and Human Services (HHS)
EXPIRED
RESEARCH ON EMERGENCY MEDICAL SERVICES FOR CHILDREN Release Date: January 25, 2001 PA NUMBER: PA-01-044 (This PA has been replaced, see PA-05-081) Maternal and Child Health Bureau, HRSA Agency for Healthcare Research and Quality National Institute for Occupational Safety and Health, CDC National Heart, Lung, and Blood Institute, NIH National Institute of Child Health and Human Development, NIH National Institute on Drug Abuse, NIH National Institute of Mental Health, NIH National Institute of Nursing Research, NIH PURPOSE This multi-agency announcement is designed to improve the quality and quantity of research related to emergency medical services for children (EMSC). The types of research included under the term EMSC are: prevention research to reduce the need for emergency care, clinical research to ensure that children receive high quality and appropriate medical, nursing and mental health care in an emergency, health systems research, from pre-hospital care, to the emergency department, to inpatient care and return to the community, cost- effectiveness analyses, and methodological studies to improve the quality of research conducted. A goal is to reduce morbidity and mortality in children through improved care delivery. Research specific to minority and inner city and rural populations is encouraged. This Program Announcement (PA) expired January 25, 2004. Former NIMH Program Announcement PA-93-075, Research on Emergency Mental Health Services for Children and Adolescents, which was published in 1993, is no longer active. RESEARCH OBJECTIVES The goal of this PA is to improve the quality and increase the quantity of EMSC research to be conducted in the U.S. in FY 2001 and beyond. Specifically, this PA seeks to inform prospective applicants regarding grant support opportunities available to conduct EMSC research under the sponsorship of a group of Federal agencies, and to broadly describe the areas where research is warranted. Each sponsoring agency has further delineated specific issues/questions as illustrative of what topics they are interested in investigating and will make more detailed information available to prospective applicants upon request. Background In 1993, the Institute of Medicine published a study of EMSC that recommended a dramatic increase in research addressing various aspects of children’s emergency care. Subsequently, the Maternal and Child Health Bureau of the Health Resources and Services Administration and the Agency for Healthcare Research and Quality jointly issued an RFA and funded projects addressing this topic, as did the Centers for Disease Control and Prevention. However, the extent of this research continued to be minimal compared to the need. In 1997, a multi-disciplinary group representing several professional organizations met to prioritize the research needs in children’s emergency services and again affirmed the need for a national commitment to research in this area. In 1998, the Ambulatory Pediatrics Association developed a set of recommendations designed to encourage EMSC research. The 1999 IOM report, Reducing the Burden of Injury (online at http://books.nap.edu/catalog/6321.html) recommends that additional funding for surveillance, research and program evaluation in injury research for children and adults be supported by a variety of federal agencies. This PA therefore responds to a need that has been clearly identified in the last decade. The sponsoring institutes/agencies are jointly issuing this PA because EMSC involves many agencies in its consequences, prevention, management, treatment and control. This document is intended to go beyond what any single organization would be likely to accomplish individually, since EMSC requires visibility and multi-disciplinary approaches to effectively address the complicated and interwoven nature of the issues. Significant differences between the health care needs of children and adults mean that the dramatic changes now affecting the organization, financing, and delivery of health services may have differing effects on children than on adults. Children are different from adults in their patterns of use of health services, in their distinctive developmental vulnerabilities and strengths, and in their dependence on others for access to care and financial resources. The same is true in children’s emergency care. Research in emergency medical services for children is essential to validate the clinical merit of care that is given, to identify better kinds of care, to devise better ways to deliver that care, and to learn where best to direct prevention activities. The use, costs, quality, accessibility, delivery, organization, financing, and outcomes of physical and mental health care services must be evaluated to increase understanding of the structure, processes, and effects of health services for both individual children and populations of children. Priority EMSC-related Program Areas by Agency Overall, seven broad areas of research on emergency medical services for children have been identified by recent national meetings, conferences, reports and symposia: (1) clinical aspects of emergencies and emergency care, (2) indices of the severity of injury and illness, (3) patient outcomes and outcome measures, (4) costs and cost-effectiveness, (5) system