MINORITY K-12 INITIATIVE FOR TEACHERS AND STUDENTS (MKITS) RELEASE DATE: November 13, 2002 RFA: HL-02-026 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) LETTER OF INTENT RECEIPT DATE: February 21, 2003 APPLICATION RECEIPT DATE: March 19, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this Request for Applications (RFA) is to provide support for the research into and development and evaluation of innovative science training programs that will provide minority students in grades K-12 with the exposure, skills, and knowledge that will encourage them to pursue advanced studies in the biomedical and behavioral sciences. The goal is to increase the number of underrepresented minorities who choose to enter scientific research careers in the future. Applications to this NHLBI MINORITY K-12 INITIATIVE (MKITS) should (1) describe programs that are designed to provide students with scientific and research experiences while they are still undecided about their future education and career choices, (2) enable teachers to improve exposure to scientific and research experiences in their schools, and (3) demonstrate an organizational infrastructure that supports development, implementation, and evaluation of exposure to scientific research experiences. Participants in the program will include NHLBI-supported investigators and K-12 students and teachers. Teacher training activities will enable teachers to enhance the scientific knowledge and skills and research experiences of students in their classrooms. Applications that propose supplementary activities, such as family-based learning, are encouraged. It has long been a goal of the NHLBI to increase the number of underrepresented minorities in scientific research. The 2000 National Science Foundation report on the status of underrepresented minorities in science shows progress since 1982 in increased numbers and percentages of African Americans, Hispanics and Native Americans who have completed bachelor's, master's and doctoral degrees in science and engineering. However, African American and Hispanic faculty were less likely than white faculty to be full professors (after adjusting for age), and earned lower salaries than White and Asian scientists within the same age range and scientific fields [National Science Foundation. Women, Minorities, and Persons With Disabilities in Science and Engineering: 2000. Arlington, VA, 2000 (NSF 00-327), http://www.nsf.gov/sbe/srs/nsf00327/start.htm. Currently, the NHLBI funds undergraduate and postdoctorate training and career development (http://www.nhlbi.nih.gov/funding/training/redbook/trgnprog.htm), however the MKITS would be the first program to promote scientific and research experiences in grades K through 12. MKITS will fund exposure to scientific and research experiences in heart, lung, blood, and sleep disorders and health, consistent with the mission of the NHLBI. (See NHLBI Mission Statement http://www.nhlbi.nih.gov/about/org/mission.htm.) Focusing on these scientific content areas is a means to facilitate students learning about the scientific process and inquiry, and to encourage their enthusiasm for science and its importance in their lives. Grant applications will be accepted in response to the RFA from NHLBI- funded organizations that propose to provide creative and innovative scientific and research experiences for program participants. This solicitation requires collaboration among NHLBI-funded institutions, local schools and school districts, the local school community, and other local organizations or educational institutions. Individual schools are eligible to participate in the MKITS program if their K-12 student population is at least fifty percent underrepresented minorities. Underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group determined by the grantee institution to be underrepresented in biomedical, behavioral, clinical, or social sciences. African Americans (Blacks), Hispanic Americans, Native Americans and Alaska Natives, and non-Asian Pacific Islanders are considered to be underrepresented nationally in biomedical, behavioral, clinical or social sciences. Scientists and educators who plan to apply for this grant are strongly encouraged to contact appropriate NHLBI staff (listed under INQUIRIES) prior to preparing an application to determine whether their application meets the program priorities of the NHLBI. PROGRAM OBJECTIVES MKITS programs provide the opportunity for underrepresented minority students in grades K-12 to meet the following primary objectives: (1) to gain scientific knowledge and research skills in heart, lung, blood and sleep disorders and health; (2) to participate in research experiences in heart, lung, blood and sleep disorders and health; and (3) to facilitate students developing career goals that include science, research, medicine and related fields. MKITS programs may serve an entire school or one or more classes, as long as the entire population is at least fifty percent underrepresented minorities. MKITS programs should aim to increase science literacy and skills among a broad group of students, not only gifted students. Although the primary participants in the MKITS programs will be students and teachers, applicants may involve guidance counselors, and parents or families in order to meet the primary and secondary program objectives. Secondary objectives are specified by applicants and may address topics such as training the trainer, peer educators, community health promotion, and scientific career opportunities. Applicants are required to collaborate with schools or the local school district, local institutions, organizations and other key