DEVELOPING CENTERS ON INTERVENTIONS FOR THE PREVENTION OF SUICIDE (DCIPS)

RELEASE DATE:  August 6, 2003

RFA Number:  RFA-MH-04-003

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)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.242, 93.279, 93.273

LETTER OF INTENT RECEIPT DATE:  October 17, 2003
APPLICATION RECEIPT DATE:  November 18, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the RFA
o  Research Objectives
o  Mechanism(s) of Support
o  Funds Available
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 RFA

The National Institute of Mental Health (NIMH), the National Institute on Drug 
Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
encourages investigator-initiated research grant applications to establish 
Developing Research Centers on Interventions for the Prevention of Suicide 
(DCIPS).  The purpose of this initiative is to establish core support for 
building research infrastructure for the study of preventive and treatment 
interventions for suicidality (severe ideation, attempts, deaths) related to 
mental health, substance use disorders (SUDs) and alcohol use disorders (AUDs).  
This RFA provides a grant mechanism to support an early phase of infrastructure 
building to be utilized by qualified institutions with active research programs 
but without the existing capacity to mount the extensive and highly integrated 
research effort expected of an advanced center (e.g., Advanced Centers for 
Interventions and Services Research, PAR-01-089 
http://grants.nih.gov/grants/guide/pa-files/PAR-01-089.html).  
The intent of this RFA is to provide the initial 5-year infrastructure support 
needed to build an integrated program that could qualify for full or advanced 
center mechanisms that may be available from participating Institutes in the 
future.

RESEARCH OBJECTIVES

BACKGROUND

In 2000, 29,350 persons died by suicide in the United States.  Suicide deaths 
outnumber 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.  
Family history of suicide, and an individual's prior history of suicide attempts 
and serious suicidal ideation are also significantly associated with later 
suicide death.  However, despite the strong associations among suicide death and 
mental illness and SUDs and AUDs, only a small proportion of persons with these 
disorders actually die by suicide.

Suicide attempts and serious suicide ideation, 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 which 
are suicide attempts, ranges from 264,000 to 864,000.  About half the number of 
persons who attempt are estimated not to seek treatment.  Since they are not 
included in treatment-setting based surveillance estimates, these attempt rates 
may be underestimated by 50%.  In addition to the burden from physical harm 
consequent to the behavior, suicide attempts are associated with increased risk
of later suicide death by 40-fold.  Severe ideation has also been found to be 
associated with later suicide death, as well as significant morbidity.

In 2002, the IOM released the report, Reducing Suicide: A National Imperative 
(see http://www.nimh.nih.gov/research/suicideiom.cfm).  
Noting suicide's high mortality and morbidity rates, the report recommended 
increasing the research infrastructure for suicide studies through a center 
mechanism.  Infrastructure supporting tissue banks and registries, as well as 
community-based approaches to understanding social forces such as cultural risk 
and protective factors, were among the specific issues highlighted.  While much 
has been documented about suicide risk factors, particularly mental illness, 
SUDs and AUDs, there has been little rigorous evaluation of the effect of 
evidence-based or empirically-validated interventions on suicidality or suicide 
risk.  There is a small but growing area of intervention research that tests 
targeted treatments of suicidal behavior per se, but much more research is 
needed to determine efficacy of those approaches along with treatments for the 
common conditions that accompany suicidality.

The IOM report also highlighted the need for evaluation of current community and 
regional suicide prevention efforts.  Many schools, communities, tribes, and 
states have suicide prevention programs in place but lack resources or adequate 
expertise to evaluate their effectiveness.  The report noted that suicide 
victims were more likely to have sought treatment in primary care rather than 
in mental health, alcohol, or substance abuse treatment systems, raising the 
challenge for how best to improve detection and treatment of suicidality in 
primary care.  The IOM report highlighted how Centers can also provide further 
training opportunities to expand the number of researchers with expertise in 
all areas of suicide research.

AIMS

The prevention and intervention research that is needed to reduce morbidity 
related to suicidality as well as suicide deaths requires the adoption of novel 
methodological and organizational approaches, building of new partnerships, and, 
in general, enlargement of research activities beyond the traditional boundaries 
of academic settings and specific academic departments.  This RFA proposes to 
support an infrastructure mechanism to build capacity at qualified institutions 
to enable them to pursue a research agenda that contributes to effective suicide 
treatment and prevention.  The goal for these centers is to:  1) build networks 
to conduct intervention/prevention trials and/or evaluate community practice and 
service systems, 2) foster interdisciplinary collaboration, 3) develop new 
research methods, 4) develop, pilot and test novel treatments for suicidal 
behavior, with particular emphasis on interventions translated from basic 
science and/or neuroscience, and 5) cultivate training opportunities for new 
and established investigators.

