Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), http://www.nih.gov).

Components of Participating Organizations
National Institute on Aging (NIA), (http://www.nia.nih.gov)

Title:  Developmental Research on Elder Mistreatment (R21)

Announcement Type
This is a reissue of RFA-AG-05-009, which was previously released March 23, 2005.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-AG-06-009

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release/Posted Date:  August 4, 2006
Opening Date: September 25, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 25, 2006
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s): October 24, 2006
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s): January 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: October 25, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1.  Introduction

2. Research Objectives

The National Institute on Aging (NIA) invites initial developmental applications from the research community that will ultimately provide the scientific basis for understanding, preventing, and treating elder mistreatment.  Scientifically gathered knowledge of the prevalence, incidence, and risk factors associated with community and institutional elder mistreatment in the U.S. is missing.  Insight needs to be gained prior to the creation of national policy on preventing elder mistreatment. Developmental research prior to a full incidence/prevalence study is a necessary first step. This solicitation is intended to fund these initial steps.

NIA will fund four to six area-based or community targeted pilot investigations to develop and test the feasibility, validity, reliability, and generalizability of methodologies for measuring the prevalence and incidence of elder mistreatment. One of the objectives of this solicitation is to develop and pilot test methodologies and techniques for estimating elder mistreatment that might be replicated subsequently in a national prevalence and incidence study. Findings from this solicitation should be useful for the Federal Government in determining the feasibility and desirability of conducting a national incidence study. The community-based orientation is essential for casting the broadest possible net to capture all cases of elder mistreatment and to validate the methods developed.

A second objective is to explore potential obstacles to a single national study. One outcome of this research then is to recommend alternatives to a national incidence/prevalence study since it is not clear that such a study is feasible.

The third and final objective of this FOA is to increase the scientific infrastructure of scholars conducting scientifically sound research in the broad area of elder mistreatment. To that end, researchers studying other socially stigmatized behaviors are encouraged to apply. Examples of these behaviors include illicit drug use, child abuse, family violence, sexual behavior, and criminal behavior.

This solicitation focuses on initial steps discussed as research priorities in Elder Mistreatment: Abuse, Neglect, and Exploitation in an Aging America (National Research Council, 2003). The NIA-funded Elder Mistreatment study and volume is a product of the National Research Council's (NRC) Panel to Review Risk and Prevalence of Elder Abuse and Neglect. These initial priorities include:

1. The development of standardized conceptual and operational definitions of elder mistreatment. Five forms of elder mistreatment are identified by the NEC Panel:  (1) physical, (2) psychological, and (3) sexual abuse, (4) neglect, and (5) financial exploitation. Operational definitions developed need to be acceptable to both the research and practice communities, the latter including social service, medical, and law enforcement/legal communities. Operational definitions developed must meet tests of validity, reliability, generalizability, and be subject to standardized measurement methods for ease of replication;

2. A community-wide approach such that all avenues of elder mistreatment detection and remediation are included (e.g., policy, Adult Protective Services, other social services, medical);

3. Testing methods of prevalence and incidence measurement using techniques that will solicit reasonable, reliable, valid, and generalizable estimates;

4. A triangulation of methods for detecting elder mistreatment at the community level;

5. Designing and fielding prevalence and incidence studies of elder mistreatment that can be replicated at the national level; and

6. Expanding the infrastructure for conducting elder mistreatment research to include experts in other fields currently studying socially sensitive and stigmatized behaviors.

3.  Background

Scientifically based knowledge of elder mistreatment is probably 30-40 years behind the acquisition of scientific information in the area of child abuse and neglect. This initiative is intended to begin closing that gap. Given the dramatic growth in the population entering age categories defined as “later life,” it is necessary that science help shape policy and practice in dealing with the prevention and remediation of elder mistreatment. As noted by the NRC study, the field is virtually devoid of science based knowledge: “…fewer than 50 peer-reviewed articles based on empirical research have been published in the field” (NRC, 2003; p18). The NRC recommends 14 agenda items needing scientific attention. This solicitation is intended to initiate research on the pilot and developmental studies necessary to produce the science for conducting a national study of prevalence and incidence of elder mistreatment. The estimation of prevalence and incidence is essential if social policy is to be created to impact prevention and remediation of elder mistreatment.

