Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
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/)

Title: Risk Factors For Psychopathology Using Existing Data Sets (R01)

Announcement Type
This is a reissue of PA-03-044, which was previously issued on December 10, 2002.

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number:  PA-06-439

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.279, 93.273

Key Dates
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

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:

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:

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, blahey@yoda.bsd.uchicago.edu.

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 mushkin@duke.edu.

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 thomas.murtaugh@med.va.gov.

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:

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/archive/grants/policy/nihgps_2003/index.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) 435-0714, Email: GrantsInfo@nih.gov.

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:

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/archive/grants/policy/nihgps_2003/index.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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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:

The following will be considered in making funding decisions:

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/archive/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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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:  kbourdon@nih.gov

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:  lopezmar@mail.nih.gov

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: mscott@mail.nih.gov

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: rclaycam@mail.nih.gov 

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: gfleming@nida.nih.gov

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: jfox@mail.nih.gov

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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