organization, configuration and operation, (6) effective approaches to education and training, including re-training and skill retention, and (7) prevention. Each agency has priority areas of scientific investigation, with some illustrative lists represented below. Agency for Healthcare Research and Quality (AHRQ) - AHRQ seeks to support research to better understand and improve the outcomes of health care and, in particular, what works, for whom, when, and at what cost. In terms of pediatric emergencies, AHRQ interests would include studies that: o Support improvements in health outcomes. For example, studies of the effect of pediatric hospitals versus trauma centers with a pediatric commitment on the outcomes for children with severe trauma and studies (including clinical trials), comparing effectiveness and costs of diagnostic or treatment alternatives. o Strengthen quality measurement and improvement and improve patient safety. For example, research to develop valid and reliable measures of the process and outcomes of pediatric emergency care, use of quality measures in programs of quality improvement, studies to show the benefits and costs of improved coding and classifications (e.g., E-codes) of the causes of injury requiring emergency treatments, studies to predict and reduce medical errors, and studies of ways to disseminate and broadly implement quality improvement mechanisms that have proven successful in studies of single settings. o Identify strategies to improve access, foster appropriate use, and reduce unnecessary expenditures. For example, the effects of managed care on utilization of emergency care for children, differentials in access to emergency care by children related to non-medical factors such as ethnicity or payment source, or effects on children of demand management strategies designed to control emergency care utilization. Applicants are strongly encouraged to consult PA-00-111, AHRQ Health Services Research, published in the NIH Guide on June 22, 2000 and available at: http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html for more detailed information on the Agency’s priority interests for extramural grants for research, demonstration, and evaluation projects. National Institute for Occupational Safety and Health (NIOSH), CDC - NIOSH supports research to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries, to develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries, to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards, and to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system. The research identified in this PA relates to the following five priority areas in the National Occupational Research Agenda (NORA): traumatic injuries, special populations at risk, health services research, social and economic consequences of workplace injuries and illnesses, and intervention effectiveness research. Information about NORA is available through the NIOSH Home Page: http://www.cdc.gov/niosh/norhmpg.html Topics of research that are appropriate for this PA include, but are not limited to, the following and should address occupational hazards associated with agriculture, construction, service and other industries: o Evaluation of the effectiveness of training programs to prevent childhood occupational injuries for example programs that are targeted to owners/operators, workers, family members and care-givers, o Development and evaluation of community-based programs to enhance the safety and well-being of children who may be exposed as bystanders, o Identification of skills, procedures and equipment needed by pre-hospital providers in responding to childhood occupational trauma, and how differences in care lead to different outcomes, o Development and evaluation of approaches for using emergency departments to introduce effective emergency management strategies that improve skills of workers and family members in handling injuries to children. o Development and evaluation of first on the scene training specific to childhood agricultural trauma for farm owners/operators, farm workers, family members, and care-givers, Maternal and Child Health Bureau (MCHB), HRSA - The research supported by MCHB is guided by a multi-year research agenda comprised of 11 areas of programmatic interest. Each area is further defined by a list of research issues/questions, from which MCHB has selected a sub-set of 15 issues/questions for "priority" consideration during FY 2000-2003. The "priority" consideration consists of a 0.5 adjustment to the funding score assigned to an application when recommended for approval by the MCHB Research Study Section. The issues/questions remaining under the 11 broadly demarcated areas are also of programmatic importance. Applications addressing this larger list will be accepted for review and considered for funding, but will not be given the special funding consideration. These lists of issues/questions within each of the 11 areas of programmatic importance are not exhaustive, however. Thus issues/questions representing applicants" own interests would qualify for non-priority consideration, as long as they are congruent with the implied meaning of the 11 broad programmatic areas of interest. Examples of EMSC-related priority and non- priority issues/questions found in the MCHB research agenda are presented below. Priority: o