kristoff@NET.BIO.NET (Dave Kristofferson) (10/21/89)
Vol. 18, No. 37, October 20, 1989
NOTICES
INTERACTIONS OF APPLICANTS WITH CONSULTANT REVIEWERS .......(84/114)......... 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
DATED ANNOUNCEMENTS (RFPs AND RFAs)
CLINICAL DENTAL RESEARCH CORE CENTERS (RFA) .......(120/261, 644/1077)....... 1
National Institute of Dental Research
Index: DENTAL RESEARCH
ONGOING PROGRAM ANNOUNCEMENTS
NATIONAL RESEARCH SERVICE AWARD FELLOWSHIPS IN LABORATORY ANIMAL
MEDICINE ....................................................(267/305)....... 3
Division of Research Resources
Index: RESEARCH RESOURCES
NEUROSCIENCE RESEARCH ON DRUG ABUSE .......................(308/452)......... 3
National Institute on Drug Abuse
Index: DRUG ABUSE
ERRATUM
MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM (PA) ..(458/575).... 5
Division of Research Resources
Index: RESEARCH RESOURCES
NOTICES
INTERACTIONS OF APPLICANTS WITH CONSULTANT REVIEWERS
P.T. 34; K.W. 1014002, 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Consultants assist the National Institutes of Health (NIH) and the Alcohol,
Drug Abuse, and Mental Health Administration (ADAMHA) by participating in the
peer review of grant applications and contracts proposals. Throughout their
periods of service, consultants are continually reminded of the
confidentiality of the peer review process and the potential harm which may
result from their providing applicants with information concerning the review.
NIH/ADAMHA policy is very explicit in prohibiting consultants from discussing
review proceedings with applicants; such discussions are permitted ONLY
between the applicant and staff of the NIH and ADAMHA.
Several recent instances have been reported to staff in which applicants have
approached consultants either to challenge them concerning their role in the
review of applications and the recommendations of the peer review group, or to
solicit information and/or guidance from them concerning the reviews.
Applicants must understand that such contact on their part is totally
inappropriate and that NIH consultants would violate their assurances of
confidentiality were they to engage in such discussions with applicants.
It is important to the integrity of the peer review system and to the
interests of both applicants and consultants that there be strict adherence to
these policies. Again, policy prohibits all such interactions between
applicant and consultant. NIH and ADAMHA staff are prepared, and solely
empowered, to discuss the review process and the review of applications with
applicants.
DATED ANNOUNCEMENTS (RFPs AND RFAs)
CLINICAL DENTAL RESEARCH CORE CENTERS
RFA AVAILABLE: 90-DE-1
P.T. 04; K.W. 0715148, 0765033, 0745020, 0745027, 0745070, 0710030, 0785035
National Institute of Dental Research
Application Receipt Date: March 13, 1990
The National Institute of Dental Research (NIDR) invites applications for
Clinical Dental Research Core Centers (P30) to facilitate clinical research
relevant to the pathogenesis, diagnosis, early detection, prevention, control
and treatment of oral diseases, disorders, and/or dysfunctions. The intent of
the Core Center Program is to provide the resources and facilities necessary
to develop and to conduct clinical research at the level of sophistication
necessary to expedite the translation of basic scientific knowledge into new
and better methods for improving the oral health of the nation. This Request
for Applications (RFA) is for a single competition with a receipt date of
March 13, 1990.
BACKGROUND
Recent advances in biomedical research are revolutionizing our understanding
of cellular and molecular processes underlying the etiology and pathology of
oral diseases, dysfunction, and craniofacial malformations. These advances
have improved our capacity to treat and prevent these conditions. However,
the full benefit of these research advances remains to be explored.
Unfortunately, many dental teaching and research institutions lack the
technical resources to conduct clinical research at the level of
sophistication required. Thus, the intent of the Clinical Research Core
Center grant is to expand and improve the clinical research capability and
potential of the Nation's dental schools and dental research institutions.
RESEARCH GOALS AND SCOPE
The objective of the Clinical Dental Research Core Center grant is to provide
an environment which will strengthen and increase productivity in clinical
research and generate new ideas through organized interdisciplinary
Vol. 18, No. 37, October 20, 1989 - Page 1
collaborative efforts. The central focus is to enable, enhance and extend
clinical research being conducted in one or more of the areas of dental
research such as: dental caries; nutrition; periodontal diseases; soft tissue
diseases (including oral manifestations of AIDS); salivary gland dysfunction;
malocclusion; craniofacial anomalies; oral-facial pain and oral sensory/motor
function; behavioral research; and restorative materials research.
