Full Text DE-96-002
 
COLLABORATIVE OPPORTUNITIES FOR RESEARCH ON MINORITY ORAL HEALTH
 
NIH GUIDE, Volume 25, Number 13, April 26, 1996
 
RFA:  DE-96-002
 
P.T. 34, FF

Keywords: 
  Oral Diseases 
  Dentistry 

 
National Institute of Dental Research
 
Letter of Intent Receipt Date:  May 1, 1997
Application Receipt Date:  June 20, 1997
 
PURPOSE
 
The National Institute of Dental Research (NIDR) invites
investigator-initiated research project grant applications for
collaborative research grants from investigators at minority
institutions.  The Collaborative Opportunities for Research on
Minority Oral Health (CORMOH) initiative supports collaborative
biomedical and behavioral research between scientists at minority
institutions and investigators at research-intensive institutions on
basic and clinical research within the mission of the NIDR.  The
purpose of the initiative is to:  (a) increase the racial and ethnic
diversity of the pool of scientists contributing to the scientific
knowledge-base relevant to oral and craniofacial health by enhancing
the research capabilities and careers of these individuals; (b)
enhance the capacity to conduct scientifically meritorious research
at minority institutions; and (c) support basic and clinical research
relevant to improving the oral and craniofacial health status of U.S.
racial and ethnic minority populations.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Collaborative Opportunities for Research on
Minority Oral Health, is related to the priority area of reducing
health disparities among Americans by improving the oral health of
minority populations.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202/512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, public and private
minority institution such as dental or medical schools, research
institutions, and universities.  Because this initiative focuses on
the oral craniofacial fealth status of U.S. racial/ethnic minorities,
applications from foreign institutions are not eligible.  In order to
expand the base of support applications from institutions receiving
concurrent funding through the Regional Research Centers in Minority
Oral Health (RRCMOH) program.
 
The principal investigator must devote at least 50 percent effort to
the research and collaborating investigator(s) may not devote more
than a combined total of 20 percent effort.  To be eligible, the
principal investigator must be a member of a U.S. racial or ethnic
minority, an employee of a minority institution, and propose an
affiliation with an investigator at one or more research- intensive
institutions.  Definitions for these terms are given in the section
titled Definitions.
 
The principal investigator for a grant under the CORMOH initiative
may not have been the principal investigator for a previous National
Institute of Health (NIH) supported investigator-initiated research
grant (e.g., R01, R29, R41, R43, R44, P01, P30, P50, or P60),
cooperative agreement (e.g., U01, U10, U18, U41, U43, or U44) or
contract (e.g., N01, N43, or N44), or served as the project director
of a subproject on a multi-project grant such as a P01 or center
grant.  Funding as a principal investigator for other NIH research
grants such as small grants (R03) or AREA (R15) grants, however, does
not disqualify individuals from applying for and receiving a grant
through the CORMOH program.  Potential applicants having questions
about eligibility should contact Dr. Norman S. Braveman at the
address listed under INQUIRIES.
 
Definitions
 
The following definitions are used for the purpose of this RFA:
 
o  U.S. Racial or Ethnic Minority -  individuals whose heritage is
traced to one of the following groups:  Black; Hispanic (not Black);
Native American; Asian/Pacific Islander.
 
o  Minority Institution - an educational, health care or research
institution staffed predominantly by ethnic minorities, renders
service predominantly to minority groups, and/or whose student
population consists primarily of individuals from minority groups.
 
o  Evidence must be included in the application documenting the
institution's eligibility regarding this criterion.
 
o  Research-Intensive Institution - an institution that received more
than $50 million or more than 200 research grants and/or cooperative
agreements from the NIH during Fiscal Year (FY) 1994.  A list of
qualifying institutions is available from the program staff listed
under INQUIRIES.
 
MECHANISM OF SUPPORT
 
This RFA is a one-time solicitation by the NIDR.  The mechanism
available for support of applications in response to the RFA is the
investigator-initiated research project grant (R01).  Applicants may
apply for and receive up to five years of support.  Responsibility
for the planning, direction, and execution of the proposed project
will be solely that of the applicant.  Issuance of a subsequent
request for new and competing continuation applications will be
contingent upon program needs and the availability of funds.
 
FUNDS AVAILABLE
 
It is expected that approximately $1.9 million will be available to
fund up to ten awards, if sufficient applications of high scientific
merit are received.  Although funds for this program are provided for
in the financial plans of the NIDR, the award of grants pursuant to
this RFA is contingent upon the availability of funds.  Subsequent
support will be dependent upon submission of a renewal application
through established NIH procedures for research grants.  Budget
increases of up to but not to exceed more than four percent for
recurring costs may be requested for each of the subsequent years.
The earliest possible award date will be June 1, 1998.
 
