BIOENGINEERING RESEARCH GRANTS Release Date: October 11, 2001 PA NUMBER: PA-02-011 Updates: - This PA has been reissued, see PA-06-419 - Expiration date extended until reissue later in 2006, see NOT-EB-06-006 - Expiration date extended, see NOT-EB-05-005 - See NOT-EB-04-003 and NOT-EB-04-003 Expiration Date: May 17, 2006, unless reissued. National Institute of Biomedical Imaging and Bioengineering National Cancer Institute National Center for Research Resources National Eye Institute National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute on Aging National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute on Deafness and Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Library of Medicine THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE Participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) invite applications for R01 awards to support Bioengineering Research Grants (BRGs) for basic and applied multi-disciplinary research that addresses important biological or medical research problems. The BRGs support multi- disciplinary research performed in a single laboratory or by a small number of investigators that applies an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat disease or to understand health and behavior. A BRG application may propose hypothesis-driven, discovery-driven, developmental, or design-directed research at universities, national laboratories, medical schools, large or small businesses, or other public and private entities. On October 1, 200l, NIH issued a related program announcement (PA) PAR-02-010 for Bioengineering Research Partnerships (BRPs). The BRPs differ from the BRGs in that the BRP research will be performed by multi-disciplinary research teams from several laboratories or organizations and by several investigators. BACKGROUND Many of today"s biomedical problems are best addressed using a multi- disciplinary approach that extends beyond the traditional biological and clinical sciences. Principles and techniques in allied quantitative sciences such as physics, mathematics, chemistry, computer sciences, and engineering can be applied to effectively address biomedical problems. Bioengineering integrates principles from a diversity of technical and biomedical fields, and the resulting multi-disciplinary research is providing new basic understandings, novel products, and innovative technologies that improve basic knowledge, human health, and quality of life. Bioengineering also crosses the boundaries of scientific disciplines that are represented throughout academia, Federal laboratories, and industry. Recognizing the importance of bioengineering in public health, the Bioengineering Consortium (BECON) was established in 1997 as a focus for bioengineering activities at the NIH. To facilitate communication between the allied and biomedical disciplines and to provide input from the scientific community on research needs and directions, the BECON has held annual two-day symposia on emerging topics of interest related to bioengineering including bioengineering (1998), bioimaging, (1999), nanotechnology (2000), and reparative medicine (2001). Summaries of the proceedings and recommendations of these symposia are available on the Internet at http://www.becon.nih.gov/becon_symposia.htm. Discussions and recommendations of symposia participants aided the formulation of the BRP and BRG program announcements. Both the BRP and BRG PAs recognize that applications for bioengineering projects often focus on technology development rather than on proving or disproving scientific hypotheses. Therefore, the NIH review criteria for bioengineering applications submitted in response to these PAs have been modified to ensure that these proposals are evaluated appropriately and fairly. In December 2000, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) was established at the NIH with a mission to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities. In support of this mission, the NIBIB funds research aimed at developing fundamental or cross- cutting technologies that can be translated into several biomedical applications. Studies involving technological application to a specific disease, organ system, or social issue will be considered by the appropriate NIH institute or center. RESEARCH OBJECTIVES Applications for a BRG award should focus on an area of basic, applied, behavioral, or clinical research in bioengineering that supports the missions of the NIH institutes and centers and where progress is likely to make a significant contribution to improving human health. MECHANISM OF SUPPORT The mechanism of support will be the NIH R01 research grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for a competitively- reviewed application may not exceed five years. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit, non-profit, public, and private organizations. Examples of eligible organizations include universities, colleges, hospitals, national laboratories, industrial research organizations, large or small businesses, units of state and local governments, eligible agencies of the Federal government, and faith-based organizations. Foreign institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. APPLICATION PROCEDURES Applicants are strongly advised to personally contact the appropriate IC scientific program staff listed under INQUIRIES to discuss the relevance of their proposed work to the institute’s mission before preparing a BRG application. Detailed information on research missions and programs for each NIH institute and center is available on the individual IC’s Web sites which can be accessed through the NIH Homepage at http://www.nih.gov. 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 and will be accepted at the standard application deadlines (https://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. Follow the PHS 398 instructions for "Preparing Your Application" with the following modifications and additions to the section titled “Research Plan”: A. Specific Aims – Applications submitted in response to this program announcement may be design-, problem, need-, or hypothesis-driven. Thus, the application should state the hypotheses, designs, problems, and/or needs that will drive the proposed research. Describe the specific aims in the appropriate area of bioengineering research and the goals for the first year and for the long term. Describe the expected applications of the bioengineering research that will improve human health. One page is recommended. B. Background and Significance - Briefly describe the area of bioengineering research that is the focus of the BRG. Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed BRG approach will advance the field. State concisely the importance and health relevance of the research proposed to achieve the Specific Aims. C. Preliminary Studies and Rationale - Preliminary studies that support the proposed research should be submitted with the application. D. Research Design and Methods - A BRG should focus on a significant area of bioengineering research where advances are likely to affect human health or health-related research. If the proposed BRG research is closely related to ongoing research, explain how the research activities of the BRG will complement but not overlap the existing research. Provide a tentative sequence or timetable for the project. Include how the data will be collected, analyzed, or interpreted. Applications should also include a plan for making available to the research community the technologies developed or enhanced by work supported by this program announcement. Investigators are required to make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published. The intent of this policy is not to discourage, impede, or prohibit the organization that develops the unique research resources or intellectual property from commercializing the products. 