University of Wisconsin-Madison

Policy Number: 1999-008 [PDF]

Adoption Date: 12/14/1999

Effective Date: 12/14/1999

Expiration Date: ongoing

Amended: 3/6/2009

Review Date: 3/6/09

Policy on Protocol Non-Compliance

Purpose: This policy establishes guidelines for dealing with non-compliance issues and situations involving the use of animals in teaching, research, and outreach. Such non-compliance issues would include, but not be limited to: failure to have an approved protocol in place; violation of the methodologies, procedures, numbers, and conditions of the approved protocol.

Policy:

1. It is recognized that non-compliance can occur as the result of simple and minor error with no intent to circumvent the requirements. As such, discretion may determine that a full investigative process is not required. Thus, this policy is not intended to eliminate the ability of an investigator to immediately correct a simple and minor oversight or error. Rather it is intended for dealing with serious issues that are beyond the scope and definition of a simple and minor oversight. It is important to note that all protocol errors regardless of magnitude must be self-reported as soon as they are identified (see point 3 below for information regarding to whom reports must be made).
2. The issue/situation will be investigated and dealt with by the School/College level Animal Care and Use Committee (ACUC).
3. When an issue of non-compliance becomes suspected or known, it shall be reported to the Chair of the School/College ACUC. Issues of noncompliance may alternatively be reported to a research animal veterinarian, the Principal Investigator, or a Facility Manager, who in turn will inform the Chair. If the issue presents a potential immediate animal health or welfare risk, the Attending Veterinarian or on-call veterinarian must assess the situation and take any action determined to be appropriate to alleviate risk to the animals.
4. The School/College ACUC Chair will advise the individual(s) involved that an issue of possible non-compliance is suspected or known and will be investigated. The Chair will also immediately inform the Chief Campus Veterinarian, and the Senior Program Veterinarian of the issue and pending investigation. The Chair and involved individual(s) will maintain open communication throughout the investigation to ensure cooperation.
5. On the behalf of the School/College ACUC the School/College Chair may delegate the investigative process to a sub-committee of the ACUC or any other individual(s) that the Chair believes appropriate to conduct the investigation. In cases of delegation, the ACUC still maintains responsibility to assure that the investigation is conducted in an appropriate and legal manner. All investigations and actions involved with issues of non-compliance shall be conducted in accordance with appropriate federal, state, and university legal and policy standards. ACUC should seek out expertise (e.g. Human Resources, Legal Services) to assure investigations and actions are properly conducted.
6. At the conclusion of the investigation, a report detailing the investigation shall be prepared and presented to the School/College ACUC for review and determination of action. The individual(s) who are the subject of the investigation shall be informed of the findings and afforded an opportunity to respond at the committee meeting. All committee actions will be reported to the All Campus ACUC and the Institutional Official by the Chair or designee.
7. The School/College ACUC will inform the involved individual(s) of the action and implement any prescribed remedial action. When appropriate, the Institutional Official will inform the appropriate regulatory and/or funding agencies.
8. The individual(s) involved may appeal the action to the committee that determined its implementation.
9. As a duly constituted and recognized ACUC and accordance with the University's PHS Assurance, the All Campus ACUC may also initiate investigations and implement remedial action as described above above.

Policy SOP

Prepared by: R. Lane, H. McEntee, B. Barker, B. Griffiths

Reference Minutes: 12/14/99, 5/7/04, 10/13/06, 8/1/08, 9/5/08, 3/6/09