The Research Core Center grant provides support for core resources and
facilities to coordinate the activities of individually-supported clinical
project investigators. A minimum of three core units must be proposed and
approved for the viability of a proposed core center. These must include an
administrative and biostatistics unit, unless a biostatistics unit already
exists at the applicant institution. Other cores proposed should relate to
the planned research activity of the Center. Examples of core units are:
o Administrative Core: To insure that the core participants are
provided with support services to meet the changing needs of their
research. This core provides funds for the Center director and
administrative staff. Costs associated with information transfer
and outreach programs may also be requested. This core must bring
together an advisory panel of experts from outside the Center who
will meet at least once a year to review and provide a written
report on the progress of the Center. This report must be included
with each year's Center's annual progress report to the NIDR.
Pilot and feasibility studies are administered through this core
and come under the purview of the Center Director.
o Biostatistics, Data Management and Analysis Core: To provide the
staff and other resources needed to enhance programs of clinical
research through the application of epidemiologic, sampling,
biostatistics, and related support methodologies to clinical
problems. To strengthen biostatistician-clinical investigator
interactions in the design and conduct of clinical research.
o Diagnostics Core: To provide and develop methods and/or
instrumentation to detect early signs, markers of and progression
of disease or malformation and to monitor for efficacy of
treatments.
o Laboratory Cores: To provide resources and scientific expertise to
carry out adjunct studies on clinical trial patients. Animal
resources may be included where appropriate. Examples of such
laboratory cores are: Molecular Biology, Microbiology, Immunology,
Pharmacology, Nutrition, etc.
o Unique Clinical Facilities Core: To provide resources to test
interventions which cannot be carried out in conventional health
care settings. An example might be the use of mobile units for
clinical studies involving the elderly and handicapped.
Cores may provide support for personnel, including the necessary expertise to
direct cores, equipment, supplies, services and facilities. The grant also
will provide limited funds (up to 20 percent of total Center costs) for pilot
and feasibility studies. The goals of the pilot and feasibility studies are
to provide start-up funds for new projects by new staff members, to train
young investigators under the direction of clinical scientists and to
encourage established investigators to utilize the newer biomedical and
behavioral techniques in addressing areas of oral health concerns. The
Research Core Center grant does not provide direct funding for ongoing
research projects as such; these are to be funded through other sources and
support mechanisms (e.g., individual research project grants). All research
projects should be highly relevant to the overall goals of the NIDR and of the
Clinical Dental Research Core Center grant.
Projects concerning oral health or disease as related to minorities, women and
the elderly and to populations in foreign countries which present special
research opportunities (via international collaboration) are encouraged.
ELIGIBILITY
This competition is open to domestic institutions. The applicant institution
should have ongoing clinical research projects or the potential to develop
clinical research projects which will utilize the shared resources and
facilities (core units) that are supported by the core grant.
The overall research plan must be relevant to the goals of the NIDR and the
Clinical Dental Research Core Center. The applicant institution must
demonstrate a strong commitment to the Center's success.
Vol. 18, No. 37, October 20, 1989 - Page 2
FUNDING MECHANISM
The Centers will be supported by Center Core Grants (P30) for a period of five
years, commencing as early as September 1, 1990. Applicants may request up to
$500,000 in direct costs for the first year. It is anticipated that a minimum
of two awards will be made, if a sufficient number of high quality
applications are received. No more than one Core Center grant will be made at
any one institution.
STAFF CONTACT
Applications should be prepared and submitted in accordance with the
objectives and requirements described in the full RFA, available from:
Joseph E. Ciardi, Ph.D.
