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Reporting
Issues of Non-compliance
Concerns
about animal care and use may be reported anonymously to the Chair of
the IACUC or to responsible personnel at each facility. Contact information
is made available through the posting of notices in facilities and laboratories
that provide contact names and phone numbers. The IACUC Chair, in most
cases with assistance from the Director of LARC, will investigate every
concern that is reported and gather pertinent facts concerning the allegations.
They will then notify the individuals involved that a complaint has been
received and that it is under investigation. If the results of the initial
investigation suggest that a significant problem or deliberate non-compliance
with the PHS Policy occurred, the issue will be discussed at a convened
meeting of the IACUC. If a quorum of the IACUC recommends that the activity
be suspended, the Dean shall be consulted. He will immediately institute
appropriate corrective measures and notify OLAW, other appropriate governmental
agencies (USDA), and university officials. As required by the Animal Welfare
Act, individuals who truthfully report concerns about the care and use
of animals are protected against reprisal.
To report
issues of non-compliance or animal use concerns contact one of the following
individuals.
Gordon McLennan, M.D., IACUC Chair
317-278-9831
gmclenna@iupui.edu
Andrew Blickman, D.V.M.
317-274-1958
pager: 541-7316
ablickma@iupui.edu
Lisa Brossia, D.V.M.
317-278-8604
pager: 541-6506
lpompos@iupui.edu
Guidelines
to Resolve Issues of Non-compliance
Introduction
The Indiana University School of Medicine Institutional Animal Care and
Use Committee (IACUC) has developed a system for evaluating issues of
non-compliance with IACUC policies and regulatory guidelines. The IACUC
will discriminate between serious issues and all other issues of non-compliance
for which a point system will now be instituted.
Serious
Issues of Non-compliance
Deficiencies or infractions directly resulting in animal distress or suffering
are considered serious issues of non-compliance. If an occurrence of non-compliance
directly results in animal distress, the Committee will interrupt all
animal work immediately pending a review and details of the non-compliance
will be reported to the appropriate regulatory agencies in compliance
with the Public Health Service Policy, Office of Laboratory Animal Welfare
(OLAW). The institution is required to “promptly provide OLAW with
a full explanation of the circumstances and actions taken with respect
to: a. any serious or continuing noncompliance with this Policy; b. any
serious deviation from the provision of the Guide; or c. any suspension
of an activity by the IACUC.”
Examples of serious
issues of non-compliance are:
- Acquiring animals
for research without an IACUC approval and knowledge of the LARC.
- Cause harm to an
animal - Performing a procedure in such a manner that animals endure
distress, pain, or suffering that is not addressed in the approved protocol.
Other issues of non-compliance will be addressed as noted below.
Other
Issues of Non-compliance
If an occurrence of non-compliance does not directly result in animal
distress, the principal investigators will be assigned points for each
occurrence. This system was designed so the seriousness of an occurrence
and/or repeated occurrence would determine the level of action taken.
The point system will be reset to 0 each year. Some examples are listed
below. Once an investigator has accumulated four points, the IACUC will
use the procedures outlined in the first level as a guide in resolving
the issue. Likewise, the second level is followed when six points are
accumulated and the third level when eight points are accumulated.
Appeal
Process
Investigators may appeal the application of points or levels of disciplinary
actions taken. To do so, written correspondence must be submitted within
two weeks of the action. The correspondence must addressed to The IUSM
IACUC Chair and mailed to the IACUC office. Further it must identify the
action they wish to appeal and clearly explain why it should be removed
from their record. Appeals will be held and discussed at the next scheduled
IACUC meeting after the appeal submission.
Examples
of deficiencies noted or infractions incurred that would result in a one-point
penalty:
- Not following
safety procedures when working at a level of BSL1 or lower (such as
proper personal protective equipment use, waste disposal or chemical
handling)
- Housing animals
in the laboratory without approval
- Insufficient records
of monitoring animals (disease condition, PI care, or survival surgery)
- Exceeding the
number of animals approved on the study (breeding colonies)
- Expired drugs
or materials used for anesthesia or survival surgery, or expired drugs
used for euthanasia
- Cage cards not
containing the required information
- Cage overcrowding
- Controlled substances
not stored properly or dispensing logs not kept
- Unlabeled bottles
- Moving laboratory
without notifying the IACUC office of the new location
- Failure to notify
the IACUC office of employee transfers of personnel with prior or existing
documented training on file.
- Uncovered water
bottles or open containers in animal rooms (PI care rooms)
- Failure to maintain
standard operating procedures for room cleanliness and upkeep
- Failing to document
post-procedure care
- Minor protocol
deviation
- Failure to respond
to IACUC concerns by designated deadlines.
Examples of deficiencies
noted or infractions incurred that would result in a four-point penalty:
- Not following
aseptic technique when performing survival surgery
- Not maintaining
up-to-date-occupational health records when working with animals where
participation is mandatory.
- Allowing new personnel
to work with animals before completing and submitting the required training
- Performing a procedure
that is not included in the protocol (not resulting in distress/suffering).
- Not observing
safety procedures when working with animals at a level of BSL2 or higher
- Failure to monitor
animals, adequately following an invasive procedure
- Major protocol
deviation
Levels
of disciplinary action
First level
When there is an accumulation of four points.
All activities involving the use of animals will not be interrupted; however,
those activities related to the infraction will only be allowed to continue
with consultation by an individual designated by the Committee. The consultation
may include training and written exams.
Second level
When there is an accumulation of six points.
Activities involving all use of animals will not be interrupted; however,
future animal orders will not be allowed until the principal investigator
provides a written response addressing the specific issues to the satisfaction
of the IACUC.
Third level
When there is an accumulation of eight points.
Activities involving the use of animals will be suspended immediately
until such time as the IACUC can discuss the infraction and develop a
recommendation during a convened meeting. These repeated offenses will
be handled on a case-by-case basis. The Public Health Service, USDA (if
applicable), and funding agencies will be notified of the suspension and
the resolution.
Possible
resolutions to a third level penalty include but are not limited to:
- Requiring that
LARC perform the service for a fee
- Continuation of
activities at a time approved by the IACUC
- Permanent suspension
of activities using animals
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