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Changing a trial procedure in study Request Form

Please specify the protocol number in the line above

Please note the following guidelines:

1. 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. Amendments in light of comments/questions of the committee/examiners will be submitted to the Committee Coordinator on the original application form (this form). 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.

3. It is not possible to make the requested change until an official approval is received by email from the Ethics Committee Coordinator.

4. Application for additional animals shall not be approved in the Protocol.

5. Addition of authorized personnel to work in the research should not be requested on this form; an application to add authorized people in ethics applications should be submitted separately.

6. 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 for change itself shall expire (validity of the application to the Committee) at the end of this period.

Details of the application
Principal Investigator
Contact Person
B. Study Details
The study period as approved in the original ethics application
C. Reasons for the application for change, and description of the requested change
Please describe the requested change in a clear and detailed manner. In 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.
Based on the description above, please indicate specific word/s or phrase/s that best describe and explain in one/few words this specific request of change: DON’T cite from the title of the research, but give your own IDENTIFYING WORDS/ PHRASE / A TERM/ / KEY WORDS:
Please specify which experiment or sub experiment the requested change is referred to. Please refer to the description in the original protocol and explain for how many animals, and for which groups or steps the change is requested. (please note, adding animals to the experiment is not possible).
D. The type of change
Please choose according to the table bellow. The choice should be referred to 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

E. The Trial'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 of trials 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.