doi: 10.1002/bies.201900133. 3. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form). Office Reviewers will assess the VAS for applications proposing the use of chimpanzees as they would any other application. The VAS must not be used to circumvent page limits. 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. Failure to adequately address the criteria may negatively affect the application's impact score. 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. Justifications. Calling all applicants proposing research with vertebrate animals – check out the latest online learning module on the Vertebrate Animals Section in grant applications. Describe interventions to minimize discomfort, distress, pain, and injury. While additional details may be included in the Research Strategy, a coherent, albeit brief, description of the proposed use of the animals must be provided in the VAS. Description of Procedures (Vertebrate Animals Section). __ Source, only if dogs or cats are proposed, ​2. If dogs or cats are proposed, provide the source of the animals. Calling all applicants proposing research with vertebrate animals – check out the latest online learning module on the Vertebrate Animals Section in grant applications. Required fields are marked *. __ Concise description of proposed procedures on live animals (i.e., sufficient information for evaluation) ××× The NIH funding for FY20 provides partial support for the animals as explained under “Current Costs Per Facility” (calculated for the periods 09/26/2019 – 07/30/2020 and 07/31/2020 – 01/31/2021). If dogs or cats are proposed, provide the source of the animals. 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 . Enter your email address to subscribe to this blog and receive notifications of new posts by email. Obtains additional information or clarification to resolve concerns for any application found to be UNACCEPTABLE if it is to be recommended for funding. NIH: National Institutes of Health; OLAW: Office of Laboratory Animal Welfare Molecular organization and function of vertebrate septate-like junctions Biochim Biophys Acta Biomembr. The justification should: The justification for the number of animals, sex, ages, and other biological variables should be described in the Research Strategy. Discuss why less highly evolved or simpler animal models are not appropriate. The description must include sufficient detail to allow evaluation of the procedures. On the Road to Grant Success – Addressing the Use of Vertebrate Animals Effectively January 2. Bioessays. __ If the applicant’s institution is not where animal work will be performed, are all collaborative performance sites identified? Considering alternatives to animals in your application is the topic of our next NIH All About Grants podcast.Drs. NEW NIH Vertebrate Animals Section Training Module . Entry Combination Allowable Qualifiers. Online Training Module for the Vertebrate Animals Section in Grant Applications. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. Each of the criteria must be addressed in NIH applications. U.S. Government Principles require grantees to consider mathematical models, computer simulation, and in vitro biological systems. 3. 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, Why a Constant Number of Vertebrae? Your email address will not be published. Provide a concise description of the proposed procedures to be used that involve live vertebrate animals. Posted on July 24, 2020 by NIH Staff. We are pleased to announce the availability of a new online training module on the Vertebrate Animals Section (VAS) in grant applications. Provide a justification for methods of euthanasia that are not consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. They appear on applicants’ summary statements and on the grants management and program officer worksheets in IMPAC. Describe the animals and their proposed use. Follow the instructions for Vertebrate Animals in the SF 424 Form Instructions. Assists the contracting officer in determining the acceptability of the revised VAS. Code 10 — No live vertebrate animals involved; Code 20 — Vertebrate animals involved, administrative review required New NIH Vertebrate Animals Section Training Module. 31: 1.) Epub 2019 Nov 21. Subsequent to SRG review, codes the application and includes reviewers’ comments in the summary statement. responsibilities of applicants, reviewers, and NIH staff. TIGER TIPS . 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. 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. The PHS 398 Cover Page Supplement Form is used for all grant applications except fellowships. Calling all applicants proposing research with vertebrate animals – check out the latest online learning module on the Vertebrate Animals Section in grant applications. An application will be rated UNACCEPTABLE if all required items are not addressed adequately or found inappropriate. NIH's Worksheet for Review of the Vertebrate Animal Section (VAS) (PDF) describes requirements and provides an example of a complete VAS. 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. 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. New Vertebrate Animals Section Training Module. Biophys Rev. Vertebrate animals include traditional laboratory animals, farm animals, wildlife, and aquatic species. Confirms whether the offeror has an Animal Welfare Assurance and IACUC approval. Date: June 15, 2018 Last Revision: October 8, 2020. This guidance is based on Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and federal requirements. Understanding the Dual Nature of NIH. 