Direct-to-Consumer Genetic Testing Focus of LLM Study

Unregulated or Not? A Legal Analysis of South Africa’s Legislative Framework Relevant to Direct-To-Consumer Genetic Testing was the title of Ms Amy Gooden’s research dissertation which earned her a Master of Laws degree at UKZN in May.

Gooden explained that direct-to-consumer genetic testing refers to DNA-based genetic tests that can be ordered and undertaken by consumers themselves, often without the involvement of healthcare professionals. These tests provide information on one’s predisposition to various diseases and genetic conditions. Given the potential risks of such testing, primarily because the results are sent directly to consumers with little professional oversight, a study on this practice was long overdue, especially in the South African context where it has not been investigated.

‘I undertook an analysis of South Africa’s extant law relevant to the direct-to-consumer genetic testing industry, and the issues associated therewith. I found that the country’s legal landscape in this regard is multi-layered and the industry is governed by a variety of sometimes overlapping statutes and regulations,’ said Gooden.

After graduating with a Bachelor of Laws summa cum laude from UKZN in 2019, Gooden chose Health Law as her area of specialisation. ‘Health Law is a field that is constantly changing, providing new challenges and opportunities. It is an innovative and promising area that has the potential to influence human health, medicine, health technologies, and research.  By working in this area, I am able to make a meaningful and positive impact through addressing global concerns and debates on various topics from a South African perspective, providing guidance to those working in the field, and offering potential solutions to legal policy development.’

Gooden is the former editor of UKZN’s Student Law Review and her goal is to join the academic sector where she can make a meaningful contribution to society through research. She is currently completing her doctoral studies in the field of Health Law and Ethics, focusing on modes of consent in genomic research, and working with the Data Science for Health Discovery and Innovation in Africa (DSI-Africa) team on a project funded by the United States National Institutes of Health (US NIH).

Gooden’s dissertation was supervised by UKZN’s Health Law expert Professor Donrich Thaldar. ‘It has been an absolute privilege to work with Professor Thaldar. He is knowledgeable, supportive, and always goes the extra mile for his students. He constantly encouraged me to strive further and gave me opportunities beyond my research field, which broadened my knowledge and provided me with invaluable experience,’ she said.

As a budding researcher Gooden has taken advantage of research opportunities which will propel her career in academia including exploring the publication of her research in reputable legal journals with Thaldar.  She has presented it at local and international conferences. At the end of 2021, she was awarded a bursary to pursue her doctoral studies through a grant for the DSI-Africa project from the US NIH which focuses on the legal aspects of the use of data science for health innovation in Africa and aims to provide legal clarity and practical guidance on issues critical to scientists.

She is extremely happy about her achievement and thanked all those who supported her academic journey.

Words: Hazel Langa

Photograph: Abhi Indarajan