Animal Care and Use Protocol (ACUP)

IACUC Office Use Only

ACUP Number:Approval Date:

Year 1 Expiration: Year 2 Expiration: Year 3 (Final) Expiration:

Submission Deadline

The IACUC review process typically takes 7-8 weeks, however complex protocols may take longer to review. Forms should be submittedat least 2-3 months prior to theanticipated start date of animal activities to allow adequate time for review. ACUP activities may not begin until IACUC approval is secured.

Required documents

  1. Animal Care and Use Protocol (ACUP): Sections 1 – 8 (Core Form)
  2. Supplemental Section(s) (as applicable):

Contact the IACUC office for supplements that apply to your work, from the list below.

Supplement A: Field Studies

Supplement B: Anesthesia, Monitoring & Surgery

Supplement C: PI-maintained Housing

Supplement D: Breeding Worksheet

Supplement E: Owner Consent Form for privately owned animals

  1. Additional Documents may be required for submission. These may include funding documents, collaborative agreements, standard operating procedures (SOPs), training documentation, etc.

Send completed forms to the IACUC office:

Questions? Comments? Concerns?

or call 541-737-2762

Useful tips/information:

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I.Administrative Information

Section 1PI Assurance

1.1Principal Investigator Assurance Statement

  1. I have determined that the research proposed herein is not unnecessarily duplicative of previously reported research.
  2. All participants who are exposed to animals or non-sanitized tissues have participated in OSU’sAnimal Exposure Program (AEP).
  3. The participants listed are authorized to conduct associated procedures involving animals under this protocol, and have completed all required and necessary education and training for independent work, or; are provided training and assistance until they are qualified to perform independent work.
  4. For all USDA Category D and Eprotocols:

I have reviewed the pertinent scientific literature and the sources and/or databases as noted in the protocol for valid methods of animal replacement and reduction; and refinement of any procedures described in this proposal which may cause more than momentary pain or distress (whether relieved or not).

  1. I will obtain approval from the IACUC before initiating any changes to this project.
  2. I will notify the IACUC regarding any unexpected study results that impact the animals.
  3. Any unanticipated pain or distress, morbidity, or mortality will be reported to the Attending Veterinarian and the IACUC.
  4. I accept and assure compliance with all federal, state, accreditation, institutional, and IACUC documents (laws, regulations, policies, guidelines) that apply to the OSU animal care and use program and to this work.
  5. I certify that the information contained in this submission is complete and accurate to the best of my knowledge.

Principal Investigator signature Date

I will submit my signature via an email statement from my work email address.

You may state in your email submission that your email can serve as your signature, if you submit your completed form from your work address.

Section 2Title, Funding, & Agreements

2.1ACUP Title

If this is a course ACUP, please include both the course ID and course name in the title, and attach the syllabus.

Title:

If this project is a replacement of an expiring ACUP, enter the previous ACUP # here:

2.2Table: Project Funding

Use the table below to listfunding(both internal and external sources) associated with this project.

Please submitalong with this form: all related proposals, executed grants, agreements, etc. to date

IACUC office use only: Grant-IACUC protocol congruency review(completed per agency requirements)

Sponsor or
Source / Cayuse #
[or N/A] / Subaward Y/N / Grant
PI Name / Title

Additional funding information:

Will part of the funded animal work be performed at a much later date – more than 2.5 years into the grant?

Yes No

If YES:

Note that the IACUC protocol must be updated withappropriate details, prior to the start of this animal work.

Add a brief description below, of the animal work described in the grantto be performed > 2.5 years in the future.

I agree to update and amend my approved ACUP to include details of the animal work described both above and in the award document,before the start of this work.

Initial here to agree:

2.3Additional ACUP Access

ACUPs can be accessed by the PI, ACUP participants, the IACUC office staff, IACUC reviewers, the IACUC Chair, the Institutional Official, and the LARC veterinary staff. In addition, oversight and accreditation representatives and authorities may access ACUPs.

Do you want to identify additional people who should have access to the ACUP? Yes No

If Yes, provide additional contact details:

2.4Confidential/Proprietary Information

Do you want to identify areas of the ACUP that should stay confidential for proprietary reasons?

