The protection of patients' rights in clinical trials.
The Helsinki Declaration is a very important document regarding the protection of patients' rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients' rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients' rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting.
Czarkowski
Marek
M
Department of Internal Medicine and Endocrinology, Medical University of Warsaw, ul. Banacha 1A, 02-097 Warsaw, Poland. mczark@amwaw.edu.pl
D002986:Clinical Trials as Topic; D028744:Ethics Committees, Research; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality; D028701:Patient Rights