Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital

Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital
Xiaohua Tang, Yi Bi, Xia Chen, Jun Li, Haiwei Zhang
China Pharmacy, 2023; 12 pp 648-652
Abstract
Objective
To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs, and to protect the legitimate rights and interests of the subjects.
Methods
The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st, 2020 to July 1st, 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital.
Results
Of the 316 clinical trials of registered anti-tumor drugs that were initially reviewed, 257 (81.3%) had problems with the contents of informed consent form, mainly domestic multi-center trials and phase three trials. The main problems included the vague notification of the test fee bearer (68.5%), the incomplete notification of the test content (59.1%), the insufficient notification of rights and interests and risks (58.4%), the insufficient notification of personal information protection (56.0%), and the nonstandard expression of the informed consent form (52.5%).
Conclusions
There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs (GCP). The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form, and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing, continue to strengthen the examination ability, improve the examination quality, and effectively protect the safety and interests of the subjects.