Help Submitting Protocols

Sample Protocol

Use this Sample Protocol form to help complete your protocol.

Personnel Information

This section is checked by administrative staff to ensure that all personnel have completed training requirements by occupational health and IACUC. Upon submitting your protocol all personnel will automatically be added to the University of Minnesota occupational health program (ROHP) and their requirements will be generated based on the content of the protocol. For more information regarding required training visit IACUC Training & Education.

Funding

This section is maintained by the Sponsored Projects Administration (SPA). For additional information, see the SPA website.

Rationale

• Have you provided enough information to give reviewers a general understanding of the overall study?
• Have you outlined the goals and potential benefits of this project to society?

Species

• Review your protocol to make sure that the number of animals requested aligns with the number of animals listed in the experimental design. The number of animals requested is carefully reviewed by the committee to ensure that it is consistent with the experimental design and justification for the number of animals requested.

Experimental Design

• Is the description sufficient to provide a good understanding of what individual animals or groups of animals will experience during the course of this project from the time they are assigned until the time they leave the study? It is strongly recommended that you provide tables and timelines to clearly outline what is done with each group of animals.
• Are all activities involving animals described in this section?
• Have you outlined the purpose of each procedure?
• Have you listed clear endpoints, and are they objective in nature?
• Does the description of the experimental design provide a clear understanding of how the requested number of animals was determined?
• Do the numbers described in the experimental design section align with the total number requested in the Species section?

Procedures: Administration of Cells, Tissues, Body Fluids

• Are the following details included: route of administration, the dose administered, vehicle used, volume administered, and frequency and duration of administration? The protocol can include multiple routes of administration and a range of doses and volumes to incorporate flexibility into the protocol.
• Are all anesthetic and analgesic agents that may be used listed in the appropriate sections? Ensure that it is clear which drugs are intended to be used in combination and which are either/or options.
• Have all questions regarding anesthetic monitoring and recordkeeping been fully answered?

Procedures: Antibody Production

• If antibodies are produced outside of the institution, a custom antibodies form will need to be completed rather than using this procedure tab. The IACUC office can assist with this process.

Procedures: Behavior

• The behavior descriptions listed are already approved procedures that are conducted by the UMN Behavioral Core. These are outlined here to provide investigators with a generally approved procedure that can they can expand on if needed. Behavioral procedures not found in the pre-filled descriptions can be entered under “Other." Note that it should be clear if the animals will undergo a battery of behavioral tests and if so, the rest time between test events should be included.

Procedures: Blood Collection

• If the blood collected exceeds the IACUC Blood Collection Guidelines, is it justified and are additional fluids provided?
• Are all anesthetic and analgesic agents that may be used listed in the appropriate sections? Ensure that it is clear which drugs are intended to be used in combination and which are either/or options.
• Have all questions regarding anesthetic monitoring and recordkeeping been fully answered?
• Procedures (Breeding).
• Does the species table account for all the animals produced through breeding, including those that will not be used for experiments due to inappropriate genotype?
• Procedures (Dietary or Fluid Modifications).
• Be sure that responses adequately address adverse effects and are consistent with any notes in the Health and Monitoring section.
• This section should include nutritional content if applicable.
• Does the protocol indicate how animals will be acclimated to fluid restriction, how this training will be evaluated and what will be done in the event that animals have difficulty with this process? If fluid restriction is used as negative reinforcement how will effectiveness be evaluated and will animals be given vacation from the restriction?

Procedures: Physical Restraint

• Does the protocol indicate how animals will be acclimated to physical restraint, how this training will be evaluated, and what will be done in the event that animals have difficulty with this process?

Procedures: Surgery

• Will animals be subjected to more than one surgery? If yes, is a reasonable justification provided?
• Do the procedures described meet the standard of currently acceptable professional practice?
• Are all anesthetic and analgesic agents that may be used listed in the appropriate sections? Ensure that it is clear which drugs are intended to be used in combination and which are either/or options.
• Have all questions regarding anesthetic monitoring and recordkeeping been fully answered?

Procedures: Tumor Induction

• Check to make sure that the endpoints listed are consistent with the experimental design and euthanasia section. Oftentimes there is confusion regarding the tumor endpoint criteria and how it impacts death as an endpoint or taking animals to a moribund state.
• Are all anesthetic and analgesic agents that may be used listed in the appropriate sections? Ensure that it is clear which drugs are intended to be used in combination and which are either/or options.
• Have all questions regarding anesthetic monitoring and recordkeeping been fully answered?

Procedures: Other

• Are the procedures fully described, including the use of any anesthetics or analgesics?
• Are all anesthetic and analgesic agents that may be used listed in the appropriate sections? Ensure that it is clear which drugs are intended to be used in combination and which are either/or options.
• Have all questions regarding anesthetic monitoring and recordkeeping been fully answered?

Health and Monitoring

• Have you clearly described plans to minimize pain and/or distress? Have you considered nonpharmaceutical methods to relieve pain and/or distress?
• Note that in some cases euthanasia may be considered an adequate means of “relief” from pain/distress, depending on the timing and pre-euthanasia observations.

Euthanasia

• Are there clear endpoints, and are they objective in nature?
• Do the method(s) described comply with the Guidelines for Euthanasia listed on the IACUC webpage?

Ancillary Information: Alternative Search

• Does the search adequately cover all the procedures that may cause more than minimal/brief pain or distress?
• Are enough sources searched? Do searches use appropriate search terms? (At least one should include “alternative” or “model” or some other means of eliciting alternative approaches to painful procedures, if they exist.) Note that the literature search field is only generated in protocols involving USDA-regulated species.

Ancillary Information: Controlled Substances

• Are there any drugs listed in this section that are not outlined in the procedures or experimental design? If so, update the protocol to clarify their use in the experimental design section and/or the procedure details.
• Are all controlled agents listed throughout the protocol listed in this section?

Ancillary Information: DEHS & OHS

• Are there any hazardous chemicals listed in this section that are not outlined in the procedures or experimental design? If so, update the protocol to clarify their use in the experimental design section and/or the procedure details.
• Are all hazardous chemicals listed throughout the protocol listed in this section, and SOPs attached if required?

Ancillary Information: IBC

• Are there any rDNA, infectious agents, or biological toxins listed in this section that are not outlined in the procedures or experimental design? If so, update the protocol to clarify their use in the experimental design section and/or the procedure details.
• Are all rDNA, infectious agents, or biological toxins listed throughout the protocol listed in this section?
• Recombinant DNA includes the use, breeding, or generation of transgenic animals, even if exempt under NIH Guidelines
• NOTE: IBC approval, if relevant, is required prior to final IACUC approval