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Research Grants In Biomedical Informatics And Bioinformatics

bullet   Introduction
 PAR Number: PAR-04-141
Release Date: 08-13-2004
Expiration Date: 11-02-2007, unless reissued

bullet   Scope and Priorities
 Purpose
The purpose of this program announcement is to reissue and update the National Library of Medicine’s research grant program for biomedical informatics and bioinformatics. NLM’s research funding centers on understanding data, information and knowledge – their nature, forms and uses – in the domains of health care and basic biological sciences.

Research Objectives
NLM defines biomedical informatics as the intersection of basic informational and computing sciences with an application domain in biomedicine, as discussed in the work of the American College of Medical Informatics referenced below. The term biomedical informatics encompasses the closely- aligned field of bioinformatics, which can be defined as the intersection of basic informational and computer sciences with an application domain in biological/biochemical sciences. NLM’s research focuses on management and efficient utilization of data, information and knowledge in health care and basic biomedical sciences.

In clinical medicine, health services administration, education and basic biomedical sciences, computers and networks are fundamental tools of discovery, learning, decision making and management. NLM’s biomedical informatics research grants support the study of how information is best captured, represented, stored, retrieved, manipulated, managed and disseminated for use in these kinds of activities.

The following general themes demonstrate the range and scope of NLM’s research interests in biomedical informatics and bioinformatics.
  • Information and knowledge processing, including natural language processing, information extraction, integration of data from heterogeneous sources or domains, event detection, feature recognition;
  • Tools for analyzing and/or storing very large datasets, including genomic and proteomic data; data supporting clinical trials; and other data used in clinical or health services research;
  • Knowledge representation, including vocabularies, ontologies, simulations and virtual reality;
  • Linkage of clinical and genomic information to benefit health care;
  • Innovative uses of information technology in health care delivery, including decision support, error reduction, outcomes analysis, and information at the point of care;
  • Efficient management and utilization of information and data, including knowledge acquisition and management, process modeling, data mining, acquisition and dissemination, novel visual presentations, and stewardship of large-scale data repositories and archives;
  • Human-machine interaction, including interface design, use and understanding of health related-information, intelligent agents, information needs and uses.
  • High-performance computing and communications relating to biomedical applications, including efficient machine-machine interfaces, transmission and storage, real-time decision support;
  • Innovative uses of information technology to enhance learning, retention and understanding of health-related information.
Informatics research is interdisciplinary and employs a range of research methodologies. NLM expects that investigators will employ sound techniques that lead to the collection and analysis of empirical evidence. These techniques may include quantitative and /or qualitative approaches, including laboratory and field studies, surveys and needs analyses, ’in silico’ experiments, modeling and simulation studies.

NLM is a participant in the National Institutes of Health (NIH) Roadmap initiatives, many of which include biomedical computing and interdisciplinary research as essential elements, in the programs of the NIH BISTI initiative, and other NIH informatics initiatives.

While biomedical informatics research projects funded by this program often require software development and tool-building, a well-defined research problem and rigorous research design are essential elements of NLM’s R01 grants. Investigators interested in demonstration projects, proofs of concept or other feasibility testing should consider NLM’s Exploratory/Developmental grant program (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) rather than this biomedical informatics research grant program. NLM’s Small Project grants (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html) are most appropriate for investigators who are just beginning their research in an area and/or need preliminary data to inform a more substantial research project.

Research in biomedical informatics or bioinformatics often employs a specific scientific discipline or medical subspecialty as the subject field or domain in which the research is undertaken, or in which tools and ideas are applied. However, grant applications whose primary focus is on a disease or biological question, rather than the informatics or computational issues that pertain to them, are more appropriate for other Institutes at NIH.

A potential applicant with questions about the suitability of a project for funding by NLM is encouraged to contact the Program Officer listed below.

bullet   Eligibility
 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
  • Faith-based organizations
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 their 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.

bullet   Mechanism
 This PA will use the NIH R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This PA uses just-in-time concepts. It also uses the modular budgeting 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 budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm .

An applicant can request funding for up to five years of support. The average duration of recent NLM informatics research awards is about three years.

bullet   Review Criteria
 The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. 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 principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research:
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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

bullet   Additional Review Considerations
 Sharing Research Data: Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

bullet   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

bullet   Application and Process
 Submitting An Application
Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/ . The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov .

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 checked.

Application Receipt Dates: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm . Application deadlines are also indicated in the PHS 398 application kit.

Specific Instructions For Modular Budget Grant Applications:
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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 .

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 who has agreed to accept assignment of the application.

Applicants requesting $500,000 or more 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: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm . 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 unfunded version 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.

bullet   Peer Review Process
 Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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:
  • 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 written critique
  • Receive a second level review by an appropriate national advisory council or board.

bullet   Contact Information
 Direct your questions about scientific/research issues to:
Valerie Florance, PhD
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive MSC 7968
Bethesda, MD 20892
Telephone: (301) 594-4882
FAX: (301) 402-2952
Email: floranv@mail.nih.gov

Direct your questions about peer review issues to:
Dr. Hua-Chuan Sim
Scientific Review Administrator
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4253
FAX: 301-402-2952
Email: simh@mail.nih.gov

Direct your questions about financial or grants management matters to:
Dwight Mowery
Grants Management Officer
Extramural Programs Division
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: 301-402-2952
Email: moweryd@mail.nih.gov

bullet   References
 1. Charles P. Friedman, Russ B. Altman, Isaac S. Kohane, Kathleen A. McCormick, Perry L. Miller, Judy G. Ozbolt, Edward H. Shortliffe, Gary D. Stormo, M. Cleat Szczepaniak, David Tuck, and Jeffrey Williamson Training the Next Generation of Informaticians: The Impact of "BISTI" and Bioinformatics—A Report from the American College of Medical Informatics J. Am. Med. Inform. Assoc. 2004;11(3):167-172.

bullet   Required Federal Citations
 http://www.nlm.nih.gov/ep/fedcitation2004.html

bullet   NIH Guide Document
 NLM Research Grants In Biomedical Informatics And Bioinformatics,
PAR 04-141
http://grants.nih.gov/grants/guide/pa-files/PA-04-141.html

Last updated: 27 October 2004
First published: 21 November 2003
Metadata| Permanence level: Permanence Not Guaranteed