and Human Services (HHS)
EXPIRED
NIDCR CLINICAL PILOT DATA GRANT
RELEASE DATE: December 4, 2002
PA NUMBER: PAR-03-043 (This PAR has been reissued, see PAR-06-025)
(see clarification NOT-DE-04-002)
EXPIRATION DATE: This Program Announcement expired on October 19, 2005
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE
The National Institute of Dental and Craniofacial Research (NIDCR)
announces a grant program to support the collection of clinical pilot
data to be used in preparing applications for definitive Phase III
clinical trials. These pilot data grants should focus on research that
is particularly innovative and/or potentially of high impact to
craniofacial, oral, and dental research. High impact research may
involve small feasibility studies in which the technological,
methodological, or theoretical approach to a problem lacks sufficient
preliminary data. This grant is not intended to support small pilot
clinical trials. The applications must develop new research relevant
to the NIDCR mission in craniofacial, oral, and dental research.
RESEARCH OBJECTIVES
The National Institute of Dental and Craniofacial Research is committed
to identifying effective preventive, diagnostic, and treatment
approaches to craniofacial, oral, and dental diseases and disorders
that will improve health by supporting well-designed, definitive Phase
III clinical trials. Before proceeding to a Clinical Trial Planning
Grant and then to the full-scale Phase III clinical trial, pilot
clinical data are often required.
The objective of the NIDCR Clinical Pilot Data Grant is to provide a
mechanism for the collection of preliminary data that is necessary to
support the development of definitive Phase III clinical trials to
evaluate interventions for the treatment or prevention of craniofacial,
oral, and dental conditions and promote craniofacial, oral, and dental
health. By providing resources to collect essential data required for
the design of a subsequent full-scale Phase III clinical trial, it is
anticipated that applicants will be in a better position to address in
a definitive way the core design issues that are involved in clinical
trial research. The research supported under this award may involve
limited pilot testing of novel experimental hypotheses, design-driven
development of new or novel techniques or technologies, and/or the
acquisition of a body of data that has potentially high-impact on
craniofacial, oral, and dental research. The NIDCR Clinical Pilot Data
Grant may include but is not limited to: collection of preliminary
data for establishing measures of effectiveness and/or safety; testing
and documenting recruitment mechanisms and their effectiveness; short-
term studies to address questions to optimize the design of the
definitive trial; small studies to refine an intervention strategy
(e.g., dosage, duration, delivery system, etc.); and, the development
and testing of participant inclusion criteria and data collection
instruments.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) R21
Exploratory/Development Grant award mechanism. Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant. The total project period for an
application submitted in response to this PA may not exceed two years,
and the annual direct costs may not exceed $100,000 per year. This
award may not be renewed.
Specific application instructions have been modified to reflect
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined
by the NIH. Complete and detailed instructions and information on
Modular Grant applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.
ELIGIBLE INSTITUTIONS
You may submit an application 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
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
Before submitting an application for an NIDCR Clinical Pilot Data
Grant, the investigator should submit a brief description of the
proposed Phase III clinical trial to the NIDCR for review for
programmatic relevance. See http://www.nidcr.nih.gov for details or
contact one of the persons listed in WHERE TO SEND INQUIRIES under
scientific/research issues.
WHERE TO SEND INQUIRIES
Inquiries are encouraged early in the development of a NIDCR Clinical
Pilot Data Grant. The opportunity to clarify any issues or questions
from potential applicants is welcome and highly encouraged. Inquiries
may fall into three areas: scientific/research, peer review, and
financial or grants management issues:
o Direct your questions about scientific/research issues to:
Dr. Richard Mowery
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4As43F, MSC 6401
Bethesda, MD 20892-6401
Telephone: (301) 594-4848
FAX: (301) 480-8322
Email: rm33a@nih.gov
Or
Dr. Bruce Pihlstrom
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4As43H, MSC 6401
Bethesda, MD 20892-6401
Telephone: (301) 594-4830
FAX: (301) 480-8322
Email: pihlstrb@mail.nih.gov
o Direct your questions about peer review issues to:
Dr. H. George Hausch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4An-44F, MSC 6401
Bethesda, MD 20892-6401
Telephone: (301) 594-2904
o Direct your questions about financial or grants management matters
to:
Ms. Anne Welkener
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS-55, MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-4806
Email: Anne.Welkener@nih.gov
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 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 the program announcement must be typed in
Section 2 on the face page of the application. As with most
applications to NIH, the research plan is limited to 25 pages. All
information for review of the NIDCR Clinical Pilot Data Grant
application must be included in the body of the application; appendices
will not be considered during the review for this mechanism.
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 GRANT APPLICATIONS: 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.
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)
In order to facilitate the review of applications assigned to the
NIDCR, the applicant must, at the same time, mail or deliver two copies
of the application to:
Dr. H. George Hausch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44F - MSC 6402
Bethesda, MD 20892-6402
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTES
OF HEALTH AND THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL
RESEARCH WILL NO LONGER BE ACCEPTED. This policy does not apply to
courier deliveries (i.e., FED EX, UPS, DHL, etc.). This policy for
applications addressed to the Center for Scientific Review was
published in the NIH Guide to Grants and Contracts at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
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.
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 by NIDCR 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 Receive a written critique
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 second level review by the National Advisory Dental and
Craniofacial Research Council.
REVIEW CONSIDERATIONS
Applications 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 receive a written critique and undergo a 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.
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 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 the proposed pilot activities
on the concepts or methods that drive this field? Will a successful
outcome from this pilot work lead directly to the development of a
definitive Phase III clinical trial that would likely advance the field
of craniofacial, oral, or dental research?
(2) Approach: Are the conceptual framework, design, and methods
adequately developed, well integrated, and appropriate to the aims of
the project? Does the applicant 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? Will the project generate a new body of data that
provides a foundation for important new clinical trials research?
(4) 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? Is the principal investigator an independent researcher?
(5) Environment: Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed
planned activities 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:
PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
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)
DATA SHARING: The adequacy of the proposed plan to share data.
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
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phase I and II 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:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the 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
(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 PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This PA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.121 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under HIN grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Part 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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