Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Nursing Research (NINR)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Chronic Illness Self-Management in Children and Adolescents (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PA-07-099

Related Notices

  • December 11, 2013 - This PA has been expired and reissued as PA-14-030.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PA-11-072

Companion FOA

PA-11-070, R01 Research Project Grant
PA-11-071, R03 Small Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)

93.361, 93.846, 93.865, 93.837

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) issued by the National Institute of Nursing Research (NINR), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Child Health and Human Development (NICHD), and the National Heart, Lung, and Blood Institute (NHLBI) is to encourage research to improve self-management and quality of life in children and adolescents with chronic illnesses.Children diagnosed with a chronic illness and their families have a life-long responsibility for self-management, to maintain and promote health and prevent complications. Biobehavioral studies of children in the context of family and family-community dynamics are encouraged. Research related to biological/technological factors, as well as, sociocultural, environmental, and behavioral mechanisms that contribute to successful and ongoing self-management of chronic illnesses in children is also encouraged. This FOA is restricted to studies of chronic illnesses in children and adolescents ages 8 to 21 grouped by developmental stages according to the discretion of the investigator. Studies of chronic mental illness or serious cognitive disability are beyond the scope of this FOA.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

January 16, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, Year, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

(Now Expired December 12, 2013 per issuance of PA-14-030), Originally January 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research to improve self-management and quality of life in children and adolescents with chronic illnesses. Children with a chronic disease and their families have a long-term responsibility for self-management. The child with a chronic illness will have a life-long responsibility to maintain and promote health and prevent complications. Biobehavioral studies of children within the context of family and family-community dynamics are encouraged. Research related to sociocultural, environmental, and behavioral mechanisms as well as biological/ technological factors that contribute to successful and ongoing self-management of particular chronic illnesses in children is encouraged.

This FOA is restricted to studies of children and adolescents ages 8 to 21 with chronic illnesses grouped by developmental stages according to the discretion of the investigator. Studies of chronic mental illness or serious cognitive disability are beyond the scope of this FOA.

Research Objectives

Although chronic diseases are more common among older adults, the rate of chronic disease among children has doubled in the past two decades; more than half of children ages 8 to 14 have had a long-term health problem at some point. Chronic diseases are recognized as a leading health concern of the nation (Center for Disease Control and Prevention [CDC], 2009); its management is one of the main challenges facing our health care system. The percentage of U.S. children and adolescents with a chronic health condition increased from 1.8% in the 1960s to more than 25% in 2007 (Halfon & Newacheck, 2010). Increasing self-management is a desirable goal for the growing number of children and adolescents who have significant ongoing health care needs related to a chronic illness. Promoting self-management in young people with chronic illness can be difficult for the child, their parent(s) and families, and communities. Self-management research has primarily focused on older populations in which the burden and costs of chronic illness and disability are increasingly evident. However, the economic and the quality of life costs of chronic illness, disability, developmental delay and behavior problems are also prevalent in young people; these effects are equally devastating and more long-term across the lifespan in this age group.

Children with chronic illnesses must live with their condition even when the condition is in remission. Examples of chronic conditions include but are not limited to: asthma, obesity, diabetes, chronic/end-stage renal disease, cystic fibrosis, cerebral palsy, migraine, epilepsy, heart disease, obesity, sickle cell disease, hemophilia, HIV and some forms of cancer. The discussion below is meant to assist the applicant and is not exhaustive.

Asthma continues to be the leading chronic disorder among children and youth, currently affecting an estimated 5.6 5-17 year olds; of which 2.9 million suffered from an asthma attack in the previous year (American Lung Association, 2009). Asthma morbidity continues to pose a significant personal and societal burden despite the availability of effective medications to manage the disease. Many children in the United States who should receive preventive medications do not receive them. Minority children and children living in poverty have a greater burden from asthma compared with white, more socioeconomically advantaged children and the same children are less likely to receive adequate treatment and are less likely to have family or community support for their asthma management. In addition, the incidence of allergy in children is on the rise. The biggest increases are seen in heavily populated areas. The rise is due to a composite of factors that are associated with the way children and adolescents live in homes and their exposure to inhalant allergens. Lower prevalence rates of allergic conditions in rural as compared with urban populations have been interpreted as indicating an effect of environmental exposures, such as air pollution. However, less is known about other factors of the rural environment which may determine the development of atopic sensitization and related illnesses.

Childhood obesity is an epidemic in the United States, one that is negatively impacting the physical and emotional health of our children, their families and society as a whole.  The prevalence of obesity among American youth increased radically between the 1980's and the present decade. For example, in 2006, the rate tripled among adolescents aged 12 to 19, increasing from 5% in 1980 to 17.6% (Ogeden, Carroll, & Glegal, 2008). Obesity in children is typically defined using the Body Mass Index (BMI), a calculation of a child's height and weight as adjusted for gender and age based on CDC's Growth Charts for the United States. A child is considered overweight if his or her BMI is between the 85th and 95th percentiles, and obese if his or her BMI is greater than or equal to the 95th percentile. The multiple, complex causes of childhood obesity and its resulting long-term health consequences present a compelling case to focus attention on the self-management issues for children and their families.

