__ Indicators for humane experimental endpoints. For complete details on animal requirements and instructions, including a checklist for applicants and reviewers, refer to OLAW’s Vertebrate Animals Section. Failure to adequately address the criteria may negatively affect the application's impact score. Your email address will not be published. __ Provisions for palliative care or housing that may be necessary after experimental procedures. Provide a concise description of the proposed procedures to be used that involve live vertebrate animals in the work outlined in the Research Strategy section. Justifications (Vertebrate Animals Section). __ If more than one performance site is planned, are descriptions of animal use addressing the required criteria provided for each site? Until then, NIH requires applicants to continue using FORMS-E. • Section 5.2/5.3 – Care of Vertebrate Animals • Section 5.4/5.5 – Research Involving Human Subjects • Section 5.6 –Inclusion of Women, Minorities, and Children in Clinical Research • Section 5.7 -Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials Performs an administrative review of each VAS, checking that all criteria are addressed, if applicable. If live vertebrate animals are to be used, applicants must address the following criteria: 1. 2020 May 1;1862(5):183211. doi: 10.1016/j.bbamem.2020.183211. For full information, visit the OLAW website on the VAS. of Laboratory Animal Welfare (OLAW) website. This form collects information on human subjects, vertebrate animals, program income, human embryonic stem cells, inventions and patents, and changes of investigator/change of institution. The agreement provides a framework to enhance communication and harmonize the agencies’ efforts while reducing regulatory burden to supported … 2. The description must include sufficient detail to allow evaluation of the procedures. We want to assist investigators and reviewers in recognizing both the required components of the VAS and the components that are no longer required, with the goals of: This interactive module can be completed in 20 – 30 minutes and includes: If the work proposed in a grant application, contract proposal, or cooperative agreement involves live vertebrate animals, federal policy requires applicants and offerors to address the criteria noted below. The FORMS-F changes are substantive and require widespread technical changes to Coeus and Grants.gov. Special housing following surgery or manipulations, if necessary. This includes work involving: The criteria must be addressed for work proposed at every performance site – this is the site (institution) where procedures with animals will be performed. 4. Molecular organization and function of vertebrate septate-like junctions Biochim Biophys Acta Biomembr. Members of scientific review groups (SRGs) must evaluate the VAS to determine if plans for the use of vertebrate animals are appropriate relative to the scientific work proposed. The following guidance is provided to assist applicants and offerors in preparing the Vertebrate Animals Section (VAS) for submission to the NIH, and to assist reviewers in evaluating the VAS of applications and proposals. Posted on July 24, 2020 by NIH Staff. Works with the applicant to provide information to the Office of Laboratory Animal Welfare (OLAW) allowing resolution of the animal welfare concerns. Developments in FOIA in the Context of Animal Research - December 10, 2020 Audience: The program is tailored to IACUC staff, IACUC members, IOs, veterinarians, investigators, compliance personnel, animal care staff, and others involved in animal programs. Provide a concise description of the proposed procedures to be used that involve live vertebrate animals. U.S. Government Principles require grantees to consider mathematical models, computer simulation, and in vitro biological systems. They appear on applicants’ summary statements and on the grants management and program officer worksheets in IMPAC. On April 16, 2020, NIH and the National Aeronautics and Space Administration (NASA) announced a new agreement to ensure consistent and effective oversight of the welfare of animals used in NASA-funded activities. Vertebrate Animals Section (VAS) Describe the animals and their proposed use. For example, the use of non-human primates, dogs, or cats should be thoroughly justified. New NIH Vertebrate Animals Section Training Module. All vertebrates/invert : All research facilities in US. Office Notify me of follow-up comments by email. Applicants should be aware that NIH may release information contained in funded applications pursuant to a Freedom of Information Act request. Here you will find an overview of the requirements, a checklist for applicants and reviewers, detailed instructions, and responsibilities of applicants, reviewers, and NIH staff. __ Concise description of proposed procedures on live animals (i.e., sufficient information for evaluation) Provides reviewers with instructions for reviewing the VAS (e.g., worksheet), noting that all criteria must be evaluated as appropriate for the VAS to be ACCEPTABLE. Digital Control of Segmental Identity during Vertebrate Development: The Somite Cycle Controls a Digital, Chromatin-Based Counter That Defines Segmental Identity and Body Plans in Vertebrate Animals. The narrative below was created to cover point 3, "information on the veterinary care of the animals involved", and is provided to the Dartmouth research community to be used in the Vertebrate Animals section of the proposal. Epub 2020 Feb 4. Posted on July 31, 2020 by krs1. With the advice of the project officer and OLAW, as necessary, determines if the concerns have been resolved and the VAS can be considered ACCEPTABLE. responsibilities of applicants, reviewers, and NIH staff. