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 Helsinki 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.
Rambam's IRB is comprised of 40 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:
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Assessing reports on side-effects, serious health-related adverse events, and/or reactions observed in each research participant
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Reviewing the research to determine that human rights and welfare are adequately protected
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Assuring that a trial’s benefits to an individual outweigh potential risks
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Requiring legally effective informed consent or assent from each participant
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Ensuring conduct of research is reviewed at timely intervals
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Approving initiation and continuance of clinical trials based on any of the above
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Periodical reporting to the Israeli Ministry of Health
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Provision of advice and guidance to researchers on submitting, updating, modifying, and/or reporting procedures
Contact us: Ms Dolly Hadad, Committee Coordinator, email: [email protected].
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