University of Wisconsin-Oshkosh
Laboratory Animal Care and Use Program
STANDARD OPERATING PROCEDURES
SOP Number: 23
Effective Date: 10/27/11
Last Reviewed: 4/25/13
Page 1 of 3 Attachment:
Prepared By: Tim Anderson
Updated by: Kelly Schill & Leah Mann
Title:
Whistle Blower Policy for Animal
Welfare Concerns
Whistle Blower Policy for Animal Welfare Concerns
Purpose: This policy is intended to provide guidelines, which meet regulatory requirements,
for the reporting of animal welfare concerns either directly or anonymously.
Policy: It is the responsibility of every person in contact with the research animals to report
any animal welfare concerns that jeopardize the safety and welfare of the research animals
outside of approved IACUC protocol research methods. The Animal Welfare Act (AWA) states
that the research institution must develop methods that allow for the reporting and
investigation of animal welfare concerns, which involves the IO and IACUC, so that the IO and
IACUC can review and, if warranted, investigate the concerns of public complaints and the
reports of noncompliance by the animal care personnel, or any employee involved with the
animal care facilities (AWA 7 U.S.C. 2142: Section 13: Animal Welfare Regulations (AWR) 9 CFR
Part 2, Subpart C, 2.32(c)(4)). The AWA also provides protection for the “whistle blower” from
reprisal for reporting a concern about the welfare of the research animal(s). The mechanisms
for reporting animal welfare concerns are to be made visible and in a prominent location in the
facility, and on applicable institutional website(s) with instructions on how to report and to
whom the report is submitted including an anonymous method of reporting.
Responsibility:
1. The Reporter(s) of the Animal Welfare Concern(s):
a. It is responsibility of every individual associated with the research/instructional
animals to report any concerns regarding the welfare of all vertebrate
research/instructional animals. This policy is relevant to all vertebrate
animals regardless of which animals are under the protection of the AWA,
APHIS, or PHS guidelines.
b. Animal welfare concerns may include the misuse or mistreatment of vertebrate
laboratory animals that violate the approved IACUC research protocols and
standard operating procedures. This may include but is not limited to:
i. Improper research procedure(s) that deviate from approved protocols
ii. Improper care of research animals
iii. Failure to recognize hazards that jeopardize the welfare of the
animal(s)
Procedure:
1. Reporter(s) of the animal welfare concern:
a. Fill out the report titled Animal Welfare Concern Report Form (AWCRF) located
in the binder labeled Animal Welfare Concern Report Forms found in each
animal care facility.
b. Deposit the completed AWCRF in the mailbox of the laboratory animal
manager, the IACUC Chair or attending veterinarian (AV). The report can also
be completed electronically and e-mailed to iacuc@uwosh.edu
c. Alternatively, the AWCRF can be submitted anonymously to any of the persons
listed above.
d. All animal welfare concern reports must be promptly reported to the IACUC
chair and a report of the issue must be completed and submitted to the IO.
2. The IACUC and the IO:
a. Any concern submitted to the laboratory animal manager, the AV (Attending
Veterinarian) or/and IACUC chair will be promptly reported to the IACUC. A
report of the issue must be submitted to the IACUC office (Compliance Officer).
b. The IACUC chairperson or office may elect to contact OLAW if there are
questions as to whether the issue meets reporting requirements. At this point,
this will not be considered an official report and OLAW will not open a report
case until a preliminary report is filed.
c. The IACUC will send notice to the PI that an animal welfare or non-compliance
issue was reported to the IACUC. The PI is responsible for submitting a
response to the allegations within two business days. PI response is submitted
to iacuc@uwosh.edu
d. If the IACUC chairperson (or another member of the subcommittee) has a
conflict of interest regarding the concern, the member must recuse
themselves. The IO will appoint another individual as Acting Chairperson to
conduct IACUC business if the chair has a conflict of interest.
e. Once a response is received from the PI, an IACUC subcommittee will be
formed to conduct a preliminary investigation of the allegations. The
subcommittee will consist of at least two members of the IACUC, typically the
chair and an additional member, and the Compliance officer. The attending
Veterinarian will be on the subcommittee if the concern is related to animal
health. The Laboratory Animal Manager will be invited to attend the
subcommittee meeting if the issue involves animal welfare or improper
activities in the animal facilities.
f.
