Analysis of the Problem of Informed Consent in Clinical Trial / 中国医学伦理学

ABSTRACT

Objective:By observing the process of informed consent in clinical trials of one top three hospital, to disclose the non - standard phenomenon existingin the process of informed consent in clinical trials, and put for-ward that there should be special protection mechanism for vulnerable groups to participate in clinical trials. Meth-ods:Combined with the actual situation of one top three hospital, we comprehensively analyzed the problems exist-ing in the process of informed consent of clinical trials in our center, put forward strict solutions, and also formula-ted strict standards for the informed consent process of vulnerable groups. Results:Through the strict requirements of the informed consent process of vulnerable groups, the test process of vulnerable groups participating in the clini-cal trial was standardized; meanwhile the vulnerable groups were given special protection. Conclusion:Informed consent is an important guarantee that protects vulnerable groups to participate in clinical trials.