IACUC Policy: Protocol Amendments    
Policy # IBT-108.03 IACUC Approval: October 23, 2017

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 procedure will define significant versus minor amendments and review requirements for each. 

Scope: 
All modifications to research with live vertebrate animals are subject to oversight by the Texas A&M University Houston/Kingsville 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. 

Amendments are classified into two categories, minor and significant, according to IACUC determined animal welfare/well-being risk perceptions. 

I. Administrative Amendment (Minor Changes) 
The following may be changed administratively. 
1. Changes in key study personnel except for the Principal Investigator 
2. Changes in animal use sites (locations that are already part of the animal program overseen by the IACUC) 
3. Changes in funding source 
4. Changes in vendor 
5. Changes in project title 
Administrative modification requests will be reviewed by the IACUC Office and written notice of approval will be sent 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. Changes in personnel require that they receive appropriate training and enrollment in the Occupational Health Program before approval may be granted. 

II. IACUC Reviewed Amendments (Significant Changes) 
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. While no list can be exhaustive, examples include changes 
a) in the objectives of the study 
b) in the species
c) 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) 
d) in the method of euthanasia 
e) in the Principal Investigator 
f) in number of animals used 
g) in route of substance administration or sample collection 
h) in the addition of experimental substances/drugs 
i) 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 
j) or addition of the use of new hazardous agents or biohazards to animal procedures 
k) in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC 
l) that impact personnel safety 
m) in method of animal acquisition, quarantine, or conditioning 
n) in anesthetic, analgesic, or tranquilizer 

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. 
5. OLAW FAQs 
6. NOT-OD-14-126 Guidance on Significant Changes to Animal Activities. OLAW/NIH August 26, 2014 

History: 
Version 00 – Initial approval: February 27, 2014 
Version 01 – Approval: May 2, 2016 
Version 02 – Approval: September 26, 2016 
Version 03 – Approval: October 23, 2017