One of the difficulties with elder mistreatment research is the plethora of definitions used. Contributing to the ambiguity are different statutory definitions for elder mistreatment across the United States (Administration on Aging, 2004; Teaster, 2003). Although every state has some form of mandated reporting of suspected elder mistreatment, Adult Protective Services (APS) mandates and definitions vary widely. Additionally, legal requirements for data systems vary across jurisdictions.  A further challenge to research on elder mistreatment is the differing perceptions of elder mistreatment among various racial, ethnic, and cultural groups (Moon, 2000). The cultural context of the perpetrator/victim relationship affects the way differing groups define elder abuse and/or mistreatment (Hudson and Carlson, 1999). Furthermore, APS or its equivalent across the U.S. have widely varying methods for taking referrals, allegation determination, and referral/case tracking (Teaster, no date).  It is clear that the use of administrative data to estimate the “real” national incidence/prevalence is most likely not possible at this time.

The NRC Panel defined elder mistreatment as “(a) intentional actions that cause harm or create a serious risk of harm, whether or not intended, to a vulnerable elder by a caregiver or other person who stands in a trust relationship to the elder or (b) failure by a caregiver to satisfy the elder's basic needs or to protect the elder from harm” (NRC, 2003, p. 40). This sufficiently broad definition invites the research community to develop specific definitions and operational terms to facilitate the reliable, valid, and generalizable assessment of elder mistreatment.

The NRC conceptual definition excludes self-neglect and victimization by strangers. This research solicitation will also exclude self-neglect and victimization by strangers.  Two critical elements of elder mistreatment are the presence of a “trust relationship” (p.40) and the elder's diminished capacity for “self-care or self-protection” (p. 41). Self-neglect warrants intervention to determine capacity for self-care.  However, self-neglect lacks a victim/perpetrator relationship. Although mistreatment by a stranger contains at a minimum a perpetrator/victim dyad, it is the nature of the “trust relationship” between the elder victim and the perpetrator that constitutes a “necessary” basis for what is commonly understood as mistreatment. Therefore, exploitation by predatory strangers is classified as a legal harm but not “mistreatment” (NRC, 2003). For example, random street mugging is not considered elder mistreatment.  On the other hand, financial exploitation such as a monetary arrangement that can be linked to a trusted other would constitute elder mistreatment, and will therefore be included in this research.

According to available estimates, between 0.5 and 10 percent of Americans age 65 or older have been injured, exploited, or otherwise mistreated by someone on whom they depended for care or protection (Administration for Children and Families and Administration on Aging, 1998; NRC, 2003; Fulmer, Paveza, & Guadagno, 2002; Pillemer & Finkelhor, 1988). Estimates are often based on sample surveys conducted in local areas, most using variable definitions, or on estimation techniques of questionable value. The National Center on Elder Abuse report (Administration for Children and Families and Administration on Aging, 1998) estimates that approximately 19 percent of all “suspected cases” are actually “reported” to appropriate agencies. Clearly, using “reported” mistreatment dramatically underestimates the incidence and prevalence of elder mistreatment. Other studies have been undertaken in Canada (Podnieks, 1992), the United Kingdom (Ogg and Bennett, 1992), Finland (Kivela et al., 1992), and the Netherlands (Comijis et al., 1998). However, there has been no systematic survey of the U.S. population to provide an accurate national estimate for the occurrence of elder mistreatment.  This solicitation is intended to provide the developmental research necessary to undertake a national study. 

Few studies examine the effects of elder mistreatment on the victim's psychological and physical health. Studies have attempted to demonstrate that victims of elder mistreatment are more likely to be depressed or suffer psychological distress. However, research designs used prevent a clear determination of whether these risk factors resulted from or preceded mistreatment (Wolfe, 2000).

