A constitutional analysis of open consent for genomics research in South Africa.

Abstract

Advancements in genomics, coupled with decreasing sequencing costs and technological innovations, have significantly expanded our understanding of the human genome and its role in health and disease. This progress has fuelled the rapid growth of genomics research globally, including in South Africa. Such research, however, requires vast amounts of data, which is typically gathered from research participants and subsequently extracted and sequenced. Informed consent is essential in this process, ensuring that participants are treated fairly and their rights are protected. While various modes of consent, such as specific consent, broad consent, and blanket consent, have been utilized in genomics research in South Africa, the concept of open consent remains under explored. Pioneered by the Personal Genome Project, open consent involves individuals openly sharing their data for research without guarantees of privacy, anonymity, or confidentiality. To ensure that consent is informed, participants undergo (and must pass with full marks) an assessment, in which their understanding of genomics and privacy is tested. Given that open consent has not yet been explored or applied in the South African context, this thesis investigates whether open consent is a suitable mode of consent for genomics research in South Africa through a constitutional lens. There are four salient constitutional rights and/or values relevant to an analysis of open consent in genomics research in South Africa, namely autonomy, a value which underlies informed consent generally; Ubuntu, which is an underlying constitutional value that places autonomy in an African perspective, and aims to strike a balance between the individual and society; freedom of scientific research, which is a right that contains elements of individual and societal interests and is facilitated by open science; and privacy, which is a right and an overriding concern in research generally, but becomes especially problematic in the context of genomics research. Through this analysis, I find that a modified version of open consent – suited to local contexts and cultures – may be usefully applied and used for genomics research in South Africa.