Full Text HL-94-001 ASTHMA ACADEMIC AWARD NIH GUIDE, Volume 22, Number 37, October 15, 1993 RFA: HL-94-001 P.T. 34 Keywords: Asthma Medical Education Disease Control+ Disease Prevention+ National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 13, 1993 Application Receipt Date: February 11, 1994 PURPOSE The primary objective of this Request for Application (RFA) is to stimulate the development and/or improvement of the quality of medical curricula, physician/patient/and community education, and clinical practice for the prevention, management, and control of asthma in the United States, with particular emphasis on support of minority schools and minority individuals. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Asthma Academic Award, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by domestic universities or schools of medicine. Although this announcement is not limited to minority institutions or individuals, the intent of the program is to assure representation in the program of minority medical schools and minority individuals, with special emphasis on Black, Hispanic, Native American, Pacific Islander and other ethnic or racial group members who have been found to be underrepresented in biomedical or behavioral research nationally. Candidates A candidate for an award must: o be an established physician and medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; o have demonstrated knowledge and commitment to medical education for medical students, physicians, and patients; o have sufficient clinical training, research, and teaching experience in asthma to develop and implement a high quality curriculum in asthma encompassing current knowledge and methods applicable to the control of asthma in individuals of all ages and to provide leadership in applied research in control of asthma; o have the support of the Dean and educational leadership at the institution; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application; and o commit 30 to 50 percent effort for a period of five years. Individuals who have held another NIH career development award (K series) are eligible to apply for the Asthma Academic Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. It is anticipated that support for this program will begin September 30, 1994. FUNDS AVAILABLE The estimated funds (total costs) for this fiscal year will be $300,000. It is anticipated that three to four grants will be awarded each year for five years under this program. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. It is the intent of the program to assure representation of minority medical schools and minority individuals, with special emphasis on Blacks, Hispanics, Native Americans, and Pacific Islanders. A maximum of $50,000 for the salary of the awardee, plus applicable fringe benefits, a maximum of $20,000 for technical support, and indirect costs not to exceed eight percent may be requested. RESEARCH OBJECTIVES Background Asthma is a serious chronic condition, affecting approximately 10 million Americans. People with asthma experience over 100 million days of restricted activity annually, and costs for asthma care exceed $4 billion a year. Asthma morbidity and mortality rates are increasing. From 1980 to 1987, the prevalence of asthma in the U.S. increased 29 percent, and the number of asthma deaths increased by 31 percent. Recent reports indicate that mortality from asthma has been rising since about 1968 in all age groups. In 1987, the overall death rate from asthma was 1.9/100,000 people with females slightly higher than males. Many of these deaths were considered to be largely preventable. The largest increase in asthma-related mortality has been among blacks, women, and persons over 65 years of age. Additionally, since about 1950 there has been a widening gap in deaths from asthma between blacks and whites. Asthma mortality has been three times higher in black compared to white males and twice as high in black than in white females. Reduction of asthma morbidity has been identified as a new objective in the U.S. Health Objectives for the Year 2000. Considerable national attention is being directed at this problem, including the following major efforts. Considerable behavioral and education research has been conducted in the area of patient/family self management to complement and enhance medical treatment regimens, and these have yielded several effective educational programs for patients and their families. With representation from 30 governmental, professional, and voluntary health organizations, a National Asthma Education Program has been initiated to educate patients, the public, and health care providers about the disease. A major early accomplishment of this Program was the preparation and dissemination of the Guidelines for the Diagnosis and Management of Asthma and the Executive Summary: Management of Asthma During Pregnancy. Yet although asthma is a disease that generally can be controlled with expert medical treatment and self-management, many patients are not receiving state-of-the-art medical care and/or are not following the prescribed treatment plans. Special programs are needed to reach health care providers in areas remote from major medical centers and to reach minority and lower socioeconomic level patients in both inner city and rural areas. Multidimensional research conducted by multidisciplinary teams will be required to improve clinical practice and patient education. Therefore, the aim of this program is to stimulate the development and/or improvement of the quality of medical education, patient and community education, research programs, and clinical practice focused on the control of asthma. Objectives The objectives of the Asthma Academic Award are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the opportunities for students, house staff, and others, including practicing physicians, to learn the principles and practice of preventing, managing, and controlling asthma; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote communication among specialists in primary care, allergy, and obstetrics and gynecology to ensure appropriate treatment of pregnant women with asthma; o encourage applied research in the control of asthma; o promote the development of a faculty capable of providing appropriate diagnosis and management instruction in asthma, with special emphasis on minority faculty; o promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic, and prevention measures in asthma in both children and adult populations; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have asthma, such as minorities, young children, and the elderly; o provide for outreach programs from medical centers to health practitioners in the community to enhance optimal care, especially in areas of high asthma morbidity, such as inner city minority communities; o facilitate an interchange of ideas among awardees