Yes No

If Yes, submit an additional copy of the ACUP and highlight the areas associated with confidential and/or proprietary statements.

Note that the unauthorized release of confidential IACUC information by members is prohibited by law (AWA § 2157. Release of trade secrets).

2.5External Collaboration Not applicable

Includes animal work performed by subawardees, contractors, consultants, or at facilities not included in OSU IACUC inspections.

Will this project involve:

  1. Facilities not inspected by the OSU IACUC? Yes No
  2. People who are not employees or students of OSU? Yes No
  3. Funding sources not associated with the Office of Sponsored Research & Award Administration (OSRAA) or not available in Cayuse? Yes No

If Yes, please submit electronic copies of relevant Memorandums of Understanding (MOUs), Inter-institutional Agreements (IIAs), subcontracts, etc. with this form, and summarize the collaboration:

Section 3Participants – Experience & Training

3.1Participant List

Starting with the Principal Investigator, list all individuals including co-investigators, instructors, employees, and participants who will perform work described in this application. Contact the IACUC office with any questions.

The PI is the primary emergency contact. List additional emergency contacts in preferred contact order.

The Attending Veterinarian (AV) or designee must be able to contact an individual on this ACUP who can make decisions for the animals described below.

PI Name: / Email:
Work/Office Address:
Department(s): / Email 2:
Work Phone:
Please select all that apply:
Contact for AV’s Daily Health Report Non-employee of OSU
Years of experience and degree(s), training, certifications, etc., related to the animals and procedures in this ACUP:
There are three (3) prerequisite requirements:
1.) IACUC: CITI’s Working with the IACUC, 2.) EH&S:Animal Handler Safety Training, and 3.) OCM:Animal Exposure/AEP Enrollment
All 3 prerequisite requirements are complete and current. PENDING completion of 1 or more
Participant Name: / Email:
Work/Office Address:
Department: / Email 2:
Work Phone:
Please select all that apply:
Co-Investigator Animal care emergency contact IACUC contact
OSU Student Non-employee of OSU
Contact for AV’s Daily Health Report
Provide a short summary of the participant’s role(s) for this ACUP:
Years of experience and degree(s), training, certifications, etc., related to the animals and procedures in this ACUP:
There are three (3) prerequisite requirements: 1.)IACUC: CITI’s Working with the IACUC, 2.)EH&S:Animal Handler Safety Training, and 3.)OCM:Animal Exposure/AEP Enrollment
All 3 prerequisite requirements are complete and current. PENDING completion of 1 or more
Participant Name: / Email:
Work/Office Address:
Department: / Email 2:
Work Phone:
Please select all that apply:
Co-Investigator Animal care emergency contact IACUC contact
OSU Student Non-employee of OSU
Contact for AV’s Daily Health Report
Provide a short summary of the participant’s role(s) for this ACUP:
Years of experience and degree(s), training, certifications, etc., related to the animals and procedures in this ACUP:
There are three (3) prerequisite requirements: 1.) IACUC: CITI’s Working with the IACUC, 2.) EH&S:Animal Handler Safety Training, and 3.) OCM:Animal Exposure/AEP Enrollment
All 3 prerequisite requirements are complete and current. PENDING completion of 1 or more
Participant Name: / Email:
Work/Office Address:
Department: / Email 2:
Work Phone:
Please select all that apply:
Co-Investigator Animal care emergency contact IACUC contact
OSU Student Non-employee of OSU
Contact for AV’s Daily Health Report
Provide a short summary of the participant’s role(s) for this ACUP:
Years of experience and degree(s), training, certifications, etc., related to the animals and procedures in this ACUP:
There are three (3) prerequisite requirements: 1.) IACUC: CITI’s Working with the IACUC, 2.) EH&S:Animal Handler Safety Training, and 3.) OCM:Animal Exposure/AEP Enrollment
All 3 prerequisite requirements are complete and current. PENDING completion of 1 or more
Participant Name: / Email:
Work/Office Address:
Department: / Email 2:
Work Phone:
Please select all that apply:
Co-Investigator Animal care emergency contact IACUC contact
OSU Student Non-employee of OSU
Contact for AV’s Daily Health Report
Provide a short summary of the participant’s role(s) for this ACUP:
Years of experience and degree(s), training, certifications, etc., related to the animals and procedures in this ACUP:
There are three (3) prerequisite requirements: 1.) IACUC: CITI’s Working with the IACUC, 2.) EH&S:Animal Handler Safety Training, and 3.) OCM:Animal Exposure/AEP Enrollment
All 3 prerequisite requirements are complete and current. PENDING completion of 1 or more
Participant Name: / Email:
Work/Office Address:
Department: / Email 2:
Work Phone:
Please select all that apply:
Co-Investigator Animal care emergency contact IACUC contact
OSU Student Non-employee of OSU
Contact for AV’s Daily Health Report
Provide a short summary of the participant’s role(s) for this ACUP:
Years of experience and degree(s), training, certifications, etc., related to the animals and procedures in this ACUP:
There are three (3) prerequisite requirements: 1.) IACUC: CITI’s Working with the IACUC, 2.) EH&S:Animal Handler Safety Training, and 3.) OCM:Animal Exposure/AEP Enrollment
All 3 prerequisite requirements are complete and current. PENDING completion of 1 or more

