All clinical trials on human subjects require approval of the Helsinki Committee (the Ethics Committee). Requests for approval from the Helsinki Committee should be submitted to the Committee Coordinator, Ms. Dolly Haddad El Hasbani. There are six different forms, each one targeted to a different type of research. Before submitting a request, check the Ministry of Health 2006 Guidelines for Clinical Trials on Human Subjects.

Helsinki Committee Forms for Downloading
Each new request for research approval must include a research protocol. An Investigator’s Brochure must also be included if it is required by regulations for clinical trials. An example of the Case Report Form (CRF) and relevant literature must also be included if they are required by regulations for clinical trials.

Ministry of Health Forms for Clinical Trials on Human Subjects
Set of documents to be submitted for request for clinical trial - medicinal product 2006
Set of documents to be submitted for request for clinical trial - medical accessory/device 2006
Set of documents to be submitted for request for clinical trial - product including live cells and tissue from human donor 2006
Set of documents to be submitted for request for genetic trial 2006
Guidelines and forms to be submitted for request for genetic clinical trial 2001
Set of documents to be submitted for request for clinical trial not involving an investigational product 2006
Request for changes in clinical trial involving human subjects – form 12 and reporting of SAEs(serious adverse events) occurring in participants in a clinical trial – form 13
Submission forms for non-medical experiments

Additional Forms
Dates of Committee Meetings
Helsinki fees for trials sponsored by commercial companies
Explanatory notes – Guidelines for managing a clinical trial file
Explanatory notes – Guidelines for completing  & signature of an Informed Consent Form by clinical trial participants
Explanatory notes – Guidelines for requesting an extension for approved clinical trial
Explanatory notes – Guidelines for submitting the notification re closing a clinical trial
Release of patient from clinical trial (to be filled in cases that a patient participating in a clinical trial who will continue to receive a clinical trial product after his/her release from the hospital)
Checklist for organizing a research project from the first submission to the Helsinki Committee all the way through its completion (acknowledgement: available through Clalit Health Services)

Contact Dolly Haddad El Hasbani, 04-8543501
d_haddad@rambam.health.gov.il