Translation of Standard Texts in Hebrew Informed Consent Forms

Israel Informed Consent Forms, Standard Texts

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.

Indeed, there are several factors that make Israel an attractive location for multinational clinical trials.

  1. Highly skilled professionals: Israel has a pool of highly educated and skilled healthcare professionals, including doctors, nurses, researchers, and other medical staff. The quality of medical training and education in Israel is recognized globally. Many of these professionals have been trained in some of the best institutions in the world and have extensive experience in their respective fields.
  2. Advanced medical facilities: Israel is home to some of the world’s most advanced medical facilities, equipped with state-of-the-art technologies. These facilities are capable of facilitating clinical trials of various types and sizes.
  3. Culturally diverse population: Israel has a culturally diverse population which is a significant advantage in clinical trials. It allows for testing on a wide range of genetic backgrounds, increasing the robustness and generalizability of the results.
  4. Modernized regulatory environment: Israel has a modern regulatory framework that aligns with international standards and guidelines, which provides transparency and predictability for pharmaceutical companies. The Israeli Ministry of Health and the Helsinki Committee (which approves medical human trials) have strict ethical guidelines that must be adhered to, ensuring the safety of participants and the integrity of the study.
  5. Presence of global CROs: Major global Contract Research Organizations (CROs) have a presence in Israel. These CROs provide a wide range of services that are essential for conducting clinical trials, including project management, clinical monitoring, data management, statistical analysis, and regulatory support.
  6. Supportive government policies: The Israeli government has implemented policies that encourage research and development, making it an attractive destination for pharmaceutical companies. These policies include tax incentives, funding opportunities, and a supportive infrastructure for clinical research.
  7. Quick turnaround times: In many cases, Israel has faster regulatory approval times compared to other countries. This can make it a more attractive location for companies that are looking to start their trials as soon as possible.

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.

MOH Form 2A AR

MOH Form 2A RU