Program Administrator
Extramural Program
National Institute of Dental Research
Westwood Building, Room 505
Bethesda, Maryland 20892-4500
Telephone: (301) 496-7884
ONGOING PROGRAM ANNOUNCEMENTS
NATIONAL RESEARCH SERVICE AWARD FELLOWSHIPS IN LABORATORY ANIMAL MEDICINE
P.T. 22; K.W. 0720005, 0201058, 0755030, 0765035, 0745020, 0795003
Division of Research Resources
Application Receipt Dates: January 10, May 10, and September 10
The Animal Resources Program (ARP), Division of Research Resources (DRR),
solicits applications for individual National Research Service Awards (NRSA)
for training in research related to laboratory animal medicine. Individuals
must hold a D.V.M. or Ph.D. degree at the time of the award. The applicant
must be interested in working in the field of laboratory animal medicine and
the proposed training must focus on some topic that will benefit laboratory
animals. Projects usually focus on some aspect of laboratory animal disease,
etiology, pathophysiology, diagnosis or control. The fellowship may be part
of a research degree program. Receipt dates are January 10, May 10 and
September 10. The January 10 receipt date is recommended with potential
funding starting during the summer months. A more detailed description of
NRSAs for Individual Postdoctoral Fellows can be obtained from:
Division of Research Grants
Office of Grants Inquiries
5333 Westbard Avenue, Room 449
National Institutes of Health
Bethesda, Maryland 20892
Telephone: (301) 496-7441
Specific information related to Fellowships in Laboratory Medicine can be
obtained from:
Director
Laboratory Animal Sciences Program
Animal Resources Program Branch
Division of Research Resources
National Institutes of Health
5333 Westbard Avenue, Room 853
Bethesda, Maryland 20892
Telephone: (301) 496-5175
NEUROSCIENCE RESEARCH ON DRUG ABUSE
P.T. 34; K.W. 1002030, 0404009, 0705055, 0760075, 0414005, 0404000, 0785115
National Institute on Drug Abuse
PURPOSE
The purpose of this announcement is to encourage and stimulate investigator
interest in broad areas of neuroscience research relevant to the problem of
drug abuse. Many research tools are now available to allow for major advances
Vol. 18, No. 37, October 20, 1989 - Page 3
in understanding the neurobiology of drug abuse to determine the effects of
drugs on the structure and function of the nervous system. These include new
histochemical and autoradiographic procedures, light and electron microscopic
analysis, imaging and analytic techniques applicable to living tissue (e.g.,
PET, MRI), and various neurophysiological and neuropharmacological techniques,
especially those monitoring neural processes during ongoing behavior (e.g.,
single-cell electrophysiology, in vivo microdialysis and voltammetry, evoked
potentials, EEG). As a final part of this initiative, The National Institute
on Drug Abuse (NIDA) expects that an increased understanding of the
relationship between brain anatomy, physiology, and pharmacology and drug
abuse behaviors will increase the capacity to design appropriate therapeutic
pharmaceuticals void of abuse liability and its consequences, and develop drug
therapies for correcting neurochemical imbalances created by the abuse of
drugs. Additionally, investigations into the neural basis of drug seeking
should identify those neurobiological factors that make an individual
vulnerable to the abuse of drugs.
RESEARCH OBJECTIVES
The neuroscience program of the NIDA's Division of Preclinical Research
encourages investigations into the basic mechanisms underlying the action of
abused drugs and substances on the central nervous system as well as research
leading to the development of drugs that potentially may be used on the
relationship between drug-receptor interactions or neurochemical alterations
and consequences of drug usage in terms of behavioral processes is
specifically encouraged. Areas of particular interest include the following:
(1) Brain Reward Mechanisms in Drug Abuse
(2) Neuropsychopharmacology of Abused Drugs
(3) Anabolic Steroid Abuse
(4) Drug-Induced Neurotoxicity
(6) Developmental Neurobiology
(7) Drug Effects on Cognitive Processes
(8) Drug Effects on Sensory Processes
(9) Blood-Brain Barrier Studies
(l0) Clinical Neuroscience
Support can be obtained in the form of R01 (Research Project Grants), R03
(Small Grants), R13 (Research Conference Grants), and R29 (First Independent
Research Support and Transition Awards).
NIMH and various NIH Institutes have specific programs in the neurosciences.
Grant applications will be assigned to the appropriate Institute based upon
existing programmatic guidelines.
ELIGIBILITY
Applications may be submitted by public or private nonprofit or for-profit
organizations such as universities, colleges, hospitals, laboratories, units
of State or local governments, and eligible agencies of the Federal
government. Women and minority investigators are encouraged to apply.
