Clinical research in south africa ethical and regulatory processes
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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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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


Time line for research ethics in south africa

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


Some pertinent south african regulatory instruments guidelines

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


National health research ethics council nhrec nha sec 72

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.”


Health research ethics committees sec 73

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


Composition rec psp

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


Definition health research national health act no 61 of 2003 sec 1

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


National health research ethics council

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


Clinical research in south africa ethical and regulatory processes

Good Clinical Practice - Guidelines

2nd edition 2006

www.doh.gov.za/docs/policy-f.html


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