The Helsinki Committee at the Tel Aviv Sourasky Medical Center works according to National Health Regulations (Medical Experimentation in Human Beings, 1980), in accordance with GCP-ICH regulations.
ICH GCP Declaration
All protocols must be approved by the Institutional Review Board (IRB).
The Committee comprises 29 members, including specialists in internal medicine and surgery, representatives of management, public representatives - lawyers, a pharmaceutical representative, and a representative of nursing management. The Chairman of the Review Board is Professor Marcel Toplisky.
The Committee Members
The IRB generally convenes every last Friday of the month.
Scheduled meetings for 2008 are: 29/08/08, 26/09/08, 28/11/08, 26/12/08
Application forms and guidelines for clinical trials are available for downloading:
Guidelines - request for clinical trials
Helsinki Fees
Form 4
Form 5
Annex 6
Annex7
Annex 7 - Extension
For further assistance, please contact Liora Etgar, Coordinator, IRB/Ethics (Helsinki) Committee helsinki@tasmc.health.gov.il
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