NOVEL APPROACHES TO STUDY POLYMICROBIAL DISEASES
RELEASE DATE: April 15, 2004
PA NUMBER: PA-04-093
December 14, 2006 - The R01 portion of this funding opportunity has been
replaced by PA-07-171, which now uses the electronic SF424 (R&R)
application for February 5, 2007 submission dates and beyond.
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Accordingly, this funding opportunity
expires on the date indicated below. A replacement R21 (PA-06-210) funding
opportunity announcement has been issued for the submission date of June 1, 2006
and submission dates thereafter.
EXPIRATION DATE: for R21 Applications: March 2, 2006
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
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/)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
(http://www.nibib.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
93.121 (NIDCR); 93.837 (NHLBI); 93.173 (NIDCD); 93.286 and
93.287 (NIBIB)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The NIH Institutes listed above invite research grant applications to
conduct studies designed to develop innovative approaches that would
contribute to our understanding of the mechanisms that impact on the
virulence of infections involving two or more microorganisms or strains
of microorganisms (with the exception of HIV). This announcement
encourages investigators to think beyond the one organism-one disease
concept and instead to consider the fact that many diseases are caused
by the synergistic and inhibitory interactions of bacteria, viruses,
parasites, and fungi. Projects should include studies aimed at
understanding the cellular and molecular interactions of pathogens with
the normal flora as well as the interactions among pathogens
themselves, and how commensal organisms can be used to prevent or treat
infections; however, this PA is limited to those projects that involve
or are based on intermicrobial interactions that have been well
documented to occur in clinical settings. In addition, extensive
research is needed on the host responses to polymicrobial infections in
order to develop new approaches to treat and prevent these infections.
The development of co-infection models and the use of genomic and
proteomic technologies to identify common virulence mechanisms and host
response patterns as well as the development of diagnostic and
prognostic microbial/host signature patterns are encouraged. Because of
the complexity of such projects, the establishment of collaborative
scientific teams, both domestic and international, with diverse
scientific disciplines studying polymicrobial diseases, including
microbiology, immunology, biochemistry, clinical medicine, pathology,
bioengineering, material science, imaging technology, and mathematical
modeling are encouraged.
RESEARCH OBJECTIVES
Background
There is increasing evidence in the literature for the importance of
polymicrobial infections in which microorganisms interact in a
synergistic or inhibitory fashion, impacting on pathogenesis or the
maintenance of health. Among these, bacteria-bacteria, virus-virus,
parasite-parasite or virus-bacteria interactions have been described.
For example, co-infection of Borrelia and Ehrlichia have been reported
to enhance the severity and complicate the diagnosis of Lyme
borreliosis. Also, it is known that the occurrence of multiple
hepatotropic viruses influence the progression of the disease and that
individuals infected with parasitic helminthes have increased
susceptibility to malaria. Further, mixed viral-bacterial infections
have been associated with excess mortality and meningitis during
influenza pandemics, increased incidence of otitis media during
influenza and respiratory syncytial virus epidemics in children, as
well as antibiotic treatment failures and severe post-transplant
complications. In addition, epidemiologic shifts in the spectrum of
bacterial infection have been noted in cancer patients resulting in
changes in the use of antimicrobial therapy during the management of
these individuals.
It is conceivable that a viral infection, for instance, may facilitate
bacterial colonization and enhanced adherence to host cells, paving the
way for invasive disease. For example, a virus infection may induce
host cell membrane changes such as the expression of viral
glycoproteins that may serve as receptors for bacteria, or up-regulate
platelet activating factor receptor thereby promoting increased
bacterial adherence. Likewise, it is equally conceivable that a
bacterial infection may pave the way for increased viral disease. Also,
the ability of various bacteria in the microbial complex of the oral
cavity to express surface molecules (e.g., bacteriocins) that
specifically interact with other bacterial species and host cells has
been suggested to be a critical determinant in plaque formation and
structure. Indeed, a number of recent studies have focused on these
research areas including those using experimental animal models.
