Israel runs one of the more decentralized clinical-trial ethics systems in the developed world. Rather than routing every protocol through a single national ethics body, Israeli law puts a functioning institutional review board — called a Helsinki Committee — inside every hospital and medical center authorized to host research, and only escalates to central, Ministry of Health (MOH)-level review when a protocol crosses specific ethical or scientific thresholds. Understanding which trials stay local and which ones move up the chain is the single most consequential classification decision a sponsor or investigator makes when planning a study in Israel.
This guide is part of CASRAI’s series on national clinical-trial regulatory pathways, alongside guides to India’s CDSCO process, South Korea’s MFDS pathway, Brazil’s ANVISA pathway, China’s NMPA process, Singapore’s HSA framework, Switzerland’s Swissmedic/ClinO system, Mexico’s COFEPRIS pathway, and South Africa’s SAHPRA process. This page covers the ethics and regulatory approval pathway specifically — for Israeli research funding mechanisms, see CASRAI’s separate guide to the Israel Science Foundation (ISF), which is a distinct national grants program, not a clinical-trial approval body.
The legal basis: Public Health Regulations, 1980
Clinical research on human subjects in Israel is governed primarily by the Public Health Regulations (Clinical Trials in Human Subjects), 1980, issued under the Public Health Ordinance, together with Ministry of Health circulars that operationalize the regulations year to year. The regulations require every clinical trial to be reviewed and approved by a Helsinki Committee — named for the Declaration of Helsinki, the World Medical Association’s foundational statement of ethical principles for research involving human subjects — before any subject can be enrolled. A trial conducted without the required Helsinki Committee approval has no legal standing in Israel, regardless of how the study itself is designed.
Every hospital has its own Helsinki Committee
The defining feature of the Israeli system, and the thing that most surprises sponsors used to a single national or regional ethics committee, is that every hospital and medical center authorized to conduct research maintains its own local Helsinki Committee — functionally, an institutional research ethics committee equivalent to an IRB. The local committee reviews the scientific and ethical merit of the protocol, the informed consent process, and site-specific feasibility, and its approval is a precondition for the institution’s director to authorize the study to proceed at that site.
For most protocols, this local review is also the only ethics review required. Israel’s system is deliberately structured so that routine research does not need to wait on a national queue — the tradeoff is that classification (below) becomes the critical gating decision, since it determines whether a study stays local or must also clear a central committee.
“Special” vs. “non-special” trials: the classification that drives the whole pathway
Under the 1980 regulations, every protocol is classified as either a “special” clinical trial or a “non-special” clinical trial, and that classification — not the phase or therapeutic area — determines the approval pathway:
- Special trials require only the approval of the local Helsinki Committee at the institution where the trial will take place, plus the sign-off of that institution’s director. No separate Ministry of Health approval is needed. This category commonly covers studies without an investigational product, questionnaire- and observational-type research, and trials using a drug or device already approved in a recognized reference country (the regulations name jurisdictions including the United States, EU member states, Switzerland, Norway, Iceland, Australia, New Zealand, and Japan) at the same approved dosage and indication.
- Non-special trials still require local Helsinki Committee and institution-director approval, but on top of that, they are also referred for review by a central Ministry of Health committee before the trial can begin. Non-special status typically applies to studies with a novel investigational product, unapproved indications or dosing for an already-approved product, and, most significantly, the two categories the regulations single out by name: genetic research in human subjects and studies involving assisted reproductive technology (ART) / techniques the regulations describe as artificial fertilization.
Sponsors and CROs planning a first Israeli site should treat this classification exercise as the first regulatory step, not an afterthought — it determines whether the pathway is a single institutional review or a two-tier review involving Jerusalem-based national committees.
The Supreme Helsinki Committee for Clinical Trials in Human Subjects
Genetic research and ART/assisted-fertilization studies — along with other categories the Ministry of Health designates as raising added ethical complexity — are routed to the Supreme Helsinki Committee for Clinical Trials in Human Subjects, a national committee convened under the Ministry of Health. Local Helsinki Committee review still happens first (and institution-director sign-off is still required), but for these categories it is not sufficient on its own; the Supreme Committee’s review and approval is an additional, mandatory layer before the trial can proceed. This structure mirrors, in principle, the way many countries route genetically modified organism work or reproductive-technology research to a specialized national ethics body rather than leaving it to a general-purpose local IRB — the distinctive part of the Israeli system is that the “default” reviewer for everything else is hospital-level, not a regional or national board.
