CENTERS FOR OCEANS AND HUMAN HEALTH
RELEASE DATE: November 21, 2002
RFA: ES-03-003
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov)
National Science Foundation (NSF)
(http://www.nsf.gov)
LETTER OF INTENT RECEIPT DATE: February 17, 2003
APPLICATION RECEIPT DATE: March 17, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Mechanism(s) of Support
o Funds Available
o Research Objectives
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Environmental Health Sciences (NIEHS) and the
National Science Foundation (NSF) (hereafter "the Government" or "the
Participating Agencies") invite applications for establishment of research
programs to elucidate underlying mechanisms that govern relationships between
marine processes and public health. The purpose of Centers for Oceans and
Human Health (COHH) is to provide linkages between members of the ocean
sciences and biomedical communities in order to support interdisciplinary
research in areas where improved understanding of marine processes and systems
has potential to reduce public health risks and enhance existing biomedical
capabilities. COHH are expected to create an environment conducive to
interdisciplinary and reciprocally beneficial collaborations among biomedical
scientists (e.g., epidemiologists, pharmacologists, toxicologists,
microbiologists, cell and molecular biologists) and ocean scientists (e.g.,
biological and physical oceanographers, geochemists, and ecologists) with the
common goal of improving our knowledge of the impacts of the ocean on human
health.
This RFA draws on the recommendations contained in the strategic plans of the
Participating Agencies (NIEHS Strategic Plan 2000,
http://www.niehs.nih.gov/external/plan2000/home.htm; NSF Geosciences Beyond
2000, http://www.geo.nsf.gov/adgeo/geo2000.htm; Environmental Science and
Engineering for the 21st Century: The Role of the National Science
Foundation, http://www.nsf.gov/nsb/tfe/nsb99133), those highlighted by the
Ocean Studies Board of the National Research Council (AFrom Monsoons to
Microbes: Understanding the Ocean=s Role in Human Health,@ National Academy
Press, 1999), and those discussed at a Government-sponsored Roundtable on
Oceans and Human Health in Research Triangle Park, NC, December, 2001 (see
report at http://www.niehs.nih.gov/translat/news.htm
ELIGIBLE INSTITUTIONS
You may submit an application 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
o Faith-based or community-based organizations
Foreign organizations are not eligible to apply for this program, although an
international partnership with a lead domestic institution is possible.
Applications may represent a single institution, or may involve several
institutions or organizations. Minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
Applications are encouraged from institutions holding other Center grants in
biomedical or ocean sciences from the Participating Agencies as well as other
public and private funders. The skills and capabilities of these Centers may
synergistically strengthen research on oceans and human health. It is
expected that consortia of institutions that might include medical schools,
environmental health science centers, ocean science centers, and schools of
public health will best support interdisciplinary COHHs.
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 Government programs.
MECHANISM OF SUPPORT
The participating agencies will jointly administer the program throughout the
duration of awards. Each award will be supported by NSF or NIEHS
individually, or through joint awards from both agencies, per agreements among
these organizations. Principal Investigators may be requested to modify their
budgets and work plans to comply with special requirements of the agency
(agencies) supporting their award. Grant awards by the NIEHS will use the P50
Specialized Centers Grant. Applicants are encouraged to discuss this
mechanism with the Program Representatives named below. As an applicant you
will be solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. The anticipated award date is
September 30, 2003.
This RFA uses the non-modular budgeting format. Follow the instructions for
non-modular research grant applications.
FUNDS AVAILABLE
The Government intends to commit approximately $6,000,000 total costs annually
to fund four new grants of up to five years in duration in response to this
RFA. An applicant may request a budget for direct costs of up to $1,000,000
per year. Should an applicant plan to include subcontracts to other
institutions or organizations, only the direct costs associated with the
subcontracts will be used to tally the direct costs that apply toward this
cap. Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the Participating
Agencies provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.
RESEARCH OBJECTIVES
Background of Agency Partnership
In view of the marked relationship between human populations and the marine
environment, it is remarkable that concerted scientific interest in the
interplay between marine processes and public health has emerged only
recently. This slow development may be due, at least in part, to the
difficulty attendant with bringing together appropriate talent from relevant
scientific fields, e.g., public health, preventive medicine, infectious
disease, environmental epidemiology, ocean chemistry and biology, and
geophysics. Hence, development of strategies for creating interdisciplinary
teams of scientists is essential for enhancing our understanding of the causal
linkages between marine processes and public health and for eventual
production of predictive models and successful interventions.
