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IACUC

Montana State University
P O Box 173085
Bozeman, MT 59717

Contact: Elizabeth Nicholas

Tel: (406) 994-6821
Fax: (406) 994-4790


Office of Research Compliance

Tel:(406) 994-6757

iacuc@montana.edu

Protocol Form

Instructions to Investigators

Overview
The Montana State University Institutional Animal Care and Use Committee (IACUC) has developed a new interactive web-based protocol form to address all current requirements for protocol review. The questions on the new protocol form, when answered completely, meet all the appropriate regulatory requirements for the use of animals in research. Below are instructions and recommendations to assist in properly completing the form.

Resource List
IACUC Coordinator Diane Harn x6757 dham@montana.edu
IACUC chair Jovanka Voyich-Kane x7184 jovanka@montana.edu

Getting Started
Log into the IACUC web-based protocol form at: https://www.montana.edulwwwarc/dev/root
Contact Diane Harn to receive your username and password. Your username will be your email address.
On the main screen, you will see two options:
My protocols -use this option to view all of your current protocols.
Add protocol-use this option to begin a new protocol submission.

Once you click on Add protocol, you will see a screen with the following sections, you must
Complete all sections prior to submission:
Project Information -protocol title, principle investigator and funding information.
General -basic information that must be completed for all protocols.
 Species -choose and complete for each animal species you will be working with.
 Personnel -complete for all personnel who will perform procedures on animals.
Modification-complete if you want to modify protocol.

**Be sure to save each section as you complete it. You can save your work and return to it at any time.

Question types: The questions are of several types -yes/no, text, or multiple choices. If a question is answered a particular way (usually yes), there may be additional questions that need to be answered and will appear on the form at that time.
Below are section by section instructions to assist you in completing the form. If you have any questions please contact any of the above people listed under resources. If you encounter any computer or database problems, please contact the IACUC Coordinator and she will work with the programmer to rectify the problems.
Project Information This section is self-explanatory and covers the protocol title, contact information for the Principal Investigator, and funding source information.
General (Instructions are listed for those questions that are not self-explanatory or have changed significantly from the previous protocol form)
Question 3: Database Search

  • The regulatory agencies recommend that a minimum of two databases be searched and that multiple relevant search words be used.
  • It is the responsibility of the Principle Investigator to maintain a permanent record of the search for the life of the protocol.
  • The following web links are helpful in answering this question:
  • Office of laboratory Animal Welfare (OLAW)

http://grants.nih.gov/grants/olaw/olaw.htm

  • Animal Welfare Act

http://www.nal.usda.gov/awic/legislat/usdalegl.htm
 

  • USDA Animal Welfare Information Center

 http://awic.nal.usda.gov/nal display/index.php?tax level=l &info center=3

  • Guide for the Care and Use ofAnimals

http://dels.nas.edu/ilar n/ilarhome/guide.shtml
 
Tips for Searching for Alternatives

  • General area of study
  • Species being used
  • Describe protocol
  • Organ systems involved
  • Acronyms
  • Names of hormones, enzymes, trade names, etc.
  • Prominent authors in field, including work published by the Investigator
  • How is the proposed study unique?
  • Are you aware of any alternatives?
  • Any previous searches conducted -keywords used

Examples of Alternative Keywords

  • Animal models
  • Animal testing alternatives
  • Alternative
  • Artificial
  • Vitro (method, model, technique)
  • Culture (cell, tissue, organ)
  • Isolated (cell, tissue, organ)
  • Computer; software
  • Mathematical method
  • Anesthesia
  • Analgesia, sedative, anxiolytic
  • Euthanasia
  • Handling
  • Housing, caging
  • Training, educating, teaching
  • Welfare, pain, stress, distress
  • Assay, method, technique
  • Environment, enrichment

Sources for Searching for Alternatives

  1. AGRICOLA (Nat'l. Ag. Library) database
  2. MEDLINE database
  3. PUBMED
  4. TOXNET Web Interface
  5. CAB Abstracts database
  6. Science Citation Index
  7. TOXLINE database
  8. BIOSIS
  9. Comparative Medicine (Laboratory Animal Science) Journal
  10. Laboratory Animals Journal
  11. Lab Animal (Journal/Magazine)
  12. USDA Animal Welfare Information Center (AWlC)
  13. ALTA (Alternatives to Lab. Animal) Journal
  14. Current Research Information System (CRIS)

Personnel
This section is self explanatory. All personnel performing procedures on animals must be listed on the protocol and should have access to a copy of the protocol.

