BACKGROUND

Wayne State University's Animal Care and Use Program maintains standards to comply with Federal Law of United States Department of Agriculture (USDA), the Office of Laboratory Animal Welfare (OLAW) and voluntary accrediting bodies such as the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). The University adheres to the Public Health Service (PHS) policy on Humane Care and Use of Laboratory Animals (PHS Policy), Animal Welfare Act and Regulations (AWAR), and the Guide for Care and Use of Laboratory Animals (the Guide). All individuals using animals at Wayne State University must follow the standards set forth in these regulatory and guidance documents. In addition, all internal policies and procedures must be followed. If the University becomes aware of potential non-compliance, comprehensive investigation and possible corrective actions may protect animal welfare, laboratory staff, and laboratory and university funding and research goals.

The Institutional Animal Care and Use Committee (IACUC) has developed this policy to establish consistent guidance on investigating and managing potential non-compliance concerns. As situations vary considerably, determinations are made on an individual basis based on the circumstances, including self-reporting, voluntary corrective actions, and any other relevant considerations. It is recognized that isolated instances of noncompliance can occur as the result of a simple and minor error with no intent to circumvent applicable requirements. As such, IACUC's have the discretion to determine that a full investigative process and formal corrective measures are not required in particular circumstances. Thus, this policy is not intended to eliminate the ability of an investigator to immediately correct a simple and minor oversight or error in conjunction with the IACUC. Rather, this policy is intended to address compliance issues that, in the determination of an IACUC and in specific cases he institutional official (IO), go beyond a simple and minor oversight.

Definitions

Non-compliance: The failure (intentional or unintentional) to comply with applicable federal, state, or local laws or regulations, IACUC Guidelines/SOPs/Policies, and/or with an approved IACUC protocol.

Minor non-compliance: Typically arises in instances where policy has been violated, but the risk of harm to researchers or animals is minimal and the IACUC authority or function has not been compromised.

Serious non-compliance: Any noncompliant event that has negative impact on the welfare of an animal constitutes a direct violation of federal standards regulating animal activities. These standards include provisions of the Occupational Health and Safety program or the Guide, or the conduct of a significant animal procedure without IACUC approval. Adverse events or unforeseen outcomes (i.e. natural disasters, unexpected phenotypes) are not considered non-compliance and should be dealt with in conjunction with the veterinarians. Serious non-compliance issues require reporting to the Institutional Official (IO). The IO will submit to federal agencies and accreditating agencies, as required.

Continuing non-compliance: Repeated episodes of non-compliance involving the same principal investigator (PI). Continuing non-compliance issues may require reporting to federal agencies and accrediting bodies. The committee will consider all non-compliance events over the last 3 years when evaluating compliance history for a PI. Continuing non-compliance issues require reporting to the IO. The IO will submit to federal agencies and accrediting agencies as needed.

Corrective Actions: Remediation steps proposed by PIs, the IACUC, the IACUC Chair or and/or Attending Veterinarian that describe how labs will resolve non-compliance concerns. These are voted upon by the IACUC.

Post-Approval Monitoring (PAM): A visit with the compliance specialist to review the protocol and observe on-going procedures in a laboratory. The goal is to prevent non-compliance and protocol drift from occurring. Visits can be random or for-cause.

IACUC Policy

1.  Reporting Non-Compliance

a.  In compliance with federal requirements, any individual with concerns involving the care and use of animals at this institution may have those concerns reviewed by the IACUC. The concerned party may remain anonymous and will be protected from discrimination and reprisal.

b.  Self-reporting is highly encouraged. Self-reporting allows the investigator to self-identify areas of potential non-compliance, develop a plan to remedy the issue, and implement self-corrective measures taken to prevent recurrence.

c.  See WSU IACUC policy on Reporting Animal Welfare Concerns.

