The South African clinical trial industry : implications of problems with the issuing of human tissue export permits
Date
2013-06-21
Journal Title
Journal ISSN
Volume Title
Publisher
Health & Medical Publishing Group
Abstract
ENGLISH 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.
AFRIKAANSE OPSOMMING: Geen opsomming beskikbaar
AFRIKAANSE OPSOMMING: Geen opsomming beskikbaar
Description
CITATION: 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.
The original publication is available at http://www.sajbl.org.za
The original publication is available at http://www.sajbl.org.za
Keywords
Clinical trial industry -- South Africa, Tissue extracts, National health services
Citation
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.