Helsinki Committee

Aneta David

Manager IRB

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).

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IRB Chairman

shmuel

Prof. Shmuel Kivity

03-6974368 allergy@tlvmc.gov.il

ברלינר

Prof. Shlomo Berliner

03-6947862 berliners@tlvmc.gov.il

אלקיים

Prof. Ori Elkayam

03 - 6973668 orie@tlvmc.gov.il

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

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

Miran Elbaz
Secretary of the Helsinki Committee
Email: miranz@tlvmc.gov.il
Phone: 52514

Zvia Landman
Assistant IRB
Email: zvial@tlvmc.gov.il
Phone: 52765

Ilana Shlasky
Assistant IRB
Email: ilanashl@tlvmc.gov.il
Phone: 52765

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

  1. Clinical trial applications must be submitted through the “Matarot” online platform. Before submission, we encourage you to review the Matarot User Guide 
  2. Guidelines for submission can be found on the Ministry of Health website.
  3. 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.
  4. 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
  5. The Committee’s decision will be shared with the Principal Investigator by mail
  6. 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.
  1. 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”
  2. 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.
  3. 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.
  4. 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.

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

A. Registrating as a New User on Matarot

  1. 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.

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

Branch: 532 Shaul Hamelech

Swift: poalilit

Address:  3 Daniel Frisch st. Tel Aviv , Israel 6473104

Bank Account: 681136

IBAN:IL-780125320000000681136

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

Mutual recognition of the Helsinki Committees

Data security form

Users table- to fill in cases of external data sharing

  Confidentiality agreement form

Clinical Trials 1

Clinical Trials 2

Clinical Trials 3

Digital agreement (video)