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Home > Funding > Funding Strategies & Policies Guidelines for NIBIB Exploratory/Developmental Grant (R21) ProgramEffective Date: December 1, 2002 Application Receipt Dates: February 16, June 16, and October 16 (http://grants1.nih.gov/grants/funding/submissionschedule.htm) Contents
PurposeThe National Institute of Biomedical Imaging and Bioengineering (NIBIB) invites investigator-initiated Exploratory/Developmental Grant (R21) applications relevant to its research mission. NIBIB seeks to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering, enabled by relevant areas of information science, physics, chemistry, mathematics, materials science, and computer sciences. Read NIBIB's Mission Statement. The guidelines provided herein are only for investigators planning to submit R21 applications to the NIBIB that are in response to PA-06-181 - NIH Exploratory/Developmental Research Grant Program (Parent R21). NIBIB supports hypothesis-, design-, technology-, or problem-driven research relating to its mission. Program areas of interest to the NIBIB include all aspects of biomedical imaging and bioengineering relevant to improving health. Examples include, but are not limited to:
The NIBIB Exploratory/Development (R21) Grant is intended to support innovative, high impact research projects that would 1) generate pilot data to assess the feasibility of a novel avenue of investigation; 2) involve high risk experiments that could lead to a breakthrough in the field of biomedical imaging and/or bioengineering; or 3) demonstrate the feasibility of new technologies that could have a major impact in a specific area. To be eligible for consideration, proposals must be distinct from those traditionally submitted through the R01 mechanism. For example, projects designed to produce incremental advances in knowledge in a well-established area will not be considered appropriate for the R21 mechanism. Proposals submitted under the R21 mechanism should be limited to those with the potential for truly groundbreaking impact. Since the R21 mechanism is intended to encourage exploratory research, no preliminary data are required to be included in the application. However, the application should make clear that the proposed research is scientifically sound, the qualifications of the investigators are appropriate, and the resources available to the investigators are adequate. Bioengineering research may also be supported under the Exploratory/Developmental (R21) Bioengineering Research Grants (EBRG) program announcement. Bioengineering integrates physical, chemical, or mathematical science and engineering principles for the study of biology, medicine, behavior or health. Eligibility RequirementsApplications for the NIBIB R21 grant may be submitted by domestic or foreign for-profit or non-profit organizations, public or private institutions, such as universities, colleges, hospitals, and laboratories, units of State and local governments, and eligible agencies of the Federal Government. Individuals from underrepresented racial and ethnic groups, women as well as individuals with disabilities are encouraged to apply as principal investigators. This program is appropriate for both new investigators seeking to establish independent research careers and established investigators exploring new areas of research in biomedical imaging and bioengineering including novel technologies. Where to Send InquiriesWe encourage your inquiries concerning NIBIB R21 grants and welcome the opportunity to answer questions from potential applicants. See a complete listing of program contacts. Or, direct your questions about scientific/research issues to: Dr. Christine A. Kelley, Director, Division of Discovery Science & Technology
Dr. Alan McLaughlin, Director, Division of Applied Science & Technology
Mechanism of SupportNIBIB R21 grants are for a maximum of two years. Applicants for the R21 grant may request total direct costs for the two-year period not to exceed $275,000. The maximum page length is 15 pages. Up to five articles as appendix material are permitted. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. Competitive renewals of grants awarded under this program will not be accepted. Application ProceduresApplications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF-424 Research and Related (R&R) forms and SF-424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.Application Receipt Dates: Applications submitted in response to the NIBIB R21 program will be accepted February 16, June 16, and October 16. The receipt date policy can be found at http://grants.nih.gov/grants/dates.htm. Modular Grants and "Just-in-Time": The NIBIB R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, with direct costs requested in $25,000 per module, up to the total direct costs limit of $275,000 for two-years project period. Complete and detailed instructions and information on Modular Grant applications can be also found at the website: http://grants.nih.gov/grants/funding/modular/modular.htm. The “just-in-time” concept allows applicants to submit certain information only when there is a possibility of an award. Application Processing: Applications must be received or mailed by the receipt dates of February 16, June 16, and October 16. The CSR will not accept any application in response to a NIBIB R21 grant 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 substantial revision of an application already reviewed, but such application must include an introduction addressing the previous critique. Peer Review ProcessAn appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will receive a written critique, undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review CriteriaThe 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 following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:
The scientific review group will address and consider each of these criteria with emphasis on the innovation nature of R21 grants in assigning your application’s overall score, weighting them as appropriate for each application. (1) Significance: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) Innovation: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (3) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (4) Investigator: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) Environment: Does the scientific environment in which your 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? Additional Review CriteriaIn addition to the above criteria, your application will also be reviewed with respect to the following:
Award CriteriaApplications submitted in response to the NIBIB R21 program will compete for available funds with all other recommended applications. The scientific merit of the proposed project as determined by peer review, availability of funds, and relevance to program priorities will be considered in making funding decisions. 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 . 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. Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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 PA 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. 93.286 and 93.287, 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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