Species Section
Complete this section for each species you plan to work with.
Question 5: General Procedures

  1. Do NOT paste entire Grant section
  2. Provide only the animal procedures and experimental design

Question 6: Justify the number of animals

  1. Animal numbers should be justified for the 3 year life of the protocol.
  2. Whenever possible, the number of animals requested should be justified on the basis of need to generate statistically significant data (Guide for the Care and Use of Animals).
  3. The total number of animals required must be justified in terms of the number of animals required per basic experimental group and the number of groups or treatments to be studied.
  4. The number of animals per group should be justified on the basis of power analysis, if possible.
  5. Complete only those sections (a through g) that pertain to your protocol. Count animals only once.

Section a: Animals assigned to experimental groups

  1. Most protocols will fall under this category.
  2. For group size, the statistical test, minimum detectable difference, and the power should be stated, if possible.
  3. Power analysis -give the minimum number of animals needed per group to show the
    important difference expected (precision) and the probability of finding that difference (power).
  4. Group numbers will also depend on the statistical test used and the statistical significance of that test (alpha).
  5. Whenever possible, use an outline format.
  6. Example: Suppose you want to measure the effect of four treatment groups on five different protein targets at five different endpoints. You determine with a difference of 25 and standard error of 8, with 4 treatment groups at a power of 0.9 and alpha of 0.05, the sample size needs to be 5. Therefore, the number of animals required is:
      1. o 5 animals per group; 4 treatments; 5 endpoints; 5 target proteins
      2. o 5x4x5x5 = 500 animals

Section b: Extra animals needed

  1. Complete this section if you expect premature animal losses and therefore need extra animals to meet your final numbers requirement.
  2. This is most common for technically difficult procedures or surgeries, or for infectious disease studies that might result in premature death before final results can be collected.

Section c: Pilot data

  1. Complete this section only if the sample distribution is unknown, or the purpose of the experiment is to determine descriptive statistics for planning future studies, or for those requiring development of a new technique.
  2. The required animal numbers can be estimated and quantitative statistics are not needed.
  3. These should be studies using small numbers of animals.

Section d: Need for specific amount of tissue or cells

  1. This can include tissue or cells needed for assay or culture, or animals used for antibody production.
  2. Animal numbers should be justified by the total amount of tissue, cells or antibody required and the expected yield of tissue, cells or antibody per animal.
  3. Also include the number of assays or tissue cultures to be conducted in three years.
  4. Example: suppose 500ug of extract X from the caudate nucleus of mice were needed to start a culture. From previous work, the amount of X available from one mouse is approximately 10 ug therefore the experiment would need 50 mice.

Section e: Breeding colonies

  1. This section should be completed if you will be using an in-house breeding colony to support your research.
  2. For established breeding colonies, transgenic or otherwise, the number of requested mice should be based on the number of mice needed for experiments.
  3. Pre-weanlings do not need to be counted unless a procedure is performed (i.e. tail snip for genetic analysis).
  4. To figure numbers, you should coordinate with the ARC technician that will be performing the breeding for you.

    Section f: Teaching or Training
    Numbers should be justified based on the number of students to be trained and the number of times the procedure must be repeated to attain competency.
    If the procedure is minimally invasive or terminal and can be repeated more than once on an animal, the total number of procedures per animal should be considered.

Section g: Other justifications
Complete for any experimental design that doesn't fit into the above categories.
Please consult with the Animal Resources Center Veterinarian or IACUC chair for assistance if necessary.

Question 7: Animal Numbers Categories
The total number of animals justified in question 6 should be listed under part d

That total number should then be divided by category using the following guidelines:

    • Category C -no pain; procedures which do not involve more than slight or momentary pain or distress and are performed without anesthesia or analgesia. Examples include breeding protocols, handling, behavioral work, blood collection, injections, etc.
    • Category D -procedures involve more than slight or momentary pain or distress to the animals, but this is relieved through the use of appropriate anesthetics, analgesics, or tranquilizing drugs. Example -surgical procedures.
    • Category E -procedures involve more than slight or momentary pain or distress for which appropriate anesthetics, analgesics, or tranquilizing drugs would adversely affect the procedures, results, or interpretation. Examples include some infectious disease work, toxicology studies, etc.

Summary
The remainder of questions on the protocol form should be self explanatory. If you need assistance in completing the protocol form, please contact the IACUC Coordinator, any member of the IACUC, or the Attending Veterinarian. Please contact the IACUC Coordinator if you have any technical difficulties with the database.

Protocol modifications and Annual Renewal Forms will continue to be submitted separately. These forms are available in a word format on the IACUC web page.