Helsinki Committee

Our Mandate

The Helsinki Committee reviews and approves clinical trial research proposals at Ichilov Hospital. The committee adheres to strict ethical and operational guidelines, including those issued by the International Conference on Harmonization (ICH-GCP).

Quick Links

Contact Info

For division into areas of responsibility click here>>

Aneta David
Manager IRB
Email: anetad@tlvmc.gov.il
Phone: 03-6974924

Carmit Ben Harosh Senior coordinator,IRB
Email: carmitbh@tlvmc.gov.il
Phone: 03-6974003

Ronit Shaporker
IRB coordinator
Email: ronitsh@tlvmc.gov.ill
Phone: 03-6974678

Yasmin Feige
IRB coordinator
Email: yasminfe@tlvmc.gov.il
Phone: 03-6947155

Sara Yaakobi
IRB coordinator
Email: saraya@tlvmc.gov.il Phone: 03-6974937

Gali Shkedy
IRB coordinator
Email: Galishk@tlvmc.gov.il Phone: 03-6974703

Tamar Pludwinski
student, Assistant IRB
Email: Tamarplu@tlvmc.gov.il
Phone: +972-3-6947169

Tamar Ginat
IRB coordinator Maternity leave replacement (Yasmin Feige)
Email:tamargi@tlvmc.gov.il Phon: +972-3-6947155

Batel Gadayev
Secretary of the Helsinki Committee
Email: batelga@tlvmc.gov.il
Phone: 52514

Zvia Landman
Assistant IRB
Email: zvial@tlvmc.gov.il

Ilana Shlasky
Assistant IRB
Email: ilanashl@tlvmc.gov.il

General Info

General Email
Email: helsinki@tlvmc.gov.il

Reception Hours
Monday, Wednesday & Thursday
10:00 – 12:30pm

Address

Arison Medical Tower

Floor 33

6 Weizmann Street Tel-Aviv Israel,64239

Information & Resources

Instructions for New Clinical Trial Submission

Clinical trial applications must be submitted through the “Matarot” online platform. Before submission, we encourage you to review the Matarot User Guide
Guidelines for submission can be found on the Ministry of Health website.
It is recommended to submit a consent form in Hebrew only. After approval of the form by the Helsinki Committee, a translation can be submitted for Committee authorization.
Applications will be scheduled for Helsinki review once:
1. Application has been submitted
2. Confirmation of proper application filing has been processed
3. Digital signature has been granted
4. Official report has been sent to the Helsinki Committee
The Committee’s decision will be shared with the Principal Investigator by mail
For applications that require revisions, amendments must be submitted in accordance with Helsinki Committee instructions.

Investigator-Sponsored Trials: A preliminary meeting must be coordinated to review the research proposal after it is uploaded to the system and before Principal Investigators affix their signature. May be coordinated over the course of the month.
Company-Sponsored Trials: An application can be submitted in parallel to the Ministry of Health and scheduled for Helsinki Committee discussion. In trials where the sponsor is a commercial entity, approval is contingent upon completion of the contracting process (a contract and insurance), or a statement approving the trial without an external source of funding.

Submission of Clinical Trial Amendments & Updates

All amendments are made through “Report of Events and Requests for Amendments”
1. Select “Addition of Request for Amendment”
2. Then select “Request” under “Description of Requested Action”
Under “Amendment Details” specify amendment/update details including the reason for request. Make sure to address each of the Committee comment sections and note on which page the amendment was made.
A “clean” copy (without tracked changes) and a file with the changes marked must be uploaded (the version and date must be specified). Amendments must be highlighted with a distinct color different from the color used to mark Helsinki Committee comments. Additionally, the body (person/company etc) requesting the amendment must be specified.
Once the electronic form has been completed, click “Send for digital signature.” If several events were submitted, they may be grouped together in order to submit one Form 12 report.

Guidelines & Procedures for Clinical Trial Registration

To be eligible, clinical trials must be registered with the Israeli Ministry of Health (MOH) and approved by Ichilov’s Helsinki Committee.
User manual for Ministry of Health registration

Further registration on the NIH website according to international guidelines is not a condition for study approval and it is the responsibility of researchers and research initiators

For NIH Registration click here

For entry details please contact the Helsinki committee

Click here for the Ministry of Health website

Opening a Matarot User Account

A. Registrating as a New User on Matarot

Account Details:
1. User name: defined by the Computer Unit
2. Password: defined by the Principal Investigator. Only hospital email addresses may be used.

B. The GCP certificate must be sent by email to helsinki@tlvmc.gov.il.

Helsinki Fees & Payments

Payment Forms

*Payment should be made upon protocol submission to the committee.

please note PI name and Helsinki number.

Cheque

Please make cheque payable to: The Medical Research, Infrastructure & Health Services Fund of the Tel Aviv Medical Center

Please send the cheque to the PI or the clinical trial coordinator upon protocol submission to the Helsinki committee.

*It must be stated whether for an extension/ new application, etc. + Helsinki number + researcher’s name.

Bank Transfer

The Medical Research, Infrastructure and Heakth Services Fund of the Tel Aviv Medical Center

Bank Hapoalim