Animal Census Tracking Policy - University of Southern Maine

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UNIVERSITY OF SOUTHERN MAINE
Office of Research Integrity & Outreach
Procedure #:
Date Adopted:
Last Updated:
Prepared By:
Reviewed By:
Procedure Title:
01-012
6/29/2007
8/2/2011
Sarah Gilliam, Animal Facilities Manager
USM IACUC Committee
Animal Census Tracking Policy
1.0 Purpose: To ensure that the use of animals within any given protocol does not exceed the number that
has been approved by the USM IACUC Committee.
2.0 Responsibility: It is the responsibility of the investigator, manager, technician, analyst or student
performing the task to follow the procedures established in this document.
3.0 Applicable Documents:
3.1 USM Animal Facility Standard Operating Procedures.
3.2 Guide for the Care and Use of Laboratory Animals
3.3 Public Health Service Policy on Humane Care and Use of Laboratory Animals
3.4 Appendix A-Daily Census Sheet
3.5 Appendix B-Census Tracking Log
3.6 Appendix C- Approaching Animal Limit Letter
3.7 Appendix D- At or Exceeding Animal Limit Letter
3.8 Appendix E- Animal Increase/Amendment/Revision Form
3.9 Appendix F- Field Study Animal Usage Form
3.10 SOP 01-011 Satellite Animal Facility Policy
3.11 SOP 02-012 Missing Animal Policy
3.12 SOP 02-013 Animals of Unknown Origin
4.0 Main Animal Facility Procedure:
4.1 For each protocol, the IACUC Committee shall approve a given number of animals for a three
year period.
4.2 Animals that are purchased, weaned, transferred, euthanized or found dead must be recorded in
the daily census sheet (Appendix A) accordingly.
4.3 Each week a facility staff member will do a physical count of the animals and cages within a
protocol and record the results.
4.3.1 If there is an inconsistency with the physical count and what the daily census
sheet reflects, then the staff shall follow the steps outlined in SOP 02-012 Missing
Animal Policy or SOP 02-013 Animals of Unknown Origin dependent on the situation.
4.4 From the beginning of the approval period for each protocol, the animal facilities manager shall
utilize information from the daily census sheets and record the number of animals used during
each week on the census tracking log (Appendix B).
4.4.1 The census tracking log will be kept on record to provide a manual backup of
census counts.
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4.5 The census tracking log will be used by the Office of Research Integrity & Outreach to enter
animal counts into the database and to compare with approved animal usage numbers for each
protocol.
4.6 If an investigator is within 50 animals or 25% of his approved animal use number, then the
Office of Research Integrity & Outreach will issue a letter (Appendix C) notifying the
investigator of this.
4.7 If an investigator is shown to be at their limit or over their limit, then the Office of Research
Integrity & Outreach will issue a different letter (Appendix D) warning that their protocol in
danger of suspension and requiring that the investigator cease all breeding, procurement, and
transfer of all animals into their protocol. Furthermore the letter will ask that the investigator
file an Animal Increase/Amendment/Revision form (Appendix E) to the IACUC if they need to
increase their animal number.
4.8 If the investigator fails to comply with their animal usage limit, and does not file an Animal
Increase/Amendment/Revision form, then it will be referred to the IACUC and the protocol will
be suspended until the situation can be resolved.
5.0 USM Satellite Animal Facility Procedure:
5.1 Each satellite facility within the University of Southern Maine campuses will be provided with
a daily census sheet.
5.2 Each investigator or designee shall perform steps 4.2 through 4.3 outlined in this document.
5.3 At the end of each week, the investigator will be required email or otherwise inform the animal
facilities manager the number of animals used for the week. Steps 4.4 through 4.8 will then be
followed by the appropriate individuals.
6.0 Field Study Procedure:
6.1 Each field study investigator is responsible for tracking their census numbers for each protocol.
6.2 Every six months each field study investigator is required to submit a Field Study Animal Usage
Form (Appendix F) for each protocol to the Office of Research Integrity & Outreach for
comparison to their approved animal usage number(s).
6.3 The Office of Research Integrity & Outreach will then follow steps 4.6 through 4.8 accordingly.
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Appendix A
Daily Census Sheet
P.I.: Dr. _____________________ Protocol #_____________
Month_____________ Room #:___________________
date
sent
+ Animals
-
total
+ cages -
total
Room checks/comments
Temp*
o
F*
Humd*
%*
sentinels #
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
*Normal temperature range should be 64o-73oF and 40%-60% humidity. Deviations from this should be reported to the Animal Facilities Manager.
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Appendix B
Animal Census Tracking Log
IACUC Protocol # _____________________
Principal Investigator: __________________
Species: ___________________
Approved Number of Animals (per year): ___________
Approval Period (1 year): ______________________
Week 1:
Week 16:
Page #: _____
Week 31:
Week 46:
+
+
+
+
Week 2:
Week 17:
Week 32:
Week 47:
+
+
+
+
Week 3:
Week 18:
Week 33:
Week 48:
+
+
+
+
Week 4:
Week 19:
Week 34:
Week 49:
+
+
+
+
Week 5:
Week 20:
Week 35:
Week 50:
+
+
+
+
Week 6:
Week 21:
Week 36:
Week 51:
+
+
+
+
Week 7:
Week 22:
Week 37:
Week 52:
+
+
+
+
Week 8:
Week 23:
Week 38:
Week 53:
+
+
+
+
Week 9:
Week 24:
Week 39:
+
+
+
Week 10:
Week 25:
Week 40:
+
+
+
Week 11:
Week 6:
Week 41:
+
+
+
Week 12:
Week 27:
Week 42:
+
+
+
Week 13:
Week 28:
Week 43:
+
+
+
Week 14:
Week 29:
Week 44:
+
+
+
Week 15:
Week 30:
Week 45:
+
+
+
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Appendix C
Approaching Animal Limit Letter
Date:
TO:
FROM:
RE:
Office of Research Compliance
IACUC Animal Census Total
Protocol IACUC #
NOTICE OF APPROVED ANIMAL LIMIT
For IACUC #
, you were approved for the usage of
animals during the period from
to
. Currently, your animal total is 50 animals or less away from this approved
number. Please make sure that you do not go over your approved animal number-if you do
your protocol will be in danger of suspension.
