and Human Services (HHS)
EXPIRED
INFORMATICS FOR DISASTER MANAGEMENT
RELEASE DATE: September 30, 2003
PA NUMBER: PA-03-178 (This PA has been suspended, see NOT-LM-05-016)
(Peer Review contact change, see NOT-LM-05-007)
EXPIRATION DATE: November 30, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Library of Medicine (NLM)
(http://www.nlm.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.879 (NLM); 93.242
(NIMH); 93.286 (NIBIB)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Library of Medicine, the National Institute of Mental
Health, and the National Institute of Biomedical Imaging and
Bioengineering wish to support informatics research that addresses
biomedical information management problems relevant to management of
disasters. Disasters can be caused by nature or by man, through
accident or by malice. Terrorism, particularly bioterrorism, is now an
important focus of federal activity, but terrorism is only one of a
number of threats to public safety classified as disasters. Disaster
management is heavily dependent on efficient flow of information and
extraction of critical knowledge. How best to utilize information
technology in a disaster situation poses a number of problems for which
relevant informatics research is necessary. This PA replaces PAR-02-137
Informatics For Disaster Management, which utilized the R01 mechanism
rather than the R21 mechanism in effect in this PA.
RESEARCH OBJECTIVES
The Federal Emergency Management Agency (FEMA) classifies disasters as
Natural (e.g. earthquakes, hurricanes, floods, wildlife fires etc.) or
Technological (e.g. terrorism, nuclear power plant emergencies,
hazardous materials etc.). Other classification schemes exist, but
whatever the cause, certain features are desirable for management of
almost all disasters:
o Prevention
o Advance warning
o Early detection
o Analysis of the problem, and assessment of scope
o Notification of the public and appropriate authorities
o Mobilization of a response
o Containment of damage
o Relief and medical care for those affected
Because efficient realization of these elements is heavily dependent on
adequate and timely flow of information and knowledge, appropriate use
of modern information technology can be of enormous help to those
responsible for disaster management. How best to use the information
systems in place, and how to improve their contribution to disaster
management are the concerns of this PA.
Some informatics issues relevant for disaster management include, among
others:
o Standards to permit collection of data from diverse sources
o Coordination of disparate information systems across jurisdictional
boundaries, and among system owners
o Design and deployment of appropriate databases for assessment of
impact pre- and post-disaster
o Current, accurate information for clinicians and public
o Decision support systems for diagnosis and treatment
o Pattern recognition, data mining, and knowledge extraction algorithms
o Preserving privacy while protecting the public
o Pre- and post-disaster tracking systems for response personnel,
disaster victims, and other resources
o Timely mobilization (including prior or standing IRB approval)
For the most part these are the same issues that have interested
informaticians during the past decade with considerable success for
clinical information systems. However, specific solutions are needed
within the context of disaster management. Universal installation of
electronic medical record systems and physician order entry would
doubtless provide multiple benefits; however, such systems are not
likely to be widely in place in the near future. Solutions are needed
that can utilize or incrementally improve the health care information
systems of today. This PA is intended to encourage applications that
seek such solutions.
Within this area, NIMH is particularly interested in encouraging
researchers to develop and test data collection technologies and
procedures that will speed and coordinate the process of acquiring and
utilizing new information about mental health consequences of
disasters. The development and testing of approaches for computerized
patient triage and tracking systems, coordination of databases and
survivor registries, data storage and confidentiality procedures, and
environmental stress/damage assessments are examples of the types of
projects that can help to gather, manage, and disseminate mental health
relevant information in a disaster situation. Such information may:
improve long-term survival, help prepare for subsequent incidents, aid
in assessing the physical and emotional needs of a population, impact
on planning and provision of mental health services for victims and
other disaster-affected persons, and increase understanding of the
human response to trauma more broadly.
The NIBIB supports hypothesis-, design-, technology- or problem-driven
research relating to the discovery, design, development, translation,
application, and assessment of new knowledge in biomedical imaging and
bioengineering. In the context of disaster management NIBIB is
interested in (i) technologies related to data reduction, data mining,
and knowledge extraction; (ii) the enhancement of the utility of
existing databases by development of tools for meta-databases and
integrative services; and (iii) methods for timely, appropriate
communication of pertinent knowledge to cognizant bodies.
MECHANISM OF SUPPORT
This PA will use the NIH R21 award mechanism
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
The evolution and vitality of informatics for disaster management
requires a constant infusion of new ideas, techniques, and points of
view. These may differ substantially from current thinking or practice
and may not yet be supported by substantial preliminary data. By using
the R21 mechanism, NLM, NIMH, and NIBIB seek to foster the introduction
of novel scientific ideas, model systems, tools, agents, targets, and
technologies that have the potential to substantially advance research
in this area.
The R21 mechanism is intended to encourage new exploratory and
developmental research projects. For example, such projects could
assess the feasibility of a novel area of investigation or a new
experimental system that has the potential to enhance health-related
research. Another example is a project that could include the unique
and innovative use of an existing methodology to explore a new
scientific area. These studies may involve considerable risk but may
lead to a breakthrough in a particular area, or to the development of
novel techniques, agents, methodologies, models or applications that
could have major impact on a field of biomedical, behavioral, or
clinical research.