partners. Additional key partners include community-based organizations with an interest in minority health, career development; minority-serving institutions; parent, student and teacher organizations; and local chapters of disease-specific associations, such as the American Heart Association, the American Lung Association, and the Sickle Cell Disease Association of America. Applicants should include a three to six month period for building partnerships ("coalition building") at the start of funding, and describe plans for this phase of the program. Applicants should specify secondary objectives for their proposed MKITS program, and the additional participants and partners. To meet these primary and secondary objectives, research scientists and other specialists at NHLBI-funded institutions must develop collaborative partnerships with students' schools, school personnel and administrators. The NHLBI recommends that applicants include parents and/or families, community organizations and/or minority-serving institutions in the collaborative partnerships. If inclusion of these is not possible for some reason, applicants should explain the reasons for their exclusion. Applicants are required to take a multidisciplinary approach to (1) establish the program infrastructure and (2) develop and implement the MKITS curricula. The MKITS infrastructure (see Cores, below) should include personnel from the applicant institution and collaborating partners with expertise in all necessary fields. For example, applicants may design a program infrastructure that includes experts in psychology, elementary and secondary science education, child development, minority health, career counseling, evaluation research, community empowerment and leadership. The program infrastructure should include representatives from participating institutions, organizations and other key partners. Multidisciplinary approaches to MKITS curricula activities should replicate how research scientists collaborate in their work lives. Curricula and activities should be developmentally and age-appropriate, and enable students to develop skills such as planning experiments or community health activities; hypothesizing; observing phenomena whether planned and cumulative or unsuspected discoveries; recording and visually displaying data; manipulating large numbers or amounts of data; and presenting information to various audiences. Curricula and activities for teachers and guidance counselors may address theory, careers in science, career development by networking and mentoring, summer internships, college applications and scholarships for science majors, how to access equipment and supplies, assistance with implementing school district curricula, and science or health fairs and other presentations. Collaborative partners, especially from local organizations, will help applicants determine the appropriateness of including parents and families in various activities, and the methods for doing so. Approaches to curricula and activities will include the traditional basic sciences such as chemistry, physics, biology, and mathematics; and may include epidemiology, nutrition, psychology, sociology, genetics, molecular biology, scientific theory and research methods, community and public health, statistics, anatomy and physiology. Applicants and collaborators will create a program infrastructure for the MKITS programs that includes: 1. An Administrative Core that will be responsible for infrastructure and capacity building, coordinating functions within and across the different organizational structures and performing oversight responsibilities. The Administrative Core will provide the organization and infrastructure that will design, promote, manage, deliver, assure evaluation, and plan for sustainability of the program. It will draw upon multiple disciplines and involve collaboration with multiple partners, many of whom may have not previously worked together. The Administrative Core should, in collaboration with members of the other organizational cores, plan for program sustainability after the period of NHLBI funding. The Program Director should be a proven leader, have the authority and institutional support for implementing the program, and be at a level in the organization where s/he can garner the necessary support and resources. The Program Director will have a leadership role in the Science and Research Core and the Evaluation Research Core. 2. A Science and Research Core that will develop and deliver the programs, scientific training, and research activities. The Science and Research Core will have primary responsibility for developing and delivering the scientific and research activities. Curricula that are age-appropriate, and combine science and research experiences in the basic and clinical sciences and public health should be developed by a multidisciplinary team that includes representatives from participating institutions. Curricula that address minority health problems are encouraged. Students should be given the opportunity to participate in projects that can be displayed or reported to a larger audience. 