Staying in Compliance with the IACUC
What is Noncompliance?
Federal animal welfare regulations and guidelines require that all activities involving the use of live vertebrate animals must be reviewed and approved by the IACUC before any research may commence. Common examples of regulatory noncompliance in the IACUC world include:
- Use of an experimental compound that is not described in the approved protocol;
- Use of an approved experimental compound or agent at a significantly different dosage;
- Performance of a procedure (e.g., surgery, behavior test) not included in the approved protocol;
- Failure to adhere to the stated humane endpoints (e.g., keeping animals alive longer than originally described);
- Inappropriate housing of animals (e.g., keeping them in the lab for more than 12 hours without an approved housing exception);
- Inadequate euthanasia (animals recover after they are presumed dead); using a euthanasia method that is not described in the protocol; or using a method that is not approved by the AVMA.
There are many more examples, but the vast majority of noncompliant acts happen because the research staff and/or Lead Researcher (a) are unfamiliar with what is in the approved protocol or (b) are inappropriately trained to perform the procedures or care for the animals.
How does the IACUC find out?
UCI's Lab Animal Program has a robust post-approval monitoring system, in which veterinarians, animal health technicians, husbandry staff and the IACUC work together to ensure the welfare of all animals in our care. The IACUC also finds out about possible noncompliance during semi-annual Facility Inspections and reports from animal users. Sometimes noncompliance is a part of whistleblower reports.
In some cases noncompliance is reported by researchers themselves - the IACUC appreciates investigators' self-reporting and take it into account when reviewing the noncompliant acts and determining remedial actions. Everyone makes mistakes occasionally - taking ownership of them is the first step in moving on and learning from the experience.
What are the consequences?
- Valuable laboratory models could be lost: Animals involved in unapproved activities must be euthanized immediately.
- Data collected as a result of the unapproved activities cannot be used for publications or as pilot data in grant proposals - it must be thrown out.
- Federal funds cannot be used for unapproved activities - if the research is funded by the National Institutes of Health or other federal agency, the Principal Investigator may be required to repay funds associated with the noncompliance, including daily husbandry costs. (Read more about this)
- And most importantly: Animals may be exposed to unnecessary pain, distress or discomfort. This is something we must always avoid!
As an institution that accepts federal funding for research, UCI is required by the terms of our Animal Welfare Assurance to report all cases of serious or continuing noncompliance to the Office of Laboratory Animal Welfare at NIH. (Read more about this requirement.)
What can researchers do to stay in compliance?
Laboratory staff, including the Lead Researcher/Principal Investigator, should meet regularly to discuss the business of the laboratory - it's a great time to review the approved protocols, discuss ongoing and upcoming projects, and ensure that everyone is on the same page with regard to all aspects of the research.
Know What's in the Protocol(s)
Don't assume that a given procedure is included -- review the document carefully and plan ahead. Know when a modification is required. The IACUC may be able to expedite your request in some circumstances - ask us!
Principal Investigators are responsible for ensuring that every member of the research team is appropriately trained and experienced before they begin to work with animals. ULAR Veterinary Services can provide free training to UCI researchers on many common research procedures used in animals.
Anticipate problems and plan accordingly: many compliance issues arise on weekends and holidays due to breakdowns in communication or lack of a back-up system. Never leave the care and monitoring of the animals to only one person - redundancy is your friend!