MEETINGS AND NETWORKS FOR METHODOLOGICAL DEVELOPMENT IN
INTERDISCIPLINARY RESEARCH
RELEASE DATE: January 23, 2004
RFA NUMBER: RFA-RM-04-014
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
This RFA is developed as an NIH Roadmap initiative
(http://nihroadmap.nih.gov/). All NIH Institutes and Centers
participate in Roadmap initiatives. This RFA will be administered by
the National Cancer Institute on behalf of the NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.394, 93.395, 93.396
LETTER OF INTENT RECEIPT DATE: March 26, 2004
APPLICATION RECEIPT DATE: April 26, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Program Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Institutes, Centers, and Offices of the National Institutes of
Health (NIH) invite applications for meetings or networks to develop
methodologies that will facilitate interdisciplinary health research
among behavioral or social scientists and investigators in the
biomedical, mathematical/computational, physical sciences and/or
engineering. The purpose of this RFA is to stimulate the development
of methods and measures in the behavioral or social sciences in order
to more fully integrate the scientific approaches and advances in these
disciplines into interdisciplinary research designed to solve complex
health problems. NIH is especially interested in applications that
identify a topic in human health/well-being research that can be
significantly advanced by using an interdisciplinary approach bringing
together a new combination of disciplines and by developing innovative,
interdisciplinary approaches and methods.
PROGRAM OBJECTIVES
The National Institutes of Health (NIH) are engaged in a series of
activities collectively known as the NIH Roadmap. The Roadmap’s goal,
in keeping with the NIH mission of uncovering new knowledge about the
prevention, detection, diagnosis, and treatment of disease and
disability, is to accelerate both the pace of discovery in these key
areas and the translation of therapies from bench to bedside. In the
course of developing the NIH Roadmap, it has become clear that
scientific advances are increasingly being made at the interfaces of
traditional disciplines, and that approaches to science are becoming
more integrative. These advances require cooperative efforts, typically
in the form of investigators from diverse research backgrounds working
collectively across traditional disciplinary boundaries to answer
scientific questions and achieve specific endpoints. The development of
methods, measurements, and technologies capable of crossing disciplinary
boundaries and contributing to integrative and team approaches to
understanding complex health problems is also required.
Interdisciplinary technology and methods innovations have therefore
emerged as one of the major themes in Roadmap implementation.
(Additional information about the NIH Roadmap can be at
http://nihroadmap.nih.gov/index.asp.)
An interdisciplinary approach is distinguished from a multidisciplinary
approach in that a multidisciplinary approach brings experts from
diverse disciplines to address collectively a common complex problem,
each from his or her unique perspective. By contrast, an
interdisciplinary approach results from the melding of two or more
disciplines to create a new (interdisciplinary) science. Biophysics,
biostatistics, bioinformatics, bioengineering, social neuroscience,
biodemography, behavioral economics, and psychoneuroimmunology are just
some examples of existing interdisciplinary sciences. NIH recognizes
the value and enormous contributions that existing interdisciplinary
approaches have made and are making to our understanding of health,
disease, and disability.
It has become increasingly apparent that the behavioral and social
sciences have broad significance and are fundamental to the
comprehensive understanding of disease etiology and treatment as well
as to the promotion of health and well being. Behavioral and social
factors have significant impacts across the lifespan on diseases
ranging from cardiovascular disease, to cancer, to diabetes, and to
oral and mental health. Innovations in behavioral and social science
methods and technologies have not kept pace with those in the
biomedical sciences, and the analytic strategies necessary for the
integration of the behavioral and social sciences with biomedical,
computational, physical and engineering sciences have not yet been
articulated. The exploration and development of new interdisciplinary
topics, methodological approaches, and combinations of the research
capabilities of disparate disciplines are needed to support the
development of interdisciplinary research that includes the behavioral
and social sciences.