PROGRAM SPECIFICATIONS

Grants awarded under this RFA will provide financial support for two types of 
activities:  (1) general development of research infrastructure and (2) funding 
of at least two specific "developing research projects."  All the activities 
will be under the overall direction and supervision of the Principal 
Investigator, who will function as director of the Developing Center.  The 
Principal Investigator should be an established independent intervention 
researcher in the area(s) of mental illness, SUDs and/or AUDs and will have a 
minimum time commitment of 30 percent to the Developing Center.  All 
applications must have an Operations Core, Methods Development Core, and 
Principal Research Core.

Development of Research Infrastructure

It is expected that the applicants will have current research activities at 
their institution and will explain how research on suicidality, mental 
disorders, SUDs and/or AUDs can be expanded and enhanced by the support 
requested under this RFA.  Particular emphasis should be given to how a Center 
would facilitate interdisciplinary collaboration that is not otherwise 
occurring, or is occurring only to a limited extent.  The application should 
describe how the Center will expand research training opportunities for junior 
investigators or established investigators willing to focus their efforts on 
suicide prevention research.  The direct support of training efforts (e.g., 
stipends), however, must be sought through other NIH training and career 
development grant mechanisms.

Operations Core

The DCIPS must have a clearly articulated Operations Core that should serve to 
integrate the scientific and infrastructure aims.  This core includes 
administrative functions, data management and statistical analysis, 
dissemination activities, intervention trials operations if appropriate, and any 
specialized interdisciplinary components.  The Operations Core should foster an 
environment of research excellence, support methodological innovation, 
facilitate multidisciplinary collaborations, coordinate efforts, and monitor 
progress according to an overall focused research agenda.  As appropriate, these 
efforts should include the engagement of community stakeholders, such as family 
members of those who have died by suicide, individuals with mental illness 
and/or SUDs and/or AUDs and their families, mental health and substance abuse 
treatment providers, medical care providers, hospital emergency departments, 
community organizations and institutions (e.g., schools, group homes, and 
extended care facilities), state, county or tribal officials, public and 
private purchasers of care, and insurers and managed care organizations.

The Operations Core should include a data management and statistical analysis 
component as well as an intervention trials operations component when relevant. 
These components may be located at a single institution or across multiple 
institutions.  Depending on the research focus, other specialized components 
might be included in the Operations Core (e.g., economics component).  
Applicants should describe efforts for recruitment and retention of research 
participants and data collection activities within this core.

The DCIPS may consist of several collaborating sites that are not all located 
in a single institution or geographic region.  The collaboration of multiple 
institutions and settings to create a "virtual center" must be specified and 
explained in the Operations Core section so the feasibility of such arrangements 
can be evaluated.

The Operations Core of the application should outline the scientific leadership 
for all anticipated research.  It should describe an administrative structure 
that maximizes efficiency through program planning and monitoring, an 
infrastructure development and maintenance plan, opportunities for investigators 
to do integrative work, and plans for accountability.  The Operations Core 
should also address knowledge and technology transfer if appropriate, and 
enhancing the availability of center accomplishments (e.g., data, methods, etc.) 
within and beyond the center.

Methods Development Core

Each application should describe a process for building a Methods Development 
Core.  The purpose of this core function is to support the initial testing and 
feasibility of innovative approaches to research design, assessment methods, 
recruitment strategies, and analytic approaches needed to advance suicide 
prevention and intervention and research.  For more specified and developed 
projects, applicants should seek funding through traditional mechanisms (R01, 
R21, R03).

