Investigation and Remediation of Non-Compliance and Animal Welfare

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. Violation of these standards could jeopardize grant funding and animal use at Wayne State University.

An Institutional Animal Care and Use Committee (IACUC) is required by federal regulations (PHS, AWAR). It is responsible for overseeing the care and welfare of animals used in teaching, research, or testing activities. The 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.

Definitions

Serious non-compliance: Any noncompliant event that has negative impact on welfare of an animal and/or is in direct violation of a federal standard regulating animal activities, including provisions of the Occupational Health and Safety program. Serious non-compliance issues may require reporting to federal agencies and accrediting bodies.

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. Minor non-compliance can often be corrected at the institutional level.

Continuing non-compliance: Repeated episodes of non-compliance (serious or minor) 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 laboratory.

Corrective Actions: Remediation steps proposed by principal investigators, the IACUC, the IACUC Chair or Attending Veterinarian that describe how labs will resolve non-compliance concerns. These may be voted upon by the IACUC.

Adverse outcome: An unforeseen clinical outcome during a research study which is reported to the IACUC by the veterinary staff but is not treated as a non-compliance concern (unless it is determined that a non-compliance event was directly involved in the adverse outcome). The veterinary staff and investigators work together to resolved adverse outcome concerns.

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).  A response is expected from the PI within 24-48 hours.

b.  The IACUC chair 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 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 of any recommended actions based on the inquiry findings in writing.

d.  The compliance specialist will 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.  If appropriate, the IO*, AV, or IACUC chair will file a preliminary 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.  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 or No)?

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

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

3.  If the committee votes yes and deems non-compliance occurred à 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 compliance specialist will provide a written formal notification to the PI within 5 business days of the IACUC decision.  The notification will be sent as described below (Table 1).

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 Institutional Official (IO), AV, or IACUC chair 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).

h.  The compliance specialist will follow-up with the PI to ensure that all corrective actions are implemented. If the committee requests follow-up on specific details, the compliance specialist will report the findings at a subsequent meeting.

4.  Corrective Action Escalation (Table 1*)

a.  Three minor incidents of non-compliance are considered to be continuing and equivalent to one serious non-compliance incident.

b.  Specific corrective actions are determined on a case-by-case basis and not every action listed will be implemented in all cases. Corrective actions listed are progressive and remediation steps used for the first incident may be applicable to subsequent incidences.

c.  Minor Non-Compliance

i.  First incident:

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

2.  Additional training may be required by completing Collaborative Institutional Training Initiative (CITI and/or hands-on).

ii.  Second incident:

1.  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.

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

3.  The written notification will also be sent to the AV, IACUC chair, IO, and department chair.

iii.  Third incident:

1.  The non-compliance will be considered continuing. This may require more serious corrective actions (e.g. notifying funding agencies, suspension of activities, revoking privileges).

2.  The written notification will also be sent to the AV, IACUC chair, IO, and department chair, as well as a meeting held with all parties.

3.  The compliance specialist will conduct a for-cause PAM visit with the laboratory.

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

d.  Serious Non-Compliance

i.  First incident:

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

2. The written notification will also be sent to the AV, IACUC chair, IO, compliance specialist, and department chair.

3.  The compliance specialist will conduct a for-cause PAM visit with the laboratory.

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

5.  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.

6.  Additional training may be required (CITI and/or hands-on).

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

ii.  Second incident

1.  The non-compliance will be considered continuing. This may require more serious corrective actions, which should include one or more of the following:

a.  Direct oversight by veterinary staff or compliance specialist.

b.  PI presence during certain procedures.

c.  A written plan and documentation of remediation.

d.  Select procedures or individual's activities or facility access may be suspended (voluntary or via IACUC vote).

2.  A meeting is held with the PI, IACUC chair, AV, IO and department chair.

i.  Third Incident

1.  All members of the laboratory must go through additional training.

2.  Suspension of related procedures and individuals until resolution can be determined.

3.  Possible suspension of entire protocol.

4.  Meeting with PI, AV, IACUC chair, IO and department chair.

Table 1. Corrective Action Escalation*

  MC1 MC2 MC3 S1 S2 S3
Formal written notification sent to PI x x x x x x
Additional Training x x x x x x
PI written response with remediation plan   x x x x x
Additional oversight (veterinary/compliance staff)   x x x    
Formal written notification sent to AV, IACUC Chair, IO and Department Chair   x x x x x
Formal meeting with AV, IACUC Chair, IO and Department Chair     x   x x
For-cause PAM     x x x x
Direct oversight by veterinary or compliance staff (presence at procedures)         x x
PI presence at procedures         x x
Suspension of individuals or specific activities         x x
Suspension of protocol**           x

MC - minor non-compliance; S - serious non-compliance

*This chart is intended for general guidance only. Specific corrective actions are determined on a case-by-case basis at the purview of the IACUC.

**Protocols can only be officially suspended by a majority vote of the IACUC during a convened meeting; likewise, suspensions can only be lifted by a majority vote of the IACUC during a convened meeting.

Approved: June 2018

Revision Approved: 2/2019