RELEASE DATE:  October 22, 2002

PA NUMBER:  PA-03-014 (This PA has been reissued, see PA-06-422 for R01 Submissions)

March 2, 2006  (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181) 
funding opportunity announcements have been issued for the submission date of 
June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34 
activities must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE: October 2, 2005

National Institute of Mental Health (NIMH)


o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations


The National Institute of Mental Health (NIMH) invites grant applications for 
research that will reduce the burden of mental illnesses on older adults.  NIMH 
has a long-standing commitment to studying mental illnesses in older individuals.  
With a recent review of the late-life research portfolio, NIMH has identified 
opportunities for enhancing and strengthening its investment in late-life 
research.  The intent of this program announcement is to intensify investigator-
initiated research in this area, to attract new investigators to the field, and 
to enhance interdisciplinary approaches to research.



The United States has the largest number of older adults than at any other time 
in its history, and this number is rapidly increasing.  As of July 2002, U.S. 
Census estimates project that 35.3 million Americans are 65 years of age or 
older, comprising 12.6 percent of the population.  In the next decade, this 
number is expected to grow by 18.8 percent.  By 2025, the number of older adults 
will have increased to over 62 million -- an increase of over 77 percent.  On 
the other hand, the nation's population will grow overall by only 20.5 percent.  
This rapid increase in our aging adult cohort creates an increased need to 
understand and reduce the public health burden of mental illnesses on older 

NIMH has a long-standing commitment to support research that helps reduce the 
burden of mental illnesses on older adults.  In 2001, NIMH formed a workgroup 
(which formally became the "Aging Research Consortium" in January 2002) to bring 
together experts on all relevant NIMH areas to ensure an organized and 
comprehensive approach to its aging research.  One of the workgroup's first 
tasks was to review the portfolio of grants, contracts, and intramural research 
targeted toward aging.  One purpose of this analysis was to help provide 
recommendations for future aging research efforts.  This program announcement 
builds on the findings from the workgroup report and outlines some of the major 
areas of interest to NIMH.

Areas of Opportunity 

Virtually every area studied by NIMH-funded researchers has opportunities for 
expansion.  The following section describes some of these areas and is not meant 
to be inclusive.

a.  Risk Factors and Basic Research

Establishing the etiology of late-life mental illnesses and identifying risk 
factors and their relationship to late-life mental illnesses remain priorities.  
Opportunities exist in developing novel models of late-life mental illnesses and 
continuing efforts in biomarker validation, including the use of imaging 
technologies.  Some research questions include:

o  What factors increase the risk for mental illnesses in late life?  What is 
the significance of age at onset?  What is the unique impact of long-term mental 

o  What are the relationships among mental illnesses, disability, and mortality 
in late life?

o  Do risk factors differ in men and women in late life?  Do risk factors differ 
in ethnic/racial minority populations in late life?  Are there identifiable 
environmental risk factors in late life?

o  What risk factors are related to recurrence or relapse in late life?

o  What are the risk factors for suicide in late life?  In what situations does 
depression increase the risk of non-suicide-related mortality in late life?

o  What is the neurobiology of specific mental illnesses in late life?  What is 
the natural history of those illnesses?  How do co-occurring physical illnesses 
alter the picture?

Other needs include:

o  Validation of biological therapeutic targets for late-life mental illnesses

o  Creation of animal models specific to late-life mental illnesses

o  Validation of surrogate markers to indicate treatment effects

b.  Diagnosis

Older adults with psychiatric symptomatology do not typically fit the categories 
of diagnostic nomenclatures.  They may have other co-occurring physical or 
mental illnesses.  They may have the same symptoms at lower severity or 
different duration, or the symptom pattern may be different.  To ultimately 
reduce the burden of mental illnesses on these individuals, it is necessary to 
have valid conceptualizations of those illnesses.  Some research questions 

o  Are the diagnoses of mental illnesses in late life well defined?  Are the 
criteria for those illnesses explicit?  Are there individuals with significant 
psychopathology who fail to meet criteria for an illness?  How does the location 
of care affect the interpretation of these criteria?

o  How does co-morbidity complicate diagnosis?  Do diagnostic criteria for 
typical disorders need to be modified in special situations (e.g., depression in 
Alzheimer's disease)?

