TRANSLATIONAL RESEARCH IN DENTAL PRACTICE-BASED TOBACCO CONTROL INTERVENTIONS
RELEASE DATE: October 7, 2002
RFA: DE-03-007
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
LETTER OF INTENT RECEIPT DATE: February 24, 2003
APPLICATION RECEIPT DATE: March 24, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Purpose of This RFA
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute on Drug Abuse (NIDA) and the National Institute
of Dental and Craniofacial Research (NIDCR) are committed to
stimulating innovative research on dental practice-based tobacco
control interventions, as well as studies which use dentistry as a
model to clarify processes underlying or influencing the translation of
research findings into clinical practice. Tobacco control provides an
important, public health-relevant venue for studying the translation of
basic and clinical research findings into clinical practice. Clear,
science-based clinical guidelines for implementing tobacco prevention
and tobacco cessation are available. Also, numerous studies have
documented harmful impacts of tobacco use on oral diseases and dental
treatment outcomes. As yet, however, evidence suggests that the
preponderance of US dental clinicians are not utilizing optimal
science-based approaches to prevent or reduce the use of oral health-
harming smoked or smokeless tobacco products.
This RFA aims to stimulate research to: 1) develop and test
interventions that translate findings from alcohol, tobacco and other
drug prevention and treatment research into effective, dental practice-
based tobacco control strategies, 2) translate findings from other
theoretically-grounded basic or behavioral science research into
effective dental practice-based tobacco control strategies, or 3)
clarify processes that underlie or influence the translation of
tobacco-related knowledge into clinical dental practice.
RESEARCH OBJECTIVES
Background
The initiation of smoked or smokeless tobacco use is promoted by a wide
array of familial, peer, community and media factors. Ongoing use is
maintained primarily by the addictive nature of nicotine, although
other constituents of tobacco products also play a role. In addition,
cues that have become conditioned to the use of tobacco can influence
subsequent use, as well as the relapse to use that often accompanies
quit attempts. Epidemiological studies indicate that experimentation
with tobacco products typically begins in early adolescence. Addiction
often develops rapidly, with the presence of addiction often
demonstrable early in an individual's history of use. Thus, preventing
initiation of tobacco use is critical. Various preventive strategies
involving family, peer and school, community, or media influences have
been studied and found to influence use, age at initiation of tobacco
use, and relative probabilities of tobacco use and addiction in
adulthood. Treatment of tobacco addiction in adults typically
incorporates behavioral support strategies in conjunction with nicotine
replacement therapies (NRT), such as the nicotine patch, polacrilex
gum, or Zyban (bupropion). Contemporary treatment research is
exploring other approaches, for example medications such as clonidine,
nortryptiline, and combinations of bupropion with NRTs.
I. Changing clinicians' practice behaviors related to preventing,
reducing, monitoring, or treating tobacco use/nicotine addiction.
In theory, front-line clinicians are in an ideal position to identify
problematic health behaviors and to intervene promptly via preventive
or treatment strategies and/or referral. Evidence from randomized
trials and observational studies demonstrates that health care
providers who intervene with smokers can reduce their patients' tobacco
use. Various approaches to help patients quit smoking have been
demonstrated to be effective in outpatient health care settings. Quit
rates generally become higher as the interventions offered by the
health provider become more frequent and intensive. Multi-modality
interventions, including identification, counseling, education,
pharmacological aids, and follow-up have more powerful and consistent
behavioral effects than do unidimensional approaches, such as advice
alone. Brief clinic-based interventions have been shown to increase
patient smoking cessation rates. In 1989, the National Cancer
Institute developed recommendations for physicians treating patients
who smoke. This recommended approach includes four steps – ask about
smoking, advise smokers to stop, assist those who want to stop, and
arrange adequate follow-up. In 1996, the Agency for Health Care Policy
Research (now the Agency for Health Research Quality) recommended a
five-step approach as a guideline for primary care providers. Similar
to the original approach, it integrates an additional step, that of
assessing the patient's willingness to stop, after the provider has
already asked about tobacco use and advised the patient to quit.
