Re: Researcher who edited babies’ genome retreats from view as criticism mounts --- Making ethics committees fit for purpose in China
Following the recent scandal over babies born in China after gene editing, the failure of ethical oversight of biomedical research requires urgent attention.1 Ethics committees are now established in more and more hospitals in China.2-5 These ethics committees review, for example, clinical trial protocols, applications for assisted reproduction procedures, and issues related to grant applications, as well as being involved in organ transplantation and other special treatments.5 The number of these applications is increasing quickly, hence the work of the ethics committees is mounting.3
There are, however, numerous difficulties for ethics committees in China.
First, the independence and fairness of ethics committees is questionable. This begins with the composition of the committee.3-6 Studies show that up to 96% of the chairpersons of ethics committees are administrative officials of institutions, such as the president of the hospital,6,7 and the majority of committee members are directors of related departments.4,5-7 To make matters worse, financial support for the majority of ethics committee is from their own institutions.2 These factors lead to potential of bias in favor of the institution and its researchers.3,7
“Methods for Ethical Review of Biomedical Research Involving Human Beings”, (http://www.moh.gov.cn/fzs/s3576/201610/84b33b81d8e747eaaf048f68b174f829....) and “Guiding Principles for Ethical Review of Drug Clinical Trials”, (http://www.gov.cn/gzdt/2010-11/08/content_1740976.htm) are the only guidelines for medical ethics review in China.8,9 These two regulations, however, leave many problems unsolved. For example, an institution only needs to keep a record in its practice registration authority to establish an ethics committee. This is straightforward and how to monitor an ethics committee is not well defined. Hence assessments of the work of the ethics committee do not take place.
Second, ethics committees lack competence to examine the scientific validity of research proposals.7 According to the aforementioned guidelines, an ethics committee should comprise at least seven people. In practice, an ethics committee usually has nearer twenty people, usually about ten of whom are scientific experts. However, these experts often do not cover all the necessary specialties.7 Opinions can be sought from outside experts, but they are not allowed to vote. In addition, although ongoing training is recommended for ethics committee members, there is no formal qualification or assessment of skills.
Third, ethics committees in China suffer from a lack of standardization. The guidelines provide some principles for ethics review, but they do not propose any national standards, leading to variations in practice between institutions.7 Proposals rejected by one ethics committee have been accepted by another ethics committee without any change to the application.7,10,11
Urgent measures are required to address the failures in ethical oversight of biomedical research in China. Some of these include establishing regional ethics committees to avoid institutional bias, creating databases of expert reviewers to cover diverse specialties and involving them in decision making, setting national standards for ethics committee so that they can be monitored and variation in practice minimised, and training introduced that leads of formal assessment of ethic committee member.6,7 By tackling the weaknesses in the form and function of ethics committees, China will raise the standard of research, protect study participants, and improve patient care. Research misconduct is hard to eliminate but China’s current approach to ethical oversight makes it easy to cheat the system.
References
1. Dyer O. Researcher who edited babies’ genome retreats from view as criticism mounts. BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5113.
2. Xu S, Ye Y, Pan X, Liu C. Study on the current situation and the management mechanism of the medical ethics committee. Chinese Medical Ethics. 2016;29:17-19.
3. Zhang L, Huang XX, Chen HF. An Exploration of the Protective Effects of investigators’ ethical awareness upon subjects of drug clinical trials in China. Bioethical Inquiry.2018;15::89-100.
4. Ma J, Chen XP, Lu YL. Analysis of the current situations of the ethics committee of the level 2 hospital. Journal of Military Surgeon in Southwest China. 2012;14:388-389.
5. Zhang JJ, Yang WY, Zheng TT, Liu Y, Liu JS, Sun N. Survey on medical institutions ethics committee operation status in Shangdong province. Medicine and Philosophy. 2014; 35:36-38.
6. Lv LN, Xiong NN, Chang YL, Yang B. Reflections on improving the working mechanism of medical ethics committee. Medicine and Society.2012; 25:26-28.
7. Zhou JY, Deng F, Liu D, Zhou SW. Problems and countermeasures of medical ethics committee in China. Chin J Clin Pharmacol. 2017; 33: 365-368.
Rapid Response:
Re: Researcher who edited babies’ genome retreats from view as criticism mounts --- Making ethics committees fit for purpose in China
Following the recent scandal over babies born in China after gene editing, the failure of ethical oversight of biomedical research requires urgent attention.1 Ethics committees are now established in more and more hospitals in China.2-5 These ethics committees review, for example, clinical trial protocols, applications for assisted reproduction procedures, and issues related to grant applications, as well as being involved in organ transplantation and other special treatments.5 The number of these applications is increasing quickly, hence the work of the ethics committees is mounting.3
There are, however, numerous difficulties for ethics committees in China.
