Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
Office of Research on Women’s Health ( ORWH )
Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD )
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. Listed NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
New
See Notices of Special Interest associated with this funding opportunity
PAR-20-179, R01 Research Project Grant
93.173; 93.213; 93.242; 93.279; 93.307; 93.361; 93.399; 93.866, 93.313, 93.865
This Funding Opportunity Announcement (FOA) invites applications that seek to support the identification of shared mechanisms and development of innovative interventions to address multimorbidity or multiple chronic conditions (MCCs) and its consequences. Intervention research supported by this initiative should be designed to study: (1) mechanisms or pathways that prevent MCCs, including the identification of early biomarkers, behavioral pathways, and individual and contextual risk factors and interactions that contribute to the development of common MCCs; (2) targeted therapies and management, including self-management, of MCCs to delay progression and prevent onset of new diseases; and (3) innovative health care partnership models for managing or treating MCCs. Studies may include shared mechanisms, and assessments of interactions between risk factors and interventions that address MCCs at different periods of the lifespan in diverse populations. Use of innovative technologies to assess and intervene on risk factors and pathways are encouraged. Studies may also include those that make use of existing data and/or data linkages to explore new research questions that may be helpful in understanding the impact of mechanisms in isolation or in combination. Of particular interest are interventions that target prevention and treatment of multiple chronic health conditions, including study designs that address therapeutic targets for preventing co-occurring MCCs.
Prospective applicants whose research interests relate to developing improved measures and methods for understanding multimorbidity, including but not limited to measures/tools to support basic mechanistic discovery of shared MCC pathways and identification and initial evaluation of MCC shared signatures, should see PAR-20-179.
April 30, 2020
Not Applicable
Standard dates apply.
The first standard due date for this FOA is October 05, 2020.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Standard AIDS dates apply.
The first AIDS application due date for this FOA is January 07, 2021.
All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Standard dates apply
Standard dates apply
Standard dates apply
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Introduction
Multimorbidity also referred to as multiple chronic conditions (MCCs) is defined as the co-occurrence of two or more chronic health conditions. A health condition is often characterized as chronic if it has lasted 3 or more months. The above link provides examples of some common chronic health conditions. Multimorbidity may include physical or mental health conditions, or a combination of both. The prevalence of MCCs is rising in the United States and worldwide. According to NHANES data, 60% of adults aged 20 and older in 2014 had two or more chronic conditions, an increase from 46% in 1998. Further, the incidence of chronic conditions and multimorbidity rises exponentially with age. An estimated two thirds of older adults have two or more chronic conditions. Among Medicare beneficiaries, 14% have six or more chronic conditions. Multimorbidity, though, is not just an issue in the adult population; an estimated one in 15 children experience MCCs. Furthermore, other sub-groups of the U.S. population experience a disproportionate burden of MCCs and health inequities related to MCCs. Women, African Americans, Hispanics, and non-Hispanic Whites have the highest prevalence of MCCs. Asians/Pacific Islanders with MCCs experience the highest mortality and cost per case compared to all other groups. Racial and ethnic minority populations also tend to experience earlier onset of MCCs compared with majority populations.
Background
In this announcement, MCCs/multi-morbidities encompass all of the chronic conditions diagnosed in one individual that could affect that individual’s global health status. The Cochrane Collaboration (2016) review of interventions designed to address co-occurring MCCs among adults across the prevention to treatment continuum showed mixed results, and that relatively few randomized controlled trials (RCTs) have been conducted. Overall, the review showed that it is difficult to improve outcomes for people with MCCs. Areas identified that need more research include identifying underlying mechanisms and pathways that are shared by co-occurring MCCs, and in clinical outcomes, use of health services, medication adherence, patient-related health behaviors/risk behaviors, behaviors of healthcare providers related to care delivery, and health care costs. Given that most chronic conditions share many risk factors and pathways, the review suggested that interventions for MCC prevention should focus on common risk factors. In addition, the functional limitations experienced by many patients with MCCs are another promising area of focus for intervention studies.