NIEHS and NSF support complementary sets of expertise within their respective
extramural research communities that can be brought to bear to address oceans
and human health more thoroughly and completely than any single agency or
single set of expertise could do on its own. Hence, the Participating
Agencies have joined forces to support this collaborative initiative and to
unite and harmonize their corresponding strengths in biomedical and ocean
sciences.
The mission of the NIEHS is to reduce the burden of human illness and
dysfunction due to environmental exposures. Environmental health is broadly
defined as encompassing the study of physical, chemical, biological, and
social exposures on human health and quality of life (Healthy People, 2010).
NIEHS carries out its mission through a three-pronged approach: basic
biomedical research to improve our understanding of the causes and mechanisms
of environmentally related disease; intervention research to enhance
development and conduct of prevention strategies; and a variety of
communication efforts to disseminate findings to the American public,
including community outreach, education, training, and technology transfer.
The NIEHS presently supports a number of research efforts that may be related
to the general study of marine processes and human health, including effects
of toxins from harmful algal blooms (HABs), contaminated seafood consumption,
and a set of Marine and Freshwater Biomedical Science Centers, which are
primarily focused on developing aquatic models for use in toxicology.
However, the Institute has not previously supported studies addressing how
physical and chemical properties inherent to the world=s oceans directly
impact human health.
NSF is an independent Federal agency whose mission is "to promote the progress
of science; [and] to advance the national health, prosperity, and welfare by
supporting research and education in all fields of science and engineering"
(National Science Foundation Act of 1950, as amended by 42 USC 1861-75). NSF
is responsible for the overall health of science and engineering across all
disciplines. In contrast, other Federal agencies support research focused on
specific missions such as health or defense. The Foundation also is committed
to ensuring the nation's supply of scientists, engineers, and science and
engineering educators. NSF funds research and education in most fields of
science and engineering through grants and cooperative agreements to more than
2,000 colleges, universities, K-12 school systems, businesses, informal
science organizations and other research organizations throughout the United
States. The Foundation accounts for about one-fourth of Federal support to
academic institutions for basic research. The agency operates no
laboratories itself but does support National Research Centers, user
facilities, certain oceanographic vessels and Antarctic research stations. The
Foundation also supports cooperative research between universities and
industry, US participation in international scientific and engineering
efforts, and educational activities at every academic level.
The field of oceans and human health currently represents a gap between the
two Participating Agencies= missions. As such, it also represents a logical
opportunity for partnership. Together, NSF and NIEHS plan to bridge this gap
and promote state-of-the-art, interdisciplinary research that unites the
oceanographic and medical communities, allows for cross-fertilization of ideas
and technologies, and provides more comprehensive insight of the potential
risks and benefits to human health generated by the oceans.
Background of Scientific Opportunities
Oceans have become conduits for a number of environmental threats to human
health. At the same time, oceans harbor diverse organisms that show great
promise for providing new drugs to combat cancer and fight infectious
diseases. To guard against such health threats and to take advantage of the
medicinal benefits that oceans might provide, the impacts of the oceans on
human health must be more fully explored and new research efforts directed to
this area.
Disease-causing organisms harmful to human health can be spread by several
different marine processes. Coastal and estuarine circulation patterns
influence the frequency and geographic pattern of HABs. Nutrient loading from
heavy runoff also poses problems of anoxia and contributes to proliferation of
algae. Circulation of waters through estuaries and coastal areas plays a role
in determining where and when the risks of contamination by human pathogens
are highest. Pathogens from human or animal waste contaminate coastal and
estuarine areas through freshwater runoff from sewers, rivers, and streams.
Viruses and bacteria of fecal origin become concentrated in filter-feeding
shellfish such as oysters and clams. Marine pathogenic bacteria such as
Vibrio cholera and harmful algal species can invade new areas through
transport in the ballast water of ships. Harmful algal species can also be
transported great distances by major ocean currents such as the Gulf Stream.
International trade also transmits algal toxins and pathogens through commerce
in seafood.
In addition to recognizing health problems associated with the ocean, the
Participating Agencies equally recognize the contributions of marine
biodiversity to biomedicine. Plants, animals, and microbes have provided
either the source or the concept for more than half of the pharmaceuticals
currently on the market. Despite continued and more sophisticated searches
for new bioactive agents, there has been a decreasing return in molecular
diversity and, correspondingly, in development of new drug compounds.
