1. Clinical Research in South Africa - Ethical and Regulatory Processes NATIONAL HEALTH RESEARCH ETHICS COUNCIL Professor A Dhai Deputy Chair National Health Research Ethics Council Director – Steve Biko Centre of Bioethics, University of the Witwatersrand, Johannesburg

2. Time line for research ethics in South Africa 1966 October - Wits establishes Human Research Ethics Committee) 1966 October - Wits establishes Human Research Ethics Committee) 1977 onwards - SA Universities establish RECs 1977 onwards - SA Universities establish RECs 1979 SA MRC issues research ethics guidelines (revised 1987, 1993, 2002-5) 1979 SA MRC issues research ethics guidelines (revised 1987, 1993, 2002-5) 1992 SAMA establishes REC 1992 SAMA establishes REC 1995 PharmaEthics REC established 1995 PharmaEthics REC established 1996 SA Constitution entrenches informed consent in research 1996 SA Constitution entrenches informed consent in research 2000 Dept of Health issues clinical trial GCP guidelines (revised 2006) 2000 Dept of Health issues clinical trial GCP guidelines (revised 2006) 2004 Dept of Health issues research ethics guidelines 2004 Dept of Health issues research ethics guidelines 2005 National Health Act of 2003 makes REC approval compulsory 2005 National Health Act of 2003 makes REC approval compulsory 2006 National Health Research Ethics Council established 2006 National Health Research Ethics Council established 2008 Registration with NHREC – first step in accreditation 2008 Registration with NHREC – first step in accreditation 2008 Dept of Health establishes public register of clinical trials 2008 Dept of Health establishes public register of clinical trials

3. Some Pertinent South African Regulatory Instruments & Guidelines Bill of Rights of the Constitution of South Africa Bill of Rights of the Constitution of South Africa National Health Act No 61 of 2003 National Health Act No 61 of 2003 Ethics in Health Research: Principles, Structures & Processes – 2004 Ethics in Health Research: Principles, Structures & Processes – 2004 Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa – 2006 (2ed) Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa – 2006 (2ed) Ethical and Legal Guidelines for Biotechnology Research in SA (DST) - 2006 Ethical and Legal Guidelines for Biotechnology Research in SA (DST) - 2006 Health Professions Council of South Africa Ethical Guidelines Health Professions Council of South Africa Ethical Guidelines

4. National Health Research Ethics Council (NHREC) – NHA sec 72 determine guidelines for the functioning of health research ethics committees; register and audit health research ethics committees; set norms and standards for conducting research on humans and animals, adjudicate complaints about the functioning of health research ethics committees; hear any complaint by a researcher who believes that he or she has been discriminated against; institute disciplinary action against any person found to be in violation of any norms and standards, or guidelines, set for the conducting of research ; and advise the national department and provincial departments on any ethical issues concerning research.”

5. Health Research Ethics Committees – sec 73 Every institution, agency, health establishment at which health research is conducted must establish or have access to a registered and accredited health research ethics committee which must: Every institution, agency, health establishment at which health research is conducted must establish or have access to a registered and accredited health research ethics committee which must: Review proposals Review proposals Grant approval Grant approval

6. Composition – REC (PSP) Collectively have qualifications and experience to evaluate science, health aspects & ethics: Collectively have qualifications and experience to evaluate science, health aspects & ethics: Both genders – not more than 70% of any one Both genders – not more than 70% of any one At least 9 members with 60% forming a quorum At least 9 members with 60% forming a quorum 2 laypersons – no affiliation to institution, not currently involved in medical, scientific, legal work, preferably from community in which research takes place 2 laypersons – no affiliation to institution, not currently involved in medical, scientific, legal work, preferably from community in which research takes place member with knowledge of & current experience in areas of research likely to be regularly considered member with knowledge of & current experience in areas of research likely to be regularly considered member with knowledge of & current experience in professional care, counseling, treatment (medical practitioner, psychologist, social worker, nurse) member with knowledge of & current experience in professional care, counseling, treatment (medical practitioner, psychologist, social worker, nurse) professional training in qualitative and quantitative research professional training in qualitative and quantitative research Legally trained Legally trained

7. DEFINITION - Health Research (National Health Act No 61 of 2003 – sec 1) biological, clinical, psychological, social processes in human being; improved methods for provision of health services; causes of disease, effects of environment on human body; development of new application of pharmaceuticals, medicines and related substances development of new applications of health technology

8. National Health Research Ethics Council 15 members 15 members Subcommittees: Subcommittees: Registration & accreditation Registration & accreditation Education and training Education and training Regulations on Human Research Participant Protections Regulations on Human Research Participant Protections Vulnerable participants Vulnerable participants Complaints – Process and Procedure Complaints – Process and Procedure DSMB Guidelines for Research Conducted in SA DSMB Guidelines for Research Conducted in SA

10. Good Clinical Practice - Guidelines www.doh.gov.za/docs/policy-f.html 2 nd edition 2006