Broad consent for biobank research in South Africa - Towards an enabling ethico-legal framework

ABSTRACT

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template.

KEYWORDS:

• Broad consent
• regulatory framework
• biobank research
• Protection of Personal Information Act
• South Africa

Acknowledgements

This work forms part of M.M.’s PhD (currently under examination) titled “An ethico-legal analysis of broad consent for biobank research in South Africa: Towards an enabling framework.” M.M would like to acknowledge her PhD supervisors, Prof. S. Mahomed and Dr J. Gardner (Steve Biko Centre for Bioethics, University of the Witwatersrand, SA).

Disclosure statement

No potential conflict of interest was reported by the author(s).

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

M.M’s PhD was funded by the National Health Laboratory Service (NHLS). Publication of this article was funded by the University of the Witwatersrand.