Israel has become an important center for conducting multinational clinical trials, with major pharmaceutical companies sponsoring studies in Israel’s advanced medical facilities. Israel has become an attractive venue for conducting clinical studies due to the high-quality medical professionals and leading academics, in addition to a culturally diverse population base and a modernized regulatory environment. Most of the major, global Contract Research Organizations (CRO) have a presence in Israel.
Clinical trials are conducted in accordance with the Public Health Regulations (Clinical Trials in Human Subjects) of 1980. The following excerpt from these regulations pertains specifically to informed consent forms.
An informed consent form should contain a summary of the information given to the participant about the clinical trial, pursuant to Sections 3.4 and 3.5 below, provided that all the information considered declarative is recorded in detail. The form should be written in standard language which is clear, lucid and understandable to any person and in the language of the participant, where possible.
Informed consent form (Form 2A for clinical trials of investigational products and for single patient access to investigational treatment; Form 2B for genetic trials; Form 2C for clinical trials not involving an investigational product; Form 3, a parent/guardian informed consent
form for clinical trials in which participants are minors/wards/legal incompetents. Form 3A, 3B and 3C for trials of investigational products, genetic trials and trials not involving investigational products, respectively. In an application for a trial that involves both adults and minors/wards/legal incompetents, the appropriate consent forms should be attached to the application documents).
For clinical trials conducted in Israel, Informed Consent Forms are usually translated into Russian and Arabic. This is due to the large Russian- and Arabic-speaking populations in Israel. It is sometimes also translated to English.
The most common Informed Consent Form is Form 2A (for clinical trials of investigational products and for single patient access to investigational treatment). There are about 600 words of standard text in these forms. As a service to our clients, we are making available translations of the standard Hebrew texts in Arabic and in Russian. Just click on one of the following links to download the file.