Legal aspects of clinical trials in Israel.

Clinical trials were mainly the concern of medical ethics until the first code on this subject was laid down in a judgment given by a military tribunal in Nuremberg in 1947. In 1964 the World Medical Association adopted the Declaration of Helsinki, which was revised in 1975, regarding clinical trials and research. The Declaration of Helsinki and the developments in the pharmacological and pharmaceutical sciences led to legislation regarding clinical trials and human experimentation. In Israel it is forbidden to use any drug that is not registered. In order to register a drug, evidence of quality, safety and efficacy is necessary, and the means by which these factors are proved is the clinical trial, which demands appropriate legislation. Developments in various medical fields, as well as new treatment techniques, brought about the need for more comprehensive legislation on experimentation on human beings and embryos. In Israel, this field is covered by two enactments, the first on drugs and the second on any other experimentation on human beings. However, these enactments are frame laws, which lay down the rule that no clinical trial may be carried out without the prior approval of the Ministry of Health. They also state the minimum conditions to be met, and provide the Ministry with the authority to add any conditions at any time, as well as the right to stop the trial. The Declaration of Helsinki serves as the minimal legal basis for clinical trials. Some legal problems relating to the clinical trial remain unsolved and are left to the discretion of the Ministry of Health. The author makes some observations and suggestions with regard to matters of consent, incompetents as subjects, the right of withdrawal, and the power of the Ministry.