Full Text AI-95-007 NATIONAL COOPERATIVE INNER-CITY ASTHMA STUDY NIH GUIDE, Volume 24, Number 4, February 3, 1995 RFA: AI-95-007 P.T. 04 Keywords: Asthma Biomedical Research, Multidiscipl Environmental Effects National Institute of Allergy and Infectious Diseases National Institute of Environmental Health Science Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH) invite applications from institutions wishing to serve as Asthma Study Centers for the National Cooperative Inner-City Asthma Study (NCICAS), as well as the central Data Coordinating Center for all participating Asthma Study Centers. This cooperative, multi-center study seeks to reduce the disproportionate burden of asthma morbidity among underserved, inner- city children and adolescents from 4 to 12 years of age. Underserved, inner-city populations are defined as those having low socioeconomic status and residing in urban areas. The goal of this study is to design and evaluate an asthma intervention, based in health care delivery settings, aimed at reducing asthma morbidity in a cost-effective manner. Health care delivery settings are defined as medical clinics, hospital clinics, or emergency room clinics. Because of the multifaceted nature of asthma, a broad-based approach to the intervention is required. The intervention will involve all of the following elements: improving asthma treatment by physicians, increasing asthma self-management by asthmatics and their families, and environmental interventions. The specific components should be derived from the experience and findings generated by the initial NIAID-sponsored NCICAS, 1991-1996, existing asthma knowledge, pre- existing asthma interventions or programs, and/or new innovative approaches to this problem. 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 Request for Applications (RFA), the National Cooperative Inner-City Asthma Study, is related to the priority areas of environmental health, diabetes and chronic disabling diseases, and age-related objectives pertaining to children. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or 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 Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All applicants must apply to participate as an Asthma Study Center. Applicants may also apply to participate as both an Asthma Study Center and the central Data Coordinating Center. Two separate applications will be required from institutions applying for both an Asthma Study Center and the central Data Coordinating Center, including a specific plan for how the independent operation of each unit will be maintained as required. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of a study funded under cooperative agreement(s) are discussed under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed five years. At this time, the NIAID and the NIEHS have not determined whether and how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for awards under this RFA will be $2,250,000: $1,500,000 from the NIAID and $750,000 from the NIEHS. In Fiscal Year 1996, the NIAID and the NIEHS plan to fund up to 7 new and/or recompeting Asthma Study Centers, one of which will serve as the central Data Coordinating Center. Applications from institutions wishing to participate as Asthma Study Centers should not request first-year budgets in excess of $280,000 in total (direct and indirect) costs. Applications from institutions wishing to participate as both an Asthma Study Center and the central Data Coordinating Center should not request first-year budgets in excess of $300,000 in total (direct and indirect) costs to support the central Data Coordinating Center functions. The NIH is currently limiting annual inflationary increases to no more than four percent for future years of awards. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID and the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Asthma is one of the most common chronic diseases of childhood. Data from the 1990 U.S. National Health Interview Survey indicate that nearly 3.7 million children, ages 17 years and less, suffer from asthma -- 5.8 percent of the U.S. population. Asthma morbidity and mortality have increased in recent years. Asthma prevalence increased by 40 percent among children less than 18 years of age during the 1980s, with African-American children having higher levels of asthma than white children. African-American children also experienced almost double the rate of increase in asthma hospitalization rates compared to white children during this time period. Little information on Latino children is available, but recent studies have found that Latino children in New York have very high levels of asthma prevalence and hospitalization. Although asthma deaths are still infrequent, mortality rates increased 6.2 percent per annum during the 1980s for 5 to 34 year olds; non-whites are two to three times more likely than whites to die from asthma. The economic costs of asthma are enormous despite its low mortality. In 1990, the cost of asthma in the United States was estimated to be $6.2 billion. Despite the widespread assumption that asthma is a mild illness, 43 percent of the cost was due to emergency room use, hospitalization and death. Most of the advances in asthma care during the 1960s and 1970s can be attributed to the development of better drugs to treat this disease. Despite the availability of these improved drugs, asthma is undertreated in the United States. Environmental factors play an important role in asthma. Air pollutants, such as nitrogen dioxide, ozone, sulfur dioxide, and particulates from diesel exhaust have been associated with worsening of asthma and higher levels of sensitization to allergens. The indoor environment has been the focus of interest, especially as individuals spend the majority of their life indoors. A wide variety of elements in the indoor environment have been associated with asthma, such as house dust mites, cockroach, cat, tobacco smoke and nitrogen dioxide. Many recent attempts at reducing asthma morbidity have focused on educational strategies. However, because of the multifaceted nature of this disease, particularly among underserved children and adolescents, a broad-based approach to intervention involving the provider, the patient, and the environment