title: Regulation of Biobanks in South Africa.
abstract: The availability of biological samples and data is critical for the establishment of biobanks for health research purposes. Such availability should be ensured in accordance with relevant national legislation and ethical principles. In this article, we consider the extent to which the current legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. These two attributes are essential for establishing biobanks in the country. Our evaluation of the frameworks is based on desk review of the current literature with a special focus on oversight mechanisms in place that ensure compliance with national legislation and ethical review processes to facilitate future and secondary uses of data, the extent to which informed consent policies foster sharing of research samples, data and protocols as well as mechanisms for safeguarding confidentiality. We established that there is an urgent need to streamline South Africa's legal and ethical frameworks because they are currently ambiguous and disjointed. There is equally a need to bring the frameworks in line with the current developments at the national and international levels.
authors.affiliation: Professor of Law at the University of the Witwatersrand, Johannesburg. She holds LL.B. and LL.M. degrees from the University of Nairobi and a Ph.D. in law from the University of the Witwatersrand, Johannesburg.
authors.forename: Pamela
authors.initials: P
authors.lastname: Andanda
authors.affiliation: Director of Research and Development at Justice College (Pretoria). She holds B.Proc., LL.B., and LL.M. degrees from the University of Natal, Bcom (hons.) from the University of Cape Town and a Ph.D. in law from the University of the Witwatersrand, Johannesburg.
authors.forename: Sandra
authors.initials: S
authors.lastname: Govender
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000331:legislation & jurisprudence; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D013019:South Africa