Several key gap areas and research directions were identified from the Cochrane and other similar reviews. First, interventions to address co-occurring MCCs, in general and in vulnerable populations may be best focused on risk factors that are common to multiple conditions (e.g. mental health, functional abilities and possibly others). However, these conclusions are based on a small number of studies that examined treatment effects and indicate a need for more research related to interventions designed to prevent, delay or manage the progression of co-occurring MCCs in the population.
Second, much of the published research on MCC treatment interventions has focused on older adults, a period in life when co-occurring MCCs are most prevalent. Comparatively little research has assessed prevention of, or risk factors for developing, MCCs at different stages of the life course. Thus, studies of interventions to address co-occurring MCCs in populations earlier in the lifespan (from childhood through middle adulthood) are needed. Individuals with chronic conditions that developed earlier in life have higher rates overall of multimorbidity, heightening the need to identify preventive interventions that are effective earlier in the lifespan.
Third, there is recognition of the need to expand health care beyond the clinic and into the community to address the many complex risk factors, including social determinants of health, that are major contributors to morbidity and mortality. Many groups have called for interventions that incorporate partnership models involving collaborations between communities and health care systems, particularly within primary care. Populations that experience MCCs are diverse by race, ethnicity, SES and other social determinants. Interventions developed to address risk factors for, or to delay progression of co-occurring MCCs, may be more effective in reaching the most at-risk populations through such partnership approaches.
For the most frequent co-occurring chronic conditions, the elucidation of common underlying risk factors and pathways is a high priority that might lead to broad clinical applications. The interdisciplinary field of geroscience aims to understand the relationship between aging biology and age-related diseases. Aging is a universally experienced risk factor underlying the development of most chronic diseases and can also accelerate disease occurrence at the levels of the cell, tissue, organ and entire human body. There is need to more fully characterize chronic diseases, which could inform personalized treatments for these conditions. Yet, few studies focus on mechanisms that contribute to multimorbidity.
Much of the recent focus of basic science has been on identifying underlying causes of multimorbid diseases and understanding the role of aging. Aging, as well as certain etiological factors, may lead to loss of reserve and organ dysfunction. Indeed, a substantial research agenda includes methods development to distinguish the effects of aging from factors that cause disease or make it progress or increase in severity (Fabbri et al., 2015). For example, within the multimorbid patient, there may be disease-disease interactions such as the hypertrophic remodeling of the right ventricle (cor pulmonale) that may accompany a variety of chronic respiratory diseases. In this case, studies are needed that assess pathways of one disease that may perturb those of another, resulting in shared clinical and pathobiological characteristics. Thus, disease-disease interactions may be identified by systematically examining the molecular mechanisms underlying complex diseases (Menche et al., 2015). In addition, animal models that pertain to combinations of chronic conditions have been targeted, but with limited success. Thus, better animal models are also needed to study multimorbidity (Salive, 2016). Together, mechanistic studies can help support the development of new interventions that will have a broader impact on multiple disease outcomes.
MCCs are also understudied in vulnerable populations during childhood. Such conditions as neuromuscular disorders due to birth trauma, prematurity, type 1 diabetes and congenital cardiomyopathies, as examples, require complex interventions for preservation of optimal health and prevention of secondary diagnosis due to deterioration in health. Further, it can be expected that multiple organs as well as mental health may be affected. This is seen in children with cystic fibrosis. As children are not independent and are reliant on caretakers, the impact of childhood MCCs on society is great. Thus, the types of studies to address prevention of MCCs in children requires special attention to contextual factors, availability of resources in addition to medical care, and caregiving functions (Humphreys et al., 2018; Romano et al., 2018).
Scope of Research
Institutes within the NIH have separately advanced FOAs related to examining the epidemiology, mechanisms and treatment of MCCs specific for their Institute and Center (ICs) mission areas. However, many risk factors are common for many chronic diseases across the NIH ICs mission areas. Thus, this trans-NIH effort aims to advance intervention research including identifying physiological and molecular pathways and behavioral and social risk factors, that target MCCs across multiple disease areas. Additionally, because these topics are relevant to prevention across NIH, the development of this FOA is coordinated by the NIH Office of Disease Prevention. Prevention research at the NIH encompasses primary and secondary prevention.
