IACUC Policy: Protocol Amendments
Policy # IBT-108.00 IACUC Approval: February 27, 2014

Purpose:
As mandated by the National Institutes of Health Public Health Service (PHS) Policy, and the Guide for Care and Use of Laboratory Animals (Guide), significant changes to an Institutional Animal Care and Use Committee (IACUC) approved protocol must be reviewed and approved by the IACUC before they occur.  This policy will define major versus minor amendments and review requirements for each.

Scope:
All modifications to research in live vertebrate animals are subject to oversight by Texas A&M Health Science Center IACUC. 

Responsibilities:
The IACUC is responsible for the review and approval of all animal care and use activities. 
The Principal Investigator (PI) is responsible for submitting complete documents outlining the proposed changes to IACUC-approved activities related to the care and use of animals.
The IACUC office is responsible for processing submitted documents and notifying the PI of IACUC decisions.

Definitions:
Amendment – a proposed alteration of or addition to an IACUC-approved activity.  Activities proposed in an amendment form may not be performed until written approval is received.

I.       Administrative Amendment

The following may be changed administratively. 

  1. Changes in key study personnel
  2. Changes in animal use sites
  3. Changes in funding source 
  4. Changes in vendor

Administrative modification requests will be reviewed by the IACUC office and written notice of approval will be send to the investigator upon completion.  Administrative amendments may be submitted as needed; there is no limit to the number of administrative amendments on a protocol.

 II.    IACUC Reviewed Amendments

The requested amendment should fit within the objectives, purpose, or aims stated in the original protocol.  If this requirement is not met, then the IACUC may require submission of a new protocol.  Amendments are classified into two categories, major and minor, according to IACUC determined animal welfare/well-being risk perceptions.  All minor amendments can be reviewed via Designated Member Review (DMR) with the option of calling the protocol to FCR.   All major amendments should be reviewed via Full committee review (FCR).

 While no list can be exhaustive, category examples are listed below:

  1. Minor Amendments
        a. Examples of changes normally considered to be minor include, but are not limited to, changes:
    • of project title
    • in anesthetic, analgesic, antibiotic and paralytic method, to include the route or dose
    • in route of substance administration or sample collection
    • in method of animal acquisition, quarantine, or conditioning
    • in or additions of the method of euthanasia that is considered “acceptable” by the AVMA Recommendations on Euthanasia
    • or addition of experimental substances/drugs

      2. Major Amendments
          a. Examples of changes normally considered to be major include, but are not limited to, changes:
    • in the species
    • resulting in greater discomfort or in a greater degree of invasiveness i.e. moving/adding of animals to a different Pain or Distress Category (C to D or D to E) 
    • in the method of euthanasia that is considered “acceptable with conditions” or “unacceptable” by the AVMA Recommendations on Euthanasia
    • in the duration, frequency, or number of procedures performed on an animal
    • in monitoring due to adverse consequences more severe than anticipated
    • or addition of a surgical procedure, change from non-surgery to surgery, from minor to major surgery, from non-survival to survival surgery, or from single to multiple survival surgeries
    • or addition of the use of new hazardous agents or biohazards to animal procedures

 References:

    1. National Research Council. Institute for Laboratory Animal Research. 2011.  Guide for the Care and Use of Laboratory Animals.  Public Health Service, Bethesda, MD.
    2. Public Health Service Policy on Humane Care and Use of Laboratory Animals http://grants.nih.gov/grants/olaw/references/phspol.htm.
    3. ARENA/OLAW Institutional Animal Care and Use Committee Guidebook. Second edition, 2002.
    4. Animal and Plant Health Inspection Service, USDA. US Animal Welfare Act (AWA 1990) and Regulations (PL-89-544, as amended, 7USC Ch. 54) 2008. CFR Title 9, Subchapter A - Animal Welfare. U.S. Government Printing Office, Washington, D.C.

History:

Version 00 -  Initial Approval: February 27, 2014