and institutions; o evaluate the impact of the proposed program; o contribute to the public health efforts to control asthma in the United States; and o enhance the teaching of asthma in minority medical schools and promote community asthma education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about asthma and among physicians who are or who will be caring for medically underserved populations. Since this is a medical education program, funds may be requested for technical support staff who have complementary expertise to the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS 1. Awardee Salary The salary requested for the awardee must not exceed the actual institutional salary rates for the effort devoted to the Academic Award, and must not exceed $50,000 plus fringe benefits. A candidate must spend at least 30 percent time on this award. An awardee may devote up to a total of 100 percent effort as an Academic Awardee and as principal or participating investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such grant(s) or contract(s) accordingly. An example of an investigator who receives the Academic Award at a level of effort of 30 percent, who wishes to devote 60 percent of effort to other Federally-sponsored research, and whose institutional salary is $130,000 is as follows: Academic Award 30 percent effort $ 37,500* Other Federally-supported grants and contracts 60 percent effort $ 75,000* Total salary from Federal sources $112,500 Salary contribution from grantee's institution $ 17,500 Total Salary $130,000 *(based on the current ceiling of $125,000) 2. Program Support Program support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the awardee if requested for the development and evaluation of the educational program. Salaries will be allowable for technical and support personnel, e.g., educational and evaluation specialists. Student stipends are allowable for students conducting projects directly related to the award; o equipment costs are not allowable; o consumable supplies essential to the proposed program; o funds for educational development to enable the awardee to develop educational skills; o funds for travel for the Principal Investigator to meet with other awardees and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Awardees may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures of equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution may apply for an award on behalf of a named individual meeting the criteria for this award. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a non-competitive basis depending upon progress being made in meeting the program's objectives. An annual report will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon approval by the Division of Lung Diseases of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Although the Asthma Academic Award is not primarily a mechanism to support research, some awardees may implement some research as a part of the overall Academic Award program. If any clinical research is proposed under this program, the policies of the NIH regarding inclusion of women and minority apply. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group and approximate percentages should be included. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Programs involving educational strategies including the effectiveness of such strategies, such as required by this program, are considered human subject research. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by December 13, 1993, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the RFA number and title in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Telephone: (301) 594-7452 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, "RFA: HL-94-001-L Asthma Academic Award" must be typed on Line 2a of the face page of the application form and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 548B Bethesda, MD 20892 Applications must be received at both locations by February 11, 1994 to be assured of review in this competition. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA NHLBI staff will return the application to the applicant. The initial review may include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this program announcement (triage); the NIH will remove from further consideration applications judged to be noncompetitive and promptly notify the Principal Investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures, including, if deemed appropriate, an applicant interview in or near Bethesda at the applicant's expense. The initial review will be conducted by a Special Emphasis Panel, managed by the Division of Extramural Affairs, National Heart, Lung, and Blood Institute. The secondary review will be by the National Heart, Lung, and Blood Advisory Council. Applications for this Asthma Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the asthma problem and the need for the program in the area to be served; o the overall merit of the proposed five-year plan for improving the institution's interdepartmental curricula in asthma control; o access to a population with high incidence of asthma; o the qualifications and background of the candidate, including experience in teaching, curriculum development and administration within a medical school, and planning and conduct of clinical research; o the ability and commitment to working cooperatively with other awardees to make innovative asthma curricula and materials available; o the institution's commitment to implement the proposed curriculum and to continue a program in education about asthma control after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with asthma, especially in areas with high morbidity from asthma, such as inner city minority communities; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, family practice, internal medicine, community medicine, and other specialties; o plans for collaborative projects with other organizations that have responsibility for and interest in asthma control, for example, health departments, medical and nursing associations, and voluntary health agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential for the program making an impact on the control of asthma among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is September 30, 1994. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Asthma Academic Award, the Division of Lung Diseases will provide funds for a project period up to five years. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are urged to contact the program administrator, as soon as they receive approval from their institution to apply for this award. Direct inquiries regarding programmatic issues to: Joan M. Wolle, Ph.D., M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CAR 52 and 45 CAR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. .
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