Helsinki Committee
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
- 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 (
:Research funded by a commercial company, Required to pay a fee.
Payment fees are:
- A new clinical submission - 4000
- 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
- For modifications and repairs - 800
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.
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 members for 2016