will be required to achieve a meaningful impact on disease burden. In 1991, the NIAID established the National Cooperative Inner-City Asthma Study, a two- part, five-year study undertaken at eight sites in seven sites nationwide. The objective of NCICAS Phase I (1991-1994) was to identify factors amenable to intervention that determine asthma severity and morbidity among inner-city children, ages 4 to 9 years. Preliminary results indicate that asthma morbidity is affected by lack of access to medical care, poor self-management skills, and environmental exposures. NCICAS Phase II (1994-1996) involves an intervention trial using an asthma counselor with a social work background to modify these factors in order to reduce asthma morbidity in these populations. The protocols for NCICAS, 1991-1996, Phases I and II will be available upon request from the NIAID program contact listed under INQUIRIES. Research Objectives and Scope Study Design This RFA solicits applications for a cooperative intervention study for underserved urban asthmatic children and adolescents, ages 4 to 12 years. Underserved urban populations are defined as those having low socioeconomic status and residing in urban areas. The objective of this cooperative study is to develop, implement, and evaluate a culturally-appropriate, comprehensive, and cost-effective intervention program aimed at reducing asthma morbidity by modifying those potentially reversible factors shown to contribute to asthma morbidity. The final study design will consist of a consensus core protocol with site-specific additions/modifications to address local issues. The core protocol will include all of the following elements: medical treatment for asthma delivered in a health care facility, self-management by asthmatics and their families, and indoor environmental interventions including studies to measure, monitor and improve the indoor environment. Although the major environmental focus of this cooperative study is the indoor environment, proposed protocols for innovative approaches may include major outdoor environmental factors. The core protocol may be modified by the individual Asthma Study Centers to tailor the core intervention to local populations, communities, or health care facilities. NOTE: Although the actual protocol to be conducted will be designed by the Steering Committee, applications must include a proposed protocol that meets the objectives and scope of this RFA. SPECIAL REQUIREMENTS A. Study Organization 1. Steering Committee A Steering Committee will be established to serve as the main governing body of the study. The Steering Committee will be composed of the Principal Investigator (or his/her designee) from each Asthma Study Center, one NIAID representative from the Office of Epidemiology and Clinical Trials, Division of Allergy, Immunology and Transplantation, hereafter designated the NIAID Study Coordinator, and one NIEHS representative, hereafter designated as the NIEHS Study Coordinator. Principal Instigators must be physicians with substantial experience in (1) asthma treatment, (2) asthma research, and (3) the design, implementation and evaluation of asthma intervention trials. All major scientific decisions will be determined by majority vote of the Steering Committee, with each Principal Investigator, the NIAID Study Coordinator, and the NIEHS Study Coordinator having one vote. The Chairperson will be selected by the Steering Committee from among the non-Federal members during the first meeting of the Committee, to be convened by the NIAID and the NIEHS Study Coordinators. The Director of the central Data Coordinating Center shall serve as a non-voting member of the Steering Committee and shall participate in all Committee activities in an advisory capacity. The Steering Committee will meet at least two times during the first 12 months of the study and at least annually thereafter. The Steering Committee will have primary responsibility for: developing the consensus core protocol; approving site-specific modifications to the core protocol as necessary to tailor the core intervention to local populations, communities, or health care facilities; facilitating the conduct and monitoring of the study; determining analyses to be performed using the collective data base; interpreting study data; and reporting study results. The study will proceed into the implementation stage only with the concurrence of the awardees, the NIAID Study Coordinator, and the NIEHS Study Coordinator. Each Principal Investigator (or his/her designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Subcommittees of the Steering Committee may be established as necessary. 2. Data and Safety Monitoring Board An independent Data and Safety Monitoring Board, to be appointed by the NIAID and the NIEHS Study Coordinators with approval of the Steering Committee, will review progress at least annually and report to the NIAID and the NIEHS Study Coordinators. Protocols will be subject to review by the Data and Safety Monitoring Board in an advisory capacity. 3. Data Coordination, Management and Analysis Each Asthma Study Center will be responsible for: collecting all site-specific data for the consensus core protocol; submitting all such data to the Data Coordinating Center; and adhering to the policies and procedures established by the Steering Committee with respect to standardized data collection, data management, and protocol implementation and compliance. Applications for Asthma Study Centers should include in their budget requests support for all of these functions. The Data Coordinating Center will have primary responsibility for: the acquisition or creation of forms and/or materials for protocol implementation; quality control; uniformity of data collection; overseeing implementation of and adherence to the consensus core protocol; and storing, managing and analyzing data generated from the consensus core protocol. Specific analyses of the collective data base to be carried out by the Data Coordinating Center will be approved by the Steering Committee and the results of those analyses will be delivered to the Steering Committee as the group responsible for reviewing and approving the use and dissemination of study findings. The Data Coordinating Center will also be responsible for providing reports, at least annually, to the Steering Committee and, when appropriate, to the Data and Safety Monitory Board, concerning any and all of the above responsibilities, and for the planning and logistical arrangements of meetings of the Steering Committee and its subcommittees. Applications for the central Data Coordinating Center should include in their budget requests support for all of these functions. B. