Release Date: June 2, 2006
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.AIDS Application Receipt Date(s): Not applicable.
Peer Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
- The purpose of this Funding Opportunity Announcement (FOA) is to invite grant applications involving extensive and innovative use of existing data sets to study the development of psychopathology, including alcohol and drug abuse, in order to guide the development of preventive and treatment intervention strategies. Under this FOA, the NIMH, NIDA and NIAAA encourage research using focused and coordinated analyses of mental health and substance abuse research data that are in public use format or that are privately held by a principal investigator.
- This funding opportunity will use the NIH Research Project Grant (R01); however, applications for the Small Research Grant (R03) mechanism are also sought. Applicants for the R03 mechanism must submit their applications electronically and should respond to the NIH Parent FOA for Small Research Grants (PA-06-180).
- Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the quality, duration, costs, as well as the number of applications received. Funding decisions will reflect the needs, priorities and mission of the funding IC(s).
- Eligible organizations include for-profit organizations, non-profit organizations, public or private institutions, such as universities, colleges, hospitals, and laboratories, units of State government, units of local government, eligible agencies of the Federal government, non-domestic institutions, domestic Institutions, faith-based or community-based organizations, Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization.
- 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.
- Applicants may submit more than one application, provided they are scientifically distinct.
- See Section IV.1 for application materials.
- Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Under this Funding Opportunity Announcement (FOA), the National Institute of Mental Health (NIMH) the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) encourage extensive and innovative use of existing data sets to study the development of psychopathology, including alcohol and drug abuse, in order to guide the development of preventive and treatment intervention strategies. The aims of the FOA are to mine the full potential of public use and other extant data sets to increase our knowledge of risk and protective factors for the development of psychopathology or resilience in community-based and clinical populations, and to encourage applications from new investigators to examine these research areas using state-of-the-art data analytic procedures. Under this FOA, NIMH, NIDA and NIAAA encourage translational research proposals to conduct analyses using mental health and substance abuse research data that are in public use format or that are privately held by a principal investigator.
In addition, investigators are encouraged to develop coordinated applications for multi-site secondary analyses of data from research studies which have employed similar methodologies, assessment measures, and risk and resilience variables, in order to examine the replicability of findings across studies, and to evaluate the strength of putative risk factors in the larger, cross-site data set.
Applicants are encouraged to consult other NIMH, NIDA and NIAAA FOAs as they prepare their applications. These include:
- Collaborative R01s for Clinical and Services Studies of Mental Disorders and AIDS and Alcohol Use Disorders http://grants.nih.gov/grants/guide/pa-files/PA-06-154.html
- Research on Co-Morbid Mental and other Physical Disorders http://grants.nih.gov/grants/guide/pa-files/PA-05-018.html
- Epidemiology of Drug Abuse http://grants.nih.gov/grants/guide/pa-files/PA-04-100.html
- Genetic Epidemiology of Substance Use Disorders http://grants.nih.gov/grants/guide/pa-files/PA-02-112.html
- Secondary Analysis of Existing Alcohol Epidemiology Data http://grants.nih.gov/grants/guide/pa-files/PA-05-088.html
RESEARCH OBJECTIVES
The overarching goal of this FOA is to elucidate risk factors and processes for the development of mental health and substance abuse problems across the life span in order to guide the development of preventive and treatment intervention strategies. The immediate objective is to support focused analytical and translational research using existing data from clinical or community-based studies. These studies may have been cross-sectional or longitudinal in scope, and may be available to researchers as public use data sets, or through negotiations with principal investigators of privately held data sets. The data sets selected should have sufficient mental health or substance abuse data to establish a categorical or dimensional measure of mental disorder or psychopathology for the age range being studied. Analyses of cultural and ethnic variations in developmental patterns and processes leading from risk or protection to psychopathology or resilience are encouraged. Applications for analyses of studies conducted in foreign countries will be accepted if there is significant relevance for the U.S. population.
Applications are particularly encouraged for analyses of longitudinal data sets using state-of-the-art statistical analyses to evaluate the sequencing and potency of environmental, socio-economic, psychobiological, and other risk and protective factors and processes in association with the developmental course of psychopathology and alcohol and substance abuse. Case-control analyses of risk factors and processes to examine the development of comorbid alcohol and substance abuse, mental or physical health disorders to inform preventive and treatment interventions are particularly encouraged. Applicants should carefully evaluate the sampling design and attrition rates of these studies to determine the feasibility of using these data sets and the generalizability of the results of the proposed analyses.
