IACUC Ongoing Training
Dr. A. Nonymouse is conducting research on a new therapeutic drug, hoping to find a treatment with fewer side effects than what is commercially available. As part of the experiment, the therapeutic drug is being compared to the current drug as a control. The current drug is available in both pharmaceutical grade and non-pharmaceutical grade. Both the pharmaceutical grade and non-pharmaceutical grade come in the same concentrations, but the non-pharmaceutical grade is 10% cheaper than the pharmaceutical grade option. Can Dr. Nonymouse use the non-pharmaceutical grade to help stretch the grant funds?
A. Yes, research dollars are hard to come by these days, so the PI must do what they can to conserve funds.
B. No, the regulatory bodies expect pharmaceutical grade substances to be used when available unless scientifically justified and approved by the IACUC.
Dr. A. Nonymouse is conducting research on a new therapeutic drug, hoping to find a treatment with fewer side effects than what is commercially available. As part of the experiment, the therapeutic drug is being compared to the current drug as a control. The current drug is available in both pharmaceutical grade and non-pharmaceutical grade. Both the pharmaceutical grade and non-pharmaceutical grade come in the same concentrations, but the non-pharmaceutical grade is 10% cheaper than the pharmaceutical grade option. Can Dr. Nonymouse use the non-pharmaceutical grade to help stretch the grant funds?
A. Yes, research dollars are hard to come by these days, so the PI must do what they can to conserve funds.
B. No, the regulatory bodies expect pharmaceutical grade substances to be used when available unless scientifically justified and approved by the IACUC.
Learner Feedback: The correct answer is B, “No.” According to the IACUC – Policy on Use of Non-Pharmaceutical Grade Agents:
“In keeping with federal expectations and policies, the Northwestern University IACUC has adopted the following standards regarding the use of chemical compounds administered to animals:
Pharmaceutical-grade substances must be used whenever possible.
Justification for the use of non-pharmaceutical-grade substances must be provided in the animal study protocol and reviewed and approved by the IACUC. The justification for the use of non-pharmaceutical-grade substances may include lack of availability of suitable pharmaceutical grade substances or scientific necessity. Cost alone is not considered an adequate reason to employ non-pharmaceutical chemical compounds. However, when drug costs have become exorbitant, it may be determined that a drug is effectively unavailable.”
A is incorrect because cost alone is not considered an adequate justification. The PI would need to provide other scientific justification as to why the pharmaceutical grade substance could not be used or why the non-pharmaceutical grade must be used.