RESEARCH OBJECTIVES
 
Background
 
The National Institute of Dental Research (NIDR), in its long-range
research plan and in response to recommendations from the National
Advisory Dental Research Council as well as other advisory groups,
has emphasized the importance of expanding the diversity of the pool
of qualified investigators who are knowledgeable in
state-of-the-science approaches to biomedical and behavioral research
as well as in the more traditional basic science and clinical
disciplines.  The NIDR has been among the leaders in supporting
increased opportunities for access to research careers by racial and
ethnic minorities.  This RFA was conceived with this focus in mind.
The development of the plan was aided by conceptual contributions
from participants in dental and oral health research who emphasized
the need for consortia arrangements to strengthen the capacity of
minority institutions to plan and conduct scientifically meritorious
research and to engage in appropriate research training and career
development.
 
The concept of the CORMOH Program was introduced to fulfill these
needs by improving the research capacity of minority institutions and
providing minority investigators with opportunities to conduct basic
and clinical biomedical and behavioral oral health research on topics
of relevance to improving oral health status of U.S. racial and
ethnic minorities.  By supporting collaborative activities the NIDR
is maximizing the use of scarce resources in a way that will be
mutually beneficial to participating partners.
 
As such the CORMOH Program will further expand research opportunities
for scientists at minority institutions as well as address the need
for continued focused biomedical and behavioral research on minority
oral health. Through collaborative affiliations with individuals who
have both the resources and experience necessary to successfully
compete in the NIH scientific peer review system, minority scientists
will have access to scientists with proven scientific and
grantsmanship expertise.  It is further anticipated that these
experiences will not only enhance the research careers of the
minority scientists but they also can attract qualified minority
undergraduate and graduate students who will follow careers in dental
and oral health research to the minority institutions.
 
Research Opportunities
 
The following topics are suggested for inclusion in response to this
RFA.  These, however, are not listed in priority order nor are they
exhaustive.  Other research topics within the scope of the purpose of
this RFA may be proposed.  While it is anticipated that many of the
proposed research projects will involve problems directly relevant to
minority populations and that clinical research will include female
patients as well as those from minority populations, research aimed
at a broad understanding of the causes of and mechanisms underlying
oral and craniofacial health and disease processes is also
encouraged.
 
o  SYNTHESIS AND DEGRADATION OF BONE - Basic research on the steps
involved in the synthesis and degradation of normal and abnormal bone
utilizing the technologies of molecular biology, enzymology and cell
culture.  Continued research could be focused on genes, gene products
and the development of probes that can be used in diagnosis
particularly in those bone diseases that disproportionately afflict
members of various minority groups.  This information could aid in
improving diagnosis and treatment.
 
o  COMPOSITION OF BONE - Studies on the qualitative and quantitative
constituents of bones and teeth (hard tissues) in different ethnic
groups and different disease states. There is a long standing
interest in the composition and strength of bone as influenced by the
presence of fluoride.  Determination of genetic differences in
composition of bone due to sex or racial origin and alteration in
this composition during aging and disease as in osteoporosis would
provide valuable information for understanding and treatment of bone
pathology.
 
o  CARTILAGE AND BONE REPAIR - Clinical studies of cartilage and bone
repair in normal and disease states such as periodontal disease,
would provide valuable information for treatment.  Studies which
would lead to a better understanding of the repair of bone and
cartilage following injury, birth defects and disease pathology would
be of great economic and medical interest particularly as it applies
to minority populations.
 
o  AUTOIMMUNE DISORDERS - Studies to investigate the oral
pathogenesis and treatment of autoimmune disorders such as Sjogren's
disease and diabetes and their impact on oral health are of great
importance to the health service profession.
 
o  THE ROLE OF DIET AND NUTRITION IN ORAL HEALTH - Diet and nutrition
are important factors in the prevention and maintenance of oral
health.  Nutritional factors are reported to  have an affect  on
cell-cell signaling at the molecular level and on the expression and
action of cell regulators such as cytokines, lymphokines and adhesion
molecules.  Dietary components including iron, riboflavin vitamins
such as A, C and beta carotene may be key factors in the prevention
or amelioration of oral cancer. Nutritional factors are also
important in the modulation of cell repair, regeneration and
replacement, including cellular and/or tissue damage and influence
the mechanisms involved in cell death. Therapy with dietary
supplementation is also believed to reduce the oral complications
encountered with traditional radiation and chemotherapy.
 
