expression becomes variable or unpredictable. Under such circumstances, research becomes critical to inform clinical care and protect future patients. Given that severely ill patients admitted to intensive care units are at high risk of mortality, establishing the cause of death at a histopathological level could prove invaluable in contributing to the understanding of COVID-19. Postmortem examination including autopsies would be optimal. However, in the context of high contagion and limited personal protective equipment, full autopsies are not being conducted in South Africa (SA). A compromise would require tissue biopsies and samples to be taken immediately after death to obtain diagnostic information, which could potentially guide care of future patients, or generate hypotheses for finding needed solutions. In the absence of an advance written directive (including a will or medical record) providing consent for postmortem research, proxy consent is the next best option. However, obtaining consent from distraught family members, under circumstances of legally mandated lockdown when strict infection control measures limit visitors in hospitals, is challenging. Their extreme vulnerability and emotional distress make full understanding of the rationale and consent process difficult either before or upon death of a family member. While it is morally distressing to convey a message of death telephonically, it is inhumane to request consent for urgent research in the same conversation. Careful balancing of the principles of autonomy, non-maleficence and justice becomes an ethical imperative. Under such circumstances, a waiver of consent, preferably followed by deferred proxy consent, granted by a research ethics committee in keeping with national ethics guidance and legislation, would fulfil the basic premise of care and research: first do no harm. This article examines the SA research ethics framework, guidance and legislation to justify support for a waiver of consent followed by deferred proxy consent, when possible, in urgent research after death to inform current and future care to contain the pandemic in the public interest.
COVID‑19 underscores the important role of clinical ethics committees in Africa
(BioMed Central, 2021) Moodley, Keymanthri; Kabanda, Siti Mukaumbya; Kleinsmidt, Anita; Obasa, Adetayo Emmanuel
Background: The COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa. Methods: Twenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses. Results: Kenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking. Conclusions: This study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs.
Critical care triaging in the shadow of COVID-19 : ethics considerations
(Health & Medical Publishing Group, 2020) Singh, J. A.; Moodley, Keymanthri
Since the World Health Organization declared coronavirus disease 2019 (COVID-19) a Public Health Emergency of International Concern, COVID-19 infection and the associated mortality have increased exponentially, globally. South Africa (SA) is no exception. Concerns abound over whether SA’s healthcare system can withstand a demand for care that is disproportionate to current resources, both in the state and private health sectors. While healthcare professionals in SA have become resilient and adept at making difficult decisions in the face of resource limitations, a surge in COVID-19 cases could place a severe strain on the country’s critical care services and necessitate unprecedented rationing decisions. This could occur at two critical points: access to ventilation, and withdrawal of intensive care in nonresponsive or deteriorating cases. The ethical dimensions of decision-making at both junctures merit urgent consideration
Data mining and biological sample exportation from South Africa : a new wave of bioexploitation under the guise of clinical care?
(Health & Medical Publishing Group, 2016) Staunton, Ciara; Moodley, Keymanthri
Discovery Health, one of the leading healthcare funders in South Africa (SA), will offer genetic testing to its members for USD250 (approximately ZAR3 400) per test from 2016. On the surface, this appears to be innovative and futuristic. However, a deeper look at this announcement reveals considerable problems in the exportation of biological samples and data out of SA, and brings into sharp focus the lack of protection in place for potential donors. In return for a reduced-cost genetic test, which will nevertheless be billed to a member’s savings plan, data from the patient’s results, and probably the sample itself, will be sent to the USA for storage, research purposes and possible commercial use, with no further benefit for the patient. This development has demonstrated the need for more stringent protection of the movement of biological samples and data out of SA, particularly with reference to consenting procedures, material transfer agreements, and the export of biological data themselves.
Disparate compensation policies for research related injury in an era of multinational trials : a case study of Brazil, Russia, India, China and South Africa
(BioMed Central, 2018-02-17) Chingarande, George Rugare; Moodley, Keymanthri
Background: Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS). Methods: A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007). The search focused on three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings (MeSH) and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. Results: The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. Conclusions: It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence.
Dual loyalties, human rights violations, and physician complicity in apartheid South Africa
(American Medical Association, 2015-11) Moodley, Keymanthri; Kling, Sharon
Introduction: From 1948 to 1994, South Africans were subjected to a period of sociopolitical segregation and discrimination based on race, a social experiment known as apartheid. South African history was tainted by a minority Afrikaner Nationalist Party that sought to plunder, exploit, divide, and rule. When that party took power in 1948, human rights abuses permeated all levels of society, including the medical profession, which was to a large extent complicit in various human rights violations. These discriminatory practices had a negative impact on the medical education of black students, the care of black patients in private as well as public institutions, and the careers of black medical doctors. Medical student training programs at most universities ensured that white patients were not examined by black medical students either in life or after death. Postmortems on white patients were conducted in the presence of white students only; students of color were permitted to view the organs only after they were removed from the corpse [1]. Public and private hospitals reflected the mores of apartheid South Africa. Ambulance services were segregated, and even in emergencies a designated “white ambulance” could not treat and transport critically ill or injured patients of color [2]. Public hospitals had separate wings for white and black patients and medical staff. Many private practices had separate entrances and waiting rooms for patients with medical insurance and those paying cash, effectively segregating white and black [1, 2]. Doctors treating political prisoners faced dual loyalties on a regular basis. Some, like Dr. Wendy Orr, resisted the gross human rights violations, while many were complicit [2]. In particular, the abhorrent treatment of medical student and political activist Steve Biko received international attention [2].
