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Introduction |
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Innovations In Biomedical Computational Science And Technology
Release Date: April 17, 2003 (see NOT-OD-03-044)
PA Number: PAR-03-106
Expiration Date: February 24, 2006 unless reissued.
Catalog Of Federal Domestic Assistance Numbers: 93.394
Letter Of Intent Receipt Dates:
May 24, 2003; September 24, 2003
January 24, 2004; May 24, 2004; September 24, 2004
January 24, 2005; May 24, 2005; September 24, 2005
January 24, 2006
Application Receipt Dates:
June 24, 2003; October 24, 2003
February 24, 2004; June 24, 2004; October 24, 2004
February 24, 2005; February 24, 2005; October 24, 2005
February 26, 2006 |
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Scope and Priorities |
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Purpose
Participating Institutes and Centers of the National Institutes of Health (NIH) invite applications for innovative research in biomedical computational science and technology to promote the progress of biomedical research.
There exists an expanding need to speed the progress of biomedical research through the power of computing to manage and analyze data and to model biological processes. The NIH is interested in promoting research and developments in computational science and technology that will support rapid progress in areas of scientific opportunity in biomedical research. As defined here, biomedical computing or biomedical information science and technology includes database design, graphical interfaces, querying approaches, data retrieval, data visualization and manipulation, data integration through the development of integrated analytical tools, and tools for electronic collaboration, as well as computational and mathematical research including the development of structural, functional, integrative, and analytical models and simulations.
Research Objectives
Computing and computational tools have become increasingly important in enabling progress in biomedical research. In recognition of the critical role computing and computer science will play in biomedical research, the NIH Director commissioned a Working Group on Biomedical Computing in June 1999. The result of the deliberations of the Working Group on Biomedical Computing was a report entitled "The Biomedical Information Science and Technology Initiative (BISTI)" which can be accessed at the following site: http://www.nih.gov/welcome/director/060399.htm . A major recommendation of the BISTI is that the NIH should provide additional resources and incentives for basic research to provide adequate support for those who are inventing, refining, and applying the tools of biomedical computing. The promotion of the interface of biomedical information science and technology with biomedical research should result in new digital and electronic tools that will have substantial impact on broad areas of biomedical research.
The Institutes and Centers of the NIH acknowledge the wisdom of this recommendation and are offering support through the current solicitation for fundamental research in biomedical information science and technology as well as for the development of new informatics, computational and mathematical tools and technologies.
This solicitation targets support for fundamental research in biomedical computing science and technology as well as the development and application of new biocomputing tools or technologies for a particular area(s) of scientific opportunity in biomedical research. Programs may target one or multiple areas of biomedical computing that will enable progress in biomedical research. Examples of data types that could be considered include but are not limited to genomic sequences, biomedical images, qualitative descriptors for health and social science, remote sensing and geospatial images, and chemical formulae. Specific research areas solicited in informatics or computational science include but are not limited to:
- Tools for data acquisition, archiving, querying, retrieval, visualization, integration and management
- Platform-independent translational tools for data exchange and for promoting interoperability
- Analytical and statistical tools for interpretation of large data sets
- New models or simulations of complex biological processes (and the development of mathematical tools for these processes)
Areas of biomedical research likely to be critically dependent on biocomputing advances include but are not limited to:
- Behavioral science
- Biological rhythms
- Biomedical imaging
- Cell biology
- Demographic and social science
- Developmental biology
- Drug design at the molecular and cellular levels
- Dynamic modeling of health, chronic disease, and disablement
- Environmental science
- Epidemiology
- Genetics
- Genomics
- Immunology/inflammation
- Medical genetics
- Morphology
- Neurobiology and cognitive science
- Pharmacology
- Physiology
- Population biology
- Structural biology
- Substance abuse research
- Surgery and virtual tools
Projects must span the interface of biomedical research and biomedical computational science and technology. Applicants will be expected to demonstrate fundamental understanding and adequate expertise in both the relevant areas of computational science and technology and biomedical research. Cross-disciplinary collaborations are strongly encouraged. Given the expanding needs in biomedical research for advances in a variety of areas of information science and technology, the approaches and technologies proposed under this announcement should ultimately be generalizable, scalable, extensible, and interoperable. The projects should take into account the needs of the biomedical research community that will be the ultimate end users of the products of the research. The projects should also address plans for ensuring the dissemination of useful products of the research, including approaches, technologies and tools, to the relevant research and user communities. The informatics and computational research proposed should be future-oriented, fill an area of need or projected need, and seek to exceed the current state-of-the-art.
