RESEARCH ON THE REDUCTION AND PREVENTION OF SUICIDALITY

RELEASE DATE:  August 7, 2003

PA NUMBER:  PA-03-161

Updates:
June 2, 2006 - The R01 portion of this PA has been reissued as PA-06-438 as 
of June 2, 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, R21 and R34 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03, R21 and R34 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: June 2, 2006

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242, 93.279, 93.891, 
93.866, 93.393

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  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

The National Institute of Mental Health (NIMH), National Institute on Alcohol 
Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), National 
Cancer Institute, and the National Institute on Aging invite grant applications 
for research that will reduce the burden of suicidality (deaths, attempts, and 
ideation).  While NIMH has a long-standing commitment to studying the mental 
health-related factors contributing to suicide risk, NIDA, NIAAA, NCI, and NIA 
supported research in suicidality is growing and has provided a broader 
perspective on the range of risk and protective factors.  For this PA, mental 
disorders, along with alcohol use disorders (AUDs) and substance use disorders 
(SUDs) and their respective trajectories, are of particular interest as they 
pertain to risk and protective factors and treatment efficacy and effectiveness 
for suicidality.  The intent of the program announcement is to intensify 
investigator-initiated research on this topic, to attract new investigators to 
the field, and increase interdisciplinary approaches to developing effective 
strategies to reduce suicidality.

RESEARCH OBJECTIVES

Background

In 2000, 29,350 persons died by suicide in the United States.  Suicide deaths 
outnumbered homicide deaths by 5 to 3.  Suicide was the third leading cause of 
death for 10-24 year olds, and the eighth leading cause of death for males.  
Vital statistics indicate that suicide rates vary dramatically by demographic 
characteristics.  Males die by suicide more frequently than females by a ratio 
of 4 to 1.  Older white males have the highest suicide rate, followed by young 
American Indian and Native Alaska males.  In contrast, older African American 
females have one of the lowest rates.  Married persons have lower rates than 
unmarried persons.  Rural suicide rates exceed those in urban areas, and state 
rates vary by region, with Western mountain states having the highest suicide 
rates in the Nation.

The health conditions most consistently associated with suicide are mental 
illness, SUDs and AUDs, affecting up to 90% of all people who die by suicide.  
The lifetime risk for suicide death among alcohol-dependent individuals has 
been estimated to be 7 to 10%, and among persons with affective disorders, 2 
to 7%.  Family history of suicide, an individual's prior history of suicide 
attempts and serious ideation are also significantly associated with subsequent 
suicide death.  Despite these strong associations, only a small proportion of 
persons with these disorders and family history die by suicide, raising 
important questions regarding what protective factors operate among persons with 
multiple risk factors.  Most medical illnesses are not associated with an 
increased risk for suicide.  However, individuals diagnosed with HIV/AIDS, 
multiple sclerosis, brain cancers have been found to have increased risk for 
suicide.  Patients with cancers who also have depression, unrelieved pain, and 
deteriorating functional ability, have been reported to have higher rates of 
suicide ideation.

Suicide attempts and serious suicide ideation (e.g., thoughts that include suicide 
plans), each more frequent than suicide deaths, also carry a substantial 
health burden.  For the year 2000, estimates of the number of persons treated 
annually for self-inflicted injuries, most of which are suicide attempts, range 
from 264,000 to 864,000.  Another estimated 50 percent of persons who attempt 
suicide do not seek treatment.  In addition to the burden from physical harm 
consequent to the behavior, suicide attempts are associated with an increase in 
the risk of later suicide death by 40-fold.  Persons with mental disorders, SUDs 
and AUDs have increased risk for suicide attempts.  Intentional overdose with 
drugs of abuse or prescription drugs is a common method of suicide attempt, 
particularly among women.  Persons with AUD and a history of an attempt have a 
greater than 20-fold increased risk for subsequent suicide death.  Among 
alcohol-dependent individuals, those with a history of suicide attempts are more 
often female, younger, currently unemployed, separated or divorced, and have 
fewer years of education.  Serious suicide ideation is more frequent among 
youth than adults, and is associated with other high-risk behaviors.  Annual 
surveys indicate that 1 in 5 high school students report suicide ideation in 
the past year.