Engaging with Community Advisory Boards (CABs) in Lusaka Zambia : perspectives from the research team and CAB members
(BioMed Central, 2015) Mwinga, Alwyn; Moodley, Keymanthri
Background: The use of a Community Advisory Board (CAB) is one method of ensuring community engagement in community based research. To identify the process used to constitute CABs in Zambia, this paper draws on the perspectives of both research team members and CAB members from research groups who used CABs in Lusaka. Enabling and restricting factors impacting on the functioning of the CAB were identified. Methods: All studies approved by the University of Zambia Bioethics Research Committee (UBNZABREC) from 2008 – 2012 were reviewed to identify those studies that were likely to include a CAB. Eight teams with studies that included a CAB were identified. For each of these studies, consent was obtained to conduct an informal interview with a research team member and to obtain contact details for one CAB member. In total 14 interviews were conducted with 8 research team members and 6 CAB members from 12–30 August 2013. Results: Identification of potential CAB members from the community and their participation in developing the terms of reference for CABs was perceived to have contributed to the success of the CAB. Due to the trust that the community had in members of their community the CABs were then in a stronger position to influence community participation in the research. Training of CAB members was identified as a factor that enhanced the functioning of a CAB. Lack of commitment and low literacy levels of CAB members posed a threat to the role of the CAB. Although compensation in the form of a stipend was not provided, CAB members were provided with transport reimbursements for attending meetings. Conclusions: Selection of CAB members from within the community contributed to community confidence in the CAB, enhancing its ability to act as an effective link between study team and community. This contributed positively to the conduct of the study and enhanced community awareness and acceptance of the research. However, establishment of study specific CABs has the potential to compromise CAB independence due to support provided by the research team in the form of transport reimbursements and other forms of support. Consideration should be given to establishing community wide Community Advisory Boards that could function across a range of studies to increase independent objective decision-making.
Ethical considerations for vaccination programmes in acute humanitarian emergencies
(World Health Organization, 2013-02-07) Moodley, Keymanthri; Hardie, Kate; Selgelid, Michael J.; Waldman, Ronald J.; Strebel, Peter; Rees, Helen; Durrheim, David N.
Humanitarian emergencies result in a breakdown of critical health-care services and often make vulnerable communities dependent on external agencies for care. In resource-constrained settings, this may occur against a backdrop of extreme poverty, malnutrition, insecurity, low literacy and poor infrastructure. Under these circumstances, providing food, water and shelter and limiting communicable disease outbreaks become primary concerns. Where effective and safe vaccines are available to mitigate the risk of disease outbreaks, their potential deployment is a key consideration in meeting emergency health needs. Ethical considerations are crucial when deciding on vaccine deployment. Allocation of vaccines in short supply, target groups, delivery strategies, surveillance and research during acute humanitarian emergencies all involve ethical considerations that often arise from the tension between individual and common good. The authors lay out the ethical issues that policy-makers need to bear in mind when considering the deployment of mass vaccination during humanitarian emergencies, including beneficence (duty of care and the rule of rescue), non-maleficence, autonomy and consent, and distributive and procedural justice.
The ethics of talking about ‘HIV cure’
(BioMed Central, 2015-03) Rennie, Stuart; Siedner, Mark; Tucker, Joseph D.; Moodley, Keymanthri
Background In 2008, researchers reported that Timothy Brown (the ‘Berlin Patient’), a man with HIV infection and leukemia, received a stem-cell transplant that removed HIV from his body as far as can be detected. In 2013, an infant born with HIV infection received anti-retroviral treatment shortly after birth, but was then lost to the health care system for the next six months. When tested for HIV upon return, the child (the ‘Mississippi Baby’) had no detectable viral load despite cessation of treatment. These remarkable clinical developments have helped reinvigorate the field of ‘HIV cure’ research. Discussion Although this research field is largely in a pre-clinical phase, talk about curing HIV has become a regular feature in the global mass media. This paper explores the language of HIV cure from philosophical, ethical and historical perspectives. Examination of currently influential definitions of ‘functional’ and ‘sterilizing’ HIV cure reveal that these conceptualizations are more complicated than they seem. Cure is often understood in narrowly biomedical terms in isolation from the social and psychological dimensions of illness. Contemporary notions of HIV cure also inherit some of the epistemic problems traditionally associated with cures for other health conditions, such as cancer. Efforts to gain greater conceptual clarity about cure lead to the normative question of how ‘HIV cure research’ ought to be talked about. Summary We argue that attention to basic concepts ethically matter in this context, and identify advantages as well as potential pitfalls of how different HIV/AIDS stakeholders may make use of the concept of cure. While concepts other than cure (such as remission) may be appropriate in clinical contexts, use of the word cure may be justified for other important purposes in the struggle against HIV/AIDS.