First, the independence and fairness of ethics committees is questionable. This begins with the composition of the committee.3-6 Studies show that up to 96% of the chairpersons of ethics committees are administrative officials of institutions, such as the president of the hospital,6,7 and the majority of committee members are directors of related departments.4,5-7 To make matters worse, financial support for the majority of ethics committee is from their own institutions.2 These factors lead to potential of bias in favor of the institution and its researchers.3,7
“Methods for Ethical Review of Biomedical Research Involving Human Beings”, (http://www.moh.gov.cn/fzs/s3576/201610/84b33b81d8e747eaaf048f68b174f829....) and “Guiding Principles for Ethical Review of Drug Clinical Trials”, (http://www.gov.cn/gzdt/2010-11/08/content_1740976.htm) are the only guidelines for medical ethics review in China.8,9 These two regulations, however, leave many problems unsolved. For example, an institution only needs to keep a record in its practice registration authority to establish an ethics committee. This is straightforward and how to monitor an ethics committee is not well defined. Hence assessments of the work of the ethics committee do not take place.
Second, ethics committees lack competence to examine the scientific validity of research proposals.7 According to the aforementioned guidelines, an ethics committee should comprise at least seven people. In practice, an ethics committee usually has nearer twenty people, usually about ten of whom are scientific experts. However, these experts often do not cover all the necessary specialties.7 Opinions can be sought from outside experts, but they are not allowed to vote. In addition, although ongoing training is recommended for ethics committee members, there is no formal qualification or assessment of skills.
Third, ethics committees in China suffer from a lack of standardization. The guidelines provide some principles for ethics review, but they do not propose any national standards, leading to variations in practice between institutions.7 Proposals rejected by one ethics committee have been accepted by another ethics committee without any change to the application.7,10,11
Urgent measures are required to address the failures in ethical oversight of biomedical research in China. Some of these include establishing regional ethics committees to avoid institutional bias, creating databases of expert reviewers to cover diverse specialties and involving them in decision making, setting national standards for ethics committee so that they can be monitored and variation in practice minimised, and training introduced that leads of formal assessment of ethic committee member.6,7 By tackling the weaknesses in the form and function of ethics committees, China will raise the standard of research, protect study participants, and improve patient care. Research misconduct is hard to eliminate but China’s current approach to ethical oversight makes it easy to cheat the system.
References
1. Dyer O. Researcher who edited babies’ genome retreats from view as criticism mounts. BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5113.
2. Xu S, Ye Y, Pan X, Liu C. Study on the current situation and the management mechanism of the medical ethics committee. Chinese Medical Ethics. 2016;29:17-19.
3. Zhang L, Huang XX, Chen HF. An Exploration of the Protective Effects of investigators’ ethical awareness upon subjects of drug clinical trials in China. Bioethical Inquiry.2018;15::89-100.
4. Ma J, Chen XP, Lu YL. Analysis of the current situations of the ethics committee of the level 2 hospital. Journal of Military Surgeon in Southwest China. 2012;14:388-389.
5. Zhang JJ, Yang WY, Zheng TT, Liu Y, Liu JS, Sun N. Survey on medical institutions ethics committee operation status in Shangdong province. Medicine and Philosophy. 2014; 35:36-38.
6. Lv LN, Xiong NN, Chang YL, Yang B. Reflections on improving the working mechanism of medical ethics committee. Medicine and Society.2012; 25:26-28.
7. Zhou JY, Deng F, Liu D, Zhou SW. Problems and countermeasures of medical ethics committee in China. Chin J Clin Pharmacol. 2017; 33: 365-368.
8. National Health Commission of the People’s Republic of China. Methods for Ethical Review of Biomedical Research Involving Human Beings. http://www.moh.gov.cn/fzs/s3576/201610/84b33b81d8e747eaaf048f68b174f829.....
9. State Food and Drug Administration. Guiding Principles for Ethical Review of Drug Clinical Trials. http://www.gov.cn/gzdt/2010-11/08/content_1740976.htm.
10. Zhang J, Cheng R, Li J. On the standardized operation of medical ethics committee. Medicine and Law. 2014;6: 6-8.
11. Wang Hb, Wang YR. Improvement of medical ethics committee system from the perspective of law. Medicine and Philosophy. 2017;38:31-33.
Competing interests: No competing interests