3. An Evaluation Research Core that will develop and conduct short-term (i.e., process and formative) and long-term (i.e., over the course of the program) evaluations of the program objectives, interventions, outreach strategies, and other program components. The Evaluation Research Core staff should be involved in all phases of program development and delivery so that mid-course corrections can be implemented. Plans for evaluating the effectiveness of the program and for identifying program features that promote program sustainability must be included. The activities supported by MKITS grants can involve training and research experiences of short (e.g., 3 months) or longer-term (e.g., year-long) duration. Formats for the programs may vary to include a series of classes, field trips, short-term or long-term research experiences or projects; curriculum development, implementation and evaluation; and teacher training or professional development. Innovative approaches to learning, including web-based technologies, are encouraged. The NHLBI expects applicants to propose their own creative and innovative MKITS programs in heart, lung, blood, and sleep disorders and health. For the MKITS programs to succeed, it will be essential for the Program Director, faculty and administration at the NHLBI-funded institution, local K-12 school teachers and administration, and members of other local institutions to collaborate in developing a program that meets local needs, designing an evaluation plan to determine program effectiveness, selecting students and/or classes to participate in the program, and designing outreach efforts to inform parents and the local community about the program. Specifically, MKITS programs will: o Provide students with science training, exposure to research and mentoring with outstanding PIs who are actively engaged in biomedical research in heart, lung, blood and sleep disorders; o Provide K-12 teachers with training in science, the philosophy of science and the scientific method; o Encourage students to continue studying science in high school and beyond into college, graduate school and postgraduate training; o Develop a pool of students who are interested in pursuing science courses and/or research careers; o Enhance students' academic performance in science; o Plan for program sustainability after NHLBI funding by describing strategies to obtain funding from other sources, and identifying those sources; and o Evaluate progress of the program in reaching its objectives. Additionally, MKITS programs may: o Familiarize guidance counselors with scientific research careers; o Improve knowledge about minority health issues and health disparities; and o Establish partnerships with local minority institutions or organizations that do not have NHLBI funding in order to include minority role models for the students. The NHLBI anticipates that the MKITS programs will increase the scientific knowledge about (1) best methods for designing and delivering programs that encourage underrepresented minority students to pursue advanced education and training in biomedical sciences and about (2) program features that encourage sustainability of K-12 science programs after NHLBI funding. MECHANISM OF SUPPORT This RFA will use the NIH R25 award mechanism. Applicants are solely responsible for planning, directing, and executing the proposed program. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this program will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2003. This RFA uses just-in-time concepts. It uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, an application submitted in response to this RFA must use the modular format. FUNDS AVAILABLE NHLBI intends to commit approximately $2,400,000 in FY2003 to fund 6 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $250,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. Since the total costs for a subcontract or consortium are included in the direct cost request, one additional module of $25,000 above the cap may be requested for the facilities and administrative costs associated with third party agreements. A module requested for this purpose must be clearly identified in the budget justification section of the application, and will be restricted for this purpose only at the time of award. ELIGIBLE INSTITUTIONS Applications may be submitted by institutions that have any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Domestic o Faith-based or community-based organizations Applicant institutions must have at least one currently (i.e., at time of submission) funded NHLBI-funded research (R series) or research training (T series) grant, or cooperative agreement (U series). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS/ PROGRAM DIRECTORS Individuals with the skills, knowledge, and resources necessary to carry out the MKITS objectives are invited to work with their institution and collaborative partners to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Eligibility Criteria Eligible institutions are organizations that have an active NHLBI- funded grant at the time of submission. Individual K-12 schools are eligible to participate with an NHLBI-funded organization in the MKITS program if their K-12 student population is at least fifty percent underrepresented minorities. Underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group determined by the grantee institution to be underrepresented in biomedical, behavioral, clinical, or social sciences. African Americans (Blacks), Hispanic Americans, Native Americans and Alaska Natives, and non-Asian Pacific Islanders are considered to be underrepresented nationally in biomedical, behavioral, clinical or social sciences. The Program Director of the MKITS program will be a faculty or staff member at an institution with at least one NHLBI-funded research (R series) or research training (T series) grant, or cooperative agreement (U series). The Program Director may be the Principal Investigator on one of these awards, but not on a mentored career development (K08 or K23) or National Research Service Award F31 or F32 fellowship award. The Program Director should have a history of mentoring or teaching, and