Submitting a request for ethics approval

All research with human participants, on material of human origin or on information of human origin, conducted by or under the guidance of a person from the University faculty under their institutional affiliation, must be submitted for examination by the faculty ethics committee prior to the start of its execution.

Research involving human subjects, human material, or human information may also require approval by the Helsinki Committee (Hospital Ethics Committee) of an Israeli medical institution (“hospital”) (for example when the material or information is received from patients who are undergoing medical treatment in said medical institution) and compliance with additional regulatory requirements.

As a rule, principal investigators shall submit a request for research approval to the faculty committee according to their academic affiliation. In cases of a collaboration between researchers from different faculties or schools, the researchers shall decide on the committee to which the request will be submitted according to the type of research, so that the request is submitted to the committee that has the necessary expertise. 

 

The submission process

Researchers wishing to receive an ethics approval for their study will fill out the request form and send it via email to the chair of the relevant faculty ethics committee. 

The request will include, as appropriate: 

  • Certificates of ethical training of every research team member
  • The text of the consent form
  • The tools that shall be used in the research (such as questionnaires, conversation scripts etc.)

The committee will issue its decision within 4 weeks from the date of receipt of the request (or from the day of document completion, if requested).

If the committee rejected the request, an appeal can be submitted to the Supreme Ethics Committee within 14 days after receiving the decision. Please send the appeal via email to the committee chair, Dr. Hagit Magen, msmagen@mail.huji.ac.il.

 

Renewal of ethics approval

A request to renew an ethics approval that has expired will be submitted in the same manner as a new request. 

If there are no changes to the protocols, you can use the original request form with a new date (please mark the change in yellow). Attach updated ethics training certificates and information about unusual events that have occured during the research thus far. 

 

Shortened approval procedure

The following types of studies can be referred to a shortened review procedure (please state on the request form that the request is suitable for the shortened procedure):

  • Research that has undergone a suitable ethical review at another institution (including Helsinki Committee).
  • Anonymous survey among the general public.
  • Research in which anonymized information and samples are collected, provided that the participants are not from a special population. 
  • Research carried out on databases and data that is legally accessible to the public, and the conduct of which raises no risk of harm to the privacy of the data subjects.
  • Research in which identifiable information is collected about a participant either through interaction or through observation, or research that includes one or more of the procedures listed in Appendix 2 of the ethics regulations, whether or not identifiable information is collected, provided that:
  • The participants are not from a special population`
  • There is no potential for legal, occupational, financial or reputational risk to the participant;
  • The research involves a risk that is at most minimal. The procedures listed in Appendix 2 are not to be regarded as posing “minimal risk” merely because they are included in the list. Inclusion in this list means only that the activity is eligible for examination using the shortened procedure when the specific circumstances of the proposed research actually involve at most “minimal risk” to the human participants.
  • Secondary research, provided that the information or samples on which the secondary research is conducted are not identifiable, or that the informed consent of the participants for such secondary use has been given.
  • Observation without the collection of identifiable details, and without photographs, in public places and sites (physical or virtual), in which there is no limitation on exposure or entry apart from payment of entrance fees (for example parks, clubs, internet sites open to the public, online groups [e.g. Facebook, WhatsApp] that are open to the public). 
  • Minor changes in a research protocol that was approved in the full procedure, during the period for which the approval was given.
  • Extension of the period of a research that does not involve a request for protocol changes.

If the committee chair approved a shortened review, the decision will be givin within 14 days from the date of receipt of the request.