There have been substantial strides in our understanding of suicide risk 
factors, and early progress in clinical trials focused on reducing suicidal 
behaviors per se.  Research in this area has been invigorated further by the 
recognition that suicidality, with its related mortality and morbidity, 
represents a significant, and usually preventable loss of human life.  A number 
of recent federal, national and international reports have proposed a public 
health framework from which to develop strategies to reduce known risk factors 
and increase protective factors.  The reports include those from the World 
Health Organization 
(http://www5.who.int/violence_injury_prevention/main.cfm?p=0000000117), 
the National Strategy for Suicide Prevention 
(http://www.mentalhealth.org/suicideprevention/default.asp), a recent 
IOM report (http://www.nap.edu/books/0309083214/html/), 
and various Surgeon General's Reports on suicide 
(http://www.surgeongeneral.gov/library/calltoaction/default.htm) and 
mental health (http://www.surgeongeneral.gov/library/mentalhealth/home.html
and http://www.surgeongeneral.gov/library/mentalhealth/cre/).
This program announcement highlights areas of research that can facilitate the 
development, implementation, and/or testing of interventions that show promise 
of preventing and reducing suicidality.

Areas of Research Opportunities

Investigators are advised to carefully consider definitions of suicidality 
(see O'Carroll, et al. (1996), Beyond the Tower of Babel: A Nomenclature for 
Suicidology, Suicide & Life-Threatening Behavior, 26 (3), 237-252) and 
approaches to measurement (see http://www.nimh.nih.gov/research/measures.pdf 
and http://www.nimh.nih.gov/research/adultsuicide.pdf), 
theoretical models of distal and proximal risk and protective factors, and 
models of behavioral and social change that have implications for reducing 
suicide risk.

a.  Risk and Protective Factors

Psychological and Cultural Factors.  Much has been learned about suicidality and 
associated psychological risk factors including hopelessness, shame, and the 
significance of stressful life events such as physical, psychological and sexual 
abuse, and interpersonal and financial losses.  Less understood are other risk 
and protective factors and their interactions, such as:

o  Individually perceived protective factors (e.g., reasons for living) in the 
context of known risk factors, such as a history of sexual abuse, or a severe 
and recurring mental disorder, AUD and SUD 

o  Trait or state dimensions, such as impulsivity or impaired executive 
functioning, that increase risk

o  The role of cultural factors and acculturative processes that can modify risk 
and its perception as well as influencing protective factors (e.g., 
religiousity)

o  The effects on trajectories of comorbid mental disorders, SUDs and AUDs and 
how those interface with suicidality 

Biological and Genetic Factors.  Various serotonin receptor and noradrenergic 
system abnormalities have been linked to suicide death and attempts.  There are 
estimates that the heritability of liability to suicidal behavior ranges from 
30-50 percent, and this high loading is likely due to the potential 
contributions of multiple genes, in addition to shared family environments that 
include living with mental disorders and stressful life events.  Research 
efforts to partition suicide risk to various genetic and neurotransmitter 
abnormalities have been limited by the short supply of characterized populations 
at high risk for suicide, as well as the low availability of autopsied brains 
of suicide victims.  Studies of biological and genetic factors include:

o  Genetic samples from characterized populations at high risk for suicide that 
are reliable phenotypes (e.g., persons with suicide attempt histories) should be 
further studied for genetic analyses.  Existing twin registries of mental 
disorders, SUDs and/or AUDs could be used to explore phenotypic reliability and 
gene/environment interactions.

o  Additional research to elucidate the neurobiological basis of suicide and 
suicidal behavior through cellular, neurochemical, and molecular studies.  
Examples include neuroimaging studies elucidating brain changes in treatment 
trials; postmortem brain analysis and human neuroimaging.

o  Determination of the biological and behavioral overlaps of mental disorders, 
AUDs and SUDs with regard to suicide risk.  Do these conditions share similar 
neuronal circuit pathways? Do they interact in ways that cause an increase in 
severity of one or both conditions?

