Q. Which documents should I prepare?
A. Documents that may be associated with submission:
- Your research protocol or research program as ms Word or PDF file (optional).
- Helsinki documents: Tofes 7 or 17 & tofes 2 or “protocol details” - in case of ethical approval in an Israeli health care institution.
- A letter of support from provider of non-human materials (data, samples).
- Advertisement for recruiting (following IRB guidelines).
- Informed consent form in relevant languages (based on embedded template).
Q. What files I’m supposed to provide?
A. 1. A short description of the research goals and description of the protocols
related to the research plan. 2. A consent letter to be signed by any individual who volunteered/agreed to participated in this specific study. 3. When a collaboration with a hospital is already established please provide a valid Helsinki approval, which carries your name as either a “hoker mishne” (in most cases) or “hoker rashi’ (when relevant).
Q. What is a consent form?
A. A letter signed by the individual who agreed/volunteered to participate in this specific study. The letter describes the experiment and the procedure he/she agrees to take upon himself, as well as the specimen, which will be used to extract the scientific data relevant to the experimental plan.
Q. Do I have to write such a consent form from scratch?
A. No. A template of the Hebrew consent letter, is provided at step #7 of the IRB application; once you fill in all the relevant details a PDF file relevant to your study will be automatically created. Please go over it and sign confirm your approval. The Hebrew template should be translated into any other language required for non-Hebrew speaking participants. The consent letter is reviewed as part of your IRB application.
Q. If I have an existent Helsinki approval which expires in a short while what should I do?
A. IRB authorization for studies covered by Helsinki is granted up to the approval expiration date. You should file for renewal of the Helsinki approval in order to have an extension of your IRB.