A Preliminary Study on Risk and Benefit Assessment in Ethical Review of Clinical Trials / 中国医学伦理学

ABSTRACT

The risk and benefit assessment is an important part of ethical review in clinical trials, of which the significance is to minimize the risk and maximize the benefit, thus to protect the rights of the subject. Begin with introducing the nature of the risk and benefit of clinical trial, this paper analyzed the way of ethical review based on risk consideration and discussed some key points of risk and benefit assessment including the minimum risk, the risk and benefit of vulnerable groups, risk informing, benefit of clinical trials, the fairness of recruitment and the importance of strengthening follow-up review. Ethical review should play a role as the balance, which neither-hinder the development of clinical trial to protect the rights of the subjects nor damage the rights and interests of subject to develop clinical trials.