Animal Research Protocols
Need a Protocol Application or Addendum?
Click on the following protocol form or addendum to download the appropriate form. See also the pointers for completing the forms. The protocol form is for both new protocols and 3 year renewals. An addendum can be submitted to the IACUC at any time.
- Protocol Form + Pointers on Filling out the Protocol Form
- Addendum + Pointers on Filling out the Addendum
Submission Deadlines and Meeting Dates
Protocol Submission Deadlines for |
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Month |
Protocol Submission Deadline |
IACUC Meeting |
January |
January 5 |
January 19 |
February |
February 2 |
February 16 |
March |
March 2 |
March 16 |
April |
April 6 |
April 20 |
May |
May 4 |
May 18 |
June |
June 1 |
June 15 |
July |
July 6 |
July 20 |
August |
August 3 |
August 17 |
September |
September 7 |
September 21 |
October |
October 5 |
October 19 |
November |
November 2 |
November 16 |
December |
November 30 |
December 14 |
Pointers On Filling Out the Protocol Form
- University policy and federal law require the review of projects for humane treatment of vertebrate animals. At the University of Colorado-Boulder, the review is conducted by the Institutional Animal Care and Use Committee (IACUC).
- Remember that principal investigators and course directors must obtain approval from the IACUC before initiating any research, testing or instructional project involving the use of vertebrate animals (The U.S. Public Health Service requires verification of IACUC approval of animal care and use within 60 days of the proposal deadline). The IACUC does not review projects for scientific merit, except where the question of merit bears upon the humane care and use of animals. Scientific merit review is the responsibility of external funding agencies or the appropriate university department. The IACUC's principal areas of concern are housing and husbandry, health status, measures to minimize pain or discomfort and the adequacy of training or experience of the personnel when using the animals. Projects with multiple components, such as Program Projects, may require several applications to cover all animal usage.
- Approved applications are valid for the specified project for a period of three years. An Annual Update Sheet will be sent to the Principal Investigator for the first two years of the project. IACUC approval must be obtained before significant changes in approved animal protocols are made (e.g., increasing the number of animals used). Only those species listed in the approved application may be obtained. Only those procedures listed in the approved application may be done.
- Before submitting an animal protocol you must make arrangements for animal housing and care. These arrangements must be specified in the protocol). Further, if the experiments involve survival surgery, specifics on how the surgical instruments will be sterilized, the drugs and dosages used for anesthesia, and post-surgical care are required in the protocol.
- Investigators are requested to categorize their use of vertebrate animals based on the discomfort or pain involved. The IACUC has designated four categories (A through D). Consideration should be given to methods that result in a lesser degree of unavoidable pain or discomfort. Use of the smallest number of animals consistent with meeting the scientific or educational objectives is mandatory.
- Minimizing animal pain, wherever possible, is important both ethically and legally. The National Academies’ Institute of Laboratory Animal Research has developed a free online resource to help those who care for and use laboratory animals, farm animals, and pets to prevent, recognize, and alleviate pain in different types of animals. The document is entitled "Recognition and Alleviation of Pain in Laboratory Animals (2009) and can be accessed at http://nas.edu/pain.
- The IACUC views justifying animal use as being very important. Therefore, you must thoroughly justify the number of animals to be used. This justification might include the number of animals used in pilot studies, the number which will not respond to a particular treatment thus inflating the number needed for an experiment, an estimate of the number of animals which might not survive a surgical procedure, etc. It is unacceptable to propose using a large number of animals without a thorough justification of those numbers. As part of that justification, you should provide an itemized list of the animal numbers by experiment (including the number of both experimental and control animals).
- If you are using methods, chemicals, or drugs which are potentially hazardous to yourself or other personnel working with animals, it is necessary to state in detail what steps you will take to minimize risk. Call Environmental Health and Safety (303-492-6025) for advice on these matters.
- You must sign the animal protocol. If you are a student, your advisor must also sign the protocol.
- If the project is not to be reviewed for merit by an external body, then the chair of the department must review the application for scientific/educational merit and sign the protocol
- The Animal Resources Department offers frequent training sessions on the humane use of animals. All faculty, staff, and students working with vertebrate animals must attend a training session. Also, on request, Animal Resources will provide technical training or instruction to individuals or groups. Animal Resources also has available information on anesthetics and tranquilizers and other aspects of animal research use.
- Help is available in filling out the application:
- For specific questions about completing the protocol which includes anesthesia, justifying the number of animals, euthanasia or other technical questions, contact the Institutional Veterinarian at 303-492-3411.
- For general questions about submitting a protocol or guidance on regulations, contact the IACUC Administrator at 303-492-8187.
Pointers On Filling Out the Addendum
- Minor changes in an existing approved protocol can be handled through submission of an addendum. Changes in an existing protocol cannot be implemented until the IACUC has reviewed and approved the addendum. An addendumidentifies the title of the protocol to be amended, specifies the change requested, includes a brief justification for the proposed change as well as the numbers of animals involved (see animal justification above). Below are some of the situations requiring submission of an addendum if you want to:
- Increase the number of animals in an experiment. Be sure to justify the reason for the increase in animal numbers.
- Modify a surgical procedure. Explain the nature of the modification.
- Test a new drug that is not on the original protocol. Provide the route of administration and dose.
- Add a new species to the study. Justify its inclusion.
- Add a new behavioral test or other procedures. Describe the new procedure and any potential impact on the animals under investigation.
- Add a pilot study to test a new, but related, method. Briefly describe the method and and justify its use.
- Change the principal investigator. Provide the reason and qualifications of the new investigator. The protocol addendum must be signed by both the previous and new principal investigators.
- Change the pain category due to a change in procedures. Provide justification.
- A new faculty member, student or employee starts working on a previously approved research project. Provide the person's name, the title and date of the approved protocol, and a brief description of the person's duties on the project.
Be sure to identify any change in the pain category (e.g., a change from Category B to C) that would result from the modification. Finally, sign and date the addendum and submit it to the IACUC Administrator for consideration by the IACUC at its next meeting.
- If a post-doc is applying to a federal agency for his/her salary only (i.e., not involving new animal use or new procedures), it is not necessary to submit a protocol. However, the individual must be listed on the existing protocol covering the research project. Adding a post-doc to a protocol can be done through submission of an addendum. This addendum must be approved by the IACUC before Animal Resources can provide an approval number for the new grant application.
The IACUC reviews protocols on the third Wednesday of each month. Please submit your protocol or addendum at least two weeks in advance to:
Richard Husser
IACUC Administrator- Campus Box 563 UCB
Phone: (303) 492-8187
Email: Richard.Husser@colorado.edu