If you need to increase the number of animals for your protocol, you will need to file an
Animal Increase/Amendment/Revision form. This form may be found on the Office of
Research Compliance (ORC) website at http://www.usm.maine.edu/orc/iacuc/forms.htm.
If you have any questions or concerns, please do not hesitate to call the ORC at 7804268.
cc:
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Appendix D
At or Exceeding Animal Limit Letter
DATE:
TO:
FROM:
Office of Research Compliance
RE:
IACUC Animal Census Total
Protocol IACUC #
NOTICE OF EXCEEDED ANIMAL LIMIT
For IACUC #
, you were approved for the usage of
animals during the
approval period from
to
. You have now reached or exceeded the total
IACUC approved number of animals. Your protocol has been referred to the IACUC and
is in danger of suspension. You must cease all breeding, animal procurement, and
transfers immediately.
If you wish to increase the number of animals for this protocol, you will need to file an
Animal Increase/Amendment/Revision form. This form may be found n the Office of
Research Compliance (ORC) website at
http://www.usm.maine.edu/orc/iacuc/forms.htm.
If you have any questions or concerns, please do not hesitate to call the ORC at 7804268.
cc:
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Appendix E
Request for IACUC Revision/Amendment
Request for Increase in Animal Usage/
Study Completion Notification
Instructions: Please check all applicable boxes below. Fill out the section(s) of this form that is applicable,
then return completed form to the Office of Research Compliance, 178 Science Wing, Portland.
 Study Completion Notification
 Request for Increase in Animal Usage
 Request for IACUC Revision/Amendment
MANDATORY SECTION
1. Study Title:
(cell will expand)
2. IACUC Study Number (Assigned at time of initial
review.):
3. Principal Investigator Information:
All Information Below is Required
Name of
Principal
Investigator:
Mailing
Address:
Are You? (Please check)
Faculty
Staff
Undergraduate Student
Graduate Student
Postdoctoral fellow
Department:
E-mail
address:
Other
Phone
Number:
Fax
:
Section I: Study Completion Notification
Check one of the following. This study is:
Active
Not Active
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Completed or
Discontinued
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Appendix D (cont.)
Please go to Section IV and complete the Signatures section.
Section II: Request for Increase in Animal Usage
Are you using transgenic animals:
□ Yes
□ No
1. Number of animals approved for use this year:
2. Additional number of animals needed for remainder of this study year:
3. Total number of animals needed for year. (#1 + #2 = #3). This should include any previously
approved increase
request(s):
4. Justification for Increased Number of Animals.
Please go to Section IV and complete Signatures section.
Section III: Request for IACUC Revision/Amendment
Instructions: For any changes/revisions to your study, complete this section, attach changed research
documents, and fill out Signatures section below.
Are you changing, adding, and/or deleting any of the following from your study?
Check those that apply:






Transgenic animals
Controlled Substances
Radioactive Materials
Hazardous Materials
Use of Risk Group 2, 3, or 4 agents
Change requiring occupational health review/assessment
Did the original study submission require IBC or RSC review?
 Yes
 No
1. Briefly describe, and explain the reason for the revision/amendment. Include a copy of the affected
study pages, with specific changes highlighted, including any changes in the use of controlled
substances, transgenic animals, and biohazards. (If any new substances (previously noted) have been
added to your study, you must request IBC approval prior to making any changes.)
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Appendix D (cont.)
(cell will expand)
Section IV: SIGNATURES
Original signatures are required. The application will not be processed until all signatures are obtained.
SIGNATURE OF PRINCIPAL INVESTIGATOR:
The undersigned accept(s) responsibility for the study, including adherence to any federal or state regulation;
IACUC policies and procedures; requirements of the granting agency (if applicable); and all USM policies
regarding research conduct, safety and security. In the case of student studies, the faculty supervisor and the
student share responsibility for adherence to policies.
Print Name of
Signature of
Date:
Principal
Principal
Investigator :
Investigator :
SIGNATURE OF FACULTY RESEARCH SUPERVISOR- REQUIRED FOR STUDENT
RESEARCH
**By signing this form, the faculty research supervisor attests that (s)he has read the attached study submitted
for IACUC review, and agrees to provide appropriate education and supervision of the student investigator,
above.**
Print Name of
Faculty
Research
Supervisor:
Signature of
Faculty Research
Supervisor :
Date:
Submit form to the Office of Research Compliance, 178 Science Building, Portland Campus.
A drop off box is located outside Science Room 178. For questions call: (207) 780-4268.
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Appendix F
Please type in the gray field below:
Field Study Animal Usage Form
PI Name(s):
IACUC #:
Date:
Current Approval
Period Dates:
(Write in Total Below)
6 Month Animal Usage Total
Return this form to:
Deborah Briskey, Operations Specialist:
U.S. Mail Address:
- OR -
Office of Research Compliance
University of Southern Maine
P.O. Box 9300
Portland, ME 04104-9300
Inter-Campus Address:
178 New Science Wing
Portland Campus
Thank You!
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