Book 5: Introduction

In the third decade of the AIDS pandemic, there is still no effective HIV preventive vaccine. As the numbers of those infected by HIV and dying from AIDS increase dramatically, the need for such a vaccine becomes ever more urgent.

Several candidate HIV vaccines are at various stages of development. However, the successful development of effective HIV preventive vaccines is likely to require that many candidate vaccines be studied simultaneously in different populations around the world, requiring an international co-operative effort drawing on partners from health sectors, intergovernmental organisations, government, research institutions, industry, and affected populations. It also requires that these partners be able to address the difficult ethical concerns that arise during the development of HIV vaccines.

In the period 1997-99 the international organisation UNAIDS undertook to elucidate the ethical concerns around HIV preventive vaccines. Based on a series of consultative meetings, 1 UNAIDS generated a guidance document in 2000 which can be found at www.unaids.org. The UNAIDS (2000) document Ethical considerations in HIV preventive vaccine research forms the basis for the current text.

In 1999 the South African AIDS Vaccine Initiative (SAAVI) was established, with the aim of accelerating the development of safe and effective HIV vaccines for South Africa, and funded by such donors as the Departments of Health and Arts, Culture, Science and Technology, Eskom, International AIDS Vaccine Initiative, and National Institutes of Health.

In addition to funding candidate vaccine development, immunology, clinical trials, education and advocacy, SAAVI funded the HIV/ AIDS Vaccines Ethics Group (HAVEG) at the University of KwaZulu-Natal to undertake research and training in ethical aspects of HIV vaccine research. In 2000 the Medical Research Council approached HAVEG to co-ordinate the development of ethical guidelines for HIV vaccine research in South Africa. HAVEG agreed to do so in consultation with national resource persons and ethics structures.

This document attempts to highlight some of the critical elements that must be considered in HIV vaccine development activities in South Africa and is conceptualised as a variant of the UNAIDS (2000) guidance document. Where necessary, adaptations have been made to take into account local context and considerations. In some cases, little change has been made to the original document.

Where ethical considerations are adequately addressed by other existing texts, there is no attempt to replace these texts, which should be consulted extensively. This document makes reference to the Medical Research Council's Book 1 in this series, Guidelines on Ethics in Medical Research: General Principles. Efforts were made to harmonise this document with MRC Book 1, and the Department of Health's Ethical Considerations for HIV/ AIDS Clinical and Epidemiological Research, and Good Clinical Practice in the Conduct of Clinical Trials in South Africa. Other codes relevant to HIV vaccine development include: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, the International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences (CIOMS), the World Health Organization's Good Clinical Practice Guideline, and the ICH Good Clinical Practice Guideline.

It is hoped that this document will be of use to potential research participants, investigators, community members, government representatives, pharmaceutical companies, and ethical and scientific review committees. In the Preface, it was stated that South African ethical guidelines should emphasise the dignity and autonomy of the individual. There is also a need for South African guidelines to emphasise social justice among ethical principles, and this document attempts to do this.

The current document addresses a controversial area of research. Ethics symposia were held to discuss a number of the guidance points. A draft version was placed on the MRC website for public comment and over 200 comments were received. For certain guidance points, there were many different viewpoints and consensus was difficult to achieve. The current document aims to present aspirational guidelines for the conduct of HIV vaccine trials. Unlike Book 1 in the series, it does not present much legalese. All the points in this document are important and many are mutually dependent.

HIV vaccines are envisaged to be an important long-term preventive measure to combat the epidemic that has overwhelmed our country. Vaccine trials in search of suitable and effective vaccines should be designed and conducted according to high ethical standards. Standards for medical research, previously developed in South Africa exclusively by the South African Medical Research Council, are now being developed and set out by the National Department of Health through the Ministerial Committee on Health Research Ethics and the Medicines Control Council, with the support and collaboration of many individuals from several institutions. The National Department of Health acknowledges the extent of such collaborative work and endorses book 5: Guidelines on Ethics for Medical Research: HIV Preventive Vaccine Research, which has been developed by the Medical Research Council in close consultation with the Ministerial Committee on Health Research Ethics.