关键词: 肿瘤临床试验, 研究参与者, 补偿, 专家共识

Abstract: Compensation/allowance for research participants in clinical trials refers to economic or other forms of compensation provided by sponsors for any inconvenience, additional expenses, additional time, and provision of biological samples, associated with the participants. Good clinical practice and medical ethics guidelines, either domestic or international, allow the research participants to be provided with certain compensation. However, there is no clear regulation on the items, standards, methods, and means of compensation; in practice, a specific reference basis is lacking for determining whether or not compensation is appropriate. Therefore, experts and personnel are recruited from the Society of Medical Ethics of China Anti⁃Cancer Association to establish this expert consensus, aiming to provide a reference for determining compensation categories and cost standards for the subjects in clinical trials of premarket and registered anti⁃tumor drugs, and to propose ethical review suggestions for compensation and supervision measures for relevant personnel or departments.

Key words: Clinical trial, Research participants, Compensation, Expert consensus