Application of Ethical Tool Kit in writing clinical trial protocols

Abstract

Objective To analysis the necessity, feasibility and route of introducing Harvard Ethics Tool Kit into China. Methods Translated and edited The Ethics Tool Kit of Multi-Regional Clinical Trials (MRCT) Center of Harvard. Analyze the necessity and feasibility of introducing Ethical Tool Kit into China from the perspective of researchers and ethics committees. Explore the ways to introduce ethical toolkits into China from clinical trials and clinical research projects. Results Harvard MRCT Center developed Ethical Tool Kit in 2014 and proposed incorporating ethical principles into clinical research protocols. The Ethics Tool Kit includes 11 essential elements: addressing relevant question, choice of control and standard of care, choice of study design, choice of subject population, potential benefits and risks, informed consent, community engagement, return of research results and incidental findings, post-trial access, payment for participation, study related injury. The Ethics Tool Kit is helpful not only for researcher to develop their protocols, but also for ethical committees to conduct efficient review. From the perspective of researchers and ethics committees, it is necessary and feasible to introduce ethical toolkits into China now. From the ways of introduction, the clinical trial is proposed to be led by the government and the medical association, and the clinical research project is proposed to be explored by the institutions. Conclusions The Harvard Ethical Tool Kit has great practical value for researchers writing protocols and ethics committee reviewing protocols. It is recommended that introducing ethics tool kits to China for improving the overall quality of clinical research. Key words: Ethics committee; Investigator; Clinical trial; Protocol; Ethics Tool Kit