The committee is working on a procedure based on human clinical trials, in accordance with the Health (clinical trials, Law, 1980, and amendments to statures of 1999), and applies the principles of the Declaration of Helsinki. The committee discusses research proposals for clinical trials in humans and confirms them, and discusses research proposals in the social field (psychology, social medicine and applications including questionnaires).

Institutional Review Committee (IRB), hereby declares that it is acting on the instructions of the Ministry of Health and procedure of internationally agreed upon, current, appropriate clinical procedures (ICH-GCP).

No clinical trial will be conducted unless approved by the Helsinki Committee of the medical institution, and by the facility director and in accordance with the rules prescribed in the regulations.

Meeting dates:

The committee meets once every 4 to 6 weeks..

Submission of new applications will be made up to 10 days before the meeting occur.

Meeting dates are published on an annual basis, there may be changes.


Helsinki Committee meeting dates for 2016

Operation hours:

 

 

 

 

 

 

Receiving Audience: Monday, Tuesday, Wednesday - 08:30-12:30

 

Phone response: Sunday to Thursday - 13:00-15:30

Phone: 04-9107267

Fax :04-9107483

Email: sharons@gmc.gov.il

Institutional procedure:
The regulation forms are in the Helsinki Committee office + quality unit.

 

Forms for submitting applications in the medical center, according to the type of research, must be submitted to the Helsinki committee secretary in accordance with the following:

 

-        An original full signed document package.

-        One full copy of the document package.

-         Three copies of Appendix 1 and ICF (in the Hebrew language).

-         Two CD of the full Submission including Appendix 1 signed on PDF file and

          on a WORD file.

-         Additional copies may be requested.

 

Link to 2016 procedure documents

http://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/ClinicalTrials/Pages/CTH.aspx


All human research, whether a clinical trial or non-clinical trial study, requires the 
approval of theIRB - Institutional Review Committee (Helsinki).

:Research funded by a commercial company, Required to pay a fee.

Payment fees are:

-         A new clinical submission - 4000 NIS.

-         A new genetic submission - 2000 NIH.

-         A new clinical/genetic submission who are linked to each other and submitted

           together - 4000 NIH.
-         For extension of validity - 800 NIS.

-         For modifications and repairs - 800 NIS.

Payment can occur by check or by bank transfer payable to - "Health Corporation at 
Galilee Medical Center (RA"(

       
Payment is to be settle upon the Submission.

Guidelines for various submissions, IRB Committee hearing:


Motion to amend the protocol.


Protocol will be submitted one copy of the application, including cover sheet signed by the principal investigator detailing the contents of the request and of the changes compared to the original protocol. Whether change is required to change the consent form in accordance with the Protocol on there and putting them up to date version. Consent forms translated into foreign languages​​must be accompanied by official confirmation a faithful translation. updating Lhokr- booklet cover sheet must be accompanied by the principal investigator, include a summary of the update.

Reported side effects

Principal investigator will submit Committee Institutional Ethics reports serious incidents occurred in other centers, inIsrael and abroad, received from the Sponsor. Reporting will include the name of the experiment: Identification Number to the Ethics Committee and the ID number of the Ministry of Health (if there is): Date of the event and taking into consideration the relationship between the preparation / the test apparatus and the side effects. Additionally investigator shall state his opinion on the termination of the study or research protocol change.

Reporting a death

Principal investigator's duty to immediately report to the CEO and Chairman Medical Center / Z of the Committee about any side effects or unexpected difficult a result of which the patient died or suffered health or termination of the experiment led. Certain cases may recommend Committee Chairman Medical Center CEO appoint a committee of inquiry.

Trial extension request

Must be submitted two months before the end of the period approved clinical trial.

Notice of termination of research

Principal investigator sign a document indicating the completion / termination of the study, while adding beams during the research activity.

NIH clinical research site

International Organization for association journals have decided to publish only studies listed on the site - )NIH - National Institute Of Health(
Registration should be made before the start of the study recruitment.
To register on the site, please contact the secretary of the Commission, Mrs. sharon savti nagola, and get an initial password.

We will be happy to help with any request or question.

We wish a successful and enjoyable study

Regards

Dr. Irith Weissman,                                       sharon savti nagola
Chairman of the Helsinki Committee             Helsinki Committee secretary

 

 

Helsinki Committee members for 2016