SPECIFIC OBJECTIVES
This RFA will support, over a 1- or 2-year period, scientific meetings
or networks to explore and/or develop innovative methodologies or
technologies in the behavioral or social sciences, with the ultimate
goal of better integrating these disciplines into interdisciplinary
health research. Applications are required to focus on a specific
research topic related to human health or well-being and to include
participation by investigators from a minimum of two disciplines, at
least one of which is a behavioral or social science. We strongly
encourage inclusion of more than two disciplines and of biomedical,
mathematical/computational, physical sciences and/or engineering, to
maximize methodological development at the intersections of these
fields and the behavioral and social sciences. A definition of
behavioral and social sciences research for the NIH can be found at
http://obssr.od.nih.gov/funding/definition.html.
In recognition of the fact that interdisciplinary projects may be in
different stages of development, this RFA will support scientific
meetings or networks. A scientific meeting is defined as a gathering,
symposium, seminar, conference, workshop or any other organized, formal
meeting where persons assemble to coordinate, exchange, and disseminate
information or to explore or clarify a defined subject, problem, or
area of knowledge. A network is defined as a group of investigators
interacting or communicating to explore the potential of research
collaborations. In all cases, applicants are encouraged to consider
adopting innovative mechanisms (e.g., web-based networks, webcasts, new
communicative media) as primary or supplementary platforms for network
or conference communications and interactions.
The aim of a research network is to foster initial development of
collaborative work; accordingly, investigators need not demonstrate any
history of prior collaboration. However, those factors in the
investigators background and/or institutional circumstances that would
facilitate success in collaboration should be clearly delineated.
Networks should provide a clear plan for developing the collaboration.
Such efforts could include travel among sites for informal meetings;
workshops and small conferences; consultants; and analyses of extant
data sets, using new methodologies or approaches. The purpose of these
activities will be to refine conceptual frameworks for methodological
development and to identify which specific research questions show the
greatest promise for scientific advancement. Networks should comprise
at least three investigators. The network’s proposed activities may
also include pilot studies to demonstrate feasibility of the
methodologies or technologies to be developed. The proposal of pilot
studies is not a requirement for applications: depending on the breadth
of disciplines involved and the current knowledge about the chosen
research topic, it is expected that some networks will be ready for
pilot research later than others.
NIH recognizes that multidisciplinary approaches may be a necessary
step in the evolution of interdisciplinary research. Thus, for the
purposes of this RFA, it is acceptable for applications to propose
meetings or networks in multidisciplinary approaches as a precursor to
interdisciplinary research, and to propose activities that facilitate
communication among different disciplines or that promote but do not
necessarily completely achieve integration of different disciplines in
the proposed project period.
The proposed scientific meetings or networks should address, in the
context of a specific, health-related topic, at least one of four
general methodological issue areas: research design, data collection
techniques, measurement, or analytic methods.
1. Research Design: Research design determines how well a research
plan can test hypotheses and achieve specific aims. Research design
encompasses many decisions including the following: sampling plan;
selection of appropriate study designs, methods, procedures and
measures; and assuring confidence in the study’s internal and external
validity. Research design issues also include new approaches to the
conduct of the research, such as intergenerational approaches to study
a health topic, or the use of a variety of assessment approaches (e.g.,
ethnography, focus groups, standardized questionnaires, semi-structured
interviews) to investigate a health topic in an interdisciplinary
fashion.
2. Measurement: The development and validation of research measures
are vitally important for improving the collection of valid and
reliable data and have implications for the inferences or conclusions
that will be drawn from the data. For research efforts that rely on
self-report, data collection instruments and questions must be
appropriate for the particular group (as defined by age, gender,
culture, or other relevant characteristics) in which they will be used.
Objective measures of individual or group behaviors or of the physical
or social environment should also be assessed for appropriateness and
relevance. For particular research questions, combinations of self-
report and objective measures may prove optimal, e.g., objective
assessment of an individual’s behavior with collection of the subject’s
own report of social context at the time the behavior occurs.