Applications involving cross-sectional data sets should include analyses aimed at the development of new hypotheses about the etiology of disorders, and/or their recurrence, and the roles of specific risk and protective factors and processes. Proposals are encouraged which are innovative in studying the association of psychopathology with a range of potential risk factors and processes which may be understudied.
Applicants are encouraged to arrange with Principal Investigators (PIs) of ongoing or recently completed studies to use their privately held data sets for analyses. The PI who holds the privately held data set should provide a statement of commitment to the applicant and to the research being proposed.
Of particular interest are applications for multi-site secondary analysis of existing data sets in order to examine the replicability of findings across studies, evaluate the strength of putative risk factors in the larger, cross-site data set, and inform development of novel preventive and treatment intervention strategies. These applications may be submitted by experienced investigators, such as the principal investigator of a study, to coordinate analyses of risk factors and models of risk and resilience for psychopathology across similar data sets, which used comparable methodologies, risk and protective variables, and assessment measures. The funding Institute will support costs for collaborative activities and statistical and database support. Collaborative activities may be funded through small subcontracts, consultant fees, or by means of collaborative R01 research grants.
Data Analyses: The data analyses proposed should include state-of-the-art biostatistical strategies suitable for complex sampling designs. These may include, but are not limited to the following: survival, life table, and hazard rate analyses; latent class variable and growth curve analyses; logistic regression; cluster analyses; structural equation modeling; random effects modeling, and methods for handling non-response and missing data. Where possible, multilevel analyses should be used to integrate risk factors, and appropriate analytic strategies should be applied to distinguish among causal factors, markers, mediators and moderators, especially as they may inform development of novel preventive and treatment intervention strategies. Analyses of Substance User Disorder (SUD) or Alcohol Use Disorder (AUD) as a risk factor or outcome should include family history of SUD or AUD when known, and distinguish among alcohol or substance initiation, alcohol or substance use, and alcohol or substance use disorders. Applications from new investigators should include consultants in biostatistical approaches to analyses of complex data sets.
Examples of research topics for analyses of existing data sets and multi-site secondary analyses include, but are not limited to, the following:
- Analyses of risk and resilience processes and pathways involved in the development of psychopathology and alcohol or substance abuse disorders over the life span, processes which interact with existing symptomatology or disorder that increase the likelihood of developing subsequent comorbid disorders, and attributable risk associated with these risk factors and processes;
- Examination of the timing and potency of putative risk processes for the onset, persistence, and recurrence of disorders and analysis of interactions between environmental risk and individual traits which may be indicators of personal vulnerabilities or susceptibilities for psychopathology, with the goal of identifying optimal timing for preventive intervention;
- Analyses of adaptive factors and processes related to positive outcomes for high risk individuals, and analyses of factors and processes that alter negative trajectories to inform development of new preventive and/or treatment interventions;
- Analyses of dimensions of behavioral expression, (i.e., impulse control, executive function, affect regulation) as they inform understanding of the development, course, or outcomes of psychopathology and alcohol or substance abuse;
- Analyses of levels and patterns of symptomatology and impairment, as these relate to: the nosology of mental disorders; categorical and dimensional diagnoses of psychopathology; comorbidity of disorders; or the use of services, with an emphasis on child and adolescent populations and ethnic minority populations;
- Analyses of family studies to identify biomarkers, endophenotypes, and subclinical phenotypes associated with mental or addictive disorders, and environmental factors and processes that may moderate or mediate individual risk and protection;
- Analyses of processes underlying different patterns of co-occurring mental and physical health symptomatology, alcohol or substance abuse and risk-taking behaviors, particularly in adolescents and young adults;
- Analyses using new approaches to examine the role of adolescent psychopathology (including depression and conduct disorder) on intermittent or chronic participation in interpersonal violence, suicidality, high risk sexual behavior, substance abuse, and other problem behaviors;
- Examination of the role of physical health, disability, nutrition, and other health risk and protective processes and the development of psychopathology over the life span; analysis of interactions between physical health and psychopathology;
- Analyses examining the mechanisms underlying long-term effects of abuse, neglect or other trauma;
- Analyses across data sets of assessment measures and risk and protective factors and processes, for disorders with low base rates in community populations, such as psychoses or completed suicides;
- Analyses of preventive and/or treatment intervention trials, to evaluate mechanisms accounting for variation in response to intervention (including social class disparities); moderating effects of contextual factors such as neighborhood, classroom structure, family changes and level of ongoing environmental stress on psychological processes and mental health symptoms;
- Analyses of preventive interventions to study: intervention impact on sub-groups such as those at highest risk within universal interventions, or those with comorbid disorders; intervention impact at key developmental transitions or socially defined periods; intervention impact on the risk for or protection from development of other, associated psychopathology;
- Examination of patterns and predictors of the long term course of alcohol or substance use and other mental health disorders (remission, desistance, relapse) within or outside the context of treatment;
- Examination of intervention studies to determine: if high-risk groups are adequately defined and representative of the original high-risk populations in intervention trials; the trajectories of control groups for continued risk, onset and course of disorders, factors associated with reduced risk for disorder, reduced risk for recurrence, and/or factors associated with trajectories of groups with early normative development and later onset of disorders.
