Recently, China updated its regulation on human genome editing. The newly published updated regulation, Measures for the Ethical Review of Life Science and Medical Research Involving Humans (the 2023 Measures), covers research institutions that perform studies which are conducted on human tissues, organs and embryonic cells. This is a positive outcome, yet there is vagueness and gaps in the updated regulation, giving rise to some concerns.
In 2018, Dr He Jiankui made a shocking announcement at the Second International Summit on Human Genome Editing that he had created the world's first genome-edited babies (see BioNews 977). In his experiment, the twin girls (Nana and Lulu) had their genomes altered by an innovative genome editing approach using CRISPR/Cas9 to increase their resistance to HIV. The world, and especially the science community, reacted with disbelief. While CRISPR-based genome editing has enormous potential, multiple concerns are associated with this approach, such as the unintended consequences of using it on humans. Moreover, heritable genome editing is not yet ready to be tried safely and effectively in people. Therefore, it is crucial that this practice can continue only when there is a favourable balance of benefits and risks. Dr He's activity was a violation of the statement laid down in the First Summit on genome editing.
Recently, the Third International Summit on Human Genome Editing was held in London, to examine scientific developments, challenges and opportunities in research, regulation and equitable access to human genome editing techniques and procedures (see BioNews 1183). Updates on China's regulations following Dr He's controversial experiment were presented by Dr Yaojin Peng, assistant professor in intellectual property law at the Chinese Academy of Sciences, Beijing, China on the first day of the Summit.
These amendments in the 2023 Measures are significant improvements. For example, life science studies are much more likely to undergo ethics reviews. In addition, the range of regulated activities is widened, including research that involves human cells, tissues, organs, fertilised eggs, embryos, fetus and health documents. Moreover, the research subjects are known as research participants for the first time in official records. However, there are concerns that private ventures may not be covered.
The revised regulations introduce a list of misconducts subject to penalties, eg, fabrication of an ethics review or failure to report research progress to the ethics team. Furthermore, article 36 makes provisions for informed consent by the research participants, including comprehensive information which should be incorporated into the informed consent procedure. This is critical as participants must be given adequate material before consenting to take part in the study. Finally, article 39 ensures that the ethics committees are adequately funded and well-resourced and that regular ethics training is arranged for scientists, administrators and students.
The Chinese government responded rapidly to address the regulatory gaps relatively soon after Dr He's alarming revelation at the 2018 summit. Within months of Dr He's announcement, China's National Health Commission revised its 2016 Measures on the Ethical Reviews of Biomedical Research Involving Humans. Dr He was charged and found guilty of committing 'illegal medical practices'. The Shenzhen Nanshan District People's Court sentenced him to three years in prison and imposed a fine of three million yuan (US$430,000) (see BioNews 1029).
Speaking at the Third Summit, Dr Joy Zhang, founding director of the Centre for Global Science and Epistemic Justice at the University of Kent, expressed concern that the revised Chinese regulation does not affect private research organisations. She explained that 'the ability to collect and access health data and bioinformation extend beyond academia and is exercised by social and private ventures.'
After serving his prison sentence, Dr He has set up a laboratory in Beijing, China, working on the development of affordable gene therapies for Duchenne muscular dystrophy (see BioNews 1179). This venture is believed to be privately funded, and Dr He is now actively recruiting participants in his research.
Professor Leigh Turner, a bioethicist from the University of California, Irvine said: 'Well-defined, carefully crafted regulatory exceptions are often abused and exploited by commercial actors that engage in activities falling outside such narrow exceptions. For financial gain, such entities try to evade regulators and determine what they are able to get away with without suffering significant consequences.'
The 2023 Measures contain a broad category of ethics review exemptions, including experiments using anonymised biodata and studies using existing biosamples or biobanks. Research projects that fulfil the exemption criteria are in hospitals, universities and research institutes, as they already have their own codes of conduct. However, scientific practice expands beyond traditional research institutions and the concern is that these exemptions may create regulatory loopholes.
While there is a requirement to document research undertakings in a public databank, simply making a record is not equivalent to a registration which needs an assessment and authorisation of the research activity issued by an ethics committee.
Furthermore, law enforcement has been a challenge in research regulation in China. There is the absence of a transparent regulatory culture as well as regional and institutional disparities in governing capacity. As an essential player in genome editing, the Chinese government has taken considerable strides in updating the rules since the CRISPR baby scandal. But we cannot overlook the ambiguities and loopholes in the revised regulation.
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