DEVELOPMENT OF IN VITRO MODELS OF HUMAN ORAL MUCOSA RELEVANT TO AIDS
AND MUCOSAL INFECTIONS
RELEASE DATE: October 31, 2003
RFA Number: RFA-DE-05-002 (This RFA has been reissued, see RFA-DE-06-003)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
No. 93.121, Oral Diseases and Disorders Research
LETTER OF INTENT RECEIPT DATE: July 28, 2004
APPLICATION RECEIPT DATE: August 26, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of This RFA
o Research Objectives
o Mechanism(s) 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 objective of this initiative is to stimulate research that will
lead to the development and validation of a practical and
physiologically relevant in vitro human model of the oral mucosa that
can be used to study HIV infection and the complications associated
with AIDS under highly controlled conditions. It is envisioned that
the availability of such an in vitro human oral mucosa system will
provide opportunities to substantially enhance the fundamental
understanding of oral HIV infections. This will establish a scientific
basis for exploring and testing diagnostic, treatment and prevention
strategies for HIV infections and AIDS associated complications. Such
models will be used to study, for example, the biology of viral (HIV,
EBV, HHV-8, HPV) infection, pathogenesis of diseases, opportunistic
complications and host defense immune responses.
RESEARCH OBJECTIVES
Background
Among the routes of transmission that HIV uses to infect the host is
the oral mucosal tissue. This route of infection has been shown in both
humans and primates. HIV RNA and proteins can be detected directly in
the mucosa, as well as in the saliva from infected subjects. However,
infectious HIV virions are rarely found in the saliva, suggesting that
the oral mucosa is not permissive for efficient HIV replication. Our
understanding of HIV pathogenesis is far from complete as is our
understanding of how other opportunistic pathogens (HHV-8, CMV, EBV,
HPV and Candida) infect and cause the oral complications associated
with AIDS. The ability of the oral cavity to resist HIV while
providing a safe haven for other pathogens provides a unique
opportunity to dissect the differential patterns of host defense or
lack thereof.
The oral mucosa is composed of both stratified and non-stratified
epithelial cells which form a continuously renewing, protective 100 um
layer in the mouth. The mucosa contains immunologically functional
cells; including dendritic cells, lymphocytes, monocytes/macrophages
and neutrophils; which increase markedly when the tissue is inflamed.
Matrix components play a central role in maintaining the structure and
function of an intact mucosa. The surface of the mucosa is covered by
salivary carbohydrates, lipids and proteins, and interacts directly
with the oral environment, containing bacteria, fungi, viruses, food,
tobacco products, alcohol etc. In addition, the mucosa produces or is
bathed by cytokines, chemokines, antibodies and innate host factors in
saliva. As such, these tissues are biologically complex and subject to
numerous environmental and host factors that regulate their function
and integrity.
Compared with vaginal and rectal mucosa, research on oral mucosa has
been aided by its relatively easy access. However, research on oral
mucosa, particularly in subjects with AIDS, has been very difficult
because of the inability to control environmental influences,
xerostomia, as well as site- and subject-specific immunological
factors. Research on identifying protective or susceptibility factors
in the oral mucosa in persons exposed to HIV would be greatly
facilitated by the availability of high quality, standardized, and
reproducible in vitro models of the mucosal tissue. Such models would
lend themselves to advanced research in studying the genomics and
proteomics of HIV infection and AIDS associated complications in the
oral cavity. Moreover, due to the impossibility of using infectious
virions in humans and the failure of animal models to recapitulate
human infectious paradigms, the availability of an in vitro human model
system is critical to advancing research on oral infection and/or
identifying potential regulatory molecules which may provide insight
into therapeutic targeting.
Recent advances in tissue engineering and molecular and cellular
biology have elucidated ways to construct tissues using carefully
designed scaffolds on which cells can grow and differentiate. These
bioengineered tissues can be manipulated to express phenotypic surface
markers and to produce immune modulatory cytokines such as interleukin-
1, tumor necrosis factor and interleukin-8. While it may be feasible to
construct a homogeneous epithelial model system, it becomes more of a
challenge to develop a system in which stem cells, lymphocytes,
epithelial cells, macrophages and dendritic cells, fibroblasts and
keratinocytes, etc. can be incorporated to form a mucosal model.
