Current situation analysis and countermeasures of informed consent and ethical review about clinical trial involving human subject in hospitals / 中华医学科研管理杂志

ABSTRACT

Objective To explore the current situation of informed consent and ethical review of clinical trial involving human subject in hospitals,and provide related countermeasures.Methods This study searches the website (http//med.wanfangdata.com.cn/Paper),selects "hospital" as the search term,and uses "all fields" as the search criteria.Collected papers were about clinical trial involving human subject that published during Jan.2018 to Feb.2018 in internal medicine,surgery,obstetrics and gynecology,pediatrics.The current situation of informed consent and ethical review of these papers were analyzed from various aspects,including the hospital grades,medical institutions types,clinical research methods,study types,fund projects,periodical category.Results (1) Among 1964 papers,only 538 (27.4％) papers obtained informed consent of subjects and the ethical review approval.(2) There are no significant differences between different hospital grades,and different medical institutions about informed consent and ethical review.(3) Experimental studies focus more on informed consent and ethical review than observational studies.(4) Drug clinical trials focuses more on informed consent and ethical review than non-drug related clinical study.(5) Fund projects focus more on informed consent and ethical review than non-fund pro jects.(6) Papers published in core periodical focus more on informed consent and ethical review than papers published in other periodical.Conclusions Currently,conducting clinical trial involving human subject still does not pay enough attention to the informed consent of subjects and ethical review,more countermeasures are needed to change the current situation and to standardize human clinical trials.