RESEARCH ON RURAL MENTAL HEALTH AND DRUG ABUSE DISORDERS

RELEASE DATE:  February 12, 2004

PA NUMBER:  PA-04-061

Update: The following update relating to this announcement has been issued: 

July 7, 2006 (PA-06-478) - This PA has been reissued as PA-06-478 for submission 
of R01 applications, as July 7, 2006.

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 Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 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 for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: July 7, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov/)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute of Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242, 93.279

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

This program announcement replaces PA-00-082.

The National Institute of Mental Health (NIMH) and the National Institute on 
Drug Abuse (NIDA) invite grant applications for research that will ultimately 
lead to a reduction in the burden of mental illness and drug abuse in rural and 
frontier populations.  The purpose of this program announcement is to stimulate 
research on mental health and/or drug abuse problems in rural and frontier 
communities that will:  (1) enhance understanding of structural (including 
community risk and resilience factors), cultural, and individual factors that 
may limit the provision and utilization of prevention and treatment services in 
these communities; and (2) generate knowledge to improve the organization, 
financing, delivery, effectiveness, quality, and outcomes of mental health and 
drug abuse services for diverse populations in rural and frontier populations.  
Applications may focus exclusively on mental disorders, drug abuse disorders, or 
on the co-occurrence of these and related disorders.  Comparison of rural and 
urban populations and/or comparisons between rural populations is encouraged 
whenever possible, but this is not a requirement.

RESEARCH OBJECTIVES

Background

The impact of mental illness and drug abuse upon the lives of people and nations 
has been profoundly underestimated and under-appreciated.  A 2003 report from the 
President’s New Freedom Commission on Mental Health 
(http://www.mentalhealthcommission.gov) and other reports such as, “Mental Health:  
A Report of the Surgeon General,”(1999) 
(http://www.nimh.nih.gov/research/sgreports.cfm), 
document the enormous public health burden of mental health and co-occurring 
disorders in the United States.  Much of the personal and societal burden of mental 
and drug abuse disorders could be prevented or alleviated if people at-risk for 
experiencing these disorders sought and received appropriate prevention and 
treatment interventions.  These reports note that barriers such as limited 
insurance coverage, scarce availability of services, and stigma must be overcome in 
order to achieve further progress in preventing and reducing the toll of mental and 
drug abuse disorders.  Other barriers such as lack of community resources and 
distance contribute to the lack of adequate prevention approaches in many rural 
areas.  Much scientific progress has been made in understanding, treating, and 
preventing mental health and drug abuse disorders, and in understanding their 
emotional and financial costs to families and society.  A variety of well-
established prevention and treatment interventions are available for the range of 
mental, emotional, and drug-abuse problems that occur across all ages, racial and 
ethnic groups, and gender.  However, these interventions are not reaching many who 
need them.

The President’s New Freedom Commission Report noted that the public health burden 
of mental illness and drug abuse is great.  Approximately 5% to 7% of adults have a 
serious mental disorder in any given year, and about 5% to 9% of children have a 
serious emotional illness.  This means that millions of individuals are afflicted 
each year.  The annual economic cost of these illnesses is estimated at $79 
billion.  Approximately $63 billion of this reflects lost productivity; mortality 
costs are $12 billion due to premature death, and almost $4 billion are attributed 
to productivity losses due to incarceration and the provision of family care.  In 
the last 15 years, mental health spending has not kept pace with general health 
care.  In 1997, the United States spent more than $1 trillion on health care.  This 
included $71 billion to treat mental illnesses.

The public health burden of drug abuse is also great, particularly in association 
with HIV-risk behavior, smoking, criminal activity, lost work productivity, 
interrupted educational careers, family violence, and other adverse health 
outcomes.  The most recent findings from the National Household Survey on Drug 
Abuse found that in 2001, more than 7% of Americans age 12 and older had used an 
illicit drug within the past month.  Despite the fact that effective prevention and 
treatment interventions exist to combat the behaviors and effects of drug use and 
abuse, too few individuals are provided with effective interventions.  For example, 
for many of those who do receive treatment, the care provided is often inadequate — 
not intensive enough, not long enough, or lacking in important supportive health 
and social services.

