ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
2.5 Use of Data Resulting From Clinical Trials The informed consent forms provided in MoH Guideline 14 on Medical Experiments on Humans (2020) state that the consent to participate in the trial also includes consent for medical and per- sonal information collected during the trial to be transferred to an external party for data process- ing. The information is to be transferred in an encoded form, free of identifying details, with the link between the code and the identifying details being kept securely by the Principal Investiga- tor in Israel. Changes in these forms require the approval of the Helsinki Committee. In addition, to the extent that the resulting data from the trials amounts to a database contain- ing identifying information about an individual (eg, their health status), it should be considered a database of “sensitive data” according to the Protection of Privacy Law of 1981. The use of such a database is subject to the provisions out- lined in the law and regulations – examples of which include the following. • If an external service provider needs access to the database in order to provide a service, the agreement with such service provider must include provisions set forth in the Pro- tection of Privacy Regulations (Data Security) of 2017 (such as provisions referring to the data security implementation, confidentiality, and annual reports). • Transfer of data from such a database to a third party outside Israel is governed by the Protection of Privacy Regulations (Transfer of Data to Databases Outside the State Borders) of 2001. These regulations set out conditions for transferring data abroad – for example, the transferee must undertake to comply with the conditions for data retention and use applying to a database located in Israel, or the trans-
Multi-centre trials are evaluated by a dedicated national committee, according to MoH Guideline 168 of 2023. 2.3 Public Availability of the Conduct of a Clinical Trial According to MoH Guideline 14 on Medical Experiments on Humans (2020), the initiation of a clinical trial is contingent upon its registration within the MoH’s MyTrial website. The informa- tion presented on the MyTrial website includes details of the disease/medical condition, the intervention being tested and how the trial is conducted, as well as criteria for inclusion and exclusion, a list of the centres where the trial is conducted, and contact details for obtaining further information. Exemptions from registration on the MyTrial website can be requested from the Helsinki Committee. They can be based on reasons of IP in feasibility trials, as long as the trial was not registered on the USA’s National Institutes of Health (NIH) website. 2.4 Restriction on Using Online Tools to Support Clinical Trials The use of digital means in the process of obtain- ing informed consent is regulated under MoH Guideline 169/01. The guideline refers to the use of digital means in presenting the information to the participants and verifying their understand- ing, as well as the use of such means in obtain- ing informed consent and documenting the pro- cess. The use of such digital means requires the approval of the Helsinki Committee as part of the approval of the trial. In addition, restrictions under additional laws and regulations exist, such as those outlined in 2.5 Use of Data Resulting From Clinical Trials .
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