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Research & Development

Principles for Clinical Investigations

The Tel Aviv Sourasky Medical Center Institutional Review Board (Helsinki Committee) complies with the following regulations:

  • Ministry of Israel public health regulations (Medical Experiments in Human Subjects of 1980) including the most recent additions and amendments through 2006
  • The Pharmacological Unit of the Ministry of Health regulations for conducting medical trials on Humans of 1999.
  • The provisions of the current International Conference on Harmonization Guidelines for Good Clinical Practice (ICH-GCP). For the formal ICH-GCP declaration, click here.

The committee approves proposals for clinical trials in humans, including social research, such as psychological studies, social medicine, and questionnaires.

Medical experiments in humans, as defined in the policies, are:

  1. Using medications; radiation; or chemical, biological, radiological, or pharmacological agents; not in compliance with approved legal use, or use that is not in practice in Israel for the designated need or not yet formulated in Israel, and there is a designated to impact the health, body, or emotional health of a person or fetus (or a part thereof), including the person’s genetic infrastructure.          
  2. Using any procedure, activity, or test in humans that is not approved or customary.

The committee also approves the following:

  • Every activity designated to be used as part of an experimental or research protocol in humans even if the activity includes approved or customary methods
  • Use of any procedure, activity or test in humans that is not approved, and conducting activities that are not yet accepted by the institution
  • Requests by outside organizations, do not need tracking or control.

Helsinki Committee Policies

The following are important policy links:
Helsinki Committee policy
Guideline for Clinical Trials in Human Subjects – Israel Ministry of Health, in accordance with public health regulations (Clinical Trials in Human Subjects, 1980)

The Director General of the Ministry of Health authorized Prof. Gabi Barbash, Director General of Tel Aviv Sourasky Medical Center to serve as the director responsible for approving Tel Aviv Sourasky Medical Center clinical trials. The committee chairperson is Prof. Marcel Topilsky.

 

The Helsinki Committee members are internal medicine physicians, surgeons, representatives of the executive leadership, community representatives, legal professionals, pharmaceutical representatives, and nursing representatives.

Department details

+972-3-697-4924
Fax: +972-3-697-3974
Sourasky Building
Wing E
Floor 2
Reception Hours: Sunday; Monday; Wednesday; and Thursday 10:00 – 12:30; Tuesday – closed; Following committee meetings on Sundays and Mondays; the office is closed

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