While inconclusive, research evidence suggests that the prevalence and incidence of 
mental illness and drug abuse for adults and children are similar for rural and 
urban populations.  Suicide rates differ in these communities, however, with rural 
suicide rates exceeding urban rates.  Much of the personal and societal burden of 
these disorders could be alleviated if people experiencing one or more of them 
sought and received appropriate treatment.  However, research has shown that major 
barriers deter many individuals from entering treatment.  For the United States as 
a whole, these barriers are primarily stigma, lack of parity placed on mental 
health and drug abuse insurance benefits in private health care, and a fragmented 
system of care.  An estimated 45 million Americans are without any health care 
coverage.  For those with insurance, mental illness and drug abuse visits carry a 
patient co-payment of about 50%, compared to 10% to 15% for other illnesses.  
Stigma remains a powerful barrier to people seeking help for mental illness and 
drug abuse addiction, and stigma is also reflected in the public’s reluctance to 
pay for treatments, particularly through insurance premiums or taxes.

Nearly 60 million Americans living in rural and frontier communities face 
additional barriers to receiving effective prevention and treatment services for 
mental health and drug abuse problems.  Access to and availability of mental health 
and drug abuse specialists, such as psychiatrists, psychologists, and social 
workers appear to be seriously lacking.  Poverty, geographic isolation, and 
cultural differences further limit the amount and quality of mental health care and 
drug abuse prevention and treatment services available to individuals in rural and 
frontier areas.  This means that rural residents often enter care later in the 
course of their illness than their urban peers, enter care with more serious 
symptoms, and require more intensive and expensive treatment.  Moreover, the cost 
of services —especially prescription medications- may be too high for many rural 
(as well as urban) Americans.  The President’s 2003 report suggests, “Affordable 
and accessible transportation services may be unavailable, especially to rural 
children, the disabled, and the elderly.”  And, “rural residents have longer 
periods without insurance coverage that their urban peers, and they are less likely 
to seek services when they cannot pay.”  Questions also arise about whether 
available providers are adequately trained to deliver culturally sensitive care to 
different groups living in these communities.  Primary care physicians are often 
the only providers of mental health and drug abuse services in rural communities, 
and many of them have not been trained and/or do not have the time to adequately 
treat these illnesses.

Recent changes in the health care system (including managed care) that emphasize 
cost containment could further imperil access to mental health and drug abuse 
prevention and treatment services for people in rural and frontier areas.  There is 
concern that, in the effort to trim health care costs, rural services could suffer 
disproportionately.  There is a continuing need for studies to assess and monitor 
the availability, accessibility, quality and outcomes of mental health and drug 
abuse services for individuals in rural and frontier areas.

Areas of Research Opportunities

The following list of potential research topics is illustrative, not exhaustive.  
Researchers responding to this program announcement are invited to identify 
additional areas of inquiry that, when explored, will lead to the enhancement of  
the delivery of mental health and drug abuse prevention and treatment services to 
diverse rural and frontier populations.  Moreover, given that many health care 
needs are developmentally-based, gender-based, and culturally/technically-based, 
and given the growing body of research indicating developmental, gender, and ethnic 
differences in the developmental trajectories of mental health and drug abuse 
problems, researchers are encouraged to take developmentally-based, gender-based, 
and culturally-based approaches in designing their research and proposing 
hypotheses.

1) Methodology

Several methodological issues challenge researchers seeking to study the provision 
of health services in rural and frontier communities.  Although rural typologies 
have been devised to guide researchers and policy makers, they often fail to 
capture the relationship between (rural/frontier) population characteristics that 
are relevant to mental health service and drug abuse treatment outcomes.  
Statistical definitions, for example, have been used for implementing public 
policy, but the term “rural,” operationalized by these definitions, is only a proxy 
variable for identifying differences in availability, access, need, and use of 
services.  When current definitions are used to design and assess mental health and 
drug abuse services, it is impossible to differentiate why a particular 
intervention is effective in one “rural” community and not another.  Rural and 
frontier studies also often encounter difficulty in obtaining a sufficient sample 
size and thus lack the power to allow “community” to be utilized as an explanatory 
variable.  Investigators are encouraged to consider promising methodologies that 
would include:  multi-level studies that would represent individuals within 
communities and communities within regions or geographic entities; multivariate 
analysis, including structural equations modeling; and state-of-the-art methods for 
analyzing small samples as well as longitudinal data.  Investigators are encouraged 
to identify or develop and test:

o  New rural typologies that capture the relationship between (rural/frontier) 
population characteristics that are relevant to mental health service and drug 
abuse treatment outcomes.

