When is it required to submit an amendment to an existing protocol?
A Principal Investigator's (PI's) research plan may change and evolve while an approved study is in progress. Both the
Animal Welfare Act Regulations (AWAR) and Public Health Service (PHS) Policy PHS Policy require that the IACUC
review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes
regarding the use of animals in ongoing activities PRIOR to initiation. (PHS Policy IV.C.)
What activities can be considered appropriate for an amendment?
In accord with our “Assurance of animal welfare” on file with the Federal Public Health Service, Office of Laboratory
Animal Welfare, a distinction must be made between minor (administrative) and major (significant) changes to an existing
approved protocol. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are
the same as those described for review and approval of new protocols under PHS Policy IV.C. Significant changes must
be reviewed by the IACUC using the full committee review (FCR) or Designated Member Review (DMR) process. The
FCR or DMR process may take up to 1 month to review and approve. Administrative changes are processed usually
within a few days of submission.
Examples of changes that are major (significant):
 Change in purpose, specific aim or objectives of a study.
 Change in Principal Investigator.
 Change in protocol that would require an animal to undergo more than one survival surgery.
 Change in protocol that would require animals to be fed, housed or cared for in a way that is not standard for that
species, or does not meet that species' minimum requirements.
 Increase in the degree of invasiveness of a procedure or discomfort to an animal.
 Change in protocol that would eliminate or restrict an animal's access to veterinary care.
 Change of species.
 Addition of USDA-regulated species.
 A greater than 10% increase in the number of animals needed
 The withholding of analgesics.
 The duration, frequency, or number of procedures performed on an animal.
 Addition of survival surgical procedure.
 Addition of a painful procedure.
 Change in protocol where death becomes the experimental end point.
Can changes to a protocol be handled administratively? Yes. There are three processes which may be used.
In accordance with IACUC policy, the following specific protocol changes may be handled administratively in consultation
with the IACUC authorized Attending Veterinarian. The veterinarian serves as a subject matter expert to verify that
compliance with IACUC policy is appropriate for the animals affected by the proposed changes. Consultation with the
veterinarian is documented. 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 IACUC policies. These changes include:
 anesthesia, analgesia, sedation, or experimental substances;
 euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals
 duration, frequency, type, or number of procedures performed on an animal.
 Addition of another strain of the same species
 Change of sex in the animal to be used
 Addition of sample collection times - not to exceed standard limits
2. In accordance with IACUC policy, the following changes may be handled administratively without additional
consultation or notification: increase in previously approved animal numbers < 10% except for protocols using USDA
regulated species; Replacing a procedure with another less painful, stressful or hazardous that achieves the same
specific objectives; Changing experimental design to reduce the use of animals; Reducing or eliminating previously
approved water or feed restrictions; Addition or deletion of animal usage location; Removing a proposed experiment from
a protocol. Addition of minor procedure provided the change is not expected to increase pain or distress e.g., changes in
needle gauge, surgical instruments, vehicle for injections, and use of post-mortem tissue (if not exceeding standard
limits); Addition of or change in dosage of an experimental drug in the same class as one previously approved
3. Changes that may be handled administratively without policy guidance, consultations, or notifications include: protocol
title changes; contact information or training updates of the PI or study personnel; correction of typographical errors;
correction of grammar; and change in personnel, other than the PI. All personnel are appropriately identified, adequately
trained and qualified, enrolled in occupational health and safety programs and registered with the public safety office as
required by the IACUC.