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the application or proposal. Bioessays. 4. Enter your email address to subscribe to this blog and receive notifications of new posts by email. animals in PHS supported research on NIH’s Office 3, 2020 • 2 TABLE OF CONTENTS 2 DIRECTOR’S CORNER 3 FEATURE STORY Transforming How Science Is Done: ... applicants to consider both male and female vertebrate animals in preclinical studies, We are pleased to announce the availability of a new online training module on the Vertebrate Animals Section (VAS) in grant applications. If the applicant institution is not the site where animal work will be performed or if the work will be performed at several sites, these performance sites must be identified. Compliance with the PHS Policy is a broad mandate as the PHS Policy incorporates a number of other standards. Notice Number: NOT-OD-20-095 Key Dates Release Date: April 16, 2020 Related Announcements None Issued by Office of The Director, National Institutes of Health ()Purpose. 1. If dogs or cats are proposed, provide the source of the animals. Investigators should identify procedures or circumstances that may result in more than momentary discomfort, distress, pain, or injury and describe: U.S. Department of Health & Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, Guide for the Care and Use of Laboratory Animals (PDF), AVMA Guidelines for the Euthanasia of Animals (external PDF), What Investigators Need to Know About the Use of Animals, Guide for the Care and Use of Laboratory Animals, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, AVMA Guidelines for the Euthanasia of Animals, U.S. Department of Health and Human Services, PHS Policy on Humane Care and Use of Laboratory Animals, 2015, increasing the number of applications deemed acceptable, reducing time spent submitting and reviewing extraneous information, Animals obtained or euthanized for tissue harvest, Total number of animals to be used by species, Source of the animals, if dogs or cats are proposed. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form). National Institutes of Health ... WOMEN’S HEALTH IN FOCUS AT NIH • VOL. Verifies that the institutional Animal Welfare Assurance number is provided. OSP has received several questions regarding a new eRA Commons warning that appears when graphics are included in either the specific aims or abstract (i.e., the publicly available sections of a grant): “The file attached to Specific Aims/Abstract on the Research Plan form contains graphic files. In this website, I have detailed my experience writing and submitting my NIH K99/R00 application for June-2020 cycle. Calling all NIH applicants proposing research with vertebrate animals – check out the latest online learning module on the Vertebrate Animals Section in grant applications.This interactive module will assist applicants in preparing this section of the application, and will serve as a valuable resource for reviewers in evaluating the Vertebrate Animal Section of applications and proposals. Biophys Rev. Date: June 15, 2018 Last Revision: October 8, 2020. All live vertebrate animals. 3, NO. Identify the species, strains, ages, sex, and total number of animals by species to be used in the proposed work. __ Procedures to alleviate discomfort, distress, pain, or injury. Manner, circumstances, and duration of all post-surgical provisions and care. doi: 10.1002/bies.201900133. Prior Approval of Planned Research Involving Live Vertebrate Animals. RESOURCES FOR AUBURN RESEARCHERS . 4. when using vertebrate animals in PHS-funded activities. Required fields are marked *. Code 10 — No live vertebrate animals involved; Code 20 — Vertebrate animals involved, administrative review required Online Training Module for the Vertebrate Animals Section in Grant Applications. ... National Institutes of Health. __ Total number of animals by species to be used  Message from NIH Staff. Discuss why less highly evolved or simpler animal models are not appropriate. The following guidance is provided to assist applicants and offerors in preparing the Vertebrate Animals Section (VAS) for submission to the NIH, and to assist reviewers in evaluating the VAS of applications and proposals. If answer is “No” to the question “Is method consistent with AVMA guidelines?”, describe the method and provide scientific justification in the text field provided. If dogs or cats are proposed, provide the source of the animals. NIH Center for Scientific Review (CSR) The Neuroscience of Interoception and Chemosensation Study Section (NIC) reviews applications to investigate the genetics, molecular biology, anatomy, and physiology of