o  New definitions of “rural” that include various ecocultural characteristics 
operationalizing the “cost of space” for rural populations under investigation.  
“Ecology” might include the resources and constraints of a community, including 
level and rate of economic development, dependability and consistency of economic 
resources; service use, social support and social networks, and factors that 
promote risk and resilience for individuals and families.  “Culture” might include 
the beliefs and values that influence community decisions and demographics 
including racial/ethnic diversity.

o  Analytic strategies for overcoming the problems posed by small sample sizes.

2) Epidemiology 

Analyses of rural and frontier populations are needed to enhance the knowledge base 
about the prevalence of mental/drug abuse disorders and access to mental 
health/drug abuse prevention and treatment services in children and older adults.  
Results from available studies suggest that there is no difference in the 
prevalence of psychiatric disorders between metropolitan and non-metropolitan 
adults; however these results may be outdated due to demographic changes in rural 
areas and how rural is defined and measured.  Existing studies also shed little 
light on intra-rural differences in the prevalence of psychiatric and drug abuse 
disorders.  Similarly, little is known about differences in these disorders among 
rural and urban children.  Thus, investigators are encouraged to:

o  Conduct meta-analyses of the epidemiology of mental health and drug abuse 
disorders in rural areas, using existing databases to inform the development of a 
typology that identifies rural communities at high risk of disorder/under 
utilization of services.  It may be useful to supplement selected existing 
databases with community-level variables to examine social and economic predictors 
of intra-rural variation.

o  Analyze the factors associated with both the risk and resilience of families and 
individuals in diverse communities.

o  Build on the identification of high-risk areas nationwide through regional 
epidemiological studies of prevalence, service capacity, use of care, etc., to 
inform policy decisions about service provision to high-risk rural communities.

o  Exploration of behavioral epidemiology of factors associated with adverse mental 
and physical health outcomes, including substance use, HIV/STD risk behavior, and 
treatment adherence.

o  Conduct social network analyses in rural settings that enhance prevention of 
HIV/STD transmission, particularly among isolated communities with low HIV/STD risk 
perceptions.

3) Demand and Need for Care

Research is needed to identify factors that predict why some individuals recognize 
and accept the need for mental health care and/or drug abuse treatment and enter 
appropriate treatment.  Metropolitan and non-metropolitan persons with psychiatric 
and drug abuse disorders have been reported as having comparable entry rates into 
care, though both populations have relatively low rates of entry into care.  Some 
investigators have reported that rural residents are less likely than urban 
individuals to enter care, but these findings are difficult to interpret because 
they do not control for need.  There is evidence that individuals in rural 
communities are more likely than their urban counterparts to use primary care 
providers, particularly if they are poor, a member of racial and ethnic groups, 
children, the elderly, individuals with substance abuse problems, or the severely 
mentally ill.  Investigators are encouraged to:

o  Analyze how the following factors impact perceived access, need, and demand for 
care by rural at-risk individuals in high-risk communities:  stigma, perceived 
service availability, accessibility, affordability, perceived communication, and 
cultural sensitivity of providers and social networks.

o  Test the effectiveness of interventions designed to heighten awareness of need 
for care, and the effectiveness of evidenced-based treatment, such as direct 
marketing and social network interventions.

o  Design research to study mechanisms that enhance and impede the dissemination 
and translation of research findings on mental health and drug abuse services into 
rural communities.

o  Analyze how health interventions designed for, and shown efficacious in, urban 
settings address the prevention needs of rural and small city populations.

o  Incorporate risk screening and prevention counseling into routine clinical care, 
STD clinics, substance abuse treatment, prenatal care or other medical settings, 
and study the feasibility, utilization, efficacy, and effectiveness of these health 
promotion interventions for rural populations.