- Analyses of longitudinal data to examine predictors (risk and protective factors) and/or mediating/moderating factors associated with later health-risking sexual behaviors, including risk for sexually transmitted diseases (STDs), the human immunodeficiency virus (HIV) and AIDS, including the role of alcohol and substance use and abuse as it relates to HIV related sexual behaviors, and the crossover effects of alcohol and drug abuse prevention programs on health-risking sexual behaviors.
Existing Data Sets: Applicants are encouraged to collaborate with investigators holding private data sets to examine risk and protective factors and processes using new statistical strategies or to link methodologically comparable data sets in order to re-examine the strength of risk factors in the larger, combined data set. Additionally, there are several public use data sets that applicants may wish to consider which may be obtained on the Internet. These data sets include, but are not limited to, the following:
The NCHS National Health Interview Surveys are available at http://www.cdc.gov/nchs/nhis.htm. Since 2001, this survey included CIDI modules for adults for major depression, panic, and generalized anxiety disorders, the Kessler K-6, and a parental report of emotional and behavioral difficulties for children ages 4 17 years using the Strengths and Difficulties Questionnaire. Since 1997, alcohol use has been included in the core questionnaire.
The NCHS National Health and Nutrition Examination Surveys (NHANES) sponsored by the National Center for Health Statistics (NCHS) are available at http://www.cdc.gov/nchs/nhanes.htm. Major depression and bipolar illness were assessed in the NHANES-3 for ages 15-39 years. The Hispanic HANES (HHANES) included the depression module from the Diagnostic Interview Schedule, the CES-D scale, alcohol consumption and some substance use and physical health measures (data are generalizable to U.S. Mexican Americans, Puerto Ricans, and Cuban Americans). The NHANES-4 includes CIDI adult modules for depression, panic and generalized anxiety disorders. Youth and a parent were administered modules of the Diagnostic Interview Schedule for Children (C-DISC) for eating disorders, depression, generalized anxiety disorder, panic, ADHD, conduct disorder, and elimination disorders. When released for public use, researchers may access the youth data only through the NCHS Data Center, see http://www.cdc.gov/nchs/r&d/rdc.htm for guidelines. Updates on future data releases will be announced on the NHANES home page listed above.
The National Survey on Drug Use and Health (NSDUH), sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA). These surveys are designed to measure the prevalence and correlates of alcohol and drug use among household residents ages 12 years and older, and include alcohol use, substance use and mental health information, treatment history, perceived need for treatment, and specific youth experience questions for ages 12 17 years. Additional information may be found at http://www.icpsr.umich.edu/SAMHDA.
The NIMH Methodology for the Epidemiology of Child and Adolescent Mental Disorders (MECA) Public Use Data Set arose from a 4-site collaborative agreement study for community based studies of mental disorders, risk factors and service utilization in youth, 9 17 years of age, using the NIMH Diagnostic Interview Schedule for Children. Information and application requirements to use a limited access data set may be obtained by contacting Dr. Benjamin Lahey, [email protected].
The National Longitudinal Study of Adolescent Health (Add Health). The Add Health is a nationally representative, multi-wave, school-based study of the health-related behaviors of adolescents, grades 7-12, designed to explore the causes of these behaviors. Add Health data for Waves 1 3 are available in two forms a public use data set and a restricted-use contractual data set. The number of respondents in the data set is approximately 6,500. Complete information about the study and the public use data set may be found at http://www.cpc.unc.edu/projects/addhealth.