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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. Additional information about Modular Grants is also available on this site. The title and number of this program announcement must be typed on line 2 of the face page of the application form, and the YES box must be marked. 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 for 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. APPLICATIONS EXCEEDING $500,000 PER YEAR DIRECT COSTS In accordance with NIH policy (https://grants.nih.gov/grants/guide/notice-files/not98-030.html), an applicant planning to submit a proposal that requests $500,000 or more in direct costs for any year must obtain approval to submit the application from scientific program staff at a research institute or center. This approval must be obtained at least six weeks before the application receipt deadline. The applicant must identify the institute or center and the scientific program staff member who agreed to accept assignment of the application in the cover letter that transmits the proposal. A list of scientific program contacts for each of the NIH IC’s is available on the Internet at http://www.nibib.nih.gov/Funding/Bioengineering/Contacts. Applications exceeding $500,000 per year direct costs in any year that are submitted without this approval will be returned. APPLICATION SUBMISSION INSTRUCTIONS Submit a signed, typewritten original of the application, including the Checklist, and five 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) REVISED APPLICATIONS The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 a substantive revision of an application already reviewed, but such an application must include an introduction addressing the previous critique. REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR staff. Applications that are complete will be evaluated for scientific and technical merit by Scientific Review Groups of the CSR. 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 applications under review) may be discussed, assigned a priority score, and receive a second-level review by the appropriate national advisory council or board. REVIEW CRITERIA The NIH review criteria have been adapted to ensure that the BRG application is evaluated appropriately. The score should reflect the overall impact that the BRG award could have on the selected area of bioengineering research based on consideration of the five criteria given below. The emphasis on each criterion can vary from one application to another depending on the nature of the application and its relative strengths. An application need not be strong in all categories to be judged likely to have major technical or scientific impact and thus deserve a high priority score. For example, an investigative partnership may propose to perform important work that by its nature is not innovative but is essential to advance a field. A BRG may propose discovery-driven, developmental, non-hypothesis-driven, design-directed, or hypothesis-driven research at universities, national laboratories, medical schools, large or small businesses, or other public and private entities. The review criteria include: 1. Significance. If the specific aims of the project are achieved, will they provide significant advances in the selected area of bioengineering research? Is the research likely to have a significant impact on other areas of research? Will the technological advances have a significant impact on human health? 2. Approach. Are the engineering, scientific and clinical approaches and methods adequately developed, well integrated, and appropriate to the aims of the project? Does the application address potential problem areas and consider alternative strategies? Is a timetable with adequate research milestones proposed? Are appropriate specifications and evaluation procedures provided for assessing technological progress? Is the plan for sharing or disseminating (through commercialization or other ways) technologies developed or enhanced under this program announcement adequate? 3. Innovation. Does the BRG propose new approaches, explore new research paradigms, or represent new concepts that combine bioengineering, physical, and clinical sciences? Will the proposed approaches or concepts solve current scientific or technical problems in novel ways? 4. Investigators. Is the PI capable of coordinating and managing the proposed project? Are the investigators (partners) appropriately trained in their disciplines and capable of conducting the proposed interdisciplinary work? 5. Environment. Does the scientific and technological environment in which the work will be done contribute to the probability of success? Does the proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements within the partnership? Is there evidence of institutional support? AWARD CRITERIA BRG applications will compete for available funds with all other recommended applications. Funding decisions will be based on the quality of the proposed research as determined by peer review, availability of funds, and the institute’s programmatic priority for the focus of the proposed research. 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 "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). Recent 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 on the Internet at https://grants.nih.gov/grants/guide/notice-files/not98-024.html. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH 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 available in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), available at: https://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: https://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. 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 program announcement is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" on the Internet at http://www.health.gov/healthypeople/. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries or contacts concerning institute-specific scientific or financial issues should be directed to the NIH BECON scientific or financial contacts listed at the following Web site: http://www.becon.nih.gov/becon_contacts.htm. These scientific contacts can also be used to obtain permission to submit applications that request more the $500,000 of direct costs in any year. Inquiries regarding general programmatic issues should be directed to: Dr. Richard E. Swaja National Institute of Biomedical Imaging and Bioengineering 31 Center Drive – Room 1B37 Bethesda, MD 20892-2077 TEL: 301-451-6771 FAX: 301-480-4515 E-mail: email@example.com Inquiries concerning review issues should be directed to: Dr. Eileen Bradley Center for Scientific Review 6701 Rockledge Drive Bethesda, MD 20892 TEL: 301-435-1179 FAX: 301-480-2241 E-mail: firstname.lastname@example.org AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.394, 93.395, 93.396, 93.306, 93.867, 93.172, 93.837, 93.838, 93.839, 93.866, 93.273, 93.855, 93.856, 93.846, 93.864, 93.865, 93.929, 93.279, 93.173, 93.121, 93.847, 93.848, 93.849, 93.113, 93.821, 93.859, 93.862, 93.242, 93.853, 93.361, and 93.879. 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 Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at https://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process, information on the terms and conditions that apply to NIH grants and cooperative agreements, and a listing of pertinent offices and officials at the NIH. The PHS strongly encourages all grant and contract 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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