Study the extent to which children who need emergency medical services receive them, with particular attention to care received (or not received) in hospital emergency departments (EDs). Nonpriority: o Conduct studies on the economic consequences of pediatric trauma or severe illness for families and geo-political units. o Study the processes involved in the evaluation and management of minor head trauma, including indications for CT scans, observation and admission. The full research agenda is available on the MCHB Web Page at: http://www.mchb.hrsa.gov/grants/default.htm. National Heart, Lung, and Blood Institute (NHLBI), NIH - The NHLBI provides leadership for national programs in diseases of the heart, blood vessels, lungs, and blood. It plans and supports, through extramural research grants and contracts, an integrated program that includes basic and clinical investigations, clinical trials, and demonstration and education projects relating to causes, diagnosis, treatment, and prevention of diseases. Because emergency department visits and hospitalizations for asthma have risen over the last 10 years, especially among young children and minority and economically disadvantaged populations, NHLBI is encouraging grant applications that will study ways to reverse this trend. Grant applications are encouraged that cover such topics as: o Demonstration and education studies to develop and evaluate programs using the emergency department to introduce effective asthma management strategies that improve patient and family skills in handling exacerbations and prevent future needs for emergency care, o Demonstration and education studies that develop program models for promoting successful referral from the emergency department to long-term sources of asthma care, o Epidemiological studies to identify risk factors for emergency department visits, or for near fatal exacerbations of asthma, o Clinical studies to identify optimal treatments for acute exacerbations of asthma in children, especially infants and young children. o Interdisciplinary clinical and mechanistic studies to evaluate varying patterns of patient responses to therapy among children with different asthma phenotypes. National Institute for Child Health and Human Development (NICHD), NIH - The NICHD conducts and supports laboratory, clinical, and epidemiological research on a variety of topics to assure that every individual is born healthy, is born wanted, and has the opportunity to fulfill his or her potential for a healthy life unhampered by disease or disability. The NICHD has a variety of EMSC research interests. With a particular focus on the biobehavioral factors involved, these research interests include: o Childhood injuries, including the surveillance of injuries, the mechanisms, risk factors, etiologies, environmental influences, interventions and preventions. o The care of suicidal children and adolescents. o The outcomes of emergency care for children acutely ill secondary to infection, trauma, or acute exacerbation of chronic illness. o The biobehavioral aspects of pain, stress, and coping with illness or injury in situations of emergency care. o Training programs for researchers interested in prevention of childhood injuries. o Behavioral factors involved in risk-taking behaviors with subsequent need for emergency medical services (drug, alcohol, or inhalant abuse, injurious behavior, pelvic inflammatory disease, tubal pregnancy, etc.) The National Center for Medical Rehabilitation Research (NCMRR), a component of NICHD, strives to foster development of scientific knowledge needed to enhance the health, productivity, independence, and quality of life of persons with disabilities, including disabilities which occur secondary to trauma. The Center is interested in research on emergency medical services for children with disabilities, and in interventions that have implications for rehabilitation in areas such as, but not limited to: o Orthopedic injuries o Traumatic brain injury o Spinal cord injury National Institute on Drug Abuse (NIDA), NIH - NIDA supports a research grant program on health services designed for children and adolescents with drug-use problems and encourages interdisciplinary study of the structures, processes and outcomes of the delivery of medical and mental health services for drug- affected youth. NIDA is especially interested in studies that examine the appropriateness and effectiveness of specialized services for children and adolescents in need of emergency medical care in terms of their mental and physical health outcomes. With special attention to issues related to illicit drug use, abuse and addiction, NIDA encourages studies on a wide range of service-related topics, including but not limited to: o Emergency service availability, access and utilization, linkages to primary care, social services, case management systems and follow-up programs designed for children and/or youth who are actively or passively exposed to drugs-of- abuse, o Emergency services delivery and the economics of specialized pediatric care, o Prevention intervention and family-oriented treatment for drug-exposed children and adolescents to reduce the need for emergency care, o Emergency medical and mental health services developmentally appropriate for children and youth affected by drug use and co-occurring