Several studies have shown that brief advice on smoking cessation,
delivered either by physicians or dentists, produces demonstrably
beneficial overall reductions in tobacco use. Research has also shown
that the effectiveness of provider-delivered smoking cessation
interventions is increased by training, the use of screening systems or
chart identifiers to indicate patients' tobacco status, and the use of
cues or reminders to intervene with smokers.
While practice-based screening and treatment to reduce use of tobacco
products are effective, tobacco control interventions remain under-
utilized in both medical and dental settings. Some significant
barriers to implementing tobacco or substance abuse screening or
interventions in health care settings have been identified. Barriers
clinicians report include: patient resistance and alienation, low
success rates, lack of time, lack of reimbursement, lack of
organizational support, and lack of appropriate patient education
materials and referral resources.
Findings indicate that many primary care providers do not see
themselves as adequately prepared or competent to treat smokers or
other patients with substance abuse problems. Engaging in training
and educational programs has, however, been demonstrated to change
practice behaviors. For example, physicians who had received formal
training in smoking cessation were observed to spend more time
counseling patients to quit smoking than did their counterparts who
lacked this extra training. Similarly, a brief training program
teaching internal medicine and family practice residents to counsel
patients to stop smoking resulted in increasing both their observed
cessation counseling skills and their reported willingness to employ
these techniques later.
II. Tobacco Use and Oral Health.
Tobacco use has serious, costly adverse effects on oral health.
Studies indicate that all forms of tobacco, including cigarettes,
cigars, pipes and smokeless tobacco products, can cause oral and
pharyngeal cancers. Smoking is known to be a major risk factor in adult
periodontitis. Strong epidemiological and clinical evidence supports
the view that fully one-half of the periodontitis cases in the US can
be attributed to cigarette smoking and that tobacco use increases risks
for a wide range of oral soft tissue changes. Tobacco use also
substantially reduces probabilities of successful outcomes from
periodontal therapies and dental implants, impairs oral wound healing,
and creates tooth discoloration and other oral changes which help fuel
demand for costly dental interventions. The American Dental Association
(ADA) Summary of Policy and Recommendations Regarding Tobacco,
(http://www.ada.org/prof/prac/issues/statements/tobac.html) "…urges
its members to become fully informed about tobacco cessation
intervention techniques to effectively educate their patient to
overcome their addiction to tobacco". However, there is limited
evidence that this policy statement has been widely implemented.
Findings from the ADA's 1997 Survey of Current Issues in Dentistry:
Tobacco Cessation Efforts Among Dentists indicate that 60% of
respondents reported they routinely asked about tobacco use and 40%
reported they routinely advised tobacco users to quit. (However,
dentists interested in tobacco cessation may have been more likely to
respond to the survey). In contrast, a recent study of dental patients
revealed that only 24% of smokers and 18% of smokeless tobacco users
who had seen a dentist in the past year reported that their dentist had
advised them to quit.
Recently published U.S. Public Health Services clinical guidelines on
treating tobacco use and dependence provide evidence-based, practical
methods which dental professionals can utilize. Despite the
availability of such guidelines, their translation into practice has
lagged and little research has focused on developing the means to
accelerate this process. Recent studies indicated that about one-half
of dental schools include didactic training in counseling tobacco users
to quit, and less than one-half of dental school clinics and dental
hygiene programs provide any significant level of clinical tobacco
intervention services. Studies from the mid-1990s indicated that at
that time only 25% of dental schools were using health history forms
that included any questions about tobacco use.
U.S. survey data for 1996-1997 indicates that 63 percent of adults aged
18-65 years and 72% of youth 5-18 years had a dental visit during the
past twelve months. Moreover, many dental visits are regularly
scheduled and preventively oriented, typically involve longer intervals
of interaction than most medical visits, and often dental patients
return to the same dental providers regularly across years or even
decades. Thus, members of the dental profession may be well positioned
to make a unique contribution to influencing tobacco use and
reinforcing sustained reductions in tobacco use in a substantial
proportion of America's youth and adults.