Since January 2020, the Ministry of Health has also operated a National Multi-Centre Study Committee, which centralizes ethics review coordination for studies running at three or more sites within Israel, so that multi-site sponsors are not required to obtain separate, potentially divergent local Helsinki Committee reviews at every participating hospital for the same protocol.
Approval timeline
For a well-prepared, single-site protocol that qualifies as “special,” sponsors and investigators should generally plan on a standard timeline of roughly two to four months from submission to the local Helsinki Committee through to institutional approval to begin enrollment. Protocols that require Supreme Helsinki Committee review, involve a novel investigational product, or raise complex risk questions typically take longer, since the additional national-level review adds a sequential step rather than running in parallel with the local review. Sponsors should treat any specific timeline as protocol-dependent and confirm current expectations directly with the receiving institution’s research office and, where applicable, the Ministry of Health, rather than assuming a fixed statutory clock — unlike some jurisdictions, Israel’s regulations do not publish a hard maximum review period in the way, for example, India’s CDSCO framework specifies a defined working-day window.
Informed consent: a multilingual requirement
Israel is a multilingual society with substantial Hebrew-, Arabic-, and Russian-speaking populations, and informed consent documentation has to reflect that in practice, not just in principle. Local Helsinki Committees routinely require the patient-facing informed consent form to be available in Hebrew (the primary language of most protocols and committee review), Arabic, and Russian, with English versions added where the study population or site population makes that appropriate. As with any jurisdiction, the substantive requirement behind the translation is the same one CASRAI covers in its general informed consent checklist: the form must be written in plain, non-technical language the specific subject population can actually understand, not merely translated word-for-word from an English master document. Committees can and do reject consent forms that are linguistically compliant but substantively unclear.
Who is involved, end to end
- Sponsor / investigator — prepares the protocol, informed consent forms in the required languages, and the classification rationale (special vs. non-special) for submission.
- Local Helsinki Committee — the institutional ethics committee at the hospital or medical center; reviews scientific and ethical merit and the consent process for every trial, regardless of classification.
- Institution director — must separately authorize the trial to proceed at that site once the local Helsinki Committee has approved it; this is a distinct sign-off, not a formality nested inside committee approval.
- Supreme Helsinki Committee for Clinical Trials in Human Subjects — the Ministry of Health’s national committee, engaged only for non-special categories such as genetic research and ART/assisted-fertilization studies, or other categories the MOH designates.
- National Multi-Centre Study Committee — coordinates review for studies at three or more Israeli sites, in place since January 2020.
Frequently asked questions
Does every clinical trial in Israel need Ministry of Health approval?
No. Trials classified as “special” under the 1980 regulations need only local Helsinki Committee approval and institution-director sign-off; the Ministry of Health is not a required approver for that category. Only “non-special” trials — including genetic research and ART/assisted-fertilization studies — are referred to a central Ministry of Health-convened committee.
What makes a trial “special” rather than “non-special” in Israel?
Broadly, studies without an investigational product, questionnaire/observational research, and trials using a drug or device already approved (at the same dose and indication) in a recognized reference country are treated as special. Novel investigational products, unapproved uses of approved products, genetic research, and ART/assisted-fertilization research are treated as non-special and require additional central review.
What is the Supreme Helsinki Committee?
It is the national committee, convened under the Ministry of Health, that reviews non-special clinical trials — most notably genetic research in human subjects and assisted reproductive technology studies — in addition to, not instead of, local Helsinki Committee review.
How long does Helsinki Committee approval take?
A commonly cited standard range for a straightforward, single-site “special” protocol is roughly two to four months from submission to approval. Protocols requiring Supreme Helsinki Committee review generally take longer because that review is sequential to, not parallel with, local committee review. Confirm current timelines with the specific institution, since Israel does not publish a fixed statutory maximum the way some other jurisdictions do.
What languages does the informed consent form need to be in?
Hebrew, Arabic, and Russian are the languages most commonly required by local Helsinki Committees, reflecting Israel’s population, with English added where relevant to the study or site population. The form must be written in plain language appropriate to the actual subject population, not just accurately translated.
Is the Israel Science Foundation the same thing as the Helsinki Committee system?
No. The Israel Science Foundation (ISF) is Israel’s national basic-research grant funder — a funding mechanism. The Helsinki Committee system is the ethics and regulatory approval pathway for human-subjects research, administered at the hospital level and, for non-special trials, by the Ministry of Health. A study can need both a funding source like the ISF and Helsinki Committee approval, but they are entirely separate processes run by different bodies.
