EFFECTIVENESS, PRACTICE, AND IMPLEMENTATION IN CMHS CHILDREN’s SERVICE SITES RELEASE DATE: November 10, 2003 PA NUMBER: PA-04-019 (Reissued as PA-06-526) 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: August 14, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 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 PA replaces PA-00-135. The purpose of this program announcement (PA) is to encourage research grant applications on services delivered to children, adolescents, and their families through the Center for Mental Health Services (CMHS) Comprehensive Community Mental Health Services for Children and Their Families Program initiative (hereafter referred to as the Children’s Services Program) or through the Safe Schools/Healthy Students Interdepartmental Initiative (SS/HS), also supported by the CMHS, and by the Departments of Education and Justice. This PA encourages studies of the effectiveness of interventions delivered at these sites, the nature and impact of routine prevention or clinical practice, and factors related to successful implementation of preventive or treatment interventions. Conducting the proposed research at one of the Children’s Services Program or SS/HS sites (either existing sites or graduated sites) is a prerequisite for funding under this PA. Within multi-site studies, only one site is required to be a past or currently funded Children’s Services Program or SS/HS site. Grant principal investigators are strongly encouraged to work collaboratively with Children’s Services Program or SS/HS site program staff and associated family members. Such collaboration might include the joint negotiation of primary research aims, direct participation in research activities, or the establishment of a community advisory board to oversee research activities. This PA addresses recommendations set forth in the NIMH report, "Bridging Science and Service: A Report by the National Advisory Mental Health Council’s Clinical Treatment and Services Research Workgroup," and in the NIMH report "Blueprint for Change: Research on Child and Adolescent Mental Health." Applicants may obtain a copy of these reports at http://www.nimh.nih.gov/research/bridge.htm and http://www.nimh.nih.gov/child/blueprint.cfm. This PA also addresses research-related issues raised in the report from the President’s New Freedom Commission on Mental Health, "Achieving the Promise: Transforming Mental Health Care in America" and in the "Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda." Applicants may obtain copies of these reports at http://www.mentalhealthcommission.gov/ and http://www.surgeongeneral.gov/topics/cmh/childreport.htm. RESEARCH OBJECTIVES Background The field of child mental health research has made enormous strides in the development, testing and application of intervention strategies. While there is still much to learn, scientific evidence indicates that the prevention or treatment of mental disorders in childhood can reduce the risk of onset of child psychopathology, reduce symptoms or delay their onset, improve adaptive functioning, and serve as a buffer to further long-term impairment. In contrast to the growing scientific base on the efficacy of interventions, empirical data on the effectiveness of research-based strategies in community settings, information about typical community practices, and evidence identifying key intervention implementation strategies remain very limited. As efficacious preventive and treatment interventions are moved into real-world community settings, scientific knowledge in these areas becomes especially important. The purpose of this PA is to encourage research to be conducted within the Children’s Services Program or SS/HS sites to assess the effectiveness of child mental health interventions (either preventive or treatment), the nature and impact of routine prevention or clinical practice, or factors related to the successful implementation of child mental health interventions. The majority of children who receive mental health care in the United States do not receive such care within the specialty mental health system. Typical child mental health-oriented preventive and/or treatment services occur across a broad array of service arenas including, but not limited to, education, primary health care, child welfare, juvenile justice, and community-based mental health settings. Preventive and treatment services within the Children’s Services Program and SS/HS sites are provided within such diverse service settings and consequently represent excellent environments in which to conduct effectiveness, practice, or implementation research. For the purposes of this program announcement, effectiveness research is defined broadly to include studies which examine the impact of specific treatment (including psychosocial, pharmacological, and/or innovative service delivery strategies) or prevention models (including universal, selective, and/or indicated preventive interventions) on clinical, functional, environmental, service, or systemic outcomes for children, adolescents, and their families. Effectiveness research may also include the study of intervention or service delivery processes (e.g., mechanisms of action) within community settings that reduce risk or delay onset of psychopathology or improve child mental health outcomes, as well as studies of the quality of preventive or treatment services. Effectiveness research is intended to facilitate the successful uptake of efficacious preventive and treatment intervention services into child service systems in the most efficient and cost-effective manner. Practice research is defined here to include research that examines those features of routine prevention program delivery or clinical care that interventionists or clinicians employ (e.g., intake, assessment, engagement strategies, case management, supervision) when providing a particular service. Such research might include the study of clinician decision-making strategies, the relationship between typical organizational structures upon care quality, the impact of routine mental health program delivery on child functioning, or care system efficiency. Practice research is intended to broaden the scientific understanding of current clinical practice and to identify promising (but as of yet untested) innovative practices. Implementation research includes the study of strategies to introduce efficacious mental