Discussion of solutions to ethical issues in real-world study

Abstract

In recent years, the paradigm of real-world study (RWS) has been at the forefront of clinical research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of real-world clinical studies are discussed, and ethical issues in different stages of RWS are raised and reviewed. Moreover, some preliminary solutions to these issues, such as protecting subjects during the process of RWS and performing ethical review, are presented based on recent practices and basic ethical rules to improve the scientific validity and ethical level of RWS.

Keywords

real-world study / ethics / strategy

References

[1] Ren DQ. Real-world study, GCP and risk minimization. Chin J Chin Mater Med (Zhongguo Zhong Yao Za Zhi)2012; 37(18): 2681-2682 (in Chinese)

[2] Tian F, Xie YM. Real-world study: a potential new approach to effectiveness evaluation of traditional Chinese medicine interventions. J Chin Integr Med (Zhong Xi Yi Jie He Xue Bao)2010; 8(4): 301-306 (in Chinese)

[3] Liu BY, Zhou XZ, Li P, Wang YH, Wen TC, Guo YF, Zhang RS, Chen SB. A unified clinical and research information platform toward individual medicine. China Digit Med (Zhongguo Shu Zi Yi Xue)2007; 2(6): 31-36 (in Chinese)

[4] Gallin JI.,. Ognibene FP. Principle and Practice of Clinical Research (2nd ed) (in Chinese, trans. Zhang YF). Beijing: Science Press, 2008: 17-27

[5] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Washington, DC, U.S. Government Printing Office. 1979

[6] Liu BY, Zhang QM. Symptoms’ standardization issues in the construction of unified TCM clinical and research information platform. J Tradit Chin Med (Zhong Yi Za Zhi)2011; 52(20): 1714-1718 (in Chinese)

[7] Wang SC, Wang XQ, Xiong NN. Promote the implementation of ethical regulation and build subjects protection system. Chin J Manag Chin Med (Zhong Yi Yao Guan Li Za Zhi), 2011, (12): 895-898 (in Chinese)

[8] Code of Federal Regulations. Protection of human subjects. Title 45 Part 46, June 23. 2005: §46.101

[9] Tian DX. Ethical Controversy of Minimal Risk in Clinical Research. Med Philos Humanist Soc Med Ed (Yi Xue Yu Zhe Xue, Ren Wen She Hui Yi Xue Ban)2011; 32(7): 13-15 (in Chinese)

[10] Zhou YJ, Hong M. Ethical requirements of the hospital digital technology construction. Chin Med Ethics (Zhongguo Yi Xue Lun Li Xue)2010; 23(3): 109-111 (in Chinese)

[11] Song HM, Liu BY, He LY, Zhang RS, Zhou XZ. Needs of data mining and pre-processing method of data in TCM clinical and research information integration system. Chin J Basic Med Tradit Chin Med (Zhongguo Zhong Yi Ji Chu Yi Xue Za Zhi)2011; 17(12): 1323-1325 (in Chinese)

[12] World Medical Association. Declaration of Helsinki. <month>October</month>2013.

[13] Council for International Organizational of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, 2002.

[14] Hu JH, Huang J. Current status and prospect of the medical research ethics. Chin Bull Life Sci (Sheng Ming Ke Xue)2012; 11(24): 1254-1255 (in Chinese)

[15] Wang SC, Wang XQ, Xiong NN, Yu H. Countermeasure to ethical review development of TCM clinical research. J Beijing Univ Tradit Chin Med (Beijing Zhong Yi Yao Da Xue Xue Bao)2010; 33(3): 156-158 (in Chinese)

[16] Chen Z.Unity but not Uniformity: Globality and Locality of Bioethics. Chin Med Ethics (Zhongguo Yi Xue Lun Li Xue), 2006, 19(4): 3-4, 10 (in Chinese)

Acknowledgements

This study was supported by the National Natural Science Foundation of China (Grant No. 81230086).

Compliance with ethics guidelines

Sicheng Wang, Baoyan Liu, Ningning Xiong, Qi Xie, Runshun Zhang, Xuezhong Zhou, and Jie Qiao declare that they have no conflict of interest. This manuscript is a review and does not involve a research protocol requiring approval by the relevant institutional review board or ethics committee.

RIGHTS & PERMISSIONS

2014 Higher Education Press and Springer-Verlag Berlin Heidelberg