NIDCR EXPLORATORY AND DEVELOPMENTAL GRANTS IN CLINICAL RESEARCH
RELEASE DATE: November 14, 2003
RFA Number: RFA-DE-04-009
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:
93.121 (Oral Diseases and Disorders)
LETTER OF INTENT RECEIPT DATE: March 5, 2004
APPLICATION RECEIPT DATE: April 14, 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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Dental and Craniofacial Research (NIDCR)
recognizes that developmental, exploratory, or pilot studies in
epidemiology, behavioral/social science research, or other areas of
clinical research may be needed to collect preliminary data or
establish an adequate foundation for R01 level clinical research
addressing oral and craniofacial diseases and conditions. Thus, the
NIDCR invites research grant applications to conduct developmental,
exploratory, or pilot clinical research in areas where data are sparse
or do not exist or where exploratory studies can establish an improved
foundation for planning and developing sound R01 level clinical
research grant applications.
The goal of this announcement is to broadly encourage developmental,
exploratory, or pilot clinical research that documents oral conditions
and risk factors for oral and craniofacial diseases and disorders,
investigates new methods of diagnosing oral disease, addresses
behavioral research topics relevant to oral health, dental care, or
oral health promotion, and /or identifies promising culturally
appropriate approaches to prevent and reduce oral health disparities.
This R-21 mechanism cannot be used to support pilot clinical trials.
RESEARCH OBJECTIVES
Background
The NIDCR research activities cover a broad range of disease and
conditions affecting the oral, dental and craniofacial structures.
Diseases and conditions of interest to NIDCR as well as prominent gaps
in knowledge are briefly described below.
Dental caries is one the most prevalent diseases. It can occur at any
age after tooth eruption and primary teeth are especially vulnerable.
In the U.S., 18% of preschoolers have experienced dental caries.
Although the prevalence of dental caries has declined in the past three
decades, this oral disease remains the most common chronic disease of
childhood in the U.S. By age 17, more than 80% of adolescents are
affected by dental caries. However, dental caries is not evenly
distributed throughout the population. For example, approximately 25%
of children 5-17 years of age experience 80% of dental caries. Studies
have shown that the people at highest risk for dental caries are least
able to seek help: the poor, the very young, the elderly, and those
with compromising medical conditions or disabilities.
Like dental caries, periodontal diseases are an infectious disease
caused by bacteria in dental plaque. Periodontal diseases range from
mild forms such as gingivitis to severe forms that result in loss of
periodontal support and tooth loss. Almost half of U.S. adults ages 35
to 44 have gingivitis which is a reversible inflammation of the
gingiva. Approximately one-fourth has the more severe condition of
periodontitis that results in periodontal attachment loss of at least 4
millimeters. Severe periodontal disease (6 millimeters or more of
attachment loss) affects 14 percent of adults ages 45 to 54, and 23
percent of people 65 to 74-years of age. Tobacco use is a major risk
factor for the development and progression of periodontal diseases.
Furthermore, diabetes, particularly if poorly controlled, increases the
risk for periodontal disease.
Overall, data on the prevalence and risk factors for the infectious
diseases of caries and periodontal disease come from national surveys,
which report on white Non-Hispanics, Black non-Hispanics and Mexican
Americans. Limited data is available on other segments of the
population such as other Hispanic subgroups, Asian and Pacific
Islanders, Native Americans, other minority populations, and special
needs populations. These data are critical to guide the development of
effective and appropriate oral preventive and treatment modalities for
people in these population groups. In addition, development and testing
of new and innovative diagnostic methods for caries and periodontal
diseases are needed to promote effective prevention and early
intervention.
Without adequate saliva individuals may experience rampant tooth decay,
mucosal infections such as candidiasis, loss of taste, and considerable
oral discomfort. Salivary gland dysfunction can occur as a result of
Sj gren’s syndrome that affects between 1 and 4 million mostly middle-
aged women. Over 30,000 individuals who have cystic fibrosis also are
at higher risk for salivary gland dysfunction. In addition, each year,
an estimated 40,000 people lose salivary gland function as a result of
radiation treatment for head and neck cancer and many medications are
associated with salivary gland dysfunction. Limited data exist on the
epidemiology of salivary gland dysfunction and such data are needed to
appropriately design research to prevent and treat this disorder.
A number of chronic and disabling pain conditions have oral, dental,
and craniofacial manifestations. Epidemiologic studies suggest that
orofacial pain occurs in at least 10% of the adult population.