APPLICATION PROCEDURES AND RECEIPT SCHEDULE
State and local government agencies may use form PHS 5161-1 (rev. 11/88).
All other applicants should use the research grant application from PHS 398
(rev. 10/88). The title of this announcement "NEUROSCIENCE RESEARCH ON DRUG
ABUSE" should be typed in item number 2 on the face page of the PHS 398
application form or in item 9 on the PHS 5161-1.
Application kits containing the necessary forms and instructions may be
obtained from business offices or offices of sponsored research at most
universities, colleges, medical schools, and other major research facilities.
If such a source is not available, the following office may be contacted for
the necessary application material: Grants Management Branch, NIDA, Parklawn
Building, Room 10-25, 5600 Fishers Lane, Rockville, Maryland 20857.
Applications received under this announcement will be assigned to an initial
review group (IRG) in accordance with established PHS Referral Guidelines.
The IRGs, consisting primarily of non-Federal scientific and technical
experts, will review the applications for scientific and technical merit.
Notification of the review recommendations will be sent to the applicant after
the initial review.
Applications will receive a second-level review by an appropriate National
Advisory Council whose review may be based on policy as well as scientific
merit considerations. Only applications recommended for approval by the
advisory council may be considered for funding.
Vol. 18, No. 37, October 20, 1989 - Page 4
The signed original and six (6) permanent, legible copies of the completed
application (original and two copies, if using PHS 5161-1) should be sent to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20892**
Receipt of Initial Advisory Council Earliest
Applications Review Review Start Date
February 1 June/July Sept/Oct December 1
June 1 Oct/Nov Jan/Feb April 1
October 1 Feb/March May/June July 1
Applications submitted in response to this Announcement are not subject to the
intergovernment review requirements of Executive Order 12372, as implemented
through Department of Health and Human Services regulations at 45 CFR Part 100
and are not subject to Health Systems Agency review.
REVIEW CRITERIA
Criteria for scientific/technical merit review of regular research grant
applications will include the following: significance and originality from a
scientific and technical standpoint of the goals of the proposed research;
adequacy of the methodology proposed to carry out the research; qualifications
of the Principal Investigator and other key research personnel; availability
of adequate facilities, other resources, and collaborative arrangements
necessary for the research, appropriateness of budget estimates for the
proposed research activities, and adequacy of provisions for the protection of
human subjects and welfare of animals subjects as applicable.
FURTHER INFORMATION
Further information and consultation on program requirements relevant to
neuroscience research inquiries can be obtained from:
Dr. Roger Brown
Neuroscience Research Branch
National Institute on Drug Abuse
Parklawn Building, Room 10A-31
5600 Fishers Lane
Rockville, Maryland 20857
Telephone: (301) 443-6975
FOOTNOTE: This program is described in the catalog of Federal Domestic
Assistance No. 13.279. Grants will be awarded under the authority of Section
301 of the Public Health Service Act, as amended (42 USC 241) and administered
in accordance with the PHS Grants Policy Statement and Federal regulations at
42 CFR Part 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.
ERRATUM
MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM
P.T. 34, FF; K.W. 0710030, 1014006
Division of Research Resources
Application Receipt Date: December 1, 1989
This Program Announcement was previously published in the NIH Guide for Grants
and Contracts on September 22, 1989, (Vol. 18, No. 33) but contained
inadvertent errors in the sections on ELIGIBILITY and APPLICATION. The
corrected announcement is repeated below in its entirety.
BACKGROUND AND OBJECTIVES
The Division of Research Resources (DRR), National Institutes of Health (NIH),
currently plans to continue the Minority High School Student Research
Apprentice Program in 1990.
Vol. 18, No. 37, October 20, 1989 - Page 5
The purpose of the program is to provide minority high school students with a
meaningful experience in various aspects of health-related research in order
to stimulate their interest in careers in science.
ELIGIBILITY
Eligible institutions are those that were awarded grants during the latest
complete Federal Fiscal Year 1989 from either the Biomedical Research Support
Grant (BRSG) Program or the Minority Biomedical Research Support (MBRS)
Program. Only one application for the Apprentice Program can be submitted by
a component of an institution that is the recipient of both the BRSG and MBRS
awards.