disorders, o Screening (e.g., biological and self-report measures) and comprehensive assessment tools developmentally appropriate and suitable for use in emergency medical service settings, o Psychosocial and behavioral determinants of parental/guardian adherence to medical staff recommendations made at the time of the emergency service. National Institute of Mental Health (NIMH), NIH - NIMH has an active grant program on mental health services for children and adolescents. Programs of research on quality of care, the organization of systems of care, economics, and methods development are among the areas of emphasis in health services research. NIMH is especially interested in studies that examine the quality and appropriateness of services for children and adolescents with mental health problems who are seen for emergency medical care, as well as the impact of the delivery of emergency care on mental health sequelae for children. Studies also encouraged will: o Examine aspects of service delivery (that is, intake, assessment, referral, case management, medical staff communication style, follow-up care, etc.) and its impact. o Focus on the quality or effectiveness of family involvement in aftercare. o Examine costs, organizational climate, or structural features of emergency departments that affect the quality, outcomes, or delivery of services. o Examine the mental health effects of violence and trauma on children and youth, including prevention and treatment. o Explore factors affecting access to mental health services by children with emergency medical conditions (for example, risk-taking behavior, suicide attempts, depression, life-threatening substance abuse, victims of violence) presenting to the emergency department. o Develop methodologies aimed at measuring post-traumatic stress in young children. o Develop strategies for resolving methodological and ethical problems in EMSC research, including issues related to informed consent, breaking of confidentiality, and selection of appropriate comparison groups. National Institute of Nursing Research (NINR), NIH - The NINR supports clinical and basic research to establish a scientific basis for the care of individuals across the life span--from management of patients during illness and recovery to the reduction of risks for disease and disability and the promotion of healthy lifestyles. The research mission of NINR is available at http://www.ninr.nih.gov/a_mission.html. For the purposes of this PA, NINR is interested in EMSC-related clinical nursing research, particularly in the areas of brain injury and asthma, as illustrated in the following examples: Traumatic Brain Injury (TBI) o Identify and test emergency room and ICU nursing interventions to reduce intracranial pressure and brain ischemia, to relieve severe pain, to prevent muscle atrophy and kidney failure, and to treat acute lung injury, fever, and seizures, to improve ICU pediatric nursing procedures such as suctioning techniques, nutritional therapies, and positioning techniques. o Identify and test rehabilitative nursing interventions to prevent motor/sensory loss to be performed immediately upon hospital admission. o Identify and test ways to engage parents and caregivers in rehabilitative care of children and adolescents diagnosed with TBI immediately upon hospital admission. Asthma o Validate optimum nursing therapies to improve the accuracy of cues to prevent asthma attacks, to alleviate adverse psychological consequences (such as fear) of shortness of breath and wheezing, in children and care providers, and to monitor adherence/compliance to therapy. o Evaluate asthma teaching plans used with adults to assess appropriate uses with children. o Develop home-based tele-health technologies with special appeal to children with emphasis on flow charts, decision trees, or algorithms. SPECIAL REQUIREMENTS FOR AHRQ APPLICATIONS AHRQ encourages research applications that will use data from the Medical Expenditure Panel Survey (MEPS), the Healthcare Cost and Utilization Project (HCUP), and other AHRQ data as is referenced in the AHRQ Health Services Research PA-00-111, published in the NIH Guide on June 22, 2000 (http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html). Data Privacy Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the possible uses and purposes of the data collection. In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook, Generally Accepted Principals and Practices for Securing Information Technology Systems, and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors should be addressed as necessary. Rights in Data AHRQ grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making research materials, data bases, results, and algorithms available for verification or replication by other researchers, and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO’s website at: http://www.access.gpo.gov/nara/cfr/index.html. MECHANISM OF SUPPORT This PA will use the investigator-initiated research project grant award mechanism known as "R01" at AHRQ, CDC, and NIH, and as "field-initiated" at MCHB/HRSA. Applicants are encouraged to contact the agency listed under INQUIRIES that matches their research interest, and to seek guidance on other potential grant mechanisms that are applicable to each agency. No set-aside of funds will be made to exclusively cover the support of scientifically meritorious applications under this PA. Applications will compete for funds with all other scientifically meritorious applications generated by each agency through their investigator-initiated research programs. