Helsinki Committee | IRB | IRC

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Helsinki Committee | IRB | IRC

The Helsinki Committee works to protect the rights and welfare of patients involved in research performed at Rambam Health Care Campus. Israeli Helsinki Committees, referred to as IRBs, are recognized by the FDA and the EMEA

The terms “IRB” (Independent Review Board) and “IEC” (Independent Ethics Committee) are synonymous with the Helsinki Committee—terms used by different regions of the world, but which perform the same important service. The Helskini Committee is responsible for ensuring that all patients participating in clinical trials are treated according to the ethical standards outlined by the Declaration of Helsinki, and other research initiatives, which serve as guides for basic ethical principles in research.

Rambam’s IRB has been active since the 1990s and operates according to the standard procedure for clinical trials in humans, in accordance with the Public Health Regulations (Human Experiments on Human Subjects, 5741-1980), and works according to the principles of the Helsinki Declaration and ICH-GCP Guidelines. The committee discusses and approves research proposals for clinical trials in humans, as well as proposals for research in the social field (psychology, social medicine and requests that include questionnaires). The function of the committee is audited by the Ministry of Health / State Comptroller.

write to Dolly Haddad at [email protected].

Rambam's IRB is comprised of 22 senior professionals and academics. A minimum quorum is 5 members, including a management representative, an internal medicine expert, and a representative of the public. The Committee convenes periodically for a plenary session to discuss requests for clinical trials and for their approval, rejection or return to the investigators for preparation for a re-examination.

 Their activities include:

  • Assessing reports on side-effects, serious health-related adverse events, and/or reactions observed in each research participant
  • Reviewing the research to determine that human rights and welfare are adequately protected
  • Assuring that a trial’s benefits to an individual outweigh potential risks
  • Requiring legally effective informed consent or assent from each participant
  • Ensuring conduct of research is reviewed at timely intervals
  • Approving initiation and continuance of clinical trials based on any of the above
  • Periodical reporting to the Israeli Ministry of Health
  • Provision of advice and guidance to researchers on submitting, updating, modifying, and/or reporting procedures

For more information please contact the Rambam R&D Unit at +972-4-777-3501

Important Documents Important Documents

The following documents are provided here for your convenience.
 

 

 

2021 IRB Meeting Calendar 2021 IRB Meeting Calendar

The dates for IRB committee meetings and the last date submitting your applications for each meeting are listed below. Printed copies of your applications must be submitted by noon of the submission deadline, at the committee office.

Rambam Helsinki Committee –

meeting calendar for 2022

Month

Submission week

IRB meeting date

Last day for submission[1]

JANUARY

28.12.2021-03.01.2022

19.01.2022

03.01.2022

FEBRUARY

01.02.2022-07.02.2022

23.02.2022

07.02.2022

MARCH

01.03.2022-07.03.2022

23.03.2022

07.03.2022

APRIL

03.04.2022-07.04.2022

27.04.2022

07.04.2022

MAY

03.05.2022-10.05.2022

26.05.2022

10.05.2022

JUNE

07.06.2022-13.06.2022

29.06.2022

13.06.2022

JULY

05.07.2022-11.07.2022

27.07.2022

11.07.2022

AUGUST

02.08.2022-08.08.2022

24.08.2022

08.08.2022

SEPTEMBER

31.08.2022-06.09.2022

21.09.2022

06.09.2022

OCTOBER

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NOVEMBER

01.11.2022-07.11.2022

23.11.2022

07.11.2022

DECEMBER

29.11.2022-05.12.2022

21.12.2022

05.12.2022

 

[1] The submissions are till 12:00 o'clock (noon) of the named day