o  Studies using animal models to examine state/trait dimensions of impulsivity 
with in vivo techniques; examining developmental trajectories of animals with 
gene knockouts related to putative risk or protective factors

b.  Clinical Trials

The established efficacy of most treatments for mental disorders is based on 
data from individuals at low risk for suicidal behavior.  With the exception of 
the newly approved clozapine indication for reduction of suicidality among 
persons with schizophrenia, no psychotropic medications have been tested to 
determine whether they are effective in reducing suicidality in randomized 
trials.  Almost 40% of treatment-seeking AUD patients report a history of 
attempting suicide.  Several psychosocial and behavioral interventions targeting 
suicidality, provided in consort with treatments for mental disorders and SUDs, 
are showing promise.  Sample topics include:

o  Improved measures of suicidality are needed to gauge the effectiveness of 
current treatments for mental disorders, AUDs and SUDs, and treatments under 
development for reducing suicidality, both in regard to immediate and long-term 
outcomes.  Measures with cross-cultural acceptability and appropriateness are a 
priority.

o  Efforts to identify factors influencing clinical efficacy of medications 
using human laboratory behavioral pharmacology paradigms are needed.  Prior to 
beginning phase 2 clinical trials, potential medications can be screened in the 
laboratory to determine the following: 1) the medication's impact to reduce 
craving and/or to diminish the negative symptoms of alcoholism; 2) likelihood 
of adverse events and/or suicide ideation, especially in the presence of SSRIs 
and alcohol; 3) pharmacokinetics for medication combinations; and 4) optimal 
dosing regimens.  Studies are sought which develop and expand use of these 
human laboratory paradigms.

o  Studies to identify possible interactions of medications to treat suicidality 
among AUD and mental illness as well as interactions with alcohol are needed to 
determine what is safe, effective treatment.  Pharmacokinetic studies might also 
be appropriate.

o  Trials to test the efficacy of innovative treatments for persons at high risk 
for suicidal behavior, in combination with established treatments for persons 
with mental disorders, SUDS and AUDs with high suicidality risk are needed.  
Determining whether treatment for SUDs and AUDs, such as psychosocial and 
behavioral treatments (e.g., "12 step" programs), reduces suicide risk, remains 
to be explored.

o  Efforts to evaluate the efficacy of established and novel pharmacological 
agents for AUD and SUD patients with comorbid psychiatric disorders are needed.  
Appropriate combination and sequencing of pharmacological, behavioral and 
psychosocial therapies need to be explored for patients suffering from 
suicidality and two or more concurrent disorders.

o  Innovative trials of suicide prevention and suicide related conditions (e.g., 
SUD and AUD) as part of multi-faceted service delivery approaches, such as 
short-term hospitalization or intensive day treatment in the public or private 
sectors are needed.

o  Trials are needed to test the efficacy of treatment approaches among 
understudied and/or vulnerable groups that experience suicidality, who have 
special needs or complex symptomatology or circumstances.  These include 
pregnant and postpartum women; ethnic minorities and immigrant groups; rural 
populations; incarcerated youth; older adults with physical illness; and persons 
with multiple comorbid disorders (e.g., PTSD, AUD, SUD, depression).

o  Identifying the mechanisms of action of effective interventions for persons 
with suicidality and associated disorders (mental illness, AUDs, SUDs) in order 
to facilitate the eventual dissemination of evidence-based interventions are 
needed.

o  Further development of techniques for the engagement, retention, and 
adherence of comorbid patients in treatment (e.g., motivational interviewing, 
contingency management) as they may need to be adapted to address specific 
patterns of comorbidity and suicidality.

