Proposal Preparation
Ensuring the responsible, judicious care and use of animals in research begins at the earliest stages of study design and grant proposal preparation with thoughtful consideration of all scientifically valid new approach methodologies (NAMs); appropriate justification for the species selected, number of animals needed, and procedures performed; and steps that have been taken to address the Three Rs – Replacement, Reduction, and Refinement.
To assist Principal Investigators (PIs) with the development of grant proposals that are comprehensive, competitive, and responsive to an evolving funding/scientific landscape, the Animal Care & Use Program has compiled the following guidance and resources (click on the links below to skip to a specific section of this page):
- Vertebrate Animal Section (VAS) Criteria –
- General Guidance & Instructions
- Description of Procedures
- Rationale/Justifications
- Minimization of Pain and Distress
- Method of Euthanasia
- Best Practices for Proposal Preparation –
- Addressing Reproducibility & the Three Rs
- Frequently Requested Grant Data & Boilerplate Language
- Budget Consultation & Planning
- References & Resources
All research activities funded by the federal government that involve live vertebrate animals, including the generation of custom antibodies and/or obtaining tissue from live vertebrate animals, must comply with various rules, regulations, and standards, namely the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy).
Among other mandates, PHS Policy requires the inclusion of a Vertebrate Animal Section (VAS) in all grant applications for National Institutes of Health (NIH) funding. This section is evaluated as part of the peer review process and is critical for assuring grant reviewers that the proposed animal models have been appropriately justified and that procedures employed minimize the potential for pain and distress.
In accordance with federal guidance, applicants must “include a concise description of all proposed procedures on live animals in the VAS,” that specifically addresses the following four criteria:
- Description of Procedures
- Minimization of Pain and Distress
- Rationale/Justifications
- Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form)
Vertebrate Animal Section (VAS) Criteria
Expand each section below for suggestions and best practices on addressing required VAS criteria. For additional tools and resources to complete the VAS, review the References & Resources section at the bottom of this webpage.
Guidance & Best Practices for Writing the VAS
- Use clear, concise, and direct language
- Avoid using scientific jargon and/or technical language specific to your field of study
- Consult with your ULAM Faculty Veterinarian and the Quality Assurance Team ([email protected]) for assistance with understanding institutional and regulatory expectations for animal use protocol submissions, which may help facilitate future congruence with grant applications
- Verify consistency with other sections of your grant application
- Reference institutional oversight processes and standards for veterinary care (see Frequently Requested Grant Boilerplate section below)
- Refrain from vague descriptions and generalities
- Do NOT omit details on euthanasia and/or pain management
To adhere to the two-page limit, PIs may elect to include specific details (e.g., written justification for the total number of animals requested, how group size was calculated, etc.) in the Research Strategy Section of their application.
Description of Procedures (Vertebrate Animals Section)
Provide a concise description of the proposed procedures to be used that involve live vertebrate animals. Identify the species, strains, ages, sex, and total number of animals by species to be used. If dogs or cats are proposed, provide the source of the animals.
In accordance with NIH guidance, this section “must include sufficient detail to allow evaluation by reviewers.”
VAS Section #1 Guidance & Best Practices
- Be thorough. For example, “We will use 30 adult male C57BL/6 mice, aged 8-12 weeks, housed in standard cages with ad libitum food and water.”
- Include specifics about administration of substances (including the use of chemical or manual restraint), surgical procedures (e.g., anesthetic regimens, monitoring, and recovery), behavioral tests, sample collection (e.g., blood, urine), tumor induction, and irradiation/post-irradiation procedures.
- Don’t forget the details – e.g., frequency, site, and amount/volume of sample collection and other procedures; units of measure; and justification if unusual methods are to be employed.
Where applicable, PIs should also refer to the ARRIVE (Animal Research: Reporting of In Vivo Experiments) Guidelines when developing their study design(s). Created by an international working group of scholars and scientists to further enhance the rigor and reproducibility of animal-based research, these guidelines have been encouraged by the NIH and endorsed by numerous academic journals, including PLOS, Nature Scientific Reports, and eBioMedicine.
Rationale/Justifications (Vertebrate Animals Section)
Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
For more than 50 years, institutional and regulatory expectations have required appropriate justification for the use of animals in research. As the scientific and technological landscape(s) surrounding laboratory animal medicine continue to evolve, PIs must place renewed emphasis on the thoughtful consideration and incorporation (where scientifically appropriate) of new approach methodologies (NAMs).
VAS Section #2 Guidance and Best Practices
The rationale/justification provided should address three specific questions:
Why use animals?
