ORC FORMS, Revised 12.18.2014
Office of Research Compliance
Institutional Animal Care and Use Committee
(Phone) 208.426.5401 | (Fax) 208.426.2055
| MS 1138
FIELD STUDY PROTOCOL APPLICATION
· Please see “Instructions & Checklist for submission of IACUC Protocol Applications” for additional information and instructions.
· Please note that spell check will not work on this application; please proofread before submitting. All information must be typed.
· Submit completed application and ALL relevant materials to:
· Submit the first two pages, signed by all PRINCIPAL investigators, to: Office of Research Compliance, Boise State University, 1910 University Drive, Riverfront Hall, Suite 311, Boise, ID 83725-1138. Campus Mail Stop 1138.
SECTION A: Researcher Information1. / Project Title:
2. / Duration of Study: / Anticipated Start Date: / Anticipated End Date:
3. / Duration of Protocol: / Anticipated Start Date: / Anticipated End Date:
4. / Principal Investigator:
Faculty
Director
Other:
Department: / Phone:
E-mail:
Roles and responsibilities in this study:
Enrolled in Animal Care Occupational Health & Safety Program (OHSP)? / Yes / No
CITI training completed? / Yes / No
Additional training received in animal care and use:
5. / Co-Principal Investigator:
Faculty
Director
Other:
Department: / Phone:
E-mail:
Roles and responsibilities in this study:
Enrolled in Animal Care Occupational Health & Safety Program (OHSP)? / Yes / No
CITI training completed? / Yes / No
Additional training/experience received in animal care and use:
**To list additional investigators and/or personnel (i.e. graduate students, students, etc.) complete the ADDITIONAL PERSONNEL form.
SECTION B: Principal Investigator Assurance and AcknowledgementI certify that the information provided in this application is complete and accurate. As the principal investigator, I have ultimate responsibility for the conduct of this study, the ethical performance of the project, the protection of welfare of animals to be used, and will strictly adherence to any stipulations designated by the IACUC. I accept and will conform to all federal, state, and institutional provisions concerning the care and use of animals in research, teaching, or testing. I will ensure all personnel involved in the research will have read and understand the protocol and will be appropriately trained for all procedures used in this project.
I agree to conduct the research involving animals as presented in this protocol application as approved by the Boise State University IACUC, and I am qualified to perform the procedures described herein. I will submit any proposed changes/modifications for review and approval. I agree to notify the IACUC and Office of Research Compliance of any adverse events that may occur during the study. I understand that Boise State University owns the research data. If I choose to transfer to another institution, I will need departmental approval to take the data with me.
I understand that data collection is not permitted until approval is granted by the IACUC.
Principal Investigator (PRINT) / Signature / Date
Principal Investigator (PRINT) / Signature / Date
**Signatures must be received by the Office of Research Compliance before final approval can be given.
Submit the first two pages, signed, to: Office of Research Compliance, Boise State University, 1910 University Drive, SimplotMicron 218, Boise ID 83725-1138. Campus Mail Stop 1138.
1. / Funding Source:
Not Applicable
External Funds
Grant Proposal Number:
Name of external sponsor/agency/organization/company:
2. / Other Funding:
SECTION D: Permissions
1. / Federal Permit
State Permit
Permit Type:
Permit Number:
Permit Valid From: / To:
Federal Permit
State Permit
Permit Type:
Permit Number:
Permit Valid From: / To:
2. / Do the permits cover all personnel? / YES / NO
If NO, explain:
3. / Where will the study take place?
4. / Has permission been obtained from all appropriate private landowners or public lands managers to conduct study on their lands?
YES / By Whom:
NO / Explain:
SECTION E: Mandatory Assurance
The United States Department of Agriculture (USDA) views alternatives with an eye to the 3R’s concept described by W.M.S. Russell and R.L. Burch in The Principles of Humane Experimental Technique – reduction of animal numbers, refined procedures to minimize or avoid pain, and replacement of animals with non-animal models. USDA requires that you specify sources or databases used to search for alternatives and determine that the model and methods described in this protocol do not:
· Unnecessarily use animals, or
· Unjustifiably expose animals to potentially painful, uncomfortable or distressful procedures, or
· Unnecessarily duplicate previous experiments.
