1. What is the South African Medical Research Council's ethics policy?

1.1 General policy
The MRC recognises injustices in our past and subscribes to the values enshrined in the Constitution of the Republic of South Africa Act, No. 108 of 1996: human dignity, the achievement of equality and the advancement of human rights and freedoms.

The ethics policy of the MRC is clear. All research sponsored by the Council must be of the highest ethics standard. No research will be sponsored without ethics clearance from a Research Ethics Committee recognised by the Council and operating in accordance with MRC ethics guidelines.

1.2 For whom are these Guidelines intended?
The MRC Guidelines are concerned with research on human participants and animals. The Guidelines consider all forms of research on individual persons, whether they be volunteers or patients, and include the study of treatment which might benefit the individual patient (therapeutic research) and the acquisition of knowledge that may be of no immediate benefit to the healthy volunteer (non-therapeutic research). These Guidelines apply also to non-clinical research on humans. Guidelines on ethics in the use of animals in research are dealt with in Book 3 of the current MRC Guidelines series.

What follows in the chapters of this Book 2 of the series Guidelines on Ethics for Medical Research is extensively based on three previous editions and on international documents1-9 (see also Appendices V - VII, in Book 1) but is adapted for South African conditions and law.

1.3 Ethics principles

1.3.1 The MRC promotes the four principles of biomedical ethics:

• autonomy (respect for the person - a notion of human dignity)
• beneficence (benefit to the research participant)
• non-maleficence (absence of harm to the research participant)
• justice (notably distributive justice - equal distribution of risks and benefits between communities)

There is considerable debate about whether one or more of these principles require or deserve preference when ethical problems are considered. For example, the trend in most Western countries seems to emphasise autonomy over beneficence. This counters the alleged danger of paternalism in the practice of medicine, and emphasises the importance of the consent and freedom of patients in making decisions about their own health and well-being. Such views are questioned in the context of many developing countries, where solidarity within communities is valued together with respect for individual choices, and where there is increasing concern about conflict between personal autonomy and public safety in the face of, for example, infectious diseases such as tuberculosis and particularly today the HIV/AIDS pandemic. Concern for distributive justice in developing countries also enjoys a higher priority than in some wealthy Western nations.

The MRC is convinced of the importance of adherence to the four classical principles of biomedical ethics, and of the importance of human rights and individual dignity, but it takes no prejudicial position in debates on the ranking of these principles. The MRC also does not commit to any one approach to moral reasoning or to any one strategy for the resolution of complex ethical dilemmas. It seems clear that, in most disputes in biomedical ethics, some balance between the four principles should be pursued. In maintaining commitment to the classical principles, the complexities of each case must be understood and taken into account in any effort to make justified moral judgements. Of more importance than the consistent adherence to a specific approach or strategy for the resolution of moral dilemmas is the willingness and ability to justify whatever position is taken through sound moral reasoning.

1.4 Conclusion
Application of ethics standards requires a critical evaluation of the relative merits of each of the four principles of ethics to produce a harmony appropriate for a particular research project.