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardees, the NIAID Study Coordinator, and the NIEHS Study Coordinator. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of the NIAID and the NIEHS Study Coordinators in all aspects of the scientific and technical management of the project. Specifically, awardees have primary responsibilities as described below. Steering Committee Membership and Meeting Attendance Each Principal Investigator (or his/her designee) will serve as a voting member of the Steering Committee and will participate in all scientific decisions. Each Principal Investigator (or his/her designee) will be responsible for attending all Steering Committee meetings, including not less than two meetings during the first 12 months of the study and one per year thereafter. The Steering Committee shall be responsible for determining the frequency of meetings and scheduling the time and location. Each Principal Investigator (or his/her designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Subcommittees of the Steering Committee may be established as necessary. The Director of the Data Coordinating Center shall serve as a non- voting member of the Steering Committee and shall participate in all Steering Committee activities in an advisory capacity. Protocol Development and Conduct The Steering Committee will define the core protocol objectives and approaches within the areas of health care delivery, asthma self- management, and environmental controls. The Steering Committee will design the consensus core protocol and approve the site-specific additions to address local issues. With Steering Committee approval, the core protocol may be modified by the individual sites as necessary to tailor the core intervention to local populations, communities, or health care facilities. Each awardee will follow the procedures required by the Steering Committee regarding study conduct and monitoring, patient management, data collection, quality control, data analysis, and data presentation and publication. Data Coordination, Management and Analysis Each awardee will be responsible for: collecting all primary, site- specific study data; providing all such data to the Data Coordinating Center; and adhering to the policies and procedures established by the Steering Committee with respect to standardized data collection, quality and analysis, and protocol implementation and adherence. All data will be available to all awardees. The awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies. Publication and Presentation of Study Findings Early publication of major findings is encouraged. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgement of the Asthma Study Centers, NIAID and NIEHS support. Analyses to be performed using the collective data from all Asthma Study Centers will be directed and coordinated by the Steering Committee. Asthma Study Centers performing analyses of local data will be subject to Steering Committee review and approval in order to avoid duplication. Review and approval by the Steering Committee will be required for all analyses prior to publication or presentation according to criteria that will be developed by the Steering Committee. Monitoring Study Progress The Steering Committee will establish mechanisms for assessing performance of the Asthma Study Centers, with particular attention to accrual of adequate numbers of eligible patients, timely submission and quality of required data, and conscientious observance of protocol requirements. Federally Mandated Regulatory Requirements Each Asthma Study Center is required to meet the DHHS/PHS regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include: o methods for assuring that each institution at which Asthma Study Center investigators are conducting clinical studies has a current, approved assurance on file with the Office of Protection from Research Risks (OPRR); that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to patient entry; that active protocols are reviewed at least annually by the IRB; and that amendments are approved by the IRB. o methods for assuring or documenting that each patient, or patient's parent/legal guardian, gives fully informed consent to participation in a research protocol prior to the initiation of the experimental intervention. 2. NIAID and NIEHS Staff Responsibilities The NIAID and the NIEHS Study Coordinators will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. Steering Committee Membership and Meeting Attendance The NIAID and the NIEHS Study Coordinators will serve as voting members of the Steering Committee, will attend all Steering Committee meetings, and will participate in other Committee activities, e.g., conference calls, special subcommittees. Protocol Development As members of the Steering Committee, the NIAID and the NIEHS Study Coordinators will serve as resources with respect to the design of the protocol and will assist the Steering Committee in protocol development. The NIAID Study Coordinator will provide all protocols and available data from NCICAS, 1991-1996, for development of the core consensus protocol. Study Materials The individual Asthma Study Centers will be responsible for the acquisition of study materials required by the protocol. The NIAID and the NIEHS Study Coordinators will arrange for the appropriate approvals (when necessary) from the Food and Drug Administration (FDA) and the Bureau of Biologics (BOB) with respect to the use of investigational drugs. Monitoring Study Performance The NIAID and the NIEHS Study Coordinators will provide assistance to the Steering Committee in the development of mechanisms and procedures for monitoring study performance. This includes participation in periodic on-site monitoring with respect to compliance with protocol specifications, quality control and accuracy of data recording, and patient accrual. Data