For Committee use only:
Protocol #:
Original:Revision:
Approved:
Tufts University- Medford Campus Animal Care and Use Committee (IACUC) Protocol Review Form for Animal Research
Ø All uses of live vertebrate animals must be approved by Tufts University-Medford Institutional Animal Care and Use Committee (IACUC).
Ø Acquisition and housing of all live vertebrate animals must be approved by the Division of Laboratory Animal Medicine (DLAM).
Instructions:
1. Protocol Form must be typed or Word-processed. The Protocol Review Form is available on diskette or the intranet for Word processing. Please contact the IACUC Administrator at 636-5612 for advice on Protocol Review Form completion. A pre-review is strongly encouraged.
2. If a letter to a granting agency needs to be submitted regarding the research in this protocol, please complete the Tufts-Medford IACUC "Grant or Funding Proposal Review Form” and submit the relevant “Vertebrate Animal” section of the grant application for verification.
3. Any proposed changes from those in an approved protocol, including: animal species, numbers, procedures, or personnel must be reviewed by the IACUC by submitting an amendment on “Supplement A”. Major changes necessitate submission of a new Protocol Review Form.
4. Send completed and originally signed Protocol Review Form to the IACUC at 20 Professor’s Row. Keep a copy of the Protocol Review Form for your records. You will receive written notification of the IACUC's review.
I. General Information
A. / Principal Investigator: / Degree(s)Academic Title: / Dept/Inst.:
Address:
phone: / fax: / email:
B. / Contact person[*]: / Degree(s):
Address:
phone: / fax: / email:
*Contact person is the individual who will be contacted regarding an animal’s health or disposition when action is required. All correspondence from the IACUC will be sent to the PI
C. / Title:SUPPLEMENTAL FORMS
The following forms should be completed and submitted with the Protocol Review Form as appropriate. Please check the forms used
Form / TitleA / Animal Use Protocol Addendum
B / rDNA Registration Form (submit to Environmental Health and Safety Office)
C / Infectious Agent Registration Form (submit to Environmental Health and Safety Office)
D / Carcinogen/Biohazard Registration Form (submit to Environmental Health and Safety Office)
E / Radioisotope Radioisotope Registration Form (submit to Health Physics Office)
F / Surgical Procedures, Ante-Mortem Tissue, and/or Fluid Harvest
G / Immunization and Blood Collection
H / Ascites Production
I / Tumor Induction (Other Than Hybridoma)
J / □ / Device Implantation
K / Genetically Engineered Animals & Breeding
L / Behavioral Training Techniques
M / Teaching or Training Proposal
N / Non-Human Primate Requirements
II. Project Personnel
Federal law requires that the Committee evaluate the training and qualifications of personnel who intend to use live animals in research or teaching. Federal and state law requires all research personnel to be appropriately qualified to conduct work with animals. Personnel must, at a minimum: 1) understand the basic needs of each species they utilize; 2) use proper techniques when handling each species and select methods that minimize animal distress; 3) provide proper pre- and post-procedural care to animals; 4) use aseptic surgical techniques, when applicable; 5) select and use anesthetics and tranquilizers appropriate for each species and 6) be aware of all procedures approved in the protocol. For each relevant animal procedure listed below, indicate all individuals who will conduct the various procedures and describe their qualifications (e.g., certification, experience, species utilized, etc.). If DLAM staff will perform all animal procedures, please indicate. Please list personnel below and use their initials in the relevant rows and columns of the table.
*Personnel must attend a Mandatory Animal Care and Use Training Session or complete the online training within 90 days of addition to an active protocol. Please contact the IACUC Administrator at 636-5612 for details and schedule of the training sessions. NOTE: Training in specific animal procedures is available from the DLAM staff by request.
NAME PHONE EMAIL
1.2.
3.
4.
5.
Procedure / Personnel involved / Specific experience with the following as pertains to this protocol
*please indicate time in years SPECIES TECHNIQUES / Mandatory Animal Care and Use Training?