The National Comorbidity Survey (NCS) and National Comorbidity Survey-Replication; Ronald Kessler, Principal Investigator. These are cross-sectional studies of the prevalence and correlates of mental disorders and service use in nationally representative samples of the U.S. population. The 1990-92 NCS sample includes individuals aged 15-55 years. The NCS-2 was a re-interview study of this sample, 2001-02. The 2002-04 NCS-R sample includes adults age 18 and over and an adolescent sample (NCSR-A) ages 12 17. Information, links to public use data, and updates may be found at http://www.hcp.med.harvard.edu/ncs; the 1990 NCS public release data set is available at http://webapp.icpsr.umich.edu/cocoon/SAMHDA-STUDY/06693.xml. Public release of NCS-R data is expected by June, 2006 and the NCS-2 later in the summer. Three NCS-R Public Use Training Workshops will be offered in July, September, and October, 2006.
The National Survey of African Americans (also called the National Survey of American Life, NSAL), James Jackson, Principal Investigator, is a collaborative study with the National Comorbidity Survey Replication. The NSAL used the same diagnostic instruments as the NCS-R to study the prevalence and correlates of mental disorders and service use in a sample of African and Caribbean-Black Americans and non-Hispanic whites. Public release of the NSAL data set is expected in summer 2006. For information and updates, see http://www.rcgd.isr.umich.edu/prba/NSAL%20Papers/The%20National%20Survey.pdf.
The Fast Track multi-site study of the prevention of conduct problems. This is a randomized, controlled, developmentally-based study using a comprehensive intervention for the prevention of conduct problems. Public use data are available for the first two years of the study at this time, and subsequent years will be made available when data sets become ready. The data sets are available to university-based researchers if appropriate data safeguards are met. Information may be found at http://www.fasttrackproject.org/. To submit an application for data access, contact Clara Muschkin, Ph.D., Center for Child and Family Policy, Duke University, email [email protected].
The National Institute of Mental Health Epidemiologic Catchment Area Study. This study was a two-wave, five-site community-based survey of mental disorders in a sample of 20,000 adults ages 18 years and over, using DSM-III diagnostic criteria. The study is described at: http://webapp.icpsr.umich.edu/cocoon/ICPSR-STUDY/06153.xml. The public use data set and documentation may be purchased from the National Technical Information Service (NTIS), telephone 1-800-553-6847; web access http://www.ntis.gov.
The National Vietnam Veterans Readjustment Survey (NVVRS) database. This is a comprehensive source of information about Vietnam and Vietnam-era veterans carried out by the Research Triangle Institute and supported by the Department of Veterans Affairs and the NIMH. It includes modules of the NIMH Diagnostic Interview Schedule for PTSD, Anxiety, Affective Disorders, Substance Abuse and Personality Disorder. A subset of the sample was selected for a clinical study using the Structured Clinical Interview for DSM-III-R. The complete database for the survey and clinical components is available from the VA Medical Center in Perry Point, MD. The contact person is Thomas Murtaugh, Ph.D., telephone (410) 642-1100, FAX (410) 642-1101, E-mail at [email protected].
The National Collaborative Perinatal Project (NCPP) sponsored by the National Institute of Neurological Disorders and Stroke (1959-1974). Data files may be ordered from the National Archives and Records Administration Center for Electronic Records, College Park, MD, telephone (301) 837-0470. Web information may be found at http://www.archives.gov/research/arc/index.html, search for Perinatal Project , or go to www.archives.gov/research/electronic-records/nih.html .
The National Longitudinal Survey of Youth, now called the NLSY79 Child and Young Adult data. In 1994, children 15 years of age were given a new instrument. Children have been interviewed biennially since 1986 the latest was 2004. Information about release of that data and previous data sets may be found at www.bls.gov/nls .
The National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). This is a household survey of more than 43,000 adults aged 18 years and older designed to measure various psychopathologic conditions including alcohol and drug use and disorders, risk behaviors, treatment utilization, family history, and victimization. NESARC consists of two-waves, with availability of Wave 2 data expected in 2007. Information about the surveys can be found at http://niaaa.census.gov.
The National Survey of Parents and Youth (NSPY). This longitudinal survey of youth, ages 9-18, and a parent was designed to evaluate the National Youth Anti-Drug Media Campaign. Measures include attitudes and behaviors related to drug use, patterns of use, exposure to drug prevention activities and media, peers, parent-child interactions, and parent awareness of youth alcohol and drug use and behaviors. Baseline and followup data are provided in a public use file, and additional restricted data linking parent and youth are available with explicit consent. Information about the study and data access is available at http://www.drugabuse.gov/despr/westat/index.html.