An NIA-supported study is the only research to examine the long-term effects of mistreatment on mortality. In a 13-year retrospective longitudinal study of abuse and neglect using a cohort of 2,812 individuals, Lachs et al. (1998) found that only nine percent of the population with reported abuse and 17 percent of those with reported self-neglect survived the duration of cohort follow-up. By contrast, fully 40 percent of those with no reported abuse or neglect survived the 13 years. Not a single death, however, was attributed directly to abuse and/or neglect. Moreover, controlling for known mortality risk factors (e.g., chronic disease, socioeconomic status, social factors, cognitive status, and demographic characteristics), the all-cause mortality odds ratio (OR) for those abused to those with no APS report is 3:1; the OR for those self-neglected is 1:7. These findings suggest that preventing abuse and neglect may have a significant impact on mortality and perhaps disability as well.

Scholars currently conducting research on elder mistreatment have made excellent inroads into a difficult topic. However, since 1990, fewer than 15 studies on elder mistreatment have been funded by the NIA, and support from other agencies has been even less substantial (NRC, 2003). This dearth of research stems not from an unwillingness to fund elder mistreatment research by NIA, but from a lack of applications meeting NIH's criteria for excellent science. It is a difficult area to investigate and presents significant scientific challenges. Seldom has an entire avenue of investigation, with the potential to impact health, well-being, and longevity of an entire population group, been so devoid of scientifically gained knowledge. The field of elder mistreatment is in critical need of sound research. While society and governmental agencies, as well as the social, behavioral, and medical sciences, recognize elder mistreatment as a significant social problem, there is little scientific information about its prevalence, causes, consequences, or prevention.

Finally, there are potential ethical dilemmas in any research involving abuse and neglect. Unlike child abuse, the older victim of mistreatment may be part of a family dynamic of abuse existing for many years. Since families create unique patterns of interaction to cope with and survive everyday living and adversity (Becker, 1997), any disruption in that interaction pattern, even though legally appropriate, may produce unintended negative consequences. Research must remain cognizant of this potential, despite the practical need to intervene. Therefore, research funded by this solicitation should offer insight on how to protect subjects and at the same time gain access to essential data for the investigation of elder mistreatment.

4.  Scope

Responsive applications will include the following topics.

In addition to these requirements, successful applications may wish to consider the following issues.  

5.  References

Administration on Aging (2004). Elder abuse: elder abuse is a serious problem. http://www.aoa.gov/eldfam/Elder_Rights/Elder_Abuse/Elder_Abuse.asp

Administration for Children and Families and Administration on Aging (1998). The National Elder Abuse Incidence Study. Retrieved January 19, 2005 from http://www.aoa.gov/eldfam/Elder_Rights/Elder_Abuse/ABuseReport_Full.pdf

Becker, G. (1997). Disrupted Lives: How people create meaning in a chaotic world. Berkeley: University of California Press.

Comijis, H.C., Pot, A.M., Smit, H.H., & Jonker, C. (1998). Elder abuse in the community:
Prevalence and consequences. Journal of the American Geriatrics Society 46:885-888.

Dilworth-Anderson, P., Williams, I.C., & Gibson, B.E. (2002). Issues of Race, Ethnicity, and Culture in Caregiving Research: A 20-Year Review (1980-2000). The Gerontologist 42:237-272.

Fulmer, T., Paveza, G., & Guadagno, L. (2002). Elder abuse and neglect: Policy issues for two very different problems. The Public Policy and Aging Report , 12:15-18.

Hudson, M.F., & Carlson, J.R. (1999). Elder abuse: Its meaning to Caucasians, African Americans, and Native Americans. In Toshio Tatara (Ed.), Understanding elder abuse in minority populations (pp.187 – 204). Ann Arbor: Braun-Brumfield.

Kivela, S.L., Kongas-Saviaro, P., Kesti, E., Pahkala, K., & Ijas, M. (1992). Abuse in old age: Epidemiological data from Finland. Journal of Elder Abuse and Neglect, 4:1-18.