There are a large number of potential areas of research methods investigation 
that could be included in this core.  The following are some examples of 
research areas that could fit in this core.  These are not meant to be 
comprehensive, nor are the examples meant to be exclusive of other topics.  
A center might:

o  develop and evaluate ways to adapt suicide prevention or suicide assessment 
and treatment protocols previously used in academic clinical settings for use in 
community settings (e.g., creating "community friendly" protocols that maintain 
potency, and are acceptable to community treatment providers, by modifying 
existing efficacious approaches);

o  develop and evaluate ways to measure and monitor suicidality and its possible 
precursors (e.g., agitation, anxiety, disinhibition, akathisia) as potential 
side effects related to interventions; develop and test other possible surrogate 
markers for suicidal crises; develop protocols that improve surveillance of 
serious suicidality side effects and rescue efforts;

o  apply research methods that integrate qualitative and quantitative methods 
into intervention development to address understudied populations with 
particular risk and protective factors (e.g., persons in rural areas, run-away 
youth);

o  develop new designs for conducting trials and statistical techniques to 
analyze data that address low base-rate outcomes;

o  develop methods for engagement, recruitment, and retention of high risk 
research participants who typically do not engage in treatment follow-up;

o  develop methods that readily translate intervention outcomes to information 
relevant to community stakeholders such as payers and public policy makers 
(e.g., economic analyses of suicide deaths, attempts, and risk factors with 
regard to years of life lost, or morbidity impact such as disability and 
functional status);

o  improve suicide research studies through utilization of theory and methods 
from related fields (population approaches to preventing cardiovascular disease) 
or outside the health fields (e.g., decision analysis, marketing and 
engineering).

o  develop new approaches for the prevention of suicide through 
interdisciplinary collaboration, by translating findings from basic behavioral 
science and/or cognitive or affective neuroscience into clinical interventions 

Applicants are encouraged to focus on how this core will enhance the research 
activities chosen in the Principal Research Core (see below).

Principal Research Core

The DCIPS must have a clearly articulated plan to develop a set of scientific 
core functions that will enhance and expand capacity for suicide intervention 
and prevention research.  Applicants should select a major focus for the 
research core and propose at least two projects to address it.  The research 
area chosen should be the primary research focus of the center and all other 
cores should clearly relate to the efforts pursued in this core.  A separate 
description must be provided for the Principal Research Core area, including 
potential research proposals in this area, summary descriptions of exploratory 
and developmental research projects, and how these proposals and projects will 
relate to and support one another as well as projects in other cores. Proposed 
projects are intended to provide preliminary data to be utilized in guiding the 
design of more definitive investigations.  These projects are similar to the 
ones typically supported under developing grant mechanisms such as the R34 
(e.g., http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html).  
Applicants should describe how the Operations and Methods Development Cores are 
integrated in the service of this Principal Research Core and related research 
projects.

Examples of research topics of interest include, but are not limited to:

o  develop and test psychotropic medications to determine whether they are 
effective in reducing suicidality in randomized clinical trials; 

o  evaluate the efficacy of various pharmacotherapies alone, and in combination 
with various behavioral therapies in the treatment of alcohol abusing and/or 
substance abusing suicidal patients, with and without co-occurring mental 
disorders;

o  develop, modify, and test behavioral treatments for drug and alcohol abusing 
individuals exhibiting suicidal behavior (see Behavioral Therapies Development 
Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html)

o  identify factors influencing clinical efficacy of medications using human 
laboratory behavioral pharmacology paradigms;

o  identify interactions of medications to treat AUD, SUD, and mental illness as 
well as interactions with alcohol and other drugs to determine what is safe, 
effective treatment;

o  test measures of suicidality side effects and/or possible precursors or 
surrogate markers for various interventions for their utility in intervention 
trial safety efforts; 

o  evaluate the efficacy of established and novel pharmacological agents for 
AUD and SUD patients with comorbid psychiatric disorders;

o  develop and test interventions for comorbid AUD, SUD, mental illness and 
suicidality, testing integrated and/or sequenced approaches (both pharmacologic 
and psychosocial) for various symptoms;

o  examine the potency of "usual care" interventions for AUDs, SUDS and mental 
illness in the community (e.g., day treatment, short-term hospitalization);

o  identify potential mediators and moderators of effective interventions 
associated with the individual, family, provider, health system, and community 
and cultural factors; examine mechanisms of action of behavioral treatments for 
comorbid alcohol and/or drug abuse and suicidality;

o  expand existing prevention and treatment programs for youth that may be 
focused on the reduction of substance use and/or alcohol use or aggressive 
behavior to include suicidality outcomes and the ethical and safety challenges 
involved in identifying imminent risk research participants;

o  while effective treatments for depressed, suicidal older adults can be 
delivered in primary care settings, efforts to improve uptake and maintenance 
of effective delivery models in community settings are needed; 

o  test the effectiveness and utility of alternative methods or settings to 
assess suicide risk and deliver interventions (e.g., religious organizations, 
tele-health, and/or web-based media) and/or studies to improve delivery of 
interventions in traditionally underserved areas (e.g., rural and frontier 
areas);

o  develop and test interventions that safely and effectively increase general 
public awareness, or awareness among particular target groups at risk (e.g., 
parents of adolescents who have attempted suicide) of suicide and its risk 
factors;

o  develop techniques for the engagement, retention, and adherence of comorbid 
patients suffering from AUD, SUD and various psychiatric illnesses and 
suicidality.

o  adapt/refine existing interventions, or develop new interventions targeted to 
the specific needs of the varied demographic groups at risk for suicide (e.g., 
older white males, young American Indian and Alaska Native males), taking into 
account the power of cultural norms that may influence behaviors related to 
suicidality.

