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Committees to Approve Clinical Trials in Humans

Research or clinical trials with humans require the approval of multidisciplinary ethics committees, usually comprising senior medical personnel, representatives of the public – lawyers and/or religious authorities ­representatives of the medical institution and/or the regulating body, and so on. Around the world, ethical committees for clinical trials have been established since the second half of the twentieth century. Statutory ethical committees were established in Israel under the Public Health Regulations (Clinical Trials in Humans), 5741/1980:

  • Hospital Helsinki Committees (“institutional committees”), whose role is to approve any special clinical trials in humans (as defined in the fourth addendum to the regulations) conducted at the hospital.
  • The Supreme Committee for Clinical Trials in Humans, whose role is to submit an assessment to the Ministry of Health’s Director General regarding the approval or non-approval of non-special experiments, as detailed in Regulation 3B, namely: any genetic experiment in humans; experiments relating to the fertilization of a woman using artificial reproduction technologies; and residual matters relating to clinical trials in humans, regarding which the Ministry of Health’s Director General has asked to determine that they do not violate the Helsinki Declaration and the regulations.

A Central Committee for Clinical Trials with Products Originating from Cells or Tissues and a Central Committee for Gene Therapy operate as extensions of the Supreme Committee. In addition to these, a Central Committee for Clinical Trials in Humans (as defined in the Clinical Trials Procedure, 5776 – 2016) has been established to advise the Ministry of Health’s Director General on the following subjects: preparations; medical devices and equipment; advanced therapies, excluding gene therapy; or any other subject to be decided in the future. Along with all these, there are also the Helsinki Committees of the health funds and the University Ethics Committees at academic institutions. The committees operate in accordance with the Public Health Regulations (Clinical Trials in Humans), 5741/1980; the rules defined in the Helsinki Declaration, which are updated periodically; and the circulars issued by the Director General of the Ministry of Health.