Coordination and Management Under the direction of the Steering Committee, the NIAID and the NIEHS Study Coordinators will provide technical guidance on data management to the Asthma Study Centers with respect to quality control, uniformity of data collection, management of the collective data base, and data analysis. The Government, via the NIAID and the NIEHS Study Coordinators, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. Information obtained from the data may be used by the NIAID and the NIEHS Study Coordinators for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards. Publication and Presentation of Study Findings The NIAID and the NIEHS Study Coordinators may contribute, through review, comment, analyses, and/or co-authorship, to reporting results of the study to the investigator community and other interested scientific and lay organizations. Co-authorship by the NIAID and the NIEHS Study Coordinators will be subject to approval in accordance with NIH policies regarding staff authorship of publications resulting from extramural awards. Organizational Changes Certain organizational changes require the prior written approval of the NIAID and the NIEHS Study Coordinators. These changes include the addition/deletion of a physician, scientific investigator, affiliate, component, or research base that is associated with this study. A change in the Principal Investigator, or in any key personnel identified on the Notice of Award, must have the prior written approval of the NIAID and NIEHS Grants Management Specialists in consultation with the NIAID and the NIEHS Study Coordinators. Program Review The NIAID and the NIEHS Study Coordinators will review the progress of each Asthma Study Center through consideration of annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting. The NIAID and the NIEHS Study Coordinators reserve the right to terminate or curtail the study (or any individual award) in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breech of the protocol, (b) substantive changes in the agreed-upon protocol to which the NIAID and the NIEHS Study Coordinators do not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination. 3. Collaborative Responsibilities A Steering Committee, composed of the Principal Investigators, the NIAID Study Coordinator, and the NIEHS Study Coordinator will be the main governing body of the study and will have primary responsibility for all scientific decisions, including: developing the consensus core protocol; approving site-specific modifications to the core protocol as necessary to tailor the core intervention to local populations, communities, or health care facilities; coordination of the site-specific protocol additions; facilitating the conduct and monitoring of the study; coordination and oversight of the development of data collection, management and quality control procedures; establishing procedures for assessing performance with respect to accrual, quality of data, and conscientious observance of protocol requirements; and coordinating and overseeing the analysis, interpretation, and publication of study data. Each member of the Steering Committee will have one vote. The Chairperson will be selected by the Steering Committee from among the non-Federal members. Subcommittees will be established by the Steering Committee as it deems appropriate. An independent Data and Safety Monitoring Board, to be appointed by the NIAID and the NIEHS Study Coordinators with Steering Committee approval, will review progress at least annually and report to the NIAID and the NIEHS Study Coordinators. The protocol will be subject to review by this Board in an advisory capacity. Awardees will be required to accept and implement the consensus core protocol and procedures approved by the Steering Committee. The study will proceed into the implementation stage only with the concurrence of the awardees, the NIAID Study Coordinator, and the NIEHS Study Coordinator. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients, the NIAID Study Coordinator, and the NIEHS Study Coordinator may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NIAID and the NIEHS Study Coordinators not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID and the NIEHS Study Coordinators, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's rights to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS The study population for this RFA is limited to underserved, inner- city children from 4 to 12 years of age. Within this population, NIH requirements for inclusion of women and minorities in study populations apply. It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by, April 15, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA, and a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows the NIAID and the NIEHS 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 Dr. Paula Strickland at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). These application forms may be obtained from the institution's office of sponsored research or its equivalent and 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "NATIONAL COOPERATIVE INNER CITY ASTHMA STUDY" must be typed in. Applications must address the requirements below. For Asthma Study Centers: 1. Applications should include a proposed protocol that meets the objectives and scope of this RFA, as well as a discussion of the rationale for the patient population, the study design and the intervention strategy selected for study, timeline for completion of the study, and an assessment of how anticipated study results can be expected to contribute to improvements in asthma morbidity among underserved urban children and adolescents with asthma. 2. The applicant institution must document its experience and capacity to recruit and retain study participants, provide a description of the population currently available for the proposed protocol, and describe proposed mechanisms for monitoring accrual performance and criteria for continued participation. 3. Applications must name a single Principal Investigator (PI) who will have scientific responsibility for the application as a whole including all Asthma Study Center-related research activities included under it. The PI must be a physician with substantial experience in (1) asthma treatment; (2) asthma research; and (3) the design, implementation and evaluation of asthma intervention trials. 