III. Adoption/Diffusion.
Research on the dissemination of information to health care providers
indicates that printed materials (including journal articles) seldom
have a strong effect on providers' behavior. Based on models of
behavior change, information alone is often not sufficient to produce
enduring behavioral changes. Additional steps are often required to
help motivate, facilitate, and reinforce changes in entrenched
behaviors. From the complementary perspectives of social influence
research, health care providers' behaviors are also accessible to
change through addressing regulatory, normative, economic, and peer
influences. Examples of regulatory influence include third party
reimbursement policies, the threat of malpractice and sanctions by peer
review or other authoritative bodies. Normative influences are
especially critical during the early professional training of health
care providers. Interventions conducted during professional training
or bridging the transition between training and early years of practice
provide some unique opportunities to test impacts of normative
influences on subsequent practice behaviors. In contrast, different
strategies and interventions may be more powerful in changing the
clinical practice behaviors of well-established, experienced health
care providers. Research addressing the translation of tobacco control
strategies into practice at various points throughout dental providers'
career trajectories is specifically encouraged.
Scope
This RFA is intended to stimulate well-designed translational research that
can ultimately provide the basis for more effective tobacco control efforts
by dental professionals within a wide array of dental health care delivery
settings. Studies focused on identifying key processes influencing
translation of effective tobacco prevention/cessation strategies into
clinical dental practice, as well as intervention research to test and
improve tobacco prevention and cessation measures within dental settings
are specifically encouraged. A number of basic science research themes are
potentially applicable to developing more effective dental-practice based
tobacco interventions. Also, prevention and treatment strategies shown to
be effective as applied to other health conditions may prove applicable
within dental settings to help prevent tobacco initiation, or to reduce
dental patients' tobacco dependence and addiction.
Studies may test innovative approaches to accelerate dental care
providers' adoption and maintenance of effective tobacco control
procedures, such as preventing tobacco use in non-users, helping current
users to quit, providing long-term feedback and reinforcement to maintain
non-use, and educating dental patients and the public regarding specific
oral health risks associated with tobacco use. To the extent feasible,
translational studies should be grounded in theory and test both immediate
and longer-term effects. Investigators may focus on interventions
initiated during the professional education process or early clinical
training, at the transition between training and professional practice, or
within established dental practice settings.
This RFA also encourages studies targeting changes in tobacco-related
knowledge, attitudes and practices of practicing dental professionals,
including dental hygienists, working with different patient populations
and within different practice settings (e.g., dental HMO, general or
specialty dental practice settings). Cross-disciplinary research
projects that foster collaboration between basic and clinical researchers
are specifically encouraged.
Illustrative examples of studies appropriate to this initiative include
the following:
o Identify and test measures to accelerate translating basic or
clinical science findings on health risks of tobacco use and effective
approaches for tobacco prevention and cessation into more widespread
clinical practice, using dentistry as a model;
o Develop and test interventions aimed at translating findings from
drug dependence and addiction research into dental practice-based
tobacco control strategies;
o Study factors influencing the adoption and acceptability of dental
practice-based prescription of nicotine replacement therapies or other
drugs which have been demonstrated to improve tobacco quit rates;
conduct intervention studies to increase the acceptability and
effective use of such therapies in dental settings;
o Identify and characterize determinants of dental professionals'
adoption, implementation, and long-term maintenance of practice
behaviors congruent with evidence-based clinical guidelines for tobacco
prevention and cessation;
o Use untapped findings on cognitive factors such as decision-making,
automatic vs. controlled thinking, affective mediators and modulators
of cognition to help develop and pilot test innovative tobacco
prevention and cessation programs and to develop more effective
strategies that can be used in clinical dental practice;
o Identify relationships between dental providers' levels of knowledge
concerning the oral health effects of tobacco and their clinical
decision-making and practice behaviors;
o Refine and test methods and results associated with delivering
motivational interviewing or other tobacco counseling approaches within
dental settings, and test such interventions involving various dental
team members;
o Develop and test methods that capitalize on the known effects of
tobacco use on dental treatment outcomes and/or diminished dental
treatment options as a result of the patient's continued tobacco use
(e.g., poor prognosis for successful dental implants, premature tooth
loss in diabetic patients) to help motivate reduced use of tobacco
products or tobacco cessation in special patient groups;
o Adapt, develop, test, and compare the effectiveness of training
programs intended to influence dental health providers' attitudes,
knowledge, and skills concerning dental practice-based tobacco
prevention or cessation, providing particular attention to the
assessment of longer term changes in actual practice behaviors.
