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
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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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

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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

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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.

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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

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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

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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

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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

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