If the PI is unavailable or unable to submit a response to the allegations then
the subcommittee will continue with the preliminary investigation.
g. The subcommittee will prepare a report of their findings discovered during the
preliminary investigation. Following the preliminary investigation, the
subcommittee will decide whether additional information is required and if the
issue represents a reportable incident. If following initial review and
investigation, the IACUC determines there is an immediate threat to animal
health or welfare, the animal work may be immediately halted by order of the
IACUC. Decisions regarding work stoppage must be made in consultation with
the AV. Any stoppage of animal work must be accompanied by a prompt IACUC
meeting to determine how to remediate the situation.
h. If the subcommittee determines, by majority vote, that the allegation is
reportable then the IACUC chair and/or IACUC Compliance Officer and
subcommittee prepare and submit a preliminary report for OLAW (PHS Policy,
IV.F.3) and provide the IO with a copy. The IACUC Chair and/or Compliance
Officer will also determine whether or not the incident may be a reportable
event to USDA and AAALAC. If the animal work is federally-funded, the Grants
Office should be contacted to determine whether the funding agency requires
notification.
If the issue is deemed non-reportable by the subcommittee, the subcommittee
can determine whether further investigation and/or corrective actions are
necessary or if no further actions are required. The subcommittee will inform
the full IACUC committee of their findings. Any IACUC member can request a
convened meeting to further discuss the issue and subsequent findings.
i.
j.
The IACUC Chair or Compliance Officer will inform the full IACUC of any
reportable event submission and will provide the full committee with the
subcommittee’s report and recommendations for corrective action. The
preliminary report is presented at the next scheduled IACUC meeting or
distributed to the IACUC with an IACUC Preliminary Determination Form. All
committee members will have the opportunity to respond to the preliminary
report and have the authority to:
i. Accept report and corrective actions in present form
ii. Request modifications to the report
iii. Request full committee review and discussion at a convened meeting
Once the committee accepts the preliminary report (in present or modified
form), the IACUC Chair or Compliance Officer drafts a Final Report for OLAW
based on the IACUC’s deliberations and plan for corrective actions. The
drafted final report is submitted to the IO. If applicable, AAALAC and USDA
will also be provided with a final report of the incident.
Corrective actions that may be taken by the IACUC include, but are not limited
to:
i. Veterinary medical intervention,
ii. Suspension of animal research activity
1. The IACUC and IO have the authority to suspend a specific
procedure or activity, an entire protocol, or the PI
2. Re-training of staff if applicable
iii. Notification of appropriate safety, occupational health, or other
officials.
k. The IO will submit the final report electronically to OLAW’s Division of
Compliance Oversight (olawdco@mail.nih.gov) on behalf of the institution and
will copy the PI, IACUC office (iacuc@uwosh.edu) and the IACUC Chair on the
final report submission. The final report will then be shared with the full
committee. It is the responsibility of the IACUC Chair to communicate their
findings of the report to the concerned employee(s), unless the report was
submitted anonymously.
l.
The reporter has the right to request, from the IACUC Administration,
clarification on resolution of the issue.
m. If corrective actions have already been completed or there were no corrective
actions needed then the IACUC must vote to close the case.
Animal Welfare Concern Report Form
This form initiates the IACUC review of allegations on the violation of:
 Deviation from approved IACUC protocols
 Animal welfare laws and regulations
 Improper care of animals
1. Animal welfare concern: (attach additional sheets if necessary) (type or print)
2. Date of when the violation occurred: ____________________
3. Reporter(s) name and signature if deemed appropriate by the reporter:
(you may remain anonymous!)
4. Signature of the IACUC Chairperson: __________________________________
a. Date the report was received: __________________
5. Signature of the Attending Veterinarian: ___________________________________
a. Date the report was received: __________________
6. Signature of the individual leading the investigation: ________________________________
a.
Date the investigation was initiated: ___________________
b. Date the investigation was completed: ___________________
7. Summary of findings: (add additional sheets if necessary)
8. Actions taken: (add additional sheets if necessary)
9. Were the findings of this report discussed with the reporter? :
Yes______
No______
Date: _______________