RISK FACTORS FOR PSYCHOPATHOLOGY USING EXISTING DATA SETS RELEASE DATE: December 10, 2002 PA NUMBER: PA-03-044 EXPIRATION DATE: November 2005, unless reissued. Updates: June 2, 2006 - The R01 portion of this PA has been reissued as PA-06-439 as of June 2, 2006. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: June 2, 2006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Drug Abuse (NIDA) (http://www.nida.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This is a reissue of PA-99-121. Under this Program Announcement (PA), the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) encourage extensive and innovative use of existing data sets to study the development of psychopathology, including drug abuse, in order to guide the development of prevention and early intervention strategies. The aims of the PA 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 PA, NIMH and NIDA encourage 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, senior 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 integrate the intent of recent NIMH and NIDA PAs in their applications. These include: o Collaborative R01s for Clinical and Services Studies of Mental Disorders and AIDS http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html; o Research on Co-Morbid Mental and other Physical Disorders (http://grants.nih.gov/grants/guide/pa-files/PA-02-047.html); o Genetic Epidemiology of Substance Use Disorders (http://grants.nih.gov/grants/guide/pa-files/PA-02-112.html); and o Research on the Origins and Pathways to Drug Abuse (http://grants.nih.gov/grants/guide/pa-files/PAR-99-168.html). Applicants interested in studying child psychiatric risk factors for drug abuse are referred to the website http://www.drugabuse.gov/Meetings/Childhood/, which contains useful materials from a meeting organized and sponsored by NIDA and NIMH on the subject. RESEARCH OBJECTIVES The overarching goal of this PA 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 prevention and early intervention strategies. The immediate objective is to support focused analytical 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 to psychopathology or resilience are encouraged. Applications for analyses of studies conducted in foreign countries will be acceptable 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 in association with the developmental course of psychopathology and substance abuse. Case-control analyses of risk factors and processes to examine the development of comorbid substance abuse, mental or physical health disorders 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 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 the research being proposed, a statement of anticipated work on the project, and a budget and budget justification. Of particular interest are applications for multi-site secondary analysis of existing data sets 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. 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. Studies of Substance User Disorder (SUD) as a risk factor or outcome should include family history of SUD when known, and distinguish among substance initiation, substance use, and 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: o Analyses of risk and resilience processes and pathways involved in the development of psychopathology and 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; o 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; o Analyses of adaptive factors related to positive outcomes for high risk individuals; analyses of factors and processes that alter negative trajectories; o 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 substance abuse; o 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; o Analyses of family studies to identify biomarkers, endophenotypes, and subclinical phenotypes associated with mental or addictive disorders; o Analyses of processes underlying different patterns of co-occurring mental and physical health symptomatology, substance abuse and risk-taking behaviors, particularly in adolescents and young adults; o 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; o 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; o Analyses examining the mechanisms underlying long-term effects of abuse, neglect or other trauma; o Analyses across data sets of assessment measures and risk and protective factors for disorders with low base rates in community populations, such as psychoses or completed suicides; o Analyses of preventive/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; o 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; o 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; 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 National Health and Nutrition Examination Surveys (NHANES)sponsored by the National Center for Health Statistics (NCHS) http://www.cdc.gov/nchs/nhanes.htm. Major depression and bipolar illness were assessed in the NHANES-3 for ages 15-39 years. Data are available from previous NHANES: the Hispanic HANES (HHANES) included the depression module from the Diagnostic Interview Schedule and the CES-D scale, and some substance use and physical health measures (data are generalizable to U.S. Mexican Americans, Puerto Ricans, and Cuban Americans); the NHANES 1 and NHANES 1 Follow-up. Information may be located for these studies at: http://www.cdc.gov/nchs/search/search.htm. Child and adult mental health measures were included in NHANES-IV and availability of the data will be announced on the NHANES home page above. The 2000 and 2001 National Household Survey on Drug Abuse (NHSDA), Substance Abuse and Mental Health Services Administration (SAMHSA). Mental health service utilization was assessed for adolescents and adults. The DISC Predictive Screener for DSM-4 was included in the 2000 survey only. A measure of serious mental illness in adults was included in 2001. For further information on this survey, contact Joan Epstein, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Office of Applied Studies, (301) 443-1038. Web address: http://www.icpsr.umich.edu/SAMHDA. 