3. Data Collection Techniques: Data collection techniques are the
tools and procedures scientists use for implementing research designs
and obtaining measurements. Methods for collecting research data have
an important impact on data validity and reliability. For example,
studies have suggested that use of self-administered instruments can
facilitate the reporting of sensitive or illegal behaviors. Innovative
methodologies can also lead to the collection of new or more complex
types of data by behavioral scientists. Recent developments in
computer-assisted interviewing have permitted more complex question
sequences in survey research, and the development of small computers
with instant data entry of self-report and/or objective information has
permitted the collection of time-specific data on a variety of
behaviors and outcomes (e.g., cigarette smoking, physical activity, and
pain). In addition, implicit measures have allowed researchers to
examine processes of which people themselves have been unaware.
Continued improvement and innovation in data collection methods are
important for many types of research, including clinical interviews,
observational studies, participatory action research, community
research and surveys. New methods for qualitative research are also
needed, as are techniques that facilitate the integration and
validation of qualitative and quantitative measurement.
4. Analytic Methods: Analytic methods encompass the concepts and
techniques used in analyzing data and interpreting and reporting
results. The goal of new and improved analytic methods is to improve
estimation, hypothesis testing, and causal modeling based on scientific
data. Challenges include developing techniques that distinguish
underlying regularities from the noise created by variability and
imprecise measurement; developing causal inferences from quasi-
experimental or non-experimental data; improving both the internal
validity and external validity (generalizability) of measures and
studies; and developing appropriate analytic techniques for the
integration of behavioral and social science data with those of other
disciplines, including the biomedical, computational and/or physical
sciences and engineering.
Examples of scientific meetings or networks for methodological
development in interdisciplinary research might include, but are not
limited to, the following:
o Gatherings of clinicians, behavioral science researchers, information
technology specialists, psychometricians, regulators, and patient
advocates to discuss how computer-based technology influences both
patient-provider communication and decision-making and researcher
knowledge;
o A network of physiologists, behavioral scientists, social scientists
and clinicians to develop methodologies for the collection and analysis
of biological and behavioral measures of an individual’s allostatic
load (i.e., the physiological price the body pays for having to adapt
to various psychosocial, physical, and environmental challenges), which
may influence a patient’s response to clinical care;
o A network of exercise scientists, engineers, cognitive scientists and
social psychologists to develop methods for the simultaneous collection
of objective measures of bodily movement and self-report of the social
context and motivational variables that might influence an individual’s
performance of physical activity;
o A meeting of cognitive neuroscientists, psychologists, statisticians,
psychometricians, and engineers to discuss development of experimental
designs and methodologies that will allow for the collection of more
sophisticated cognitive, emotional, social, and biological data during
brain imaging studies than are currently possible;
o A meeting of geneticists, behavioral researchers, and statisticians
to develop methods for the analysis of gene-social environment
interactions that influence physiological variables and health;
o A network of gerontologists, epidemiologists, economists, and
cognitive neuroscientists to develop epidemiological surveys of the
elderly that would include measures of age-related changes in brain
function and cognition and the impact of changing cognition on
decision-making in the areas of health and finances;
o A network of demographers, ecologists, biologists, and geographic
information systems experts to develop methods of examining how
population processes and health interact with changes in the natural
environment;
o A network of statisticians, econometricians, demographers, and health
care providers and/or psychologists to develop methods of dealing with
biases in clinical trials (including both medical and behavioral
interventions) that result from enrollees not being representative of
the overall target population;
o A network of health care providers, social workers, and statisticians
to develop methods of assessing the effectiveness of health
interventions for children and the factors affecting that
effectiveness;
o A network of nutritionists, epidemiologists, psychometricians,
psychologists, geneticists, engineers, and clinicians to refine current
approaches and develop innovative methods to understand
dietary/nutritional patterns and their relation to health outcomes;
o A meeting of anthropologists, sociologists, computer scientists,
cognitive neuroscientists, and health researchers to discuss the
meaning, validity, and improvement of health information gathered by
serial time-intensive assessments via innovative technology for
different segments of the population (e.g., older adults, ethnic
minorities, children); and
o A network of family researchers, demographers, gerontologists,
pediatricians, psychologists, clinicians, and epidemiologists that
would begin to develop surveys or research instruments to assess health
states and family functioning from both life-span and systems
perspectives.
Reference Reports:
In June, 2000 the NIH Office of Behavioral and Social Sciences Research
(OBSSR) held a conference "Toward Higher Levels of Analysis: Progress
and Promise in Research on Social and Cultural Dimensions of Health."
In an agenda-setting activity that followed the conference, a panel of
scientists developed an ambitious research agenda on the social and
cultural dimensions of health that included detailed recommendations
relating to needed methodological development in this area. Potential
applicants are encouraged to consult this report, available at
http://obssr.od.nih.gov/Conf_Wkshp/higherlevel/conference.html.
In September 2001, NIH sponsored an International Conference entitled
Stigma and Global Health: Developing a Research Agenda. Among the
recommendations was one to encourage research intended to develop
methodological, evaluative, and analytic tools for 1) studying stigma
and its consequences with respect to health and 2) development,
evaluation, and optimization of interventions to prevent or mitigate
the negative effects of stigma and discrimination on health. In both
areas, it was recommended that the social and cultural dimensions of
stigma and its manifestations be included. Applicants are encouraged to
refer to the stigma conference website at www.stigmaconference.nih.gov
for further resources and information.
In addition, the following reports may be useful as general references
on behavior and social sciences research as it relates to health:
New Horizons in Health: An Integrative Approach. (2001). B.H. Singer
and C.D. Ryff, Editors, Committee on Future Directions for Behavioral
and Social Sciences Research at the National Institutes of Health,
Board on Behavioral, Cognitive, and Sensory Sciences, National Research
Council (http://www.nap.edu/catalog/10002.html).
Health and Behavior: The Interplay of Biological, Behavioral, and
Societal Influences (2001). Committee on Health and Behavior:
Research, Practice and Policy, Board on Neuroscience and Behavioral
Health, Institute of Medicine (http://books.nap.edu/catalog/9838.html).
Cells and Surveys: Should Biological Measures be Included in Social
Science Research? (2001) C.E. Finch, J.W. Vaupel, and K. Kinsella,
Editors, Committee on Population, Commission on Behavioral and Social
Sciences and Education, National Research Council
(http://www.nap.edu/books/0309071992/html/).
From Neurons to Neighborhoods: The Science of Early Childhood
Development (2000). J.P. Shonkoff and D.A. Phillips, Editors;
Committee on Integrating the Science of Early Childhood Development,
Board on Children, Youth, and Families, National Research Council
(http://books.nap.edu/catalog/9824.html).
Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences
(2000). T.C. Pellmar and L. Eisenberg, Editors; Committee on Building
Bridges in the Brain, Behavioral, and Clinical Sciences; Division of
Neuroscience and Behavioral Health, Institute of Medicine
(http://books.nap.edu/catalog/9942.html).
Expanding the Boundaries of Health and Social Science: Case Studies in
Interdisciplinary Innovation (2003). F. Kessel, P.Rosenfield and N.
Anderson, Editors; New York: Oxford University Press.
Rebuilding the Unity of Health and the Environment (2001). K. Hanna and
C. Coussens, Editors; Roundtable on Environmental Health Sciences,
Research, and Medicine, Division of Health Sciences Policy, Institute
of Medicine (http://www.nap.edu/books/030907259X/html/).
MECHANISMS OF SUPPORT
This RFA will use the R13 Support for Conferences and Scientific
Meetings and for networks, the R21 Exploratory/Developmental Research
Grant Award. An applicant or group of applicants may submit an
application for the R13 or R21 award, but not for both mechanisms. As
an applicant you will be solely responsible for planning, directing,
and executing the proposed project. The anticipated award date is
September 30, 2004. This RFA may be re-issued at a later date. Future
unsolicited, competing-continuation applications based on this project
will compete with all investigator-initiated applications and will be
reviewed according to the customary peer review procedures.
This RFA is distinct from PAR 03-176, NIH Support for Conferences and
Scientific Meetings, which was issued by NIH in September, 2003
(http://grants.nih.gov/grants/guide/pa-files/PAR-03-176.html), and
which also uses the R13 award mechanism. This RFA has different
requirements, budgetary limits, and application instructions. In
addition, this RFA DOES NOT require that applications for an R13 award
present a letter from the appropriate NIH Institute/Center (IC) staff
documenting advance permission to submit an R13 application.
This RFA is distinct from PA 03-017,
NIH Exploratory/Developmental Research Grant Award
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html),
which was issued in April, 2003, and which describes the
use of the R21 award mechanism for investigator-initiated applications.
Again, the requirements, budgetary limitations and applications of this
RFA differ from those stipulated in PA 03-017.
For R21s: This RFA uses just-in-time concepts. It also uses the
modular budgeting format (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Since the
direct costs of the meetings and networks will always be less than
$250,000 yearly, the modular budget format is required. 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.
For R13s: This RFA does not use just-in-time concepts and does not use
modular budgeting formats. Follow the instructions in the PHS 398
http://grants.nih.gov/grants/funding/phs398/phs398.html for non-modular
research grant applications.
FUNDS AVAILABLE
The NIH intends to commit approximately $400,000 in FY 2004 to fund
three to five new and/or competitive continuation grants in response to
this RFA. Support will be offered for a maximum of two years.
Requests for R13 awards may not exceed $40,000 total costs per year.
Facilities and administrative (F&A) costs are not allowed for the R13
mechanism. For R21 awards (networks), requests may not exceed $150,000
total direct costs for the entire term of support (2 years maximum),
with F&A costs paid at the grantee institution’s negotiated rate.
Because the nature and scope of the proposed meetings/networks will
vary from application to application, it is anticipated that the size
and duration of each award will also vary. Awards pursuant to this RFA
are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has 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 for R21 awards; and
o Domestic institutions/organizations for R13 awards (only domestic
institutions or organizations, including established scientific or
professional societies, are eligible to apply for R13 support)-- Both
domestic and international meetings may be supported; however, an
international meeting can be supported only through the U.S.
representative organization of an established international scientific
or professional society.
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
o For 2-year awards, the progress report (Form PHS 2590, available at
http://grants.nih.gov/grants/funding/2590/2590.htm) must be submitted 2
months prior to the next budget period start date. It should include a
report on the previous gathering supported by the current grant, as
well as a full description of the next planned meeting(s).
o A critical part of the application for NIH support of scientific
meetings and networks is documentation of appropriate representation of
women, racial/ethnic minorities, persons with disabilities, and other
individuals who have been traditionally underrepresented in science.
These individuals must be included in all aspects of planning,
organization and implementation of NIH-sponsored and/or supported
meetings. "Appropriate representation" means representation based on
the availability of scientists from these groups known to be working
in a particular field of biomedical or behavioral research. If
appropriate representation is not apparent, no award will be issued
until program staff are assured of concerted recruitment efforts.
Organizers of scientific meetings must document compliance with the
GUIDELINES FOR INCLUSION OF WOMEN, MINORITIES, AND PERSONS WITH
DISABILITIES IN SCIENTIFIC MEETINGS SUPPORTED BY THE NIH (included at
http://grants.nih.gov/grants/funding/r13/index.htm).
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Deborah H. Olster, Ph.D.
Office of Behavioral and Social Sciences Research
National Institutes of Health
One Center Drive, Room 256
Bethesda, MD 20892-1146
Telephone: (301) 451-4286
Fax: (301) 402-1150
E-mail: olsterd@od.nih.gov
Audie A. Atienza, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN 4074A
Bethesda, MD 20892-7335
Telephone: (301) 402-8426
Fax: (301) 480-2087
E-mail: atienzaa@mail.nih.gov
o Direct your questions about peer review issues to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
o Direct your questions about financial or grants management matters
to:
Bill Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Room 243
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-8634
E-Mail: wellsw@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other Key Personnel
o Participating institutions
o Number and title of this RFA
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 plan the review.
The letter of intent is to be sent by March 26, 2004. The letter of
intent should be sent to:
Audie A. Atienza, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN 4074A
Bethesda, MD 20892-7335
Telephone: (301) 402-8426
Fax: (301) 480-2087
E-mail: atienzaa@mail.nih.gov
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 document 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: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS
The following instructions are to be used in conjunction with the
Instructions accompanying application form PHS 398 (rev. 05/2001):
o Form Page 2 (Description, Performance Site(s)& Key Personnel).
Complete a very brief description of the proposed meeting or networks,
including the dates, location, types of participants, goals, and topics
to be covered. Enter the site of the meeting as the Performance Site.
For R13 awards, Key Personnel are defined as the Principal Investigator
and those individuals responsible for the scientific planning, and
organization of the meeting. For R21 awards, Key Personnel are defined
as the Principal Investigator and additional network participants.
o The budget justification should include a justification for each
proposed personnel position, including role and proposed level of
effort. Although funding from other sources to support these projects
is not required, include information regarding efforts to obtain
funding for this meeting/network from other sources, if such efforts
are anticipated, ongoing or complete.
Allowable Costs: Salaries in proportion to the time or effort spent
directly on the meeting or network; rental of necessary equipment;
travel and per diem or subsistence allowances; supplies needed for
conduct of the meeting or network, only if received for use during the
budget period; conference services; publication costs; registration
fees; speakers' fees.
Non-allowable Costs: Purchase of equipment; transportation costs
exceeding coach class fares; visas; passports; entertainment; tips; bar
charges; personal telephone calls; laundry charges; organization dues;
honoraria or other payments for the purpose of conferring distinction
or communicating respect, esteem or admiration; patient care;
alterations or renovations.
o Form Page 6 (Biographical Sketch). Complete for Principal
Investigator, Key Personnel, and for R13 awards, and any confirmed key
speakers.
o Research Plan.
SECTIONS A-D OF THE RESEARCH PLAN MAY NOT EXCEED 15 PAGES.
Use this section of the application to describe the objectives,
specific program, and logistical arrangements for the scientific
meeting or network. Describe the format and agenda, including the
principal topics to be covered, problems to be addressed, and
developments or contributions the meeting might stimulate. Provide the
names and credentials of key participants in the meeting or network,
including the basis for their selection. Letters of agreement from
participants should be included in Section I ( Consultants ).
Applications requesting two years of support should provide the
following additional information for the second year requested, in as
much detail as possible: meeting topic(s); tentative dates, locations,
and participants; and contingency plans for future gatherings dependent
on, for example, the outcome of the first year's meeting or
developments in the field.
This section should also include the following:
a. A description of the health or well-being issue that will be the
focus of the meeting(s) or network.
b. A description of how the proposed methodological innovation(s) will
advance the specific interdisciplinary research goals and objectives in
the chosen health topic area.
c. A cogent rationale as to why an interdisciplinary approach is needed
to address the chosen health research topic. This discussion should
include a compelling justification for the interdisciplinary potential
of the research collaboration, including the relevance for clinical or
practical utility, the theoretical progress that will be accomplished
through multi- or interdisciplinary networking, and the reasons why an
interdisciplinary approach will advance the field or answer previously
intractable questions. In all cases, a strong knowledge base should
already be available that is germane to the interdisciplinary effort.
d. A description of the overall impact the proposed methodology will
have on other health or well-being research topics, on the general
scientific fields represented by the participants, and on future
research efforts to integrate the behavioral and social sciences in
interdisciplinary health research.
e. A description of the partnerships among the behavioral or social
scientists, scientists of other disciplines, key stakeholders and
others with relevant expertise that now exist or that will be developed
or nurtured by the proposed meeting(s) or network. Applications must
include participation by investigators from a minimum of two
disciplines, at least one of which is a behavioral or social science.
We strongly encourage inclusion of more than two disciplines and of
biomedical, mathematical/computational physical sciences and/or
engineering, to maximize methodological development at the
intersections of these fields and the behavioral and social sciences.
