NHLBI SHARED MICROARRAY FACILITIES Release Date: October 9, 2001 RFA: RFA-HL-02-007 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov/index.htm) Letter of Intent Receipt Date: January 29, 2002 Application Receipt Date: February 26, 2002 PURPOSE This RFA seeks to facilitate the application of microarray technology to fundamental, hypothesis-driven research in the areas of cardiovascular, pulmonary, hematological, and sleep disorders. The National Heart, Lung, and Blood Institute (NHLBI) will meet this goal by establishing (or expanding) Shared Microarray Facilities with the appropriate infrastructure, including equipment and expertise in relevant disciplines (molecular biology, robotics, bioinformatics, genomics, statistics, etc.), to facilitate the application of microarray technology and analysis to ongoing NHLBI supported research. Each Shared Microarray Facility must serve a minimum of five ongoing NHLBI-funded research projects, encompassing two of the four program areas (cardiovascular, pulmonary, hematology, and sleep), at their local institution. The Shared Microarray Facilities will provide study design guidance, microarray services, analytical tools and guidance in the interpretation of gene expression profiling results, and applicable knowledge/skills development and education to the NHLBI-supported researchers in all relevant aspects regarding microarray technology and its application. As there are different needs and circumstances of NHLBI-supported investigators, a companion Notice (HL-02-003) will be issued for administrative supplements for microarray applications and analysis to ongoing NHLBI-supported studies. 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), "NHLBI Shared Microarray Facilities," is related to several 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, 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. Foreign institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. To be eligible, institutions must have substantial ongoing NHLBI-supported research activity; give firm assurance concerning the availability of strong institutional commitment and support; assure continued maintenance and operation, including professional direction and technical support; and demonstrate that the Shared Microarray Facility will increase the effective application of microarray technology for the research community supported by NHLBI. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Project 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 four years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2002. FUNDS AVAILABLE The NHLBI intends to commit approximately $4,500,000 in FY 2002 to fund six new grants in response to this RFA. An applicant may request a project period of up to four years and a budget for direct costs of up to $500,000 per year. The grantee must provide a description of institutional support, such as equipment, supplies, laboratory space and other funding sources . No award will be issued unless the availability of strong institutional support has been certified by an appropriate institutional business official. No escalation of costs will be allowed beyond this maximum amount. Because the nature and scope of the research proposed may vary, it is anticipated that the size 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. RESEARCH OBJECTIVES A. Background Heart, lung, blood, and sleep disorders are complex conditions that are currently investigated from the perspective of the impact of only one or a few genes operating at a time. With the progress of the Human Genome Project, the ability to examine all human genes and their products simultaneously and attempt to relate them to research questions relevant to heart, lung, blood, and sleep disorders is approaching. One key tool in this endeavor is microarray technology. Through the use of this technology to study the differing patterns of gene expression of normal and pathological cells and tissues, investigators may be able to dissect important molecular pathways, delineate pathogenic mechanisms, and identify novel therapeutic targets. The knowledge gained through this application may have tremendous potential for the development of new and more effective diagnostic, preventive, and therapeutic approaches. B. Objectives and Scope Many heart, lung, and blood investigators are eager to apply microarray technologies to further their research questions. The major barriers to applying this technology are (1) the lack of funds to purchase or fabricate the microarrays, (2) access to bioinformatic resources and analytical tools to store, edit, share and analyze data derived from microarrays, and (3) access to a critical mass of investigators with the essential capabilities and sophistication for appropriate design and interpretation of experiments. The NHLBI Shared Microarray Facilities are designed to overcome these barriers and enable multiple NHLBI-supported research groups to employ this contemporary technology in their approach to research problems in one centralized facility. This Shared Microarray Facility will require the collaboration of investigators with expertise in many fields, such as molecular biology, bioengineering, robotics, bioinformatics, genomics, and statistics. This RFA will support the establishment (or expansion) of a Shared Microarray Facility that will provide study design guidance, microarray services, analytical tools and guidance in the interpretation of gene expression profiling results, and applicable knowledge/skills development and education to the NHLBI-supported researchers in all relevant aspects regarding microarray technology and its application. SPECIAL REQUIREMENTS o The primary intent of this RFA is to enhance the capability of NHLBI- funded investigators to work at the cutting edge of contemporary biomedical science through the establishment or expansion of shared microarray facilities. Each Shared Microarray Facility will provide study design guidance, microarray services, analytical tools and guidance in the interpretation of gene expression profiling results, and applicable education and knowledge/skills development to the NHLBI-supported researchers in all relevant aspects regarding microarray technology and its application. Applicants must carefully describe the services, technology, and education plans that the Shared Microarray Facility will provide to the supported studies. Discussion and justification of methodologies, technologies, bioinformatics, statistical analytical tools, knowledge/skills development and education plans, and the limitations of the approaches should be included. A specific discussion of quality control/quality assurance must be included. Time lines for each phase of the service should be provided. As the Shared Microarray Facility may be working with both animal model and human subject samples, care should be given to the issues regarding the use of these samples. o Each Shared Microarray Facility supported under this program must be initiated by providing service to a minimum of five ongoing NHLBI-supported research projects, where at least two of the four major scientific areas (cardiovascular, pulmonary, hematology, and sleep) are the focus of the research. Each of these initial microarray studies must be summarized in the application. The applicant should address the goals of the NHLBI-supported research and how the new microarray study will enhance those goals, the microarray study design (including quality control), the microarray analysis plan, and the time line associated with achieving the microarray study aims. In addition, the studies that have access to the Shared Microarray Facility must be committed to putting the data into the public domain through publication and public databases. o The Shared Microarray Facility must also describe future plans, including an access and prioritization process and a time line, for supporting new NHLBI-supported projects once the initial microarray studies are completed. A description or list of available NHLBI-supported studies at the grantee institution will be useful to