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. The public-use data contains information on Add Health's sample from Waves 1 and 2; Wave 3 will be released in Spring 2003. 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). This was a one-wave epidemiological study of the prevalence and correlates of DSM III-R mental disorders and service use for individuals ages 15-55 years. Web addresses: http://webapp.icpsr.umich.edu/cocoon/ICPSR-STUDY/06693.xml; and http://www.hcp.med.harvard.edu/ncs. Data from two ongoing follow-up surveys, the NCS-2 (a 10-year follow-up of participants in the original NCS) and the NCS- Replication will be released as public use data sets as soon as possible after data cleaning is completed. Check the Harvard web site listed above for the most current information. 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. A public use data set is under development. For information, contact Kenneth A. Dodge, Ph.D., Director, Center for Child and Family Policy, Duke University, email dodge@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 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 1988 National Maternal and Infant Health Survey (NMIHS) and the 1991 Longitudinal Follow-up (LF), NCHS. Both surveys contain the CES-D for the mothers, and the LF contains a brief problem behavior index on the children. Data tapes may be purchased from NTIS. Web address: http://www.cdc.gov/nchswww/about/major/nmihs/abnmihs.htm 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_room/center_for_electronic_records/center_ for_electronic_records.html The National Longitudinal Survey of Youth, now called the NLSY79 Child and Young Adult data. In 1994, children age 15 years were given a new instrument. Children have been interviewed biennially since 1986. The current release is for data through 2000, released as one dataset, and is available through the Center for Human Resource Research, Ohio State University, 921 Chatham Lane, Suite 100, Columbus, Ohio, 43221, telephone: (614) 442-7366 or E-mail at McClaskie.1@osu.edu. NLS data sets are available for download at http://www.bls.gov/nls. The 2001 National Health Interview Survey public use data set is expected to be available in 2003. This survey included modules from the CIDI for adults for major depression, panic, and generalized anxiety disorders. A child assessment, the Strengths and Difficulties Questionnaire Extended version was included in the 2001 NHIS. The availability of this data set will be announced on the NCHS Web site at http://www.cdc.gov/nchs/nhis.htm. 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: http://www.icpsr.umich.edu. MECHANISM(S) OF SUPPORT This PA will use the NIH research project grant (R01) and small grant (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R03 application may not exceed two years and funding is limited to $50,000 in direct costs per year. The R01 should be used for applications in which additional project time and cost are clearly justifiable. It is recommended that applicants discuss the appropriate award mechanism for their study with program staff listed under INQUIRIES. The Small Grant (R03) application includes special eligibility requirements and review criteria. The R03 also has a special application format and the narrative portion of the application is limited to ten pages. Information on requirements for the NIMH Small Grant may be obtained at http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html and for the NIDA Small Grant at http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html. Applicants should obtain the appropriate program announcement for the grant mechanism being used and are encouraged to consult with program staff listed under INQUIRIES about any questions regarding their proposed project and the goals of this PA. This PA uses the just-in-time concepts. It also uses the modular as well as the non-modular budgeting 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 format. Otherwise follow the instructions for non-modular research grant applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic (R01s and R03s); or foreign (R01s) o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. New investigators are also encouraged to apply. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues related to mental health outcomes to: Karen H. Bourdon, M.A. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200 MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-5944 FAX: (301) 480-4415 Email: kbourdon@nih.gov o Direct inquiries about scientific/research issues related to mental health intervention/prevention to: Belinda E. Sims, Ph.D. Division of Services and Interventions Research National Institute of Mental Health 6001 Executive Boulevard, Room 7149, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: bsims@mail.nih.gov o Direct inquiries about scientific/research issues related to substance abuse outcomes to: Naimah Weinberg, M.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-6637 Email: nw46w@nih.gov o Direct inquiries regarding financial or grants management matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS 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 AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 and 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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