Simultaneously, many bacteria causing life-threatening diseases have become
resistant to existing antibiotics, making the need for new drug discovery more
urgent. Due to the diversity of life within the world=s oceans, marine
organisms offer a promising source of novel compounds with therapeutic
potential.
Based upon these considerations, the Government has identified the following
special areas of emphasis for this initiative:
o Harmful algal blooms (HABs)
o Water- and vector-borne diseases
o Marine-derived pharmaceuticals and probes
A. Harmful algal blooms (HABs)
The environmental conditions that foster large blooms of microscopic algae are
not well understood and seem to vary from species to species. Red tides and
other toxic algae have suddenly appeared in previously unaffected coastal
areas. For most harmful algal blooms (HABs), the underlying causes (physical,
chemical, biological) for bloom development are not understood. Thus, we are
not able to predict the potential impact of HABs on human health. For many
HABs, potential pathways of toxins to humans are not well known, and the
effects of low-level, chronic exposure have not been examined.
Worldwide, HABs cause a variety of acute, sub-acute, and chronic diseases in
humans, as well as in other mammals, fish, and birds. Health effects in
humans range from acute neurotoxic disorders (such as paralytic shellfish
poisoning, neurotoxic shellfish poisoning, and ciguatera finfish poisoning) to
chronic and persistent diseases (such as amnesic shellfish poisoning and
chronic liver disease caused by the cyanobacterial toxins, the microcystins).
Disease caused by exposure to the environmental chemicals produced by HAB
organisms may be initiated by consumption of contaminated seafood or
inhalation of toxins entrapped in sea spray.
The ecology of each HAB is different. Mechanisms leading to initiation,
maintenance, and termination of a bloom are not completely understood for any
species. Over the last 30 years, both the range and frequency of HAB events
have increased along US coastlines. The reasons for this expansion are
unknown. The detailed mechanism of toxicity is known for only one of the
HABs, saxitoxin. Additional information on HAB ecology and toxicity is
essential for development of therapeutic strategies.
B. Water- and vector-borne diseases
Humans may be exposed to marine water-borne disease via eating fish,
especially shellfish, and recreational contact, such as swimming or surfing.
There is little question that both routes are the cause of illness in the US
and globally. Shellfish are of particular concern because they are filter-
feeders and efficiently remove extremely small particles from seawater. Some
even feed directly on bacteria, but most target slightly larger algae and
suspended detritus that may contain numerous attached bacteria and viruses.
Also, many shellfish are eaten whole, including gills and stomach, and
sometimes eaten raw. These both increase the chance of disease transmission.
In recreational contact, illnesses can arise from skin or wound infections,
ear, sinus, and respiratory infections, or GI and systemic infections from
swallowing seawater.
The principal agents of diseases that derive from seawater are bacteria,
viruses, and protists. Bacteria include native marine organisms (e.g., Vibrio
vulnificus, V. parahemolyticus), but mostly those originating from humans and
terrestrial animals. Because viruses tend to have a limited host range, human
pathogenic viruses in seawater most probably come from human sources
(primarily via fecal transmission). Protists can include native forms, such
as toxin-producing dinoflagellates and possibly others such as Cryptosporidium
and Giardia.
Water-borne illnesses continue to be a major killer of children throughout the
world. Disease incidence is increasing worldwide, promoted by both natural
phenomena such as El Nino and human activities, including sewage disposal.
Human- and animal-derived pathogens in seawater primarily enter the sea from
sewage and runoff, including agricultural runoff. Relatively little is known
about the fates of most pathogens in marine environments. A more detailed
understanding of the fates of particular pathogens would necessitate specific
studies of target pathogens, or surrogates, in selected environments of
interest. One relevant question is how pathogens may become attached to
particles and sink to the sea floor, possibly to be re-suspended later.
Sediments may protect the pathogens and serve as a long-term reservoir.
Particle-pathogen interactions are also particularly relevant to understanding
how pathogens may be taken up by shellfish or swimmers, and how they are
transported.
