Guidelines for Completion of IACUC Amendments

If you need to amend your current IACUC protocol, this may usually be done in letter format, if the changes requested are minor. If the changes are minor, you must address ALL the questions (A — I) below.

If major changes are needed (e.g. the addition of some surgical procedures or in-depth non-surgical procedures, major change in experimental aims, etc.), you must complete the FULL application with the amendment changes incorporated within it. In addition, outline the amendment changes in a cover letter using the nine questions below (A — I) required for a minor amendment.

If you are unsure whether the amendment or surgical procedure would constitute a major change, please contact Tom Zimmerman (444-2194) to discuss the amendment with you and, in consultation with the IACUC chair if necessary, determine whether an amendment (minor) or a new protocol submission (major) is needed.

Please be aware that no more than 3 amendments may be made to any protocol. If more than three amendments are requested, the Committee requires a new full application be submitted which includes all changes.

Submit amendment to maryoneill@notes.cc.sunysb.edu.

Amendment Request — Address ALL of the questions below:

General Administrative Information

• Name of the principal investigator
• Title of the current IACUC protocol
• Current protocol number
• If this amendment is in support of a grant, provide

• sponsor name,
• submission deadline,
• RF pending number (if known), and
• grant title

A. Change in Experimental Aims

Such a change should be a reasonable extension of those aims for which you are already approved (if not, a new IACUC application may be required). An outline should be provided containing:

• the current IACUC-approved aims,
• the proposed aims, with scientific justification.

B. Personnel Changes

• If adding personnel, include name/title, phone number, years working with the proposed species and their specific role in the study. If personnel have no experience, state who will provide the training and their phone number.
• A History and Risk Assessment Survey for Staff with Animal Contact needs to be completed for each new personnel and submitted to the Center for Occupational and Environmental Medicine.

C. Species and/or Number of each Species Changes

For change in species:

• List the species, specifying if this is in addition to, or replacement of, species for which you are currently approved. State why the species requested is/are the most appropriate for the study.
AND
• Complete the following information for the number of animals: State the number previously approved, number being requested, and complete Section G and H of the IACUC application.

D. Animal Housing

• List the building and room numbers where procedures will take place, if different from the original protocol.
• Describe any special housing or animal care that may be required in this amendment.

E. Minor Changes in Experimental Procedures

Describe, in detail, any procedural changes or new procedures to be performed. A sequential list is usually the clearest format. Include information on:

• Anaesthesia (agent, dose, route and frequency of administration; monitoring parameters and frequency; how recovery monitoring will be performed)
• If the changes proposed may cause adverse effects to the animals:

• Describe the adverse effects
• How will the animal be checked to monitor for the presence of pain, discomfort or distress?
• How often will the animals be monitored and by whom?
• Are there early endpoints (i.e., complications) that will lead to the removal of the animal from the study?

• If the proposed changes are not expected to produce adverse effects, please provide a citation or brief explanation of why no adverse effects are anticipated.

F. Changes in Administration of Substances

• List all therapeutic and experimental agents including dose, route, frequency of administration and duration.

G. Changes Involving Restraint of Conscious Animals

• Describe the type of restraint.
• Specify the duration and frequency of restraint.
• How often the animal will be monitored and what will be checked.
• Provide a scientific justification to support the need for unanesthetized restraint.

H. Changes in Euthanasia

• If animals will now be euthanized, or if the method of euthanasia will be different from the method already approved, describe the method, including agent, dose, and route of administration.
• If the animals are not going to be euthanized at the end of the amended project, describe what will happen to the animal.

I. Changes in Hazardous Substance Use

• Complete Section Q of the IACUC protocol form and attach to the amendment.