Principal Research Cores should be integrated with Methods Development Cores to 
address critical suicide intervention and prevention research needs.  The 
following are some examples of how a DCIPS could integrate Research Methods and 
Principal Methods Development Cores.

A Center could propose, for example, as a primary aim, tests of efficacy of 
established and novel pharmacological agents for AUD and SUD patients with 
comorbid psychiatric disorders and suicidality.  Combination and/or sequencing 
of pharmacological and psychosocial therapies would be explored.  Assessment of 
possible interaction side effects of medications to treat AUD, SUD and mental 
illness as well as interactions with alcohol and/or other substances would be 
assessed.  Pilot pharmacokinetic studies would also be implemented.  Experts in 
combordity interventions, and pharmacokinetics are a part of the center research 
team, and a partnership with state substance abuse treatment programs involve 
patients and providers from that system.

A Center could propose to focus on the development, efficacy testing, and 
community-based testing of innovative behavioral treatments, and/or combined 
behavioral and pharmacological treatments, for suicidal individuals with co-
occurring AUD or SUD.  Innovative behavioral treatments could be based upon 
findings from basic science, such as cognitive and affective neuroscience.  The 
Center could propose Stage I, Stage II, and Stage III research activities (see 
Behavioral Therapies Development Program Announcement:  
http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html) 

A DCIPS could have a primary aim to develop methodologies to evaluate state/ 
community suicide prevention efforts; develop appropriate intermediate target 
outcomes (reduced injury, substance use, depressive symptom rates) for suicide 
prevention, and collaborate with and train state and community partners so that 
evaluation efforts can continue post-grant period.  PIs would have expertise in 
community-based prevention, epidemiology and dissemination research, and would 
demonstrate the capability of engaging state entities such as mental health/ 
substance abuse treatment centers, and coordinate with state public health 
officials regarding CDC funded surveillance on morbidity or mortality outcomes 
(e.g., Emergency Department Ambulatory Surveys, State Fatality Reviews).

A DCIPS could expand evidence-based treatments for suicidality across specific 
as well as comorbid disorders (AUDs, SUDs, major depression, schizophrenia, 
bipolar disorders), and consider common "active ingredients" of psychosocial 
interventions, as well as further refining the use of effective pharmacologic 
agents with putative anti-suicidality effects (e.g., lithium, clozapine) among 
adults.  Collaboration with community-based primary care, mental health and 
substance abuse treatment centers ensures the representativeness of treatment 
samples, and efforts are made to train clinic staff as field trial providers.  
Testing effective treatments adapted for younger persons (adolescents) or older 
adults could be exploratory aims.  Center personnel would include bioethicists 
able to collaborate on developing safe and ethical trial designs.

A Center aim could be to develop and initially test novel interventions for 
known high-risk groups who do not intersect with traditional specialty mental
health or AUD or SUD treatment service settings (older white males, adolescents/
young adults who are not in school, unemployed).  Intervention approaches could 
include optimization of protective factors, reframing of the need for health 
care seeking to reduce "stress" and/or improve employment options, or harm 
reduction approaches.  PIs have expertise in social and community psychology, 
violence and substance use prevention, health education, and partner with EAP 
staff, state unemployment offices, and/or juvenile detention settings.

Specific Research Projects

At least two developmental research projects must be described in the 
application with enough detail to allow appropriate peer-review of their 
scientific merit and methodological soundness.  Due to the purposes of this RFA 
and its funding limitations, such projects are not expected to be major 
research proposals, able to test major experimental hypotheses in a definitive 
manner.  Rather, such projects are intended to provide preliminary data to be 
utilized in guiding the design of future more definitive investigations.  These 
projects are similar to the ones typically supported under developing grant 
mechanisms such as the R34 (e.g., 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html).  
The focus of these specific research projects will be relevant to the focus of 
the Principal Research Core that the applicant has chosen to include in the
developing center.