4) Socio-cultural Beliefs About Mental Illness and Disparities in Use of Mental 
Health Services

Rural and frontier communities are no longer viewed as being homogeneous, as more 
individuals from various racial and ethnic groups migrate to rural communities.  
Addressing these demographic changes is crucial to the delivery of effective health 
care.  Research evidence suggests that cultural beliefs and values may shape one’s 
definitions of mental illness and drug abuse and influence one’s decision to seek 
formal or informal care and complete care.  For example, studies have found that 
depressed and suicidal farmers are often reluctant to seek help because of their 
strongly-held values of self-reliance and concerns about confidentiality.  Other 
studies suggest that members of ethnic and racial groups often may not seek care 
for mental illness or drug abuse due to distrust of outsiders, discrimination, 
religion, or a sense of fatalism.  Investigators are encouraged to:

o  Study community readiness to identify and address mental health, health risk, 
and drug abuse problems; and care needs; and to  develop appropriate responses and 
deliver effective interventions.

o  Analyze various community partnership processes required to identify mental 
illness, drug abuse, and related health problems and develop appropriate responses 
leading to the delivery of effective interventions and outcomes of care.

o  Analyze the socio-cultural factors that predict use of mental health and drug 
abuse services in rural areas, including the distribution of these factors across 
racial/ethnic groups.

o  Study the socio-cultural beliefs about mental illness, drug abuse, and treatment 
that influence how people of various racial and ethnic groups seek care; the 
cultural beliefs practitioners bring to the clinical encounter; and how these 
beliefs affect clients’ decisions to use or continue treatment.

o  Develop research to test interventions that improve the quality and outcomes of 
mental health services in culturally diverse populations.

o  Analyze factors that influence the efficacy of treatment and prevention 
interventions within a specific racial or ethnic group, and the adaptability of 
successful interventions to other racial or ethnic groups and geographical areas.

o  Design research to study the impact of severe psychological trauma on different 
subpopulations in the rural U.S., especially racial and ethnic groups, including 
how, if at all, trauma affects drug use and abuse, treatment seeking behavior, and 
retention in treatment.

o  Study the impact of social and community norms on the effectiveness of 
prevention programs that target socially sensitive health risk behaviors.

o  Design research to study the prevention needs of seasonal migrant populations, 
who may experience acute isolation, lack of access to mental health care, and 
considerable social, economic, and language barriers affecting mental health care 
utilization and public health in rural settings.

5) Access to and Quality of Care  

Investigators have raised questions about whether specific aspects of “rural” life 
contribute to differences in access to and quality of mental health care and 
substance abuse treatment among rural communities and between rural and urban 
communities.  An alternative view is that larger societal and structural factors 
are responsible for differences in access to and quality of services in rural and 
frontier areas.  This remains an open question, so investigators are encouraged to:

o  Study the extent to which successful urban and rural interventions for mental 
health and drug abuse problems have been implemented successfully in diverse rural 
and frontier communities, and how successful urban/rural interventions can be 
modified to work most effectively in rural and frontier settings.

o  Design research to analyze initiatives to improve the quality and outcomes of 
care for persons with co-morbid psychiatric and drug abuse disorders.
 
o  Design research to study the type, quality, accessibility, and availability of 
preventive interventions in rural and frontier communities.

o  Test the effectiveness of family, school, and community programs in addressing 
prevention in rural settings.

o  Study the extent to which “rural” or “frontier” status increases the effect of 
known barriers to care in these communities.  For example, are the poor, elderly, 
children, homeless, or racial and ethnic populations in rural communities less 
likely to have access to treatment, or are less likely to demand, enter, and remain 
in care than their urban counterparts?

o  Compare the quality of care delivered in rural and urban communities and 
determine factors associated with discrepancies in quality, such as clinicians who 
may not be providing evidence-based care, individuals who choose not to enter care, 
or to a combination of other local, regional, or national factors.