Monitoring the Future Series (MTF). These studies have surveyed youth since 1975 to measure their attitudes, behaviors and lifestyles. Core demographic and alcohol and drug use questions are included on all questionnaires, with multiple versions including additional questions on a variety of subjects such as parental influences, criminal activity, education, and religion. Further information and public use data sets are available at http://webapp.icpsr.umich.edu/cocoon/SAMHDA-SERIES/00035.xml.
National Drug Abuse Treatment Clinical Trials Network. Availability of the data and documentation is expected in mid/late 2006 at http://www.drugabuse.gov/CTN.
The National Data Archive on Child Abuse and Neglect (NDACAN) is the repository for data collection efforts supported by the Children Bureau, DHHS. It includes the National Child Abuse and Neglect Data System, the Adoption and Foster Care Analysis and Reporting System, the National Survey of Child and Adolescent Well-Being, the National Incidence Studies of Child Abuse and Neglect, Longitudinal Studies of Child Abuse and Neglect, etc. For information see www.ndacan.cornell.edu.
The Murray Research Center of Radcliffe College has established an archive of longitudinal mental health data to provide research opportunities for those interested in reanalyzing longitudinal data. Web address http://murray.hmdc.harvard.edu/mra/index.jsp.
The Inter-University Consortium for Political and Social Research (CPSR). This Consortium is located within the Institute for Social Research at the University of Michigan and provides access to a large archive of computerized social science data. Web Address is http://www.icpsr.umich.edu.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement.
Section II. Award Information
1.
Mechanism of Support
This FOA will use
the NIH Research Project Grant (R01) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project. The total project period for an R01 application submitted in response
to this FOA may not exceed 5 years.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible
Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
- For-profit organizations
- Non-profit organizations
- Public or private institutions, such as universities, colleges, hospitals, and laboratories
- Units of State government
- Units of local government
- Eligible agencies of the Federal government
- Foreign Institutions
- Domestic Institutions
- Faith-based or community-based organizations
- Indian/Native American Tribal Government (Federally Recognized)
- Indian/Native American Tribal Government (Other than Federally Recognized)
- Indian/Native American Tribally Designated Organizations
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application
Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
- Charge back of customs and import fees is not allowed.
- Format: every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5" x 11.
- Funds for up to 8% administrative costs (excluding equipment) can now be requested. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html).
- Organizations must comply with federal/NIH policies on human subjects, animals, and biohazards.
- Organizations must comply with federal/NIH biosafety and biosecurity regulations. See Section VI. 2. Administrative and National Policy Requirements ".
- For additional information, see the NIH Grants Policy Statement regarding foreign grants: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A.
Submission, Review and Anticipated Start Dates
Application Submission Date(s): Standard dates apply.
See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are allowable. A grantee may, at
his/her own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing continuation award if such costs:
are necessary to conduct the project, and would be allowable under the grant,
if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting
$500,000 or more in direct costs for any year 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) Include a cover letter with the application that
identifies 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.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing
Research Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
- Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
- Receive a written critique
- Receive a second level of review by an appropriate National Advisory Counsel or Board.
The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review
- Availability of funds
- Relevance to program priorities.
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative arrangements?
Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection of Human Subjects from Research
Risk: The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan, Section E on Human Subjects in the PHS Form 398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr.
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award
Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions
of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the signing official shown on the
electronic application.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency
Contacts
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Karen H. Bourdon, M.A.
Division of
Pediatric Translational Research and Treatment Development
Division of
Adult Translational Research and Treatment Development
National
Institute of Mental Health
6001 Executive
Boulevard, Room 7107 MSC 9625
Bethesda, MD 20892-9625
Telephone (301) 443-5944
FAX: (301) 443-4611
Email: [email protected]
Marsha F. Lopez, Ph.D.
Division of Epidemiology, Services,
and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5156 MSC
9589
Bethesda, MD 20892-9589
Telephone: (301) 443-6504
Email: [email protected]
Marcia S. Scott, Ph.D.
Division of
Epidemiology and Prevention Research
National
Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2067 MSC
9304
Bethesda, MD 20892-9304
Telephone: (301) 402-6328
Fax: (301) 443-8614
Email: [email protected]
2. Peer
Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
Rebecca Claycamp, M.S., CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard,
Room 6122 MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: [email protected]
Gary Fleming, J.D.
Grants Management Branch/OPRM
National Institute on Drub Abuse
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
Fax: (301) 594-6849
Email: [email protected]
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Fax: (301) 443-3891
Email: [email protected]
Section VIII. Other Information
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).
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); 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 Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
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 (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 applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
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).
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 FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal
Domestic 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.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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