The Research & Development unit is responsible for reaching and drafting research agreements in compliance with the Guidelines for Clinical Trials on Human Subjects of the Ministry of Health. The following issues are included: • Negotiating contracts for performing clinical trials at Rambam• Ensuring an appropriate insurance coverage for clinical trials• Overseeing the regulatory process of approving clinical trials
In order to expedite the regulatory process it is suggested that researchers fill out the necessary forms and that company representatives contact the Research & Development unit in order to finalize details of any agreement and its approval, in parallel to submitting the application for approval of the Helsinki Committee.Contracts Please contact Attorney Ronya Rubinstein, 04-8543436 r_rubinstein@rambam.health.gov.il
Research InsuranceMust comply with Appendix 2 of the Ministry of Health Guidelines for Clinical Trials on Human Subjects
Regulations for Contacting Commercial CompaniesForms and Guidelines: Contracts with Commercial Companies Procedure, 2004
Internal Hospital FormsClinical trials/research projects initiated by a commercial company
Research projects initiated by Rambam staff members
Contact Ronya Rubinstein, 04-8543436r_rubinstein@rambam.health.gov.il