o  Analyze the frequency of use and outcomes of alternative or nontraditional care 
(e.g., faith-based care) for mental disorders and drug-abuse addiction in rural 
communities.

o  Study how to maintain client confidentiality in rural service delivery and 
research, including:

1.  Studying the most effective ways to overcome stigma as a means of helping 
individuals enter and remain in care until treatment is completed, 

2.  Analyzing the relation between organizational characteristics (structural and 
cultural) and the provision of confidential services to rural patients, and

3.  Analyzing the relation between organizational and culture issues and the 
management of care-giving systems and patient utilization of services.

o  Study the contextual supports necessary to promote compliance with
treatment regimens for severely mentally ill (SMI) and drug addicted patients, 
particularly when they are discharged from care centers that are a great distance 
from their community and when they live in communities where little or no follow-up 
care is available.

o  Define the cultural components of care needed to sustain recovery in the local 
community, and study interventions that deliver these components to determine their 
impact on subsequent hospitalization rates for rural SMI and drug addicted clients.

o  Study whether telecommunication technologies can be cost-effectively used to 
increase access toand  availability of and quality care for rural SMI and drug-
addicted clients.

o  Design research to determine if the barriers to disseminating evidence-based 
care models for SMI and drug-addicted clients in rural areas are related to 
provider, patient, community factors, or a combination of these factors.  [For 
further discussion of this issue see:  Research on Community Reintegration for 
People with Psychiatric Disabilities – PA-03-144].

6) Suicide in Rural and Frontier Areas

Higher rates of suicide are found in rural versus urban areas.  Also, states vary 
by region, with Western mountain states having the highest rates of suicide in the 
nation.  Investigators are encouraged to:

o  Study why rates of suicide are greatest in selected rural states and 
communities.

o  Analyze risk and protective factors that explain rural-urban and intra-rural 
differences in suicide rates, such as psychological and cultural issues, biological 
and genetic characteristics, access to care by mental health and addictions 
specialists, etc.

o  Design research to test interventions that address modifiable factors related to 
suicide risk.  [For further discussion of this issue see:  Research on the 
Reduction and Prevention of Suicidality – PA-03-161].

o  Study the efficacy of interventions to identify and intervene with socially 
isolated, rural residents who experience frequent or serious suicidal ideation, 
particularly among those living with HIV or other health/mental health conditions 
that lead to increased life stress.

7) Economics of Mental Health Care and Drug Abuse Service

It is important to determine the impact of different costs and financing models on 
service delivery in rural and frontier communities.  The health care plans for 
mental health and drug abuse services and the service systems that provide care to 
rural populations differ from plans and service systems for urban populations.  
Rural and frontier populations are less likely to have managed care, and there is a 
lack of mental health and addiction specialists to provide these specialized 
services.  Studies are sought on the economics of mental health and drug abuse 
services for treatment and prevention, especially for research on alternative 
payment systems, public and private financing systems, and the design of insurance.  
Investigators are encouraged to:

o  Study the financing of mental health and drug abuse treatment and prevention 
services in rural and frontier communities, including whether carve-outs 
differentially affect entry into care or the quality of care in rural areas.

o  Analyze alternative delivery systems and managed care practices in rural and 
frontier communities.

o  Conduct cost-benefit, cost-effectiveness, and cost-utility analyses to examine 
the costs and production of mental health and drug abuse treatment and prevention 
services.  [More information on NIDA’s program of research on the economics of drug 
abuse prevention or treatment is available in PA-01-013.] 

o  Compare managed health care plans and services for mental health and drug abuse 
problems in rural versus urban areas.

o  Analyze how, if at all, rural/urban differences in credentialing, selective 
contracting, and risk sharing, moderate the impact of managed health care services 
for mental health and drug abuse problems.

