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OF
RECORD
Institutional
Animal Care and Use Committee (IACUC) Policy for Review and Investigation
of Animal Welfare Concerns
Purpose
The purpose of this policy is to describe the procedures that
will be followed for addressing animal welfare concerns at the
University of Pennsylvania.
Background
Congress amended the Animal Welfare Act (AWA) in 1985 in Public
Law 99-198. The Secretary of Agriculture was directed to promulgate
new rules governing the humane handling, care, and treatment,
and transportation of animals by dealers, research facilities,
and exhibitors. A requirement under the AWA is that the IACUC,
as an agent for the research facility, "review and if warranted,
investigate concerns involving the care and use of animals at
the research facility resulting from public complaints received
and from reports of noncompliance received from laboratory or
research facility personnel or employees from reports of noncompliance
received from laboratory or research facility personnel or employees
[Federal Register Vol. 54, No. 168, Thursday, August 31,
1989, final rule 2.31[c][4]:p. 36152]. "The research facility
must maintain documentation of the Committee's reviews and investigations
conducted in response to complaints received in order to demonstrate
its compliance with these regulations". The research facility
determines the form and method of such documentation [ibid. p.
36128].
Reporting
Animal welfare concerns can be expressed in writing, by telephone
or in-person. They can be sent anonymously. Concerns can be made
to the Office of Regulatory Affairs (ORA), (215-898-2614), the
University's Corporate Compliance Office (1-888-236-8477), the
Chairperson or members of the Institutional Animal Care and Use
Committee (IACUC). All concerns will be reviewed regardless as
to how they are received. The two recommended ways of reporting
a concern are:
An
animal welfare concern can be reported and the individual will
be known to the IACUC and will be part of the investigation process.
An animal welfare concern can be anonymously submitted. An individual
can approach any IACUC member, the ORA office or the UCCO. The
person approached will act as the complaint or employee's representative
throughout the process. The rest of the IACUC, ORA, or UCCO will
not know the individual's name.
Procedures
The procedures when any concern involving the care and use of
animals at the University of Pennsylvania is received by the IACUC,
ORA, or UCCO is as follows:
The
Director of ORA will be responsible for bringing the concern to
the attention of the IACUC Chairperson and to the Vice Provost
for Research.
The
IACUC Chairperson will be responsible for the review and if warranted
the investigation. The IACUC Chairperson will notify the IACUC
Committee of the pending reviewand investigation. The IACUC Chairperson
will keep the IACUC Committee informed on the progress of the
review and the investigation (if warranted) on the preparation
of action steps and recommendations and on the completion of the
welfare concern.
An
investigation, if warranted, will proceed immediately (normally
no later than 5 working days). The investigation will involve
the participation of the IACUC Chairperson and the Director of
ULAR (University Laboratory Animal Resources). The investigation
will include contacting the Principal Investigator for the animals
which the animal welfare concern was raised, along with others,
if warranted. Consultants and others may assist in the investigation.
Generally, within 10 working days after completion of the investigation,
the IACUC Chairperson and the Director of ULAR [including consultants
and additional designated resources, if deemed appropriate] will
meet to discuss the review/investigation and preparation of action
steps/recommendations. The results of this meeting will be provided
to ORA and to the Vice-Provost for Research. The results of the
investigation/resolution of the concern will be shared with the
person reporting the animal welfare concern by ORA. This may take
the form of a meeting, letter, or other communication. If the
concern is anonymous, the University member (IACUC, ORA, UCCO)
representing the person reporting the concern will meet as above
and then inform the person of the resolution.
Record
Retention
A report of the animal welfare concern and the appropriate documents
from the IACUC investigation and the action steps/recommendations
process will be maintained by the ORA for a period of 3 years.
The AWA stipulates that "the research facility must maintain documentation
of the Committee's reviews and investigations in response to complaints
received in order to demonstrate its compliance with these regulations"
[ibid. p. 36128].
Public
Notification
On an annual basis, the Director of ORA will submit this policy
to Almanac for publication. Within the animal facilities,
informational signage regarding this policy will be posted.
-- Joseph R. Sherwin, Director of Office of Regulaatory Affairs
Almanac, Vol. 48, No. 2, September 4, 2001
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