Networks require a minimum of three investigators. In all cases,
applications should be clear about how communication will occur across
boundaries; network applications should detail communication plans so
that the feasibility of achieving a fully-developed collaborative
research partnership is apparent.
f. A description of any planned pre-meeting or follow-up activities
(e.g., preparation of conference papers, publications of proceedings)
to the meetings or workshops. If applicable, plans for broader
dissemination of any materials should be described.
g. Plans for the appropriate involvement of women, minorities, and
persons with disabilities in the planning and implementation of the
proposed meeting or network. For meetings (R13 awards), estimate the
expected size and composition of the audience, as well as the method of
selection. Describe plans for publicizing the meeting and publication
of proceedings. Identify related meetings held on the subject during
the past three years. If this is one of a series of periodic meetings
held by a permanent sponsoring organization, briefly describe and
evaluate the last meeting in the series.
h. Applications for networks (R21) should present a description of the
anticipated longer-term goals of the collaboration as it develops.
Such goals might variously include an application for a developmental
grant (R03), an R01-based research collaboration, or a larger center
mechanism.
o Appendix. The Appendix is limited to announcements and reports of
previous meetings under the same sponsorship. Appendix materials should
be comprised of single-sided, unbound materials, with separators
between documents.
o Checklist. The checklist should be submitted.
For R13 awards, no information regarding Facilities and Administrative
(F&A) Costs should be included as this is not an allowable cost for
this mechanism. For R21 awards, the applicant institution’s negotiated
F&A cost rates should be indicated on the Checklist.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications for
R21 awards 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.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three 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)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
Appendix materials should be comprised of single-sided, unbound
materials, with separators between documents.
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER
INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to
courier deliveries (i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html).
This policy is similar to and consistent with the policy for
applications addressed to Centers for Scientific Review as published in
the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will not be reviewed.
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.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the National Cancer Institute. Incomplete and/or
non-responsive applications will not be reviewed. Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the
National Cancer Institute in accordance with the review criteria stated
below. As part of the initial merit review, all applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score;
o Receive a written critique; and
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 evaluate the
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 the following
criteria in assigning the 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, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this proposed methodological development address an
important health research topic? If the aims of the application are
achieved, how will scientific knowledge be advanced, in the chosen as
well as in other health research topic areas, in the general scientific
fields represented by the participants, and in future efforts to
integrate the behavioral and social sciences in interdisciplinary
health research?
APPROACH: Is the need for an interdisciplinary approach to advance the
science in the chosen health research topic area justified? Will the
proposed methodological innovation(s) advance the specific
interdisciplinary research goals and objectives in the chosen health
topic area? The feasibility of accomplishing the stated objectives and
proposed products through the proposed venues and agendas will be
review criteria, as will the plans for inclusion of women, minorities
and persons with disabilities in the planning, organization, and
implementation of the proposed meeting(s) or network.
INNOVATION: Does the proposed methodological development employ novel
concepts or approaches? Will it challenge existing paradigms or allow
for new research designs, measurement, data collection or analysis?
Does the meeting/network employ novel approaches or methods to fulfill
its purpose?
INVESTIGATOR: Is the principal investigator appropriately trained and
well suited to the project? Is the proposed project appropriate to the
experience level of the principal investigator and other participants
and do they have a strong commitment to interdisciplinary research?
ENVIRONMENT: How appropriate is the meeting/network site? Does the
applicant organization have the ability to contribute to the
probability of success? Do the proposed meetings, exhibits,
interactions, etc., take advantage of unique features of the scientific
environment or employ useful collaborative arrangements?
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 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. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
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 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed meeting(s) or network.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 26, 2004
Application Receipt Date: April 26, 2004
Peer Review Date: June/July 2004
Council or Advisory Board Review: September 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review);
o Availability of funds; and
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
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.
All investigators proposing conferences and workshops should read the
NIH Guidelines for Inclusion of Women, Minorities, and Persons with
Disabilities in NIH-Supported Conference Grants. A complete copy of
the updated guidelines is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-066.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under 21 years of age) 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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
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 RFA 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information , the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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 RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
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
|
|
|
|
Department of Health and Human Services (HHS)
|
|
|
|
NIH... Turning Discovery Into Health®
|