Yes/No* / Occupational Health and Safety clearance?
Yes/No
Animal handling
Breeding
Agent administration
Sample collection
Animal surgery
Animal euthanasia
Other
III. Animal Numbers and Categorization
/ Species 1 / Species 2 / Species 3Animal species to be used
Total number requested (3 years)
ASSESSMENT OF PAIN AND DISTRESS: For each species, identify the number of animals that will be utilized in each category below. If research involves procedures in either Category D or E, you must complete Section IV.
USDA Category C: procedures with minimal, momentary, or no distress
USDA Category D: use of appropriate anesthetics, tranquilizers, or analgesics to alleviate pain and/or distress
USDA Category E: animals may experience unrelieved pain and/or distress without intervention
Species 1 / Species 2 / Species 3Category C
Category D
Category E
IV. Search for Alternatives
A. Federal regulations mandate that you describe how the lack of alternative methods was verified for each potentially painful/distressing procedure (required for use of Category D and/or E). The alternatives search must include all of the following:
the database(s)searchedthe date that the search was conducted
the years covered by the search
the keywords or search strategy used
the number of references found
B. It is recommended that a printout of the most relevant searches be submitted with the protocol. In addition, a narrative must incorporate the information above and be written so that the Committee can readily assess whether the search topics above were appropriate and whether the search was sufficiently thorough. Please include the narrative below.
V. Project Objectives and Justification
Federal regulations mandate that responses, in Section V only, must be understandable to a layperson. Therefore, please simplify or define all field-specific terms. The target audience is a non-scientist in the general public that will understand the objectives and importance of this specific project from the following explanations.
A. Specific objectives of this project: (Please describe hypothesis to be tested and indicate explicit goals.)
B. Describe the potential contributions and significance of this project to human and/or animal health and to the advancement of scientific knowledge.
C. Justify the use of animals: Explain why animals are needed for this project. Please include a brief discussion of why non-animal alternatives cannot be utilized. Responses must be understandable to a layperson.
D. Justify the choice of species: Explain why this particular animal or animal model was selected. Describe the unique characteristics that each species, stock, strain, or mutant you plan on using has that are necessary for your investigations. List stocks or strains for each species. Responses must be understandable to a layperson.
E. Justify the number of animals requested: (Explain how the number of animals requested was determined. Please briefly detail the experimental design so that the reviewer(s) can ascertain how the total number of animals was obtained. You are encouraged to include a table or flowchart. Please include a brief description of the statistical analyses, including tests, power and probability levels utilized, if applicable.
VI. Project Details [necessary supplement(s) indicated]
1. Is tissue harvest involved? yes no
Supplement F required if harvest is ante-mortem
2. Is blood or body fluid collection involved? yes no
Supplement G for blood collection or Supplement F for body fluid harvest
3. Is surgery involved? yes no
Supplement F
4. Is anesthesia administered? yes no
Supplement F may be required
5. Is immunization and antibody harvest involved? yes no
Supplement G
6. Is ascites production involved? yes no
Supplement H
7. Is a hazardous chemical, microbial agent, or radiation administered? yes no
Supplement, C, D, and/or E.
GIVE APPROVAL #
8. Is recombinant nucleic acid administered to animals? yes no
Supplement B
GIVE APPROVAL #
9. Are tumor(s) induced, transplanted, or passaged? yes no
Supplement I
10. Is device implantation performed? yes no
Supplement J
11. Are genetically modified animals constructed or used? yes no
Supplement K
12. Is behavioral training involved? yes no
Supplement L
13. Is teaching or training involved? yes no
Supplement M
(attach a copy of any written material pertaining to animals
used in this course that will be distributed to the students)
14. Will there be any non-standard housing conditions? yes no
(For an explanation of standard housing,
consult the Division of Laboratory Animal Medicine’s Users Guide)
If yes, please explain
15. Will non-human primates be used? yes no
Supplement N
16. Are unanesthetized animals restrained OVER 30 min? yes no
If yes, indicate the method, duration, and frequency below
17. Are there multiple survival surgeries? yes no
If yes, indicate the time between surgeries below
18. Will water and/or food be restricted during any portion of this project? yes no
If yes, please describe (substance restricted, duration, location, monitoring, etc.) unless restricted for behavioral training,
in which case Supplement L should be completed. This does not include overnight fasting for anesthetic induction.
