notice for resubmission of animal experimentation protocol

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Revised September 6, 2011
HMS IACUC PI/REVIEWER CHECKLIST FOR ANIMAL PROTOCOL
_____
(A.) Animal checklist page for animal procedures is properly completed.
REMINDER: any procedure in Category D or E has a search for Alternatives completed
in Section P.
_____A.2. Adequate justification is provided for animal numbers and species requested
including statistical analysis used or groups defined.
_____ (B.1) Aims and Significance of the research is clearly defined in lay summary and not
as a grant excerpts.
_____(B.2) All Procedures to be performed on the animals clearly detailed with comparable
flow chart included or appended with consistent information in written section and
Flowchart.
______(B.3) Progress report describes results and changes over the course of three years.
References included as appropriate but cannot be only documentation.
______(B.4.): FLOWCHART MUST BE INCLUDED. It will be in Medical Record of each USDA
Covered Species
_____ (C) Qualifications of persons performing procedures appropriately described and
training clearly documented including date of last AALAS Learning Library completion.
_____ (D) Housing and animal identification described with special attention to toe clipping
requests and request for Exemption Form.
______(D.4): Confirm request for not socially housing NHPs is scientifically justified.
_____ (E) Methods of euthanasia properly described with drugs, dosages, routes, and
secondary method if CO2 or inhaled anesthetic; also methods such as cervical
dislocation (CD) or decapitation scientifically justified if performed without prior
anesthesia and name and training of person performing the method.
_____(E2) Appropriate Disposition of Animals documented.
_____ (F) Appropriate immunization procedures or adjuvant use described.
REMINDER: CFA can only be used once.
______(G) Ascites production should be included in the search for Alternatives in Section P3
as an alternative exists.
_____ (H) Transgenic Animals appropriately described and methods for assessment and
alleviation of discomfort caused by phenotypes detailed. COMS # given.
_____ (I) Complete explanation of involvement of all experimental agents given;
COMS # given. Agents are correctly categorized in I.1.
REMINDER: CHECK FOR PHARMACUETICAL GRADE ADHERENCE
_____ (J) Appropriate and complete explanation of surgical procedures and justification for
multiple major surgeries and procedures provided.
REMINDER: Procedures must coincide specifically with Flowchart. Surgical procedures
must also be included in the search for Alternatives in Section P.
_____ (J.2.c.6-9. and Q) Full and correct description of monitoring of post-procedural
animals for pain and distress including drugs, dosing, and frequency of administration.
Long-term monitoring should also be described in Q.
______(L, M, N) Appropriate methods in place to minimize distress in studies
involving pain, paralytics, restraint, food and water deprivation, or behavior. All must
be included in a search for alternatives in Section P.
_____ (P) PI provides reasonable assurance that alternatives to either animal use or
proposed painful or distressing procedures do not exist or if alternatives do exist,
explanation for procedures to minimize pain and distress is adequate and appropriate.
REMINDER: For each procedure checked in Category D or E, PI must conduct a
literature search for alternatives to the painful or distressful procedure. Key words
must be specific to painful or distressing procedures and not just to the animal model
or general disease (i.e., arthritis, atherosclerosis, etc.)
_____ (R) PI provides assurance that procedures do not unnecessarily duplicate previous
experiments and uses Key words different from those used in Section P.
_____ Signature pages signed by PI, Department head, and staff performing procedures on
the animals
NB: Death as an Endpoint Studies and other category E procedures: PI has addressed issues
of discomfort by including possibility of giving analgesia or other comfort or relief measures
(i.e. temperature or environmental adjustments) to reduce animal stress during monitoring
for moribund state requiring euthanasia. PI justification for lack of comfort measures based
on interference with experimental endpoints. PI has addressed emergent situations and
problems specific to the research.
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