ORGANIZATION OF CENTERS

A Developing Center on Interventions for the Prevention of Suicide (DCIPS) may 
be organized in a variety of ways and may include one institution or several.  
There is no single model for a DCIPS; the structure will depend upon the 
research questions and approaches selected to study them.  One type of center 
could adopt a Clinical Research Organization type approach, providing 
administrative, management, and operational support to a large set of ongoing 
and planned suicide intervention and/or prevention studies in various community 
sites.  Another type of center could adopt a decentralized, multi-site focus in 
which specialized activities are supported in different sites.  A conceptual 
and theoretical rationale for the organizational structure should be discussed 
in the application.  However, they must include the required cores outlined 
above.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Exploratory Center 
Grant award mechanism (P20).  This mechanism supports planning for new programs, 
expansion or modification of existing resources, and feasibility studies to 
explore various approaches to the development of interdisciplinary programs that 
offer potential solutions to problems of special significance to the mission of 
NIH.  Support is limited to a maximum of 5 years and is not renewable.  Grants 
are awarded directly to the applicant's institution and are not transferable to 
another institution.  Under this RFA, applicants can request up to $410,000 per 
year for direct costs, where $10,000 per year should be designated for travel 
for annual meetings in Washington and for networking visits with other Centers.  
Although the Facilities and Administrative (F&A) costs associated with all 
contractual and consortium arrangements are considered as direct costs to the 
applicant organization, for the purposes of this RFA only, these will not count 
against the direct cost limits for this RFA.  (However, these costs should be 
indicated as instructed on PHS 398, rev. 5/2001.)

FUNDS AVAILABLE

NIMH, NIDA, and NIAAA intend to commit up to approximately $2.3 million in FY 
2004 to fund up to 3 new grants in response to this RFA.  An applicant may 
request a project period of up to 5 years and a budget for direct costs of up 
to $410,000 per year.  Although the financial plans of the participating ICs 
provide support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number of 
meritorious applications.  

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your domestic 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  Faith-based or community-based organizations

Foreign institutions are not eligible to apply.

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.  The Principal Investigator should be an established 
independent intervention researcher in the area(s) of mental illness, SUDs and/
or AUDs and will have a minimum time commitment of 30 percent to the Developing 
Center.  Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Institutions eligible under this RFA should have both ongoing research activity 
in suicide prevention, mental disorder and/or SUD and/or AUD prevention or 
intervention, and a demonstrated need for infrastructure support to take full 
advantage of their research potential.  The existence of research activity is 
evidenced by the presence of ongoing research funded under PHS grants or 
equivalent sources of peer-reviewed support, and recent record of peer-reviewed 
scientific publications.

This RFA is intended to support research directly relevant to suicide preventive 
interventions.  Basic research in suicide risk is also of interest to NIMH.  
Applicants interested in seeking support for a center for basic neuroscience 
research relevant to mental illnesses should see PAR-02-121, Silvio Conte 
Centers for Neuroscience Research 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-121.html)
and those interested in a center for translational research between basic 
and clinical neuroscience research on severe mental illnesses should consider
PAR-02-122, Silvio Conte Centers for the Neuroscience of Mental Disorders 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html).  Applicants 
interested in seeking support for a center for research at the interface between 
basic behavioral research and neuroscience should see PAR-00-130, 
Interdisciplinary Behavioral Science Centers for Mental Health 
(http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html).  
Applicants interested in a center that would foster research projects on the 
translation of basic behavioral research to mental disorders and public health 
applications should consider PAR-01-027, Translational Research Centers in 
Behavioral Science 
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html).

Under this RFA, $10,000 per year should be designated for travel for one annual 
meeting in Washington and for additional networking visits with other Centers.

Allowable Costs

The grant mechanism of this RFA (P20) provides funding for infrastructure and 
developmental research projects only.  Investigators seeking support for 
specific investigator-initiated research projects should use mechanisms other 
than the P20 (e.g., R01, R03).

Under this RFA, funds can be used to support research participant recruitment 
for all populations, especially activities to ensure appropriate participation 
by women, children and adolescents, elderly and other traditionally understudied 
populations, such as racial and ethnic minorities and people in rural areas.  
Those developing centers that will conduct intervention trials may request funds 
to support the establishment of a Data and Safety Monitoring Board for those 
trials.  Funds may also be used for travel, salaries, meeting expenses, 
subcontracts and paying consultants.  Applicants are referred to the General 
Clinical Research Center program at the NIH/National Center for Research 
Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a 
potential resource for inpatient and outpatient facility costs.