Students eligible for support under this program are those who: (1) identify
themselves as minority (i.e., Black, Hispanic, American Indian, Alaskan
Native, Pacific Islander, or Asian); (2) are U.S. citizens or have a permanent
visa; and (3) are enrolled in high school during the 1989-90 academic year.
(Students who will graduate from high school in 1990 are eligible, as are
students who participated in a previous year - provided they are still
enrolled at the high school level.)
MECHANISM OF SUPPORT
The mechanism of support for this program will be the NIH grant-in-aid (SO3).
Support will be provided at a level of $1,500 for each apprentice position
allocated. No indirect costs will be paid. Direct support to the apprentice
must be as salary; stipends are not allowed. Within the $1,500 per student
allocation, funds may also be utilized for supplies, extending the research
experience through the school year, or if adequate funds exist, for an
additional apprentice. However, funds from these grants may only be used for
the costs of the apprentice program. The Program Director is responsible for
recruitment and selection of the apprentices and assignment of each to an
investigator. Recruitment and selection of students should emphasize factors
of the students' motivation, ability, scholastic aptitude and accomplishments.
In addition, consideration should be given to science teachers'
recommendations and, where possible, the degree of parental commitment.
Assignments should be made to investigators involved in health-related
research who are committed to developing in the high school student both
understanding of the research in which they participate and the technical
skills needed. Awards will be for one year.
APPLICATION
Eligible institutions should submit an application consisting of no more than:
1. A one-page letter stating the number of student positions requested, plus
2. An original and two signed and completed copies of the Grant Application
Form, PHS 398 (Rev. 10/88) face page and checklist only.
Mark the "YES" box in item 2 and indicate the announcement title as "Minority
High School Student Research Apprentice Program."
Mark items numbered 4, 5, 7, 8b, 10 and 14 as Not applicable (N.A.). Complete
item 8a with the total dollar amount of your request, which is the sum of the
number of student positions requested times $1,500 per student.
The original and one copy of the signed Program Director's report and each
student report should be submitted with the renewal application due December 1
annually in order that the data contained in these reports can be used by DRR
to decide about policies and future funding for the Minority High School
Student Research Apprentice Program. These reports should be submitted by
December 1 even if renewal support is not requested.
Furthermore, all reports including the Financial Status Report must be
submitted to the NIH by the grantee institution no later than May 31, 1990,
unless an extension of the budget period end date has been authorized in
writing.
Please Note: Limited funds and increased requests for such student positions
may restrict the final allocations by DRR to three or four students per
eligible applicant institution. Upon recommendation of the National Advisory
Research Resources Council, DRR will give preference in making awards to those
institutions that can support a summer program having a "critical mass" of at
least five or six students using institutional as well as DRR funds.
Vol. 18, No. 37, October 20, 1989 - Page 6
The applications should be submitted to:
Biomedical Research Support Program
Division of Research Resources
National Institutes of Health
5333 Westbard Avenue
Westwood Building, Room 10A11
Bethesda, Maryland 20892
Inquiries can be made of Dr. Marjorie A. Tingle at the above indicated address
or by calling (301) 496-6743.
The firm deadline for receipt of applications is December 1, 1989. Awards
will be effective March 1, 1990, contingent upon availability of appropriated
funds.
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816
Vol. 18, No. 37, October 20, 1989 - Page 7
FULL TEXT OF RFAs FOR ONLINE ACCESS
CLINICAL DENTAL RESEARCH CORE CENTERS
RFA AVAILABLE 90-DE-1
P.T. 04; K.W. 0715148, 0765033, 0745020, 0745027, 0745070, 0710030, 0785035
National Institute of Dental Research
Application Receipt Date: March 13, 1990
The National Institute of Dental Research (NIDR) invites
applications for Clinical Dental Research Core Centers (P30) to
facilitate clinical research relevant to the pathogenesis,
diagnosis, early detection, prevention, control and treatment of
oral diseases, disorders, and/or dysfunctions. The intent of the
Core Center Program is to provide the resources and facilities
necessary to develop and to conduct clinical research at the
level of sophistication necessary to expedite the translation of
basic scientific knowledge into new and better methods for
improving the oral health of the nation. This Request for
Applications (RFA) is for a
single competition with a receipt date of March 13, 1990. It may
be reissued at a later date.