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. Because the nature and scope of the research proposed in response to this PA will vary, it is anticipated that the size and length of the awards will also vary. For applications assigned to the NIOSH, NHLBI, NICHD, NIDA, NIMH, or NINR, specific application instructions have been modified to reflect MODULAR GRANT AND JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm ELIGIBILITY REQUIREMENTS ALL APPLICANTS ARE STRONGLY ENCOURAGED TO CONTACT THE APPROPRIATE AGENCY REPRESENTATIVES LISTED UNDER INQUIRIES TO VERIFY ELIGIBILITY, INQUIRE ABOUT FUNDING MECHANISMS OR OTHERWISE CLARIFY ANY PART OF THIS PROGRAM ANNOUNCEMENT AS IT PERTAINS TO THAT AGENCY. A. MCHB/HRSA Applications submitted to the MCHB/HRSA may be submitted by domestic non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State and local governments. Applications may be from a single institution or may include arrangements with one or more institutions (for example, consortia, clinical trials cooperative group) if appropriate. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. For MCHB, eligibility is restricted to public or nonprofit institutions of higher learning and public or private nonprofit agencies engaged in research or in programs relating to maternal and child health and/or services for children with special health care needs. Only these entities may apply to MCHB for grants, contracts or cooperative agreements. B. AHRQ For AHRQ, applications may be submitted by domestic and foreign, public and private nonprofit organizations including universities, clinics, units of State and local governments, firms, and foundations. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. Applications may be from a single institution or may include arrangements with one or more institutions (for example, consortia, clinical trials cooperative group) if appropriate. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. AHRQ also encourages new investigators (as defined in the PHS 398 application instructions) to apply as Principal Investigators. Organizations described in Section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible to receive grant or cooperative agreement awards. B. NIOSH/CDC, and NIH For applications assigned to the NIOSH, NHLBI, NICHD, NIDA, NIMH, or NINR, applications may be submitted by domestic and foreign, non-profit and for- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State and local governments, and eligible agencies of the Federal Government and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. Applications may be from a single institution or may include arrangements with one or more institutions (for example, consortia, clinical trials cooperative group) if appropriate. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. INQUIRIES Copies of the PA are available from: AHRQ Publications Clearinghouse P.O. Box 8547 Silver Spring, MD 20907-8547 Telephone: 1 (800) 358-9295 TDD Service: 1 (888) 586-6340 The PA is also available on the AHRQ website at: http://www.ahrq.gov/fund/ as well as on the NIH Guide website at: http://grants.nih.gov/grants/guide/index.html, and through the AHRQ InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The PA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. Inquiries regarding agency- or institute-specific scientific (including eligibility), fiscal, or grants management issues should be directed to the individuals listed on the following website: http://www.nimh.nih.gov/grants/emschildcontacts.cfm Inquiries regarding agency- or institute-specific scientific (including eligibility), fiscal, or grants management issues should be directed to the individuals listed on the following website: http://www.nimh.nih.gov/grants/index.cfm APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. The title and number of this Program Announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. A. MCHB/HRSA Further guidance on HRSA application procedures may be obtained at http://www.mchb.hrsa.gov/html/grantguidances.html#forms or Grants Management Officer, MCHB, HRSA Grants Application Center, 1815 N. Fort Myers Drive, Suite 300, Arlington, VA 22209, Telephone: 1 (877) 477-2123, Email: [email protected]. For a HRSA application, mail the application per MCHB guidance directions to: GRANTS MANAGEMENT OFFICER, MCHB HRSA GRANTS APPLICATION CENTER 1815 N. FORT MYERS DRIVE SUITE 300 ARLINGTON, VA 22209 B. AHRQ For AHRQ, State and local government applicants may use PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. These AHRQ applicants can find copies of the PA and application kits from AHRQ Publications Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907-8547, Telephone: 1 (800) 358-9295, TDD Service: 1 (888) 586- 6340. AHRQ is not using the Modular Grant Application and Award process. Applicants for funding from AHRQ should prepare applications according to instructions provided in form PHS 398 (rev. 4/98). Questions regarding HCFA data for AHRQ applications should be directed to the program official listed under INQUIRIES. For an AHRQ 