Herd/Flock/Stock ACUPsNot applicable

Authority to Approve Animal Use across Multiple ACUPs

Provide both a primary and backup contact who can review and approve proposed use of animals across multiple ACUPs below, or add this role to the appropriate participants, above.

1st Contact: 2nd Contact:

3.2Animal Care - Training& Assurance

Who will provide education, training, and otherwise ensure participant(s) have acquired the appropriate skill set foranimal well-being, animal handling, and animal husbandry & caredescribed in this ACUP, before they begin independent work?

PI

Subject matter expert (SME) from Participants section above:

Other SME not listed in the Participants section:

Credentials/qualifications:

Additional Information:

3.3ACUP Procedures- Training & Assurance

Who will provide education, training, and otherwise ensure participant(s) have acquired the appropriate skill set forACUP proceduresdescribed in this ACUP, before they begin independent work?

PI

Subject matter expert (SME) from Participants section above:

Other SME not listed in the Participants section:

Credentials/qualifications:

Additional Information:

3.4Project Hazards Safety Procedures - Training & Assurance

Who will provide education, training, and otherwise ensure participant(s) have acquired the appropriate skill set forProject Hazards & Safety Proceduresdescribed in this ACUP, before they begin independent work?

PI

Subject matter expert (SME) from Participants section above:

Other SME not listed in the Participants section:

Credentials/qualifications:

Additional Information:

Select all topics that apply:

Allergen Exposure Biological/Chemical/Radiation

Facility conditions Disease exposure

Animal Handling Field Conditions

Equipment Use Other

Additional Information:

3.5Teaching/Class ACUPs and Occupational Health & Safety Not applicable

If this is a class ACUP, how will students be educated about the associated risks and informed about Student Health Services consult availability regarding occupational health concerns?

The PI/Instructor will present this information in class, as described in the syllabus

The PI/Instructor will provide a handout and/or other written material in class

Additional Information:

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Section 4Animal Sources, Locations, Care, & Safety Committees

4.1Animal Sources

Choose all that apply:

Transfer from my previous ACUP

Transfer from anotherACUP: PI:, ACUP#: , Expiration Date:

AnRS farm facilities: Herd PI:, ACUP#: , Expiration Date:

CVM large animal facilities: Herd PI:, ACUP#: , Expiration Date:

Donation

Private/Client - owned

Vendor:

Transgenic import, originating facility:

Wildlife

Breeding on ACUP

Other; describe:

4.2Animal Housing and Procedure Locations

Facilities must be appropriate for the species and activities proposed, and approved prior to use. Contact the Attending Veterinarian and/or IACUC office with any questions about IACUC-approved animal facilities.