VII. Experimental Plan
Detail how you will use these animals. Outline the experimental design sequentially. Describe all procedures and time intervals between procedures. Include specific information on how study duration and endpoint will be determined. Indicate how all procedures and compounds administered will affect animal health. Explain the ultimate disposition of the animals. Flow charts may add clarity. Reserve specific experimental details for the supplemental forms.
VIII. Location of Animals
Are live animals ever removed from the centrally-managed housing facilities? yes no
If yes, please respond to the following:
Purpose for which room is used / Room number / Longest period of time theanimals would be present
sacrifice/tissue harvest
surgery (non-survival)
non-surgical procedures (survival)
surgery (survival)
other (specify):
IX. Therapeutic Restrictions
In an emergency, animals will be treated to relieve suffering and preserve life, or if necessary, euthanized. Investigators will be contacted prior to diagnostic testing, therapy, or euthanasia whenever possible. In the event that contact is not possible, please respond below, and list restrictions on therapy where applicable:
A. No therapeutic restrictions exist.
B. Do not use the following medications (e.g., corticosteroids, antihistamines, antibiotics):
C. If emergency euthanasia is necessary, please save the following specimens: (NOTE: Special arrangements must be made by the responsible investigator with DLAM before onset of the project.)
X. Post-Procedural Care and Monitoring
A. What adverse effects may occur as a result of these experiments to the animals? (Describe distress, pain, significant discomfort, morbidity, etc.) If adverse effects occur, how will they be alleviated?
B. State the nature and frequency of observations to evaluate pain/distress of the animals during the course of the research.
XI. Disposition of Animals Following Study
Provide details of euthanasia for each species. If animals are not euthanized please describe their final disposition. Even if some animals are not euthanized, protocols must include an emergency plan in case euthanasia becomes necessary. (If a physical method of sacrifice, such as cervical dislocation or decapitation, is used without prior anesthesia or sedation, please provide scientific justification in Section F, including research references.
c All/Some animals described in this protocol will be euthanized upon completion.
1) Euthanasia method:
Dose (mg/kg) of: / Route: / Volume (ml):If applicable, give
2) What tissues from euthanized animal(s) will be available for utilization by other investigators?
3) Individual(s) responsible for administering euthanasia:
c All/Some animals described in this protocol will NOT be euthanized upon completion.
Please describe the fate of these animal(s). (Please note that no animal may be given away without permission from DLAM.)
XII. AuthorizationPrincipal Investigator: As the individual responsible for this project, I confirm that (check boxes):
The information contained in this protocol is true and accurate, and that, to the best of my knowledge, it conforms with Tufts- Medford IACUC, NIH, USDA, and MDPH policies on the use of animals in research and teaching.
I have considered alternatives to the biological models used in this project, and have found these other methods unacceptable on scientific or educational grounds.
This project does not unnecessarily duplicate previous experiments.
All personnel named in Section II have agreed to participate in this study. All individuals who will be involved with the animals used in the project have been instructed in the humane care, handling, and use of animals, and I have reviewed their qualifications.
No change will be made to procedures, care, or housing without prior written notification to and approval by the Institutional Animal Care and Use Committee (IACUC).
I understand that failure to comply with IACUC policies and procedures will jeopardize Tufts-Medford’s Animal Welfare Assurance on file with the NIH, and may lead to revocation of my privileges to conduct animal research at this institution.
Principal Investigator / DatePlease submit this form bearing the original signature of the Principal Investigator
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