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Clinical Research in South Africa - Ethical and Regulatory Processes

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

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Clinical Research in South Africa - Ethical and Regulatory Processes

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  1. NATIONAL HEALTH RESEARCH ETHICS COUNCIL Clinical Research in South Africa - Ethical and Regulatory Processes 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) • 1977 onwards - SA Universities establish RECs • 1979 SA MRC issues research ethics guidelines (revised 1987, 1993, 2002-5) • 1992 SAMA establishes REC • 1995 PharmaEthics REC established • 1996 SA Constitution entrenches informed consent in research • 2000 Dept of Health issues clinical trial GCP guidelines (revised 2006) • 2004 Dept of Health issues research ethics guidelines • 2005 National Health Act of 2003 makes REC approval compulsory • 2006 National Health Research Ethics Council established • 2008 Registration with NHREC – first step in accreditation • 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 • National Health Act No 61 of 2003 • 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) • Ethical and Legal Guidelines for Biotechnology Research in SA (DST) - 2006 • 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: • Review proposals • Grant approval

  6. Composition – REC (PSP) • Collectively have qualifications and experience to evaluate science, health aspects & ethics: • Both genders – not more than 70% of any one • 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 • 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) • professional training in qualitative and quantitative research • 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 • Subcommittees: • Registration & accreditation • Education and training • Regulations on Human Research Participant Protections • Vulnerable participants • Complaints – Process and Procedure • DSMB Guidelines for Research Conducted in SA

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

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