c.  Multi-level Prevention Approaches

The IOM report, Reducing Suicide, highlighted the particular challenges in 
assessing population-based prevention approaches due to the relatively low base 
rate of suicide deaths, and the limited prevalence data on suicide attempts and 
ideations.  However, it also highlighted the opportunities to examine whether 
the substantial number of preventive interventions that have proved successful 
in reducing early substance use, drinking and driving, binge drinking, and 
aggression, also reduce suicidality.  These intervention approaches are 
developmentally specific and wide-ranging; involving parents, extended families, 
health professionals, schools, worksites and employee assistance programs, and 
community agencies and task forces.  Including suicidality outcomes in these 
preventive intervention investments would be an efficient means of testing the 
potential power of these approaches in reducing suicide risk.  Similarly, 
suicidality prevention and treatment interventions for youth may also confer 
some protection from involvement with alcohol and other substances.  Other 
preventive intervention opportunities include:

o  Assessing the efficiency of prevention of early comorbid patterns; For 
example, does prevention of anxiety reduce the risk for depression and substance 
use, as well as suicidality?

o  Community-level and policy interventions, such as those to reduce underage 
drinking, alcohol-related community problems and other unwanted behaviors, can 
be evaluated for their potential effects on suicidality.  Examples include 
evaluations of efforts to reduce commercial availability of alcohol to youth 
under age 21, increased enforcement of driving under the influence (DUI) laws, 
changes in laws and enforcement regarding antisocial behavior, and public 
education efforts to improve health and safety.

o  Some policy changes may occur that are not necessarily instituted for the 
purpose of reducing population risk, but may have unanticipated effects 
relevant to suicide.  These policies may provide opportunities to conduct 
"natural experiment" studies.  Such research may involve prospective 
longitudinal studies of intervention and control sites, comparisons across 
communities, or use of archival data.

o  Where risk of suicide is excessively high in particular communities (e.g., 
some American Indian tribes), it may be appropriate to approach the problem 
simultaneously at universal, selective, and indicated levels.  Interventions 
could be adapted to subpopulations within the community according to their 
relative risk and the intensity of their interactions with vulnerable 
individuals (e.g., such an approach is being used to address the problem of 
Fetal Alcohol Syndrome [FAS] among American Indian tribes).

o  School-based suicide preventive interventions have included awareness 
training, screening, skills-building, and social support-building for students, 
and gatekeeper and post-intervention training for school staff, but few have 
been well specified or evaluated for efficacy or safety.  Although a number of 
popular programs are assumed to be useful, the costs and benefits of such 
existing programs need more systematic evaluations.  Refinement of existing 
programs, as well as tests of new theory-driven interventions, are also needed.

o  Prevention approaches that carefully consider cultural expectations and 
assumptions about suicidality when addressing both known higher risk (gay, 
lesbian, transgendered and bisexually active youth) and lower risk youth 
(African Americans) are needed to better match the needs of certain subgroups 
of youth, as well as avoid untoward intervention effects.

d.  Services Research

Due to the lack of empirically-based assessment and treatment approaches to 
reducing suicidality, there are few practice guidelines to implement in order 
to improve the quality of care provided in emergency, specialty, or primary care 
sectors.  Alternatively, there may be helpful practice policies that are not 
adequately implemented, while other policies may unintentionally limit efforts 
to provide better care.  Topics include:

o  Tests of emergency care approaches to adequately assess, treat, and 
facilitate follow-up care of suicide attempters are needed.

o  Research within settings where high-risk populations can be found are also a 
priority, such as juvenile detention, unemployment offices, farm credit offices, 
home health care, and youth and women's shelters.  Investigators are encouraged 
to identify emotional states or conditions most associated with suicidality, 
including loss of self-worth, perceived loss of desired level of functioning, 
hopelessness, and depression.  Investigators are encouraged to draw from the 
behavioral science literatures on identity, self-esteem, culture, and emotion 
dysregulation.

o  Research is needed to improve the quality of:  suicidality assessment, 
referral, treatment and management, and consequent system changes for specific 
settings that reach large segments of the population, such as schools, primary 
care, the criminal justice system, and the workplace.

o  Information on the effectiveness of screening for suicidality in primary care 
in reducing suicide risk, and information on the possible costs of such efforts, 
or unintended harms, is needed.

o  Because few males access traditional sites of care prior to suicide death, 
tests of acceptable outreach and referral practices through non-health care 
settings (e.g., unemployment offices, workplace, DWI court, agricultural loan 
offices) are needed.