Choose all that apply:

LARC-managed facility (LARC, LPSC, ALS, RAIL vivarium areas)

AnRS farm facility (Corvallis area)

CVM-VTH facility

Dedicated Aquatic facility

OSU Extension facility

PI-managedSatellite Animal Facility or area (complete Supplement C: Satellite Animal Housing)

OSU field site(s)

Field site(s) not affiliated with OSU

Private facility – business(requires an Owner Consent Form or other agreement – contact the IACUC office)

Private facility – personal property (complete Supplement E:Owner Consent Form)

Other (describe):

4.3Table: Animal Care and Use Facilities

Per the Locations list above, complete the table below.

  • Note whether the facility is used for Housing (H), Procedures (P), or both (H, P).
  • Indicate Housing (H) when animals will stay at a facility overnight or for more than 12 hours.
  • For procedures/housing locations not described by a building/room, please describe the area/site.

Species / Facility/Site Name / H/P / Room/Building or Description of Location

4.4Transportation

Transportation of animals must conform to all institutional guidelines/policies and federal regulations. A copy of the LARC Transportation Guideline can be requested from the LARC office.

Will the LARC Transportation Guideline be used for transporting rodents on campus? Yes No

If No, please provide methods, containers, and vehicles that will be used:

A summary of regulations and best practices is available in Guidelines for the Humane Transportation of Research Animals(2006), and AAALAC has a Transportation FAQ here.

4.5Veterinary Care

I confirm that the OSU Attending Veterinarianwill be contacted promptly about all unexpected animal health and OSU facility-related events.

Will LARC veterinarians provide veterinary and emergency care? Yes No

Will CVM services (clinics, RVP) provide veterinary and emergency care? Yes No

Will other designated veterinarian(s) provide veterinary and emergency care? Yes No

If Yes, ensure that they are included in the Participant Section.

Additional Veterinary Care information:

4.6Genetic Manipulations and Phenotypic ConsequencesNot applicable

Describe potential or anticipated phenotypes due to any genetic manipulations to the animals:

Describe any special care or monitoring that the animals will require in the Potential Adverse Consequences and Experimental and Humane Endpoint sections below.

4.7OSU Safety and Compliance CommitteesNot applicable

Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated with this study:

Some aspects of the project may require review/approval from the appropriate OSU Safety or Compliance Committee prior to IACUC approval.

Committee / Y or N / Applicable Hazard / Approved
IBC/Biologic
Chemical/Drug
Radiation
Scientific Diving
Scientific Boating
IRB/Human Subjects
COI/Conflict of Interest
Export Control
Drone Use/UAV
Other

Additional considerations:

4.8Biological Materials or ProductsNot applicable

Material / Sterile / Attenuated? / Pathogen Testing? / Source / FDA review or approval req’d?

Additional considerations:

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II.Animal Care and Use Protocol (ACUP)

Section 5Project Objectives, Design, & List of Events

5.1Project Objectives

Briefly summarize the purpose, goals, and scope of the animal work described in this ACUP. Use language appropriate for a nonscientist.

  • Research/Teaching ACUPs: What questions underlie this animal work, and what will be accomplished in the next 3 years?
  • Herd/Flock/Stock, Breeding, SentinelACUPs: What are the primary and secondary uses of the animals over the next 3 years?

Purpose:

Goals:

Scope:

5.2Project Design

Briefly describethe design of the study or project used to achieve the objectives above.

  1. Describe or provide a separate table withanimal/animal group identification. Include ages,breed/strain, etc., if part of the project design.
  2. Briefly summarize live animal proceduresand activities, per group
  3. Will the same animals be reused during the project?
  4. Describe likelyresults or effects on animals
  5. Identifyanimal monitoring and decision points
  6. Identify plans for veterinary care in case of illness or injury
  7. Identifyexperimental and/or humane endpoints for animals or groups
  8. Identify the disposition of animals at the end of the project

Proceduredetails (howprocedures are performed) are requested later in Section 6and in the Supplement sections.Do notinclude those details below.

Similarly, description ofnon-animal work should be limited to a sentence or two, if appropriate, to help reviewers understand the scope of the project.

Project Design:

5.3List of Events and Animal Procedures

Provide a sequential list of events and procedures for each group of animals for the next 3 years. This information should allow the IACUC to follow a given animal or group from beginning to end.