o  ORAL MANIFESTATIONS OF AIDS - The oral cavity is often the site of
the first indications of the presence of opportunistic infections
associated with AIDS.  Specific molecular markers or other tests
could be used in the oral cavity for diagnosis of the disease and its
associated infections.  The oral cavity can also serve as the site of
the introduction of HIV-1 to the body.  Studies of a reported anti
viral protein in the saliva and the effect of mucosal immunity in the
oral cavity are of great interest as potential protection against HIV
infection.
 
o  TEMPOROMANDIBULAR JOINT DISORDERS - Determine the molecular and
cellular composition of normal, aging, and abnormal tissues of the
temporomandibular joint.  Determine the molecular , cellular and
physiological changes in the joint due to injury and the use of
replacement devices.
 
o  INFLAMMATION AND PAIN IN THE ORAL CAVITY - Conduct studies to
define the mediators and inhibitors of inflammation in orofacial
tissues.  Study the involvement of nerves in inflammation and injury
and ways to prevent or ameliorate the associated pain.
 
o  ORAL CANCER - The major risk factors for oral cancer factors for
oral cancer are tobacco and alcohol use.  Utilization of tobacco is a
problem of our youth, particularly those from minority populations,
who smoke their first cigarette at age 14 years and use smokeless
tobacco in the 4th or 5th grade.  Some of the information needed on
how the use of tobacco and alcohol result in the development of oral
lesions and cancer includes:  identifying the chemical, physical, and
biological substances that cause or promote the pathology;
determining the ways in which cancer-causing agents are activated in
the body; discovering how and when carcinogens cause damage to cells
(gene mutation and chromosomal alterations); and the reasons for
increased cancer susceptibility in certain families and ethnic
groups.  Of prime importance is research on the behavioral aspects of
developing effective means of prevention as well as cessation
strategies.
 
o  ORAL MUCOSAL IMMUNITY - Studies in the oral cavity examining the
protective and therapeutic effects of mucosal immunity against
viruses such as human papilloma virus (HPV), herpes viruses, HIV,
yeast and bacteria as well as the use of this route of administration
for various anti-sera against infectious diseases.
 
o  BEHAVIORAL AND EPIDEMIOLOGICAL ORAL HEALTH RESEARCH -  Of interest
are studies evaluating determinants of clinical decision making,
effects of intervention research on adoption and use of preventive or
therapeutic measures, and studies of patient or provider behaviors
influencing oral health. Also of interest are descriptive and
analytic epidemiological and health services studies identifying the
magnitude and characteristics of differing levels of oral diseases in
the general population or population subgroups and studies clarifying
the impact of different health care delivery systems on oral health
outcomes and health care costs.
 
o  MOTOR, CHEMOSENSORY, AND SOMATOSENSORY FUNCTION - Research on
signal transduction in gustatory and olfactory receptors and on
biological mechanisms through which oral conditions/diseases or
dental treatments influence chemosensory or oral somatosensory
function is of interest as are neurophysiological studies on
processes controlling complex oral movements and oral dysfunctions
(e.g., tardive dyskinesia, apnea). In addition, epidemiological
studies are needed on the prevalence and distribution or oral sensory
and oral motor disorders in both general and special populations
(e.g., the aged).
 
o  BIOBEHAVIORAL RESEARCH - Studies examining the interrelationships
between behavioral, environmental and biological factors as related
to the prevention, treatment and/or etiology of craniofacial and oral
conditions are encouraged.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be involved in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS  of March 28, 1994, Volume
23, Number 11.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by May 1, 1997, a letter
of intent that includes a descriptive title of the proposed research,
the name, postal and email addresses, and fax and telephone number of
the Principal Investigator, the identities of other key personnel and
participating institutions, and the 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 provides will assist in planning for the timely
review of applications.  Receipt of such letters will allow NIDR
staff to estimate the potential review  workload and make review
plans that will avoid possible conflict of interest.  NIDR staff will
provide no response to letters of intent.
 
The letter of intent is to be addressed to Dr. Norman Braveman at the
address and listed under INQUIRES.
 
APPLICATION PROCEDURES
 
Prospective applicants are encouraged to communicate with program and
grants management staff of the NIDR's Division of Extramural Research
as early as possible in the planning phase of application
preparation.  Advice and suggestion by staff may materially assist
applicants in insuring that the objectives of the CORMOH initiative
are met and that the application format and structure, including the
budget, are acceptable.
 