Lachs, M.S., Williams, C.S., O'Brien, S., Pillemer, K., & Charlson, M. E. (1998). The mortality of elder mistreatment. JAMA, 208:428 – 432.

Moon, A. (2000). Perceptions of elder abuse among various cultural groups: Similarities and differences. Generations, 24:75-80.

National Research Council. (2003). Elder mistreatment: Abuse, neglect, and exploitation in an Aging America. Panel to Review Risk and Prevalence of Elder Abuse and Neglect. Richard J. Bonnie & Robert B. Wallace (Eds). Committee on National Statistics and Committee on Law and Justice, Division of Behavioral and Social Sciences and Education. Washington, D.C: The National Academies Press.

Ogg, J. & Bennet, G. (1992). Elder abuse in Britain. British Medical Journal, 305:998 -999.

Pillemer, K., & Finkelhor, D. (1988). The prevalence of elder abuse: A random sample survey. The Gerontologist, 28:51-57.

Podnieks, E. (1992). National survey on abuse of the elderly in Canada. Journal of Elder Abuse and Neglect, 41:5 -58.

Teaster, P. (2003). A response to the abuse of vulnerable adults: The 2000 survey of state Adult Protective Services.
http://www.elderabusecenter.org/pdf/research/apsreport030703.pdf

Wolf R. (2000). Introduction: The nature and scope of elder abuse. Generations, 24:6–11.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH R21 award mechanism.  The applicant  will be solely responsible for planning, directing, and executing the proposed project.  See http://grants2.nih.gov/grants/funding/r21.htm for additional generic instructions for R21 submissions.

This FOA uses “Just-in-Time” information concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed 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.

The R21 mechanism limits the research plan to 15 pages and does not allow for renewals.

The participating organization(s), National Institute on Aging, intends to commit approximately $1,100,000 dollars in FY2007 to fund 4-6 applications.

NIH grants policies as described in the NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Grants funded by the earlier FOA on this topic (RFA-AG-05-009) are NOT eligible to apply for the current FOA.   Applications submitted in response to RFA-AG-05-009 that were not funded can be submitted as new applications in response to this current FOA.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 
PHS398 Modular Budget

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations

Not Applicable.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: September 25, 2006  (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 25, 2006
Application Submission Receipt Date(s): October 24, 2006
Peer Review Date(s): January 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Dr. Sidney M. Stahl, Chief
Behavioral Processes Branch 
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax:  (301) 402-0051
Email:  Sidney_Stahl@nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the National Institute on Aging Scientific Review Office by email (NekolaM@nia.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R21 applications:

Research Plan Component Sections

Items 2-5 of the Research Plan component of the R21 application may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.

Introduction (required for a resubmission application) is limited to one page.

Preliminary data are not required but may be included if available.

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

Appendix Materials

The following materials may be included in the Appendix:

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may be delayed in the review process.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established Public Health Service (PHS) referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/) will evaluate applications for scientific and technical merit.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Aging in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important scientific health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women and Minorities in Research:
The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups) as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: Not applicable.

Biohazards: Not applicable.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data
Not Applicable.

2.D. Sharing Research Resources
Not applicable. 

Model Organism Sharing Plan: 

Not applicable

3. Anticipated Announcement and Award Dates
Not applicable.

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., “Funding Restrictions.”       

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.

3. Reporting

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

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Sidney M. Stahl, Chief
Behavioral Processes Branch
National Institute on Aging 
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax:  (301) 402-4156
Email:  Sidney_Stahl@nih.gov

2. Peer Review Contacts:

Dr. Mary Nekola, Chief
Scientific Review Office 
National Institute on Aging
7201 Wisconsin Ave., #2C/212
Bethesda, MD 20892-9205
Telephone: (301) 402-7702
Fax:  (301)402-0066
Email:  NekolaM@nia.nih.gov

3. Financial or Grants Management Contacts:

Mr. Richard Proper, Grants Management Specialist
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #2N/212
Bethesda, MD 20892-N9205
Telephone: (301) 402-7735
Fax (301) 402-3672
Email:  ProperR@nia.nih.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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