Three searches must be performed:
1. / Database Searched: / Date of Search:
Keywords used: / Dates Search Covered (e.g. 1985 to present)
2. / Database Searched: / Date of Search:
Keywords used: / Dates Search Covered (e.g. 1985 to present)
3. / Database Searched: / Date of Search:
Keywords used: / Dates Search Covered (e.g. 1985 to present)
4. / Conclusion (summary of the methods and sources used to determine that alternatives were not available):
SECTION F: Justification for the Use of Animals
Federal regulations require that all investigators provide a narrative describing the rationale for using animals, the appropriateness of the species and the methods and specific sources used to determine that alternatives (e.g. replacement, reduction, refinement) to the use of animals and to the procedures have been considered.
1. / Explain why animals are required for these studies, and why non-animal model replacements, such as cell culture or computer modeling, cannot fully replace animals:
2. / Explain why the proposed species are the most appropriate:
3. / List references justifying your specific animal use:
SECTION G: Project Overview
Please provide a summary and description of your study. Use non-technical language that IACUC members with varied research backgrounds, non-scientists and community members will understand.
· Photocopied portions of grant applications or annual report are unacceptable in lieu of completing the application.
· Avoid scientific terminology, jargon or unexplained abbreviations; where use of such language is unavoidable, provide definitions of all terms.
1. / Summarize your proposed use of animals (the IACUC suggests the use of a table(s) for timelines, etc.):
2. / Describe the significance of this project: Provide its potential value in obtaining or establishing significant information relevant to the understanding of humans or animals and/or improvement to human or animal health, or achievement of educational objectives:
3. / Describe observation methods (e.g. naked eye, binoculars, spotting scope), observer-animal distance, and stage of animal’s life during which observations will be made (e.g. courting, nest-building, gestating/incubating, with dependent juveniles, etc.):
4. / Describe capture and handling techniques, including size and type of traps and cages, how long the animal will remain in captivity, and how negative effects on the animal will be minimized.
5. / If procedures involving animals may cause more than momentary or slight pain, consultation with the attending veterinarian or designee is required. Describe how the pain is minimized and provide a statement regarding the attending veterinarian’s involvement in planning.
6. / Describe any tissue collection procedures (e.g., blood samples, scales, feathers, hair, fat or muscle tissue, etc.):
7. / Is appropriate medical care available for the animals?
8. / Describe any restraint devices to be used (Guide, p 29):
a. / Duration of restraint:
b. / Restraint justification:
9. / Describe the humane endpoint if appropriate (Guide, p 27):
10. / Describe in detail the euthanasia process (method: drugs used, dose, route of administration, when, who):
11. / Describe any alteration to the animal’s environment (e.g., food or breeding/roosting sites manipulated, models of conspecifics presented, tape-recorded vocalizations broadcast, etc.):
12. / How will the traps and/or cages be disinfected and at what frequency?
13. / Describe how all investigators will be protected from applicable exposures, specifically animal bites and scratches, West Nile Virus, rabies, and tularemia while conducting this field study.
14. / Describe the procedures that will be performed in the event an employee, student, or coworker sustains injury (bites, scratches) resulting from animal handling and/or becomes ill and/or exhibits symptoms and signs consistent with a zoonotic infection due to animal exposure in this research.
Note: All incidents that occur in the field/lab need to be reported. Please use the attached link Report an Incident to notify campus personnel of incidents as they occur. This link is also available on the following websites: IACUC, EH&S, Risk Management, Security, and Emergency Management. Please notify your supervisor of any near miss, injury, or incident.
SECTION H: Animal Model
Complete questions 1-4 for each species being used. If using more than one species download additional pages of the Animal Model Form online and submit as a separate document.
