Guidelines for Modification of an
Animal Study Proposal
The NCI-ACUC has developed the following question to
be used by principal investigators and the committee to determine whether a new
animal study proposal is warranted instead of a modification to an existing
animal study proposal:
Has purpose or scientific rationale
changed significantly from original intent as described in Part C of the animal
study proposal form?
The following are examples of common changes to an
animal study proposal which are considered acceptable as modifications
and may not require submission of a new animal study proposal:
Administrative Changes:
- Change in principal investigator
- Addition or change of personnel listed on the
animal study proposal
- Change in the number of animals to be used (less
than 5%)
- Addition of or change in the strains of animals
- Addition of or change in location where the
animals will be housed
Significant
Changes:
- Change in the number of animals to be used
(greater than 5%)
- Modification of existing surgical procedures; a
change from non-surgery to surgery; from minor to major surgery; from
non-survival to survival surgery; or from single to multiple survival surgery
- A change which may involve an increase in the
levels of pain, distress, and/or discomfort
- Change in anesthetic agent or in the use or
withholding of analgesics
- Addition of or change in hazardous agents
- Change in method of euthanasia
NCI Animal Care and Use Committee - Issued 9/30/98, Revised 10/22/2003
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