Research Submission

Stage 1: Research Committee

The committee's role is to verify whether the submitted research complies with the standards dictated by the Ministry of Health for conducting research and whether it aligns with the Fund's policy.

Submission Process

The researcher will fill out a request form and protocol summary (link to forms), attach a full research protocol, attach a CV and GCP certificate, and send it by email to the committee coordinator. Reviewers review the request, and their decision is provided within two weeks. If there are comments, they are sent to the principal investigator for corrections. After receiving the committee's approval, the research can be submitted to the Helsinki Committee (IRB). According to the regulations, the principal investigator must be a Leumit employee (independent or salaried). It is possible to connect researchers from outside and inside the Fund.

Stage 2: Helsinki Committee (IRB)

The Helsinki Committee of Leumit Health Services operates following the "Public Health Regulations (Medical Experiments in Humans, 1980)" with its additions and amendments up to 1999 and under the "Procedure for Medical Experiments in Humans 2016" of the Pharmacy Division of the Ministry of Health with its additions and amendments, based on the guidelines of the ICH-GCP (E6) Harmonized Tripartite Guideline for Good Clinical Practice. Procedure 14 version 2020 replaced Procedure 14 version 2016 except for topics not included in the update: labeling research products, importing research products for medical experiments, advertising for participant recruitment, providing research products for medical experiments.

In these matters, the guidelines of Procedure 14 version 2016 still apply. Compliance with these procedures aims to ensure that research participants' rights, safety, and welfare are maintained and consistent with the principles of the Helsinki Declaration and that the information collected in the research is reliable.

Submission Process

The research submission to the Helsinki Committee is done online through the "Matarot" software. The authorization is given only to fund employees.

1. After filling in all the application details in "Matarot" and submitting it online, two printed and signed copies of the application should be sent to the committee coordinator, including scanning “Form 1” generated by the software.
2. The application (both in Matarot and printed copy) should be submitted at least 14 days before the IRB meeting date.
3. For clinical research, it should be submitted at least 21 days before the meeting date.

The committee meets every six weeks (subject to changes), and its decisions are sent to the researchers 7-14 days after the meeting and documented in the research documents in Matarot.

Here are the planned meeting dates for 2025, including submission deadlines:

.Please follow up in Matarot for decisions and approvals of requests