Animal Subjects Protocol Summary Form
Project Title:
CRDF Global Proposal #: (If known)
SECTION A: INVESTIGATOR & IACUC1 SUMMARY INFORMATION
SECTION A.1: PRINCIPAL INVESTIGATOR (PI) (TEAM 1)
PI and Institution Information
Name (Last, First, Middle)
Institution
Department
City, Country
E-Mail Address
Telephone
IRB Information
Does Team 1 IACUC2 have primary responsibility for the study?
Is the IACUC based at the Team 1 PI Institution?
If “NO,” identify where the IACUC is based?
Has the IACUC approved the proposed study?
Will the Performance Site include Institutions other than the Principal
Organization(s)? List in Section A.3
Comments:
YES ☐
NO ☐
YES ☐
NO ☐
YES ☐
NO ☐
YES ☐
NO ☐
SECTION A.2: CO-PRINCIPAL INVESTIGATOR (TEAM 2) AS APPLICABLE
Co-PI and Institution Information
Name (Last, First, Middle)
Institution
Department
City, Country
E-Mail Address
Telephone
IRB Information
Does the Team 1 IACUC have primary responsibility for the study?
Is the IACUC based at the Team 1 PI Institution?
If “NO,” identify where the IACUC is based?
Has the IACUC approved the proposed study?
Will the Performance Site include Institutions other than the Principal
Organization(s)? List in Section A.3
Comments:
YES ☐
NO ☐
YES ☐
NO ☐
YES ☐
YES ☐
1
IACUC stands for “Institutional Animal Care and Use Committee. Reference Resources: 1) American Association for
Laboratory Animal Science (AALAS) https://www.aalas.org/iacuc#.U-0OuBB7Rbs, 2) Office of Laboratory Animal Welfare
(OLAW) http://grants.nih.gov/grants/olaw/guidebook.pdf and 3) OLAW IACUC Guidelines:
http://grants.nih.gov/grants/olaw/olaw.htm.
2 If an institute does not have an IACUC, an equivalent institutional ethics committee such as an IRB with the capacity to review
animal related protocols is an acceptable alternative.
As of August 14, 2014
SECTION A.3: PERFORMANCE SITES
List all collaborating and performance sites:
1.
2.
If other than above Principal Institution(s), list name and contact information of performance
site(s): (replicate table for additional sites)
Institution
Address
Main Contact Name
Contact Phone
Contact E-Mail
Study tasks to be performed at site:
SECTION B: RESEARCH SCOPE
SECTION B.1: SUMMARY OF PROPOSED RESEARCH
Summarize the proposed research using non-technical language that can be understood by
persons whose primary concerns are nonscientific.
I.
Brief statement of the purpose, background, significance, research design, and methods:
II.
III.
Description in non-scientific terms of how animals will be used. Include all manipulations and
procedures (including dietary manipulations). This description should provide an understanding of
what happens to an animal from the time of acquisition/interaction to the endpoint of the activity.
Description of the rationale for using animals for this activity. Could this study be done without
using animals?
SECTION B.2: PROJECT CHARACTERISTICS
Will investigator(s) intervene or interact with a living animal subject(s) to obtain
specimen or other information?
If yes, list directly involved investigators:
1.
2.
3.
4.
YES ☐
Does the research involve (check all that apply):
1. Research involving live animals maintained in a laboratory setting (Complete Section
C.1)
2. Research involves field study on live domesticated animals from a farm, slaughterhouse or
other monitored setting? (Complete Section C.2)
NO ☐
☐
☐
As of August 14, 2014
3. Research involves field study on live wild animals (Complete Section C.2)
☐
4. Research involves animal euthanasia for research or teaching purposes (Complete
Section D.5)
☐
5. Research involves observational study of live animals (non-invasive)
☐
6. Research involves invasive collection for research purposes of biological specimens
(Complete Section D.1)
7. Research procedures have potential to cause pain or distress, or discomfort to animals
(Complete Section D.2)
8. Research involves substance administration (including implants and devices) (Complete
Section D.3)
9. Research involves surgery (Complete Section D.4)
10. Research will include euthanasia and/or disposal of animals after use (Complete Section
D.5)
☐
☐
☐
☐
☐
SECTION C: ANIMAL STUDY ENVIRONMENT
Animal Selection. Provide the following information for all animals. No animal should be listed more than
once; count each in the highest proposed category of use. Add rows as needed.
* For field studies involving capture methods, anticipated non-target (by catch) species should also
be indicated by species or in aggregate as “miscellaneous.”
** Give ranges if the specific information is unknown.
*** Please choose from the following sources: commercial vendor, collected from the wild, third party
owned, or other (provide details).
**** See Appendix A
Species
Age and
(include common
Weight**
name)*
Source***
Category of
use****
Total Number
Requested
SECTION C.1: USE OF LIVE ANIMALS IN A LABORATORY SETTING (As applicable – If indicated
in Section B.2)
I. Description of the appropriateness of the species to be used.
II. How did you determine the number of animals to be used in this study?
III. Who will be responsible for animal care and maintenance? Describe the type of training they have
received.