4. Applications must name a Project Coordinator who is an individual with substantial technical/administrative experience in managing patient enrollment, patient follow-up, and multi-source data collection for intervention trials. 5. Applications must provide: a clear, concise plan in narrative and diagrammatic form that depicts the interrelationships among the members of the Asthma Study Center, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this RFA; an organizational chart of the Asthma Study Center showing the name, organization, and scientific discipline of the PI and of all key scientific, technical and administrative personnel; and a mechanism for selecting and replacing key professional or technical personnel. 6. Applications must provide a plan to assure the maintenance of close cooperation and effective communication among members of the Asthma Study Center. 7. Applications should discuss the capability of the applicant organization to participate and interact effectively in a cooperative, multi-center asthma intervention trial. 8. Applications must include a written commitment to accept the participation and assistance of the NIAID and NIEHS Study Coordinators in accordance with the guidelines outlined under "Terms and Conditions of Award: NIAID and NIEHS Staff Responsibilities." The application must also include a written commitment to the cooperative organization and willingness to serve on the Steering Committee and adhere to the decisions reached by that Committee, including following the consensus core protocol. 9. All costs required for the proposed protocol must be included in the application and must be fully justified. These include the additional costs of clinical research associated with the proposed protocol, costs for patient recruitment and follow-up, laboratory studies, materials or forms required by the protocol, data collection and management, and participation in on-site quality assurance audits. Requested budgets should also include: (1) travel to the Washington, DC area for two 2-day Steering Committee meetings during the first 12 months of the study and annual Steering Committee meetings thereafter for the Principal Investigator. For the Data Coordinating Center: 1. Applications must provide documentation of the specific competence and previous experience of professional, technical and administrative staff pertinent to the operation of a Data Coordinating Center for a multi-center, cooperative clinical intervention, including prior experience in similar or related studies with respect to the collection, management and analysis of data from multiple sites and experience in monitoring the quality and timeliness of such data. 2. Applications must include a proposed plan for data management, quality assurance and analysis, as well as proposed methods for monitoring protocol implementation and adherence in similar and/or related projects. 3. Applications must describe the adequacy of the proposed facility, technical hardware, and space. 4. Applications must provide evidence of the degree of commitment and support of the institution for the proposed program, including the relative position of the proposed project staff within the applicant organization's structure. It is highly recommended that the Director of the Office of Epidemiology and Clinical Trials, NIAID Division of Allergy, Immunology and Transplantation or the Program Administrator, Organs and Systems Toxicology Branch, NIEHS Division of Extramural Research and Training, be contacted in the early stages of preparation of the application. (See program contacts listed under INQUIRIES.) Applications must be received by June 15, 1995. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit will be judged nonresponsive and will be returned to the applicant. The RFA label available in the PHS 398 must be affixed to the bottom of the face page. 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. Applications received after the receipt date will be returned without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not exclude the submission of substantial revisions of an application already reviewed. These applications must, however, include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced 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 exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Paula Strickland at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by NIAID and NIEHS staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non- competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly notified. The second level of review will be provided by the NIAID and NIEHS Advisory Councils. Review Criteria Applicants are expected to address the requirements identified under APPLICATION PROCEDURES. The review criteria for applications in response to this RFA are: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Peter J. Gergen, M.D.,M.P.H. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A29 6003 Executive Boulevard - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-0982 FAX: (301) 402-2571 Email: pg17q@nih.gov George S. Malindzak, Jr., Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 T. W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-3289 FAX: (919) 541-2843 Email: gm26f@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Paula Strickland, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C02 6003 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-0643 FAX: (301) 402-2638 Email: ps30f@nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda M. Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C23 6003 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: ls15k@nih.gov Schedule Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: June 15, 1995 Scientific Review Date: October 1995 Advisory Council Date: January 1996 Earliest Award Date: April 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance N0. 93.855, 93.113 and 93.115. 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, 43 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free work place and promote the nonuse of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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