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Eligibility |
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Eligible Institutions
You may submit (an) application(s) if your institution has any of the following characteristics:
- For-profit or non-profit organizations.
- Public or private institutions, such as universities, colleges, hospitals, and laboratories.
- Units of State and local governments.
- Eligible agencies of the Federal government.
- Domestic or foreign.
Individuals Eligible to Become Principal Investigators
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with an eligible institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
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Data And Software Sharing |
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Applicants should detail their plans for sharing data and distributing software developed under this initiative. |
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Mechanism |
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This PA will use the NIH Phased Innovation Award (R21/R33) and R01 award mechanisms. The R21/R33 mechanism is designed specifically for those projects which lack sufficient preliminary results to demonstrate feasibility. Applicants can also submit an R01 application, if feasibility can be documented, as described in the Application and Process section of this program announcement. Applications for R21 support alone will not be accepted. The R33 grant mechanism provides a second phase for the support of innovative exploratory research initiated under the R21 mechanism.
The combined R21/R33 application offers two advantages over the regular application process:
1. Single submission and evaluation of both the R21 and the R33 as one application.
2. Minimal or no funding gap between R21 and R33. The award of R33 funds will be based on program priorities, on the availability of funds and on successful completion of negotiated scientific milestones as determined by institute staff in the context of peer review recommendations.
To be eligible for the Phased Innovation Award, the R21 phase must include well-defined quantifiable milestones that will be used to judge the success of the proposed research, as well as a credible plan for the development of tools or technology for the R33 phase. The Phased Innovation Award must have a section labeled "Milestones" at the end of the Research Plan of the R21 application. This section must include well-defined quantifiable milestones for completion of the R21 part of the application, a discussion of the suitability of the proposed milestones for assessing the success in the R21 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study.
The total project period for an application in response to this PA may not exceed two years for the R21 phase of a combined application, three years for the R33 phase, and five years for a combined R21/R33 proposal. R01 proposals may request up to five years. For combined R21/R33 applications, the R21 phase may not exceed $100,000 direct costs per year. R21 budgets can exceed this cap to accommodate F&A costs to subcontracts to the project. Although the R33 phase of the R21/R33 application and R01 application have no official budgetary limit, applications requesting in excess of $500,000 direct costs in any single year of the grant period require prior approval before submission. It is strongly recommended that applicants contact institute staff at an early stage of application development to convey critical information, such as potentially large budget requests or to discuss programmatic responsiveness of the proposed project. Refer to the Contact Information sections of this program announcement for institute staff contacts.
This PA uses just-in-time concepts (see http://grants.nih.gov/grants/peer/jit.pdf ). It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm) . Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. For R21/R33 applications which exceed $250,000 in any given year of the R33 phase, the R21 portion should be submitted with a modular budget and the R33 phase with a detailed budget.
Some NIH institutes and centers may have other grant mechanisms that could apply to biomedical computing projects. Interested participants should contact the institute or center technical contact indicated in the "List of BISTI Contacts" located at the URL given in the INQUIRIES section of the announcement.
Through a separate program announcement, the participating Institutes and Centers of the NIH are inviting applications for SBIR and STTR support, focusing on the identical research areas as described in the Research Objectives section of this solicitation. For the SBIR/STTR solicitation, the expedited NIH review and cost allowance policies and procedures will be identical to this PA. Qualified applicants are strongly encouraged to consider responding to the SBIR/STTR program announcement. SBIR and STTR application information is available on the Internet at: http://grants.nih.gov/grants/funding/sbir.htm .
