Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute on Aging (NIA) |
|
Funding Opportunity Title |
Regional and International Differences in Health and Longevity at Older Ages (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
New |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PA-13-124 |
Companion Funding Opportunity |
PA-13-125, R01 Research Project Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.866 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applications from institutions/organizations proposing to advance knowledge on the reasons behind the divergent trends that have been observed in health and longevity at older ages, both across industrialized nations and across geographical areas in the United States. This FOA is intended to capitalize on provocative findings in the literature which have been insufficiently understood and addressed. This FOA is also intended to capitalize on NIA’s investment in the development of cross-nationally comparable datasets that can be harnessed to study these research questions; these include the Health and Retirement Study (HRS), the English Longitudinal Study on Ageing (ELSA), the Survey of Health, Ageing and Retirement in Europe (SHARE), and the Human Mortality Data Base. Applications proposing secondary analysis, new data collection, calibration of measures across studies, development of innovative survey measures, and linkages to administrative sources are encouraged. Applications are not restricted to projects using the NIA-supported datasets above and may propose research using any relevant data. |
Posted Date |
February 21, 2013 |
Open Date (Earliest Submission Date) |
May 16, 2013 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
September 8, 2016 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (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.
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
This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applications from institutions/organizations proposing to advance knowledge on the reasons behind the divergent trends that have been observed in health and longevity at older ages, both across industrialized nations and across geographical areas in the United States. This FOA is intended to capitalize on provocative findings in the literature which have been insufficiently understood and addressed. This FOA is also intended to capitalize on NIA’s investment in the development of cross-nationally comparable datasets that can be harnessed to study these research questions; these include the Health and Retirement Study (HRS), the English Longitudinal Study on Ageing (ELSA), the Survey of Health, Ageing and Retirement in Europe (SHARE), and the Human Mortality Data Base. Applications proposing secondary analysis, new data collection, calibration of measures across studies, development of innovative survey measures, and linkages to administrative sources are encouraged. Applications are not restricted to projects using the NIA-supported datasets above and may propose research using any relevant data.
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could pursue novel explanations for the divergent trends that have been observed in health and longevity at older ages, as discussed below. Another example could include the unique and innovative use of an existing methodology to explore this question. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, methodologies, models, or applications that could have a major impact on social and behavioral research. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the R03 small grant mechanism.
Life expectancy at birth in the United States has improved dramatically over the past century. Also, throughout the second half of the century, advances in medicine particularly in the treatment of heart disease and stroke along with healthier lifestyles, better access to health care, and better overall health before age 65 combined to produce impressive improvements in life expectancy above age 65. Yet U.S. life expectancy (at birth and at older ages) -- especially for women has lagged behind other wealthy nations since 1980. And evidence from cross-national research indicates that older Americans get sicker sooner compared to older Europeans. Within the United States, similar disparities in health and longevity are observed across geographical areas.
The recent availability of longitudinal data expressly designed to be cross-nationally comparable has begun to prompt research inquiry into the underlying dynamics of, and reasons for, these differences in health and longevity at older ages. For example, research using the Health and Retirement Study (HRS), English Longitudinal Study of Ageing (ELSA) and the National Health and Nutrition Study (NHANES), indicates that older white non-Hispanic U.S. adults aged 55-64 are less healthy than their English counterparts for a range of diseases including diabetes, hypertension, heart disease, myocardial infarction, stroke, lung disease, and cancer (Banks et al., 2006). This analysis also controlled for education and a standard set of comparably-measured behavioral risk factors (smoking, overweight, obesity, and alcohol drinking), which explained little of these health differences. In addition, analysis of biomeasures from ELSA and NHANES showed that the differences between the U.S. and England and across SES groups within each country are not due to biases in self-reported disease or screening rates, because biological markers of disease (although they have not been calibrated against one another) exhibit exactly the same patterns. Finally, the results showed that these differences are not solely driven by the bottom of the SES distribution, and that for many diseases, the top of the SES distribution (which in the U.S. has near universal health insurance coverage) is less healthy in the United States as well. Surprisingly, English lower SES individuals have better health than high SES U.S. individuals. This is a provocative finding, that U.S. residents in late middle-age are much less healthy than their English counterparts and that these differences exist at all points of the SES distribution. Possible explanations include survival advantages among U.S. adults with chronic illness, behavioral differences in risk factors not (or imperfectly) measured in these studies, psychosocial factors, the obesity epidemic (which is more advanced in the U.S.), differences in health care systems, social policy contexts other than medical care (e.g., social retirement benefits, unemployment compensation, sick pay, housing policies, transportation options, social integration, etc.), how health influences wealth (e.g., in the U.S., major health events lead to wealth depletion), measurement differences across studies, quality and comparability of biospecimen assays, etc.
