Voluntary informed consent and good clinical practice for clinical research in South Africa : ethical and legal perspectives
Date
2012-09
Authors
Britz, Retha
Le Roux-Kemp, Andra
Journal Title
Journal ISSN
Volume Title
Publisher
Health and Medical Publishing Group (HMPG)
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 fulfil 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.
Description
The original publication is available at http://www.samj.org.za
Keywords
South African Guidelines for Good
Practice in the Conduct of Clinical Trials with Human Participants
in South Africa, Clinical research -- Moral and ethical aspects -- South Africa, Consent (Law), Informed consent (Medical law), Doctor-patient relationship, Patients -- Legal status, laws, etc
Citation
Britz, R. & Le Roux-Kemp, A. 2012. Voluntary informed consent and good clinical practice for clinical research in South Africa : ethical and legal perspectives. South African Medical Journal, 102(9):746-748, doi:10/7196.SAMJ.5498.