The Institutional Review Board

עברית

Professor Eran Dolev Chairman, Institutional Review Board.

 

Professor Meir Lahav – Chairman, Departmental Review Board of Life Sciences, Exact Sciences, Medicine and Engineering.

 

Professor Dafhna Hacker/Professor Shoshana Shilo – Chairman, Departmental Review Board of Humanities, Social Sciences, Law, Arts and Management.

 

Ms. Einat Berlowitz – Coordinator, Institutional Review Board – Tel: 03-6409673.

Email: ethicsbe@tauex.tau.ac.il

 

A board operates at Tel Aviv University, as in other academic institutions in Israel, which is engaged in the ethical aspects of research studies on humans – the IRB - Institutional Review Board (hereinafter: the “Board”).

 

The function of the Board is to verify that the research being conducted on human subjects by the University’s investigators meet ethical criteria and to approve such research. It should be noted that this is not the “Helsinki Committee” which approves human trials under the law and operates solely in medical institutions. The Institutional Review Board may not – according to the current regulations, approve clinical trials. Instead the Board operates two departmental – inter-faculty boards – one in the area of Humanities, Social Sciences, Law, Management and Arts, and the other in the areas of Life Sciences, Exact Sciences, Medicine and Engineering. The function of these Boards is to ensure compliance with ethical rules in human research studies, bio-medical research and research in areas of Social and Behavioral Sciences.

 

Research will not be conducted at any level whatsoever on humans, either in the framework of degree studies or in the framework of research studies being conducted by members of staff without the prior written approval of the Board and subject to the regulations and guidelines of the Board or of the sub-boards concerned.

 

An investigator proposing the research or instructing whosoever is proposing such research will apply in writing to the Chairman of the Board concerned to obtain approval. The Board will examine the proposal in light of acceptable ethical principles, including conducting a risk benefit analysis, proper treatment of subjects, including the safeguarding of their wellbeing, dignity and rights, respecting privacy and informed consent.

 

In each case, even after obtaining the Board’s approval to conduct the research, the investigator is still fully responsible for maintaining ethical principles when conducting the research, in particular in all matters relating to ethical treatment of the human subjects participating in the research. Furthermore, the investigator participating in a clinical trial being conducted in hospitals or other medical entities and in collaboration with them, must ensure that there is insurance.

 

The documents required for the deliberations of the Board as noted below must be sent in one file (in other words, all the documents must appear together in one continuous file) by email to the following address:

 

ethicsbe@tauex.tau.ac.il

 

Documents required for the deliberations of the Board:

 

1. Research proposal.

 

2. Informed consent form.

 

3. Application form for the Institutional Review Board’s approval of research studies on humans the investigators must complete and sign the form at the bottom. The responsible investigator must be part of the senior academic staff.

 

**A handwritten form will not be accepted.

 

4. Approval of the “Helsinki Committee” and approval of the director of the medical institution / ethics board of the hospital, HMO or any other official institution (such as the IDF, the Ministry of Education and such like) – if the research is being conducted in one of the above institutions.

** The responsible investigator appearing in the hospital’s Helsinki Committee approval must sign the application form for the Institutional Review Board’s approval of research studies on humans and the investigators’ declaration on the proper conduct in research and the absence of any conflict of interest.

 

5.  Investigators’ declaration – the investigators must read the regulations on ‘Proper Conduct in Research’ and ‘Absence of Conflict of Interest’.

 

The principal investigator, student and supervisor must sign the following declaration. In case of a research student, the responsible investigator appearing in the hospital’s approval (if any). After the above declarations have been signed they must be transferred to the Institutional Review Board.

 

Furthermore, the principal investigator is responsible for checking that all those involved in the research, including those who are not University employees, undertake to comply with all the requirements under the Tel Aviv University Regulations on Proper Conduct in Research and the Regulations on the Absence of Conflict of Interest in Research. To this end he will sign all those involved in the research on a declaration concerning proper conduct in research and conflict of interest. The signed declarations will be kept by the principal investigator for record and control purposes for at least two years after completion of the research.

 

6. Confidentiality agreement for those participating in the research not employees of the University and subcontractors – the principal investigator is responsible for signing those persons involved in the research who are not University employees and subcontractors in the research on the following  confidentiality agreement.

 

The signed documents will be kept by the principal investigator for purposes of record and control for at least two years after completion of the research.

 

For the attention of the investigators: this approval will remain in effect for one year from the date of its issue, unless stated otherwise. 

 

אוניברסיטת תל-אביב, ת.ד. 39040, תל-אביב 6997801
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