Diabetes, a leading cause of nephropathy, retinopathy, neuropathy, and coronary and peripheral vascular disease, is the third most prevalent severe chronic disease of childhood in the U.S. (National Diabetes Data Group, nd). About one in every 440 children and adolescents has diabetes (American Diabetes Association, 2009). The SEARCH study reported that the rate of new cases of diabetes among youth was 19.0 per 100,000 each year for type 1 and 5.3 per 100,000 for type 2 diabetes (rates vary by race/ethnicity). Until a decade ago, diabetes diagnosed in children and adolescents was almost entirely considered to be type 1, most often due to the autoimmune destruction of the ß-cells of the pancreas leading to an absolute deficiency of insulin. More recently, coincident with the rise in obesity in the population, there has been an increase in the incidence of type 2 diabetes, especially in adolescents from racial/ethnic minority groups.  For all types of diabetes, effective therapies are available; however, diabetes management requires complex balancing of medication dosing, diet and exercise in order to achieve good glucose control, while avoiding hypoglycemia. Achievement of good control is also dependent on frequent self-monitoring of blood glucose values. Complex and demanding treatment regimens may be overwhelming to families and especially difficult for adolescents. New technologies are available (e.g., insulin pumps, continuous glucose monitoring) that have been shown to improve outcomes but have lowered acceptability among adolescents with type 1 diabetes than among adults. Research to help youth with diabetes and their families manage this chronic diseases is essential, as self-management is crucial to improving health outcomes and quality of life, as well as to preventing numerous diabetic-related complications.

Diabetes is the leading cause of kidney failure and end-stage renal disease (ESRD). Being overweight is the sixth most important risk factor contributing to the overall burden of chronic kidney disease (CKD) worldwide (Haslam & James, 2005). Obesity is a potent predictor of albuminuria, and a recent meta-anlysis demonstrated that obesity is a risk factor for the development and progression of CKD (Wang, Chen, Song, Caballero, Cheskin, 2008). Unfortunately, as the proportion of children who are overweight or obese grows, they are also at risk complications of CDK. The incidence of ESRD in patient’s age 0 – 19 years in the United States is 15 per million people (2005 USRDS Annual Data Report). Exact numbers for young people who have chronic kidney disease, but do not yet require dialysis, are not available, but are certainly higher than for those with ESRD. There are now data emerging on the detrimental impact of the lack of self-care ability as this patient population reaches adolescence and have their ESRD care transferred from pediatric nephrologists to internist nephrologists. Therefore, assessment and monitoring of symptom management, functional health status and health-related quality of life are increasingly important aspects of treatment outcomes for families and children who are diagnosed with CKDs including kidney failure and ESRD.

The main clinical manifestation of atherosclerosis, i.e., coronary heart disease (CHD), is usually not evident before middle age. However, the atherosclerotic process that eventually leads to clinical disease begins in childhood. Studying the cardiovascular risk factors in the young promises to increase our understanding of their influence in the development of cardiovascular changes and disease. Questions about the independent and combined effects of body composition, obesity, hypertension, and insulin resistance are of particular relevance. For example, hypertension (now classified as pre-hypertension) in children and adolescents continues to be defined as systolic BP (SBP) and/or diastolic BP (DBP), that is, on repeated measurement, >95th percentile. BP between the 90th and 95th percentile in childhood had been designated “high normal.” Both require lifestyle modification according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7).  Both hypertension and pre-hypertension have become a significant health issue in the young because of the strong association of high BP with overweight and the marked increase in the prevalence of overweight children. One health concern associated with hypertensive changes in the young is the change in cardiac ventricular mass. Left ventricular mass in normo-tensive children has been related to lean body mass and measures of visceral fat. However, little is known about the progression of left ventricular mass changes from childhood to adulthood. More research is needed to address this issue, as well as, biobehavioral, environmental, and genetic associations resulting in cardiovascular disease development in children and adolescents.

Cystic fibrosis (CF), an autosomal recessive genetic disorder, is the second most common life-shortening and fatal inherited disease. CF frequently has its first health impact in infancy often progressing through childhood into young adulthood. Respiratory symptoms and infections and pancreatic insufficiency increase with age; mortality is most often associated with chronic obstructive pulmonary disease and respiratory failure. CF is one of the most common fatal inherited diseases. It is most prevalent among Caucasians and Ashkenazi Jews: one in 25 people of European descent carries one gene for cystic fibrosis, making it the most common genetic disease among them. Individuals with cystic fibrosis can be diagnosed prior to birth by genetic testing or in early childhood by a sweat chloride test. There is no cure for cystic fibrosis, and the current median age of survival for people living in the U.S. is 36.6 years. Ultimately, lung transplantation is often necessary as cystic fibrosis worsens.

