Non-Compliance

Rationale:
The UT Southwestern IACUC is responsible for oversight of the animal care and use program. Accordingly, it must enforce the regulations, policies and procedures that apply to the conduct of animal research. Where potential occurrences of noncompliance are identified, the procedures described in this policy will be followed.

Policy:
In order to demonstrate appropriate oversight of research activities and to comply with all applicable regulatory requirements, the IACUC will investigate and resolve all allegations of possible noncompliance. The IACUC will strive to achieve informal resolution of compliance issues whenever appropriate.

When an allegation of possible noncompliance cannot be resolved informally, the IACUC has the authority to impose corrective actions, make reports to external oversight entities and recommend additional sanctions to the Institutional Official. The IACUC also may halt research activities temporarily or suspend approval of protocols at any time during the compliance review process.

Applicability:
Examples of non-compliance for which the IACUC may impose corrective action, make reports to external oversight entities, and/or recommend additional sanctions are listed below:

conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to the animals;
conduct of animal-related activities without appropriate IACUC review and approval;
failure to adhere to IACUC-approved protocols;
implementation of a significant change to an IACUC approved protocol without prior IACUC approval;
conduct of animal-related activities beyond the expiration date established by the IACUC;
participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained;
failure to monitor animals post-procedurally as necessary to ensure well-being;
failure to maintain appropriate animal-related records;
failure to ensure death of animals after euthanasia procedures;
failure of animal care and use personnel to carry out veterinary orders; and
IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with PHS Policy, the Animal Welfare Act, the Guide, or UT Southwestern Medical Center’s Animal Welfare Assurance.

Procedures:
All reports of possible non-compliance or alleged animal misuse that are discovered by or arrive in the IACUC Office will be communicated to the IACUC Chair and/or Vice Chair. The IACUC Chair and/or Vice Chair, in cooperation with the IACUC staff, will decide whether to proceed to Step 1.

Step 1 - Administrative Review
The purpose of an Administrative Review is to determine whether the allegation can be substantiated and if it requires further review. Administrative Reviews are conducted by the IACUC staff. An Administrative Review may include: review of files, literature, and documents from the Investigator and others, which could serve to validate or dismiss the allegation. When an Administrative Review reveals information that appears to substantiate an allegation of noncompliance with policies or regulations, the IACUC Chair or Vice Chair is consulted for further action. All efforts will be made to resolve the matter informally.

When there is a finding, the results of an Administrative Review will be communicated by the IACUC staff in writing to the Investigator (with a copy to the IACUC Chair) within 60 days of the commencement of the review. This communication will either: confirm that compliance was achieved, inform the Investigator that a Committee Review was recommended, or apprise the Investigator that the incident has been referred to the Institutional Official as a matter of possible scientific misconduct.

In cases where the result of an Administrative Review suggests that an Investigator has demonstrated an apparent pattern of disregard for research regulations, policies, or procedures, a Committee Review may be recommended even when the specific finding of noncompliance is resolved informally.

Step 2 - Committee Review
A Committee Review is initiated after a completed Administrative Review suggests that an incident of noncompliance appears to have occurred and when informal resolution was not achieved or when informal resolution is achieved but the Investigator has been determined to have engaged in a pattern of disregard for research regulations, policies or procedures. Committee Reviews may be conducted by the full IACUC or by a subcommittee charged by the IACUC Chair. Whenever possible, the result of a Committee Review will be informal resolution. Such reviews may include: review of files, literature, and other documents; requests for additional information from and/or interviews with the Investigator, complainant or others, and review of other documents which could serve to validate or dismiss the allegation.

The results of a Committee Review will be communicated by the IACUC Chair in writing to the Investigator (with a copy to the appropriate protocol file) within 90 days of commencement of the review. This communication will either: notify the Investigator that the allegation was dismissed, confirm that compliance was achieved, inform the Investigator of recommended sanctions, or apprise the Investigator that the incident may be investigated as a matter of scientific misconduct.

If sanctions are recommended or if a report to an external oversight entity is required, a copy of the results of the review will also be sent to the Institutional Official and the Principal Investigator’s Department Chair.

Step 3 – Corrective Actions
Whenever possible, IACUC staff will be available to assist Investigators with resolving noncompliance issues. In cases where cooperation does not occur or when it is determined that the institution has been placed at risk, corrective actions may be imposed by the IACUC.

In addition, the IACUC may recommend sanctions to the Institutional Official. Possible sanction recommendations include: