Human Subjects/Specimens Research
The Weizmann Institutional Review Board (IRB)
Scope of activity:
The The Weizmann Institute Institutional Review Board (IRB) operates to ensure that all research performed at the Weizmann Institute that involves human individuals, human samples, and human data is performed according to the highest ethical standards and in full compliance with all relevant legislation and regulations.
The committee also operates as a human embryonic stem cell research oversight (ESCRO) Committee to oversee all issues related to derivation and research use of human embryonic stem cell lines, and to facilitate education of investigators involved in human embryonic stem cell research.
Guiding principles and regulations:
The IRB operates according to the following ethical guiding principles and regulations (see links below):
- Declaration of Helsinki
- Local Legislation and Regulations: Human Subjects Research is to be carried out in compliance with the principles of the Public Health Regulations (Clinical Trials in Human Subjects) 1980, and the Ministry of Health regulation.
- Research supported by US federal agencies or the European community is further subject to US DHHS guidelines and/or EU guidelines.
- Research involving human embryonic stem cells will be conducted according to the guidelines established by the US National Academy of Sciences.
Forms and Assurances:
- Apply for WIS IRB protocol approval HERE <http://www.weizmann.ac.il/IRB>, for any research involving human subjects/specimens research.
Contact IRB@weizmann.ac.il with questions
Laws and Regulations pertaining to Human Subjects/Specimens Research:
- Declaration of Helsinki
- Public Health Regulations (Clinical Trials in Human Subjects) 1980
- Ministry of Health regulation, last updated 2014
- Basic HHS Policy for Protection of Human Research Subjects
- EU regulations for clinical trials - Regulation No 536/2014
- US National Academy of Sciences Guidelines for Human Embryonic Stem Cell Research
- See a letter from the WIS Bioethics committee, dated 16 June 2014, regarding revised Bioethics guidelines for human cell lines
- Download the Human Participant Protections Education for Research Teams PDF, published by the US DHHS, Nov. 2002.
- Guidelines (May 2013) regarding research that does not constitute a "clinical trial".
- See a letter from the Vice President, dated 7 May 2013, to Weizmann Institute researchers involved in human subjects/specimens research.
- See a letter from the Vice President, dated 24 August 2010, to Weizmann Institute researchers regarding the establishment of the Weizmann Bioethics and ESCRO Committee.
- See a letter from the Vice President, dated 31 May 2009, to Weizmann Institute researchers involved in human subjects/specimens research.
- See a letter from the Vice President, dated 26 May 2009, regarding the activation of projects involving human subjects/specimens research.