WHERE TO SEND INQUIRIES

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

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
Telephone:  (301) 443-3598
FAX:  (301) 594-6784
Email:  jp36u@nih.gov

Lisa Onken, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4123 MSC 9551
Bethesda, MD  20892-9551
Telephone:  (301) 443-2235
Email:  Lisa_Onken@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

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Rockville, MD  20852-9608 (for express/courier service)
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  kozakm@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, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  jknipple@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

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@mail.nih.gov

LETTER OF INTENT

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

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel
o  Participating institutions
o  Number and title of this RFA

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

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent 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
Telephone:  (301) 443-3598
FAX:  (301) 594-6784
Email:  jp36u@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.

SUPPLEMENTAL INSTRUCTIONS:  Applications for this RFA are limited to the 
following:  Introduction and Operations Core: 10 pages; Methods Development 
Core: 10 pages; Principal Research Core:  12 pages.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked.  The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the Checklist, and three 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)

At the time of submission, two additional copies of the application must be sent 
to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9663
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  jnoronha@mail.nih.gov

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 
review.

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.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is the application for the RFA 
must not include an Introduction describing the changes and improvements made, 
and the text must not be marked to indicate the changes.  While the investigator 
may still benefit from the previous review, the RFA application is not to state 
explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the participating ICs.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.  
Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the participating ICs in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the 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 
the 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 the application's overall score, weighting them as appropriate for 
each application.  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, an investigator may propose to carry out important 
work that by its nature is not innovative but is essential to move a field 
forward.

SIGNIFICANCE:  Does this center and its associated research projects address 
suicidality as an important public health problem?  If the aims of the 
application are achieved, how will scientific knowledge of intervention research 
be advanced?  What will be the effect of the center and its affiliated studies 
on care in community settings?

APPROACH:  Is there adequate rationale to support the importance of a center 
approach as opposed to other mechanisms (e.g., individual R01 applications)?  
Does a conceptual and theoretical framework focused on a major topic in 
intervention research inform the center organization and infrastructure 
development?  Is the concept of a center fulfilled, including:  (1) an 
integrated theme bringing together a multidisciplinary team of investigators in 
a common mission, (2) development of a pooled, core database or access to 
research participants that can yield results beyond that accomplished with 
individual projects alone, (3) attraction of established investigators and 
development of collaboration among investigators with diverse backgrounds and 
areas of expertise, (4) a research mentorship component for new investigators 
through research training and career development mechanisms, and (5) a process 
for stimulation and evaluation of new pilot study proposals?  Is the approach 
for the center adequately developed, well integrated, and appropriate to the 
general aims of the center?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?  Are collaborations across sites well 
justified and reasonable to carry out the research activities?

INNOVATION:  Does the center propose to develop novel concepts, approaches, 
measures or methods in the development and assessment of interventions?  Are the 
aims original and innovative?  Does the center extend existing approaches or 
develop new methodologies or technologies appropriate to the assessment of 
interventions?

INVESTIGATOR:  Are the center director and other senior investigators at the 
forefront of their respective fields?  Do they have the experience and authority 
necessary to organize, administer and direct the center?

ENVIRONMENT:  Does the scientific environment of the center contribute to the 
probability of success?  Does the center take advantage of unique features of 
the scientific environment or employ useful collaborative arrangements?  Is the 
center able to gain and sustain access to a representative range of people in a 
broad set of academic and community settings?  Is there evidence of 
institutional support?  Are the collaborating sites chosen for the center the 
appropriate ones to address the research questions proposed?

ADDITIONAL REVIEW CRITERIA:  With regard to the developmental research projects 
proposed, such projects are not expected to be major research proposals where 
major experimental hypotheses can be tested in a definitive manner.  Rather, 
such projects are intended to provide preliminary data to be utilized in guiding 
the design of future more definitive investigations.  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.  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.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    October 17, 2003
Application Receipt Date:         November 18, 2003
Peer Review Date:                 February 2004
Council Review:                   May 2004
Earliest Anticipated Start Date:  July 1, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic 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

MONITORING PLAN AND DATA AND SAFETY 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 and Safety Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  
For further consideration of safety and ethical issues specific to suicide 
intervention research, see 
http://www.nimh.nih.gov/research/highrisksuicide.cfm.

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 
he 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 RFA 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 
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 RFA 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.


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