BACKGROUND
Recent advances in biomedical research are revolutionizing our
understanding of cellular and molecular processes underlying the
etiology and pathology of oral diseases, dysfunction, and
craniofacial malformations. These advances have improved our
capacity to treat and prevent these conditions. However, the
full benefit of these research advances remains to be explored.
Unfortunately, many dental teaching and research institutions
lack the technical resources to conduct clinical research at the
level of sophistication required. Thus, the intent of the
Clinical Research Core Center grant is to expand and improve the
clinical research capability and potential of the Nation's dental
schools and dental research institutions.
The establishment of Core Centers by the NIDR was recommended by
an expert panel and included in the 1985 Director's report to
Congress as a means to provide the appropriate foundation for the
conduct of clinical trials and clinical studies. At a recent
meeting, the National Advisory Dental Research Council strongly
reemphasized the need for clinical research to expedite both the
translation of new knowledge from the laboratory to the clinic
and the testing of new agents and procedures for diagnosis,
prevention and treatment of oral and dental diseases. The NIDR
initiative, "Research and Action Program for Improving the Oral
Health of Adults and Older Americans", emphasizes the need for
clinical studies involving these populations.
The Clinical Dental Research Core Center grant is a mechanism to
develop state-of-the-art clinical research centers by supporting
shared resources and facilities (core units) for a number of
investigators from different disciplines, who provide a
multidisciplinary approach to a joint research effort or from the
same discipline who focus on a common research area. Research
projects other than those designated pilot or feasibility studies
are not supported by this mechanism.
ELIGIBILITY
This competition is open to domestic institutions. The applicant
institution should have ongoing clinical research projects or the
potential to develop clinical research projects which will
utilize the shared resources and facilities (core units) that are
supported by the core grant.
The applicant must describe his/her plan for the research
activity of the Center, and must propose at least three Core
activities with the ultimate goal of transferring basic and
applied research findings and new technical advances into
clinical research leading to enhanced diagnosis, prevention
and/or treatment of oral diseases, disorders and/or dysfunctions.
The overall research plan must be relevant to the goals of the
NIDR and the Clinical Dental Research Core Center. It may
include proposals for collaborative studies with other
institutions (foreign or domestic) and the private sector. The
applicant institution must demonstrate a strong commitment to the
Center's success. This commitment may take the form of faculty
appointment for investigators, assignment of research space and
purchase of research equipment to expedite and facilitate the
development of the Clinical Research Center.
RESEARCH GOALS AND SCOPE
The objective of the Clinical Dental Research Core Center grant
is to provide an environment which will strengthen and increase
productivity in clinical research and generate new ideas through
organized interdisciplinary collaborative efforts. The central
focus is to enable, enhance and extend clinical research being
conducted in one or more of the areas of dental research such as:
dental caries; nutrition; periodontal diseases; soft tissue
diseases (including oral manifestations of AIDS); salivary gland
dysfunction; malocclusion; craniofacial anomalies; oral-facial
pain and oral sensory/motor function; behavioral research; and
restorative materials research. Projects concerning oral health
or disease as related to minorities, women and the elderly and to
populations in foreign countries which present special research
opportunities (via international collaboration) are encouraged.
The Center activity is also intended to: encourage increased
collaboration among the various disciplines of clinical research
in dentistry and among basic and clinical scientists; encourage
training of clinical research scientists; and develop the
expertise required to translate knowledge and advances in
biomedical and behavioral science into new and improved methods
for patient care.
CENTER CHARACTERISTICS
Each center must be a clearly defined organizational entity
within the institution with a director who will be responsible
for management of the center grant. The Research Core Center
grant provides support for core resources and facilities to
coordinate the activities of individually-supported clinical
project investigators. A minimum of three core units must be
proposed and approved for the viability of a proposed core
center. These must include an administrative and biostatistics
unit, unless a biostatistics unit already exists at the applicant
institution. If justifiable, the biostatistics component may be
incorporated into the administrative core. Other cores proposed
should relate to the planned research activity of the Center.
