Original Article

Challenges for ethics committees in biomedical research governance: illustrations from China and Australia


In this paper, the evolution of the ethics committees for health research, their history, membership, and function in China and Australia is described. Investigators in each country compared the history and governance of their ethical systems based on the published evidence rather than personal opinions. Similarly, examples of challenges were selected from the literature. In both countries, the aim was to maximize the social benefits of research and minimize the risk imposed on the participants. Common challenges include maintaining independence, funding and delivering timely ethical reviews of the research projects. These challenges can be difficult where research ethics committees rely on voluntary contributions and lack a strong resource base. They must adapt to the increasingly rapid pace of research as well as the technological sophistication.  Population health research can challenge the conventional views of consent and privacy. The principles of the sound ethical review are common in both countries; governance arrangements and operational procedures, however, can differ, reflecting the cultural values and norms of their host countries and in respect of legal environments. By studying the evolution and function of ethics committees in the two countries, we established the differences in the governance and health systems, while similar ethical objectives helped sustain collaborative research.

The Nuremberg Code (1947). British Medical Journal. 1996; 313: 1448.

Roelcke V, Maio G. Twentieth Century Ethics of Human Subjects Research: Historical Perspectives on Values, Practices, and Regulations. Stuttgart: Franz Steiner Verlag; 2004, p.167–80.

Brandt AM. Racism and research: the case of the Tuskegee syphilis study. Hastings Cent Rep. 1978; 8: 21–9.

Paulsen NA, Lie AK. Research ethics on the agenda – the debates preceding the establishment of ethics committees. Tidsskriftet Den Norske Legeforening 2016: 36: 1739-43.

Beecher HK. Ethics and clinical research. The New England Journal of Medicine. 1966; 274 :1354-60.

Pappworth MH. Human Guinea Pigs: Experimentation on Man. London: Routledge; 1967.

Rothman DJ. Strangers at The Bedside: A History of How Law and Bioethics Transformed Medical Decision Making. New York: Basic Books; 1991.

Wang M, Zhao M. Biomedical Ethics, 5th ed. Beijing: People’s Health Press; 2018.

Hennig W. Bioethics in China: although national guidelines are in place, their implementation remains difficult. EMBO Rep. 2006; 7: 850-54.

Anonymous. National Institutes of Health: ClinRegs: China: Oct 28, 2021 [cited Dec 2021]; Available from: https://clinregs.niaid.nih.gov/country/china#_top

China’s Ethical Review System. [cited Dec 2021]; Available from: http://trust-project.eu/wp-content/uploads/2016/03/Chinese-Ethics-Review-System.pdf

[13 Codes of the ethics on Biomedical research, Shanghai Municipal Surveillance Bureau]. [cited Dec 2021]; Available from: http://yxky.fudan.edu.cn/4f/d3/c6382a85971/page.htm

Dyke T, Anderson W. A history of health and medical research in Australia. Med J Aust. 2014; 201: S33-6.

Leggat PA. A college of tropical medicine for Australasia. Med J Aust. 1992; 157: 222-3.

Cumpston JHL. The Health of the People; A Study in Federalism Canberra. Australia: Roebuck Society; 1978.

Anonymous. National Statement on Ethical Conduct in Human Research 2007. [cited Dec 2021]; Available from: https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

Anonymous. National Health and Medical Research Council (NHMRC). Statement on human experimentation. [cited Dec 2021]; Available from: http://esvc000239.bne001tu.server-web.com/Downloads/CRIAH%20Tools%20for%20Collaboration%20ver1%20December2007/4%20Ethics/National%20Statement%20on%20Ethical%20Conduct%20in%20Research%20involving%20Humans.pdf

National Health and Medical Research Council. Australian code of practice for the use of animals for scientific purposes. [cited Dec 2021]; Available from: https://www.nhmrc.gov.au/about-us/publications/australian-code-care-and-use-animals-scientific-purposes

Australian Vice-Chancellors’ Committee, Guidelines for responsible practice in research and problems of research misconduct. [cited Dec 2021]; Available from: https://www.nhmrc.gov.au/sites/default/files/documents/reports/australian-code-responsible-conduct-research.pdf

National Health and Medical Research Council. [cited Dec 2021]; Available from: https://www.nhmrc.gov.au/research-policy/ethics/national-certification-scheme-ethics-review-multi-centre-research

Olver IN, Fallerio SP, Marson ML, Bishop JF. A case study of a single ethics committee for multicentre trials. Med J Aust. 2011; 195(10): 582-3.

