Standard on the Use of Blanket Protocols
This standard defines/describes “blanket” approval for animal use where procedures can be described but specific treatments and/or animal numbers are not yet determined. Blanket protocols cover studies such as non-invasive and non-painful use of food animals for feed/ nutrition studies, genetic studies or production activities in which the study design is similar but different drugs, agents or feeds may be given to the animals for evaluation.
Pharmacokinetic studies for drug evaluation (Absorption, Distribution, Metabolism, excretion) may also qualify for a blanket protocol but the protocol must be specific similar classes of PK studies with specific routes of administration not all encompassing of every route or not specific to a class of drug being tested (pharmaceutical agents must be separated by class, analgesia, antibiotics, etc.)
Novel experimental agents would require a separate protocol.
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.
All persons involved with the care and/or use of animals in research and/or teaching at the University including, but not limited to Principal Investigators, researchers, animal handlers, and students.
Standard
The IACUC requires a complete description of the animal-use activity. This description includes:
- A central aim (i.e. drug class for pK studies, infectious disease category for vaccine efficacy studies, nutritional class for dietary studies, etc.)
- The procedures performed with/on animals
- Clear and timely study endpoints, to include maximum age or duration an animal may be on the blanket protocol prior to disposition
- Euthanasia methods
- Humane endpoints
The individual experimental details will be supplied by completing an amendment to the protocol including the study specific details, which must be submitted and must be reviewed and approved by the IACUC before an animal activity begins.
- The details of the experimental treatments: specific therapeutics/intervention to be tested; dosages (volume and mg/kg) and routes of administration;
- Dietary manipulations;
- Sampling methods and maximum frequencies
- Justification of animal numbers for the specific study based on the general experimental design
- Clear and timely study endpoints, to include maximum age or duration an animal may be on the blanket protocol prior to disposition
- Humane endpoints related to the experiment
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.