Clinical Research in South Clinical Research in South Africa - Ethical and Africa - Ethical and

Regulatory Processes Regulatory Processes

NATIONAL HEALTH RESEARCH ETHICS COUNCIL

Professor A DhaiDeputy Chair National Health Research Ethics CouncilDirector – Steve Biko Centre of Bioethics, University of the Witwatersrand, Johannesburg

Time line for research ethics in South AfricaTime 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 RECs1977 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 REC1992 SAMA establishes REC

1995 PharmaEthics REC established1995 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 guidelines2004 Dept of Health issues research ethics guidelines

2005 National Health Act of 2003 makes REC approval compulsory2005 National Health Act of 2003 makes REC approval compulsory

2006 National Health Research Ethics Council established2006 National Health Research Ethics Council established

2008 Registration with NHREC – first step in accreditation2008 Registration with NHREC – first step in accreditation

2008 Dept of Health establishes public register of clinical trials2008 Dept of Health establishes public register of clinical trials

Some Pertinent South African Some Pertinent South African Regulatory Instruments & Regulatory Instruments &

GuidelinesGuidelines

Bill of Rights of the Constitution of South AfricaBill of Rights of the Constitution of South Africa

National Health Act No 61 of 2003National Health Act No 61 of 2003

Ethics in Health Research: Principles, Structures & Processes – Ethics in Health Research: Principles, Structures & Processes – 20042004

Guidelines for Good Practice in the Conduct of Clinical Trials with Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa –Human Participants in South Africa – 2006 (2ed) 2006 (2ed)

Ethical and Legal Guidelines for Biotechnology Research in SA (DST) Ethical and Legal Guidelines for Biotechnology Research in SA (DST) - 2006 - 2006

Health Professions Council of South Africa Ethical GuidelinesHealth Professions Council of South Africa Ethical Guidelines

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 Health Research Ethics Committees – sec 73Committees – sec 73

Every institution, agency, health Every institution, agency, health establishment at which health establishment at which health research is conducted must establish research is conducted must establish or have access to a registered and or have access to a registered and accredited health research ethics accredited health research ethics committee which must:committee which must:

Review proposalsReview proposals Grant approvalGrant approval

Composition – REC (PSP)Composition – REC (PSP) Collectively have qualifications and experience to Collectively have qualifications and experience to

evaluate science, health aspects & ethics:evaluate science, health aspects & ethics: Both genders – not more than 70% of any oneBoth genders – not more than 70% of any one At least 9 members with 60% forming a quorumAt least 9 members with 60% forming a quorum 2 laypersons – no affiliation to institution, not currently 2 laypersons – no affiliation to institution, not currently

involved in medical, scientific, legal work, preferably involved in medical, scientific, legal work, preferably from community in which research takes placefrom community in which research takes place

member with knowledge of & current experience in member with knowledge of & current experience in areas of research likely to be regularly consideredareas of research likely to be regularly considered

member with knowledge of & current experience in member with knowledge of & current experience in professional care, counseling, treatment (medical professional care, counseling, treatment (medical practitioner, psychologist, social worker, nurse)practitioner, psychologist, social worker, nurse)

professional training in qualitative and quantitative professional training in qualitative and quantitative researchresearch

Legally trainedLegally trained

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 National Health Research Ethics CouncilEthics Council

15 members15 members Subcommittees:Subcommittees:

Registration & accreditationRegistration & accreditation Education and trainingEducation and training Regulations on Human Research Participant Regulations on Human Research Participant

ProtectionsProtections Vulnerable participantsVulnerable participants Complaints – Process and ProcedureComplaints – Process and Procedure DSMB Guidelines for Research Conducted in DSMB Guidelines for Research Conducted in

SASA

Good Clinical Practice - Guidelines

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

2nd edition 2006