Anonymous. Supporting research and ethics – about us. [cited Dec 2021]; Available from: https://bellberry.com.au/about-us/

Wang ZH, Zhou GH, Li-Ping S, Gang J. Challenges in the ethics review process of clinical scientific research projects in China. J Int Med Res. 2019, 47: 4636-43.

Ballantyne AJ, Rogers WA. Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs. Med J Aust. 2008; 188(11): 653-6.

McLoughlin F, Hadgraft NT, Atkinson D, Marley JV. Aboriginal health research in the remote Kimberley: an exploration of perceptions, attitudes and concerns of stakeholders. BMC Health Serv Res. 2014; 14: 517.

Zhang J, Zhang ZM, The challenges of ethical review in clinical research of traditional Chinese medicine. Evid Based Complement Alternat Med. 2021; 2021: 6754985.

Lewis JW, Keightley DN, Young EP, et al. China. [cited Dec 2021]; Available from: https://www.britannica.com/place/China

Anonymous. Australian Bureau of Statistics. Regional Population 2019-2020. [cited Dec 2021]; Available from: https://www.abs.gov.au/statistics/people/population/regional-population/latest-release

Sabesan S, Malica M, Gebbie C, Scott C, Thomas D, Zalcberg J. Implementation of the Australasian teletrial model: translating idea into action using implementation science frameworks. J Telemed Telecare. 2021; 1357633X211017805.

Zhang X, Zhang W, Zhao Y. The Chinese ethical review system and it compliance mechanisms. [cited Dec 2021]; Available from: http://trust-project.eu/wp-content/uploads/2016/03/Chinese-Ethics-Review-System.pdf

Liu J, Shen J, Liu P-Z. A survey of five first-level hospital ethics committees in Urumqi, China. J Zhejiang Univ Sci B. 2013, 14: 541-8

Fitzgerald MH, Phillips PA. Centralized and non-centralized ethics review: a five-nation study. Account Res. 2006; 13(1): 47-74.

National Health and Medical Research Council. The human research ethics applications; research policy. [cited Dec 2021]; Available from: https://www.nhmrc.gov.au/research-policy/ethics/human-research-ethics-application-hrea

Zhou P, Xue D, Wang T, et al. Survey on the function, structure and operation of hospital ethics committees in Shanghai. J Med Ethics. 2009, 35: 512-6.

Anonymous. National Institutes of Health: ClinRegs: United Kingdom. [cited Dec 2021]; Available from: https://clinregs.niaid.nih.gov/country/united-kingdom

Newson AJ, de Lacey S, Dowling DK, et al. Public attitudes towards novel reproductive technologies: a citizens’ jury on mitochondrial donation. Hum Reprod. 2019; 34(4): 751-57.

Anonymous. Association for the Accreditation of Human Research Protection Programs Inc. [cited Dec 2021]; Available from: https://www.aahrpp.org

Anonymous. Strategic initiative for developing capacity in ethical review. [cited Dec 2021]; Available from: https://www.who.int/sidcer/en/

Anonymous. National Health and Medical Research Council. Ethical guidelines on the use of assisted reproductive technology in clinical practice and research. [cited Dec 2021]; Available from: https://www.nhmrc.gov.au/about-us/publications/ethical-guidelines-use-assisted-reproductive-technology

Lipworth W, Mason PH, Kerridge I. Ethics and epistemology of big data. J Bioeth Inq. 2017; 14(4): 489-500.

Ienca M, Ferretti A, Hurst S, Puhan M, Lovis C, Vayena E. Considerations for ethics review of big data health research: a scoping review. PLoS One. 2018; 13(10): e0204937.

Courtwright A, Rubin E. Who should decide for the unrepresented? Bioethics. 2016; 30(3): 173-80.

Broadman F, Hale R. Responsibility, identity, and genomic sequencing: a comparison of published recommendations and patient perspectives on accepting or declining incidental findings. Mol Genet Genomic Med. 2018; 6(6):1079-1096.

Olver IN. Ethical issues with xenotransplantation clinical trials. Med J Aust. 2014; 204(6): 212.

Olver IN. Opting in for opt-out consent. Med J Aust. 2014; 200(4): 201-2.

IssueVol 14 (2021) QRcode
SectionOriginal Article(s)
DOI https://doi.org/10.18502/jmehm.v14i25.8279
Australia China Ethics committees History

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
Huanhuan C, Li M, Wang M, Roder D, Olver I. Challenges for ethics committees in biomedical research governance: illustrations from China and Australia. J Med Ethics Hist Med. 2021;14.