Protocol Submission
ACUC Protocol Help
1) Protocol Title
Enter a descriptive title for the protocol. If you have a grant, it is not necessary for this to be identical to your grant title, but this will make it easier to for us to match the two (and keep your grant from being delayed).
2) Principal Investigator (Instructor) PI
The PI should be the person with primary responsibility for animal use. Normally this is a faculty member, but if a student or fellow is PI, a faculty member must sign in (7).
HA= Will this person be handling animals?
ES= Years of experience with the species.
PP= Will this person be performing procedures?
EP= Years of experience with the procedures.
AW= Has this person completed basic Animal Welfare training course? (The protocol will not be approved until everyone has completed this course.)
3) Other Personnel
Anyone who will be caring for the animals (except for OLAR and Davis College farm staff) or working with them must be listed in this section. For courses, individual students do not need to be listed, but they do need to complete the Animal Welfare course.
CO= Is this person a co-investigator?
HA= Will this person be handling animals?
ES= Years of experience with the species.
PP= Will this person be performing procedures?
EP= Years of experience with the procedures.
AW= Has this person completed basic Animal Welfare training course? (The protocol will not be approved until everyone has completed this course.)
4) For Academic Courses
It is the instructor’s responsibility to ensure that all students have completed the Animal Welfare course.
5) Classification of Protocol
6) Years Requested
Federal law prohibits the ACUC from approving protocols for more than 3 years. If you have received a grant for a longer period (a 5 year NIH grant, for example) you will need to submit a protocol renewal after 3 years.
We suggest that you put all of the procedures in your protocol. The ACUC does not care whether the proposed experiments can be completed in 3 years, and this way you can assure the granting agency that all your animal work has passed review.
7) Signatures
You can submit the protocol without all of the signatures, but final approval will not be granted until the completed signature page has been received by the ACUC office.
8) Animal Information
Wildlife projects that involve sampling fauna of unknown species can list “birds”, “fish”, “small mammals”, and so on. It is not necessary to list all of the possible species. Numbers do not need to be exact for these types of projects, but the total should represent a realistic maximum.
Numbers: Unhatched eggs and unweaned rodents are not animals for the purpose of counting animal numbers.
There are three places for numbers of animals on the protocol for:
(8) Protocol total is the number of animals that you will be permitted to use. This must be identical to the numbers for the experiments in (14) and justified in (31). Yearly number and average daily census are not critical- they are planning information for the animal facilities. Usually yearly numbers multiplied by number of years equals the protocol total, but not always. A horse protocol using the same animals for three years would have the same number for protocol total, yearly number, and average daily census.
(14) You need to include a clear description of exactly how you are going to use each animal or group of animals. If this involves anything more complex than a single experimental group you should include a table or diagram with totals at the bottom. If you need to include extra animals to make up for unusable animals, you can either adjust the individual group numbers or the total at the end. The ACUC expects this adjustment to usually be about 5%, but it can be more or less depending on the specific procedures.
(31) You need to provide a justification for the numbers needed for each group in (14). Usually this justification is statistical, but for teaching protocols it would depend on the number of students.
9) Sites / Rooms where Procedures will be Conducted
It is necessary to know the locations of the procedure areas for the semi-annual inspections of the animal facilities, which includes all animal study areas.
10) Animal Housing and Care
11) Special Animal Housing
12) Fund Source
It is not necessary to indicate a funding source, but it makes it easier to correlate a grant with the protocol (and reduces the chance of your money being delayed).
13) Lay Description
A lay abstract must be provided so that the nonscientist ACUC member and other members who are not experts in the particular area of interest can understand the description of the proposed work. Do not use your grant abstract!
One way to write this is to answer the following three questions:
- What is the general problem? “Heart disease kills more Americars than any other disease.”
- What are you studying? “We are studying a protein that is involved in the inflammation process that leads to heart disease. We will create mutant mice that have more or less of this protein.”
- What results do you expect? “We will evaluate these mice to see if they have a greater incidence of heart disease.”
- What is the long-term goal? “This research may lead to new treatments for heart disease.”
14) Experimental (or Teaching) Design
This is the most important part of the protocol. The ACUC must have enough information to understand what you are doing, why you are doing it, and exactly how many animals you will need.
Many people insert this information directly from their grant.
