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Analysis of the status of informed consent in medical research involving human subjects in public hospitals in Shanghai
  1. Wang Jianping1,
  2. Lan Li2,
  3. Di Xue3,
  4. Zhongjin Tang4,
  5. Xieyang Jia5,
  6. Rong Wu6,
  7. Yiqun Xi7,
  8. Tong Wang8,
  9. Ping Zhou9
  1. 1Department of Scientific Research and Education, Shanghai Municipal Health Bureau, Shanghai, PR China
  2. 2Department of Hospital Management, Fu Dan University, Shanghai, PR China
  3. 3Department of Hospital Management, Fu Dan University, Shanghai, PR China
  4. 4Department of Scientific Research and Education, Shanghai Municipal Health Bureau, Shanghai, PR China
  5. 5Department of Hospital Management, Fu Dan University, Shanghai, PR China
  6. 6Department of Scientific Research, Hua Shan Hospital, Shanghai, PR China
  7. 7Office of Directors, Shanghai Children's Hospital, Shanghai, PR China
  8. 8Department of Publicity, Shanghai Municipal Health Bureau, Shanghai, PR China
  9. 9Department of Hospital Management, Fu Dan University, Shanghai, PR China
  1. Correspondence to Professor Di Xue, Department of Hospital Management, School of Public Health, Fu Dan University, PO Box 197, No 138, Yi Xue Yuan Road, Shanghai 200032, PR China; xuedi{at}shmu.edu.cn

Abstract

Objectives The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries.

Methods In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed by questionnaires.

Results The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research.

Discussion Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research.

Conclusion The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors.

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Footnotes

  • Funding The study was made possible by the research funding provided by the Shanghai Municipal Health Bureau.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the IRB, School of Public Health, Fu Dan University.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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