Study on the influencing factors of ethical misconduct in medical researchers / 中华医院管理杂志

ABSTRACT

Objective:To understand the ethical misconduct of Chinese medical researchers and its influencing factors, so as to provide a reference for regulating such misconduct in clinical research.Methods:From September to November 2021, a stratified random sampling method was adopted to select medical researchers from the China Clinical Trial Registration Platform as interview objects, and semi-structured interviews were made on ethical misconduct and its influencing factors in clinical trials. The interview data were analyzed using NVivo11 software.Results:A total of 28 interviewees were included, 57%( n=16) of whom holding that medical researchers accept research ethics passively in most cases. The influencing factors of ethical misconduct of medical researchers are summarized into 7 secondary nodes and 43 tertiary nodes, including 248 reference points. The environmental factors included poor ethical supervision, great research pressure information asymmetry between subjects and researchers, and insufficient ethical atmosphere, including 54, 40, 38, and 29 reference points respectively. The self-factors included lack of ethical knowledge, weak ethical awareness, and individual characteristics of researchers, including 48, 21 and 18 reference points respectively. Conclusions:The attitude and behavior of clinical research ethics of Chinese medical researchers are generally in the transitional stage from passive acceptance to positive compliance, and there are many factors influencing ethical misconduct. In order to further standardize the ethical behavior of medical researchers, the authors suggest relevant authorities to improve ethical review and supervision, establish systematic ethical training, improve the scientific research environment, and actively carry out clinical trials and science popularization.