Analysis of the initial ethical review of Investigator-Initiated Trails research and discussion of standardized management / 中华医学科研管理杂志

ABSTRACT

Objective:By analyzing the data of Investigator-Initiated Trials (IITs) in a grade A tertiary hospital and common problems in the initial ethical review, this study puts forward corresponding countermeasures, providing a reference for standardizing the ethical management of clinical scientific research projects in medical institutions.Methods:A causal analysis was conducted based on the statistics of the number of IITs undergoing ethical review in a grade A tertiary hospital from January 2012 to August 2021, and the analysis of the problems in the ethical formal review of 271 clinical research involving human beings.Results:At present, there are some problems in scientific research ethics, such as weak review execution, inadequate supervision, and weak ethical awareness of researchers.7 targeted measures were put forward.Conclusions:Establishing a hospital subject protection system, strengthening the construction of a scientific research ethics supervision system, refining ethical norms and standards, and promoting the institutionalization of scientific research ethics training are of great importance for standardizing investigator-initiated clinical research, improving research quality, avoiding scientific research ethical risks, and effectively guiding the ethical management of clinical research in hospitals.