Book 1: Foreword to the fourth edition

In his foreword to the third edition of these Guidelines, Professor Solly Benatar eloquently wrote of the 'resurgence of interest in the moral aspects of medical practice' including research. In the intervening years, that interest has increased at an exponential rate. Investigators, participants and sponsors have become more aware of rights and responsibilities.

This increase in ethics information has made the task of the Editorial Committee a difficult one. We decided to keep the basic framework of the third edition, but to split the original single volume into five. Our reasoning is that this will facilitate future updating and reprinting and will enable people with specific interests to find the book that suits them best. We tackled much of the task ourselves, but approached experts in specific fields to produce specialised sections. To these colleagues we are indebted, and they are acknowledged in the front of each book. Draft copies were placed on the South African HealthInfo website (http://www.sahealthinfo.org/ethics/ethics.htm) for comment, and we thank those people who responded.

As with anything written by different teams, there are differences in style for which we ask our readers' indulgence. Fortunately the differences have been eased by the editorial skills of Mr Brian Johnson-Barker. For consistency throughout the books, the 'research subject' has been replaced with 'research participant' to emphasise the team approach, 'researcher' is now 'investigator' and 'doctor' is now 'clinician'. This last term acknowledges that clinicians other than doctors do medical research.

The large section on clinical trials that appeared in the third edition has been removed. In its place there is reference to South African and international Good Clinical Practice Guidelines. We saw no need to reinvent the wheel and thereby waste scarce resources.

Of course these Guidelines are among many produced round the world. While all share principles, inevitably there are differences. Such differences have been starkly indicated by the passionate response to the 2000 revision of the Declaration of Helsinki (Appendix VI) which has been welcomed by some and rejected by others. Our Guidelines have a developing-country perspective, an African outlook, we believe. Our approach has been strongly influenced by the South African Constitution, which was adopted in 1996 and entrenches in the Bill of Rights the principle of informed consent of participants in medical and scientific experimentation. Given the vulnerable populations in our country, the Editorial Committee's decision has been to emphasise the principle of autonomy - particularly from the perspective of 'non-exploitation' of research participants. The theme of 'informed consent' recurs throughout. This is a complex matter and recommended reading includes the excellent compendium of views produced by the British Medical Journal (Doyal L, Tobias JT, Editors. Informed consent in medical research. London: BMJ Books, 2001: 1- 334).

There are two final points. First, there is considerably more 'legalese' in this edition. This is deliberate and has arisen from the many queries directed to members of the Ethics Committee. Second, we accept that there will be colleagues who disagree with some things we have written; some may have additional points and some may spot errors. Please send comments to the MRC (see the HealthInfo website mentioned opposite) so that whoever writes future editions may consider them.

The Editorial Committee

There are five books in the series Guidelines on Ethics for Medical Research.

Book 1
Guidelines on Ethics for Medical Research: General Principles.

Book 2
Guidelines on Ethics for Medical Research: Reproductive Biology and Genetic Research.

Book 3
Guidelines on Ethics for Medical Research: Use of Animals in Research.

Book 4
Guidelines on Ethics for Medical Research: Use of Biohazards and Radiation.

Book 5
Guidelines on Ethics for Medical Research: HIV Vaccine Trials.