8) Use of Technological Innovations In the Diagnosis and Delivery of Care 

Rural advocates suggest that the use of telecommunications technology may offer an 
opportunity to overcome many barriers to service delivery and to enhance the 
quality of care provided to underserved rural and frontier populations.  However, 
until there is evidence that services can be effectively delivered via 
telemedicine, third party payers are unlikely to reimburse for such services.  
Investigators are encouraged to:

o  Study the extent to which telecommunications are used in the delivery of mental 
health care and drug abuse treatment in rural and frontier communities, and study  
barriers that exist to implementing this technology.

o  Study whether individuals with various mental/drug abuse disorders can be 
effectively diagnosed and treated via telemedicine.

o  Design research to study whether certain mental and drug abuse disorders are 
more amenable to effective diagnosis and treatment face-to-face versus long 
distance, including whether the type of or severity of mental disorders or drug 
abuse problems influences the effectiveness of long distance treatment.

9) Primary Care and Mental Health/Drug Abuse Services

Up to 80% of the mental health care in rural communities is delivered by primary 
care physicians, social workers, and psychiatric nurses.  Availability of and 
access to mental health and drug addiction specialists remains a serious problem in 
many places.  Several questions have been raised about the effects of provider 
distribution on the quality and outcomes of care.  Studies of primary care 
providers and mental health/drug abuse treatment are needed to understand several 
issues.  Thus, investigators are encouraged to:

o  Study whether rural primary care providers are adequately trained to deliver 
high quality and effective mental health care and drug abuse treatment services to 
a range of client populations.  Can primary care providers be trained to use mental 
health and drug addiction guidelines for treating various disorders?

o  Study whether primary care providers are adequately trained to deliver 
culturally appropriate care to the increasing number of minority groups moving to 
rural areas.

o  Study what non-mental health and non-addictions specialists in rural communities 
can do to increase effective diagnosis and treatment of individuals with mental 
disorders and drug abuse problems.

10) Juvenile and Adult Justice and Mental Health/Drug Abuse Care

Rural communities are often called upon to respond to mental health and substance 
needs of offenders identified through the criminal justice system.  In addition to 
managing the mental health and substance abuse issues of offenders initially 
entering the juvenile and adult criminal justice systems, rural areas increasingly 
need to address the treatment and service needs of offenders returning to their 
communities following incarceration.  Studies are needed to identify, develop, and 
test other more effective therapeutic strategies for responding to persons in the 
justice sytem with mental illness and drug addiction problems who live in these 
remote areas.  Investigators are encouraged to:

o  Conduct research to understand the mental health/drug abuse treatment currently 
being delivered to mentally ill/substance abusing offenders in rural communities, 
and how this treatment is linked or coordinated with criminal justice requirements.

o  Design research to study how rural organizations or agencies dealing with 
mentally ill/substance abusers can improve their interactions to achieve better 
public health, public safety, and individual outcomes.

o  Analyze the role the criminal justice system plays in the delivery and financing 
of mental health/drug abuse services in rural areas.

MECHANISM(S) OF SUPPORT

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 project.  
The objective of the R01 is to support a discrete, specified project.  The 
objective of the R21 is to encourage applications from individuals who are 
interested in testing innovative or conceptually creative ideas that are 
scientifically sound and may advance our understanding of how to more effectively 
deliver high quality services to underserved rural and frontier populations.

Exploratory/developmental grants (R21) are limited to 2 years of support with a 
combined budget for direct costs of up to $275,000 for the two-year period.  
Normally, no more that $200,000 may be requested in any single year.  Information 
on the Exploratory/Development (R21) grant is available at:  
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). 
Information on the Small Grant (R03) is available at:  
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html

Investigators might also want to consider relevant Institute-specific mechanisms, 
such as the NIMH R34 mechanism for exploratory interventions and services research 
grants “From Intervention Development to Services:  Exploratory Research Grants”, 
PAR-03-078, which is located at
http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html.  
Competing supplements to existing descriptive studies of risk and 
resilience factors in rural areas can also be used.  Secondary analyses of existing 
data have been successfully used to determine the incidence and prevalence of 
disorders in rural versus urban areas.

This PA uses just-in-time concepts.  It also uses the modular budgeting format.  
(See http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 or 
less, use the modular budget format.  This program does not require cost sharing as 
defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

ELIGIBLE INSTITUTIONS

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

o  For-profit or non-profit institution
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 institutions/organizations
o  Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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 programs.