determine the ultimate capacity of the Shared Microarray Facility. A description of how the Shared Microarray Facility will attract new studies should be discussed. The Shared Microarray Facility must have a process to document which studies gain access and are completed. o The Shared Microarray Facility must have an Internal Operations Committee. This group will be involved in the oversight of the Shared Microarray Facility, the progress of the microarray studies, monitoring the timely dissemination of the microarray data to the scientific community, the access to the Shared Microarray Facility, the quality of the data, and the adaptation to changing technologies. The applicant should describe the composition, function, process, and procedures of the Internal Operations Committee. o Genome-wide expression analysis is a rapidly evolving field. Hence, applicants will need to discuss how they will be poised to take advantage of technical and methodological advances and their impact on the throughput and costs proposed. o This RFA is intended to support the cost-effective introduction of techniques to measure patterns of gene expression in specific tissues or cells of interest to NHLBI-supported investigators. The Principal Investigator must detail a complete description of his or her Institutional resources and existing microarray facilities and describe how the application does not duplicate existing resources. Assurance of the appropriate institutional commitment for the establishment, maintenance, staffing, and operation of a facility must be provided. o To encourage exchange of information among investigators who participate in this RFA program, yearly meetings will be held. A major goal of these meetings is to facilitate interaction by providing a forum that will lead to sharing technology, informatic, and analytical ideas. In addition, discussion can include issues of quality assurance, bioinformatics, coordination, and knowledge/skills development and education. Applicants must include travel funds that will allow the Principal Investigator and at least two other key scientists to participate each year at a two-day meeting in Bethesda, MD. At least one of the key scientists should be at the doctoral, post-doctoral or junior faculty level. Applications should include a statement indicating the willingness to participate in these meetings. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (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. 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 scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 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 the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of 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 Dr. Deborah P. Beebe (see INQUIRIES) by the letter of intent receipt date listed. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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. If an application is received after that date, it will be returned to the applicant without review. 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 yet received such a letter within 10 business days of your submission, contact Dr. Deborah Beebe at the address listed under Inquiries. 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. 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 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 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 NHLBI National 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 the written comments reviewers will be asked to discuss the aspects of the application listed below, 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, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. o Significance: Does the proposed Shared Microarray Facility address important problems? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the impact of the Shared Microarray Facility on the productivity of multiple NHLBI-supported investigators and advancement of NHLBI program areas? Are there sufficient numbers of NHLBI-supported research projects to establish a Shared Microarray Facility? o Approach: How well did the applicant address the special requirements listed in this RFA? Does the applicant adequately describe the services and technology that the Shared Microarray Facility will provide to the NHLBI- supported studies? Are the methodologies, technologies, bioinformatics, statistical analytical tools, knowledge/skills development and education plans, and the limitations of the approaches discussed and justified? Is a plan for quality control/quality assurance included? Are the proposed time lines for each phase of the service appropriate? Are the descriptions of the initial microarray studies well thought out and appropriate? Will the Shared Microarray Facility significantly improve progress made by the initial studies selected? Are the conceptual framework, design, methods, and analysis adequately developed, well-integrated, and appropriate to the aims of the microarray studies? Are there appropriate controls considered in each study that allows for meaningful results and data interpretation? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the bioinformatics support adequate? Are the plans for providing future access to the Shared Microarray Facility adequately described? Is the applicant willing and able to participate actively in a collaborative program? o Innovation: Are the services and resources provided by the Shared Microarray Facility innovative? Will this proposed Facility achieve the goals of the RFA? o Scientific and Technical Competence of Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the investigators? o Environment: Do the scientific and administrative environments in which the work will be done contribute to the probability of success? Do the proposed technologies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of strong institutional support? Is there evidence of adequate infrastructure (e.g., technologies, equipment, analytical tools and bioinformatic expertise)? 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. 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. Schedule Letter of Intent Receipt Date: January 29, 2002 Application Receipt Date: February 26, 2002 Peer Review Date: June/July, 2002 Council Review: September 5-6, 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA The anticipated award date is September 30, 2002. Criteria that will be used to make award decisions include: o Scientific merit as determined by peer review; o Availability of funds; o Geographic balance; o Quality of meeting the special requirements stated in this RFA; o Programmatic balance; o Total cost of the project. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Martha S. Lundberg, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Rm 9146, MSC 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0513 Fax: (301) 480-1335 Email: lundberm@nhlbi.nih.gov Sandra Colombini Hatch, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10124, MSC 7952 Bethesda, MD 20892-7952 Phone: (301) 435-0222 FAX: (301) 480-3557 Email: hatchs@nhlbi.nih.gov Greg Evans, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10152, MSC 7950 Bethesda, Maryland 20892-7950 Telephone: (301) 435-0055 FAX: (301) 480-0868 E-Mail: evansg@nih.gov Heidi Krause-Steinrauf, M.S. Division of Epidemiology and Clinical Applications National Heart, Lung and Blood Institute 6701 Rockledge Drive, Rm 8151 Rockledge II, Rm , MSC 7936 Bethesda, MD 20892-7936 Telephone: (301) 435-0399 FAX: (301) 480-3667 Email: krauseh@nhlbi.nih.gov Direct inquiries regarding review issues to: Deborah P. Beebe, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, 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: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7156, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: ZimmmermR@nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, and 93.839. 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 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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