15) Nonsurgical Experimental (or Teaching) Procedures or Conditions
Each nonsurgical procedure should be described in enough detail so that the ACUC can determine whether it minimizes animal pain and distress.
Many people, especially those cutting and pasting from their grant, also put this information in (14).
16) Nonsurvival Surgery
It is difficult to make a clear distinction between non-survival surgery and post-mortem harvesting of tissue. However, there is a big difference in the amount of regulation required (post-mortem harvesting of tissue is category A). If you are not sure, ask the attending veterinarian for his or her opinion.
All surgical procedures must be approved by the attending veterinarian. This normally happens during routine ACUC review, but if you are proposing a new procedure you should discuss it with the veterinarian in advance.
17) Survival Surgery
All surgical procedures must be approved by the attending veterinarian. This normally happens during routine ACUC review, but if you are proposing a new procedure you should discuss it with the veterinarian in advance.
It is the policy of the WVU ACUC that analgesics shall be routinely given after any procedure that would cause pain in humans (which includes all survival surgery. Any exceptions must be scientifically justified.
18) Multiple Major Survival Surgery
Multiple major surgeries are not permitted without strong scientific justification.
19) Description of procedures using death as a measured end-point
This only applies to studies in which you are planning to let the animals die and use that as a data point. If you will euthanize animals when they become moribund then do not fill out this section. If you expect some mortality as a result of the procedures but are not using that as a measure, then do not fill out this section.
The ACUC discourages the use of death as an end-point and would approve such a protocol only with strong scientific justification.
20) Euthanasia
Any deviation from the AVMA guidelines must be scientifically justified and approved by the ACUC.
21) Disposition of Animals Other than by Euthanasia
Besides transfer to another project, OLAR has a adoption policy for animals that have no more scientific use.
22) Shared Biological Samples
We encourage people to share animals and samples. This reduces the overall number of animals used by WVU and increases the amount of information produced by each animal.
23) Transportation of Animals by Investigators
24) Experimental Materials and Safety Considerations
25) Category of Animal Use
Contact the veterinarian, the ACUC office, or an ACUC member if you are not sure which category to check.
26) Alternatives to Potentially Painful or Distressful Procedures
Category A protocols do not need this section.
We assume that WVU researchers are experts in their field and know whether or not an alternative to animal use exists. In the past we accepted the statement by the researcher that no feasible alternatives existed, but we have been forced by the USDA to adopt the use of database searches. The search requirements are based on USDA regulations. We did not develop them and had no input into them. The USDA inspects our records at least yearly, so we need to conform to their requirements.
You must conduct searches of two separate databases. Medline and Agricola are currently the two most people use.
You should use terms that are specific enough that extraneous research will not show up, but not so specific that nothing shows up. You should also use the term “alternative”.
In results report the total number of hits and give a brief explanation of the hits. It is not necessary to give all of the citations.
If there are any alternative to animal use that are directly relevant to your work, you must address each one and explain why you can not conduct the work using it.
Consultation with experts in the field is also permitted, but the USDA rules discourage this. If you do this, you must provide the credentials of the expert, and they must be specific to area of research and include knowledge of the 3R’s relative to that field.
27) Justification for the Use of Procedures Involving Prolonged Restraint
Restraint means that the animal cannot move. Caging is not restraint.
Prolonged restraint is not permitted without strong scientific justification.
28) Rationale for Using Animals Rather Than Nonanimal Alternatives
Cost is not a justification and should not be mentioned.
29) Justification of the Choice of Animal Species
You must explain why you cannot use an animal that is less likely to suffer distress. The scale that is usually used is: human > primate > other mammals > rodents (rats and mice) > birds > reptiles, amphibians, fish > invertebrates.
Cost is not a justification and should not be mentioned.
30) Assurance that the Proposed Project Does Not Unnecessarily Duplicate Previous Work
31) Justification for the Use of the Number of Animals Requested
A statistical power test is encouraged.
32) OLAR provides and oversees an environmental enrichment program for all species of laboratory animals.
This only applies to animals that will be housed in OLAR. If your animals will not be exposed to the standard enrichment procedures you must describe a satisfactory alternative.
33) All people working on this protocol will follow any WVU Occupational Health policies for working with animals.
WVU policies for specific animal species are found here: ACUC Guidelines and Federal Regulations
