Approaches to Increasing Ethical Compliance in China with Drug Trial Standards of Practice

Article type: Research Article

Authors: Rosenberg, Jacob^*

Affiliations: Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Correspondence: [*] Correspondence to: Jacob Rosenberg, MD, DSc, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark. Tel.: +45 26237323; E-mail: jacob.rosenberg@regionh.dk.

Abstract: Zeng et al.’s Ethics Review highlights some of the challenges associated with clinical research in China. They found that only a minority of published clinical trials of anti-dementia drugs reported that they fulfilled the basic ethical principles as outlined in the Declaration of Helsinki. With recent reports of scientific misconduct from China, there is an urgent need to find approaches to compel researchers to adhere to ethical research practices. This problem does not call for a simple solution, but if forces are joined with governmental regulations, education in ethics issues for medical researchers, and strong reinforcement by Chinese journal editors not to publish studies with these flaws, then research ethics and publication standards will probably improve. Other solutions to foster ethical practice of drug trials are discussed including Chinese initiatives directed at managing conflict of interest from the pharmaceutical industry and educating clinical researchers.

Keywords: Research ethics, Helsinki declaration, informed consent

DOI: 10.3233/JAD-151196

Journal: Journal of Alzheimer's Disease, vol. 52, no. 3, pp. 825-827, 2016