Funding Opportunity Description
Purpose

This FOA allows for applications that propose large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions.

Background

Aging research frequently entails a multidisciplinary effort, drawing on the expertise and resources of multiple individuals, institutions, and communities. Some studies require large-scale approaches requiring coordination of multiple components or across multiple sites in order to leverage a wide range of necessary resources and expertise. However, the scale and complexity of such projects are often unsuitable for traditional NIH mechanisms (e.g., R01) and instead require more specialized mechanisms to successfully coordinate their multiple interacting components and allow for adequate presentation of the breadth and complexity of the proposed project to peer reviewers.

Scope

This FOA invites applications that propose large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging. Such projects will likely involve an integrated multidisciplinary team of investigators within a single institution or a consortium of institutions. Resources and study expertise will be tightly coordinated across multiple sites or cores, such as:

One or more coordinating centers
Clinical or study sites
Specialized cores, such as for data management and analysis, measurement and phenotyping, animal models, etc.
Examples of the kinds of studies supported under this announcement include, but are not limited to, one or a combination of the following:

Large-scale longitudinal observational studies of diseases or conditions that are common in aging populations involving integration of multiple clinical outcomes with molecular, genetic, or other mechanistic data.
Large-scale, multi-site intervention studies in human subjects and/or animal models for aging-related conditions involving multiple endpoints to assess efficacy or effectiveness of gerotherapeutic or geroprotective interventions and to elucidate mechanisms.
Complex research programs on interactions among the underlying molecular causes of aging, and on changes in inter-organ communication as drivers of aging.
Large-scale, multidisciplinary geroscience studies with human participants and/or animal models of aging to elucidate cellular, molecular, and integrated physiological mechanisms, identify influencers of health, environmental and other factors impacting health outcomes including Social Determinants of Health, and determine potential clinical targets to delay or prevent aging related multimorbidity.
Large-scale, complex research projects with multiple highly integrated components focused on a common research question relevant to aging and diseases of brain aging, particularly studies focused on Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD).
Large-scale, multidisciplinary behavioral and social science studies of aging that might examine mechanistic pathways at multiple levels of analysis across the lifespan, especially those that could identify and explain risk and protective factors related to physical, cognitive, and emotional health outcomes that might lead to the development of future interventions to improve the health and well-being of older populations.
Comprehensive, integrative, and/or multidisciplinary studies using a range of scientific approaches to examine mechanisms underlying brain aging and AD/ADRD.
Translation of basic science findings into pre-clinical or clinical studies, or of clinical findings into practice or community settings, for prevention, diagnosis, or treatment of aging-related conditions, requiring coordination of broad multidisciplinary expertise across multiple settings.
The structure and approach of proposed projects will vary depending on the hypotheses under study; however, it is expected that all projects will focus on an overarching scientific question that integrates all study components into a unified whole.

This FOA utilizes the complex cooperative agreement awards (U19) funding mechanism, which is different than the program project awards (P01) mechanism. To learn how these two mechanisms differ, applicants are encouraged to visit NIA’s P01 guidelines webpage. Please refer to the NIA website for areas of emphasis in aging research and consult NIA Program Officers to determine whether your proposal would be appropriate for the U19 or other funding mechanism.

Additional Guidance

Applicants are required to contact NIA Scientific/Research staff well in advance (2-3 months) of the anticipated application due date. This will help applicants ensure their prospective projects are aligned with NIA program priorities and consistent with administrative and budgetary policies.

Successful projects are expected to have a sound scientific rationale based on adequate preliminary data; however, investigators may propose preliminary activities, where necessary, to refine methods or protocols or to test effectiveness of study component integration prior to full-scale study implementation.

Studies that include health disparity populations and studies that examine sex as a biological variable are highly encouraged.

In addition, investigators may choose to establish standing committees among study personnel for specialized cross-project functions such as a steering committee, data access and publications oversight, training of study personnel, etc. Applicants may also propose an external advisory committee to regularly review the progress of the multi-component project and provide non-binding recommendations for its activities.

Studies involving human interventions/human clinical research should comply with NIH's and NIA's policies on human clinical research, including development of a data and safety monitoring plan. Specific individuals who may constitute a data and safety monitoring board (DSMB) should not be named in the application or contacted prior to the review.

Research infrastructure development necessary to achieve the scientific aims of the planned study may be proposed.

Applications Not Responsive to this FOA

If the application does not encompass complex integrated multi-component projects in aging research, and if any single project could be completed as stand-alone project (e.g., R01), then the application will be considered non-responsive and will be administratively withdrawn.

Clinical Research Operations Management System

NIA supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.