o  Many states have initiated their own suicide prevention plans, most of which 
involve multiple sectors (education, mental health, law enforcement).  There is 
a critical need to develop evaluation strategies to assess the safety and 
effectiveness of these efforts, in collaboration with suicide prevention and 
SUD, AUD and mental illness services advocates, and state officials.

e.  Contagion, Media Campaigns, and Health Education

Public health approaches have used mass-media campaigns to varying success to 
reduce smoking, alcohol and other substance use, but few evaluation efforts have 
been implemented to test campaigns to reduce suicide.  Evidence of suicide 
contagion from media coverage of youth suicide deaths has been one reason for 
concern in mounting broad campaigns.  If the National Strategy for Suicide 
Prevention is to be adequately implemented, safe approaches to building 
awareness in the public about suicide and its risk factors must be developed.

o  Further research on methods of disseminating information and messages related 
to suicidality (e.g., stories about celebrity decedents; descriptions of types 
of suicide methods; descriptions of mental illness, AUD/SUD as risk factors) for 
various subgroups (youth at risk; parents of youth not at risk; adult men; 
alcohol abusers) is needed, specifically to understand the risks of untoward 
effects (e.g., possible suicide contagion).  Research by multi-disciplinary 
groups (social psychology, marketing, health education) is considered essential. 
(See addendum to related PA-02-131, "Dissemination and Implementation Research 
in Mental Health," 
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-009.html)

o  Due to the "triple stigma" around suicidality, mental illness, and AUDs and 
SUDs, safe and innovative education and referral efforts are needed to reach 
persons least likely to seek help (e.g., white males; traditionally underserved 
populations skeptical about mental health or SUD treatment).  In addition, 
research on the effectiveness of alternative methods of education and referral 
efforts, such as faith-based or other community organizations, is needed.

o  Research on the inclusion of information on suicidality within ongoing 
dissemination efforts for related mental illnesses (e.g., depression, bipolar 
illness) or harm reduction campaigns for AUDs and SUDs by industry, nonprofit, 
and federal efforts, is encouraged.

f.  Ethical and Safety Issues  

o  The study of the competency of individuals at high risk for suicidal behavior 
to participate in research is needed.  Various approaches to addressing 
questionable competency (e.g., advance directives) need to be evaluated.

o  Potentially unique issues to suicide research, such as whether repeated 
assessment of suicidality increases risk, needs to be determined for various 
subgroups (e.g., youth) and contexts (schools, primary care) for screening and 
intervention research.

o  Development and evaluation of risk management strategies that could be 
incorporated into intervention trials in order to optimize the inclusion of 
persons at high risk for suicidality is needed.

o  Innovative research on the ethics and safety of mass-media public service 
campaigns, specifically around determining, and minimizing unintended negative 
consequences of these campaigns, is encouraged.

Other institutes and agencies with relevant resources and related interests:

The Substance Abuse and Mental Health Services Administration (SAMHSA) Office of 
Applied Studies supports surveys assessing prevalence of suicidality and related 
risk factors (see http://www.drugabusestatistics.samhsa.gov/).  
SAMHSA's Center for Mental Health Services supports the National Suicide 
Prevention Resource Center (see: http://www.sprc.org), 
the National Suicide Strategy Indicators project (see http://www.nsspi.org) 
as well as demonstration programs in the prevention and treatment of mental and 
substance abuse disorders, including suicide prevention.  Demonstration funding 
opportunities can be found at http://www.samhsa.gov/.

The Centers for Disease Control and Prevention's (CDC) National Center for 
Injury Prevention and Control (NCIPC), focuses on addressing the need for 
effective, population-based prevention and intervention strategies regarding 
self-directed violence.  NCIPC's activities fall into four categories: 
disseminating information about suicidal behavior and its prevention and 
supporting the implementation of proven programs and policies; applying 
scientific methods to evaluate the effectiveness of intervention and prevention 
programs; enhancing the knowledge base about risk and protective factors and 
the consequences of suicidal behavior; and continuing to improve methods for 
data collection in order to describe and track suicidal behaviors.  The NCIPC 
internet site is http://www.cdc.gov/injury.

