The South African clinical trial industry : implications of problems with the issuing of human tissue export permits

Simple item page
dc.contributor.authorBurgess, Lesley Jeanen_ZA
dc.contributor.authorPretorius, Deodandaen_ZA
dc.date.accessioned2014-07-07T12:28:18Z
dc.date.available2014-07-07T12:28:18Z
dc.date.issued2013-06-21
dc.descriptionCITATION: Burgess, L. J. & Pretorius, D. 2013. The South African clinical trial industry : implications of problems with the issuing of human tissue export permits. South African Journal of Bioethics & Law, 6(1):13-15, doi:10.7196/SAJBL.228.
dc.descriptionThe original publication is available at http://www.sajbl.org.za
dc.description.abstractENGLISH ABSTRACT: The National Health Act requires a valid permit before human biological tissue samples are exported from South Africa. However, delays in issuing export permits make it difficult for many researchers and pharmaceutical companies to comply. There are misconceptions about who is responsible for obtaining such a permit. Delays have caused many new trials to start without a permit, and biological samples from ongoing trials have been exported using expired permits. This could have detrimental consequences for the South African trial industry, especially with the country’s history of vulnerable populations in developing areas. Medicine Control Council inspections have listed findings related to export permits for several trial sites. Researchers must be aware that it remains their responsibility to apply for such a permit. The most important steps to ensure a smoother approval process are for applicants to (i) familiarise themselves with the permit issue process and (ii) recognise the importance of correctly completing and signing application forms.en_ZA
dc.description.abstractAFRIKAANSE OPSOMMING: Geen opsomming beskikbaaraf_ZA
dc.description.urihttp://www.sajbl.org.za/index.php/sajbl/article/view/228
dc.description.versionPublisher's version
dc.format.extent3 pagesen_ZA
dc.identifier.citationBurgess, L. J. & Pretorius, D. 2013. The South African clinical trial industry : implications of problems with the issuing of human tissue export permits. South African Journal of Bioethics & Law, 6(1):13-15, doi:10.7196/SAJBL.228.en_ZA
dc.identifier.issn1999-7639 (online)
dc.identifier.otherdoi:10.7196/SAJBL.228
dc.identifier.urihttp://hdl.handle.net/10019.1/93963
dc.language.isoen_ZAen_ZA
dc.publisherHealth & Medical Publishing Groupen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectClinical trial industry -- South Africaen_ZA
dc.subjectTissue extractsen_ZA
dc.subjectNational health servicesen_ZA
dc.titleThe South African clinical trial industry : implications of problems with the issuing of human tissue export permitsen_ZA
dc.typeArticleen_ZA
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
burgess_south_2013.pdf
Size:
63.13 KB
Format:
Adobe Portable Document Format
Description:
Download article
Download
Collections
Research Articles (Cardiology)