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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). ApplicationSubmission/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
This Funding Opportunity Announcement (FOA) will utilize the Exploratory/Development
award mechanism (R21; see http://grants2.nih.gov/grants/funding/r21.htm)to initiate the systematic scientific study of Elder Mistreatment. Several
of the basic priority areas elaborated in the National Academy of Sciences
publication Elder Mistreatment. Abuse, Neglect, and Exploitation
in an Aging America (2003) are included in this solicitation. This
FOA addresses initial scientific stages for understanding Elder Mistreatment
in community and institutional settings. These research priority areas
include: (1) innovative methods for estimating incidence; (2) standardization
of definitions and measurement; (3) elaboration of risk factors; (4) methods
of survey, clinical, and psychosocial identification of Elder Mistreatment;
and (5) identification of Elder Mistreatment in institutional settings.
NIA seeks scientific pilot or developmental research on the tools and feasibility
of conducting a national incidence study of elder mistreatment. In addition,
because of the paucity of research in this area, NIA is intent upon expanding
the research infrastructure for Elder Mistreatment. This FOA therefore
solicits applications from scientists with expertise in related areas (e.g.,
child abuse; sexual behaviors; other illicit behaviors) as well as those
with expertise in Elder Mistreatment.
The participating organizations
intend to commit approximately $1,100,000 to this FOA for payment of applications
responsive to this announcement. Awards issued under this FOA
are contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
Four to six awards are anticipated.
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. The total amount awarded and
the number of awards will depend upon the mechanism numbers, quality, duration,
and costs of the applications received.
Budget and Project Period: The
total project period for an application submitted in response to this funding
opportunity may not exceed two years. Direct costs are limited to $275,000
over an R21 two-year period, with no more than $200,000 in direct costs
allowed in any single year.
Eligible Organizations: For profit organizations;
Non-profit organizations; Public or private institutions, such as universities,
colleges, hospitals and laboratories; Units of State government; Units of
local government; Eligible institutions of the Federal government; Domestic
institutions; Faith-based or community-based organizations; Indian/Native
American Tribal Government (Federally Recognized or Other than Federally
Recognized); Indian Native American Tribally Designated Organizations.
Eligible Project Directors/Principal Investigators
(PDs/PIs): Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution 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.
Applicants may submit more than one application, provided
each application is scientifically distinct.
The R21 mechanism limits the research plan to 15 pages.
The R21 mechanism does not allow for renewals.
See Section IV.1 for application materials. The SF424
(R&R) Application Guide for this FOA is located at these Web sites:
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
This Funding Opportunity Announcement (FOA) differs
from the previous Request for Applications (RFA; RFA-AG-05-009)
in several important ways. Applicants are urged to carefully attend to
these changes. In addition there are similarities between the two solicitations.
Applicants should note the following.
This solicitation uses the electronic submission system and the SF424 (R&R)
rather than the PHS398 format. (See: http://www.grants.gov.)
Since a registration process is required before submission, applicants are
encouraged to start the process at least four weeks prior to the grant submission
deadline.
Of the various types of elder mistreatment (physical
abuse, psychological abuse, sexual abuse, neglect, and financial exploitation),
two will be required for study in this FOA. The two selected are at the
discretion of the applicant. The exception to this is the case of financial
exploitation. Applicants studying financial exploitation may choose to
study that form of elder mistreatment alone. (See below for details.)
Survey expertise or experience is required for applicants that use survey
research methods in their application. However, if applicants are using administrative
or secondary data, no such expertise will be required.
While attention to mistreatment of frail elderly and
cognitively impaired elderly is important, it is suggested but not required
that the applicant discuss how data will be gathered from cognitively impaired
individuals if appropriate.
Applications for this FOA will follow NIH Guidelines for R21 submissions
in which items 2-5 of the Research Plan may not exceed 15 pages, including
tables and figures. (See http://grants2.nih.gov/grants/funding/r21.htm
for general guidance with R21 applications.)
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.
Elder mistreatment will be addressed in specific,
identifiable communities. Each application must include at a minimum
one community that can be geographically (e.g., a city or community), conceptually
(e.g., an institutional setting), or socially (e.g., race, ethnic, or cultural
group) defined. The applicant should justify their community choice relative
to the ability to inform elder mistreatment across the U.S. Applications
must present a conceptual and methodological approach to measuring and assessing
the prevalence and incidence of elder mistreatment. Additionally, the researcher
must show that the techniques developed capture as much of the elder mistreatment
in the community as feasible.
