Voluntary informed consent and good clinical practice for clinical research in South Africa : ethical and legal perspectives

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dc.contributor.authorBritz, Rethaen_ZA
dc.contributor.authorLe Roux-Kemp, Andraen_ZA
dc.date.accessioned2013-07-03T08:19:31Z
dc.date.available2013-07-03T08:19:31Z
dc.date.issued2012-09
dc.descriptionThe original publication is available at http://www.samj.org.zaen_ZA
dc.description.abstractMost 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.en_ZA
dc.description.versionPublishers’ versionen_ZA
dc.format.extentpp. 746-748
dc.identifier.citationBritz, 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.en_ZA
dc.identifier.issn2078-5135 (online)
dc.identifier.issn0256-9574 (print)
dc.identifier.issndoi:10/7196.SAMJ.5498
dc.identifier.urihttp://hdl.handle.net/10019.1/82340
dc.publisherHealth and Medical Publishing Group (HMPG)en_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectSouth African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa
dc.subjectClinical research -- Moral and ethical aspects -- South Africaen_ZA
dc.subjectConsent (Law)en_ZA
dc.subjectInformed consent (Medical law)en_ZA
dc.subjectDoctor-patient relationshipen_ZA
dc.subjectPatients -- Legal status, laws, etcen_ZA
dc.subject.corpSouth African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africaen_ZA
dc.titleVoluntary informed consent and good clinical practice for clinical research in South Africa : ethical and legal perspectivesen_ZA
dc.typeArticleen_ZA
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