Scope
The objective of this initiative is to encourage research that will
lead to the development and validation of in vitro models of the human
oral mucosa that are suitable for studying the pathogenesis of HIV and
AIDS-related oral complications in a controlled environment. It is
expected that investigators will capitalize on new findings in tissue
engineering, cell biology of the oral mucosa, genomics, proteomics,
bioimaging and real time analysis of gene expression. Multidisciplinary
approaches and collaborations are encouraged. Examples of research
topics that are responsive to this RFA are listed below but are by no
means all inclusive:
Development of the models:
o Development of a model that can adequately address the effects of
certain cells (e.g., neutrophils) and soluble factors (e.g., cytokines)
on the oral mucosa. Such cells and cytokines may be critical for viral
adherence and internalization.
o Utilization of 3D bioinductive scaffolds that can support growth of
the cellular components and deliver essential growth factors.
o Isolation, enrichment and characterization of epithelial basal layer
stem cells required for maintaining long term survival of an in vitro
oral mucosa. Other somatic stem cells, such as mesenchymal or
circulating hematopoietic stem cells, might also be evaluated.
o Application of bioreactors designed to provide spatially uniform
concentrations of cells within scaffolds; control conditions in
culture medium (e.g., temperature, pH, osmolarity, levels of oxygen,
nutrients ); provide physiological relevant physical signals (e.g.,
interstitial fluid flow, shear, pressure, mechanical compression)
needed to obtain long-term survival of the in vitro oral mucosa.
o Establishment of the parameters under which optimal HIV
infection/transcytosis of the mucosal epithelium occurs in the in vitro
models.
o Determination of the optimal conditions for infection of the in vitro
models with other relevant oral mucosal pathogens.
o Utilization of a mucosal model to study the mechanisms by which
pathogens that are associated with oral complications in HIV infection,
such as EBV, HHV-8, HPV, CMV, HSV and Candida impact HIV permissiveness
and vice versa.
Validation of the in vitro human models:
o Use of sophisticated histological techniques and analysis of specific
tissue markers to show that the in vitro oral mucosa is physiologically
relevant to in vivo mucosa.
o Studies on transmembrane signaling pathways that are activated during
HIV-host cell interaction.
o Analysis of structural proteins involved in viral adsorption,
internalization and endocytosis to cells in the model system.
o Identification or function of proteins and other molecules (e.g.,
lipids, mRNA) involved in cross talk between HIV infected and non-
infected host cells.
o Comparison of gene expression in infected and uninfected oral mucosal
tissues.
o Gene and protein expression profiles of cells infected with orally-
relevant microbes and opportunistic pathogens (CMV, EBV, HPV etc.),
prior to and during progression of simulated AIDS conditions;
identification of factors which promote or inhibit the virus in this
context.
o Analysis of the gene and protein expression profiles of HIV and host
cells under quiescent and stress (pH, oxygen, heat) conditions.
o Gene and protein profiles of host leukocytes recruited to HIV
infected oral mucosal tissues; use of laser confocal microscopy to
identify and characterize infected cells.
o Studies on HIV inhibitory factors using in situ and real time
techniques.
o Development of assays applicable to the in vitro model for analyzing
the effect of natural or pharmaceutical interventional agents.
o Development and testing of potential agents that would impede, HIV
and/or opportunistic oral pathogen amplification and dissemination
within the mucosa.
Applications using animal cells or tissue will not be responsive to
this RFA.
MECHANISM OF SUPPORT
This RFA will use NIH Individual Research Project Grant (R01) and the
Exploratory/Development Research Grant (R21) award mechanisms. As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review procedures.
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular format. Otherwise
follow the instructions for non-modular research grant applications.
