The University of Iowa

Updating your Animal Protocol to the New Form

We have made every effort to create a user-friendly updated form to collect the information in our new eIACUC system.

As a result, some of the questions you are accustomed to seeing in the Word document form may have changed, or the information described will be collected in a different place.  Please read each question carefully prior to answering, as familiar questions may have changed.

In an effort to ease the transition to the new form, the eIACUC Team has assembled a table which matches each new question in the eIACUC form with the location in the previous Animal Protocol form where this information might be found. It will also indicate which questions are new in the eIACUC form, which will hopefully minimize any confusion in searching for the answer to an updated question in a previous template. 

 

eIACUC Section/Question

 

Location in Old Animal Protocol Form

Project Information

Type of Protocol

 

IV. Type of project

If renewal, Previous Animal Protocol #

 

IV. Type of project

IF duplicate, Original Animal Protocol #

 

IV. Type of project

Project Title

 

II. Project Information

Project Start Date

 

II. Project Information

Is this an Overall Protocol?

 

This is a New Question

Is this a Training Grant?

 

IV. Type of project

Is this a Center or Program Project?

 

IV. Type of project

Species

 

#5 Animal Information

Internal Funding

 

III. Funding Information

External Funding

 

III. Funding Information

Funding Source

 

III. Funding Information

Funding Agency Number

 

III. Funding Information

Is this NIH funding?

 

III. Funding Information

Is this grant subcontracted through another institution?

 

This is a New Question

 

 

 

Principal Investigator

Principal Investigator Search

 

I. Principal Investigator

Is a Co-Principal Investigator involved in this protocol?

 

I. Co-Investigators and #4 Co-Investigators

Are Technical/Student Personnel involved in this protocol?

 

#4 Technical Personnel

 

 

 

Co-Principal Investigator

Co-Principal Investigator Search

 

I. Co-Investigator

 

 

#4 Principal Investigator/ Co-Investigators

 

 

 

Technical/Student Personnel

Technical/Student Personnel Search

 

#4 Technical Personnel

 

 

 

Rationale and Purpose of Animal Use

The aims and objectives of this project including long term goals. (The grant abstract may not be used.)

 

#1 The aims and objectives of this project including long term goals

Briefly explain the relevance this work will have to human or animal health, the advancement of knowledge, or the good of society.

 

#1 The aims and objectives of this project including long term goals

Will animals in this project be used in an instructional course?

 

V. Special Concerns

 

 

 

Consideration of Alternatives

Was a literature search performed?

 

#2  Questions specifically mandated by regulations

If Yes:

 

 

Database(s) Searched

 

#2.a You must perform a databse search…

Date Search Performed

 

#2.a You must perform a databse search…

Year Began Search

 

#2.a You must perform a databse search…

Year Ended Search

 

#2.a You must perform a databse search…

Search terms. The phrase "animal testing alternatives" must be one of the phrases paired with all potentially painful or distressing procedures.

 

#2.a You must perform a databse search…

Were any alternatives identified by the literature search

 

#2.c Comment upon the potential application of any identified alternatives

If No:

 

 

Provide a narrative to explain how it was determined that no acceptable animal testing alternatives are available.

 

#2.b If a literature serach is NOT performed, provide a narrative to justify why this project is not duplicative and that no acceptable alternatives are available

Reduction in number of animals required

 

#2.d Describe what consideration has been given to the following alternatives:  Reducing the number of animals required

Replacement of vertebrate species with non-mammalian or invertebrate species

 

#2.d Describe what consideration has been given to the following alternatives:  Use of a non-mammalian or invertebrate species

Refinement of procedure(s) to lessen or eliminate pain or distress to the animal

 

#2.d Describe what consideration has been given to the following alternatives:  Modifying a procedure to lessen or eliminate pain or distress to the animal

Use of a non-animal system (cell or tissue culture, computer or mathematical model, etc)

 

#2.d Describe what consideration has been given to the following alternatives:  use of a non-animal system

 

 

 

Animal Information

Describe the characteristics of this species which make it essential to the proposed study

 

#5 Animal Information

Animal Housing Location

 

#8 Animal Housing Location

Animal Numbers

 

#6a. Approximately how many of each species will be used

Justification of Animal Numbers

 

#6b.Describe how the number of nimals needed for the study was determined

Does the phenotype of any animals used result in adverse effects, distress or pain?

 

#6e. Does expression of the transgene/knockout phenotype result in pain/distress?

If Yes:

 

 

Describe how any adverse effects, distress, or pain related to the phenotype(s) will be humanely managed, including clinical signs which would result in supportive care and/or veterinary consultation. Include criteria for euthanasia if applicable

 

#23  Are there any predictable adverse pre- or poest-procedural events that may occur

Will non-naïve animals be used on this Animal Protocol? Examples include surgically-altered animals obtained from a vendor or animals used on another Animal Protocol (including procedures such as genotyping).