This list is illustrative and not intended to be inclusive.
Investigators are encouraged to propose other studies related to the
adoption and translation of science-based tobacco control measures
within dental educational and dental practice settings. They are also
encouraged to contact the NIDCR and NIDA research/science staff listed
later in this RFA with specific questions they may have regarding
whether a topic is responsive.
For purposes of this RFA, NIDA will assume primary programmatic
responsibility for all applications involving phase I or phase II
clinical trials. Moreover, the applicant needs to consult with NIDA
program staff prior to the preparation of any such application.
MECHANISM OF SUPPORT
Applicants responding to this RFA may use the NIH Research Project
Grant (R01) or Exploratory/Developmental 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. The anticipated award date is September 1, 2003.
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting format (see
https://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.
R21 applications only: Use of the R21 mechanism to support pilot
studies is intended to encourage innovative new research directions and
the exploration of approaches and concepts new to a particular area or
study population. As such, this mechanism encourages the entry of
investigators to a field, as well as encouraging new research
approaches and new collaborations. R21 applications will be expected
to provide less preliminary data than would be the case for other
funding mechanisms. Applicants should, however, make clear that the
proposed pilot research is scientifically sound, that the long-term
research goals are both scientifically significant and relevant to the
aim of tobacco control, the qualifications of the investigators are
appropriate, and resources available to the investigators are adequate
for the work proposed. An R21 grant cannot be renewed. If additional
research support is necessary, investigators could then apply for
further funding through the regular research grant (R01) mechanism.
FUNDS AVAILABLE
NIDCR and NIDA intend to commit a total of $2,000,000 in FY2003 to fund
6 to 8 new grants in response to this RFA. An applicant may request a
project period of up to 2 years for an R21 or up to 5 years for an R01
application. R01 applicants may request a budget for direct costs of
up to $375,000 per year. An R21 applicant may request a project period
of up to 2 years and a budget with direct costs of up to $150,000 (6
budget modules) per year. 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 and NIDA include 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) R01 or R21 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
Foreign institutions are not eligible under this RFA; however, a
domestic institution may, as scientifically appropriate, propose
research that includes foreign components.
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 be expected to attend a one and one-half day meeting
annually at or near NIH, Bethesda, MD, to share results and provide an
opportunity for collective problem solving. Applicants should budget
travel funds to attend this annual meeting in their requested budget.
The travel costs requested should be sufficient to permit attendance by
either the principal investigator and one additional investigator (for
R01 awards) or the principal investigator solely (for R21 awards).
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:
Direct scientific/research questions related to tobacco prevention and
control studies within dental educational settings or involving the
transition from professional education into clinical practice to:
Patricia S. Bryant, PhD
Director, Behavioral and Social Sciences Research Program
Clinical, Epidemiology and Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4An24E
Bethesda, MD 20892-6402
Telephone:(301)594-2095
Fax:(301) 480-8318
Email: Patricia.Bryant@nih.gov
Direct scientific/research questions related to tobacco prevention and
control studies involving dental clinicians within private dental
practice settings or other dental care delivery settings 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 Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AN24K
Bethesda, MD 20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
E-mail: maria.canto@nih.gov
Direct scientific/research questions related to the translation of
basic science findings into practice-based tobacco research or relevant
clinical trials within dental settings to:
Herbert Weingartner, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd.