a strong commitment to training young people and advancement of underrepresented minorities in scientific research careers. The Program Director should be in a position to coordinate and direct use of facilities and resources by program participants. At least one Principal Investigator on the applicant institution's NHLBI-funded research (R series) or research training (T series) grants, or cooperative agreements (U series) must participate in at least one activity in the MKITS program. For example, the NHLBI-funded PI may deliver a lecture, demonstrate a lab experiment to students, act as a resource for curriculum development especially for lab-based projects or experiments, or lead teacher training activities. If the applicant institution has more than one NHLBI grant or cooperative agreement, the NHLBI encourages the applicant to involve additional Principal Investigators in MKITS activities. Allowable Costs Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and justified for the MKITS program. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Personnel Costs - individuals participating in the design and implementation of the MKITS program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated maximum ($166,700 in fiscal year 2002). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Consultation costs, equipment, supplies, necessary travel, and other program related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for programs at the host institution. Participant Support – K-12 students may not receive support for participating in the program. Individuals, other than the primary Program Director, who are supported by NIH training and career development mechanisms (K, T or F Grants), may not receive stipend or salary support from the MKITS award. However, if funds are not available from other sources, limited support to defray costs (e.g., travel, meals, lodging) may be provided. Partial costs for off-site rental space will be considered if it is short term and shown to be necessary for the implementation and execution of the MKITS program (museum workshop, laboratory space, computer lab, etc.). Matching funds from applicant institutions or other organizations for such off-site costs are strongly encouraged. Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," will be reimbursed at a rate of 8% of modified total direct costs for the applicant organization and any approved subcontract. Funds will not be provided for fringe benefits or health insurance for participants involved in the MKITS program. Note that all costs associated with consortium/contractual arrangements, both direct and F&A costs, are considered direct costs and are included in the $250,000 direct costs ceiling limitation for this program. Normally, funds for the evaluation plan are not expected to exceed 5% of the total direct cost. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. o Direct your questions about scientific/research issues to: Ellen M. Werner, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Rockledge II, Room 10156 6701 Rockledge Drive, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0061 FAX: (301) 480-0868 Email: wernere@nhlbi.nih.gov Patrice Desvigne-Nickens, M.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 9158 6701 Rockledge Drive, MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0494 FAX: (301) 480-1336 Email: DesvignP@nhlbi.nih.gov Jared B. Jobe, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8122, MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0407 FAX: (301) 480-1773 Email: jobej@nhlbi.nih.gov Sri Ram, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 10206 6701 Rockledge Drive, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: rams@nhlbi.nih.gov Carl E. Hunt, M.D. Center for Sleep Disorders National Heart, Lung, and Blood Institute Rockledge II, Room 10038 6701 Rockledge Drive, MSC 7920 Bethesda, MD 20892- 7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: huntc@nhlbi.nih.gov o Direct your questions about peer review issues to: Anne P. Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health Rockledge Drive, Room 7214, MSC 7924 Bethesda, MD 20892-7924 (20817 for express mail) Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: clarka@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Ryan Lombardi Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health Rockledge Drive, Room 7160, MSC 7926 Bethesda, MD 20892-7926 (20817 for express mail) Telephone: (301) 435-0170 FAX: (301) 480-3310 Email: lombardr@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator/Program Director o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHLBI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to Dr. Clark at the address listed under WHERE TO SEND INQUIRIES. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001) with the exceptions listed below. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applications that do not conform to the specific instructions under SUPPLEMENTAL INSTRUCTIONS will be returned without review. For further assistance contact GrantsInfo, Telephone (301) 435- 0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS 1. Application face page: item number two on this page must include the RFA number and the title, MINORITY K-12 INITIATIVE FOR TEACHERS AND STUDENTS (R25). 2. Description, Performance Sites, and Key Personnel (Form Page 2): under Performance Sites include "Consortium/Contractual Arrangements," and a list of collaborating sites. If multiple sites are to be used, the applicant institution or local school must be one of those sites. A strong justification must be included if any other sites will be used. 3. Resources (Resources Format Page): describe the scientific and research environment; include a description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the proposed program. Use continuation pages, as necessary. 