Responsive applications will examine a minimum of two of the five types
of elder mistreatment defined by the NRC panel: (1) physical abuse, (2) psychological
abuse, (3) sexual abuse, (4) neglect by a trusted other, and (5) financial
exploitation. NOTE: Financial exploitation, because of its unique nature,
may, at the applicant’s discretion, constitute the only form of elder mistreatment
proposed for study in an application. Risk factors associated with each type
of mistreatment should be identified and measured. It should be noted that
self-neglect is not part of this initiative. There is sufficient evidence
to indicate that self-neglect is a separate form of mistreatment (see NRC,
2003).
The elder mistreatment problem will be approached as a
pilot or developmental effort that will eventually prepare the research
community for undertaking a national prevalence and/or incidence study of
elder mistreatment.
Responsive applications will indicate that they will include, as Key Personnel
or Consultants, experts who provide links to the practice community. This
requires that, for example, APS, other social services, medically related
personnel, and/or law enforcement professionals be included. This is to assure
the field that recommendations arising from this pilot effort are based on
practical aspects of working in the field, and in turn will provide the field
with information that can be used to shape policy and programs. NOTE: Unless
deemed essential by the applicant, the specific names of practice-related
Consultants should not be used; only their role should be included.
Responsive applications will include an expert in survey research or a scientist
with experience in establishing and conducting large-scale surveys as Key
Personnel or Consultant. This is to create a research environment for
scaling-up pilot findings to a possible full-scale national incidence/prevalence
study, to inform the design of the pilot, and to assess the feasibility of
the larger effort. NOTE 1: the exception to this requirement is if the
proposed research does not involve survey techniques but instead uses, for
example, some form of administrative or secondary data source. The exception
must be made clear to the reviewers. NOTE 2: Unless deemed essential by
the applicant, the specific names of survey Consultants should not be used;
only their role should be included.
Agree to meet with other Principal Investigators
(PIs) and Program Staff, most likely in the Washington, DC area, once during
the two-year term of the project. The PI and key staff, the latter at the
PI's discretion, are to be included in this meeting. The purpose of this
meeting is to share scientific knowledge, measurement expertise, and unique
approaches to the research tasks. In addition, the agenda will include
a discussion of issues related to IRB clearance of grants dealing with sensitive
matters. It is not intended that the funded projects duplicate measurement
or scientific approaches. However, it is anticipated that each project
and the field in general will be enriched by an informal discussion of ideas,
problems encountered, approaches, and findings from the other projects.
Additionally, the group of researchers, possibly augmented by others, will
advise NIA/NIH and others on the advisability of a national incidence/prevalence
study or recommend other steps that will eventually lead to scientifically
based incidence and prevalence estimates.
In addition to these requirements, successful applications may wish to consider
the following issues.
Applications may deal with either community- or institution-based
mistreatment. Applications may combine community-based and institutionally-based
mistreatment in a single study. Pending peer review outcomes, at least one
application that includes institutional abuse will be selected. That project
may deal exclusively with institutional abuse or include it as a component
of the community studied.
Applicants may wish to consider how they intend to gain access to reliable
and valid information from cognitively impaired respondents.
Each application may specify how it will deal with sensitive
material.
Applicants may wish to assess scientifically obstacles to a valid, reliable,
and fully generalizable national incidence study. For example, there is strong
evidence that various cultural groups provide family rather than institutional
or formal help for vulnerable elderly (Dilworth-Anderson, et al., 2002). To
what extent does delaying care seeking influence the incidence of elder mistreatment
in various groups? Are language barriers or the cultural context of the victim
and perpetrator (Hudson and Carlson, 1999) a sufficiently problematic impediment
to conducting a single national incidence study? If so, are there scientific
alternatives?
Applicants with prior experience in elder mistreatment and those without
such prior experience in elder mistreatment are encouraged to apply. Scientists
in the latter category and/or their colleagues should display some scientific
expertise in related areas. These related areas include, for example: child
abuse, epidemiology, scientific experience in asking questions about socially
stigmatized behaviors, research on family and family dynamics, the sociology
of law, society, and criminology, the economics of crime and deviance, and
the psychology of deviance. (The foregoing list is intended to provide examples
and not to exclude other scientific areas that can contribute to the field.)
This FOA thus encourages new combinations of scientists with expertise in
related fields to apply that expertise to the field of elder mistreatment
through interdisciplinary approaches.
Applicants are asked not to list the names of consultants on their applications,
unless they are essential to the conduct of the research, such as survey research
expertise.
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.