WHERE TO SEND YOUR INQUIRIES

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:

Anthony Pollitt, Ph.D.
Office of Rural Mental Health Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7130
Bethesda, MD 20852
Telephone:  (301) 443-4525
FAX:  (301) 443-4045
Email:  apollitt@mail.nih.gov

Beverly Pringle, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4222
Bethesda, MD 20892
Telephone:  (301) 443-4060
FAX:  (301) 443-6815
Email:  bpringle@mail.nih.gov

Carmen Moten, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146
Bethesda, MD  20892
Telephone:  (301) 443-3725
FAX:  (301) 443-4045 
Email:  cmoten@mail.nih.gov

Andrew Forsyth, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6201
Bethesda, MD  20892
Telephone:  (301) 443-8403
FAX: (301) 443-9719
Email:  aforsyth@mail.nih.gov 

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
Bethesda, MD  20892
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  knipplej@mail.nih.gov

Catherine Mills
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  cm108w@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS research grant application instructions 
and forms (rev. 5/2001).  Applications must have a Dun and Bradstreet (D&B) Data 
Universal Numbering System number as the Universal Identifier when applying for 
Federal grants or cooperative agreements.  The DUNS number can be obtained by 
calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/.  
The DUNS number should be entered on line 11 of the face page of the PHS 398 form.  
The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, Telephone (301) 
435-0714, Email:  GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at http://grants.nih.gov/grants/dates.htm.  Application deadlines are 
also indicated in the PHS 398 applications kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a modular 
budget grant format.  The modular budget 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 
http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
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 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 person 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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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

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)

APPLICATIONS PROCESSING:  Applications must be mailed on or before the receipt 
dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.  
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 unfunded version of an application already reviewed, but 
such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established PHS 
referral guidelines.  Appropriate scientific review groups convened in accordance 
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) 
will evaluate applications for scientific and technical merit.

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

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 written critique
o  Receive a second level review by the appropriate national advisory council 

REVIEW CRITERIA

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 evaluate the application in order to judge the 
likelihood that the proposed research will have a substantial impact on the pursuit 
of these goals.  The scientific review group will address and consider each of the 
following criteria in assigning the application’s overall score, weighting them as 
appropriate for each application.

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The 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.

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 the field?

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 tactics?

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?

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)?

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, the following items 
will 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 criteria included in the section on Federal 
Citations, below).  http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of plane to 
include subjects from both genders, all racial and ethnic groups (and subgroups), 
and children 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 Inclusion Criteria in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001 will be assessed.

ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs in 
any year of the proposed research are expected to include a data-sharing plan in 
their application.  The reasonableness of the data sharing plan or the rationale 
for reviewers will not factor the proposed data-sharing plan into the determination 
of scientific merit or priority score.

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

AWARD CRITERIA

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

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) 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).  The establishment of data and safety monitoring boards (DSMBs) 
is required for multi-site clinical trials involving interventions that entail 
potential risk to the participants.  (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:  
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or more in 
direct costs in any single year are expected to include a plan for data sharing or 
state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing/).  
Investigators should seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and Federal laws 
and regulations, including the Privacy Rule.  Reviewers will consider the data-
sharing plan but will not factor the plan into the determination of the scientific 
merit or the priority score.

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 – Amended, 
October 2001,” published in the NIH Guide for Grants and Contracts on October 9, 
2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are 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 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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  The 
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 
http://grants.nih.gov/grants/funding/children/children.htm.

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 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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry 
will be eligible for Federal funding (see http://escr.nih.gov).  It is the 
responsibility of the applicant to provide, in the project description and 
elsewhere in the application as appropriate, 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 review.

PUBLIC 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 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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) 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 DHHS Office for Civil Rights (OCR).  Those who 
must comply with the Privacy Rule (classified under the Rule as “covered entities”) 
must do so by April 14, 2003  (with the exception of small health plans which have 
an extra year to comply).

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.  Unless 
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be 
used to provide information necessary to the review because 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 http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 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 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 NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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