4. Research Plan: part "c" of this section should be re-titled "Preliminary Data and Activities" and included if applicable. This section should contain information on steps that have led to the proposed MKITS program, including collaborations to date. 5. Research Plan: part "d" of this section should be re-titled "Scientific and Research Training Program Plan" and should contain material organized under the following subheadings, as appropriate to the specific program: a) Program Direction - describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching, and can organize and administer the program; include evidence of institutional and community commitment and support for the proposed program. Include a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources, including faculty, equipment, and facilities. b) Program Faculty/Staff - describe the characteristics and responsibilities of the faculty; provide evidence that participating faculty are actively engaged in research or other scholarly activities related to heart, lung, blood or sleep disorders or health, and in other disciplines relevant to the proposed program. c) Proposed Scientific and Research Training Program - provide programmatic detail about the special activities proposed, including a description of plans to provide information to participants regarding the responsible conduct of research; if human subjects will participate, the use of human subjects in research; and if animals will be used, the use of animals in research. See the Required Federal Citations section of this RFA. d) Program Participants - provide details about the proposed participants; include a description of plans for recruiting teachers, students, and other participants. The application should include the total number of students in each participating K-12 school's student population, and the number of students in each underrepresented minority. e) Evaluation Plan - include evaluation plans for determining success of the program in achieving its objectives. Please note that applications that do not have an adequate evaluation plan will be considered non-responsive to this RFA. The inclusion of evaluation instruments is encouraged. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All applications submitted to this RFA must use the modular budget format. Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Applications requesting one module ($25,000) above the cap due to subcontract or consortium facilities and administrative costs associated with third party agreements must also be submitted in modular format and may request up to $275,000 per year in direct costs. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application as well as all 5 collated sets of appendix material must be sent to Dr. Clark at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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. The CSR 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. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not received such a letter within three weeks after submitting the application, contact Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. Incomplete and/or 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 NHLBI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the NHLBI National Advisory Council. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed program will have a substantial impact on the pursuit of the RFA goals. The scientific review group will address and consider each of the criteria in assigning your application's overall score. Scientific and Research Training Program o Quality of the research training program and activities o Adequacy of plans for providing students with appropriate science and research experiences Evaluation Plan o Adequacy of plans and methods for monitoring student progress o Adequacy of plans for evaluating the short- and long-term effectiveness of the MKITS Program Program Infrastructure o Documentation of schools', collaborating partners', and consultants' willingness to participate in the MKITS program. o Adequacy and appropriateness of plans for outreach and building collaborative partnerships o Evidence of involvement of a wide variety of research areas in disciplines relevant to heart, lung, blood diseases and sleep disorders Program Leadership o Qualifications and experience of the Program Director, and level of effort that will be devoted to direction and leadership essential for a successful program o Relevant scientific, research and training experience of MKITS faculty and staff o Plans for effective program administration and coordination among faculty and collaborating partners by the Administrative Core o Expertise in the disciplines required for the Administrative, Science and Research, and Evaluation Cores Institutional Commitment and Resources o Access to facilities and related resources, including laboratory space, computer time, equipment, and research samples o Adequacy of facilities and resources at the applicant institution or local school to sponsor the program ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, applications will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 21, 2003 Application Receipt Date: March 19, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, 93.839 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92). The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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