Bethesda, MD 20892-9555
Telephone 301-435-1321
Fax 301-594-6043
E-mail: herbw@nih.gov
Direct scientific/research questions related to the translation of
research on the treatment of drug use, dependence, or addiction into
tobacco interventions or relevant clinical trials within dental
settings to:
Debra Grossman, M.A.
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Room 4123
Bethesda, MD 20932
Telephone: (301) 443-0107
Fax: (301) 443-6814
E-mail: dg79a@nih.gov
Direct scientific/research questions regarding the translation of
research on the prevention of drug use, dependence, or addiction into
tobacco interventions or relevant clinical trials within dental
settings to:
Shakeh Jackie Kaftarian, Ph.D.
Health Scientist Administrator
National Institute on Drug Abuse
National Institutes of Health
6001Executive Blvd, Rm 5153
Rockville, MD 20852
Telephone:301-443-8892
Fax: 301-480-2542
E-mail: jk362j@nih.gov
Direct questions about peer review issues to:
H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov
Direct questions about financial or grants management matters to:
Anne Welkener
Acting Chief
Grants Management Office
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44K
Bethesda, MD 20892-6402
Telephone: (301) 594-4800
FAX: (301) 480-8303
Email: Ann.Welkner@nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@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 Dr. 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). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
For R21 applicants, PHS 398 requirements should be followed, with the
exception of those specific modifications provided for in the R21
application instructions provided at the URL
http://www.nidcr.nih.gov/funding/rfa/r21applications_nida.asp. R01
or R21 applications not conforming to the requested format will be
returned to the applicant without review.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:
Applications requesting up to $250,000 per year 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. Applicant request direct costs in $25,000 modules. Section C of
the research grant application instructions for the PHS 398 (rev. 5/2001)
at https://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:
https://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:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF
DENTAL AND CRANIOFACIAL RESEARCH WILL NO LONGER BE ACCEPTED. This policy
does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.). This
change in practice is similar and consistent with the policy for
applications addressed to the Centers for Scientific Review as published
in the NIH Guide Notice
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is
received after that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the participating ICs. Incomplete and/or non-
responsive applications will be returned to the applicant without
further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDCR in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have
the highest scientific merit, generally the top half of the
applications under review, will be discussed and assigned a priority
score
o Receive a second level review by the National Advisory Dental
Research Council and the National Advisory Council on Drug Abuse.
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 your application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning your application's overall score, weighting them
as appropriate for each application. Your 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,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If
the aims of your application are achieved, how do they advance
scientific knowledge? What will be the effect of these studies on the
concepts or methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Do you acknowledge potential problem areas and
consider alternative tactics?
(3) 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, or employ innovative approaches for assessing
sustainability within health care delivery settings?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans or
the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 24, 2003
Application Receipt Date: March 24, 2003
Peer Review Date: June/July 2003
Council Review: August 2003
Earliest Anticipated Start Date: September 1, 2003
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
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH
policy that all clinical trials require data and safety monitoring,
with the method and degree of monitoring being commensurate with the
risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants
and Contracts, June 12, 1998:
https://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 AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (HESC): Criteria for federal funding of
research on HESCs can be found at
https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using HESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s) for the HESC line(s)to be used
in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
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.
Specifically it addresses Healthy People 2010 objectives related to
oral health, drug dependence and addiction, and tobacco. 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 Nos. 93.121 (NIDCR) and 93.279 (NIDA) and
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. Awards are made
under authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and administered under NIH
grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
REFERENCES
Applicants may wish to view selected references, which are available at
the following URL (http://www.nidcr.nih.gov/funding/rfa/references_nida_r21.asp)