DEVELOPMENT OF HIGH RESOLUTION PROBES FOR CELLULAR IMAGING
RELEASE DATE: September 9, 2003
RFA Number: RFA-RM-04-001 (formerly RFA-GM-03-013, see NOT-OD-04-008)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
The National Institutes of Health (NIH)
(http://www.nih.gov/)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov)
National Human Genome Research Institute (NHGRI)
(http://www.genome.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.859 (NIGMS); 93.286,
93.287 (NIBIB); 93.172 (NHGRI)
LETTER OF INTENT RECEIPT DATE: October 20, 2003
APPLICATION RECEIPT DATE: November 20, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism 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 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 General Medical Sciences (NIGMS), the National
Institute of Biomedical Imaging and Bioengineering (NIBIB), and the
National Human Gnome Research Institute (NHGRI) invite applications for
P20 Exploratory Center Grants to support multi-investigator teams to
develop new technologies to enable higher sensitivity biological imaging
in living cells. The purpose of this RFA is to encourage and facilitate
novel, high-risk strategies to create fundamentally new probes with
enhanced spectral characteristics with the goal of improving detection
schemes by a factor of 10 to 100. Parallel improvements in probe
targeting, cellular delivery, and signal detection will be required. The
ultimate goal will be to develop probes that can be used to routinely
achieve single molecule sensitivity for imaging dynamic processes in
living cells. Although the focus of the RFA is on the development of
probes for live cell imaging, the NIBIB will accept applications that
emphasize pre-clinical development of imaging agents for the detection,
diagnosis, or measurement of treatment efficacy for different disease
processes.
RESEARCH OBJECTIVES
Background
Recent growth in atomic level structural information, obtained through X-
ray crystallography and nuclear magnetic resonance (NMR), has greatly
increased our knowledge of biological structures. Despite the tremendous
value of these structures, little is known about molecular movement,
intracellular molecular dynamics, and the formation of transient
assemblies inside the cell. Temporal or spatial relationships among
individual molecules as they move within the cell cannot be captured by
examining isolated static structures in vitro or by analyzing indirect
biochemical or genetic data. Imaging organelle structure in frozen or
fixed cells gives information about cellular context but is limited by its
static 'snapshot' view. Dynamic imaging of molecules in vivo is required
to track structural changes over time and to obtain direct information
about native structures within the cell. Despite the increasing demand to
image cellular processes, however, the tools and reagents are not well
developed.
The lack of sufficiently sensitive molecular probes and detection schemes
for imaging individual molecules in vivo is a significant barrier to
obtaining real-time information on dynamic cellular processes. A variety of
probes are currently used for in vivo studies, but their chemical and
photophysical properties limit their use and resolution within the 3-D
context of the living cell. Detection in eukaryotic cells using currently
available probes typically requires signals from tens to thousands of
molecules. Problems with spectral intensity, photobleaching, isomerization,
and large size limit their utility. Additional difficulties with probe
targeting, cell delivery and detection instrumentation contribute to a
detection sensitivity level that is estimated to be too low by a factor of
100-1000. The development of improved technology to increase the sensitivity
of the probe signal 10-100 fold from what is currently possible would be a
significant step forward.
Scope of Research
The objective of this RFA is to encourage and enable teams to initiate
collaborative projects to develop new probes for molecular and cellular
imaging. The overall goal is to establish programs to create complete
toolsets for detection of single molecule events in living cells and to
generate new strategies for dramatically increasing the resolution of
imaging dynamic cellular processes. It is expected that new principles and
high-risk approaches will be employed in the construction of probes.
Although the probes developed under this RFA will be used for the study of
basic molecular and cellular processes, the technology developed may
eventually be adapted for clinical use.
