On February 4, a Letter to the Editor was published online in Science and Engineering Ethics (read HERE), addressing some of China’s current problems related to biomedical research. In the article, the authors refer to the fact that Jian-kui He, a professor at the Southern University of Science and Technology in China, had recently announced that he had managed to produce the first babies genetically modified to make them immune to HIV, using CRISPR Cas9, and that he had presented his work at the Second International Summit on Human Genome Editing in Hong Kong. His announcement caused a huge shock and even greater controversy among the scientific community.
Similarly in November 2017, Xiao-ping Ren and his group from Harbin Medical University, also in China, announced that they had carried out the first head-to-body transplant on a corpse.
What is happening with biomedical research in China especially as regards its ethical assessment?
Both experiments, although banned in other countries, were approved by the Institutional Review Boards (IRB) of their hospitals, but not by the Ethics Committees of the universities in which both researchers worked.
In light of these experiments, there is a need to reflect on what is happening in China in relation to biomedical research, especially as regards its ethical assessment.
There is no doubt that, in parallel with the country’s wider economic development, a profound revolution is taking place in all matters affecting medical research. One example of this is that 32 national research centers and 2100 medical institutions have been set up in 260 cities, making China one of the countries in the world where biomedical experiments and clinical trials can be conducted more easily. At the same time, however, the ethics committees and bioethical oversight that these research projects warrant—especially high-risk studies—are not being developed.
To date, only 78 Chinese universities and hospitals have been approved by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). Similarly, not all Chinese hospital institutions have an IRB, so there is no certainty that the bioethical assessment of the work carried out in them is properly supervised.
The difficulties that Chinese medicine presents revolve around basic bioethical values
In order to overcome the ethical difficulties that Chinese medicine presents, hospitals would require capacity building and the implementation of IRBs at national level, while at the same time setting up systematic training in medical ethics for researchers, as well as encouraging greater communication and collaboration between hospitals and universities.
To that end, the authors of the aforementioned article propose to avoid Chinese biomedical research lacks of transparency:
- a wider network of IRBs should be established, so that the clinical trials conducted in the different institutions are registered online according to standard procedures, have adequate transparency and traceability, and thus have proper ethical supervision;
- ethics training programs should also be developed for research groups and physicians involved in these experiments; and
- greater collaboration between universities and hospitals, especially with private ones, should also be encouraged because, as mentioned, in the case of the gene-editing of the two children born in China, Dr. He’s experiments received IRB approval from the private hospital where the research was carried out, but not from the university to which he belonged. Thus, the University reported that the ethical decision taken by the IRB in its hospital was not, in its view, valid.
Conclusion. Chinese biomedical research risks
In short, at the present time, more transparency and specification of clinical trials (read HERE) and research carried out in China are needed, as well as greater collaboration between the different institutions where they are conducted, so that their bioethical supervision is more effective.
Justo Aznar MD Ph
Bioethics Observatory – Institute of Life Sciences