NHLBI INNOVATIVE RESEARCH GRANT PROGRAM Release Date: July 12, 2001 RFA: RFA-HL-01-016 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) Letter of Intent Receipt Dates: One month prior to application receipt Application Receipt Dates: Applications will be accepted every four (4) months during fiscal year 2002 on the following receipt dates: October 18, 2001; February 15, 2002; June 18, 2002. THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. USE THE MODULAR BUDGET INSTRUCTIONS THAT BEGIN ON PAGE 13 IN THE PHS 398 (REVISION 5/2001) AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.pdf. THE INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS MUST BE USED WHEN RESPONDING TO THIS RFA/PA. PURPOSE The purpose of this Request for Applications is to provide limited support, not to exceed $100,000 in direct costs per year for up to two years, for innovative research activities to test imaginative ideas and explore new approaches to heart, lung, and blood diseases and sleep disorders that utilize existing data sets or existing biological specimen collections whether obtained through NHLBI support or not. Meritorious studies will be supported that are designed to provide preliminary results to demonstrate feasibility of novel approaches. These grant applications should focus on new research that is particularly innovative, potentially of high impact and require the use of existing data sets or existing biological specimen collections. Studies are limited only to those involving human subjects; however, funds may be used to supplement existing data sets and specimen collections to the extent feasible within the time and dollar limits of the RFA. The establishment of new collaborations is strongly encouraged. To simplify the application submission process, a shortened research plan format will be used as described in the "Special Instructions for Completion" section. To facilitate the timely conduct of the studies approved for support, the Institute will use procedures that enable successful applicants to receive funds, to the extent possible, in approximately four to six months following application receipt. 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 Request for Applications (RFA), the NHLBI Innovative Research Grant Program, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed two years. The goal is to have highly meritorious applications that are selected for funding under this RFA receive their awards insofar as possible approximately four months to six months after the application receipt date. The ability to achieve this goal will be significantly influenced by the number of applications received for a given submission date, the applicant's submission of a complete application, and the ability of a recipient's institution to respond quickly with the necessary JUST-IN-TIME information when it is requested by NHLBI staff. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at https://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE The NHLBI intends to commit $3 million total costs in FY2002, and an additional $1.5 million in total costs in FY2003, to award up to 10 new grants following each of the three application receipt dates (October 18, 2001; February 15, 2002; June 18, 2002). An applicant may request a project period of up to two years and a budget for direct costs of up to $100,000 (4 modules) per year, including facilities and administrative (F&A) costs on consortium arrangements. Although the financial plans of the National Heart, Lung, and Blood Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds in each fiscal year, and receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background The NHLBI supports laboratory and clinical research to provide better understanding of the development and progression of cardiovascular, respiratory, blood, and sleep disorders through a variety of research support mechanisms. The goal of this NHLBI program is to facilitate performance of short term projects that explore innovative approaches that are not readily supported by other funding mechanisms and that require the use of existing data sets or existing biological specimen collections. The program is intended to allow exciting new ideas to be investigated in an expeditious fashion by relaxing the stringent need for preliminary data and demonstration of concept feasibility required by standard NIH research project (R01) reviews. The NHLBI Innovative Research Grant Program encourages both new and experienced investigators to explore new collaborations and approaches that address promising, yet underdeveloped, research topics and therapeutic approaches while employing existing data sets or existing biological specimen collections. Considerable time often is required before promising, innovative grant applications are developed, reviewed, and funded. In part, this limitation is because the time from submission to award of NIH investigator-initiated research proposals is traditionally greater than 9-10 months and frequently requires one, or more, revisions for investigators to obtain compelling enough preliminary data to merit support. This program attempts to overcome this difficulty by providing a simplified, one-time only submission with a review procedure which, to the extent possible, is aimed at enabling successful applicants to receive funds in approximately four to six months following application receipt. This will depend on the number of applications received on each receipt date, the receipt of complete applications, and the submission from applicant institutions of all required information [e.g., for studies involving human subjects (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), IRB approval (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html) and documentation of education in the protection of human subjects (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html)] in a timely manner prior to award. Research Scope The NHLBI Innovative Research Grant Program focuses on support of research activities that are not easily, or currently, supported by other NIH funding mechanisms and that require use of existing data sets or existing biological specimen collections. Activities that promote the formation of new research collaborations and explore new approaches and test imaginative new ideas while providing preliminary data to demonstrate concept feasibility are especially encouraged. For the purposes of this RFA, grant applications will be allowed in either of the two areas defined below as they relate to heart, lung, blood, and sleep research: o Studies to analyze existing data sets to explore new hypotheses. o Studies employing existing biological specimens to test new hypotheses. As one example, investigators could propose collaborative feasibility studies between NHLBI-funded epidemiologic studies and investigators expert in genetic approaches to examine hypotheses significantly different from those of