Examples of research that are appropriate for support by this RFA include:
1) Addressing the need for higher sensitivity and greater flexibility in
probes for in vivo imaging
2) Addressing current bottlenecks related to spectral intensity, blinking,
photobleaching, isomerization, signal-to-noise, and large size of labels
3) Developing new approaches to create genetically encoded probes with
high quantum yield for routine detection of single molecules in vivo in
eukaryotic cells; to develop probes that emit the maximum number of
photons before bleaching
4) Identifying genetically encoded fluorescent proteins in nature that are
superior to those currently used
5) Developing new strategies to create genetically encoded domains that
'capture' optically active, membrane permeable, diffusible probes
6) Exploiting in vitro evolution strategies to maximize the spectral
characteristics of genetically encoded probes
7) Exploiting strategies in combinatorial chemistry or coordination
chemistry to find new ways to intensify the probe signal
8) Creating multifunctional probes that generate a signal in more than one
imaging modality (e.g., optical microscopy/electron microscopy, or
x-ray/optical microscopy)
9) Developing new approaches to deliver and adapt inorganic materials
(metallic colloids, magnetic nanoparticles, quantum dots, nanocrystals, or
other) to the cellular environment; to address problems related to
membrane permeability
10) Developing strategies for 'multiplexing' probe signals by combining or
linking optically active molecules
11) Developing novel strategies for delivering probes into cells and for targeting
specific molecules without disrupting cell physiology
12) Developing detection strategies and hardware to maximize signal amplification
NHGRI, as a participant in this solicitation, is especially interested in
technologies that fall under examples 3, 5, and 6 above, with emphasis on
technologies that have a reasonable future potential to provide information
regarding the dynamic presence, location, association, and/or activity of
proteins.
The participating Institutes strongly encourage potential applicants to
discuss their ideas with Institute program staff and to send a letter of
intent prior to submission to ensure that the application will be
responsive to the mission and intent of this RFA.
Exploratory Center Grant Activities
Exploratory Center Grants will be expected to: 1) establish a
collaboration that requires the interaction of a minimum of three to four
investigators with different expertise spanning areas relevant to the
development of the proposed technologies. These are likely to include
investigators from the following areas: (i) molecular/cell biology,
including delivery and targeting technologies; (ii) chemistry (especially
synthetic organic chemistry and photochemistry); (iii) current cellular
or molecular imaging methods; (iv) physical and engineering principles of
the instrumentation used in cellular imaging; 2) establish a strategy for
creating and testing new probes, including setting up the detection
instrumentation and the model test system; and 3) develop methods for
delivering probes into cells and targeting them to specific molecules.
Groups of investigators at different institutions are welcome to apply.
MECHANISM OF SUPPORT
This RFA will use NIH P20 Exploratory Center Grant mechanism.
Applicants will be solely responsible for planning, directing, and
executing the proposed project. The earliest expected award date is
July 2004. It is anticipated that this RFA will be re-issued for a
second time with a submission deadline in late 2004 and an expected
award date in 2005. P20 Exploratory Grants will not be renewable, but
rather are expected to lead to more mature projects that can attract
other sources of funding. Plans for subsequent full-scale imaging
centers are under discussion and will depend upon the resources
available for this activity.
This RFA uses just-in-time concepts and the non-modular budgeting
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Proposals to develop technologies to advance other aspects of imaging, but
are not specifically designed to achieve single molecule detection in vivo
or to amplify probe sensitivity, should be submitted in response to NIH's
bioengineering announcements:
http://grants.nih.gov/grants/guide/pa-files/PA-03-058.html
http://grants.nih.gov/grants/guide/pa-files/PA-02-011.html
FUNDS AVAILABLE
The participating ICs intend to commit approximately $7 million in FY
2004 to fund seven to nine new P20 Exploratory Center Grants in
response to this RFA. An applicant may request a project period of up
to four years and a budget for direct costs of up to $500,000 per year.
Costs for major items of equipment or indirect costs associated with
consortium or sub-contractual arrangements will not be considered as
part of the $500,000 direct cost limit. 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 Institutes include funds to support
this program, 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 domestic institution has any
of the following characteristics:
o 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
Applications from foreign institutions and for-profit organizations
will not be accepted; however, participating collaborators can be at
foreign institutions and for-profit organizations and may be included
through subcontracts.
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
It is essential that the P20 Exploratory Center Grant be used to
support a true collaborative team effort. Participating investigators
may be at the same or different institution as the PI. A significant
contribution from a chemist is a requirement; it will be the
responsibility of the Principal Investigator (PI) to demonstrate how
the chemist and the other collaborators will be integrated into the
project. Ideally, since a minimum of three to four investigators will
be included, each investigator must have primary expertise in different
areas covering (i) molecular/cell biology, (ii) chemistry (especially
photochemistry and synthetic organic chemistry), (iii) cellular
imaging, and (iv) physics, engineering, instrumentation. The role and
level of effort of each investigator should be justified within the
context of the specific aims.
A plan should be presented for coordination of the efforts of the
individual investigators. This should include how (and how often) the
team will meet and a description of the anticipated flow of work
between the PIs that indicates how they will interact to accomplish the
aims.
The NIH is interested in ensuring that the information about new methods,
technologies, and reagents developed through this program become readily
available to the research community. Applicants should develop and propose
specific plans for sharing of data, materials, and resources, taking into
consideration the guidance issued by NIH http://ott.od.nih.gov/ and
http://grants.nih.gov/grants/policy/data_sharing. The plans for sharing of
data, materials and resources must be approved by NIH staff prior to award.
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:
Catherine Lewis, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS-13C
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
Email: lewisc@nigms.nih.gov
Brenda Korte, Ph.D.
Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard Suite 200
Bethesda, MD 20892-5469
Telephone: 301-451-4774
Fax: 301-480-4973
Email: kortebr@mail.nih.gov
Adam L. Felsenfeld, Ph.D.
Program Director
Large-scale Sequencing
National Human Genome Research Institute
Building 31 Room B2B07
Bethesda, MD 20892-2033
Telephone: (301) 496-7531
Email: adam_felsenfeld@nih.gov
o Direct your questions about instrumentation and software to:
James F. Deatherage, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS.13J
Bethesda MD 20892-6200
Telephone: (301) 594-3828
Email: deatherj@nigms.nih.gov
o Direct your questions about peer review issues to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room 3AN.12F
Bethesda, MD 20892-6200
Telephone: (301)594-2881
Email: sunshineh@nigms.nih.gov
o Direct your questions about financial or grants management matters
to:
Grace Olascoaga
Grants Management
National Institute of General Medical Sciences
Building 45, Room 2AN.32E
Bethesda, MD 20892
Telephone: (301)594-5520
Email: olascoag@nigms.nih.gov
Nancy Curling
Acting Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd., Suite 900
Bethesda, MD 20892-2077
Telephone: 301-496-9315
Fax: 301-480-4974
Email: curlingn@mail.nih.gov
Ms. Jean Cahill
Grants Administration Branch
National Human Genome Research Institute
Building 31, Room B2B34, MSC 2031
Bethesda, MD 20892-2031
Telephone: (301) 402-0733
FAX: (301) 402-1951
E-mail: Jean_Cahill@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 IC 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:
Catherine Lewis, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS-13C
Bethesda, MD 20892-6200
Telephone: (301)594-0828
Email: lewisc@nigms.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
This research solicitation is for high-risk exploratory studies to
explore the potential of possible new enabling technologies. Proof of
principle may be lacking in the preliminary data prior to submission,
and obtaining it should be one of the goals of the research.
Nevertheless, a complete research and development pathway leading to
single molecular event detection should be proposed. The strategy
should address all the steps needed to assemble the components of a
complete system including delivery into cells, targeting, reporting,
and detection. The timeframe for achieving the goals may be longer
than five years; the proposal should present a plan for the first four
years of support, but also address the longer term strategy. The total
page limit for the sections "Background and Significance," "Progress
Report and Preliminary Data," and "Research Design and Methods" is 15
pages.
Specific Aims:
It is anticipated that the initial coordination, strategy discussions,
and planning will require time during the first year of the project,
primarily because the nature of the research will be new and the groups
may not be fully formed. Thus, it will be acceptable to include
planning as a legitimate first step (aim) and to defer much of the
experimental work for years 2-4 of the project, if necessary. For
groups that are already working well together, however, it will be
possible to initiate experiments soon after the award is made.
Background and Significance:
It is expected that the proposed research activities may not have been
initiated. In these cases, the rationale for the research strategy
should be developed from the published literature and not necessarily
the applicants' own publications.
Progress Report and Preliminary Data:
Develop and describe the scientific rationale. It is expected that many
of the most promising ideas relevant to this RFA will be untested and
that most applicants will not have carried out systematic preliminary
studies on the design of new probes. Unpublished preliminary data may
exist on a new approach but may be in a relatively crude form. For these
reasons, preliminary data (published or unpublished) are not required,
should be kept to a minimum, and will not be a major criterion for
review. More emphasis will be placed on development of the proposed
strategy based on the combined insight, knowledge and experience of the
collaborators. Applicants should discuss the qualifications of the
collaborators and the criteria for selecting any additional collaborators
who would participate but have not yet been recruited.
Research Design and Methods:
The general approach should be described. An explanation should be
provided for how this approach will lead to increased sensitivity in
signal detection. Relevant literature to support the potential of the
proposed approach should be cited. The proofs of principle that must be
obtained should be described. In view of the long-term nature and
anticipated difficulty of the goals, elements of risk in approach and
research plans are expected and acceptable. Nevertheless, the potential
difficulties and feasibility issues must be addressed. Where specific
solutions to them have not yet been identified, more general strategies
should be proposed.
A timeline for the project should be presented. This timeline should
outline how the project's goals can be met within the time frame of the
grant. Explicit, quantitative milestones should be presented, if
possible.
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/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, three signed
photocopies, and all five copies of appendix material, 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:
Helen Sunshine, Ph.D.
Office of Scientific review
National Institute of General Medical Sciences
Building 45
45 Center Drive, Room 3AN.12F,
Bethesda, MD 20892-6200
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 be returned to the
applicant without review.
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 sponsoring ICs. 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 NIGMS 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
o Receive a second level review by an appropriate national advisory
council or board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of 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 these 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 study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field? Because the goal of this solicitation is
to encourage technology that has the potential to have significant
impact on improving the state of the art, this criterion will be
especially important.
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies? This criterion will be especially important for this
solicitation since the goal is to encourage novel technology with the
potential to improve imaging resolution by several orders of magnitude.
INVESTIGATOR: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers (if
any?) Since the purpose of this solicitation is to initiate new lines of
inquiry, the applicant(s) need not have publications on the immediate
research topic. However, applicants should have a record of
accomplishment in relevant research areas and a history of innovative
discovery and creativity.
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
Impact and the Acceptability of Risk: The purpose of this announcement
is to recruit active established investigators to form
multidisciplinary collaborations and develop new lines of inquiry. It
is expected that most of the proposed research activities have not yet
been initiated in the applicants' laboratories, and in some cases may
be so new that they are not yet underway anywhere. Thus, the nature of
the projects may be untested and risky, and the success may be
difficult to predict. Evaluation of the application's merit should be
made on the basis of the rationale and potential impact and the track
records of the investigators.
Technology Development: It is expected that the major focus of the P20
Exploratory Centers will be to develop technology with the goal of
generating more sensitive imaging probes and imaging systems. Thus, the
evaluation of merit will be based on the impact of the technology that
is proposed. The biological aspects of the proposal will be secondary
and will, for the most part, be used only to test the probes in the
appropriate biological environments. The purpose will not be to
discover new biological phenomena.
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
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research must include a data sharing plan in their
application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or priority score.
Guidance issued by the NIH on the sharing of data, materials, and
resources can be found at http://ott.od.nih.gov/ and
http://grants.nih.gov/grants/policy/data_sharing.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 20, 2003
Application Receipt Date: November 20, 2003
Peer Review Date: March/April 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 1, 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
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000
or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible. See
http://grants.nih.gov/grants/policy/data_sharing. Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This 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 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
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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