o  Can we improve how primary care and other physicians diagnose these 

Other needs:

o  Useful, valid, and cost-effective approaches to screening in primary care and 
other community settings

c.  Treatment

One goal of NIMH is to validate treatments that reduce the effects of mental 
illnesses on older Americans.  Some research questions include:

o  Which treatments work best in late-life mental illnesses?  Do the treatments 
that work best in adult-onset disorders work as well in late-life disorders?  
What are the special concerns regarding safety of pharmacotherapy in the elderly, 
particularly when other medical disorders exist?

o  Does early treatment affect the course of mental disorders in the elderly?  
How long should such treatment occur?  What criteria should determine optimal 
length of this treatment?

o  When should treatment be given prophylactically?  How can treatment be used 
to reduce the possibility of relapse or recurrence?

o  Which psychotherapies work in late life?  Can cost-effective 
psychotherapeutic treatment be developed and validated?

o  Do treatments vary based on such identifiable factors as gender, race, 
ethnicity, or medical comorbidities?  Can the underlying causes of the observed 
variance by these factors be identified?

o  Can treatment of mental illnesses by primary care and other physicians be 

o  What is the role of the family in treatment of mental illnesses in late life?

o  What rational approaches to combination treatments (e.g., pharmacologic and 
psychotherapeutic) should be considered?  To what degree does combination 
therapy affect adherence/compliance?

Other needs:

o  Development of assessment instruments with greater sensitivity, validity, and 

o  Development of validated methods that reduce barriers to participation for 
underrepresented racial/ethnic populations

d.  Prevention and Services

Ultimately, the knowledge that is created by NIMH researchers to improve the 
mental health of older Americans needs to be useable by providers and 
individuals outside the laboratory.  Of equal importance is the attempt to 
prevent mental illnesses before they occur.  Some research questions include:

o  What are the social costs/economic consequences of not treating elderly 
persons with mental illnesses?  What is the role of economic factors in the 
delivery and use of mental health services by elderly persons with mental 

o  Does reimbursement policy for mental health services for the elderly promote 
cost-effective care?

o  What is the clinical epidemiology of services provided across service 
settings; what methods can characterize day-to-day practice? 

o  What are the patient, provider, and encounter factors that enhance or detract 
from access to and effective delivery of services?

o  How can the mental health and human services systems be coordinated to 
maximize receipt of effective services?

o  How can the organization and delivery of clinical services optimize outcomes 
for the elderly with mental illnesses?

o  How do preventive and support services differ in different racial/ethnic 
populations, if at all?

o  What models of rehabilitation are effective in helping the elderly with 
mental illnesses reintegrate into community settings?

Other needs:

o  What are effective models for the delivery of mental health services to the 
elderly within the general medical care sector, including diagnosis, management, 
and treatment?

o  Development of prevention and services methods that can reduce the onset of 
late-life mental illnesses or reduce the duration or severity of late-life 
mental illnesses

e.  Mood Disturbance

NIMH held a workshop in July 2002 organized by the Aging Research Consortium on 
the topic of mood disturbance in late life.  The participants concluded that a 
significant number of older adults have mood symptomatology, which does not meet 
criteria for either an anxiety or mood disorder.  Although these individuals 
have not been the focus of research, they are burdened with symptoms of mental 
illness.  Whether they will later develop a mood disorder is unknown, but they 
are at risk.  Areas of interest for addressing mood disorders include but are 
not limited to:

o  Establishing risk factors for mood disturbance

o  Better characterization of individuals with mood disturbance

o  Development and validation of scales for assessing mood in late life, 
particularly for anxiety and suicidal ideation

o  Improving scales of disability in late life

o  Following at-risk groups (e.g., those with a stressful life event) and 
sampling a wide range of domains (e.g., arousal, disability, affect regulation, 
constitutional vulnerability, setting, costs, diversity, cognition)

o  Developing treatment models that account for the higher placebo response rate 
in less severely impaired individuals

o  Targeting community-based samples where comorbidity, including substance 
abuse and disability, leads to a higher risk of mood disturbance

f.  Bioethics

o  Late-life research remains at a crossroads between the need to protect 
individual research participants from harm and the need to test treatments that 
help individuals with mental illnesses.  Studies that involve following healthy 
individuals have to manage the risk that mental illnesses may appear.  Studies 
that wish to determine when to stop treatment for those in remission have to 
weigh the risk of recurrence.  Studies involving decisionally-impaired 
individuals have to protect these individuals.  Some research questions include:

o  Designing ethical studies that determine rates of recurrence

o  Methods for ensuring informed consent from individuals whose decision-making 
capacity may be compromised

o  Methods for enhancing the informed consent process

The National Institute on Aging

The National Institute on Aging (NIA) also supports late-life research, 
including studies of the aging process, age-related diseases (including 
neurodegenerative diseases), and special problems of the aging population 
(including disability).  This program announcement in particular is targeted to 
mental illness research in late life and not the above-mentioned areas.  
Applicants should consider contacting program staff at NIMH or NIA to determine 
the Institute most appropriate for them.