The Indian Health Service (IHS) supports suicide prevention activities through 
consultation and technical assistance to tribes through 12 Area Offices.  
Additionally, IHS operates nine regional alcohol and substance abuse treatment 
centers for youth 12-18 years of age (see http://www.ihs.gov).  Reports 
on the prevalence of various markers of Indian health by region, including 
suicide mortality, are available at 
http://www.ihs.gov/publicinfo/publications/index.asp.

Health Resources and Services Administration supports suicide prevention 
activities through the Bureau of Primary Health Care, the HIV AIDS Bureau, 
Maternal and Child Health Bureau (MCHB), and Office of Rural Health Policy 
(see http://www.hrsa.gov). The MCHB provided 
funding for the Children's Safety Network that has developed youth suicide 
prevention activity inventories across various states (see 
http://www.childrenssafetynetwork.org/links/youthsp.asp)

MECHANISMS OF SUPPORT

This PA will use the NIH research project grant (R01), small grant (R03), and 
exploratory/developmental grant (R21, R34) award mechanisms.  As an applicant, 
you will be solely responsible for planning, directing, and executing the 
proposed project.  Ancillary studies to clinical trials (e.g., see 
http://grants.nih.gov/grants/guide/pa-files/PAR-00-095.html) 
and/or competing supplements to existing descriptive studies of risk and 
protective factors related to suicidality, can also be used.

The Small Grant (R03) provides 2 years of funding with a maximum of $50,000 
direct costs for each year.  Instructions for the R03 application can be found 
at (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).

The Exploratory/Developmental Grant (R21) provides 2 years of funding with a 
maximum of $275,000 direct costs over the entire budget period; with no 1 year 
exceeding $200,000.  Instructions for the R21 application may be found at:  
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.

The R34 mechanism provides up to $450,000 direct costs for 3 years with no one 
year exceeding $225,000 for research on 1) the development and/or pilot testing 
of new or adapted interventions, 2) pilot testing interventions with 
demonstrated efficacy in broader scale effectiveness trials, or 3) innovative 
services research directions that require preliminary testing or development.  
Instructions for R34 applications can be found at 
(http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html).

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 format.

ELIGIBLE INSTITUTIONS

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

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
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 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:

Jane L. Pearson, Ph.D.
Chair, Suicide Research Consortium
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-3598
FAX:  (301) 594-6784
Email:  jp36u@nih.gov

Lynda Erinoff, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD  20892-9589
Telephone:  (301) 402-1972
FAX:  (301) 480-2543
Email:  le30q@nih.gov

Charlene E. LeFauve, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505, MSC 7003
Bethesda, MD  20892-7003
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 402-9401
FAX:  (301) 443-8774
Email:  clefauve@NIAAA.nih.gov

Ann O'Mara, Ph.D., M.P.H., RN
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Room 2011, MSC 7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541 
FAX:  (301) 496-8667
Email:  omaraa@mail.nih.gov

Sidney M. Stahl, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Room 533, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
FAX:  (301) 402-0051
Email:  Sidney_Stahl@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, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  jk173r@nih.gov

Catherine Mills
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  cm108w@nih.gov

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD  20892-7003
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-2434
Email:  jsimons@niaaa.nih.gov

Jane Paull
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-2184
Email:  Jp97x@nih.gov

Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippl@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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.

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 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications requesting 
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 
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 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 
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 the checklist, and five signed 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)

APPLICATION 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 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.  An appropriate scientific review group 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  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 appropriate national advisory council 
or board.

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 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 
field?

(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 
tactics?

(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, 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).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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 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 CONSIDERATIONS

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.

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

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
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: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  
Investigators are also referred to 
http://www.nimh.nih.gov/research/highrisksuicide.cfm for safety 
and ethical issues specific to suicidality research.

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.

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 http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under the authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and under Federal Regulations 42 CFR 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


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)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.