For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. Part I. Overview Information contains information about Key Dates and times. National Institute on Aging (NIA) The application describes how the project will be able to access administrative data (e.g. Applicants are required to follow the instructions for post-submission materials, as described in the policy. These interventions may target behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health systems level. Applicants must submit an application in response to a Notice of Funding Availability (NOFA) posted on Grants.gov. This Funding Opportunity Announcement (FOA) solicits mechanism-focused dementia care and caregiver support intervention development research at Stages I through V of the NIH Stage Model to address the care needs and promote the health, function, and well-being of persons with Alzheimer's disease (AD) and Alzheimer's disease-related dementias (AD. Through this program, the NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. Awardees must comply with any funding restrictions described in Section IV.5. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. The activities called for in this FOA are designed to facilitate the success of these trials by providing additional stepping stones toward ultimate implementation. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. 2313). Organizations are eligible to apply. As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. You are here Home Grants & Funding The National Institutes of Health is the largest public funder of biomedical research in the world. An overview of the proposed study design that must include the following: Stage of Intervention Research (e.g., Stage I, II, III, IV or V of the NIH Stage Model). Find training and career development opportunities in aging research. Search All Grant Programs Search All Past Awards Information for First-time Applicants Match Your Project to a Grant Program Late Submission Policy Manage Your Award AD/ADRD care and caregiver support interventions may be studied within Stages I, II, III, or IV. Applications that address the principles underlying the care needs and challenges for individuals from diverse racial, ethnic, geographic, and socioeconomic backgrounds are strongly encouraged. Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. The NIH Stage Model for Behavioral Intervention Development: The NIH Stage Model has the goal of creating efficacious, ultimately implementable interventions defined by their principles. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. Current Openings. Within the experimental medicine approach to behavior change, intervention targets may include mechanisms or processes at any level of analysis (e.g., environmental, social, contextual, interpersonal, behavioral, psychological, and/or neurobiological). This Funding Opportunity Announcement (FOA) solicits mechanism-focused dementia care and caregiver support intervention development research at Stages I through V of the NIH Stage Model to address the care needs and promote the health, function, and well-being of persons with Alzheimers disease (AD) and Alzheimers disease-related dementias (ADRD) and of those providing their care. The NIH will not accept duplicate or highly overlapping applications under review at the same time. Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? The NIH announced a policy on allowable appendix materials (NOT-OD-17-098); however, this FOA allows specific materials to be included as appendices that are otherwise disallowed by the general policy. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. For Stage IV pragmatic trials and Stage V studies, the application describes the partnerships with home health agencies, meal delivery services, adult day centers, respite care centers, assisted living facilities, memory units, nursing homes or other care providers, both nonresidential and residential, and the application documents the commitment of the organization to the project. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Small Business Program. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). An official website of the National Institutes of Health, Division of Behavioral and Social Research, Division of Geriatrics and Clinical Gerontology, Training Opportunities for Special Populations, Alzheimer's Disease and Related Dementias Funding Announcements, Alzheimers & Related Dementias Press Kit, National Advisory Council on Aging (NACA), Advances in Aging and Alzheimer's Research, U.S. Department of Health & Human Services (HHS), Find Alzheimer's and related dementias funding opportunities. Connect with NIA extramural staff on scientific and funding matters. Is the intervention suitable for use in real-world settings? The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. NIH expects registration and results reporting of all trials whether required under the law or not. to Grants.gov and, Stage I mechanism-focused, adequately powered studies to leverage and incorporate Stage 0 (basic science) findings to, Stage I mechanism-focused, adequately powered studies to. Learn more about NIA Scientific Workforce Diversity at NIA If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. The following will be considered in making funding decisions: Information regarding the disposition of applications is available in the NIH Grants Policy Statement. Before sharing sensitive information, make sure youre on a federal government site. Does the application adequately address the following, if applicable. Modules to train community interventionists (e.g., caregivers, nursing assistants, nurses, occupational therapists, physicians) to deliver specific elements of a complex AD/ADRD care intervention with fidelity in nursing homes or assisted living settings. All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. This includes the development, testing, and validation of scalable training materials and procedures so that these interventions can be delivered with fidelity in community settings or health systems. Applicants must complete all required registrations before the application due date. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigators scientific interest, funding limitations, recruitment requirements, and other considerations. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. Use the NIH ASSIST system to prepare, submit and track your application online. An insufficient understanding of the underlying principles of interventions, or the mechanisms of action of the interventions, may impede implementation in several ways: 1) simplifying and streamlining an intervention while ensuring that it will retain its potency is not possible when the underlying principles of an intervention are unknown; 2) many interventions need to be modified for a specific population or setting, but modification may interfere with intervention potency if the active ingredients necessary for efficacy are inadvertently removed due to adaptation/modification; 3) flexible delivery of interventions is critical to implementation in the community, but interventions cannot be delivered with both flexibility and fidelity if the main underlying principles of an intervention cannot be explained to the person delivering the intervention. If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. For Stage IV and V trials: Do not address generalizability to diverse populations. Section III. The recipient is reminded that active awards must have a measurable level of effort." A comprehensive list of all activity codes is also available. Technical Guidance: The Section 202 Supportive Housing for the Elderly Program is authorized by section 202 of the Housing Act of 1959 (12 U.S.C. To what degree does the application address potential threats to validity and present clear power calculations that reflect a range of effect sizes of clinical significance? Digital/mHealth or other technology approaches may be harnessed. Additional Information on Eligibility, Section I. View archived research funding opportunities. Specific to this FOA: Does the application challenge and seek to shift current behavioral intervention research or clinical dementia care practice paradigms by utilizing NIH Stage Model? Please see. A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Applicant organizations may submit more than one application, provided that each application is scientifically distinct. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. See Part 1. This may include Stage IV Rapid Pragmatic Trials. Hypothesized principles or mechanism of action of the intervention, including the behavioral, cognitive, affective, or social targets it is hypothesized to engage. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Specific grant mechanisms are available for individuals at different career stages, from trainees to senior investigators. Additional Information on Eligibility. Get weekly updates on NIA funding policies and research priorities with the Inside NIA Blog. TheOER Glossaryand the SF424 (R&R) Application Guide provide details on these application types. Funding Policies & Pay Lines Read policies relevant to NIA applicants and grantees. The application should also address how the intervention will be well poised to be adopted within a Stage V study (dissemination and implementation). Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)? Are potential ethical issues adequately addressed? Additional information may be found in the SF424 (R&R) Application Guide. This assistance supports the advancement of the NIH mission of enhancing health, extending healthy life, and reducing the burdens of illness and disability. Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Complex interventions are defined in this FOA as single- or multi-component interventions that require training to administer with high fidelity (e.g., interventions administered by clinical personnel, such as palliative care interventions, or interventions to cope with a dementia diagnosis). Any costs incurred before receipt of the NoA are at the recipient's risk. Some of these are systematic barriers that impede implementation and dissemination generally. NIH's use of multiple principal investigator awards makes calculations of the total funding received by individual departments impractical and there are multiple ways in which the funding data can be aggregated across universities . Nursing Innovation Grant Program 2023-2025 APPLICATION DEADLINE: 11:59 p.m. CT, July 7, 2023 . 2023 Application - Form 1 . Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. This means that the NIH will not accept: The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. NIA provides support for aging research, Alzheimer's Disease and Related Dementias, and COVID-19 research in older adults. How well does this study test generalizability, and sustainability of findings across distinct health care settings and diverse staff, caregiver, and patient populations? Eligibility Information contains information about registration. For other NIH funding opportunities, please see the NIH Guide for Grants and Contracts. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. For Stage IV rapid pragmatic trials only: do not identify as a simple or complex intervention. 6 Things You Should Know About Hospice Care Does Medicaid Cover Hearing Aids? When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Social isolation and loneliness can be harmful to the physical, mental, cognitive, and emotional health of older adults. The recipient must also make semiannual disclosures regarding such proceedings. Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging , in accordance with NIH peer review policy and procedures, using the stated review criteria. Funding Restrictions. Interventions may be at the individual, interpersonal, or systemic level and can include such things as environmental modification, electronic health record (EHR) modification, care coordination modification, etc. Is the prior research that serves as the key support for the proposed project rigorous? GrantWatch ID#: 180757. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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