Welcome to All About Grants. This is Megan Columbus from NIH’s Office of Extramural Research. Today we have with us Dr. Patricia Brown, director of the Office of Laboratory Animal Welfare, also known as OLAW. She will be talking about including animals in your research proposal to the NIH and how you should write that information into your grant application or contract proposal

Dr. Brown, could you tell us a bit about why the NIH monitors the care and use of animals in our grant applications?
Federal policy requires that if you are going to use live vertebrate animals in NIH funded research, you must adhere to the requirements in the PHS Policy on Humane Care and Use of Laboratory Animals, the NIH Grants Policy Statement and also in the instructions for the PHS398 and SF424 application forms. These requirements state that the specifics of animal use should be described in the grant application. For contract proposals, you should follow  the instructions that accompany the request for proposal

So what exactly is considered research on animals only ?
All funded activities involving research, research training or biological testing with live animals are considered research on animals. This would include research and training grants, cooperative agreements, and contracts.

And why is it limited to vertebrate animals?
When the PHS Policy was first issued over 25 years ago, it defined an animal as any live vertebrate used or intended for use in research, training, experimentation, and testing. And that’s why the PHS Policy is currently limited to vertebrates.

What’s that mean for tissue samples are then included or only live animals ?
If you are obtaining live animals or if you are killing animals for tissue harvest, it is considered use of live animals. Also, the generation of custom antibodies is considered use of live animals.

So if our listeners are developing a grant application or contract proposal. What information should they include about the use of animals?
You will be asked to describe the proposed use of animals in your research in the grant application, Vertebrate Animals Section – the VAS. In 2016, this section was simplified to remove redundancy with IACUC review, but there are specific criteria that you must address.

And what information should they provide in the vertebrate animal section to address these criteria’s
First, you need to provide a concise description of the proposed procedures that involve vertebrate animals in the work that you’ve outlined in the application. Identify the species, strains, ages, sex and total number of animals – by species. If you are proposing to use dogs or cats, provide the source of the animals.

Second, justify that the species are appropriate for the research that you are proposing. Explain why the research goals can’t be accomplished using an alternative model – such as, computational, human, invertebrate, or in vitro.

Third, describe interventions to minimize discomfort, distress, pain, and injury. This includes analgesia, anesthesia, sedation, palliative care, and humane endpoints.

Lastly, you need to state whether the method of euthanasia is consistent with the AVMA Guidelines for the Euthanasia of Animals. If it isn’t, describe the method and provide a scientific justification. Beginning May 25 for grant applications when the forms the application is available the euthanasia statement will be replace with two yes or no questions about the euthanasia of animals. This changes further simplifies the VAS criteria.

So as this our listeners are pulling together this information for their grant application or contract proposal. How much detail do you recommend they provide?
You need to provide a complete description of the animals and the proposed procedures, but be concise – 1-2 pages. Your description should be cohesive and should include sufficient detail to allow evaluation by the peer reviewers that the proposed research involving animals is scientifically appropriate. However, the VAS must not be used to circumvent page limits.

Does additional information need to be provided if the research uses cats, dogs, or primates?
No, the basic requirements for the VAS are the same no matter what species is being proposed. However, provide justification that the species are appropriate for the proposed research. Provide the source for dogs and cats. And explain why the research goals cannot be accomplished using an alternative model.

Can you tell us what the reviewers are looking for when they evaluate the vertebrate animal section?
Members of scientific review groups will evaluate the VAS to determine if your plans for the use of vertebrate animals are appropriate relative to the scientific work proposed. Your application will be rated “unacceptable” if the requirements are not addressed adequately or if found inappropriate. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals.

If an application that is deemed unacceptable by the NIH peer reviewers due to animal welfare concerns, can it move forward in the review process?
Yes, an application that is rated as unacceptable due to animal welfare concerns may move forward in review, but the concerns must be satisfactorily resolved before a grant award can be made.

 

How is that different from what the IACUC will look at?
The IACUC will review the proposed research and provide oversight of the individual animal study protocols after approval. IACUC approval indicates that the proposed protocol conforms to PHS Policy.

While the IACUC does consider whether the proposed protocol is appropriate to the investigator’s scientific goals, the primary goal of the IACUC’s evaluation is to assure that the animal activities conform to animal welfare regulations and to PHS Policy. The animal study protocol focuses on how the animals will be handled for each of the procedures and what interventions are in place to prevent or minimize pain and distress.

So is IACUC approval needed for the submission of the grant application or the contract proposal?
No, IACUCs can provide approval after peer review by a process called “just-in-time.” This reduces the burden on applicants and IACUCs so that the review of animal activities is on those likely to be funded. The grant award can be made only after IACUC approval is complete.

What types of information are required at the Just-In-Time stage. If someone does well in peer review?
Verification that the IACUC has reviewed and approved the proposed animal activities may be submitted during the just-in-time stage.

But people need to wait for grants management at NIH to actually ask them for that information and that’s an important point to make.
Yes I would agree completely

Can you recommend some additional resources that our listeners can explore for putting together their grant application?
Yes, you can go to the OLAW website and see the Vertebrate Animals Section webpage for more information on the VAS requirements. Here you will find:

 

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

The OLAW website can be found at http://Grants.nih.gov/grants/olaw/olaw.htm. Here you will find policies, guidance and resources pertaining laboratory animal welfare. Once again the website is http://Grants.nih.gov/grants/olaw/olaw.htm