Compliance

Compliance

Compliance

What is a deficiency or noncompliance?
A deficiency or noncompliance is any deviation from an approved IACUC protocol, UAB policy or the regulations and standards dictated by oversight agencies (e.g. OLAW, USDA, or AAALAC) and regulatory documents (e.g. the Guide, PHS Policy, or Animal Welfare Act) for the care and use of research animals. Depending on the type of deviation and its impact on animal welfare, various corrective actions are applied to both correct the deficiency and prevent future recurrence. The institution is required to report some deficiencies to external oversight groups and/or to the applicable funding agency.

What are the most common types of noncompliance?
The most common types of noncompliance are deviations from approved IACUC protocols. Even small deviations can be considered noncompliance so if you are unsure whether you are allowed to perform a procedure it is best to check with the IACUC office first. Other types of noncompliance inlcude but are not limited to:

  • Overcrowding of cages
  • Improper transportation of animals
  • Ineffective euthanasia
  • Using expired drugs
  • Performing experiments without an approved protocol

How are events of noncompliance handled?
In general a noncompliance event is observed by or reported to the IACUC office, office staff speak with the involved persons, and report their observations and findings to the Compliance Subcommittee. The Compliance Subcommittee is a group of IACUC members that use the regulations and requirements of animal care and use oversight agencies to apply the appropriate corrective actions and initiate reporting requirements where applicable. The Subcommittee presents its recommended actions and reports to the full IACUC committee for approval or modification. After approval from the full committee, the IACUC office staff or designated persons communciate the committee's decision to the noncompliant party and follow-up on implementation of corrections and reports to internal and external entities as needed. 

How does IACUC track and follow-up with overcrowded cages?
As soon as a cage is tagged as overcorwded it is already out of compliance. Breeding colonies should be maintained in a manner to avoid having cages tagged and not depend on notices for colony maintenance. ARP copies IACUC on the email notices that are sent to PIs and research staff. The IACUC logs and tracks the number notices received for each PI, the number of cages tagged, number of cages on census, and the APN involved. Once a particular PI has reached the limit of 4 notices per month, the IACUC will contact the PI to determine why there is an overcorwding issue and how the problem may be corrected. This limit is flexible to take into consideration the % of overcorwded cages or housing in multiple rooms. If overcrowding continues to be a problem after the initial contact by IACUC additional corrective actions may include mandatory retraining of personnel or meeting with the Compliance Subcommittee.

What should I do if I suspect someone is not using or caring for animals appropriately?
If you have any suspicion that animals are being used or cared for inappropriately it is very important that you report it immediately to the IACUC so that we may intervene and suspend any noncompliant actions or behavior. There are many methods of reporting concerns about animal welfare including an anonymous hotline. Please see the IACUC's Reporting Deficiencies Policy for further information.

What will happen if my protocol expires/lapses?
Approved protocols must be renewed every year and will lapse after 365 days. If your protocol expires you will receive an automatic email notice informing you of the lapse. If you have animals on census, the Compliance Coordinator will send an email notifying you that any animals under this protocol have been temporarily moved to the ARP Holding Protocol. Until your protocol is approved, you may not conduct any experimental procedures on animals under that protocol. You are allowed to perform normal colony maintenance (breeding, weaning, genotyping, etc.) or treatments related to the health of the animals (e.g. providing insulin for diabetic animals). Once your protocol has been renewed, the animals will be released from the holding protocol and you may resume experimental activities. To prevent lapses, pay attention to the renewal reminder notices you recieve for your protocols. They are sent 90, 75, and 60 days prior to protocol expiration, and will tell you which form is due for renewal.