However, in future studies it will be important to develop appropriate
experimental models to examine the mechanisms associated with the
actual pathogen-to-pathogen interaction within the same host
environment that may lead to increased susceptibility or resistance to
infection.
It is anticipated that a better understanding of the mechanisms
involved in the observed clinical phenomena may provide opportunities
to more critically evaluate the role of suspected virulence
determinants involved in these mixed infections and the innate or
specific host immune response patterns involved; these projects should
also provide useful information for investigators in the development of
more effective diagnostic, prevention and treatment strategies. For
example, there is good clinical evidence that eradication of
predisposing viral infections reduce the onset of otitis media. Thus,
therapeutic approaches can be strengthened by taking into account the
polymicrobial nature of the disease.
Research Objectives and Scope
A major focus of this PA is to encourage investigators to develop novel
approaches for examining polymicrobial interactions and to think beyond
the one organism-one disease concept. Projects will be considered
responsive to this PA if the studies involve intermicrobial
interactions that have been well-documented to occur in clinical
settings or are based on clinically significant studies and are
designed on the basis of sound scientific arguments with clearly
defined endpoints such as profiles of immunological responses,
synergizing metabolic activities or the inhibition/promotion of
adherence to host cells. The NIBIB has specific interest on the
development of new imaging and bioengineering technologies. Proposals
submitted to the NIBIB should have a primary emphasis on the
development of new technologies useful for studying polymicrobial
interactions.
Research studies to be investigated under this PA are expected to
develop novel, mechanistic ideas for polymicrobial interactions.
Projects to be examined include, but are not limited to the following:
o Elucidation of the mechanisms by which viral or parasitic
infections increase the risk for bacterial infection or vice
versa;
o Determination of how surface adhesions are altered during
microbial interactions;
o Identify the mechanisms by which polymicrobial infections lead
to enhanced resistance of microbes to acquired or innate
immunity;
o Development of co-infection animal models or cell culture
systems for multiple pathogens;
o Development of vaccines against polymicrobial infections;
o Use of genomics and proteomics to identify microbial virulence
genes and/or proteins that may be uniquely expressed during
co-infection;
o Evaluation of host response patterns, in response to single
vs. multiple infections (simultaneous or sequential
activation), required to elicit synergy or inhibition;
o Ability of bacteria to colonize or invade host tissues
following recent viral infection;
o Development of biotherapeutics such as phage therapy and the
ability of bacteria to block the pathogenicity of other
bacteria (i.e. probiotic organisms);
o Characterization of lung host responses to polymicrobial
infections and lung host response patterns;
o Polymicrobial interactions as determinants of lung disease;
o Development of new imaging techniques for probing
polymicrobial interactions; and,
o Development of mathematical models and analysis tools for the
study of polymicrobial interactions.
MECHANISMS OF SUPPORT
This PA will use the NIH R01 and R21 award mechanisms. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project. The R21 proposals should have the
potential for truly groundbreaking impact. Use of this mechanism to
explore new biomedical approaches to address basic and applied research
questions is encouraged. Applicants are encouraged to contact program
staff for advice about choosing the appropriate grant mechanism. R21
applications may request up to a total of two years of support, and
total direct costs for the two years cannot exceed $275,000.
The objective of the R21 mechanism is to support innovative, high
risk/high impact research requiring preliminary testing or development;
exploration of the use of approaches and concepts new to polymicrobial
research; research and development of new technologies, techniques or
methods; or initial research and development of data upon which
significant future research may be built. Applications will be
considered as high impact if they demonstrate the potential for ground-
breaking, precedent-setting significance, and high risk because they
either lack sufficient preliminary data to ensure their feasibility, or
involve using a new model system or technique. While this PA is
intended to encourage innovation and high impact research, and while
minimal preliminary data are expected to be described in the
application, applications should clearly indicate that the proposed
research and/or development is scientifically sound, that the
qualifications of the investigators are appropriate, and that resources
available to the investigators are adequate.