See the following link for a listing of types of prevention studies: https://prevention.nih.gov/about-odp/prevention-research-defined.
General topics that are considered within scope of this opportunity include, but are not limited to:
In addition, studies are considered within scope of the opportunity that make use of existing data and/or data linkages to explore new research questions that may be helpful in understanding the impact of interventions targeting prevention of one chronic health condition on related chronic conditions, or in designing future interventions to prevent co-occurring MCCs. Topics that are considered within scope of this opportunity include, but are not limited to:
Prospective applicants whose research interests relate to developing improved measures and methods for understanding multimorbidity, including but not limited to measures/tools to support basic mechanistic discovery of shared MCC pathways and identification and initial evaluation of MCC shared signatures, should see PAR-20-179.
The specific research priorities for participating NIH Institutes and Offices are listed below:
Priority Areas
National Cancer Institute (NCI)
The National Cancer Institute is interested in observational and intervention research to understand and promote primary, secondary, and tertiary prevention of multimorbidity for cancer survivors (https://cancercontrol.cancer.gov/ocs/statistics/index.html#definition-survivorship), and the prevention of cancer among those diagnosed with other chronic conditions (e.g., diabetes, hypertension, obesity). The pathways by which healthy and unhealthy practices/risk factors may lead to clusters of co-occurring conditions, including cancer, remain unclear. Clinical management of cancer in the context of other chronic conditions complicates clinician-patient decision-making and care coordination, medical treatment adherence, psychosocial and financial well-being, and follow-up care transitions, among other issues. Furthermore, clinical guidelines for cancer patients/survivors with other chronic conditions are under-developed. The NCI seeks to support research to identify those persons with cancer and co-occurring conditions at risk of complications, uncoordinated care delivery, and increased psychosocial and financial burden. The NCI also solicits research to develop, test, and implement preventive and accommodative strategies to reduce adverse health outcomes and improve the quality of care for those living with cancer and multiple other chronic conditions.
Examples of research areas include, but are not limited to:
National Institute on Aging (NIA)
NIA encourages experimental, observational, or interventional studies focused on prevention of multimorbidity in adults in midlife and at older ages. Observational studies are permitted for the development and planning of future interventional trials.
Areas of interest include, but are not limited to:
National Institute on Deafness and Other Communication Disorders (NIDCD)
The National Institute on Deafness and Other Communication Disorders (NIDCD) welcomes applications in which disordered communication processes, including diseases or conditions affecting hearing, balance, taste, smell, voice, speech, and language, are a component of the MCCs being examined. Populations of interest include both pediatric and adult. Examples include, but are not limited to:
National Institute on Drug Abuse (NIDA)
NIDA encourages research on prevention of substance use related MCCs, including studies to understand mechanisms underlying intervention effectiveness. Prevention intervention studies targeting common risk and protective factors for substance use related MCCs across the lifespan are encouraged. In addition, studies should attend to the settings and systems where interventions to prevent substance-use related MCCs would be implemented and incorporate relevant involvement of stakeholders in the research process.
Areas of interest include, but are not limited to:
National Institute on Mental Health (NIMH)
NIMH is interested in developmentally focused and theoretically informed research on the prevention of mental health-related multimorbidity (or multiple chronic conditions ((MCCs), that spans the life course. NIMH support for clinical trials research follows an experimental therapeutics approach, whereby clinical trials are designed, not only to test the intervention effects on outcomes of interest, but also to inform understanding of the intervention’s mechanisms of action. As such, applications that propose to develop and/or test the efficacy/effectiveness of preventive, therapeutic or services interventions must include specification of the intervention target(s)/mechanism(s) and assessment of intervention-induced changes in the presumed target mechanism(s) that are hypothesized to account for the intervention outcome. See the Support for Clinical Trials at NIMH web page for additional information regarding dedicated FOAs for NIMH clinical trials research support.
Areas of interest include, but are not limited to:
National Institute on Minority Health and Health Disparities (NIMHD)
NIMHD is interested in projects that address interventions for multimorbidities that are more prevalent in health disparity populations. Health disparity populations include African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. Projects are encouraged that encompass multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, healthcare system) and multiple levels (e.g., individual, interpersonal, community, societal) to effectively address multimorbidities among health disparity populations (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html).
