Note: OLAW has a Topic Index,
which is a new online resource to OLAW Guidance by subject matter. You
can browse and search OLAW responses to Frequently Asked Questions, commentaries, and articles written by OLAW staff.
Frequently Asked Questions about Protocol Review
- What activities are exempted from review?
NONE! Any activities involving the use of live vertebrates (captive or free-ranging) must be reviewed by the IACUC. Even if all you are doing is watching free-ranging animals through a spotting scope.
- Can non-UAA researchers (i.e. agency employees) or teachers use the University's research animals or animal facilities?
Yes. This is usually arranged through a Dean or Director and the animal facility supervisor. Anyone using UAA animals MUST file an Assurance of Animal Care form (no exceptions).
- I am a Research Associate - do I need to file an Assurance of Animal Care form?
Research Associates and Research Faculty come in a wide array of types. You must file an Assurance of Animal Care form any time you are involved in a project with ties to UAA (for example: funding is channeled through UAA, a UAA student is using the project for his/her thesis research, or you are using UAA animals/animal facilities). In other words, any time you use your UAA affiliation you must file a protocol. Research Associates/Faculty conducting work for their own agency or institution need not file. If you are unsure -- please ask!
- I am a graduate student - how do I file an Assurance of Animal Care form?
As a graduate student, you will likely be required to fill out the form; however, please list your supervisor as the PI. He or she must sign the declaration because they are the responsible individual for your training and therefore your research project. If there is another PI (i.e. an agency employee), please contact the IACUC Chair to determine who gets listed as the PI on the Assurance.
- My project involves the use of animals at another University's animal facility. I have submitted a protocol to that University's IACUC. Does the UAA IACUC need to review this work too?
YES. If you are a UAA employee or working on a project funded through UAA, you must file the UAA Assurance of Animal Care form to this committee. (DO NOT TURN IN A FORM FROM A DIFFERENT UNIVERSITY!)
- My project involves the use of captive animals housed at a facility that is not registered under the Animal Welfare Act nor has it filed an Assurance of Compliance with PHS Policy on the Humane Care and Use of Laboratory Animals with OLAW, NIH. Can I conduct my research there?
It depends on a few factors! Absolutely no research may be conducted at a facility if they are not in compliance with the Animal Welfare Act (please note that at this time some state run animal facilities holding captive wildlife are not required to be registered under the AWA). Assuming that registration under the Animal Welfare Act is not an issue, then the source of funding might influence your ability to conduct research at certain facilities. A facility MUST have an Assurance on file with OLAW for PHS funded research to be conducted there. You cannot conduct research at this facility if you are supported with PHS funding or funding from any agency that has adopted PHS Policy (i.e. NIH, NSF).
- I filed an Assurance of Animal Care form but the staff in the animal facilities did not reserve an animal room for me. Why not?
Protocol review by the IACUC is separate from arranging space and staff assistance in the Animal Facilities. You must contact the Animal Facility supervisor to arrange for animal rooms and caretaker or technician assistance/support.
- I want to use animals for a lab course. What do I do?
Use of animals in teaching requires IACUC approval. It is our preference that one (1) Assurance of Animal Care form be filled out for each individual course. Therefore, use of animals in many different labs for a single course should be listed on one (1) form. Multiple courses may all be listed on a single form if they use common labs (for example Biol 103, 104, 105 may all use the same mouse metabolism lab). To avoid confusion, be sure to contact the IACUC Chair before trying this.
- I am just catching fish and killing them to collect tissues for my study. Do I need to file a protocol?
Yes. The capture and euthanasia of fish are covered activities. You must provide the following minimal information about your work in the appropriate sections of the form: objectives, sample size, scientific methodology, capture technique, and euthanasia technique. What you are collecting (liver for p450 analysis, kidney for heavy metal analysis, liver stable isotopes, stomach content for prey species, etc) addresses the scientific methodology and ultimately the justification to kill fish. However, the specifics of blood and tissue collection techniques are only required if you collect samples PRIOR to killing the animals. You need not describe details of the tissue collection if you humanely euthanize the animal first.
- Grants and Contracts is holding up my proposal because I do not have an IACUC protocol number! Why?