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 FY2007to fund4-6applications.
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.
Facilities and Administrative (F&A) costs requested by consortium participants are not included
in the direct cost limitation. See 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:
For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals,
and laboratories
Units of State government
Units of Local government
Eligible agencies of the Federal government
Domestic Institutions/organizations
Faith-based or community-based organizations
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organizations
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.
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:
If your organization does not have a Taxpayer Identification
Number (TIN) or Employer Identification Number (EIN), allow for extra time.
A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue
Service records, a step that will take an additional one to two business
days.
Direct questions regarding Grants.gov registration to: Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
Direct questions regarding the Commons registration
to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
The individual designated as the PD/PI on the application
must also be registered in the NIH eRA Commons. It is not necessary for
PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the Commons and
must be affiliated with the applicant organization. This account cannot
have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized
Organization Representative/Signing Official (ARO/SO) or their designee
who is already registered in the Commons.
Both the PD/PI and AOR/SO need separate accounts in
the NIH eRA Commons since both are authorized to view the application image.
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
301-710-0267, Email: [email protected].
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/APPLYwill 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.)
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:
Descriptive title of proposed research.
Name, address, and telephone number of the PD/PI.
Names of other key personnel.
Participating institutions.
Number and title of this funding opportunity.
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: [email protected]
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 ([email protected]) 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.
If everything is acceptable,
no further action is necessary. The application will automatically move
forward for processing by the Division of Receipt and Referral, Center for
Scientific Review, NIH, after two business days.
Prior to the submission deadline, the AOR/SO can
Reject the assembled application and submit a changed/corrected application
within the two day viewing window. This option should be used if the AOR/SO
determines that warnings should be addressed. Reminder: warnings do not stop
further application processing. If an application submission results in warnings
(but no errors) it will automatically move forward after two business days
if no action is taken. Please remember that some warnings may not be applicable
or may need to be addressed after application submission.
If the two day window falls after the submission
deadline, the AOR/SO will have the option to Reject the application if,
due to an eRA Commons or Grants.gov system issue, the application does not
correctly reflect the submitted application package (e.g., some part of the
application was lost or didn t transfer correctly during the submission process).
The AOR/SO should first contact the eRA Commons Helpdesk to confirm the
system error, document the issue, and determine the best course of action.
NIH will not penalize the applicant for an eRA Commons or Grants.gov system
issue.
If the AOR/SO chooses to Reject the image after
the submission deadline for a reason other than an eRA Commons or Grants.gov
system failure, a changed/corrected application still can be submitted but
it will be subject to the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications
when the application is rejected or the application automatically moves forward
in the process after two days.
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.
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
Expertise must be evident in the application (as Key
Personnel or Consultants ) from the social service professionals dealing
with elder mistreatment.
Expertise must be evident in the area of survey research or through experience
in the conduct of large-scale surveys (unless the application uses secondary
or administrative data).
PIs (and key personnel at the PI’s discretion) must agree to meet once,
most likely in the Washington, DC area, with other awarded PIs. Funds for
this meeting should be budgeted into the application.
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:
Up to fivepublications, manuscripts (accepted
for publication), abstracts, patents, or other printed materials directly
relevant to the proposed project. Do not include manuscripts submitted
for publication.
Publications in press: Include only
a publication list with a link to the publicly available on-line journal
article or the NIH PubMed Central (PMC) submission identification number. Do
not include the entire article.
Manuscripts accepted for publication but not yet
published: The entire article may be submitted electronically as a PDF attachment.
Manuscripts published but a publicly available online journal
link is not available: The entire article may be submitted electronically
as a PDF attachment.
Surveys, questionnaires, data collection instruments, clinical protocols,
and informed consent documents.
Graphic images of gels, micrographs, etc. provided that the image (may be
reduced in size) is also included within the (stated) page limit of Items
2-5 of the Research Plan component. No images may be included in the
Appendix that are not also represented within the Research Plan.
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:
Undergo a selection process in which only those applications
deemed to have the highest scientific merit, generally the top half of applications
under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review bythe National Advisory Council on Aging.
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:
Scientific merit of the proposed project as determined
by peer review.
Availability of funds.
Relevance to program priorities.
At least one application that includes the study of
institutional elder mistreatment will be recommended for funding if determined
to be of high scientific merit by peer review.
Program staff will recommend for funding those applications
that cover as many of the types of elder mistreatment as feasible, pending
peer review outcomes.
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.
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
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: [email protected]
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: [email protected]
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: [email protected]
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 Assistanceat 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.