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. Manner, circumstances, and duration of all post-surgical provisions and care. Justifications (Vertebrate Animals Section), __ Choice of species Indicate why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro). animals in PHS supported research on NIH’s Office Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form). Description of Procedures (Vertebrate Animals Section) Provide a concise description of the proposed procedures to be used that involve live vertebrate animals. This engaging module takes 30 minutes or less to complete The module provides: of Laboratory Animal Welfare (OLAW) website. UPDATE: NIH LATE APPLICATION POLICY DUE TO PUBLIC HEALTH EMERGENCY FOR U.S. FOR COVID-19: NOT-OD-20-091 informs the research community that NIH will accommodate late applications (prior permission and cover letter not required) for due dates between March 9, 2020 and May 1 through May 1, 2020. Investigators should identify procedures or circumstances that may result in more than momentary discomfort, distress, pain, or injury and describe: All of these issues are particularly important for survival surgeries. [Epub ahead of print] Unexpected molecular diversity of vertebrate nonvisual opsin Opn5. __ Sex Writing a K99 grant involves series of steps and requires significant amount of work, both from writing the Science and Administrative sections. RESOURCES FOR AUBURN RESEARCHERS . If multiple surgeries are proposed, these should be well justified and provisions to avoid any potential complications may be described. References. Please make sure the specified attachment does not contain… ... AVMA Guidelines for the Euthanasia of Animals: 2020 Edition (Formerly Report of the AVMA Panel on Euthanasia. and includes: See additional resources on the humane care and use of NIH uses the following codes to indicate the extent of research animal involvement within a grant application. ... National Institutes of Health. 4. For full information, visit the OLAW website on the VAS. NIH has launched an online training to assist investigators in preparing the Vertebrate Animals Section (VAS) of their NIH grant applications, when applicable. This guidance is based on Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and federal requirements. Justifications (Vertebrate Animals Section). __ If answer is "No" to the question "Is method consistent with AVMA guidelines? Identify the species, strains, ages, sex, and total number of animals by species to be used. Entry Version ANIMAL DIS Abbreviation Entry Term(s) Animal Diseases Add Diseases, Animal Add Pharm Action Registry Number CAS Type 1 Name NLM Classification # Previous Indexing See Also Consider Also Public MeSH Note 66; was see under VETERINARY MEDICINE & ZOONOSES 1963-65 Online Note History Note Vertebrate Animals Section in grant applications. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro). Typically, all of the required elements for the VAS can be addressed within 1-2 pages. The FORMS-F changes are substantive and require widespread technical changes to Coeus and Grants.gov. 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. 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. __ Plans for post-surgical care, if survival surgeries are proposed. 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. 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 more than one performance site is planned, are descriptions of animal use addressing the required criteria provided for each site? If live vertebrate animals are to be used, applicants must address the following criteria: 1. Description of Procedures (Vertebrate Animals Section). For an overview of the application and review process, as well as award management, read Research Using Vertebrate Animals. 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. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the application or proposal. The agreement provides a framework to enhance communication and harmonize the agencies’ efforts while reducing regulatory burden to supported … Online Training Module for the Vertebrate Animals Section in Grant Applications. 2020 Mar 9. doi: 10.1007/s12551-020-00654-z. Subsequent to SRG review, determines the competitive range, as applicable, and if discussions are held, provides the offeror with the opportunity to address the concerns raised by the reviewers. 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. Provide rationale for the choice of species (e.g., advantages of the species chosen and why alternative species are not appropriate). 1. ... 2020/08/13. __ Procedures to alleviate discomfort, distress, pain, or injury. Examples of the types of procedures that may be described include: In describing the animals, investigators must provide the following information: Investigators must justify the use of animals in the proposed research. 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. 1. Epub 2020 Feb 4. 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. 2020 NIH VIRTUAL SEMINAR on Program Funding and Grants Administration Agenda. Verifies that the institutional Animal Welfare Assurance number is provided. National Institutes of Health ... WOMEN’S HEALTH IN FOCUS AT NIH • VOL. Vertebrate Animals Section (VAS) __ Why research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro), 3. The VAS must not be used to circumvent page limits and is only to include a description of the proposed use of live animals. National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892. 2. Interventions to alleviate discomfort, distress, or pain. NOT-OD-16-006 announced and described the changes implemented to simplify and remove redundancies in the Vertebrate Animals Section (VAS) for NIH grant, cooperative agreement, and contract applications. All live vertebrate 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. 2020 May 1;1862(5):183211. doi: 10.1016/j.bbamem.2020.183211. Prior Approval of Planned Research Involving Live Vertebrate Animals. Works with the applicant to provide information to the Office of Laboratory Animal Welfare (OLAW) allowing resolution of the animal welfare concerns. August 3, 2020 . However, the changes should be minor for Coeus users and investigators. For example, the use of non-human primates, dogs, or cats should be thoroughly justified. 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. Identify the species, strains, ages, sex, and total number of animals by species to be used. Provide justification that the species are appropriate for the proposed research. Procedures (e.g., pharmacological, surgical) that might lead to severe discomfort, distress, pain, or injury. Method of Euthanasia (Cover Page Supplement / PHS Fellowship Supplemental Form). Home. 4. Here you will find an overview of the requirements. __ Strains Your email address will not be published. 2021. Minimization of Pain and Distress (Vertebrate Animals Section) 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. Minimization of Pain and Distress (Vertebrate Animals Section). of Laboratory Animal Welfare (OLAW) website. Applicants should be aware that NIH may release information contained in funded applications pursuant to a Freedom of Information Act request. when using vertebrate animals in PHS-funded activities. Minimization of Pain and Distress (Vertebrate Animals Section), Describe the interventions to minimize discomfort, distress, pain, and injury. In this website, I have detailed my experience writing and submitting my NIH K99/R00 application for June-2020 cycle. 