Potential applicants who believe that they may be eligible for the SBIR/STTR award should consult the PHS SBIR; and STTR Omnibus Solicitation prior to discussions of their eligibility with NIH staff listed under Contact Information.
This PA will expire on the date indicated on the front of this solicitation. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement dated March 2001, http://grants.nih.gov/grants/policy/nihgps_2001/ . |
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Review Criteria |
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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 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:
- Significance
- Approach
- Innovation
- Investigator
- Environment
Each of these criteria will be addressed and considered by the reviewers 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 a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a technology forward.
- Significance
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- Does this study address an important problem?
- Are the results of the study likely to enable a compelling area of biomedical research?
- 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?
- To what degree does the research or development of technologies or tools support the needs of the targeted biomedical research community?
- For systems intended for clinical research or use the additional criteria will be considered:
- to what degree is the approach, technology or tool appropriate for clinical research and likely to have utility in a clinical setting?
- do applicants adequately address such issues as the protection of patient information and confidentiality?
- Approach
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- 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?
- What is the time frame for developing the proposed approaches, tools, or technologies and is it suitable of this time frame for meeting the needs of the relevant biomedical research community's needs?
- How easy will it be to use the proposed approach, tool, or technology?
- Are the plans for dissemination of the proposed endpoints, tools or technologies of the project adequate?
- Innovation
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- 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?
- Does the project adequately address end user needs?
- Will there be additional application opportunities for the approach, technology or tool proposed?
- Does the project use high-end computing?
- Investigator
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- Is the investigator appropriately trained and well suited to carry out this work?
- Does the project team have adequate expertise in both the areas of biomedical information science and technology and biomedical research?
- Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?
- Environment
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- 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?
Additional Review Criteria: In addition to the above criteria, your application will also be reviewed with respect to the following:
Milestones: For the R21/R33 Phased Innovation Award Application, the initial review group will evaluate the specific goals for each phase and the feasibility of milestones that would justify expansion to the R33 phase. A single priority score will be assigned to each scored application. As with any grant application, the initial review group has the option of recommending support for a shorter duration than that requested by the applicant, and basing the final merit rating on the recommended portion of the application.
Protections: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application.
Inclusion: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.)
Data And Software Sharing: The adequacy of the proposed plan to share data and distribute software.
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.
Award Criteria
Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review
- Availability of funds
- Relevance to program priorities
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Letter Of Intent |
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Prospective applicants are asked to submit by the dates listed at the beginning of this program announcement 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 PA 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 NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program contact listed under Contact Information. |
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Application and Process |
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Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html For further assistance contact:
GrantsInfo@nih.gov
Telephone (301) 435-0714
Specific Instructions for Modular Grant Applications: The NLM BISTI program is covered by the NIH policy requiring all applications requesting up to $250,000 per year in direct costs to be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm . For R21/R33 applications that request more than $250,000 in any year in the R33 phase, a modular budget for the R21 phase and a detailed budget for the R33 phase should be submitted.
Specific Instructions for Applications Requesting $500,000 Or More Per Year: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application.
More specifically, applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html .
Sending an Application to the NIH: 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)
Application Processing: The application must be received by the date listed on the first page. The 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 substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. |
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Peer Review Process |
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Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An 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:
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
- Receive a second level review by the appropriate national advisory council
or board
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Contact Information |
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We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants.
Milton Corn, MD
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Phone: (301) 496-4621
Fax: (301) 402-2952
Email: CornM@mail.nih.gov
Web site: http://www.nlm.nih.gov/
Direct more general questions regarding programmatic issues to:
James Cassatt, Ph.D.
NIGMS
45 Center Drive, Room 2AS.19C
Bethesda, MD 20892-6200
TEL: 301-451-6446
FAX: 301-480-2004
Email: jc12b@nih.gov
Direct your questions about peer review issues to:
Donald Schneider, Ph.D.
CSR
Rockledge 2/Room 4172, MSC 7806
6701 Rockledge Drive
Bethesda, MD 20892
Tel: 301-435-1727
Fax: 301-480-2327
Email: ds39x@nih.gov |
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