Explain why the research goals cannot be accomplished using an alternative model (e.g., mathematical; computational, including the use of artificial intelligence; in vitro, such as organoid models; less sentient species, such as invertebrate; or human subject studies). Remember that some VAS reviewers may have never conducted research with animals, so it’s important your justification be clearly communicated. If no scientifically valid alternatives exist, explicitly state this fact (e.g., “no non-vertebrate model currently replicates the complex immune response under study.”)
Why is this species/model the most valid method of study?
Provide rationale for the choice of species, including the specific advantages obtained from the selected species as well as inappropriateness of alternative species, especially but not limited to, studies involving sensitive species (e.g., non-human primates, dogs, cats). Include scientific relevance and/or existing literature if it will enhance the provided rationale. Note: age, sex, and biological variables should be included in the Research Strategy portion of the grant application.
Why is this number of animals required?
Briefly outline why this number of animals is required for the study, noting that details regarding the calculation, such as group size, should be included in the Research Strategy portion of the grant application.
Minimization of Pain and Distress
Describe the interventions to minimize discomfort, distress, pain, and injury. These include analgesia, anesthesia, sedation, palliative care, and humane endpoints.
Researchers have an ethical, scientific, and legal obligation to prevent and alleviate animal pain and distress. Accordingly, appropriate alternatives must be considered and carefully justified for any procedure likely to cause more than momentary pain or distress to the animal. Examples may include invasive tissue collection, food and/or fluid restriction or regulation, and survival surgical procedures.
VAS Section #3 Guidance and Best Practices
- Identify any procedures that have the potential to cause more than momentary pain or distress, including descriptions of interventions planned to minimize discomfort.
- Identify (by name or class) any tranquilizers, analgesics, anesthetics, and other treatments (e.g., antibiotics) and describe their use. Note: These pharmacological agents must also be included in the animal use protocol on file with U-M’s Animal Care & Use Office.
- Describe plans for post-surgical care, if applicable.
- Detail palliative care and/or special housing provisions required for post-procedural monitoring and treatment.
- Describe any anticipated adverse consequences of the procedure(s) or model-induced morbidity, including the clinical signs or other observations that will be used to identify these effects, even if interventions (e.g., analgesia, clinical treatment) are planned. The description should include measurable observations to determine humane endpoints (i.e., signs indicating the need for removal from the study and/or euthanasia).
- The selection of procedures for which alternative methods with a lower potential for inducing pain and/or distress exist must be carefully justified. Examples may include retro-orbital blood collection and avoidance of analgesics following survival surgery.
Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form)
If investigators are proposing to use a method of euthanasia that is not consistent with “AVMA Guidelines,” they must describe the method and provide a scientific justification in the text field provided.
To ensure that animals experience minimal pain, discomfort, and/or distress, federal regulations and institutional policy require strict adherence to the methods for species-specific euthanasia outlined by the American Veterinary Medical Association’s (AVMA) Guidelines for the Euthanasia of Animals (2020 Edition).
All methods must be performed in accordance with the animal use protocol approved by the U-M’s Institutional Animal Care & Use Committee (IACUC). Any deviation from AVMA Guidelines must be scientifically justified in the VAS and approved by the IACUC.
More information is available in the U-M Euthanasia Guidelines on the Animal Care A-Z website.
Vertebrate Animal Section (VAS) Feedback Questionnaire
Our program is committed to helping the U-M research community remain responsive to an evolving funding landscape that supports the responsible, judicious use of animals in research to answer important scientific questions. To assist in these efforts, please consider sharing feedback you have received on the VAS of recently-submitted (e.g., within the last 15 calendar months) grant proposals.
The information you provide will be used to further refine guidance and best practices for writing a competitive VAS.
Best Practices for Proposal Preparation
To ensure that practices align with advancements in laboratory animal medicine and the scientific process, Study Teams should routinely re-assess their experimental design(s). This assessment may include, but is NOT limited to:
- Updated/revised literature reviews
- Incorporation of new approach methodologies (NAMs), computer-based modeling, and other new/emerging technologies (e.g., artificial intelligence, organoids) where scientifically appropriate
- A more thorough explanation of how the data collected from the selected animal models/experiments will be used to inform other phases of scientific discovery, including direct translation to human/animal medicine
- Steps taken to address the Three 3Rs:
- Reduce the number of animals used to the minimum required for the study,
- Replace animals with less sentient or non-animal models, if feasible; and
- Refine all practices to provide the best possible animal welfare.
The U-M Library has developed a curated collection of resources that includes a list of literature databases, online journals, and Three Rs / Alternatives Resources.