1. / Genus/Species:
Common Name:
Sex: / Age: / Weight:
Number : / Annually / per Semester / Total for the life of the protocol
Source of Animals:
Final disposition of animals:
2. / Justify the number of animals to be used; provide a power analysis or justification as to why a power analysis is not appropriate.
Power analysis software can be found at: http://www.cs.uiowa.edu/~rlenth/Power/
3. / Is this species threatened or endangered? / YES / NO
If YES, explain:
4. / Is this species listed as a species of concern by any state or federal agency? / YES / NO
If YES, explain:
5. / Indicate Pain and Distress Categories (A-E) relevant to your study:
(For complete details on the research procedures, see Table 1 at end of application)
A / Experiments involving either living or non-living materials or use of plants, bacteria, protozoa, or invertebrate animal species.
B / Animals being bred, acclimatized, or held for use in teaching or research but not yet used for such purposes.
C / Animals that are subject to procedures that cause no pain or distress, or only momentary or mild/slight pain or distress, and do not require the use of pain-relieving drugs.
D / Animals subjected to painful or distressful procedures for which they receive appropriate and timely anesthetics, analgesics and/or tranquilizer drugs.
E / Animals subjected to potentially painful or stressful procedures that are not relieved with appropriate and adequate anesthetics, analgesics and/or tranquilizer drugs.
TABLE 1
Protocol Preparation: In completing an animal protocol, the PI needs to provide the IACUC with a full understanding of how a proposed procedure might impact an animal. Assigning a USDA Pain Category is just one piece of information that must be provided, but the PI must also share with the IACUC any and all manifestations of altered behavior or altered clinical status that either will or might possibly arise because of the procedure. Below we have provided examples of types of procedures and their appropriate designation as Pain Category B, C, D and E, as a guide to the PI. Procedures that are likely to fall into Pain Categories D/E must be planned in consultation with a veterinarian. This guide is not exhaustive; if a PI is unsure of how to categorize a procedure they should indicate the nature of their indecision to the IACUC or an attending veterinarian for their consultation and advice.
Pain Category B: Animals being bred, acclimatized or held but not yet used for research, testing or teaching.
· Animals being bred or housed, without any research manipulation, prior to either euthanasia (culling) or transfer to a research or teaching protocol.
Pain Category C: Animals that are subject to procedures that cause no pain or distress, or only momentary or mild/slight pain or distress, and do not require the use of pain-relieving drugs.
· Handling or weighing animals in teaching or research activities
· Observation of an animal in the wild, but for which no interaction, manipulation or intervention occurs
· Observation of free behavior of an animal in a laboratory setting
· Peripheral injections, fluid collections (in modest amounts) or catheter placements
· Ear-punch of rodents
· Dietary studies that do not alter clinical health
· AVMA-approved euthanasia procedures not involving prior surgical procedures
· Feed studies not resulting in clinical health complications
· Live-trapping and marking
Pain Category D: Animals subjected to painful or distressful procedures for which they receive appropriate and timely anesthetics, analgesics and/or tranquilizer drugs. (If the procedure would cause the animal pain or distress without the use of anesthesia, analgesia, or sedatives, but such treatment will be provided, the procedure should be in this category.)
· Survival surgery
· Non-survival surgical procedures
· Retro-orbital blood collection
· Exposure (cut-down) of blood vessel for catheter placement
· Exsanguination or cardiac puncture after anesthesia
· Tails snips in mice with appropriate analgesia or anesthesia
Pain Category E: Animals subjected to potentially painful or stressful procedures that are not relieved with appropriate and adequate anesthetics, analgesics and/or tranquilizer drugs. Withholding analgesia/anesthesia must be explicitly justified in such cases.
· Toxicological or microbiological testing/research that may result in moderate/severe clinical symptoms for which an animal must either be treated with analgesia/anesthesia or euthanized
· Any procedures that cause more than transient or mild pain or distress, for which administration of analgesics, anesthetics or sedatives would compromise the scientific conclusions
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FOR ORC USE ONLY / DATE RECEIVED: / PROTOCOL #: