|
|
Introduction |
|
PAR Number: PAR-04-142
Release Date: 08-13-2004
Expiration Date: 11-02-2007, unless reissued |
|
|
Scope and Priorities |
|
Purpose
The purpose of this program announcement is to reissue and update the
National Library of Medicine’s grant program for support of the development,
maintenance and dissemination of databases or software tools that are unique,
of major importance to an important research domain, and sufficiently mature
to have a broad, describable community of users. These tools and resources
should advance research or practice in the biomedical sciences, clinical
medicine or health services research. To quality for support, biomedical
informatics resources – software, algorithms, knowledge resources – must be
of proven value to a large community of users. The NLM Biomedical Informatics
Resource grant supports ongoing research, development and maintenance of the
tool or resource, user training and services, and wide dissemination of the
tool or resource.
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 funding centers on
understanding data, information and knowledge – their nature, forms and uses
– in the domains of health and basic biological sciences. In clinical
medicine, health services administration, education and basic biomedical
sciences, there are information needs and problems that transcend
organizational, regional and national boundaries. Biomedical informatics
resources – software, algorithms and knowledge resources – that are of proven
value to a large community of users, should be improved, sustained and widely
shared. The kinds of tools and resources appropriate for support by NLM’s
Biomedical Informatics Resource grant program include:
-
Software for 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;
- Systems for knowledge representation, including vocabularies, ontologies,
simulations and virtual reality;
- Algorithms for linking clinical and genomic information to benefit health
care;
- Technology-based tools for clinical decision support, error reduction,
outcomes analysis, and the delivery of usable, useful information at the
point of care;
- Effective human-machine interfaces, retrieval tools and intelligent agents
for health and scientific information;
- Unique collections of data, information or knowledge that support learning,
decision making, research and administration at national /international
levels;
- Tools and resources that foster translation of research findings into
health care practice.
NLM’s Biomedical Informatics Resource Grant can not be used to support
research and development intended as proof of concept, to ascertain
feasibility, or to underwrite the initial development of a tool or resource.
NLM offers several kinds of informatics research grants. Applicants who wish
to undertake biomedical informatics research, to develop and test novel
information technologies, or to perform feasibility or proof-of-concept
studies, should use one of NLM’s other research grant mechanisms.
NLM’s Biomedical Informatics Resource grants are not intended to support
research projects that utilize a tool or database being supported through
this resource grant program. Such projects should seek funding through
customary NIH research grant mechanisms. These grants are not intended to
support tools and resources that duplicate activities of the National Library
of Medicine.
|
|
|
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
- Foreign institutions are not eligible to apply--however, domestic
applications with foreign components are permitted.
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.
Special Requirements
NLM’s Biomedical Informatics Resource grants provide funds to support an
operations center whose functions include: (1) maintenance of scalable,
appropriate infrastructure to support local and distant users; (2) support
services and/or collaboration with users and stakeholders; (3) research and
development to improve the longevity, effectiveness and value of the
resource; (4) user training; and (5) dissemination of information about the
resource. Applicants must provide plans for each of these areas.
1. Maintenance of the resource: A unique, widely-used resource requires
expertise, equipment and a plan to keep up with the pace of technological
change and evolving approaches to information handling. Such maintenance is a
principal purpose of NLM’s Biomedical Informatics Resource grant, and
evidence of plans to assure continued usefulness and sustainability are a
major component of the application for support.
2. Service: Assisting the biomedical investigators and clinicians who use or
want to use a tool or database is a fundamental activity of a biomedical
informatics resource center. Providing access to the resource's technology
should include techniques for helping users obtain, install and use a tool or
database, and offering consultation and technical assistance.
3. Technological Research and Development: A biomedical informatics resource
requires continuing development of its features and components to sustain
value for the user community, and to meet changing needs of health care and
biomedical research. Such research and development may involve modification
or even reconceptualization of databases and software. Informatics research
and development to improve a biomedical informatics resource is most
effective when it responds to perceived, unfulfilled needs of those who use
it.
4. Training: This includes educational programs designed to inform the user
community about the features of a tool or database, demonstrating new
features as they are developed, and attracting new users to the community.
Training may encompass many techniques, including short courses, workshops,
and individual training of visiting scientists and students. Applicants
should include some training approaches that involve in-person, hands-on
training.
5. Dissemination: This activity involves informing the scientific community
about the resource and its potential for science by publishing articles or
books, conducting conferences, distributing software products, or
transferring technologies to industry where they will be distributed widely.
In biomedical informatics resource centers that are developing software,
emphasis should be placed on producing portable software. Open source
software is strongly encouraged as is cooperation with complementary
resources. Biomedical informatics resource centers that are providing
databases should have techniques for supporting localization of the resource,
and open access policies. Requests to charge for access must be approved in
advance by NLM staff.
Applicants for this grant are strongly encouraged to establish an advisory
committee for the resource. Members of this committee should be knowledgeable
about the resource's technology and its value to the user community. The
committee should have members that represent the geographical regions served,
and the types of users served. The chair of the Advisory committee should
have knowledge of the resource's value, but should not be a member of the
resource center’s staff or the major external user of the resource. The
Advisory Committee should provide guidance to the principal investigator on
all aspects of the 5 areas discussed above, including future directions,
growth, marketing, guidelines for the resource's use, and sustainability
plans. The Advisory Committee should meet at least annually. Funds should be
budgeted to support yearly meetings of the committee. Proposed members of
the Advisory Committee should not be contacted in advance of the application.
Applicants should plan for one progress visit each year, to discuss and
coordinate plans and activities with NLM.
|
|
|
Mechanism |
|
This PA will use the NIH P41 award mechanism. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project. The applicant may request a project period of up to 4 years. These
grants may renewed by submission of a competing continuation application.
The budget request should be tailored to the needs of the project. Applicants
who wish to request $500,000 or more in direct costs per year must obtain
permission in advance from NLM’s Extramural Programs Division. Applications
received without proof of this advance permission will be returned without
review.
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 .
|
|
|
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.
A Biomedical Informatics Resource grant is not a research grant, thus the
traditional NIH criteria describe above are used, but modified to suit the
purposes of the grant program. In a well-developed Biomedical Informatics
Resource grant application, the following criteria are of high importance:
- Significance: Convincing evidence that the resource is unique and of
substantial value to biomedical research or practice
- Approach: Provisions are made for insightful, timely development, sound
maintenance, quality assurance, and project evaluation
- Innovation: The plans for improvement of the resource incorporate new
techniques and technologies
- Investigator: An appropriate and sufficient array of expertise is
available for planning, training and service
- Environment: The technological infrastructure is adequate to meet
current needs and scalable to meet future needs.
- Users: Evidence of a broad, describable existing community of users.
In addition, reviewers will expect to see an evaluation plan that documents
(1) sustained use by the community of users for which a resource is intended,
(2) increasing number of new users, (3) examples of advances in research or
practice that can be traced to the resource.
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. |
|
|
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. |
|
|
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
|
|
|
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. |
|
|
Peer Review Process |
|
Applications submitted for this PAR will be assigned on the basis of
established PHS referral guidelines. Applications that are complete and
responsive to the PAR will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the NLM in accordance with the
review criteria stated below. As part of the initial merit review, all
applications will:
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.
|
|
|
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
o 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 |
|
|
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. |
|