Examples of core units are:
o Administrative Core: to insure that the core participants
are provided with support services to meet the changing needs of
their research. This core provides funds for the Center director
and administrative staff. Costs associated with information
transfer and outreach programs may also be requested. This core
must bring together an advisory panel of experts from outside the
Center who will meet at least once a year to review and provide a
written report on the progress of the Center. This report must
be included with each year's Center's annual progress report to
the NIDR. Pilot and feasibility studies are administered through
this core and come under the purview of the Center Director.
o Biostatistics, Data Management and Analysis Core: To
provide the staff and other resources needed to enhance programs
of clinical research through the application of epidemiologic,
sampling, biostatistics, and related support methodologies to
clinical problems. To strengthen biostatistician-clinical
investigator interactions in the design and conduct of clinical
research.
o Diagnostics Core: To provide and develop methods and/or
instrumentation to detect early signs, markers of and
progression of disease or malformation and to monitor for
efficacy of treatments.
o Laboratory Cores: To provide resources and scientific
expertise to carry out adjunct studies on clinical trial
patients. Animal resources may be included where appropriate.
Examples of such laboratory cores are: Molecular Biology,
Microbiology, Immunology, Pharmacology, Nutrition, etc.
o Unique Clinical Facilities Core: To provide resources to
test interventions which cannot be carried out in conventional
health care settings. An example might be the use of mobile units
for clinical studies involving the elderly and handicapped.
The above list is not intended to describe the full range of
possible activities to be supported nor to direct applicants to
these areas. Inclusion of cores of all these types in a single
proposed center is not required or even necessarily advisable.
Applicant institutions are encouraged to focus on their areas of
greatest strength.
Cores may provide support for personnel, including the necessary
expertise to direct cores, equipment, supplies, services and
facilities. In addition they may provide funds for the
integration of activities with other research centers in the same
or related biomedical and/or behavioral science area, for
purposes of program enrichment. The grant also will provide
limited funds (up to 20% of total Center costs) for pilot and
feasibility studies. Each individual pilot/feasibility study
should not extend for a period of more than two years. The goals
are to provide start-up funds for new projects by new staff
members, to train young investigators under the direction of
clinical scientists and to encourage established investigators
to utilize the newer techniques of molecular and cellular
biology, immunology, microbiology, virology, genetics,
epidemiology and related sciences in addressing areas of oral
health concerns. It is expected that at the end of
pilot/feasibility studies the investigators will apply for their
own research grant support to extend their preliminary findings.
The Research Core Center grant does not provide direct funding
for ongoing research projects as such; these are to be funded
through other sources and support mechanisms (e.g., individual
research project grants). All research projects should be highly
relevant to the overall goals of the NIDR and of the Clinical
Dental Research Core Center grant.
FUNDING MECHANISM
The Centers will be supported by Center Core Grants (P30) for a
period of five years, commencing as early as September l, 1990.
Subsequent support will be contingent upon program needs and
successful competitive reviews. Applicants may request up to
$500,000 in direct costs for the first year. Modest increases
may be requested for the subsequent four years to strengthen
existing areas of research support and broaden the range of
activities. It is anticipated that a minimum of two awards will
be made, if a sufficient number of high quality applications are
received. However, award of grants for this program is
contingent upon receipt by the NIDR of funds for this purpose.
Policies governing research grant programs of the National
Institutes of Health will prevail. No more than one Core Center
grant will be made at any one institution.
REVIEW PROCEDURES AND CRITERIA
Prior to initial scientific merit review, a triage mechanism may
be employed to screen out applications that are clearly non-
competitive or non-responsive to the RFA. Such applications and
those received after March l3, 1990, or those which exceed the
first year budget limit of $500,000 in direct costs, will be
returned to the applicant without further consideration. Waivers
of the receipt deadline and budget limitation will not be
granted. However, where indirect costs are assigned to a
subcontract and counted as direct costs on the parent grant, the
allowable direct cost maximum of $500,000 may be exceeded by the
amount of the indirect costs assigned to the subcontract. Those
applications judged to be competitive will be further evaluated
for scientific and technical merit by a special grants review
committee convened by the NIDR Scientific Review Branch. This
review may involved a site visit or an applicant interview.
Secondary review will be by the National Advisory Dental Research
Council.
Major factors to be considered in the evaluation of applications
will include:
1 The scientific, clinical and administrative qualifications,
experience and commitment of the Center Director and his/her
ability to provide effective leadership.