Study Teams are also encouraged to review the United States Department of Agriculture (USDA)’s Literature Searching: How to Find Animal Use Alternatives website for comprehensive step-by-step instructions on performing literature searches, including sample keywords, search examples, and resources for proper records and citation management.
ARRIVE Guidelines
To further enhance the rigor and reproducibility of animal-based research, the NIH and numerous academic journals have encouraged use of the ARRIVE Guidelines to ensure that researchers are utilizing internationally-recognized standards throughout study planning and design, execution, and publication.
As such, a review of the following is strongly recommended:
- ARRIVE (Animal Research: Reporting of In Vivo Experiments) Guidelines – A “checklist of recommendations for the full and transparent reporting of research involving animals.” For convenience, pocket-sized versions of the guidelines can be requested free-of-charge via the ARRIVE website.
- NIH’s NOT-OD-23-057 – A notice issued by the NIH in 2023 encouraging “award recipients to include the ARRIVE Essential 10 – which are essential elements of study design – in all NIH-supported publications describing vertebrate animal and cephalopod research.”
- NIH’s Plan to Drive Gold Standard Science – Published by the NIH in 2025, this document outlines the agency’s plan to “incorporate the nine, interlocking tenets of gold standard science adopted by the U.S. Government and aligns with the Department of Health and Human Services’ framework for achieving these principles.”
For additional tools and resources to address the Three Rs, reproducibility, and incorporation of NAMs into project proposals, review the References & Resources section at the bottom of this webpage.
Sponsors often require detailed information about specific U-M processes and programs as part of the proposal development and submission process.
Frequently required grant data (e.g., most recent AAALAC accreditation date and unit number; PHS Assurance Number; and USDA Registration Number) is outlined below and can also be found on the homepage of the Animal Care & Use Program website.
AAALAC Accreditation:
Most Recent Accreditation Date:
November 23, 2023;
Unit Number: 000285
PHS Assurance Number:
D16-00072 (A3114-01);
Assurance Dates:
July 2025 – July 2029
USDA Registration Number:
34-R-0001
Many proposals also require a brief summary of the university’s facilities and/or animal care and use program to ensure that the institution and – by extension – the PI is sufficiently supported and equipped to perform the proposed research. The following boilerplate language can be adapted to fit the specific needs of the proposal:
Grant Application Boilerplate Language:
Animal husbandry will be provided by Unit for Laboratory Animal Medicine (ULAM) staff under the guidance of supervisors who are certified by the American Association for Laboratory Animal Science (AALAS). Veterinary services – including clinical care and pathology – will be provided by ULAM faculty members (16), veterinary residents (7), and veterinary technicians (~14). As of July 1, 2026, 12 members of the faculty are diplomates of the American College of Laboratory Animal Medicine (ACLAM), 3 faculty members are diplomates of the American College of Veterinary Pathology (ACVP), and 1 faculty member is a diplomate of the American College of Veterinary Surgery (ACVS). Veterinarians are available during regular business hours, and are on-call after hours, on weekends, and holidays. Directions for obtaining emergency veterinary care are posted throughout the vivarium and on the Program website.
The University of Michigan is accredited by AAALAC International, and the Animal Care & Use Program conforms to the standards outlined in the Guide for the Care and Use of Laboratory Animals (NRC 2011). The Program includes required inspections of animal facilities, review of all funded projects for humane use of animals, and the appropriate use of surgical anesthesia, analgesics, and tranquilizers. The University of Michigan has an approved assurance statement on file with the Office of Laboratory Animal Welfare (OLAW) regarding these matters.
Word Count: 217, Updated: July 27, 2026
This description is updated on a routine basis to ensure that PIs have access to the most up-to-date data about U-M’s Animal Care & Use Program.
For additional information about U-M’s operations, visit the Facility & Resource Profile Templates page on the Michigan Medicine website or the Frequently Required Proposal Data & Documents page on the Office of Research & Sponsored Projects website.
The Unit for Laboratory Animal Medicine (ULAM) Business Office is available to assist PIs and Study Teams with budget planning for a variety of animal care and use projects.
Financial consultation for project proposals includes:
- Providing current prices for animal and other ULAM-related supply purchases,
- Help estimating animal care costs,
- Assistance with cost estimates for specialized research support services:
- ULAM Pathology Core pathology and animal diagnostics
- Animal surgery operating room fees
- Germ-free facility usage, and
- Technical support services such as blood collection, compound administration, animal identification, and more
To request a budget consultation, contact the ULAM Business Office at [email protected]. Please allow up to three business days for review.
References and Resources
Questions?
If you have additional questions about grant proposal preparation or completing the VAS, please contact [email protected] and your question will be routed to the appropriate contact.