A subsequent analysis using data from the HRS, ELSA, and the Survey of Health, Ageing and Retirement in Europe (SHARE) found similar results (Avendano, 2009). American adults ages 50-74 of all wealth levels reported worse health than did European adults at comparable wealth levels. Indeed, on many measures England was shown to have worse health than other European countries. Similar to the paper discussed above, this analysis excluded U.S. minorities, indicating that the worse health of Americans compared with Europeans cannot be attributed to racial disparities within the United States. And, similar to the U.S.-U.K. results, this analysis also found that the disparities were only partially explained by differences in a standard set of behavioral factors. Finally, while poor Americans were at particularly worse health compared with their English or other European counterparts in this analysis, even well-off Americans reported health comparable to substantially poorer Europeans suggesting that access to and quality of health care is unlikely to be the full explanation.
Cross-national analyses provide insight into potential causal explanations for observed differences in health and longevity because institutional factors vary (e.g., universal health care in England at all ages vs. universal health care after age 65 in the U.S.). However, comparative analyses can also be done within the U.S. where there is also variation. Extensive research has focused on health disparities within the U.S. and many investigations have documented the consistent gap in measures of mortality and functional health by race, income, social class, education, community characteristics, insurance coverage, health care access and utilization, quality of care, etc. Less has been done exploiting the internal variations by geography in the U.S. Using data from the U.S. Bureau of the Census and the National Center for Health Statistics, researchers have divided the U.S. into eight subgroups based on a number of sociodemographic and geographical variables (such as location of county of residence, race and income), which they termed the eight Americas (Murray, 2006). They found disparities in mortality across the eight Americas that are enormous by international standards and that cannot be explained by race, income or basic health-care access and utilization alone. A related analysis looked at trends in U.S. county mortality and cross-county mortality disparities from 1961-1999, including the contributions of specific diseases to county level mortality trends (Ezzati, 2008). This study found that there was a steady increase in mortality inequality across the U.S. counties between 1983 and 1999, resulting from stagnation or increase in mortality among the worst-off segment of the population, and that female mortality increased in a large number of counties, primarily because of chronic diseases related to smoking, overweight and obesity, and high blood pressure. Other examples of U.S. geographic disparities in health include scholarship on the stroke belt . While no consensus has been reached to explain geographic differences in stroke mortality, recent research suggests that both early life exposures and adult residence independently contribute to stroke mortality risk (Glymour, 2009).
A recent National Academy of Sciences panel determined, based on available evidence, that past smoking rates are a major reason for shorter lifespans in the U.S. compared to other high-income countries, and that obesity rates in the U.S. also appear to be a significant factor. The summary report from the National Research Council, which also identified research gaps, is entitled "Explaining Divergent Levels of Longevity in High Income Countries" (NRC, 2011) and is available at http://www.nap.edu/catalog.php?record_id=13089. A volume of background scientific papers is entitled "International Differences in Mortality at Older Ages: Dimensions and Sources" (NRC, 2011) and is available at http://www.nap.edu/catalog.php?record_id=12945.