The fabricius decision on the Stransham-Ford case – an enlightened step in the right direction
(2015) Moodley, Keymanthri
Many diseases are associated with incredible pain and suffering. Others impair function and independence to the extent that human dignity is eroded. In many instances the natural history of such conditions often leads to death within a reasonable period of time. In some cases, protracted ill health, pain, suffering and indignity ensue. Such circumstances have since time immemorial triggered the debate on euthanasia – a debate on what it means to have a good death. Acting compassionately, many South African doctors have, to some extent, either passively or actively assisted patients in achieving a good death.
Family practice ethics : postmodern ethics for a postmodern discipline?
(Medpharm Publications, 2000) Moodley, Keymanthri
This paper is aimed at describing an ethics of Family Practice. ln order to achieve this, universal ethical theories and the four principles of ethics - autonomy, beneficence, non-maleficence and justice - are placed in perspective. The concepts of modernism and postmodernism are also introduced and explored. The principles of Family Medicine are examined within the context of postmodernism and a parallel is drawn. In keeping with this concept, the revival of virtue ethics is highlighted. In conclusion, a practically relevant approach to ethics is proposed as an ethical model for Family Practice, in which elements of pre-modern, modern and postmodern ethics are combined to complement one another and to form a relevant framework for the resolution of ethical dilemmas in family practice.
Health Research Ethics Committees in South Africa 12 years into democracy
(BioMed Central, 2007-01) Moodley, Keymanthri; Myer, Landon
Background: Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods: The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results: Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion: Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.
HIV Vaccine Trial participation in the Third World : an ethical assessment
(Stellenbosch : Stellenbosch University, 1999-12) Moodley, Keymanthri; Van Niekerk, Anton A.; Stellenbosch University. Faculty of Arts and Social Sciences. Dept. of Philosophy.
ENGLISH SUMMARY: This essay examines the issue of trial participation in the proposed my Vaccine Trials in South Arica. It is set against the backdrop of ethical issues relating to research in the Third World in general. Trial participation is examined in the context of the ethical tension that exists between international ethical research standards based on Liberal Individualism and local standards of care and cultural norms in the Third World. Two areas of conflict are inherent here: universality versus particularity on the one hand and individualism versus communitarianism, on the other. The Tuskegee Syphilis Study as well as the HIV Vertical Transmission Trials are used as a point of departure to set the stage for the controversy surrounding the proposed HIV Vaccine Trials. The important concepts of informed consent, the risk-benefit ratio and fair treatment of trial participants are framed within the Four Principle Approach of autonomy, beneficence, non-maleficence and justice. These principles form the cornerstone of the Declaration of Helsinki. This Western ethical guideline - grounded in universality - has become the mantra of all liberal democracies the world over and is chanted slavishly by the international research community. It bears the hallmark of liberal individualism with its mandate that "the concern for the interest of the individual must always prevail over the interests of science and society". Followed to its logical conclusion, any infringements of the moral interests of trial participants must be viewed using a subject-oriented approach. Such an approach sees the trial participant as being of paramount importance and views research as "highly desirable but morally optional". Clearly, this would mean the end of the road for medical research, especially in the Third World, where a truly subject oriented approach would render research tantamount to exploitation of vulnerable, educationally disadvantaged persons. In Africa, in traditional, rural communities, a moderate form of communitarianism referred to as "Ubuntu" or "communalism" is still prevalent. In such communities, the concept of personhood is embedded in the community or society. In these communities, a balancing approach, in which infringements on the rights of trial participants are permissible in the name of science or society, provided the subject is not placed at significant risk, would be acceptable. However, liberal individualism is making inroads here too. As such, the ethical tension between liberal individualism and communitarianism, which is unavoidable in research settings, is growing. This essay highlights many internal contradictions in liberal individualism - especially where research ethics is concerned in Third World countries. One of the outcomes of such contradiction is the attempt by the World Medical Association to amend the Declaration of Helsinki - in the name of ethical relativism: different standards for different countries or cultures. Surely, such liberal individualism cannot be seen as the "endpoint of mankind's ideological evolution" as Fukuyama phrases it, nor can it be the final solution to the problems of the world and, as such, "the end of history". In the context of the HIV Vaccine Trials, individual good clashes with societal good, universality with particularity and ultimately, modernism with postmodernism. In Western cultures, the individual enjoys priority; in other cultures, society is more important - somewhere in between, we need to find common ground which can be incorporated into a balancing approach with minimal risk to the individual when infringement of rights is unavoidable.

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