Orofacial pain by itself or as a symptom of untreated oral problems is
often a major source of poor quality of life. Sources of orofacial
pain include caries, some types of periodontal diseases, and
neuropathic and musculoskeletal conditions. Few well-designed studies
on the prevalence, etiology and pathogenesis of orofacial pain of non-
dental origin are available. In addition, limited data are available on
the underlying causes of muscular and joint facial pain that may
involve physiological, behavioral or environmental factors.
Numerous hereditary diseases, syndromes, developmental and acquired
disorders have oral and craniofacial manifestations with serious
functional, esthetic and social consequences. Craniofacial anomalies
are among the most common of all birth defects. Birth defects and
developmental disorders can be isolated or may be part of complex
hereditary diseases or syndromes. Cleft lip and cleft palate occurs in
about 1 to 2 out of 1,000 births in the U.S. Diseases of the bones and
connective tissue such as Paget’s disease and osteogenesis imperfecta,
osteoporosis, and scleroderma can have devastating oral and
craniofacial effects. Similarly, ulcers and erosive lesions associated
with oral and pharyngeal cancer treatment, immune dysfunction,
infectious diseases such as herpes simplex, HIV/AIDS, fungal infection,
aphthae as well as dermatologic and hematologic diseases may also have
serious oral and general health implications. Additional research is
needed to identify risk factors associated with these diseases so that
effective means of preventing and treating these conditions may be
developed and tested in clinical trials.
Oral facial injuries can lead to disfigurement and oral dysfunction.
While it is recognized that the leading causes of oral and craniofacial
injuries are sport, violence, falls and motor vehicle collisions, there
has been only limited research on the epidemiology, prevention, and
behavioral consequences of orofacial injuries.
The age-adjusted incidence rate of oral cancer for total oral cavity and
pharynx was 10.3 per 100,000 people in 1999 and this represents
approximately 3% of all cancers in the United States. The overall five-
year survival rate is 53%, and it has not changed in the past thirty
years. This five-year survival rate represents one of the lowest five-
year survival rates of any of the major cancer sites. These low
survival rates may be attributed to the fact that these cancers tend to
be diagnosed at advanced stages. Moreover, treatment for these
malignancies can be extremely disfiguring and often results in severe
loss of function including speech impairment and the inability to
swallow. Identification of effective means of screening and early cancer
diagnosis is an important priority of the NIDCR.
For the purpose of this RFA, people with special needs include those
with developmental or acquired physical or mental disabilities, people
with mental retardation (MR), people living with HIV/AIDS, and frail or
functionally dependent elders. There are limited data documenting that
individuals with these special needs are at increased risk for dental
and oral disease. Such data are critical to guide the development of
effective and appropriate oral preventive and treatment modalities for
people with special needs.
Goal and Scope
This RFA provides funds for exploratory, developmental, or pilot
clinical research that can help expand the scope of the NIDCR’s
clinical research portfolio and its potential impact on oral health in
the U.S. Some relevant aims for exploratory studies include: 1)
documenting the prevalence, incidence, and risk factors for oral and
craniofacial diseases and disorders, 2) investigating new methods for
diagnosing oral disease, 3) examining determinants of behaviors that
influence oral health or treatment outcomes and identifying approaches
to increase behaviors supporting oral health, 4) identifying culturally
appropriate preventive and treatment approaches for reducing oral
health disparities, and 5) stimulating research directed to improving
the oral health of special needs populations, including those with
developmental or acquired physical or mental disabilities, people with
mental retardation, people living with HIV/AIDS, and frail or
functionally dependent elders.
Applicants are encouraged to review the NIDCR Strategic Plan
(http://www.nidcr.nih.gov/about/strat-plan/) issued in 2003 and NIDCR’s
Plan to Eliminate Oral Health Disparities
(http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf).
Examples of exploratory research that would be responsive to this RFA
include, but are not limited to the following:
o Development, testing, and validation of methods for determining
prevalence, incidence, risk factors and determinants of disease for a
wide variety of oral diseases and orofacial pain in the general
population and in minority and special needs populations
o Development and /or testing of new diagnostic methods for diagnosing
oral or craniofacial diseases or conditions
o Development, testing, and validation of methods to measure the impact
of oral health-related quality of life on the general health in special
needs populations
o Development and preliminary testing of innovative ways to improve
oral health of people with special needs
o Development of innovative health promotion approaches (social,
educational, legal, fiscal) to address environmental, behavioral and
biological determinants of oral health and oral health-related quality
of life
o Development of ways to improve dissemination and implementation of
research findings to people with special needs, their caregivers, and
health care professionals
o Testing novel use of technology to improve dissemination of oral
health information, compliance with recommendations for oral health
care, oral health literacy, and oral health.
