Ethics Committee for the Treatment of Animals

An application for changing a trial procedure in study no. ______

(Please make sure to specify the protocol number in the line above)

The Form should be submitted to the Ethics Coordinator of the Faculty's Ethics Committee as detailed below:

University and hospital researchers who submit ethics applications to the faculty committee in EinKerem: to the mail address Telephone: 02-6758138

Researchers of the Faculty of Natural Sciences and the Department of Psychology in the Faculty of Social Sciences: to the mail address: Telephone 02-6586533

Researchers of Agriculture Faculty (except for Veterinary School):

To the address: Telephone: 08-9489317

Please note the following guidelines:

  1. The form should be submitted in WORD format only, and typed only. Forms submitted in a different format, or in handwriting, or forms not signed by the Principal Investigator, will not be accepted. There is no need for a separate letter of addressing the Committee. The reasons for the application should be entered in section E in this form.
  2. The form should be sent by e-mail with a designated title for the subject, and the protocol number for which the changes request is submitted should be specified in the email title; the table at the end of the form must indicate the exact section that relates to the requested change.
  3. Amendments in light of comments/questions of the committee/examiners will be submitted to the Committee Coordinator on the original application form (this form), in WORD format with the required additions/answers and not by email. The original argument noted in the application form to the committee should not be omitted, but the amendments/answers should be attached to this form in section E.
  4. It is not possible to make the requested change until an official approval is received by email from the Ethics Committee Coordinator.
  5. Application for additional animals shall not be approved in the Protocol.
  6. Addition of authorized people to work in the research should not be requested on this form; an application to add authorized people in ethics applications should be downloaded from the site and sent by email to the Faculty Ethics Committee Coordinator.
  7. If responses from the Principal Investigator or designee regarding the application submitted in this form are not received within two months, the validity of the application forchange itself shall expire (validity of the application to the Committee) at the end of this period.

Details of the application:

  1. The name of the Principal Investigator: ______

Personal number of the Principal Investigator______

  1. Study title in Hebrew ______

______

  1. Study title in English ______

______

D. The study period as approved in the original ethicsapplication:

Date of study initiation: ______Study duration (in months): ______

E. Reasons for the application for change, and description of the requested change:

Please describe the requested change in a clear and detailed manner and the reason for this change. The original application should be considered in the description and explain in which groups or stages the change is requested, and if it is a supplement to the original procedures or instead of some of them. It should also be noted whether the requested change requires a change in the follow up methods and the early withdrawal points from the trial.

In the case of administration of a substance, please also specify the dosage of substances, injection methods, and place of injection in the animal's body. For any new material that was not approved in the original application, please provide references on the use of this material. Article/s can be attached.

F. Reviewers’ comments and questions:

G. The type of change (minor / significant) should be exactly marked in the table (in the central or right column) and refer in the rationale section (section E) also to the points marked in this table:

IACUC Significant Change vs. Minor Change Guide

PROPOSED CHANGE / SIGNIFICANT CHANGE
(requires IACUC review – minimum 3 members) / MINOR CHANGE
(need to be reviewed/approved by a veterinarian)
Change in Type of Surgery / • From non-survival to survival / • From survival to non-survival
Change in Timing of Endpoint / • Increase in discomfort / • Less / shorter discomfort
Change in Procedure
(including blood collection) / • More invasive / more discomfort
• Involves change in anesthetic / • Less invasive / less discomfort
• No change in anesthetic
Change in, or addition of, Anesthetic, Analgesic, or Euthanasia Agent or Method / • Requires a protocol amendment if the change involves non-approved agents in the IACUC request form / • May be reviewed as a minor change if the change involves approved agents in the IACUC request form
Change in route of administration of approved Anesthetic, Analgesic, or Euthanasia Agent / • Change to a route that is non-approved in the IACUC request form / • Change to a route that is approved in the IACUC request form
Change in route of
approved test article(s) / • Change in route that is more invasive or may cause more discomfort / • Change in route to less invasive or less discomfort
Change or addition of different test articles (e.g. diet components, antigens, some pharmaceutical agents) / • Substantively different from test articles already approved / • Innocuous and/or substantively similar to test articles already approved in protocol
• Change results in less invasiveness, less discomfort, or fewer side effects
Change in duration / frequency / number of procedures performed on an animal / • ALWAYS requires a protocol amendment
Change in species / • ALWAYS requires a protocol amendment
Change in number of animals used / • NOT APPROVED! ALWAYS requires a new protocol
Change in study objectives / • ALWAYS requires a protocol amendment
Change in PI / • NOT APPROVED! ALWAYS requires a new protocol
Minor changes to approved
non-survival procedure / • Minor Change
Change in total research duration / • May be reviewed by a single IACUC member only if the total length is less than 4 years.
Change in research title / • May be reviewed by a single IACUC member

H. TheTrial's Principal Investigator’s Statement:

I have read the law and the regulations and I undertake to ensure the use of animals as detailed in the original application and in this application, according to the law and according to the regulations of the institution.

I undertake to conduct the trials only in the facilities that have been approved by the Committee for Trials in Animals at the institution.

I undertake to contact the Committee for approval of any change in the details in this document.

I have read the guidelines file of the Institution in the subject oftrials in animals and I undertake to act according to them and according to the instructions of the Council.

I declare that the requested trial does not have a suitable alternative.

I underwent training in conducting trials in animals and in minimizing the pain caused to them. My authorization number (please specify authorization number):

Signature of Principal Investigator ______

Date of submission to the Ethics Committee Coordinator ______

For office use

Examination team:Name and signatureApproval date:

Examining veterinary______

Committee member 1______

Committee member 2______

1