Guideline for Blanket Protocols
A principal investigator (PI) may wish to seek “blanket” approval for animal use where procedures can be described but specific treatments and/or animal numbers are not yet determined. The potential advantage of this approach is that only an amendment would need to be filed, as these additional details are known.
The process for approving amendments that involve significant changes requires essentially the same steps as a new submission; therefore, there may not ultimately be significant time savings in review. On the other hand, if amendments include only nonsignificant changes, then those changes would generally be approved quickly.
- If a PI has a special need for rapid turnaround time on review of an application, s/he should contact the IACUC office.
- The IACUC requires a complete description of the animal-use activity. This description includes not only the procedures performed with/on animals, but also the details of the experimental treatments: specific drugs, dosages (volume and mg/kg) and routes of administration; dietary manipulations; justification of animal numbers based on the experimental design; etc.
- The above information may be supplied in some combination of protocol and amendment form, and must be reviewed and approved by the IACUC before an animal activity begins.
- If details of animal use are not available at the time of initial application submission, then the application should indicate specifically what additional information will be provided as an amendment.
- For each amendment submitted, the IACUC chair decides whether the proposed changes are “significant.” The decision is based on this IACUC guideline: Review Procedures for Significant Changes in an Approved Protocol.