Ames Dhai

Towards a framework convention on global health

A global health treaty, a Framework Convention on Global Health (FCGH) – grounded in the right to health, with the central goal of reducing immense domestic and global health inequities – could serve as a robust global governance instrument to underpin the United Nations post-2015 Millennium Development Goals (MDGs). It would ensure for all people the three essential conditions for a healthy life – public health, health care, and the positive social determinants of health – while advancing good governance, responding to drivers of health disadvantages for marginalized populations, elevating health in other legal regimes, and enhancing peoples ability to claim their rights.The legally binding nature of the FCGH would enhance accountability and compliance through rigorous monitoring and reporting, domestic human rights litigation, and international incentives. It would overcome the collective action problem of global health financing through a health financing framework with clear domestic and international obligations.Stakeholders have made thoughtful critiques of the FCGH, such as the opportunity costs of advocacy, the time and expense of treaty negotiations, and reporting burdens. Nevertheless, these costs could be turned into opportunities through civil society participation in negotiations, by taking advantage of extensive reporting and monitoring requirements to expand accountability around and strengthen strategies to respond to health inequities, and through non-binding frameworks on the way towards the treaty.The greatest challenge in achieving an FCGH is the political obstacles it will face. Social justice movements united behind an FCGH, to secure the treaty and to ensure its implementation, are vital to the success of an FCGH – and the right to health. With its aim of securing this right, the FCGH could unite disparate health-related movements, all of which should contribute to developing the treaty and taking ownership of its realization.

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Highlights • Placebo controls may be acceptable even when an efficacious vaccine exists, in the following four possible situations:• When developing a locally affordable vaccine.• When evaluating the local safety and efficacy of an existing vaccine.• When testing a new vaccine when an existing vaccine is not considered appropriate locally.• When determining the local burden of disease.

Uniquely South African: time to consider offering HIV-positive donor kidneys to HIV-infected renal failure patients?

Kidney transplantation has been established as the most effective form of renal replacement therapy from a cost and quality of life perspective in the developed world.

Laws, regulations and guidelines of developed countries, developing countries in Africa, and BRICS regions pertaining to the use of human biological material (HBM) in research

Human biological material (HBM) is an invaluable resource in biomedical research. Although research ethics committees (RECs) are guided by international guidelines and frameworks, some RECs might not be fully informed about local ethical and regulatory requirements regarding the use, collection, storage, ownership, transfer and benefit-sharing of HBM in collaborative research.

Research ethics review - protecting participants in research

The global proliferation of medical research has imposed a huge responsibility on research ethics committees (RECs). While South Africa has a climate conducive to serious growth in research, it is also home to a large number of vulnerable groups of poor populations. The potential for misuse of power in research cannot be ignored. Stipulations within the National Health Act now make the ethical practice of research a statutory requirement in South Africa. Commitment to REC support by institutions will be reflective of their commitment to ethical research. However currently RECs are overworked and understaffed. Regrettably, protecting participants in research has not kept pace with the rapid increase of research in the country.

Ethical and legal controversies in cloning for biomedical research--a South African perspective.

Therapeutic embryonic stem cell research raises a number of ethical and legal issues. The promised benefits are new and important knowledge of human embryological development, gene action, and the production of transplantable tissue and organs that could be effective in reversing or curing currently irreversible disease processes. However, this research involves the deliberate production, use, and ultimate destruction of cloned embryos, hence re-awakening the debate on the moral status of the embryo. Other moral anxieties include the possibility that women (as donors of ova) would be exploited, that this research would land on the slippery slope of reproductive cloning, and that promises made too early could lead to false hope among sick patients. It also raises the question of intellectual and actual property rights in human cell lines and the techniques by which they are produced. Review of legal systems internationally reveals that there is no global consensus on therapeutic embryonic stem cell research. Legal considerations are very much influenced by ethical deliberations on the moral status of the embryo. The South African parliament is promulgating legislation permitting therapeutic cloning, thereby demonstrating a commitment by the state to act in the best interests of patients and of regenerative medicine.

A pilot study evaluating an intervention designed to raise awareness of clinical trials among potential participants in the developing world.

Background This pilot study evaluated the speaking book ‘What it means to be part of a clinical trial’. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book—at significant cost—is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place. Objective The objective of the study was to measure the efficacy and ease of use of the book. Methods Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group (‘experimental’ group). The other group (‘control’ group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked ‘ease of use’ questions. Results A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of ‘ease of use’ questions proved that the book is easy to use, although some changes would be beneficial. Conclusion This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided.

The research ethics evolution: From Nuremberg to Helsinki

Health research sets out to acquire not only theoretical knowledge but also benefits for many people and often society as a whole, and is therefore justified. The quandary, though, is how such an important, shared purpose can be pursued with full protection of individuals and communities, in particular those with vulnerabilities. Abuses in the field surfaced in the early 1800s, and by the 1890s, anti-vivisectionists were calling for laws to protect children because of the increasing numbers of institutionalised children being subjected to unethical research. When read together, the Nuremberg Code and the Universal Declaration of Human Rights can be interpreted as establishing a basis for underpinning the principles of free and informed consent and avoiding harms and exploitation in scientific experiments involving human participants. The Declaration of Helsinki has been recognised as one of the most authoritative statements on ethical standards for human research in the world.

A health system that violates patients' rights to access health care

During the apartheid era, disproportionate resource allocation policies by the state at a systemic level resulted in poor-quality and inferior services being available to black people. Healthcare services were not spared the discriminatory constraints of apartheid rule. As a consequence, there were treatment delays, drug and bed shortages, and black South Africans in psychiatric hospitals were refused sheets, made to sleep on the floor, and given inferior foods. In many instances, black women were made to leave healthcare facilities immediately after giving birth. No doubt the state had the resources to provide better care, but because of apartheid racist policies did not.

Addressing authorship disputes

Extracted from text ... EDITORIALs 49 January 2006, Vol. 96, No. 1 sAMJ Addressing authorship disputes Journal articles are a means of communicating new work between scientists and scholars.1 While authorship of these publications establishes the accountability and responsibility of the author, misappropriation undermines integrity of the authorship system and the research enterprise.2 Authorship disputes are becoming an increasing problem in the scientific community, accounting for 2.3 - 11% of all disagreements.3, 4 It is therefore incumbent on the scientific community to address the disquiet arising from these authorship-related disputes. The leading cause of authorship disputes is multiple authorship, defined as more than ..