South Africa needs to overhaul the laws and ethical guidelines that govern its genetics research, testing and databases, says its national science academy – especially given the country’s troubled history of race-based discrimination.
The country has become a hotspot for genomics research with the launch of projects to characterise and understand the genetics of its diverse population – work that often involves long-term storage of samples in biobanks. The nation hosts about a dozen such facilities, which enable large-scale analysis of diseases and health phenomena. However, regulations have not kept up with the pace of research or technological developments. They cover issues such as forensics and assisted reproductive technologies, but there is no overarching law that relates to genetics and genomics, areas that require participants to give informed consent.
“This has consequences for the people who could benefit from all of this research and for industry. It confuses researchers, and makes investment and entrepreneurship difficult,” says geneticist Michael Pepper, chair of the report into the ethical, legal and social implications of human genetics and genomics in South Africa. “It is important that the right people in government hear about it.”
The report – written by a 13-member panel that included geneticists, bioethicists, lawyers and industry specialists – was presented on 4 December at a meeting of the Academy of Science of South Africa (ASSAf). ASSAf represents academics and scientists and has a mandate to provide evidence for government policy-making.
The review’s aim is to inform the drafting of policy, regulations and guidelines by the government’s health and science departments. But researchers will now need to lobby the government to create such ethical and legal frameworks, Pepper says.
The academy makes several recommendations to fill gaps in the law and regulations, as well as suggestions for how best to engage with communities. For example, it says that South Africa needs clearer laws regulating information in biobanks. Other recommendations include the creation of a national Human Genetics Advisory Board, which would guide the formation of national regulations and policy, and the establishment of committees to determine who can use data and samples.
Any committee that makes decision pertaining to South African samples should include South African members, the report says. Currently, there is no overarching body making these decisions and no requirement that a South African takes part. The report also addresses the country’s history of using science to stigmatise, exploit and discriminate against various population groups.
During the apartheid era, from 1948 to 1994, the South African government enforced policies of racism and segregation. The justification for this was often backed by spurious data on differences between races. The report says that legislators must be aware of and sensitive to the context in which they are developing policy and laws governing genetics.
It also warns scientists to be sensitive to the contexts in which they announce their findings, and take care that they do not do it in ways that may be harmful or offensive.
One group that has advocated for clearer guidelines on research ethics is the South African San Council, an organisation that represents indigenous San people in the country, which issued its own research-ethics code last year. “There was a lot of harm done by researchers. The presence of researchers caused conflict in our communities and opened a lot of old wounds,” Collin Louw, a member of the council, said at a meeting last year where the code was discussed.
Brenna Henn, a population geneticist at the University of California-Davis, who collaborates with South African researchers, welcomes the report. She says that it “establishes South Africa as a global leader in the realm of human genetics ethics and social responsibility”.
But she worries that any regulations will be successful only if accompanied by training and consistent funding. “There should be a recognition that implementing many of the guidelines will take years of training individuals, and finding consistent financial support and oversight from the South African government,” Henn says.
The two government departments responsible for health research in the country, the South African Health Department, and the Department of Science Technology did not reply to requests for comment.
[link url="https://www.nature.com/articles/d41586-018-07637-x"]Nature material[/link]
[link url="http://research.assaf.org.za/bitstream/handle/20.500.11911/106/2018_assaf_ethical_genetics_genomics_consensus.pdf?sequence=1&isAllowed=y"]ASSAF report[/link]