health interventions into community settings. Such research includes the study of specific implementation strategies (e.g., training, program fidelity, care setting capacity building) as well as the study of barriers and facilitators to program implementation (e.g., program accessibility, provider attitudes, or organizational culture). Of particular interest are studies that will examine aspects of prevention or treatment program delivery that improve child and family outcomes, and enhance the likelihood of program adoption, whether these aspects are specific to the intervention strategy, routine clinical practices, or implementation models. Implementation research is intended to develop a knowledge base about how interventions are integrated within real-world practice settings. Children’s Services Program The Comprehensive Community Mental Health Services Program for Children and their Families (or Children’s Services Program) was created as part of the Alcohol, Drug, and Mental Health Administration Reorganization Act -- Public Law 102-321, Section 119). This program is administered by the CMHS of the Substance Abuse and Mental Health Services Administration (SAMHSA). Under this authority, grants and cooperative agreements are provided to State governments, governmental units within political subdivisions of States (e.g., counties, cities, towns), Indian tribes, tribal organizations, territories, and the District of Columbia, to provide a broad array of comprehensive community-based services for children with serious emotional, behavioral, or mental disorders in order to enable communities to develop local systems of care consisting of mental health, child welfare, education, juvenile justice, and other child- serving agencies. Funds for the CMHS program are authorized to be spent on services that are underdeveloped or nonexistent in most communities such as intensive home-based services; school or clinic-based services; crisis intervention; emergency services; therapeutic foster care; day treatment; diagnostic and evaluation services; and, respite care. Children can be served in small therapeutic group homes that have a capacity of less than 10 beds. Additionally, each child must have an individualized service plan, developed with the participation of family and, where appropriate, the child. The plan must designate a case manager to assist the child and family by coordinating services among several child-serving agencies. To date, 85 grants or cooperative agreements have been awarded in 46 states, 10 American Indian or Alaskan Native Tribes, and two territories by the CMHS since the first Request for Applications was announced in the Spring 1993. Over 56,000 children and adolescents with serious emotional, behavioral or mental disorders have received or are receiving services in systems of care. Many Children’s Services Program sites serve a substantial number of children and families from American Indian, Hispanic, and African-American backgrounds. Some of these communities have developed and used services and treatments that are specific to the culture. Such services may offer the opportunity to gather empirical evidence around the effectiveness of these practices. Further information on the Children's Services Program, including a list of currently funded sites, may be found at http://www.samhsa.gov and at http://systemsofcare.net. Safe Schools/Healthy Students Interdepartmental Initiative The Safe Schools/Healthy Students Interdepartmental Initiative (SS/HS) is supported by an unprecedented collaboration among the Departments of Education, Health and Human Services, and Justice. The CMHS is the primary DHHS partner. The goals of SS/HS are to 1) help students develop the skills and emotional resilience necessary to promote positive mental health, engage in prosocial behavior, and prevent violent behavior and drug use; 2) ensure that all students learn in a safe, disciplined, and drug-free environment; and 3) develop an infrastructure that will institutionalize and sustain integrated services. The Federal partners have challenged communities to develop a new way of doing business by forging formal partnerships across 3 traditionally disparate sectors--education, mental health, and justice. Sites are required to establish a comprehensive, integrated strategy to promote healthy students and families in a safe school and community environment. Each local strategic plan addresses six required elements across the three sectors: 1) school safety; 2) alcohol, other drugs, and violence prevention and early intervention programs; 3) school and community mental health preventive and treatment services; 4) early childhood psychosocial and emotional development programs; 5) educational reform; and 6) safe school policies. In addition to the key partnership across education, mental health, and justice, the local SS/HS coalitions have multiple partners, including representatives of the faith community. A total of 143 SS/HS grant awards have been made between 1999 to 2002 to urban, suburban, rural, and tribal sites in nearly every U.S. state. In addition to grant funds, support is provided for technical assistance to all SS/HS grantees; there is additional support for a SS/HS communications component to help local sites achieve sustainability after Federal support ends. Sites are required to conduct local evaluations; the majority of the SS/HS sites also participate in a cross-site National Evaluation. Additional information about the SS/HS initiative along with a list of currently funded sites may be found at: http://www.sshsevaluation.org/initiative/. Research Issues Examples of research topic areas that are of interest under this PA include, but are not limited to: o Studies of the portability, adaptation, and/or implementation fidelity of efficacious preventive, pharmacological, psychosocial or combined interventions in novel communities, settings, and populations. o Research on factors associated with the development of effective prevention and treatment practices in specific geographic contexts such as urban, suburban, rural and frontier. o Examination of the economic issues (e.g., financing streams and mechanisms, costs, benefits, cost offsets) associated with effective preventive or treatment interventions. o Research on the potent elements of effective preventive and/or treatment services, including elements directly associated with