BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent.Cross-sectional (...) study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%–77% and for understanding 75% (IQR = 50%–87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. (shrink)

Wars must be won if our country … is to be protected from unthinkable outcomes, as the events on September 11th most recently illustrated…. This best protection unequivocally requires armed forces having military physicians committed to doing what is required to secure victory…. As opposed to needing neutral physicians, we need military physicians who can and do identify as closely as possible with the military so that they, too, can carry out the vital part they play in meeting the needs (...) of the mission.Counterpoint:We believe the role of the “physician–soldier” to be an inherent moral impossibility because the military physician, in an environment of military control, is faced with the difficult problems of mixed agency that include obligations to the “fighting strength” and … “national security.”. (shrink)

BackgroundInternational codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for the relevance and cogency (...) of an ethical code in occupational health for an African context through an iterative consultative process.DiscussionFirstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace.SummaryA stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region. (shrink)

International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developing by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an African Working Group addressed key challenges for the relevance and cogency (...) of an ethical code in occupational health for an African context through an iterative consultative process. (shrink)

Despite growing advances in medical technologies, health status inequalities continue to increase across the globe. Developing countries have been faced with declining expenditures in health and social services, increasing burdens posed by both communicable and non-communicable diseases, and economic systems poorly geared to fostering sustainable development for the poorest and most marginalized. Under such circumstances, the challenges facing health practitioners in countries in transition are complex and diverse, and require the balancing of many conflicting imperatives. This is particularly so in (...) relation to the development of public health policy, where equity, redress of past inequalities, and the god of social justice may seemingly be pitted against macroeconomic adjustments required for national economic development in an increasingly globalized economic order.For example, pressures to deregulate as part of a market-oriented development philosophy will increase the risks from occupational hazards in populations desperate for paid employment. (shrink)

Despite growing advances in medical technologies, health status inequalities continue to increase across the globe. Developing countries have been faced with declining expenditures in health and social services, increasing burdens posed by both communicable and non-communicable diseases, and economic systems poorly geared to fostering sustainable development for the poorest and most marginalized. Under such circumstances, the challenges facing health practitioners in countries in transition are complex and diverse, and require the balancing of many conflicting imperatives. This is particularly so in (...) relation to the development of public health policy, where equity, redress of past inequalities, and the god of social justice may seemingly be pitted against macroeconomic adjustments required for national economic development in an increasingly globalized economic order.For example, pressures to deregulate as part of a market-oriented development philosophy will increase the risks from occupational hazards in populations desperate for paid employment. (shrink)

Global debates in approaches to HIV/AIDS control have recently moved away from a uniformly strong human rights-based focus. Public health utilitarianism has become increasingly important in shaping national and international policies. However, potentially contradictory imperatives may require reconciliation of individual reproductive and other human rights with public health objectives. Current reproductive health guidelines remain largely nonprescriptive on the advisability of pregnancy amongst HIV-positive couples, mainly relying on effective counselling to enable autonomous decision-making by clients. Yet, health care provider values and (...) attitudes may substantially impact on the effectiveness of nonprescriptive guidelines, particularly where social norms and stereotypes regarding childbearing are powerful, and where providers are subjected to dual loyalty pressures, with potentially adverse impacts on rights of service users. Data from a study of user experiences and perceptions of reproductive and HIV/AIDS services are used to illustrate a rights analysis of how reproductive health policy should integrate a rights perspective into the way services engage with HIV-positive persons and their reproductive choices. The analysis draws on recognised tools developed to evaluate health policies for their human rights impacts and on a model developed for health equity research in South Africa to argue for greater recognition of agency on the part of persons affected by HIV/AIDS in the development and content of policies on reproductive choices. We conclude by proposing strategies that are based upon a synergy between human rights and public health approaches to policy on reproductive health choices for persons with HIV/AIDS. (shrink)

The massive growth in global health research in past decades has posed many challenges for its effective ethical oversight, not least of which is how best to provide effective protection of research participants. The extent of the HIV epidemic in sub-Saharan Africa in particular makes research into prevention technologies for HIV, including HIV vaccine research, a global priority. However, the need for vaccine research must be considered in conjunction with the individual's right to informed consent, which is based on the (...) principle of respect for autonomy. One of the primary human rights violations likely to occur in the context of HIV vaccine research is that potential research participants may not fully understand what participation in research studies entails. People who elect to enrol in HIV vaccine trials are required to understand both the potential negative effects of participation (eg, discrimination) as well as complex scientific concepts such as randomisation and prophylaxis in order to be ethically enrolled. In this study, two vignettes are presented to illustrate two core issues in conducting phase III HIV vaccine trials in low-income countries—namely, (1) from the perspective of participants, the extent to which understanding is a prerequisite for consenting to participate in a trial, and (2) from the perspective of trial investigators, whether it is appropriate to persuade eligible people to enrol in a trial, even though their initial reaction is to decline to participate. These vignettes are used to analyse these issues through the prisms of research ethics and human rights in order to identify helpful synergies. It is argued that the human rights perspective provides a helpful lens on ethical issues. (shrink)

The health and human rights movement (HHR) shows obvious signs of maturation both internally and externally. Yet there are still many questions to be addressed. These issues include the movement’s epistemological status and its perspectives of development. This paper discusses critically the conditions of emergence of HHR, its identity, its dominant schools of thought, its epistemological postures and its methodological issues. Our analysis shows that: (a) the epistemological status of HHR is ambiguous; (b) its identity is uncertain in the absence (...) of a validated definition: is it an action movement, an interdisciplinary field, a domain, an approach, a setting or a scientific discipline? (c) its main schools of thoughts are defined as “advocacists”, “ethicists”, “interventionists”, “normativists”; (d) the movement is in the maturation process as a discipline in which “interface”, “distance”, “interference” and “fusion” epistemological postures represent the fundamental steps; (e) parent disciplines (health sciences and law) competences, logics and cultures introduce duality and difficulties in knowledge production, validation and diffusion; (f) there is need to re-write the history of the HHR movement by inscribing it not only into the humanitarian or public health perspectives but also into the evolution of sciences and its social, political and economical conditions of emergence. The ambiguous epistemological status of this field, the need to re-write its history, the methodological duality in its research, the question of the competence of the knowledge validation, as well as the impact of HHR practice on national and international health governance are the challenges of its future development. To meet those challenges; we call for the creation and implementation of an international research agenda, the exploration of new research topics and the evaluation of the movement’s contribution to the national and global public health and human rights governance. (shrink)