This program does not require cost sharing as defined in the current
NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NIDCR intends to commit $2,000,000 total costs in FY 2005 to fund 6
to 8 new and/or competitive continuation grants in response to this
RFA. An R01 applicant may request a project period of up to 4 years and
a budget for direct costs of up to $499,999 per year. An R21 applicant
may request a project period of up to two years with a combined budget
for direct costs of up to $275,000 for the two year period. For
example, the applicant may request $100,000 in the first year and
$175,000 in the second year. The request should be tailored to the
needs of the project. Normally, no more than $200,000 may be requested
in any single year. This R21 cap may be exceeded by $25,000, direct
costs per year to accommodate the facilities and administrative
(indirect) costs associated with collaborative research at another
institution. 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 NIDCR 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. At this time, it is not
known if this RFA will be reissued.
ELIGIBLE INSTITUTIONS
You may submit application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
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
Grantees will meet annually at or near NIH, Bethesda, MD, to share
results, to ensure that the NIDCR has a coherent view of the advances
in the field, and to have an opportunity for collective problem solving
among investigators. Applicants should budget for travel in their
requested budget for the principal investigator and one additional
junior investigator to attend this annual meeting.
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:
Mostafa Nokta, MD, PhD.
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial research
Building 45, Room 4AN-18H
45 Center Drive
Bethesda MD, 20892-6402
Telephone: (301) 594-7985
Fax (301) 480-8319
Email: Mostafa.Nokta@nih.gov
o Direct your questions about peer review issues to:
H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44F
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
Fax: (301) 480-8303
Email: George.Hausch@nih.gov
o Direct your questions about financial or grants management matters
to:
Mary Daley
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44B
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301)-594-4808
Fax: (301)-480-3562
Email: md74u@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 NIDCR 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 Dr. George
Hausch at the address listed above.
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 FOR R21 APPLICATIONS:
All application instructions outlined in the PHS 398 application kit
are to be followed with the following modifications for R21
applications:
1. FACE PAGE, Item 6: Up to a total of two years of support may be
requested. Total direct costs for the two years may not exceed
$275,000.
2. RESEARCH PLAN: Items a-d may not exceed fifteen (15) pages,
including tables and figures. The following information should be
taken into account for items a, b and c:
o Item a, SPECIFIC AIMS--The instructions for this section suggest that
the applicant state "the hypotheses to be tested". Since some
applications submitted in response to this RFA may also be design- or
problem-driven (e.g., development of novel technologies), or need-
driven (initial research to develop a body of data upon which future
research will build), hypothesis testing per se may not be the driving
force in developing such a proposal and, therefore, may not be
applicable. The application should state the hypotheses, design,
problem and/or need which will drive the proposed research.
o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is
important to identify clearly how the application addresses
the specific objectives of this RFA and the purpose of the R21
mechanism.
o Item c, PRELIMINARY STUDIES/PROGRESS REPORT No preliminary data are
required for an R21 application.
3. APPENDIX. Up to five articles may be submitted as appendix
materials.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: (include if
appropriate) Applications requesting up to $250,000 per year in direct
costs must be submitted in a modular grant format. The modular grant
format simplifies the preparation of the budget in these applications
by limiting the level of budgetary detail. Applicants request direct
costs in $25,000 modules. Section C of the research grant application
instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed 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, send two additional copies of the
application and all appendix material to:
H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44F
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov
APPLICATION PROCESSING: Applications must be received on or before
August 26, 2004. 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 NIDCR. 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 NIDCR 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 the NIDCR 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?
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?
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)?
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:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
R21 APPLICATIONS: The potential for ground-breaking, precedent-
setting research, with particular emphasis on novel and innovative
approaches; and the potential to stimulate new concepts or approaches
regarding important biomedical/behavioral problems, or provide a
technique/system of wide applicability.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: July 28, 2004
Application Receipt Date: August 26, 2004
Peer Review Date: October 2004
Council Review: January/February 2005
Earliest Anticipated Start Date: February 2005
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information , the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans, which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.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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