a specific intervention or its implementation. o Studies of the effectiveness of preventive and/or treatment services for co- occurring conditions, such as other emotional, behavioral, or mental disorders; drug or alcohol abuse; AIDS; or homelessness. o Studies that propose secondary analyses of site-specific SS/HS or Children’s Services Program National Evaluation data, or studies that combine National Evaluation data with local evaluation data, especially studies focused on outcomes. o Research on the effectiveness of family-driven or culturally-based treatment or services, contrasted with provider-driven or usual care delivery. o Research on the impact of efficacious prevention or treatment approaches on the routine community delivery of mental health interventions, associated outcomes, or quality of care. o Studies of the impact of different levels of service intensity, service quality, service integration, or service matching on short-term and long-term outcomes for children and adolescents with different levels of impairment. o Studies of routine practices (e.g., supervision, assessment, referral, triaging) by clinical practitioners (e.g., case managers, pediatricians, social workers, clinicians) which impact clinical outcomes or the quality of care. o Studies examining the impact of processes within preventive and/or treatment interventions or services (e.g., therapeutic engagement, family choice or involvement in program care delivery) on outcomes. o Development of improved methods for measuring and analyzing preventive and/or treatment service integration, intensity and/or outcomes within comprehensive systems. o Studies of the meaning of quality to children and families from diverse ethnic or geographic backgrounds. o Pilot intervention outcome research studies to test the impact of innovative service delivery models identified as promising practices within Children’s Service Program or SS/HS sites. o Research on implementation strategies (e.g., fidelity monitoring, provider training, sustainable infrastructure support) for successfully deploying efficacious preventive or treatment interventions into service communities. o Research on the barriers (cultural, administrative, structural) to deploying preventive and treatment interventions into service communities. o Research on organizational (e.g., culture, structure) or individual-level (e.g., provider or consumer beliefs/attitudes) variables that enhance or detract from the implementation of (or outcomes associated with) efficacious preventive and/or treatment services. MECHANISM(S) OF SUPPORT This PA will use the NIH research project grant (R01), small grant (R03), exploratory/development grant for intervention and services research (R34) and the Collaborative R01s for Clinical Studies of Mental Disorders mechanisms. 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 PA may not exceed five years. An application for an R03 award is limited to $50,000 direct costs per year, is limited to two years, and is not renewable. An application for an R34 award is limited to $450,000 in direct costs for up to three years, with no single year exceeding $225,000, and is not renewable. Instructions and information on the Small Grant (R03) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html Instructions and information on the R34 mechanism is available at: http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html Instructions and information on the collaborative R01 mechanism is available at: http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html This PA uses just-in-time concepts. It also uses the modular budgeting 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 budget format. Otherwise follow the instructions for non-modular budget 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 or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about NIMH scientific/research issues related to the Children’s Services Program to: Heather Ringeisen, Ph.D. Chief, Child and Adolescent Services Research Program National Institute of Mental Health 6001 Executive Boulevard, Room 7146, MSC 9631 Bethesda, MD 20892-9621 Telephone: (301) 496-7227 FAX: (301) 443-4045 Email: hringeis@mail.nih.gov o Direct your questions about NIMH scientific/research issues related to the Safe Schools/Healthy Students Initiative to: Eve K. Moscicki, Sc.D., M.P.H. Office of Child and Adolescent Research National Institute of Mental Health 6001 Executive Boulevard, Room 7167, MSC 9630 Bethesda, MD 20892-9630 Telephone: (301) 443-3775 FAX: (301) 480-3257 Email: em15y@nih.gov o Direct your questions regarding the CMHS Children’s Services Program to: Rolando L. Santiago, Ph.D. Center for Mental Health Services Substance Abuse and Mental Health Services Administration 5600 Fishers Lane, Room 11C-16 Rockville, MD 20857 Telephone: (301) 443-3808 FAX: (301) 443-3693 Email: rsantiag@samhsa.gov o Direct your questions regarding the CMHS Safe Schools/Healthy Students Initiative to: Denise L. Middlebrook, Ph.D. Division of Program Development Substance Abuse and Mental Health Services Administration 5600 Fishers Lane, Room 17C20 Rockville, MD 20857 Telephone: (301) 443-4199 FAX: (301) 443-7912 Email: dmiddle@samhsa.gov o Direct your questions about financial or grants management matters to: Joy R. Knipple Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6131 MSC 9605 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jk173r@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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. The title and number of this PA must be typed in line 2 of the face page of the application form and the YES box must be checked. 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 BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. 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: 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 written critique 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 evaluate your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator 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 (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. 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 priority score. 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 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance/ the physical and mental health of the American people.


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