Applications for R21 awards should describe projects distinct from
those supported through the traditional R01 mechanism. For example,
long-term projects, or projects designed to increase knowledge in a
well-established area will not be considered for R21 awards.
Applications submitted under this mechanism should be exploratory and
novel. These studies should break new ground or extend previous
discoveries toward new directions or applications.
The applicant may request a project period of up to 2 years with a
combined budget for direct costs of up to $275,000 for the two year
period. The request should be tailored to the needs of the project.
Normally, no more than $200,000 may be requested in any single year.
This PA uses just-in-time concepts. It also uses the modular budgeting
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).
All applications submitted in response to this announcement must use
the modular budget format. This program does not require cost sharing
as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Exploratory/developmental grant support is for new projects only;
competing continuation applications will not be accepted. Two
revisions of a previously reviewed exploratory/developmental grant
application may be submitted as defined in NIH Policy at
http://grants.nih.gov/grants/policy/amendedapps.htm.
ELIGIBLE INSTITUTIONS
Applications may be submitted by institution with any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-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.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the
opportunity to answer questions from potential applicants. Inquiries
may fall into two areas: scientific/research and financial or grants
management issues:
o Direct your questions about NLM scientific/research interests to:
Valerie Florance, PhD
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4882
FAX: 301 402-2952
Email: [email protected]
o Direct your questions about NIMH scientific/research issues:
Farris Tuma, Sc.D.
Traumatic Stress Research Program
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6197, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5944
FAX: (301) 480-5514
Email: [email protected]
O Direct your questions about NIBIB scientific/research issues:
Peter M. Lyster, PhD
Program Director
Division of Discovery Science & Technology
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health, DHHS
6707 Democracy Bvd. Suite 200
Bethesda, MD 20892-5469
(301)402-1337
(301)480-1614 FAX
[email protected]
o Direct your questions about NLM financial or grants management
matters to:
Dwight Mowery
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301, 6705 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-4221
FAX: (301) 402-0421
[email protected]
Direct your questions about NIMH financial or grants management matters
to:
Brian Albertini
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-0004
FAX: (301) 443-0219
Email: [email protected]
Direct your questions about NIBIB financial or grants management
matters to:
Ms. Nancy Curling
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
Suite 900
6707 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 451-4782
Fax: 301-480-4974
Email: [email protected]
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 DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS 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) 710-0267, Email: [email protected].
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.
SUPPLEMENTARY INSTRUCTIONS: All instructions for the PHS 398 (rev.
5/2001) must be followed, with these exceptions:
Research Plan. Items a - d of the Research Plan (Specific Aims,
Background and Significance, Preliminary Studies, and Research Design
and Methods) may not exceed a total of 15 pages. No preliminary data
are required but may be included if available.
Appendix. Use the instructions for the appendix detailed in the PHS
398 except that no more than 5 publications or manuscripts accepted for
publication may be included.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All investigator
initiated R21 applications must 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 the NIH Exploratory/Developmental Grant (R21), applicants may
request direct costs in $25,000 modules, up to a total direct cost of
$275,000 for the combined two year award period.
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
R21 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 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:
o 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
o Receive a written critique
o Receive a second level review by the appropriate national advisory
council or board
REVIEW CRITERIA
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. The scientific review group will address and
consider each of these criteria in assigning your application's overall
score, weighting them as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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, you 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 the study address an important problem? If the
aims of the 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) APPROACH: 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?
(3) INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Is the investigator 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
(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 CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
The NIH R21 exploratory/developmental grant is a mechanism for
supporting novel scientific ideas or new model systems, tools or
technologies that have the potential to significantly advance our
knowledge or the status of health- related research. Because the
research plan is limited to 15 pages, an exploratory/developmental
grant application need not have extensive background material or
preliminary information as one might normally expect in an R01
application. Accordingly, reviewers will focus their evaluation on the
conceptual framework, the level of innovation, and the potential to
significantly advance our knowledge or understanding. Reviewers will
place less emphasis on methodological details and certain indicators
traditionally used in evaluating the scientific merit of R01
applications including supportive preliminary data. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or, when available, from
investigator-generated data. Preliminary data are not required for R21
applications.
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 criteria
included in the section on Federal Citations, below).
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 Inclusion Criteria
in the sections on Federal Citations, below).
ADDITIONAL CONSIDERATIONS
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:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is
required for all types of clinical trials, including physiologic,
toxicity, and dose-finding studies (phase I); efficacy studies (phase
II), efficacy, effectiveness and comparative trials (phase III). The
establishment of data and safety monitoring boards (DSMBs) is required
for multi-site clinical trials involving interventions that entail
potential risk to the participants. (NIH Policy for Data and Safety
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 "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
http://grants.nih.gov/grants/funding/children/children.htm.
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.
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 at http://www.cfda.gov/ at No. 93.879 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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