Body
University Standard
Title
University of North Carolina at Chapel Hill Standard for Amendments and Other Protocol Changes
Introduction
Purpose
The Standard described below provides guidance to Institutional Animal Care and Use Committee (IACUC) members and UNC researchers/investigators on changes and amendments to UNC approved IACUC protocols. Investigators may wish to make changes to approved applications during the three-year protocol approval time. These changes are handled in a variety of ways and depend on the type of change being requested.
Scope
All personnel, including animal handlers and Principal Investigators (PI) involved in the writing, revising, and amending of IACUC protocols. The standards described in this document apply to changes and amendments to all IACUC approved protocols.
The UNC-Chapel Hill IACUC expects that all individuals involved in animal work at the University will comply with this Standard. Requests for exceptions to this Standard must be reviewed and approved by the IACUC.
Standard
Amendments requesting the addition of personnel, a change in an individual’s role on the protocol (other than change in PI) or the addition of specific techniques are handled directly by the OACU staff and are not sent to the IACUC for review. Significant changes to an IACUC approved protocol, defined as changes that negatively impact animal welfare, or have the potential to negatively impact animal welfare, are sent electronically for Designated Member Review (DMR) to a Designated IACUC reviewer, a Division of Comparative Medicine (DCM) veterinarian (for consultation), and all members of the IACUC. Any IACUC member can request a Full Committee Review (FCR) of the amendment to be conducted at the next convened IACUC meeting or the submission of a new protocol instead of an amendment. Alternatively, some significant changes are handled administratively according to IACUC-reviewed and -approved policies in consultation with a veterinarian authorized by the IACUC. The veterinarian may refer any request to the IACUC for review for any reason and must refer any request that does not meet the parameters of the IACUC-reviewed and -approved policies.
1. Application Changes Handled by Email
Changes handled by email submitted to iacuc@med.unc by the PI, Co-PI, LAC, or an Official Contact listed as personnel on the protocol:
- Termination of protocol(s)
- Removal of personnel (include full name, PID number and relevant protocol number(s) in message)
- Adding the role of “Official Contact” to personnel
- Change in animal housing, investigator lab, or Core facility location due to relocation directed by DCM, Facilities, or Environment, Health, and Safety (EHS) because of building renovations or facility issues/repairs. Indicate new housing location, old location and protocol number(s) for which changes are requested. (When new/additional space is assigned to a PI for other reasons an amendment is required.)
2. Significant Changes to an Approved Application Requiring the Submission of an Amendment
A. Significant Changes handled by DMR
- Addition of new procedures
- Change in specific study objectives
- Addition of rodent strains that have significant health phenotypes
- PI transfer from one qualified UNC-Chapel Hill faculty member to another
- Changes that result in greater pain, distress, or degree of invasiveness. (Note: changes to painful/distressful procedures involving USDA-regulated species, and studies using Department of Defense (DOD) or Veteran’s Affairs (VA) funding, require an updated literature search)
- Unanticipated or marked increase in clinical signs or animal death
- Changes to surgical procedures, assessed case-by-case to determine need for FCR, and including:
- The addition of a non-survival or survival surgery to a protocol that does not already include approved surgical procedures
- Changing a protocol that is approved for non-survival surgery to include survival surgery
- Changing a protocol that is approved for survival surgery to include non-survival surgery
- Changes to diet and/or diet administration, including brand and type of chow, feeding schedules, and responsibility for feeding by PI or DCM.
- Changes involving tumor studies, including tumor size, monitoring, and care.
- Adding or removing the use of Neuromuscular Blocking Agents (NMB)
B. Significant changes handled as DMR by the IACUC Chair
- Increase in animal numbers not exceeding 25% of originally approved number. (An associated change in animal species, study objectives, health status of animals, or addition of procedures requires DMR by the IACUC.)
- Removing the services of a Core or Collaborator that was previously performed by both the lab and Core with full details already approved in the protocol.
- Addition of, or changes to, details in the media collection section of the protocol.
C. Significant changes handled administratively by the OACU staff
- Addition of or changes to qualified personnel (other than change in PI)
- Addition or change to personnel technique(s) or roles
- Addition of a qualified UNC-Chapel Hill faculty collaborator to lab personnel
- Changes in housing location when new/additional space is assigned. (Excludes changes due to renovations or facility issues/repairs. See changes handled by email above.)
D. Significant Changes handled administratively according to IACUC-reviewed and -approved policies in consultation with an authorized veterinarian.
This includes:
- Changes in the use of anesthetics, analgesics, sedatives/tranquilizers (drugs must be listed in the IACUC-approved drug formulary), or experimental compounds
- Changes in euthanasia to any method approved in the 2013 AVMA Guidelines for the Euthanasia of Animals
- Changes in the duration, frequency, type, or number of procedures performed on an animal
- Addition or change of a UNC collaborator or an approved UNC Core facility and any associated changes in housing location, or location where procedures will be performed
3. Significant Changes Requiring Submission of a New Protocol
Changes that require the submission of new protocol:
- Change in overall purpose of a study
- Greater than 25% increase in the number of animals indicated in the original approved application (handled on a case-by-case basis)
- Change to animal species in protocols approved for single species use. Note: In some protocols approved for multiple species use (e.g., wildlife studies using fish, reptiles) changes to species may be allowed by amendment (handled on a case-by-case basis)
4. Other Changes
The changes below do not require the submission of an amendment or IACUC notification, consultation, or review.
- Administrative correction of typographical errors and grammar
- Administrative updates to contact information
- Use of fewer animals than approved. No action is required.
Exceptions
Requests for exceptions to this Standard must be reviewed and approved by the IACUC.
Definitions
IACUC: Institutional Animal Care and Use Committee
DCM: Division of Comparative Medicine
OACU: Office of Animal Care and Use
University Standard: The minimum acceptable limits or rules used to achieve Policy implementation, enforceable by the IACUC.
IACUC Protocol: The animal use application which describes research activities in detail and is reviewed and approved by the IACUC.
Amendment: Changes to the IACUC protocol which require IACUC review prior to implementation.
USDA: United States Department of Agriculture
Non-USDA Regulated Species: Not governed under the Animal Welfare Act (AWA); includes mice (genus Mus), rats (genus Rattus), fish, reptiles, amphibians, and birds specifically bred for research
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Primary Contact
- Name: Michael Chi
- Title: Associate Director, Office of Animal Care and Use
- Email: mchi@unc.edu
Other Contacts
Animal Health
- Contact: DCM Vet Services
- Telephone: 919-962-5535
Office of Animal Care and Use