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 BETHESDA, MD 20817 (for express/courier service) C. CDC and NIH Applications submitted to NIOSH, NHLBI, NICHD, NIDA, NIMH, and NINR will use the "modular grant" and "just-in-time" concepts. The following modifications to the standard instructions must be used in preparing applications in response to this PA. Applicants planning to submit a grant application requesting $500,000 or more in direct costs for any year are required to discuss their eligibility with the program staff contact listed at the end of this program announcement before submitting the application. Furthermore, the applicant must obtain agreement from program staff that the agency/institute will accept the application for consideration of award. Finally, the applicant must identify, in a cover letter sent with the application, the program staff member who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998, which is available at http://grants.nih.gov/grants/guide/notice-files/not98-030.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 Direct Costs in any year must follow the traditional PHS 398 application instructions.) The Total Direct Costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language, salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. 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) REVIEW CONSIDERATIONS Applications will be assigned prior to review on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIH or the appropriate institute or agency in accordance with standard PHS peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a 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. NIH and CDC applications will receive a second level review by the appropriate national advisory council, secondary review committee 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. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a 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. (1) 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 and methods that drive the field? (2) 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? Are measures used that are appropriate to the phenomenon under investigation? If reliability and validity characteristics are not yet known for a particular assessment procedure, does the application contain specific plans for establishing these features? If an analysis of secondary data is proposed, how are concepts operationalized, and how are limitations of the data addressed? (3) 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? (4) 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 and/or staff members? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? How adequate are the facilities and resources available to the applicant to perform the project? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support, including documentation of cooperation from project collaborators, where applicable? In addition to the above criteria, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (For example, do plans for implementing interventions or programs (if any) include procedures for: establishing and maintaining the necessary community relations, training and supervising staff, insuring implementation fidelity, securing ongoing access to the subject population pool, recruiting a representative sample of the target population, recruiting minorities for the staff of the research intervention, and monitoring subject participation over time?) o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. (For example, what provisions have been made for the protection of experimental subjects and the safety of the research environments? How does the applicant plan to handle issues of confidentiality and compliance with mandated reporting requirements?) AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. For AHRQ, to receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (WP5.1 or WP6.0 are preferable). In the case of AHRQ and MCHB/HRSA awards, applicants must agree to notify the funding agency immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. To the extent possible, AHRQ requires adherence to these NIH Guidelines. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS AHRQ and NIOSH encourage investigators to consider including children in study populations, as appropriate. It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned 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, Research on Emergency Medical Services for Children, is related to several 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. 93.110RS (MCHB), 93.226 (AHRQ), 93.262 (NIOSH), 93.838 (NHLBI), 93.865 and 93.929 (NICHD), 93.278 (NIDA), 93.242 (NIMH), and 93.361 (NINR). AHRQ Awards are made under authorization of Title IX of the Public Health Service Act, amended (42 USC 299-299c-7 as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. NIOSH/CDC This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. MCHB/HRSA Authorization: Title V of the Social Security Act, 42 U.S.C. 701. Eligibility: 42 CFR Part 51a.3 NIH 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of CDC appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. SMOKE-FREE WORKPLACE The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and 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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