 

#7 Will the animals used in this study be subjected to any of the following:  The animal(s) utlized in this study will have already been used in a previous study (non-naïve animals)

 

 

 

Experimental Design

Provide a succinct timeline of all procedures which may be performed on each animal/group, from the start of the study until the experimental endpoint (e.g. euthanasia). Include relevant information for each experimental group, such that it is clear what will happen to any given animal.

 

This is a new field. Some information may have previously been included in Question #27.

 

 

 

Non-surgical Procedures

Will tissues be collected for identification and/or genetic analysis?

 

#17 Are tissues collected before euthanasia? 

Will blood samples be collected for any reason?

 

#21 Will antemortem blood samples be taken?

Will any agent(s) be administered for experimental use? (Exclude anesthetics and analgesics)

 

This information was previously included under #27

Will food and/or water be restricted?

 

#24 Will food and/or water be restricted?

Will any special husbandry or housing conditions be required for this project? (check all that apply)

 

# 10 Will any special housing conditions be required for this project (lighting, feed, special caging, biological containment, etc.)?

Will animals be kept outside of the OAR animal facilities for longer than 24 consecutive hours?

 

#9 Will animals be kept outside of the OAR animal quarters for longer than 12 or 24 hours

Will animals be restrained by methods other than brief manual restraint?

 

#25 Will animals be restrained by tethers, stanchions, metabolism cages, etc.?

Will additional non-surgical procedures be performed?

 

This information was previously included under #27

 

 

 

Surgery

Will Survival Surgery be performed?

 

#26 Will Survival surgery be performed?

Surgical Description

 

This information was previously included under #27

Describe the immediate post-anesthesia recovery care (e.g. fluids, physical support methods), including the monitoring schedule until fully ambulatory.

 

#26.c  Describe the postoperative care, fluids, physical support methods and postoperative monitoring given to the animals

Describe post-surgical animal monitoring to be performed by laboratory personnel until incision closures are removed

 

#23 Are there predictable adverse pre- or post-procedural events that may occur?

Will multiple survival surgeries be performed on the same animal?

 

#26.a Will "multiple" survival surgeries be peformed on the same animal?

How are the instruments sterilized?

 

#26.e "How are the instruments sterilized?

How do you confirm that proper sterilization has occurred?

 

#26.f  How do you insure that proper sterilization has occurred?

Minimum Surgical Garb

 

#26.g  Does the surgeon utilize the following during surgery?

Will non-survival surgery be performed?

 

This information was previously included under #27

 

 

 

Analgesia

Will any non-surgical OR surgical procedure(s) be performed that may potentially cause more than momentary pain or distress?

 

#22 Is any procedure (including survival surgery) likely to cause pain or distress?

 

 

 

Anesthesia

Will anesthesia be administered? Please refer to Anesthesia Guidelines for routinely used anesthetic agents and dosages.

 

#19 b Anesthetic agent(s), dosage and route

Will any euthanasia procedure(s) be performed under anesthesia?

 

This is a New Question

Maximum number of times this anesthetic protocol will be used (per animal).

 

#19.d How many times will anesthesia be required for each animal during the study

Describe how this anesthesia will be maintained, if applicable

 

#19.c For prolonged procedures how will anesthesia be maintained?

Indicate the methods used to monitor the level of anesthesia and animal’s well-being. At least two methods must be used during any procedure.

 

#19.e  Describe the methods used to monitor the state of anesthesia and general wellbeing

Will paralytic agents be employed?

 

#19.f Will paralytic agents be employed?

 

 

 

Endpoints & Euthanasia

Will any studies be conducted where death is an expected endpoint (e.g., death due to septicemia)?

 

Part V. Will any studies be conducted where death is an expected endpoint (e.g., death due to septicemia)?

Will all animals utilized in this protocol be euthanized as part of the planned studies?

 

#16 a. Describe fully the method of euthanasia that will be employed for each species

 

 

 

Special Circumstances & Hazards

Will custom antibodies be produced for these studies?

 

V. Custom antibody production

Does this study utilize nucleic acid molecules in vivo AND are the animals returned to the OAR after exposure?

 

#14 Does this study utilize rDNA in vivo AND the animals are returned to the Animal Care Unit after exposure?

Will this Animal Protocol involve the use or breeding of genetically engineered animals?

 

#6, #14

Will the project involve stem cells?

 

#15  Are any of the substances listed in 15.a. used in this project?

Will any radioactive materials be used in this Animal Protocol?

 

#15  Are any of the substances listed in 15.a. used in this project?

Are any [hazardous] substances listed below used in this project?

 

#15.a  Specify the hazardous substance

Do any of the hazardous substances listed above require special handling, such as ABSL-2 or ABSL-3 handling precautions or yellow “Hazardous Agent” cards?

 

#15b Containment/#10 Special housing ABSL

If Yes:

 

 

Are any of these substances introduced into animals that are returned to the OAR facilities ALIVE?

 

#15.b  Are any of the substances listed in 15.a introduced into animals that are returned to the Animal Care Unit ALIVE?

Could any of the hazardous substances listed above contaminate animal caging?

 

#15.e  Could any of the hazardous substances listed in 15.a contaminate Animal Caging?