Survival and persistence of various pathogens is strongly influenced by
environmental conditions, and global change has the potential to alter
significantly the existing patterns. For example, pathogens now largely
limited to tropical areas are likely to move pole-ward under a general warming
scenario. Therefore, the current pathogen types found at coastal US cities
may change in the near future, and organisms such as pathogenic Vibrio
cholerae may become a problem. It is also important to realize that
microorganisms undergo gene transfer, including genes coding for virulence
factors and antibiotic resistance. Therefore, relatively benign forms may
become pathogenic and/or resistant to antibiotics, and pathogenic forms may
become more prevalent. As we experience increased human population pressure
in coastal areas and changes in environmental conditions, this may lead to an
increased importance of marine-borne pathogens.
C. Marine-derived pharmaceuticals and probes
Nature has traditionally been the source of new pharmaceuticals. Over 50% of
drugs on the market today are either extracted from natural sources or
produced by synthesis using natural products as templates or starting
materials. Despite new approaches to drug discovery, it seems likely that
natural products, which have evolved over millions of years of selective
pressures, provide one of the most important components of this process.
The marine environment constitutes the greatest source of chemical diversity
on the planet. Representatives of every phylum are found in the sea; twelve
phyla are exclusively marine. More than 200,000 species of invertebrates and
algae in the ocean have been described. However, it is estimated that this
number is only a small percentage of the total number of species yet to be
discovered. Based upon such diversity, the ocean represents a virtually
untapped resource for discovery of novel chemicals with pharmaceutical
potential.
An important application of bioactive compounds derived from the marine
environment is their use as molecular probes, i.e., as non-drug substances
that can be used to probe important biochemical processes. Very often, marine-
derived compounds possess unique biological properties that render them of use
in basic biology. For example, discovery of the potent marine toxin
tetrodotoxin led to a much more refined understanding of the receptors for
human pain. Similarly, the red tide toxin okadaic acid and the sponge
metabolite illimaquinone are now in use to probe basic cellular processes. In
addition, marine natural products have provided visual markers for proteins
specified by antibodies, for cellular events mediated by calcium, and for
elucidating mechanisms of tissue-specific gene expression.
Objectives and Scope
The purpose of this RFA is to support interdisciplinary research leading to
improved understanding of the connections between oceans and human health.
COHH will be multidisciplinary research programs in the diverse areas of
oceanography, climatology, ecology, biomedical science, and computational
biology. These Centers will provide for a national network of investigators
and will foster an interconnected research approach dedicated to understanding
the physical, chemical, and biological complexities linking oceans and human
health.
To achieve this goal, COHH will support three or more thematically linked
research projects, facility cores that support two or more projects, an
administrative core, and pilot projects. COHH will present opportunities to
study oceanographic processes and their biological impacts on human health.
Each COHH should be organized around a central theme that unites all
components of the Center. The theme of a proposed COHH may address one of the
following two possibilities:
o One of the three special areas of emphasis identified above (HABs; water-
and vector-borne disease; marine-derived pharmaceuticals and probes).
o A defined geographical area or ecosystem (e.g., polar regions, urban
harbors, tropical coastal areas, small islands, estuaries, the Great Lakes) in
which two or more of the special emphasis areas can be studied.
Identified research needs within the special areas of emphasis include, but
are not limited to:
A. HABs
o Determine the physical, chemical, and biological factors that promote
blooms and toxin release. Are there specific conditions, nutrient profiles,
or physical parameters that support maximal toxin synthesis? What is the
nature of the ecological, genetic, and enzymological conditions that confer
toxigenicity? Is toxin production constitutive or inducible? What is the
natural progression of HAB events? Do they exhibit toxic potential at all
stages?
o Genomics of harmful algal species should be developed for many
applications, from improved systematics and molecular detection techniques, to
determination of the genes controlling toxin production, to developing methods
to suppress toxicity.
o Develop new and improve existing methods for identifying the algal species
responsible for a bloom. This work should utilize novel, state-of-the-art
methods in biomedical, chemical, and physical sciences to advance
significantly our capacity to recognize specific algae-bloom linkages.
o Examine molecular mechanisms of action of marine toxins to improve
detection, develop antidotes, and design new compounds for research tools.
Are there specific molecular targets that can be exploited for assessment?