This PA 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_2003/NIHGPS_Part2.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the
opportunity to answer questions from potential applicants. Inquiries
may fall into two areas: scientific/research and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Dennis F. Mangan, Ph.D.
Division Basic and Translational Sciences, NIDCR
Building 45, Room 4AN-12J
Bethesda, MD 20892-6402
Telephone: (301) 594-2421
FAX: (301) 402-8319
Email: Dennis.Mangan@nih.gov
Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases, NHLBI
Two Rockledge Center, Suite 10018
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: Schleges@nih.gov
Bracie Watson, Jr., Ph.D.
Hearing Program
Division of Scientific Programs, NIDCD
6120 Executive Blvd., 400-C, MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
E-mail: watsonb@nidcd.nih.gov
Peter Moy, Ph.D.
Division of Discovery Science and Technology, NIBIB
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892
Telephone: (301) 496-9270
FAX: (301) 480-4973
Email: moype@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Mary Daley
Chief Grants Management Officer, NIDCR
45 Center Drive MSC 6402
Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: (301) 594-4808
FAX: (301) 480-8303
Email: md74u@nih.gov
Robert A. Pike
Lung Team Section Chief
Grants Operations Branch, NHLBI
Two Rockledge Center, Room 7154
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0182
FAX: (301) 480-3310
Email: Piker@mail.nhlbi.nih.gov
Sara Stone
Chief, Grants Management Branch, NIDCD
Executive Plaza South, Room 400B
6120 Executive Boulevard, MSC-7180
Bethesda, MD 20892
Rockville, MD 20852 (express mail)
Telephone: (301) 402-0909
Email: stones@nidcd.nih.gov
Karen Shields
Grants Management Specialist, NIBIB
6707 Democracy Boulevard, Suite 900
Bethesda, MD 20892
Telephone: (301) 451-4971
FAX: (301) 480-4974
Email: shieldsk@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 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.
The title and number of this program announcement must be typed on line
2 of the face page of the application form and the YES box must be
checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application
deadlines, which are available at
http://grants.nih.gov/grants/dates.htm. Application deadlines are also
indicated in the PHS 398 application kit.
SUPPLEMENTARY INSTRUCTIONS:
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 cannot exceed
$275,000.
2. Items a-d of the Research Plan for the R21 application 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 PA 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 PA 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 - Use the instructions for the appendix detailed in the
PHS 398 except that no more than 5 manuscripts, previously accepted for
publication, may be included.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application
deadlines, which are available at
http://grants.nih.gov/grants/dates.htm. Application deadlines are also
indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:
Applications requesting up to $250,000 per year in direct costs must be
submitted in a modular budget grant format. The modular budget 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.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER
YEAR: Applications requesting $500,000 or more in direct costs for any
year must include a cover letter identifying the NIH staff member
within one of NIH institutes or centers (IC) who has agreed to accept
assignment of the application.
Applicants requesting more than $500,000 must carry out the following
steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff
member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended
or revised version of these grant application types. Additional
information on this policy is available in the NIH Guide for Grants and
Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed original copy of the
application, including the checklist, and five signed photocopies in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by or mailed on
or before the receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of a substantial revision of an
application already reviewed, but such application must include an
Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review
group convened in accordance with the standard NIH peer review
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed
to have the highest scientific merit, generally the top half of
applications under review, will be discussed and assigned a priority
score
o Receive a written critique
o Receive a second level review by the appropriate national advisory
council or board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this 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?
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research will be assessed. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
in the sections on Federal Citations, below).
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 are expected to 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. (See:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities
involving live, vertebrate animals must comply with PHS Policy on
Humane Care and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf),
as mandated by the Health Research Extension Act of 1985
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the
USDA Animal Welfare Regulations
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.
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
SHARING RESEARCH DATA: Investigators submitting an NIH application
seeking $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. 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.
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.
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).
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 PA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm .
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
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