OLAW is seeking input on a proposed guidance in NOT-OD-14-063, entititled “Request for Information: Invitation to Comment on Proposed Guidance Regarding Significant Changes to Ongoing Animal Activities“.
The proposed changes changes include:
Proposed Guidance on Significant Changes
Significant changes must be approved by one of the valid IACUC approval methods described in the PHS Policy IV.C.2., full committee review or designated member review.
The IACUC has the authority to approve ranges of variables as long as it can determine that the range does not interfere with the welfare of the animal or the range is scientifically justified. If the investigator chooses to use a single value rather than a range, he or she is required to adhere to that standard.
The IACUC has discretion to add to the following sections A. and B. or to establish a mechanism for determining significance on a case-by-case basis while remaining consistent with A. and B. It is the responsibility of the IACUC to clearly define and communicate to investigators its policy for determining significance.
A. Significant changes are those changes that have or may have a direct impact on animal welfare including but not limited to changes:
- that have the potential to increase the level of pain or distress of the animal and includes all changes that involve anesthesia, analgesia, sedation, or euthanasia;
- in frequency, interval, type, number, or anatomical location of:
- procedures; and
- substances delivered to the animal.
B. Some activities that may not have a direct impact on animal welfare are also significant. These include but are not limited to changes:
- in animal numbers (see Guide for the Care and use of Laboratory Animals, p. 25) or species;
- to house or use animals in a location that is not part of the animal program overseen by the IACUC;
- in the scope of an approved animal activity (see NIH Grants Policy Statement Part 2 126.96.36.199.); and
- in Principal Investigator.
C. Changes that are not significant may be handled by the IACUC staff without IACUC review and approval. However, the IACUC is to be informed of changes handled by the IACUC staff. This information may be provided after the change has been reviewed and initiated. Such minor changes include but are not limited to:
- total increase in animal number for animals not regulated by USDA that does not exceed 10% of the number reviewed and approved by the IACUC;
- change that would result in less discomfort or invasiveness to the animal, except the changes described in section A.;
- change in stock, strain, or genetic modification, unless the new stock, strain, or modification results in abnormalities that require special support;
- change to house or use animals in a location that is currently used for the same purpose and is part of the animal program overseen by the IACUC;
- change in personnel other than the Principal Investigator (An appropriate administrative review must be conducted to ensure that all such personnel are appropriately identified, adequately trained and qualified, enrolled in applicable occupational health and safety programs, and meet other criteria as required by the IACUC. The IACUC should have a procedure in place to ensure that this review is conducted.);
- correction of typographical errors;
- correction of grammar; and
- contact information updates.
All comments must be submitted electronically at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=36 by May 15, 2014