Ethical Approval by the IRB Towards Grant Submission or Activation at WIS Research Grants and Projects Office
Updated August 2019
Human subject research conducted at the Weizmann Institute of Science (“Weizmann”) must meet ethical standards, including acceptable risk-benefit relationship, equitable subject selection, informed consent, protections of privacy, maintenance of confidentiality, protections for vulnerable populations and potential conflict of interest, as described in IRB operational doctrine.
All human research performed at Weizmann, require the review and approval by the Weizmann Institutional Review Board – IRB (“Weizmann IRB”), for research involving interaction or intervention with human subjects, or the use of human material, or human data. Weizmann IRB also functions as the Embryonic Stem Cell Research Oversight (ESCRO) committee for research work with human stem cell, according to the guidelines published by the US National Academy of Sciences.
Weizmann has adopted a human subject research policy, based on the major principles of the Code of Federal Regulations Title 45 Public Welfare Department of Health and Human Services, Part 46 Protection of Human Subjects ("the Common Rule"). It is because current Israeli legislation - Public Health Regulations (Clinical Trials in Human Subjects) 1980 (“the Regulations”) apply to clinical trials in human subjects, which are conducted only in medical institutions (‘Hospitals’) and is silent about research involving human subjects, human material, or human data, performed in academic / research institutions.
Weizmann IRB employs an encryption and pseudonymization (de-identification) system for personal data on research subjects and separation from research-related data about them, compliant with regulations regarding Israeli Privacy Law, EU General Data Protection Regulation (GDPR) and US Health Insurance Portability and Accountability Act (HIPAA).
Applications for review of human subject research protocols should be submitted through the Weizmann IRB website. The activation of a research project grant, as well as that of subsequent project periods, is conditioned upon full IRB compliance, including the provision of ethical approval document (from Weizmann IRB) for the research to the Research Grants and Projects Office.
Research involving human subjects, human material or human data may also require an appropriate ethical approval of a collaborating research institution, from which the human material or human data is obtained. Furthermore, an approval by an Israeli medical institution (‘Hospital’) Helsinki committee may be required when (i) the material / data is obtained from patients in a Israeli medical institution; or (ii) Weizmann IRB determines that the nature of the research protocol require a close medical monitoring of participants and / or the procedures; or (iii) funding of research is provided via an agency that requires a Helsinki committee approval. In such cases the Ministry of Health regulations shall apply (http://tiny.cc/helsinki).