Applications are encouraged that pursue novel potential explanations for the divergent trends that have been observed in health and longevity at older ages, both across industrialized/high life expectancy nations and across the U.S. by geographic area. Research projects are not restricted to using NIA-supported datasets and may propose research using any relevant data. Applicants are encouraged to consult the aforementioned National Research Council consensus report entitled Explaining Divergent Levels of Longevity in High Income Countries and a companion volume of scientific papers written or invited by the NRC consensus report committee, entitled International Differences in Mortality at Older Ages: Dimensions and Sources (see References below). These reports discuss potential explanations for the observed divergent trends that have been observed in longevity and health at older ages across high-income countries; discuss internal heterogeneity in the U.S.; present the available cross-national harmonized data useful for analysis; and raise many interesting and provocative hypotheses for future research. Following a previous Funding Opportunity Announcement (RFA-AG-11-004), the National Institute on Aging funded seven research projects exploring the extent and determinants of international and U.S. regional differences in health and longevity at older ages. These projects are described at this website: http://www.nia.nih.gov/research/announcements/2012/12/updates-selected-rfas .
Applications submitted to this Funding Opportunity Announcement should advance beyond the NAS reports and existing projects to explore determinants of trends and of international and interregional differences, quantify the contributions of particular determinants, and point the way to likely policy or systemic changes that can improve population health measurably in the United States. In order to make existing studies more suitable for comparative analyses of health status and longevity in middle aged adults, applications may propose secondary analysis, new data collection, calibration of measures across studies, and/or linkages to administrative data sources. These represent example approaches and topics only. Other approaches and topics are welcome.
- The prevalence of a condition is a function of its incidence, duration, and survival. These three parts have not been adequately differentiated in the comparative analysis of major chronic conditions. Do Americans have a higher prevalence of major conditions because they have a higher incidence of a condition, are more likely to have it diagnosed earlier or at all, or experience better survival from it?
- The cross-national studies discussed above found that differences were not explained by behavioral risk factors. Applicants are encouraged to conduct investigations of the adequacy and comparability of the behavioral risk factors measured in these studies and consider whether a fuller set of risk factors and would offer additional explanatory power. Also, these studies do not include data on past differences in risk factors, or may not adequately measure cumulative exposure over the life course. Behavioral risk factors of interest include: physical activity, exercise, diet, eating patterns, tobacco/smoking, alcohol, drug use and abuse, obesity, sleep duration, sleep quality, time use, etc. Environmental exposures and risk factors are also of interest. Studies that quantify the contribution of risk factors and conditions to observed differences (as, for example, Preston and Stokes, 2011, did for obesity) are encouraged.
- Smoking behavior has been hypothesized to account for a significant portion of the mortality differential among countries. Recent methodological research estimating the number of deaths attributable to smoking has shown that the ranking of the U.S. in international comparisons of longevity is heavily affected by the smoking history of American men and women (Preston, 2009). When the mortality profiles of a set of industrialized countries were adjusted by removing the effect of smoking, the relative position of both U.S. women and men significantly improved. Related analysis suggests that because of reductions in smoking that have already occurred or can be reliably projected, U.S. mortality is likely to decline much faster than is commonly anticipated (Wang and Preston, 2009). Applicants are encouraged to study the effect of smoking and cohort smoking histories as a potential explanation for the U.S.’s international standing in health and longevity.
- Psychosocial factors such as social support, social integration, stress, well-being, etc. have not adequately been studied as potential explanations for observed health and longevity differences. Applicants are encouraged to develop better measures of psychosocial factors for incorporation into the above-mentioned NIA-funded cross-national surveys of the older population, and investigate their potential explanatory power.
- Available cross-national comparative data do not include much information on early life factors. Applicants are encouraged to gather retrospective data (both recall data and information from administrative records including vital statistics) from older cohorts in ongoing studies.
- Social policy contexts differ between the U.S. and Europe and it has been hypothesized that contextual factors may have causal effects in producing the observed health disadvantages in the U.S. Studies of the effect of contextual factors including retirement benefits, unemployment compensation, sick pay, working conditions, housing policies, transportation options, social integration etc. are encouraged.