What are the structure/activity relationships that govern interaction with
molecular targets for each toxin type?
o Determine toxin levels and environmental conditions at which chronic or
acute health effects become important. Only acute rather than chronic health
effects have been documented in most HAB-related diseases. Can acute
poisonings or long-term, low-level exposure to HAB toxins result in chronic
health effects? At what level of toxin do chronic or acute effects become
important, and under what suite of environmental conditions?
o Couple oceanographic and biomedical technologies to produce smart sensors
that detect developing blooms. This effort should unite biological data with
relevant ecological and physical data to create innovative strategies and
processes for early detection and prevention. In order to develop precise
analytical detection methods, specifically labeled toxin derivatives are
necessary. Designer toxins, developed through organic manipulation, genetic
manipulation of HAB genomes, and metabolic manipulation through use of
designer substrates, hold potential for producing many new tools for research
and diagnostic uses. Technologies should be refined and improved to target
detection of toxic strains and to quantify toxins in environmental samples,
which should be combined with use of remote sampling techniques such as
automated platforms, drifters, and fixed moorings.
o Improve exposure and effect assessment through development of new
biomarkers and their application to population-based studies. Biomarkers of
exposure are crucial for diagnosis, treatment, prognosis, and epidemiological
evaluation of these toxins and their possible human health effects. Document
the incidence of toxin-related illnesses in high-risk areas and establish
cause-effect relationships. Assess health effects in sensitive
subpopulations, such as children or persons with underlying neurological or
immune disease. Can health effects be mitigated and/or prevented? Develop
and evaluate potential molecular therapeutic and antidote candidates.
B. Water- and vector-borne diseases
o Use genomics and proteomics to better understand pathogenicity and survival
of marine-borne pathogens and to target genetic and immunological detection
approaches.
o Develop rapid, accurate, and affordable tests, requiring relatively small
sample volumes, to detect and quantify various pathogens in water and
shellfish.
o Characterize factors controlling pathogen survival in seawater and
spatial/temporal patterns of dispersal, transport, and partitioning into
suspended particles and sediments.
o Assess the value of indicators vs. direct pathogen detection, bacterial and
viral. Introduction of newer molecular genetic and immunological methods for
direct detection of pathogens offers promise.
o Evaluate risks of various pathogens (and/or connection to indicators) in
population-based studies.
o Apply near-shore physical and geological oceanography to understand
transport of pathogens where human exposure occurs, for evaluating problems
with existing systems, and to assist in siting and design of new or
replacement sewage and runoff outfalls.
C. Marine-derived pharmaceuticals and probes
o Develop new approaches in marine cell culture, aquaculture, and biochemical
methods for production of marine pharmaceuticals.
o Apply molecular genetics to isolate and express biosynthetic genes and to
express these pathways in expression hosts for the production of marine
pharmaceuticals.
o Design new technologies to facilitate saline cultivation and large-scale
fermentation of marine microorganisms.
o Expand exploration of marine plants and animals to less favorable
environments, e.g., polar oceans and deep ocean environments, and to
underinvestigated taxonomic groups, e.g., marine microorganisms.
o Implement novel sampling methods to access marine organisms for biomedical
investigation.
o Screen marine compounds and derivatives for potential pharmaceutical value,
particularly for neurodegenerative, cardiovascular, and infectious diseases.
DESCRIPTION OF A CENTER
Centers established under this RFA will have in common support for the
following four basic elements: research projects; an administrative core;
pilot projects; and facility cores. For the purpose of this RFA, a Center for
Oceans and Human Health (COHH) is defined as an interdisciplinary
collaborative arrangement among a group of scientists located at the same or
different institutions, committed to conducting at least three individual but
interrelated and interdependent research projects that address the goals of
this RFA. Plans for interaction among the components within Centers must be
explicitly described.
A. Research Projects
Each Center will minimally support three meritorious research projects with a
conceptual theme focusing on oceans and human health. Research projects must
be interdisciplinary and address one or more of the identified special
emphasis areas (HABs; water- and vector-borne disease; marine-derived
pharmaceuticals and probes). Research projects should unite the skills of
basic and clinical biomedical scientists with physical, chemical, and
biological oceanographic scientists. A Center will be asked to describe a
plan for promotion and support of interdisciplinary planning, implementation
and synthesis of research across and within individual projects.
Hypotheses and specific aims developed and described for research projects
must demonstrate the thematic, interdisciplinary, and collaborative nature of
the Center proposal. This requirement is meant to promote interdisciplinary
collaboration in development and design of Center research projects as well as
continued collaboration throughout the duration of Center support.
B. Administrative Core
The administrative structure should include, in addition to the Center
Director, a Co-Director, a business manager, an internal steering committee,
and an external advisory committee. The Director and Co-Director should
possess complementary expertise in biomedical and oceanographic sciences. An
individual with expertise in either field can be Director or Co-Director.