o Exploratory clinical studies on cognitive neuroscience and persistent
orofacial pain conditions.
o Studies on the genetic and environmental determinants of oral health.
o Studies using available databases to explore factors related to oral
diseases and conditions, especially for high risk or poorly studied
population subgroups.
o Studies assessing gaps in oral health knowledge, attitudes and
behaviors of the public and providers and developing innovative
strategies to address such gaps.
o Investigations aimed at clarifying the determinants of behaviors
influencing oral health and evaluating promising strategies to improve
oral health.
o Studies assessing oral health literacy and language skills as these
relate to oral health or treatment outcomes.
o Studies assessing the impact of parent-child education or other
interventions in dental settings relative to injury prevention,
prevention of tobacco use, or dietary changes promoting oral health.
In summary, a central focus of this RFA is to encourage developmental,
exploratory, or pilot epidemiological and behavioral science research
that addresses goals and objectives identified in the NIDCR’s Strategic
Plan and that have the potential for strengthening NIDCR’s portfolio of
clinical research. Some of these exploratory projects may strengthen
the capability for developing scientifically meritorious clinical
trials by identifying pertinent risk factors or promising interventions
that warrant larger scale research efforts or multi-site clinical
trials (see also
http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp).
MECHANISM OF SUPPORT
This RFA will use the NIH Exploratory/Developmental (R21) award
mechanism(s). 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. The anticipated award date is September 30,
2004. Applications that are not funded in the competition described in
this RFA may be resubmitted as NEW investigator-initiated applications
using the standard receipt dates for NEW applications described in the
instructions to the PHS 398 application.
This RFA uses just-in-time concepts. It also uses the 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 budget format. 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 approximately $1.5 million in FY 2004 to
fund 8 to 10 new grants in response to this RFA. Applicants may request
a project period of up to two years with a combined budget for direct
costs of up $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. 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.
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 institutions/organizations
o Foreign institutions are not eligible to apply
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 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 scientific questions about epidemiology research issues
to:
Maria Teresa Canto, DDS, MPH
Director, Population Sciences Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS43B
Bethesda, MD 20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
E-mail: maria.canto@nih.gov
o Direct your scientific questions about behavioral research issues to:
Patricia S. Bryant, PhD
Director, Behavioral and Social Science Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS43A
Bethesda, MD 20892-6401
Telephone:(301) 594-2095
Fax: (301) 480-8319
E-mail: patricia.bryant@nih.gov
o Direct your scientific questions about special needs populations and
oral health disparities research issues to:
Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS43J
Bethesda, MD 20892-6401
Telephone:(301) 594-5394
Fax: (301) 480-8319
E-mail: ruth.nowjack-raymer@nih.gov
o Direct your questions about peer review issues to:
H. George Hausch, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, Maryland 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
National Institutes of Health
Building 45, Room 4AN44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
FAX: 301-480-3562
Email: daleym@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows 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:
H. George Hausch, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, Maryland 20892-6402
Telephone: (301)594-2904
Fax: (301)-480-8303
Email: George.Hausch@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.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 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/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
H. George Hausch, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, Maryland 20892-6402
Telephone: (301)594-2904
Fax: (301)-480-8303
Email: George.Hausch@nih.gov
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 NIDCR. Incomplete applications will not be
reviewed.
If the application is not responsive to the RFA, NIH staff may contact
the applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
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 National Advisory Dental and
Craniofacial Council (NADCRC).
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
Reviewers will be asked to evaluate the R21 application in light of the
goals of the subsequent full-scale study (R01 type) to evaluate whether
the proposed research is likely to 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 for which
developmental, exploratory, or pilot research is needed prior to the
initiation of a full-scale (R01 type) study? Will the proposed R-21
research generate concepts, methods, or findings that will support a
subsequent full-scale (R01 type) study? Are the planned questions/aims
that are posed for the full-scale study important and, if achieved,
lead to significant advancement of scientific knowledge?
APPROACH: Does the applicant identify gaps that are critical to
carrying out the full-scale clinical research study? 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? To what degree will support of the proposed developmental,
exploratory or pilot research assist in the conduct of the full- scale
study? Does the applicant demonstrate that once the
developmental/exploratory research is completed a full-scale study
could be carried out?
INNOVATION: Is it likely that the developmental, exploratory, or pilot
project will lead to full-scale research that employs 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
developmental, exploratory, or pilot research and full-scale study 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 and / or community 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 will be
evaluated.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 5, 2004
Application Receipt Date: April 14, 2004
Peer Review Date: June/July 2004
Council Review: August 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
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
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.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information , the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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