the original study. The NHLBI Stored Genetics Sample Inventory Database (http://webapp.nhlbi.nih.gov/Genetics/) should help identify possible areas of new collaborative investigations. The NHLBI Population Studies Database (http://apps.nhlbi.nih.gov/popstudies/) may also be useful in identifying sources of existing data sets or existing biological specimen collections. SPECIAL REQUIREMENTS As stated, applications will be accepted only in the two areas defined above. For example, applications to develop technology or for tissuegenesis would not be responsive. To simplify the request process applications will be limited to 10 pages (as described in the "Special Instructions for Completion" section). An applicant may not submit more than one application per receipt date, and a Principal Investigator can not have more than one concurrent grant award under the aegis of this RFA. Replacement of the Principal Investigator on this award is not permitted. Revisions of applications previously reviewed under this initiative but unfunded are not permitted. A new application must be substantially different from one previously reviewed and have a different title in order to be accepted for review. The application must focus on one of the topics in the announcement when the new application is submitted. All applications will be reviewed as new applications. Establishment of new collaborations is an important goal of this program. A letter indicating that the investigators from the original study intend to cooperate and are willing to share samples and data, and have approved the proposed study must be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL: https://grants.nih.gov/grants/guide/notice-files/not98-024.html URLs IN NIH GRANTS APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA 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. LETTER OF INTENT Prospective applicants are asked to submit one month prior to the application receipt dates a letter of intent that includes: a descriptive title of the proposed research; the name, address and telephone number of the Principal Investigator; the identities of other key personnel and participating institutions; and the number and title of this RFA. 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 review to estimate the potential review workload and to plan the review. IT IS HIGHLY RECOMMENDED THAT THE LETTER OF INTENT BE SUBMITTED, and it should be sent to Dr. Beebe at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call program staff listed in INQUIRES below with any questions regarding the responsiveness of their proposed project to the goals of this RFA. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.pdf is to be used in applying for these grants, with the modifications noted below. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at https://grants.nih.gov/grants/funding/modular/modular.htm. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA The research plan in the application should be limited to 10 pages, excluding references. The research plan includes specific aims, background and significance, preliminary studies, and research design and methods (Sections A to D). Following the submission of the application and appendix material, no additional supplementary material is to be submitted. To facilitate the accelerated award schedule, applicants will be notified of the need to submit JUST-IN-TIME information when there is the potential for an award. Amended applications will NOT be accepted. 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 should be included with the application. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 5/01) at https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus F&A costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus F&A costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the letter of intent to establish a consortium. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Please note that color figures or photos present in the body of the grant application should also be present in the appendix, or high-quality reproductions of the pages containing color or half-tone figures should be included in the appendix. The reviewers will receive a black-and-white copy of the grant application together with the appendix. 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 five collated sets of Appendix material must be sent to Dr. Deborah Beebe at the address listed under Inquiries. Applications must be received by the application receipt date listed in the heading of this RFA. The receipt dates are October 18, 2001; February 15, 2002; and June 18, 2002. If an application is received after the receipt 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. REVIEW CONSIDERATIONS 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 a review process convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In their written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score. Because of the nature of this RFA, and application must be judged to be innovative to deserve a high priority score. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. If the proposed research includes studies in human subjects, plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. 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 program priorities. INQUIRIES 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: David A. Lathrop, Ph.D. Division of Heart And Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9186 (MSC 7940) Bethesda, MD 20892-7940 (20817 for Courier) Telephone: (301) 435-0504 FAX: (301) 480-1454 Email: LathropD@nhlbi.nih.gov Darrell L. Ellsworth, Ph.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8166 (MSC 7934) Bethesda, MD 20892-7934 (20817 for Courier) Telephone: (301) 435-0444 FAX: (301) 480-1455 Email: EllsworD@nhlbi.nih.gov John W. Thomas, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10154 (MSC 7950) Bethesda, MD 20892-7950 (20817 for Courier) Telephone: (301) 435-0050 FAX: (301) 451-5453 Email: ThomasJ@nhlbi.nih.gov Carol E. Vreim, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10120 (MSC 7952) Bethesda, MD 20892-7952 (20817 for Courier) Telephone: (301) 435-0233 FAX: (301) 480-3547 Email: VreimC@nhlbi.nih.gov Send letter of intent and 2 copies of application and direct inquiries regarding review matters to: Deborah P. Beebe, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr., Room 7178 (MSC 7924) Bethesda, MD 20892-7924 (20817 for Courier) Telephone: (301) 435-0270 Fax: (301) 480-3541 Email: BeebeD@nhlbi.nih.gov Direct inquiries regarding fiscal matters to: Robert Vinson Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7156, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 E-mail: VinsonR@nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, 93.839. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, 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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