Both fields should be covered by the Director and Co-Director team. The
external advisory committee should consist of a group of three to five
scientists, having expertise appropriate for the Center's research focus, who
are outside the applicant institution. The membership of the advisory
committee must be approved by the Participating Agencies post review. Names
should not be submitted in the application. Individuals in senior leadership
positions should provide intellectual, administrative, and scientific
leadership for the Center and are critical to its overall effectiveness and
evolution. These individuals should be in place and committed to a defined
percent effort.
The administrative core should promote joint planning and evaluation
activities as well as collaborations and interactions among different
components of the Center. The Center must have appropriate and adequate
management capabilities to conduct research and to evaluate the performance of
the Center in achieving the goals of the RFA. Objective criteria for
evaluation, including intermediate markers for assessing the impact of the
science conducted by each Center in elucidating connections between the oceans
and human health, are required as part of this core.
In addition, each Center should describe a mechanism for data sharing and
technology transfer with other Centers and with potential end users of
research results, such as state public health and environment agencies.
It is anticipated that a Center will devote no more than 10 percent of its
budget to the administrative core.
C. Pilot Project Program
Funds can be used to provide support for short-term research projects to
explore the feasibility of new areas of study and to enable investigators to
collect preliminary data for other funding mechanisms. Centers may provide up
to $200,000 per year in direct costs for pilot projects, which based on
internal peer review, are deemed to have a high potential to lead to more
fully developed, competitive research projects. The process of internal peer
review must be specified in the application. General conceptual examples of
two proposed pilot studies should be given; but details of the content of
pilot studies are not required. Scientific merit of pilot projects should be
evaluated based on the potential to address research gaps in the scientific
focus of the Center. Management of the program must include a means of
announcing its availability, a mechanism of scientific merit review, and a
record of results. This record must be available to Government program
directors for review post-award.
D. Facility Cores
Centers may support shared core resources common to two or more research
projects. Each Center may support facility cores that provide a technique,
service, or instrumentation to enhance ongoing research efforts. Examples of
such facilities include: biostatistics and/or bioinformatics, genomics and
proteomics, exposure assessment, and sensor development. Budgeted Center
projects as well as research projects external to the Center may have access
to facility cores. The application should provide a total operational budget
for each facility core together with the percentage of support requested from
the Center grant. The application should explain the organization and
proposed mode of operation of each core, including a plan for usage, priority
setting, allocation of resources, and any applicable charge back system.
Allocation among various components of the Center should be balanced and well
justified.
SPECIAL REQUIREMENTS
Interaction among different Centers could contribute significantly to the
objectives of this initiative. Centers are encouraged to describe creative
strategies for fostering inter-Center collaborations, data sharing, technology
transfer, and for identifying overarching scientific and methodological
issues. COHH Principal Investigators and each research project and core
facility leader from each Center will be required to attend an annual meeting
in the Washington, DC metropolitan area, and Research Triangle Park, NC (in
alternating years). The travel budget should therefore reflect appropriate
allocation for this activity. The purpose of these annual meetings will be to
share scientific information, assess progress, identify and solve common
methodological problems, identify new research opportunities, and consider
possible strategies for evaluating progress.
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:
Allen Dearry, Ph.D., Chief
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC 27709
Telephone: (919) 541-4943
FAX: (919) 316-4606
Email: dearry@niehs.nih.gov
Donald L. Rice, Ph.D., M.P.H., Director
Chemical Oceanography Program
Division of Ocean Sciences
National Science Foundation
4201 Wilson Boulevard
Arlington, VA 22230
Telephone: (703) 292-8582
FAX: (703) 292-9085
Email: drice@nsf.gov
o Direct your questions about peer review issues to:
Linda K. Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-30)
111 T.W. Alexander Drive
79 T.W. Alexander Drive, Bldg 4401, Room 3172 (express/courier service)
Research Triangle Park, NC 27709
telephone: (919) 541-1307
fax: (919) 541-2503
Email: bass@niehs.nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Laura Williams-Boyd
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-22)
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7629
FAX: (919) 541-2860
Email: Willia27@niehs.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 Participating Agency staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Linda K. Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 (MD EC-30)
79 T.W. Alexander Drive, Bldg 4401, Room 3172 (express/courier service)
Research Triangle Park, NC 27709
Telephone: (919) 541-1307 Fax: (919) 541-2503
Email: bass@niehs.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://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.