This PA will use the NIH research project grant (R01), small grant (R03), and 
exploratory/developmental grant (R21) award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the proposed 

The Small Grant (R03) provides two years of funding with a maximum of $50,000 
direct costs for each year.  Information and application instructions for the 
NIMH Small Grant are available at

The Exploratory/Development Grant (R21) provides up to two years of funding with 
up to $100,000 in total direct costs annually.  The Research Plan for this R21 
application (Sections a-d of the 398 application kit) is 10 pages long.  
Information and applications instructions for the NIMH Exploratory/Developmental 
Grant are available at:

This PA uses just-in-time concepts.  It also uses the modular budgeting format 
(see  Specifically, 
if you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.


You may submit an application if your institution has any of the following 

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of State and local governments
o  Eligible agencies of the Federal government
o  Domestic or foreign  (only domestic organizations are eligible for the R03 
o  Faith-based or community-based organizations


Individuals with the skills, knowledge, and resources necessary to carry out the 
proposed research are invited to work with their institutions to develop 
applications for support.  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are always encouraged to apply 
for NIH programs.


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

o  Direct your questions about scientific/research issues to:

Jason T. Olin, Ph.D.
Chair, Aging Research Consortium
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC-9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-6328
FAX:  (301) 594-6784

o  Direct your questions about financial or grants management matters to:

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-8811
FAX:  (301) 443-6885


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive format.  
For further assistance, contact GrantsInfo, Telephone (301) 710-0267, Email

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at  Application deadlines are 
also indicated in the PHS 398 application kit.

up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants 
is available at

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of the NIH 
institutes or centers who has agreed to accept assignment of the application.

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your application 
for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff member and 
IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (Type 1), competing 
continuation (Type 2), competing supplement, or any amended or revised version 
of these grant application types.  Additional information on this policy is 
available in the NIH Guide for Grants and Contracts, October 19, 2001 at

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the checklist, and five signed photocopies in one package 

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by or mailed on or before 
the receipt dates described at  The CSR will not 
accept any application in response to this PA that is essentially the same as 
one currently pending initial review unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is essentially the 
same as one already reviewed.  This does not preclude the submission of a 
substantial revision of an application already reviewed, but such application 
must include an Introduction addressing the previous critique.


Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  An appropriate scientific review group convened in 
accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.

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

o  Receive a written critique
o  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
o  Receive a second level review by the National Institute of Mental Health 
Advisory Council.


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written comments, reviewers will be asked to discuss the following aspects of 
your application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals:

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria in 
assigning your application's overall score, weighting them as appropriate for 
each application.  Your 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, you may propose to carry out important work that 
by its nature is not innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims of 
your application are achieved, how do they advance scientific knowledge?  What 
will be the effect of these studies on the concepts or methods that drive this 

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 

(3) INNOVATION:  Does your project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does your project challenge existing 
paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR:  Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your application 
will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated (see Inclusion Criteria included in the section 
on Federal Citations, below).

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.


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

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Relevance to program priorities


involving Phase I and II clinical trials must include provisions for assessment 
of patient eligibility and status, rigorous data management, quality assurance, 
and auditing procedures.  In addition, it is NIH policy that all clinical trials 
require data and safety monitoring, with the method and degree of monitoring 
being commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(; a complete 
copy of the updated Guidelines are available at  
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 new PHS Form 398; 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.

NIH maintains a policy that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  This 
policy applies to all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at

requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see  
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

Office of Management and Budget (OMB) Circular A-110 has been revised to provide 
public 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

Applicants may wish to place data collected under this PA 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to 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 PA is related to 
one or more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance No. 93.242, and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.  
Awards are made under authorization of Sections 301 and 405 of the Public Health 
Service Act as amended (42 USC 241 and 284) and administered under NIH grants 
policies described at and under 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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 

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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