December 7, 2021
PAR-21-167 - Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
Background
The success of developing drugs and other therapeutic approaches relies heavily on the use of animal models in preclinical studies. The rigor and reproducibility of animal models are recognized as key factors facilitating the translation of findings in animal studies to successful clinical trials. The Office of Research Infrastructure Programs (ORIP) convened a group of experts in broad areas of animal research for a workshop entitled “Validation of Animal Models and Tools for Biomedical Research” that was held as a series of virtual sessions between November 2020 and January 2021 (https://orip.nih.gov/about-orip/workshop-reports#vss). This workshop was organized by ORIP in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Aging (NIA), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of General Medical Sciences (NIGMS), and the National Institute of Neurological Disorders and Stroke (NINDS). The workshop participants identified technology and resource gaps and needs for assessing the value and limitations of animal models and for improving rigor, reproducibility, and translatability of animal research. The participants stressed the importance of, and need for, two-way communication between basic science researchers using animal models and clinical researchers and clinicians. The NIH Advisory Committee to the Director (ACD) has recognized the importance of rigor and reproducibility in animal research in a working group report entitled “Enhancing Rigor, Transparency, and Translatability in Animal Research” (https://acd.od.nih.gov/documents/presentations/06112021_ACD_WorkingGroup_Presentation.pdf) published in June 2021.
Research Objectives
With this Notice of Special Interest (NOSI), ORIP intends to support exploratory/developmental and highly innovative projects aimed at developing broadly applicable technologies, tools, and resources for validating animal models and enhancing the rigor, reproducibility, and translatability of animal research. This NOSI is for two-year projects that address key animal resource- and technology-related gaps identified in the “Validation of Animal Models and Tools for Biomedical Research” workshop organized by ORIP, NHLBI, NIA, NIDDK, NIGMS, and NINDS. Animal models of interest for this NOSI include, but are not limited to, invertebrate and vertebrate organisms ranging from C. elegans and Drosophila to zebrafish, mouse, rat, pig, and nonhuman primates.
ORIP advances the NIH mission by supporting research infrastructure and research-related resource programs, including animal models and facilities for research relevant to human health and diseases (for more details see ORIP Strategic Plan for 2021-2025). Proposed studies, models, resources, or technologies under this NOSI must either address research interests of multiple NIH Institutes and Centers (ICs), explore multiple body or organ systems, or be applicable to diseases and processes that impact multiple body or organ systems. Applications are not acceptable and will be withdrawn if they only address a specific disease or area of research, are relevant to the mission and programs of a single IC, or are related predominantly to the interest of one IC and only peripherally to the interests of other ICs.
Examples of projects suitable for this FOA include but are not limited to:
- High-efficiency gene editing technologies, including gene mutation and tagging, for developing animal models.
- Biosensors for genotypic, phenotypic, physiological, or metabolomic monitoring in animal models.
- Animal models that facilitate detecting and understanding protein-protein interactions in cells and organelles.
- High-efficiency and high-resolution imaging technologies, analytic tools, or atlases for visualization and integrative analysis of cells and cellular networks across animal species, especially tools that can be broadly and easily utilized by the research community.
- Technologies, including informatic, genetic, and biochemical technologies, to facilitate the systematic animal model phenotyping at multiple scales (single-cell, tissue, organ, whole organism) or for integrating different types of related data (transcriptomics, proteomics, metabolomics, morphology, behavior).
- Artificial intelligence (AI) or machine learning (ML) tools to integrate the collection of multi-omics, biochemical, physiological, morphological, and behavioral data from animal models, or AI or ML strategies that allow user-friendly informatic searches and integrative mining of bioinformatic and phenomic data for comparative human-animal biology.
- Technologies to improve the efficiency, reliability, and accuracy of developing animal models by means of xenotransplantation of human cells or by engineering the models to express human gene products.
Projects that ARE NOT suitable for this NOSI and would be deemed nonresponsive and withdrawn include but are not limited to:
- Projects that are related strictly to a specific disease or area of research or are primarily relevant to the mission and programs of only one NIH IC.
- Development of cell lines of a single cell type that relate strictly to a specific disease or area of research or are primarily relevant to the mission and programs of only one NIH IC.
- Investigations of the effects of drug(s), toxin(s), infectious agent(s), diet, or other environmental factors on wild-type animals.
- Studies of physical or surgical manipulation(s) in wild-type animals.
- Development or maintenance of databases, including genome and model organism databases.
- Development or maintenance of repositories of tissues and related biospecimens from model organisms.
- Studies primarily involving human subjects or human cell lines.
- Projects that involve threatened or endangered species.
Applications submitted under this NOSI should aim to enhance the rigor, reproducibility, and translatability of animal research through the development of resources and technologies that have significant impact in a broad range of research areas using animal models. Applications must demonstrate how the proposed animal models and technologies impact rigor and reproducibility of animal research. Demonstration of the impact of the proposed project on translatability is not required but is a strength.
Investigators interested in submitting applications are strongly encouraged to contact ORIP program staff before submission to discuss whether their research plans are appropriate for and responsive to this NOSI. Applications with projects outside the areas of interests of this NOSI will be considered nonresponsive and will be administratively withdrawn.
Application and Submission Information
The due dates and expiration dates of PAR-21-167 and its re-issue apply to this Notice.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
- PAR-21-167, Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
- For funding consideration, applicants must include “NOT-OD-22-039” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Scientific/Research Contact(s)
Sige Zou, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: (301) 435-0749
Email: [email protected]
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Nicole Franklin
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-8682
Email: [email protected]
and Human Services (HHS)