For projects requiring oceanographic research platform support through the
University-National Oceanographic Laboratory System (UNOLS), the Principal
Investigator should submit a request to the UNOLS Office at www.unols.org no
later than March 1 of the year prior to the year of the first cruise. A copy
of the UNOLS request must be appended as an appendix at the end of the
application.
SUPPLEMENTAL INSTRUCTIONS
The body of the scientific application will be composed of the following
sections with the appropriate page limitations:
- Introduction and organization of the Center - 5 pages maximum
- Administrative Core - 15 pages maximum
- Research Projects - 25 pages maximum each
- Pilot Project Program - 10 pages maximum
- Facility Cores - 15 pages maximum
- Appendices
Human subjects and animal welfare issues should be addressed in each of the
appropriate sections. Discussions of these issues will not be subject to the
page limitations. An overall Center description, list of all performance
sites, and list of all key personnel (i.e., PHS 398 Form Page 2) should be
included at the beginning of the application. Appropriate budget pages for an
overall consolidated Center budget, including consortium or contractual
arrangements, should appear at the beginning of the application. Budget
pages, personnel descriptions, and biosketches specific to Research Projects
and Facility Cores should be incorporated in the appropriate sections. All
appendices should be labeled appropriately and should appear at the end of the
proposal, after the checklist. Applications not organized in this manner may
be returned without review.
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:
https://grants.nih.gov/grants/funding/phs398/label-bk.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 must be
sent to:
Linda K. Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive, Bldg 4401, Room 3172 (express courier)
Research Triangle Park, NC 27709
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: bass@niehs.nih.gov
APPLICATION PROCESSING
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after that date, it will
be returned to the applicant without review.
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. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIEHS and NSF. Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration.
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 NIEHS in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique
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 second level review by the National Advisory Environmental Health
Sciences Council and NSF 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. The
goals of NSF-supported research are to advance the national health,
prosperity, and welfare.
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.
A. Research Projects
Reviewers will be asked to evaluate each research project using the criteria
listed below. Reviewers are asked to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of the goals of this
RFA as implied by the criteria below. Each criterion will be addressed and
considered by the reviewers in assigning the overall score for each project:
o Significance. Does your study address an important problem? If the aims of
your 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?
o Approach. Are the conceptual research 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 interdisciplinary approaches? Is there clear evidence of
significant interdisciplinary interactions in the conception, design, and
proposed implementation of the project?
o Innovation. Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies? Does the
study reflect sufficient originality, novelty, and innovation to make it
highly relevant to the overall goals and objectives of COHH?
o Investigators. Are all investigators appropriately qualified with
demonstrated competence to conduct the proposed research? Is the proposed
work appropriate to the experience level of the principal investigator and
other project researchers? Are the proposed time commitments for all key
researchers reasonable and appropriately associated with the project?
o Environment. Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed projects take
advantage of unique and interdisciplinary features in the scientific
environment and reach out to useful collaborative arrangements? Is there
evidence of adequate institutional support? Is the project interactive with
and supportive of other components of the COHH conceptually and
experimentally?
B. Facility Cores
o Evaluate overall use of each core by research projects. Determine whether
projected use is sufficient to warrant establishment of the core. Determine
if the usage is balanced and broadly based.
o Evaluate the core for its overall importance to research activities in the
Center. Evaluate whether the core is likely to become of greater or lesser
importance to Center members in the future. Determine if the facility core
can contribute to expansion of research into new areas.
o Evaluate whether there is sufficient institutional commitment to meet the
requirements of the core.
o Determine if the requests for equipment, supplies, and other items are
appropriate for the activity of each core.
o Evaluate the cost effectiveness and efficiency of use of the core in the
context of the quality, breadth, and utility of service provided.
o Assess the total operational budget of the facility core and the percentage
of support requested from the Center grant and determine if the facility core
usage by Center members is proportional to support requested.
o Adequacy of the justification for specialized resources relative to its
essential need for the conduct of COHH research or pilot projects.
o Adequacy of qualifications and performance (if applicable) of core
personnel to conduct high quality, reliable resource operations.
o Adequacy of plans for oversight of resources and prioritization of work.