All Institute Business Offices and/or Grants and Contracts check to ensure that any proposal using live vertebrates has been reviewed and approved by the UAA IACUC. Your proposal will be held up if there is even a suggestion of live vertebrate use and there is no indication of IACUC review or approval. If you believe that your proposal does not require an approved Assurance of Animal Care form, it is your responsibility to provide the necessary information to the IACUC. This is easily accomplished by sending an explanation via e-mail to Dr. Eric Murphy at firstname.lastname@example.org.
Does the IACUC have to review proposed animal research
activities at the time of grant award if the animal research activities
will not be conducted until year 4 or 5 of a grant?
YES. IACUC review must be performed prior to the conduct of any PHS-supported animal activity. The OLAW FAQ page provides a further response on this issue.
- The agency I am submitting a proposal to has requested a letter from the IACUC. What do I do?
The UAA IACUC will issue a signed letter confirming that your protocol has been reviewed and approved. Please provide the name of the individual and/or agency the letter must be addressed to. If you need this letter then YOU must request it!
- I am collecting tissues from animals killed by subsistence hunters. Do I need to file a protocol?
Yes, but you should complete a post-mortem tissue protocol, which is much abbreviated. If you hire a hunter (native or otherwise) to kill animals for the purpose of scientific collection, then you must justify your work and must file an Assurance of Animal Care form.
- I am using chick embryos. Do I need to file my protocol? Only if your research will take the embryo to the stage of hatching. You need not file an Assurance of Animal Care form if the chick embryos are killed prior to hatching.
- Are there any reporting requirements?
There has not been any formal reporting requirement in the past; however, we have been asked to institute a reporting process. This is being designed and PIs will be notified shortly. You have always been required to keep your protocol current as to changing activities and to report any modifications made. Also, once a year UAA must submit a report to USDA on our activities involving species covered under the Animal Welfare Act. This means listing species used and providing the number of animals used as categorized by the level of invasiveness or pain induced.
- I am doing surgery in the field. Is there a reporting requirement for this?
Yes. In the Animal Welfare Regulations, a field study means any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study. So, a field study is not subject to the Animal Welfare Regulations if it adheres to the above definition. However, many of our field surgical procedures that involve implantation of telemetry devices are subject to the Animal Welfare Act and these activities must be reported to USDA on an annual basis.
- Can the IACUC stop my research project after a protocol has been approved?
Yes. The IACUC can suspend activities if animals under your care experience a high morbidity/mortality rate or if the University receives complaints. The IACUC with the PI reviews the situation and, if required, make modifications to the protocol. OPRR, NIH and USDA must be notified if any suspension of activities occur. Suspension of a protocol to correct unforeseen problems is not a problem for the PI and does not question his/her capability. A PI only runs into problems if they are conducting unapproved protocols or they have been negligent in their animal care.
- I do not have an approved protocol but want to get my animals. Can I?
No. Animals may not be purchased from vendors or collected from the wild until you have an approved IACUC protocol. If time is crucial, please contact the IACUC Chair.
- I was never told that I needed IACUC approval to use animals!
Surprisingly, some researchers claim ignorance about the animal welfare requirements. To a certain extent this is understandable given the multitude of regulations and guidelines that need to be followed. However, ignorance or misunderstanding of the requirements is no excuse for failing to comply. This, in part, is why a formal training program is now a federally mandated requirement for individuals using animals in research, teaching and testing.
- I disagree with some of the current requirements and want to do something about it. Who do I talk to?
You are welcome to submit questions, comments and recommendations about the UAA Animal Care Program to any member of the UAA Institutional Animal Care and Use Committee or to the Vice Provost for Research and Graduate Studies (Dr. Douglas Causey). However, keep in mind that we are working to ensure that UAA stays in compliance with regulations and guidelines set by federal agencies and professional societies. Whether conducting laboratory based research or field research, you can influence animal welfare requirements more by getting involved in your professional society and providing comments to OLAW, NIH and/or Animal Care, USDA.
- IACUC's use of Designated Member Review (DMR) to review animal study protocols subsequent to Full Committee Review (FCR)? OLAW has updated their guidance on this issue on their FAQ 19 under the Protocol Review section here.
Are laparoscopic procedures considered major surgery? OLAW has recently updated their guidance on this issue here.
Does the IACUC need to approve research studies that use privately owned animals, such as pets? OLAW recently posted the answer to this question here.
How can the IACUC determine if activities involving privately owned animals constitute veterinary clinical care or research activities? OLAW also posted the answer to this question here.