Key criteria for interventions:
Areas of interest include, but are not limited to:
National Institute of Nursing Research (NINR)
The National Institute of Nursing Research supports research that can build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, and enhance end-of-life and palliative care.
In the context of this FOA, examples of research areas of interest include, but are not limited to:
National Center for Complementary and Integrative Health (NCCIH)
The mission of the National Center for Complementary and Integrative Health (NCCIH) is to determine, through rigorous scientific investigation, the fundamental mechanisms, usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. For the purposes of this FOA, NCCIH will support research to understand the mechanisms of action through which complementary and integrative health approaches impact MCCs that impact multiple physiological systems, such as nervous system, musculoskeletal and fascia systems, cardiovascular systems, endocrine system, gastrointestinal system, and immune system. NCCIH priority outcomes and conditions of interest include pain, sleep, anxiety, stress, and depression. Complementary approaches of high programmatic interests include natural products such as botanicals, probiotics/microbials, naturally-derived peptides, dietary supplements, and special diets, as well as mind and body approaches such as acupuncture, yoga, tai chi, qi-gong, meditation, hypnosis, music, art, spinal or chiropractic manipulation, and massage. Integrative approaches include therapies that combine complementary approaches with conventional medical interventions such as pharmacological, surgery, or device-based treatments. NCCIH will accept projects proposing secondary analyses, observational studies, and basic and mechanistic studies (animal and human). NCCIH will not fund research proposing efficacy or effectiveness clinical trials through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). NCCIH will not fund applications focused on cancer prevention or treatment. Investigators are strongly encouraged to discuss their research plans with NCCIH program staff prior to submitting their application.
Office of Disease Prevention (ODP)
The Office of Disease Prevention encourages applications using interventions or observational research designs that have promise for: characterizing trends in the co-occurrence of MCCs, the mechanisms for development of co-occurring MCCs and the study of intervention to prevent or delay the onset of multimorbidity. These interventions should have strong implications for disease prevention and make use of innovative design, measurement, and analytic methods relevant to the overall objectives of this funding opportunity announcement. Applications must also be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed above. ODP does not award grants. Please contact the relevant IC program contact listed for questions related to IC research priorities and funding.
Office of Behavioral and Social Sciences Research (OBSSR)
The Office of Behavioral and Social Sciences Research promotes the integration of behavior change mechanisms into biologic and social science interventions. This includes studying not only the mechanisms and pathways of behavior change, but the interaction of behavioral and biologic mechanisms within the context of social determinants of health. OBSSR is further interested in applications that promote study design targeting dissemination and implementation of preventive strategies that can be adopted and scaled up for intended populations in intended settings, thus improving generalizability and reach of proven interventions. Where appropriate, OBSSR promotes the evaluation of diverse intervention approaches to help establish cost effectiveness and applicability to diverse and under-resourced populations across the lifespan.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
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. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. 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.
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. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Research Strategy:
The following modifications also apply:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
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. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this FOA: For applications that include aims to study mechanisms or pathways that prevent MCCs, evaluate the applicants explanation of how their findings will contribute to advancing interventions to address multimorbidity and its consequences if the aims of the project are achieved.
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this FOA: Do the PD(s), co-investigators, collaborators, and others on the research team have demonstrated experience with prevention and the designated MCCs?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this FOA: Does the application propose novel, innovative, plausible partnership models (e.g., across health and non-health sectors) and/or strategies (e.g., mHealth and other technologies) for preventing, assessing, managing, and treating MCCs?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA: Are appropriate stakeholders/partners, relevant to the populations to be included in the research and the sectors/settings where the research is to be conducted, included in the project, and is there clear indication of their support?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
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).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. 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.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
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. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. 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 additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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Ashley Wilder Smith, PhD, MPH
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Marcel E. Salive, MD, MPH
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Judith A. Cooper, PhD
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National Institute on Drug Abuse (NIDA)
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Tamara Kees
National Institute of Mental Health (NIMH)
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Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
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Kelli Oster
National Institute of Nursing Research (NINR)
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Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
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