C. Administrative Core
o Evaluate whether the lines of authority and the administrative structure
are designed for effective Center management.
o Evaluate the qualifications, responsibilities, and effectiveness of senior
leaders. Identify if the percent effort is appropriate.
o Evaluate the duties and percent efforts of administrative staff of the
Center in terms of their qualifications and contributions to the specialized
needs and conduct of the Center's research activities.
o Evaluate the effectiveness of the Center's internal planning and evaluation
activities. Determine who is involved and the mechanisms used. Determine if
these activities are documented. Determine if Center members have input into
decision-making; if so, how.
o Evaluate how well the administrative structure maximizes the Center's
capability to take advantage of research opportunities.
o Assess the strategy and effectiveness of plans for sharing of data,
technologies, and products with other Centers and with potential end users.
D. Pilot Project Program
o Evaluate whether pilot project funds will be used to test innovative ideas
of particular importance to the development of new ideas within the COHH.
o Evaluate the review process used by the Center to distribute funds for
pilot projects.
o Evaluate the overall plan for and potential effectiveness of the pilot
project program in filling gaps in research areas relevant to the scientific
focus of the COHH.
o Evaluate the adequacy of the proposed process for continuously reviewing
and funding a spectrum of pilot projects for their quality, innovation,
interdisciplinary nature, and importance to oceans and human health research.
o Evaluate the degree to which pilot project funds will be used to stimulate
projects of an interdisciplinary nature that will promote collaborative
interactions within the Center.
o Evaluate the appropriateness of the budget relative to the scope of the
proposed pilot project program and potential of the program to generate
innovative pilot projects on a consistent basis.
E. Overall Program Organization and Capability
Centers must include three or more research projects with a conceptual theme
focusing on one of the two thematic areas outlined in the RFA. There must be
evidence of the potential for a meaningful interdisciplinary collaboration
with an integrated identity relevant to oceans and human health.
o Evaluate the overall programmatic structure of the Center=s research
capability.
o Evaluate whether the organization of the Center is structured and managed
in a way that maximizes scientific productivity.
o Evaluate the interdisciplinary nature of the proposed research activities,
integration of the projects around an overarching theme, and plans to
effectively pursue interdisciplinary research objectives.
o Evaluate the strength of the procedures, processes, and plans for promoting
interdisciplinary interactions, including coordination, interaction,
collaboration, and synthesis.
o Evaluate the strength of plans for synergistic and effective collaborations
within the Center.
F. Institutional Commitment
o Evaluate the effectiveness of the Center as a formal organizational
component within the institution relative to other organizational components.
Determine whether the reporting, accountability, and management structure of
the COHH within the institution are equivalent to that of comparable
organizations within the institution. Adequacy of institutional procedures
and plans for monitoring, evaluating, and assuming accountability for the
general success of the COHH.
o Evaluate the specific resources provided by the institution such as
personnel, appropriate facilities, financial support, and other forms of
support that reflect the level of the institution's commitment to the
functional stability, continuing development, and success of the Center.
o Adequacy of the institutional infrastructure for assessing progress and
needs.
ADDITIONAL REVIEW CRITERIA
In addition to the above criteria, your application will also be reviewed with
respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and retention
of subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below.)
o DATA SHARING: Adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
Overall Evaluation and Scoring of the Application
A single numerical priority score will be assigned to the COHH application as
a whole after discussing all of the review elements listed above. The score
will be based on the overall quality of the research projects, administrative
core, pilot project program, facility cores, institutional commitment, and
overall program organization and capability. Primary emphasis will be placed
on scientific merit.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 17, 2003
Application Receipt Date: March 17, 2003
Peer Review Date: June, 2003
Council Review: September, 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
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 AMENDMENT "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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://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
https://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
https://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
https://grants.nih.gov/grants/stem_cells.htm and at
https://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 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
https://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.
NSF advocates and encourages open scientific communication. NSF expects
significant findings from supported research and educational activities to be
promptly submitted for publication with authorship that accurately reflects
the contributions of those involved. It expects Principal Investigators to
share with other researchers, at no more than incremental cost and within a
reasonable time, the data, samples, physical collections and other supporting
materials created or gathered in the course of the work. It also encourages
grantees to share software and inventions, once appropriate protection for
them has been secured, and otherwise act to make the innovations they embody
widely useful and usable.
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.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.113, 93.115, 93.866, and 47.050 (Geosciences) 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,
405, and 1861 of the Public Health Service Act as amended (42 USC 241 and 284)
and administered under NIH grants policies described at
https://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.