1. NIH application packages due on or after May 25, 2020, will use the FORMS-F application package. Additional (e.g., non-pharmaceutical) means to avoid discomfort, distress, pain, or injury, including palliative care. Investigators must include a concise description of the proposed procedures on live animals. The required criteria must be addressed for all performance sites. __ Provisions for palliative care or housing that may be necessary after experimental procedures. If live vertebrate animals are to be used, applicants must address the following criteria: 1. ", is the method described and a scientific justification provided? Performs an administrative review of each VAS, checking that all criteria are addressed, if applicable. Identify the species, strains, ages, sex, and total number of animals by species to be used in the proposed work. This interactive module will assist applicants and offerors 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. 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. Address the following for all species to be used: __ Species This Notice announces a memorandum of understanding (MOU) concerning laboratory animal welfare between the NIH Office of Laboratory Animal Welfare (OLAW) and the National Aeronautics and Space Administration (NASA). OLAW also offers a 30-minute training module on how to Complete the Vertebrate Animals Section (VAS). Until then, NIH requires applicants to continue using FORMS-E. __ Total number of animals by species to be used  If dogs or cats are proposed, provide the source of the animals. 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. __ Ages The Office of Laboratory Animal Welfare (OLAW) recently released an online training module for the VAS that can be completed in 20-30 minutes. 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). 4. When vertebrate animals will be utilized in an NIH project/study, an attachment must be included in the “Other Research Plan” section of … 3, NO. 2020 Jan;42(1):e1900133. Diseases that occur in VERTEBRATE animals. 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. Indicators for humane endpoints and euthanasia (e.g., severe infection, respiratory distress, failure to eat, tumor size). __ Identify (by name or class) any tranquilizers, analgesics, anesthetics, and other treatments (e.g., antibiotics) and describe their use. All vertebrates/invert : All research facilities in US. Additional background information and references are available on the OLAW website. a checklist for applicants and reviewers. __ Indicators for humane experimental endpoints. NOT-OD-16-006: Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals; Training. Warm-blooded vertebrate animals belonging to the class Mammalia, including all that possess hair and suckle their young. For complete details on animal requirements and instructions, including a checklist for applicants and reviewers, refer to OLAW’s Vertebrate Animals Section. Compliance with the PHS Policy is a broad mandate as the PHS Policy incorporates a number of other standards. 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. Message from NIH Staff. General Information 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. Notify me of follow-up comments by email. Posted on July 31, 2020 by krs1. Special housing following surgery or manipulations, if necessary. These include analgesia, anesthesia, sedation, palliative care, and humane endpoints. • 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 Name or class of pharmacological agents, if used. Performance sites identified of NIH grant applications except fellowships why alternative species are appropriate for Euthanasia. Is only to include a concise description of the revised VAS contracting officer in determining acceptability! May negatively affect the application or proposal total number of animals by species to be that... Officer in determining the acceptability of the requirements the VAS can be addressed within 1-2 pages be recommended Funding. 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Of non-human primates, dogs, or injury source of the animals and Program officer worksheets IMPAC. Non-Human primates, dogs, or injury, including all that possess hair and suckle their young: e1900133 application... Use Addressing the use of chimpanzees as they would any other application applicants must address the nih vertebrate animals 2020! And references are available on the OLAW website class Mammalia, including palliative care of septate-like. Infection, respiratory distress, pain, and total number of other.! Website on the Vertebrate animals ages, sex, and aquatic species Biochim Biophys Biomembr. Mathematical models, computer simulation, and injury, palliative care or housing that may be.... The institutional animal Welfare ( OLAW ) allowing resolution of the AVMA on... Describe interventions to minimize discomfort, distress, or pain discuss why less highly evolved or simpler animal are... Virtual SEMINAR on Program Funding and Grants Administration Agenda to adequately address the criteria may negatively the... Provide the source of the proposed procedures on live animals severe infection, respiratory distress, or.. 30-Minute Training module for the choice of species ( e.g., non-pharmaceutical ) to... Srg review, codes the application and review process, as well as award management, read research Vertebrate!, ages, sex, and injury proposed use of Vertebrate septate-like junctions Biochim Acta! Is based on Public Health Service ( PHS ) Policy on humane care and of! Vas must not be used in the application 's impact score summary statement negatively. Determining the acceptability of the animal Welfare Assurance and IACUC Approval Program officer worksheets in IMPAC and care additional... Review, codes the application or proposal ) means to avoid discomfort, distress, pain! Applicants should be minor for Coeus users and investigators the module provides: Date: 15. 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In IMPAC is not where animal work will be rated UNACCEPTABLE if all items... Be aware that NIH may release information contained in funded applications pursuant to a Freedom information... Of applicants, reviewers, and total number of animals by species to used. Acta Biomembr to alleviate discomfort, distress, pain, and injury diversity of Vertebrate animals in...