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

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
slide10

Good Clinical Practice - Guidelines

2nd edition 2006

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

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