2 A base of ongoing clinical research projects or the
potential to develop a base of clinical research projects which
will utilize the shared resources and facilities (core units)
that are supported by the core grant. The research projects may
be supported by the NIH, other government agencies, foundations
and industry.
3 The commitment of the institution to the proposed clinical
center.
4 The potential of the Center to promote advances in clinical
dental research leading to improvements in the oral health of
children and adults.
5 The appropriateness and relevance of the proposed cores in
the research plan, including evidence of an organization
structure which will promote multidisciplinary, collaborative
research.
6 The appropriateness and relevance of the proposed pilot and
feasibility studies in the research plan.
7 The appropriateness of the existing and proposed clinical
and laboratory facilities in the research plan.
8 The plans for establishing and developing the center, for
monitoring research, and for reviewing changes in research
direction (e.g., external and internal review committees).
9 The plans for training new investigators in clinical
research. Utilizing existing funded projects, requested
pilot/feasibility projects and/or training grant mechanisms
supported by the NIH or by private funds.
10 The appropriateness of the budget.
11 The availability of appropriate populations and the efforts
to include women and minorities in study populations, where
appropriate.
12 The provisions for the protection of human subjects and
humane treatment of animals.
METHOD OF APPLICATION
It is suggested that prospective applicants submit a letter of
intent as soon as possible, but no later than December 15, 1989,
to Dr. Joseph E. Ciardi at the address indicated below. The
letter of intent is not binding nor is it a prerequisite for
acceptance of applications. Such letters, giving the names of
the director and key personnel, the institution(s) participating
and a descriptive title of each core unit and research project,
will help NIDR staff in planning for timely review of
applications. Center grants will only be made to domestic
institutions.
Applications should be prepared on form PHS-398 (Rev. 10/88),
Application for PHS Grant, which can be obtained from the
Division of Research Grants (DRG), NIH, or from the institution's
Office of Research and Sponsored Programs. To identify the
application as a response to this RFA, check "yes" on item 2 of
page l of the application and enter "RFA: 90-DE-1 Clinical Dental
Research Core Centers" in the space provided. THE RFA LABEL
AVAILABLE IN THE 10/88 REVISION OF FORM PHS-398 MUST BE AFFIXED
TO THE BOTTOM OF THE FACE PAGE. FAILURE TO USE THIS LABEL COULD
RESULT IN DELAYED PROCESSING OF AN APPLICATION SUCH THAT IT MAY
NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW.
The instructions accompanying form PHS-398 should be followed as
far as possible, but some modifications will be necessary. For
example, a new Table of Contents must be prepared giving page
numbers for all items in the application. Each core unit must be
identified by number and principal investigator. Separate
detailed budgets for each year of the entire center, and core
resources and pilot and feasibility projects must be prepared. A
consolidated budget for the center, for all years of support,
must be included. Direct and indirect cost estimates must be
provided. Funds may be requested for professional, technical,
and administrative personnel, equipment, supplies, minor
renovations, consultant services, travel, publication costs, and
patient costs directly related to the functions of the core units
and not covered by the funded research projects in the Center.
Detailed justification of the budget requests will be required.
Under Section 2, Research Plans, describe the goals of the center
and explain how the core resources and pilot and feasibility
studies will contribute to achieving those goals. Describe the
administrative structure and define the responsibilities of the
director, advisory groups, and individual investigators.
Describe the core units and explain how they will relate to the
research projects that will utilize the core units and how they
relate to the overall goals of the Center. Each core unit and
pilot or feasibility study should be represented as if it was a
research grant application; that is, the instruction pages 19-23
of for PHS-398 should be followed. The page limitations will
apply to each core unit and pilot/feasibility study. A page 2
(Abstract) form PHS-398 must be completed for all core
resources, each research project, each pilot/feasibility study
proposed for the first year and for the entire application.
The original and four copies of the application must be received
by March 13, 1990 at:
Grant Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892-4500**
Applicants must also furnish two copies by March 13, 1990 to:
George Hausch, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental Research
Extramural Program
Westwood Building, Room 519
Bethesda, MD 20892-4500
Telephone: (301) 496-7659
Letters of intent and all inquiries should be directed to:
Joseph E. Ciardi, Ph.D.
Program Administrator
Extramural Program
National Institute of Dental Research
Westwood Building, Room 505
Bethesda, MD 20892-4500
Telephone: (301) 496-7884