Applicants should include written assurance from the appropriate
institutional official(s), e.g., department chair or dean, outlining
arrangements that will be made to allow sufficient release time from
teaching and other administrative responsibilities for the principal
investigator to devote at least 50 percent effort to the research
project.  Further, while regional proximity between the applicant and
collaborating institutions may be an asset to successful
collaboration, it is not a requirement of the CORMOH initiative.  In
all instances, applicants are asked to provide written evidence of
procedures and/or processes that will be used to facilitate
collaborative activities, particularly those in which the
institutions are geographically separated.
 
Applications are to be prepared on grant application form PHS 398
(rev. 5/95).  Applications kits are available at most institutional
offices of sponsored research and may be obtained from the Grants
Information Office, Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:
ASKNIH@odrockm1.od.nih.gov.  The RFA label available in the PHS 398
application form must be affixed to the bottom of the face page.
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 ("CORMOH") and number
(DE-96-002) must be typed on line 2 of the face page of the
application form and the YES box must be checked.
 
Specific attention should be given to efforts to contain costs and
ensure cost-competitive implementation of the project~s research
goals. Investigators are also encouraged to examine the potential for
securing supplementary funds for the project from non-NIDR sources,
such as foundations or industry.  If additional financial support
from non-NIDR sources is planned to complement or expand the research
proposed for support by the NIDR, the applicant should explain how
such activities will further the goals of the project and make it
more cost-effective. Awardees will be expected to update this
information on an annual basis.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
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 also be sent to:
 
Dr. H. George Hausch
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44F
45 Center Drive, MSC 6402
Bethesda, MD  20892-6402
 
Applications must be received by June 20, 1997.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) 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, it is
allowable to submit the same project as both an RO1 or R29 and as a
component project of a program project.  The DRG 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 previously reviewed.  Such applications must not only
include an introduction addressing the previous critique but also be
responsive to this RFA.
 
Applicants or collaborators from institutions that have a General
Clinical Research Center (GCRC) funded by the National Center for
Research Services may wish to identify the GCRC as a resource for
conducting the proposed research.  If so, a letter of agreement from
either the GCRC program director should be included with the
application.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be initially reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NIH staff function.  If the application is not responsive
to the RFA, NIH staff will contact the applicant to determine whether
it should be returned to the applicant, or whether it should be held
until the next regular receipt date and reviewed in competition with
all other applications.
 
All applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by the appropriate peer
review group convened by the NIDR in accordance with the review
criteria stated below.  As part of the initial merit review, a
streamlined review process may be used by the initial review group in
which the applications will be determined to be competitive or
non-competitive based on their scientific merit relative to other
applications received in response to the RFA.  Applications judged to
be competitive will be discussed and assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.
 
Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group convened for this RFA by
the Scientific Review Office, NIDR.  Successful applications will be
given a secondary review by the National Dental Research Advisory
Council.
 
Review criteria for this RFA are generally the same as those for
unsolicited research grant applications and include:
 
o  scientific merit of the project, including its significance,
originality, feasibility and experimental design;
 
o  training, experience and research competence of the mix of the
investigators from the minority institution and the
research-intensive institution and their documented commitment to the
accomplishment of the goals and objectives of this RFA;
 
o  adequacy of the combined facilities, resources and administrative
capabilities;
 
o  appropriateness of the period of support and budget requested;
 
o  availability and appropriateness of study populations and the
utilization of minorities and women as study subjects in clinical
studies;
 
o  institutional commitment to provide release time for the principle
investigator to provide at least 50 percent time commitment to the
project; and
 
o  adequacy of the administrative and organizational structure to
ensure efficient inter- and intra-institutional collaboration,
interaction and dissemination of information among investigators
necessary to attain the objectives of this RFA.
 
AWARD CRITERIA
 
The anticipated date of award is June 1, 1998.  Funding decisions
will be made on the basis of the scientific and technical merit as
determined by peer review, program priorities and the availability of
funds.
 
INQUIRIES
 
Written and telephone inquires concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
 
Inquires regarding programmatic issues may be directed to:
 
Dr. Norman S. Braveman
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-24B
45 Center Drive MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-2089
FAX:  (301) 480-8318
Email:  BravemanN@DE45.NIDR.NIH.GOV
 
Direct inquires regarding grants management issues to:
 
Mr. Martin Rubinstein
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-44A
45 Center Drive MSC 6402
Bethesda MD  20892-6402
Telephone:  (301) 594-4800
Email:  RubinsteinM@DE45.NIDR.NIH.GOV
 
Schedule
 
Letter of Intent Receipt Date:  May 1, 1997
Application Receipt Date:       June 20, 1997
Scientific Review:              September/October 1997
Advisory Council Date:          January/February 1998
Earliest Award Date:            June 1, 1998
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.848.  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 PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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