Improving and Maintaining Ethical Standards in Research

Professor Tuviah Zabow
Human Ethics Research Committee
Faculty of Health Sciences UCT

Introduction:

The following points will serve to highlight the importance of research ethics for medical research workesr:

• High profile both nationally and internationally.
• Growing public and professional awareness.
• Need to protect both patient and volunteer subjects of research.
• National Health Act - National Research Ethics Council.
• Department of Health guidelines on Human Research.
• MRC updated guidelines on Human Research Subjects.
• Examples of research fraud and misconduct.
• SA unique environment for quantitative and qualitative research.
• Vulnerable populations with poverty, illiteracy, the unquestioning acceptability of authority and the need for health care.
• Research ethics standards development for local conditions.
• Ethical imperative for research in relation to evidence based practice.

Specific considerations in SA:

• Relevance to the need of local populations.
• Exploitation potential of subjects.
• Potential benefits of the research vs the potential risks /harm.
• Research in developing countries should be linked to capacity building in health care (economic, educational improvement and progress).
• Long term benefits to the participating communities.
• The need is to protect all participants of research activities coupled with meticulous ethical review.
• Increasing research activity.
• Competition in research.
• Attractive research environment in SA
     - potential for dishonest /fraudulent practices.

Key issues:

The key issues that must be addressed are:

• ethical responsibilities;
• scope and functioning of ethics committees;
• varieties of research;
• research governance and clinical care;
• informed consent;
• capacity and competence;
• legal principles and practical guides;
• exploitation;
• academic freedom/intellectual property;
• conflict of interests;
• scientific fraud;
• publication ethics.

Historical perspective:

Prior to1960 medical research was uided bu the traditional codes, such as the Hippocratic Oath.
After 1960, new considerations were taken into account, notably:

• “new”ethics/technology/human rights;
• paternalism vs autonomy.

There were serious attempts "to learn from mistakes of the past"

• Nuremberg Code (1949) - Nazi Doctors.
• Helsinki Declaration (1964).
• Belmont Report (1979) -Tuskegee Study.
• CIOMS Guidelines (WHO) (1982).
• Royal College of Physicians (1984).
• MRC (SA) (1993).
• DoH Guidelines (SA) (2000).
• Research Ethics Committees.
• Helsinki Declaration (2000).
• Royal College of Psychiatrists (2001).