As of August 14, 2014
SECTION C.2: USE OF LIVE ANIMALS IN A FIELD SETTING (As applicable – If indicated in
Section B.2)
I. Description of the appropriateness of the species to be used.
II. How did you determine the number of animals to be used in this study?
III. Who will be responsible for handling animals in the field? Describe the type of training they have.
SECTION D: CARE AND USE OF ANIMALS (As applicable – If indicated in Section B.2)
SECTION D.1: Invasive sample collection from live animals
(blood/urine/feces/tissue/other)
Species
Sample
Site(s) of
Sample
Collection
Method(s)
Volume(s)
Frequency
of Collection
Provide details for any sample collection procedures that may not be clear from this table.
SECTION D.2: Potential Pain and Distress
I. List each procedure or condition with potential for pain, distress, or discomfort, and give the
species and number of animals affected. Describe the clinical signs or abnormalities that are
expected or possible.
II. Describe the monitoring plan for pain and distress, including frequency and duration of checking
for health or behavioral abnormalities.
III. Describe how pain, distress, and discomfort will be minimized, consistent with scientific objectives
under the following conditions, as applicable.
Include the actions to be taken, and the specific criteria/endpoints for euthanasia, if applicable.
(Examples include not eating for >24 hours, loss of >15% of normal body weight, self-mutilation,
non-weight bearing for >24 hours, etc.)
As of August 14, 2014
a. If painful or distressful procedures or conditions are relieved with anesthesia, analgesia,
tranquilization, or other therapies:
(1) For each species to be used, list procedure or condition in which
methods will be used. Provide drug, dose, route, frequency of administration, and
anticipated duration of therapeutic effect. Include all medications, such as pre- and postanesthetics, antibiotics, paralytics, etc. (If applicable, describe surgery in next section.)
Species
Procedure or
condition
Agent
Dosage, route
Frequency
Duration
(2) Describe monitoring procedures to ensure adequacy and safety of anesthesia or
tranquilization.
(3) Describe monitoring procedures for recovery from anesthesia or tranquilization.
b. If painful or distressful procedures or conditions will NOT be relieved with anesthesia,
analgesia, tranquilization, other palliative therapies or humane endpoints, please explain
why.
c. If death is intended to serve as an experimental endpoint (i.e., if animals must be allowed to
die from an experimental condition or procedure), please explain why this experimental endpoint
is necessary for the study.
IV. If physical restraint (defined as more than 1 hour) will be used, describe physical restraint methods.
How will potential distress be minimized (e.g. sedation, acclimation/training)?
V. If trapping or other method of capture will be used in field studies, describe methods. Explain
how pain, distress, and discomfort are minimized.
As of August 14, 2014
VI. Exceptions to standards: Describe and justify any exceptions to federal (U.S. Government)
regulations or standards and give the species of animal and number to be used. (Examples of
exceptions: use of an animal in more than one protocol involving a major operative procedure from
which it is allowed to recover; deprivation of food or water; maintaining animals at temperatures
and/or humidity outside the ranges specified by the standards; not cleaning and/or sanitizing at
required frequencies; not providing diurnal lighting as required; not meeting space requirements;
exceptions from the exercise plan for dogs.)
VII. Consideration of Alternatives. If there are procedures or conditions that may potentially cause
more than momentary or slight pain or distress (by definition, this includes all Category D and E
studies outlined in Appendix A.), were alternatives considered?
Yes
No
"Alternative" refers to methods, models, and approaches that result in the reduction of the number of animals
used, that incorporate refinements of procedures which result in the lessening of pain or distress to animals,
or that provide for the replacement of animals with non-whole animal systems or the replacement of one
animal species with another, particularly if the substituted species is non-mammalian or invertebrate.
If Yes, list Alternatives and describe methods and sources consulted to determine availability or
appropriateness of alternatives for this protocol.
SECTION D.3: Substance Administration
I. Will anything be administered to, implanted in, or will devices be
used on animals?
YES
NO
II. If YES, list specific agents below and provide dosage information (mg/kg body weight and volume),
unless provided in Section B.3.
Radioisotopes? List/dosage: ______________
Pathogenic or viable organisms? List/dosage: ______________
Toxic chemicals? List/dosage: ______________
Carcinogens? List/dosage: ______________
Transplantable tumors*? List/dosage: ______________
Biological materials such as tissue, sera, or cell lines*? List/dosage: ______________
Recombinant DNA? List/dosage: ______________
Others not listed above, including implants or devices*? List/dosage: ______________
*If materials have been derived or passed through rodent species, they must be free of infectious agents
(Mouse Antibody Production [MAP]/Rat Antibody Production [RAP]/Hamster Antibody Production [HAP]
testing are diagnostic assays used as indicators of viral contamination of rodent products).
