title: Voluntary informed consent and good clinical practice for clinical research in South Africa: ethical and legal perspectives.
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.
authors.affiliation: Department of Public Law, Stellenbosch University, Western Cape, South Africa.
authors.forename: Retha
authors.initials: R
authors.lastname: Britz
authors.forename: Andra
authors.initials: A
authors.lastname: le Roux-Kemp
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence*; D013019:South Africa