临床试验中受试者知情同意权的保护——以美国C.E.A诉临床试验研究人员案为例

On the Protection of the Subjects' Informed Consent in Clinical Research——Taking the Case of the Legal Action of C.E.A. Against Clinical Researcherse for Example

在医学人体试验的过程中,研究者对受试者负有一种关爱责任,其直接体现在研究者要尊重患者的知情同意权,向受试者告知其病情、试验的研究背景、研究的目的和方法、受试者有随时退出临床试验的权利等等。文章通过对美国C.E.A诉临床试验研究人员案的详细介绍,指出在任何情况下,研究人员都不能将科学研究的利益置于受试者的生命健康利益之上,且都应当履行详尽的告知义务,以最大限度地保证受试者的权益。

In medical human subject research, researchers bear the liability to care the subjects who participate in their research, which embodies directly in the researchers＇ respect to their subjects＇ informed consent, in describing the state of illness to their subjects, in the exposition of the background information,purpose and methods of the research to the subjects, and in respect the subjects＇ right to quit such clinical research at anytime he or she prefers, and so on. Through the detailed introduction of the legal action of C. E. A.against clinical researchers, this paper indicates that in no case researchers should put the interests of scientific research above the life and health interests of their subjects, and researchers should fulfill their obligation to completely inform their subjects in detail and ensure the interests and the subjects＇ rights with their greatest effort.