- Despite its huge policy implications, the role of health and long-term care systems in international variations in disease prevalence and mortality is only beginning to be understood. The cross-national, longitudinal studies of older people referenced in this FOA, which have frequent follow-up via biomarkers and linked data on medical records, should be further exploited to shed light on differences in the way medical systems interface with patients, and how such differences may have survival and disability implications. Applicants are also encouraged to take advantage of available natural experiments in medical care as they occur internationally.
- Applicants are encouraged to calibrate the biomeasure assays (e.g., assays of CRP, cholesterol, etc.) and self-reported physical performance measures across datasets used for comparative analyses.
References:
Avendano, M., Glymour, M.M., Banks, J. and Mackenbach, J.P. (2009) Health Disadvantage in U.S. Adults Aged 50 to 74 Years: A Comparison of the Health of Rich and Poor Americans with that of Europeans. American Journal of Public Health 99/3:540-47.
Banks, J., Marmot, M., Oldfield, Z. and Smith, J.P. (2006) Disease and Disadvantage in the United States and England. Journal of the American Medical Association 295:2037-45.
Banks J, Muriel A, Smith JP. (2010) Disease prevalence, disease incidence, and mortality in the United States and in England. Demography. 2010;47 Suppl:S211-31.
Ezzati, M., Friedman, A.B., Kulkarni, S.C., and Murray, C.J.L. (2008) The Reversal of Fortunes: Trends in County Mortality and Cross-County Mortality Disparities in the United States. PLoS Med 5(/4): e66:557-68.
Glymour, M., Avendano, M., and Berkman, L.F. (2007) Is the Stroke Belt worn from childhood? Risk of first stroke and state of residence in childhood and adulthood. Stroke 38: 2415-21.
Glymour, M., Kosheleva, A., and Boden-Albala, B. (2009) Birth and Adult Residence in the Stroke Belt Independently Predict Stroke Mortality. Neurology 73: 1858-1865
Murray, C.J.L., Kulkarni, S.C., Michaud, C., Tomijima, N., Bulzacchelli, M.T., Iandiorio, T.J., and Ezzati, M. (2006) Eight Americas: Investigating Mortality Disparities across Races, Counties, and Race-Counties in the United States. PLoS Med 3(9):1513-24.
National Research Council. Explaining Divergent Levels of Longevity in High-Income Countries . Washington, DC: The National Academies Press, 2011. Authors:
Eileen M. Crimmins, Samuel H. Preston, and Barney Cohen, Editors; Panel on Understanding Divergent Trends in Longevity in High-Income Countries; National Research Council (http://www.nap.edu/catalog.php?record_id=13089 )
National Research Council. International Differences in Mortality at Older Ages: Dimensions and Sources. Washington, DC: The National Academies Press, 2011. Authors:
Eileen M. Crimmins, Samuel H. Preston, and Barney Cohen, Editors; Panel on Understanding Divergent Trends in Longevity in High-Income Countries; National Research Council (http://www.nap.edu/catalog.php?record_id=12945 )
Preston, SH and A Stokes (2011) Contribution fo Obesity to International Differences in Life Expectancy. Amer J Public Health 101: 2137-2143.
Wang, H and Preston, SH. (2009) Forecasting United States Mortality Using Cohort Smoking Histories. PNAS 106(2): 393-398.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New |
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 |
The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. |
Award Project Period |
The total project period may not exceed 2 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.
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the SF424 (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.
- System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
- Grants.gov
- eRA Commons
All Program Directors/Principal Investigators (PD(s)/PI(s))
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 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
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.
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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.
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.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before 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 before the deadline 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 Applying Electronically.
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.
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 (SAM). 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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
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.
For this particular announcement, note the following:
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.
Reviewers will provide an overall impact 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).
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(s)/PI(s), 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?
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 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
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
- Will receive a written critique.
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:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
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.
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’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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
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 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Service Desk (Questions regarding ASSIST, 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
Georgeanne E. Patmios, M.A.
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: PatmiosG@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Lesa McQueen, M.Sc.
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: McQueenL@mail.nih.gov
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.
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.