III. For each of the above, describe in detail the precautions taken to protect people and animals in the
environment, including handling practices for contaminated excreta, bedding and toxic metabolites.
IV. Describe the effects of these agents on the experimental animal. Potential for pain or distress should
be addressed in SECTION D.2.
As of August 14, 2014
SECTION D.4: Surgery
I. Surgery and postoperative monitoring and records must be in accordance with IACUC (or relevant
animal care and use body) guidelines.
II. Will surgery be survival or non-survival*? *(animal does not recover from anesthesia prior to
euthanasia)
Survival
Non-Survival
III. Describe in detail the surgical procedure(s) for each species to be used. Include description of presurgical preparation and method of closure, if applicable.
IV. If the animal will recover from anesthesia, how long will the animal be maintained after recovery?
V. Describe in detail the postoperative care, including any specialized care.
VI. Will individual animals undergo more than one surgical procedure?
Yes
No
If yes, provide scientific justification below.
SECTION D.5: Euthanasia/Disposition
I. Provide the following information for all planned/experimental euthanasia of animals.
Complete Section D.5.VI. (below) if animals will not be euthanized as part of these planned
animal use activities.
.
Species
Method/agent
Dosage, Route
II. How will death be confirmed?
observation for 20 minutes
bilateral thoracotomy
cervical dislocation after administration of euthanasia (drug, carbon dioxide, etc.)
other – please describe:
As of August 14, 2014
III. If applicable, justify methods that vary from the American Veterinary Medical Association
Guidelines on Euthanasia (http://www.avma.org/issues/animal_welfare/euthanasia.pdf).
Physical methods such as gunshot, decapitation and cervical dislocation also require
scientific justification.
IV. If these animals are not to be euthanized as part of your protocol, what will become of them?
V. Describe in detail the postoperative care, including any specialized care.
SECTION E: DOCUMENTATION & REVIEWS
Please submit or plan to obtain the follow documentation applicable to your study:
Documentation
Status/Comments
IACUC application (or equivalent ethics committee approval)
IACUC (or equivalent ethics committee approval) approval letter or form
Certificate of Training use and care of animals involved in Research
As of August 14, 2014
Appendix A
Pain and Distress Categorization
USDA Reporting: CFR Ch.1, 2.36(b)(5-7)
Category B
Animals being bred,
conditioned, or held for
use in teaching, testing,
experiments, research, or
surgery but not yet used
for such purposes.
Category C
Teaching, research,
experiments, or tests
conducted involving no pain,
distress, or use of pain
relieving drugs
Examples
Category D
Category E
Experiments, teaching,
research, experiments, or
tests conducted involving
accompanying pain or
distress to the animals and
for which appropriate
anesthetic, analgesic, or
tranquilizing drugs were
used
Teaching, experiments,
research, surgery, or tests
conducted involving
accompanying pain or distress
to the animals and for which the
use of appropriate anesthetic,
analgesic, or tranquilizing drugs
would have adversely affected
the procedures, results, or
interpretation of the teaching,
research, experiments, surgery,
or tests.
Examples
Examples
Standard agricultural
husbandry procedures (Ag
Guide 1999) not for
research, teaching or
testing.
1. Holding or weighing
animals in teaching or
research activities.
1. Diagnostic procedures
such as laparoscopy or
needle biopsies.
1. Research or procedures that
require continuation until
death occurs.
2. Euthanasia to relieve pain
and/or distress
2. Non-survival surgical
procedures.
Standard animal health
programs. i.e. routine
physical examinations,
vaccinations, etc.
3. Injections, blood collection
or catheter implantation via
superficial vessels.
3. Survival surgical
procedures, including
biopsies and cut-downs
for catheter placement.
2. Application of noxious
chemicals or stimuli (e.g.,
electrical shock) if the animal
cannot avoid/escape the
stimuli, and/or it is severe
enough to cause pain or
distress.
1. Pre-weaning methods of
identification (toe or tail
clipping, tattooing, wing
banding, ear notching,
etc.)
4. Teaching routine physical
examinations.
5. Observation of animal
behavior.
6. Feeding studies that do not
result in clinical health
problems.
7. Humane euthanasia
procedures that meet
AVMA standards.
8. Live trapping with minimal
potential for injury.
4. Postoperative pain or
distress is alleviated.
5. Ocular blood collection
in mice.
6. Exsanguinations under
anesthesia.
7. Induced infections with
appropriate anesthesia
and post-op/postprocedure analgesia
when necessary.
3. Novel prolonged restraint
4. Exposure to extreme
environmental conditions.
5. Prolonged withholding of food
and water.
6. Infectious or neoplastic
disease studies involving
unrelieved pain or distress.
9. Chemical immobilization or
restraint
10. Studies involving clinical
signs not judged to involve
more than slight pain or
distress.
As of August 14, 2014