Voluntary Informed Consent and Good Clinical Practice for Clinical Research in South Africa: Ethical and Legal Perspectives

South African Medical Journal (S Afr Med J) 2012; 102(9), 746-748

3 Pages Posted: 18 Apr 2014

See all articles by Retha Britz

Retha Britz

Stellenbosch University - Law

Andra le Roux-Kemp

Lincoln Law School, University of Lincoln (UK)

Date Written: September 1, 2012

Abstract

Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in Health Research: Principles, Structures and Processes (2004). These documents do not fulfill all the ethical and legal requirements for voluntary informed consent for clinical research participation in South Africa. International guidance documents reflect the minimum of the ethical requirements for the conduct of clinical research. Country-specific documents should be updated and aligned with relevant legislative and legal principles of that jurisdiction to ensure that research participants are adequately protected. The South African-specific guidance documents therefore require revision to address these deficiencies.

Keywords: Informed consent, Clinical Research, South Africa

Suggested Citation

Britz, Retha and le Roux-Kemp, Andra, Voluntary Informed Consent and Good Clinical Practice for Clinical Research in South Africa: Ethical and Legal Perspectives (September 1, 2012). South African Medical Journal (S Afr Med J) 2012; 102(9), 746-748 . Available at SSRN: https://ssrn.com/abstract=2425864

Retha Britz

Stellenbosch University - Law ( email )

South Africa

Andra Le Roux-Kemp (Contact Author)

Lincoln Law School, University of Lincoln (UK) ( email )

Lincoln LN2
United Kingdom

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