chemosensation and interoception in humans as well as vertebrate and invertebrate animals, including insect disease vectors. __ Identify (by name or class) any tranquilizers, analgesics, anesthetics, and other treatments (e.g., antibiotics) and describe their use. Interventions to alleviate discomfort, distress, or pain. 2020 Jan;42(1):e1900133. NEW NIH Vertebrate Animals Section Training Module . The Office of Laboratory Animal Welfare (OLAW) recently released an online training module for the VAS that can be completed in 20-30 minutes. Describe interventions to minimize discomfort, distress, pain, and injury. Reviewers will assess the VAS for applications proposing the use of chimpanzees as they would any other application. __ Source, only if dogs or cats are proposed, ​2. The VAS must not be used to circumvent page limits. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form). On the Road to Grant Success – Addressing the Use of Vertebrate Animals Effectively January 2. Please make sure the specified attachment does not contain… TIGER TIPS . When vertebrate animals will be utilized in an NIH project/study, an attachment must be included in the “Other Research Plan” section of … NIH uses the following codes to indicate the extent of research animal involvement within a grant application. NIH application packages due on or after May 25, 2020, will use the FORMS-F application package. ", is the method described and a scientific justification provided? __ Why research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro), 3. This guidance is based on Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and federal requirements. 3. Minimization of Pain and Distress (Vertebrate Animals Section). The justification should: The justification for the number of animals, sex, ages, and other biological variables should be described in the Research Strategy. Here you will find an overview of the requirements. Calling all applicants proposing research with vertebrate animals – check out the latest online learning module on the Vertebrate Animals Section in grant applications. Additional (e.g., non-pharmaceutical) means to avoid discomfort, distress, pain, or injury, including palliative care. Considering alternatives to animals in your application is the topic of our next NIH All About Grants podcast.Drs. ... AVMA Guidelines for the Euthanasia of Animals: 2020 Edition (Formerly Report of the AVMA Panel on Euthanasia. 31: Justifications (Vertebrate Animals Section), __ Choice of species Provide justification that the species are appropriate for the proposed research. 1. Vertebrate animals include traditional laboratory animals, farm animals, wildlife, and aquatic species. 2020 Mar 9. doi: 10.1007/s12551-020-00654-z. Assists the contracting officer in determining the acceptability of the revised VAS. __ Sex Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. NIH New Vertebrate Animals Section Training Module Posted August 4, 2020 Calling all applicants proposing research with vertebrate animals – check out the latest online learning module on the Vertebrate Animals Section in grant applications . Home. If live vertebrate animals are to be used, applicants must address the following criteria: 1. New Vertebrate Animals Section Training Module. The module provides: NIH's Worksheet for Review of the Vertebrate Animal Section (VAS) (PDF) describes requirements and provides an example of a complete VAS. NIH: National Institutes of Health; OLAW: Office of Laboratory Animal Welfare Indicate why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro). Vertebrate Animals Section in grant applications. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form). NOT-OD-16-006: Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals; Training. and includes: See additional resources on the humane care and use of Entry Combination Allowable Qualifiers. Why a Constant Number of Vertebrae? Examples of the kinds of items that may be appropriate to include are: __ Circumstances relevant to the proposed work, when animals may experience discomfort, distress, pain, or injury. The PHS 398 Cover Page Supplement Form is used for all grant applications except fellowships. Online Training Module for the Vertebrate Animals Section in Grant Applications. 2021. Address the following for all species to be used: __ Species These include analgesia, anesthesia, sedation, palliative care, and humane endpoints. __ If answer is "No" to the question "Is method consistent with AVMA guidelines? References. Investigators must include a concise description of the proposed procedures on live animals. The required criteria must be addressed for all performance sites. If dogs or cats are proposed, provide the source of the animals. NIH has launched an online training to assist investigators in preparing the Vertebrate Animals Section (VAS) of their NIH grant applications, when applicable. The PHS Policy incorporates the standards in the Guide for the Care and Use of Laboratory Animals (PDF) and the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, and requires that euthanasia be conducted according to the AVMA Guidelines for the Euthanasia of Animals (PDF). 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