2.  Inquiry Process

a.  The compliance specialist will contact the PI and/or individuals involved in the allegation of non-compliance providing all relevant information in writing to describe the alleged incident.  The compliance specialist will inquire on the accuracy of the report, and if accurate will request the PI to provide a plan to resolve the issue(s).  If not accurate, the PI has a chance to modify the report. A response is expected from the PI within 24-48 hours.

b.  The IACUC chair, IACUC vice chair, associate director for Responsible conduct of Research, and AV (Attending Veterinarian) (or designated DLAR veterinarian) will have 24 hours to decide on the best course of action based on the information obtained during the inquiry. This may include one or more of the following:

i.  Dismissal of the allegation (unsubstantiated)

ii.  Referral to other appropriate university process

iii.  Immediate corrective action required (implemented by AV, IO and/or IACUC chair). Immediate action is always taken if there are animal welfare concerns.

iv. Review at a convened IACUC meeting

 v.  Further investigation required by the compliance specialist

c.  The PI will be informed in writing of any recommended actions based on the inquiry findings.

d.  The compliance specialist will also create a formal written report for each substantiated inquiry. The PI will be given 5 business days to provide a written response to the inquiry report and will be given the opportunity to attend the IACUC meeting.

e.  As required, the IO files a report with federal and/or accrediting agencies.

*Institutional official

3.  IACUC Investigation Process

a.  Prior to the next convened IACUC meeting, the compliance specialist will distribute the final report to all IACUC members.  At the IACUC meeting, the compliance specialist will discuss the inquiry report with the IACUC members

b.  If available, the response letter from the PI will be provided to the committee members. The PI may join the meeting if s/he wishes to provide information relevant to the IACUC review of the issue. The IACUC may discuss the incident with the PI during this time but deliberations regarding the incident by the IACUC will only occur in the absence of the PI.

c.  Following IACUC deliberations, the members may vote on the following outcomes:

i.  Is the concern non-compliance (Yes, No, or Tabled)?

1.  If further information is required vote on this issue --  tabled, compliance specialist gathers more information for next meeting

2.  If the committee votes no -- no further action is needed.

3.  If the committee votes yes and deems non-compliance occurred -- the committee votes on the degree of non-compliance:

a.  Serious non-compliance

b.  Continuing non-compliance

c.  Minor non-compliance

ii.  Is the issue satisfactorily resolved?  If not, what corrective actions will be required?

iii.  Are programmatic changes needed to prevent future occurrences?

d.  Once the investigation is complete, the IACUC Chair or Vice Chair will provide a written formal notification to the PI within 5 business days of the IACUC decision.

e.  The PI will have 5 business days to appeal the decision in writing (extensions can be granted by the IACUC Chair in certain circumstances).  Appeals will be considered at the next convened IACUC meeting.

f.  If the decision is being appealed, the IO will file a preliminary report with federal and/or accrediting agencies (when required).

g.  Once finalized, a final written report will be sent to relevant federal and/or accrediting agencies through the IO (when required).

 

4.  Corrective Actions and Validation of Corrective Actions

a.  Specific corrective actions are determined on a case-by-case basis.

b. Implementation of corrective actions should be checked (validated) to ensure implementation.

c.  Minor Non-Compliance, examples of corrective actions include but are not limited to:

i.  The PI receives formal notification from the IACUC that emphasizes the importance of maintaining compliance.

ii.  Additional training may be required by completing Collaborative Institutional Training Initiative (CITI) and/or hands-on Department of Laboratory Animal Resources (DLAR).

iii.  PI will provide a written response to the committee outlining a plan to prevent this from occurring in the future. The response will be reviewed by the IACUC.

iv.  Extra monitoring by the veterinary staff may be implemented if necessary.

v.  Modification (i.e. amendment) submitted to the protocol.

 

d.  Serious and/or Continuing Non-Compliance, examples of corrective actions include but are not limited to:

i.  The PI receives formal notification from the IACUC Chair (or Vice Chair) that emphasizes the importance of maintaining compliance which will be copied to the AV, Associate Director, Responsible Conduct of Research, IO, compliance specialist, and department chair.

ii.  The compliance specialist will conduct for-cause PAM visits with the laboratory.

iii.  Federal and/or accrediting agencies will be notified, when required.

iv.  Modification (i.e., amendment) submitted to the protocol.

v.  PI will provide a written response to the committee outlining a plan to prevent this from occurring in the future. The response will be reviewed by the IACUC.

vi.  Additional training may be required (CITI and/or DLAR training).

vii.  Extra monitoring by the veterinary staff may be implemented if necessary.

viii. Direct oversight of procedure(s) by veterinary staff or compliance specialist.

ix. PI presence/enhanced oversight of lab members during certain procedures.

x.  Meeting with PI, AV, IACUC Chair or (Vice Chair), IO and Department Chair to discuss non-compliance corrective actions.

xi. Suspension or termination of protocol.

xii. Suspension or termination of personnel on protocol.

Approved: June 2018

Revision Approved: 2/2019, 6/2022, 8/2023