Migraine and tension-type headaches can be a chronic problem in children; between 2-10% of children experience migraine headaches and about half of all school-aged children have some type of headache – often interfering with school activities. The exact cause of migraine headaches remains unknown. Frequencies of migraine headaches increase as children go through puberty. Although prepubescent boys and girls suffer from migraine at approximately the same rate, more girls are affected post-menarche. Like the onset of migraine episodes in adults, migraines experienced by children are often incapacitating due to their sudden onset and accompanying symptoms (e.g., nausea, abdominal pain, vomiting. photophobia). Very young children may exhibit pain by irritability, crying, rocking, or seeking sleep in a dark room. Frequent migraines result in significant disability, lost time in school, reduced socialization, increased depression, and impaired quality of life. Key to prevention and treatment and a mainstay of self-management approaches to headache in children has been the identification of putative headache “triggers.” Headache triggers refer those aspects of a child’s environment or behavior that occur in close proximity to the onset of the headache episode. Self-monitoring and self-management are essential to migraine management as there are currently no biologic measures to predict headache onset or to assure accurate diagnosis.

10.5 million children worldwide are estimated to have active epilepsy. Annual incidence rates range from 41-50 per 100,000 in developed countries; with the highest incidence in the first year of life. Epilepsy manifested by generalized onset seizures accounts for most of the newly diagnosed cases in the first 5 years of life. Temporal lobe epilepsy, the most common form of epilepsy that affects approximately one percent of the adult population, begins in late childhood and adolescence. However there is an association between temporal lobe epilepsy and febrile seizures in childhood, Over the past 15 years, syndrome-oriented clinical and EEG diagnosis, and better aetiological diagnosis, especially supported by neuroimaging, has helped to clarify the diversity of epilepsy in children, and has improved management. However, children and adolescents with epilepsy must adhere to daily prescriptions, manage drug side effects (e.g., lethargy, increased clumsiness and confusion), and cope with the social stigma of their condition and the potential of reduced autonomy (such as the inability to drive) in their teens.

An estimated 3,792 children aged under 13 were living with AIDS in the U.S. at the end of 2007. The vast majority of these children acquired HIV from their mothers during pregnancy, labor, delivery or breastfeeding. As these children mature, they need to manage a regimen of medication that requires strict (95%) adherence. They also need to manage associated side-effects, and psychosocial issues related to stigma, and avoiding risk behaviors that can lead to transmission of the virus. Some of these issues may be even more complex among those young people who first become infected as adolescents since it can be assumed that these teenagers engage in high risk behaviors. In all situations, the relationship between the young person responsible for self-management and the caretakers must be considered.

About 10,730 children in the United States under the age of 15 will be diagnosed with cancer in 2009. Because of major treatment advances, 80% of these children will survive 5 years or more. Despite its rarity and major advances in treatment and supportive therapy, cancer is still the leading cause of death from disease in children younger than 15 years of age. The types of cancer that occur in children vary greatly from those seen in adults. Treatment is often a lengthy process resulting in long-term side effects and lifelong attention. For example, acute lymphocytic leukemia, the most common form of cancer in young children requires a maintenance phase of treatment following the more intensive induction treatment. Although children return to the community during maintenance treatment, they must deal with a wide range of concerns. These range from avoiding infection to dealing with cognitive issues, such as difficulties in learning mathematical skills. Other common forms of childhood cancer may result in the need to cope with loss of a limb, other permanent changes in body image, later concerns about fertility, or the need to avoid behaviors that will increase risk for heart disease or a second cancer as adults. In addition to childhood cancers, hematological disorders, such as sickle cell disease or hemophilia also require biobehavioral research on self-management.

While childhood chronic illnesses vary relative to etiology, symptoms, treatment regimens, etc, children and families affected and dealing with any chronic illness share a number of challenges and commonalities. As a result, learning to live with a childhood chronic condition can be very difficult for a child, their parents, siblings and other family members, and the community in which they live. The development of self-management practices for children and adolescents with chronic illness requires active engagement of both young people and their parents/families, with attention to the psychosocial and environmental world of the young person. In order to develop a more acute understanding of what constitutes the best self-management in children living with a chronic illness, as well as being developmentally appropriate for children of all ages and as they mature into adolescents and young adults, additional research is needed.

 As self-management includes sensitivity to cultural norms, values and practices, it informs the emerging science of research on health disparities. Also technology is becoming an increasing part of day-to-day patient care, presenting new challenges and driving new areas of research in self-management.  Specific research areas of interest include, but are not limited to, the following areas:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.  

Award Project Period

 The total project period for an application submitted in response to this funding opportunity may not exceed two years.    

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

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

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed. 

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?  

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?   

Innovation

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?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories 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 six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

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.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described 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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 agreements are 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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.     

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Dr. Linda S. Weglicki, PhD, RN, MSN
National Institute of Nursing Research (NINR)
Telephone: 301-594-6908
Email: weglickils@mail.nih.gov

Victoria Pemberton, RNC, MS, CCRC
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0510
Email: pembertonv@nhlbi.nih.gov

James Witter, MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-1963
Email: witterj@mail.nih.gov

Lynne M. Haverkos, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6881
Email: haverkol@mail.nih.gov

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)

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2870
Email: : wertzr@mail.nih.gov

Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-0610

Bryan S. Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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