Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.

Megan Columbus: Welcome to another edition of All About Grants. This is Megan Columbus from NIH’s Office of Extramural Research, sitting today with Dr. Pat Brown, who’s the director of the Office of Laboratory Animal Welfare, also known as OLAW, that’s housed with the National Institutes of Health. Today we’ll be talking about including animals in your research proposal to the NIH and how you should write that information into your grant application. I guess a good place to start would be why does NIH monitor the care and use of animals in our grant applications?

Pat Brown: Well federal policy requires that if live vertebrate animals are used in NIH funded research that that use should be described in the application. There are specific details about that in the Public Health Service policy on Humane Care and Use of Laboratory Animals, also in the NIH grants policy statement and in the instructions in the PHS398 and SF424 application forms.

Megan: What exactly is considered research on animals?

Pat: Well all funded activities that involve research, research training, or biological testing with animals is considered research on animals. And this would include research and training grants, cooperative agreements and contracts.

Megan: And is it vertebrate or non-vertebrate animals?

Pat: The PHS policy when it was first issued back 25 years ago defined an animal as any live vertebrate, either used or intended for use in research or research training. And that’s where the idea that vertebrate animals are what needs to be included in the grant applications.

Megan: What about tissue samples. Are they included?

Pat: If live animals are obtained or if they’re killed for tissue harvests, then that also would be considered use of live animals. And the generation of custom antibodies is also considered the use of live animals.

Megan: So if I go to actually taking that information you just provided us and talking about developing a grant application, what information and how much of this information is required to be included in the application itself?

Pat: Well there are five required elements that are needed to be in the application. And this particular section of the application is called the Vertebrate Animal Section or the VAS. Those five elements are: a detailed description of the proposed use of the animals, and that should include the species, the strains, the ages, the sex, and number of animals that are going to be used; justifications for the use of animals for the choice of the species being proposed and for the numbers of animals to be used; information on the veterinary care for the animals; a description of procedures for minimizing discomfort, distress, pain, or injury that the animals might experience; and lastly, the method of euthanasia and the reasons for its selection.

Megan: So, as we’re putting together this information for our application, how specific and how long does it need to be?

Pat: Well, the recommendation is that it should be concise but complete, and usually one to two pages will cover that. As I said, there should be a description of the animals and the proposed procedures that needs to be included. It should be cohesive, but include sufficient enough detail so that the peer reviewers when they review it can understand the proposed research and determine whether it’s scientifically appropriate. Last year NIH posted a worksheet and that is to assist applicants in preparing the vertebrate animal section. It’s also used by reviewers as guidance in how they evaluate the vertebrate animal section. It provides a detailed description of the requirements of the vertebrate animal section and it also has an example of a vertebrate animal section that meets those requirements. It’s linked to the funding opportunity announcements and it’s also available on the NIH resources for applicants website.

Megan: Does the amount of information that you have to provide vary with the type of animal model proposed? So for example, are there additional requirements if the research uses cats, dogs or primates?

Pat: The basic requirements for the vertebrate animal section are the same no matter what species is being proposed; however, if there’s less highly evolved animal models that are available, then the applicant would be expected to justify why they were using a more advanced species. So if they were using a non-human primate or a dog or a cat, that should be thoroughly justified as to why they had selected that species over a less evolved species.

Megan: Do I need to worry about page limits in this section of the application?

Pat: There are no page limits for the vertebrate animal section; however reviewers are instructed they should not consider putting inappropriate text or other materials into the VAS as reviewers are instructed not to accept that information. It should not be a way to circumvent page limits for some other part of the application.

Megan: So you need to stick with what’s supposed to be there.

Pat: Yes.

Megan: What are reviewers really looking at in this section of the application?

Pat: Well, the focus for reviewers is that the proposed research is scientifically appropriate. This includes both the suitability of the animal usage that’s being proposed and also the protections to minimize pain and distress for the animals. If the vertebrate animal section is missing, then the application could be deferred. If one or more of the five required elements isn’t addressed, then that could affect the impact or priority score. The vertebrate animal section is considered one of those additional review criterion by the reviewers in that they determine both the scientific and technical merit of the overall application, and they consider the vertebrate animal section in that determination. So they may have additional scientific questions related to what was described in the vertebrate animal section that would cause them to then have it affect the priority score.

Megan: So this would be as part of the overall impact score rather than for one of the individual scored criteria.

Pat: Correct. It’s not given a separate score, but it’s part of the reviewers deliberations prior to final scoring and it could be reflected in the final score for the application. They will either rate the application as acceptable or unacceptable with regard to the vertebrate animal section. Then they would include specific comments that would provide information where they either wanted clarification because they had a concern or there was specific other information that they thought needed to be addressed concerning the use of animals.

Megan: Can you tell me a little bit about the distinct roles of the NIH review committee and what the IACUC looks at, the Institutional Animal Care and Use Committee?

Pat: Well the IACUC has a different role in that they’re responsible for reviewing the research and the actual oversight of the animal study as it’s going on at the local institution. And their approval indicates that they’ve determined that it’s conforming to the federal animal welfare requirements. And while they will be looking at the appropriateness of the protocol to the investigator’s scientific goals, that’s not their primary concern. They’re looking to assure that the procedures involved with the animals conform to the regulations, and that the animals are going to be handled appropriately and, that again, this idea of preventing or minimizing pain and distress is appropriately addressed in the animal study protocol.

Megan: So as I’m submitting my grant application, do I have to have IACUC approval before I submit the application?

Pat: No. NIH allows institutions to provide IACUC approval after peer review but prior to award. This is called “Just-In-Time.” So this reduces the burden on both the applicant and the animal care and use committees so that they don’t have to review animal activities until they’re likely to be funded.

Megan: And so there’s a checkbox right on the standard form 424, the Research and Research Related Application.

Pat: That’s right, yes. If they have not had IACUC approval of their grant application and animal activities then they can just check on the box “Yes to question 2A” that indicates that the IACUC review is pending. Then they should leave the IACUC approval date blank on the form, and that’s just below where the review pending question occurs.

Megan: Then we get that just-in-time for award. Can an application that’s deemed unacceptable by the NIH peer reviewers due to animal welfare concerns move forward in the review process?

Pat: Yes, the application, even though it’s rated unacceptable, may move forward in review, but those concerns raised by the reviewers have to be addressed satisfactorily and resolved before the grant award can be made.

Megan: And the NIH program official’s the one responsible for taking care of that?

Pat: The grants management staff and the program official will be involved in notifying the PI and obtaining those clarifications that have been raised by the reviewers. Those clarifications also come back through the Office of Lab Animal Welfare, and we review them also to confirm that the answers have been appropriately provided.

Megan: Are there additional resources that you would recommend that our listeners explore as they’re putting together their grant application?

Pat: Yes. OLAW has a brochure called “What Investigators Need To Know About The Use of Animals.” It’s a very succinct resource. It describes the requirements for investigators, and it also gives a little bit more information in terms of Web links and things like that related to other resources that the investigator might find helpful. I also wanted to mention that the National Institute of Allergy and Infectious Diseases has a more detailed guide on their website. It’s called “How To Write an Application Involving Research Animals” and it’s part of their All About Grants tutorial.

Megan: Thank you so much for joining us today. For NIH and OER, this is Megan Columbus.

Announcer: You can find the resources mentioned above by going to our website, grants.nih.gov, and clicking on the “Office of Laboratory Animal Welfare” located under the “Grants Policy” tab.