Are you an applicant or offeror looking for guidance on preparing the Vertebrate Animals Section (VAS) for submission to the NIH? Or maybe you’re a reviewer who wants to evaluate the VAS of applications and proposals more efficiently? Look no further! In this comprehensive guide, we’ll provide an overview of the requirements, a checklist, detailed instructions, and responsibilities for all parties involved.
Applicability
First things first, let’s talk about when these criteria apply. If your grant application, contract proposal, or cooperative agreement involves live vertebrate animals, federal policy requires you to address the following:
- Animals obtained or euthanized for tissue harvest
- Generation of custom antibodies
It’s crucial to address these criteria for each performance site where procedures with animals will be performed, even if it’s not the applicant institution. So if you have multiple sites, make sure to identify them all.
Requirements
Now let’s dive into the requirements you need to address if you’re using live vertebrate animals in your research:
1. Description of Procedures (Vertebrate Animals Section)
Provide a concise description of the proposed procedures involving live vertebrate animals. Don’t forget to identify the species, strains, ages, sex, and total number of animals to be used. If you’re proposing to use dogs or cats, provide the source of the animals as well.
2. Justifications (Vertebrate Animals Section)
Justify why the chosen species are appropriate for your research. Explain why alternative models such as computational, human, invertebrate, or in vitro systems cannot achieve your research goals.
3. Minimization of Pain and Distress (Vertebrate Animals Section)
Describe the interventions you’ll implement to minimize discomfort, distress, pain, and injury. This includes analgesia, anesthesia, sedation, palliative care, and humane endpoints. We want to ensure the welfare of the animals involved!
4. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form)
If you plan to use a euthanasia method that is not consistent with the American Veterinary Medical Association (AVMA) Guidelines, provide a scientific justification for your chosen method.
Checklist for Applicants and Reviewers
To help you stay organized, here’s a checklist to ensure you’ve covered all the necessary aspects:
Performance Sites
- Identify all collaborative performance sites if the applicant’s institution is not where animal work will be performed.
- Provide descriptions of animal use addressing the required criteria for each site.
1. Description of Procedures (Vertebrate Animals Section)
- Describe the animals and their proposed use.
- Include species, strains, ages, sex, and total number of animals by species.
- Provide a concise description of proposed procedures on live animals.
- Remember to mention the source if dogs or cats are proposed.
2. Justifications (Vertebrate Animals Section)
- Justify the use of animals in your research.
- Explain why alternative models cannot achieve your research goals.
- Discuss why less evolved or simpler animal models are not suitable.
- Thoroughly justify the use of non-human primates, dogs, or cats if applicable.
3. Minimization of Pain and Distress (Vertebrate Animals Section)
- Identify procedures or circumstances that may cause discomfort, distress, pain, or injury.
- Describe interventions to alleviate discomfort, distress, pain, or injury.
- Specify the use of pharmacological agents or non-pharmaceutical means.
- Address provisions for post-surgical care and special housing if necessary.
- Indicate indicators for humane endpoints and euthanasia.
4. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form)
- If your euthanasia method is not consistent with AVMA guidelines, describe it and provide a scientific justification.
Instructions
Now let’s talk about how to approach the Vertebrate Animals Section (VAS) in your application:
1. Description of Procedures (Vertebrate Animals Section)
Include a concise yet comprehensive description of the proposed procedures on live animals. Make sure to provide enough detail for evaluation. Examples of procedures include behavioral tests, blood collection, surgical procedures, administration of substances, tumor induction, and post-irradiation procedures.
When describing the animals, provide the following information:
- Species
- Strains
- Ages
- Sex
- Total number of animals by species
- Source of the animals (if dogs or cats are proposed)
2. Justifications (Vertebrate Animals Section)
Justify the use of animals in your research by considering alternative models. U.S. Government Principles encourage the use of mathematical models, computer simulations, and in vitro biological systems. Your justification should:
- Explain why your research goals cannot be achieved using alternative models.
- Provide a rationale for your choice of species, highlighting their advantages over alternative species.
- Thoroughly justify why less highly evolved or simpler animal models are not appropriate.
- If using non-human primates, dogs, or cats, provide a robust justification for their selection.
The research strategy should cover the justification for the number of animals, sex, ages, and other biological variables.
3. Minimization of Pain and Distress (Vertebrate Animals Section)
Identify procedures or circumstances that may cause discomfort, distress, pain, or injury to the animals. Describe the following:
- Interventions to alleviate discomfort, distress, or pain.
- Use of pharmacological agents (if applicable).
- Other means to avoid discomfort, distress, pain, or injury, including palliative care.
- Post-surgical provisions and care.
- Special housing requirements after surgery or manipulations.
- Procedures that might lead to severe discomfort, distress, pain, or injury.
- Indicators for humane endpoints and euthanasia.
These considerations are crucial, especially for survival surgeries. If proposing multiple surgeries, make sure to justify them and address any potential complications.
4. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form)
If your proposed method of euthanasia does not align with AVMA guidelines, describe the method and provide a scientific justification.
Applicant Responsibilities
As an applicant, ensure that you address all the criteria in your NIH applications. Inadequate addressing of the criteria may negatively impact your application’s impact score. Remember, the VAS should only include a description of the proposed use of live animals and should not be used to circumvent page limits.
Reviewer Responsibilities
As a reviewer, your role is to evaluate the VAS and determine the appropriateness of the plans for using vertebrate animals in relation to the proposed scientific work. An application will be rated as UNACCEPTABLE if all required items are not adequately addressed or found inappropriate. Review the VAS for applications proposing the use of chimpanzees as you would for any other application.
NIH Staff Responsibilities
Let’s see what the NIH staff members’ responsibilities entail:
Grants Review Staff
- Perform an administrative review of each VAS to ensure that all criteria are addressed.
- Provide reviewers with instructions and worksheets to evaluate the VAS appropriately.
- Code the application and include reviewers’ comments in the summary statement after SRG review.
Grants Program Staff
- Obtain additional information or clarification for any UNACCEPTABLE application recommended for funding.
- Work with the applicant to resolve animal welfare concerns raised by the Office of Laboratory Animal Welfare (OLAW).
Grants Management Staff
- Verify that the institutional Animal Welfare Assurance number is provided.
- Obtain verification of IACUC approval.
Contracting Officer
- Provide instructions to reviewers for evaluating the VAS.
- Determine the competitive range and hold discussions if necessary.
- Assess whether concerns raised by reviewers have been resolved and if the VAS is ACCEPTABLE.
- Confirm the presence of an Animal Welfare Assurance and IACUC approval for the offeror.
- Make contract awards.
Project Officer
- Assist the contracting officer in determining the acceptability of the revised VAS.
FAQs
Q: Where can I find additional resources and training?
A: You can check out the frequently asked questions, the grant application VAS worksheet, the contract proposal VAS worksheet, factsheets, and online training modules available.
Conclusion
We hope this guide has provided you with all the information you need to navigate the Vertebrate Animals Section. Remember to address each criterion diligently and ensure the welfare of the animals involved in your research. For more information and to stay up-to-date on the latest news in the world of pets and animals, visit Hot Pets News – Pets and Animals.
Note: This article has been created for informational purposes and does not constitute legal or professional advice.
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