kristoff@GENBANK.BIO.NET (Dave Kristofferson) (01/03/91)
NIH GUIDE - Vol. 20, No. 1, January 4, 1991
NOTICES
NATIONAL RESEARCH SERVICE AWARD STIPEND INCREASE ......(84/121)............. 1
Public Health Service
Index: PUBLIC HEALTH SERVICE
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ..(124/249)............ 1
National Institutes of Health
Food and Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
NOTICES OF AVAILABILITY
CLINICAL CORE CENTERS FOR ORAL HEALTH RESEARCH (RFA DE-91-02) ..(255/393)... 3
National Institute of Dental Research (1204/1882)
Index: DENTAL RESEARCH
ONGOING PROGRAM ANNOUNCEMENTS
MINORITY INSTITUTIONS TRAVEL AWARD PROGRAM (PA-91-17) .....(404/705)........ 5
National Center for Human Genome Research
Index: HUMAN GENOME
BIOTECHNOLOGY RESEARCH TRAINING (PA-91-18) ................(721/913)........ 9
National Institute of General Medical Sciences
Index: GENERAL MEDICAL SCIENCES
BIOMEDICAL RESEARCH SUPPORT SHARED INSTRUMENTATIONS GRANTS (PA-91-19) ......11
National Center for Research Resources (916/1130)
Index: RESEARCH RESOURCES
NOTICES
NATIONAL RESEARCH SERVICE AWARD STIPEND INCREASE
P.T. 22, 44; K.W. 0720005, 1014006
Public Health Service
Effective October 1, 1990, the annual stipend levels for all individuals
receiving support through institutional or individual National Research
Service Awards (NRSA) made under Section 487 of the Public Health Service Act
will be as follows:
Years FY 1991
Of Stipend
Level of Training Experience Level
----------------- ---------- -----
Predoctoral All $8,800
Postdoctoral 0 $18,600
1 $19,700
2 $25,600
3 $26,900
4 $28,200
5 $29,500
6 $30,800
7 or more $32,300
Stipend level adjustments can be made only on the award date of the fellowship
or the appointment date of the trainee. These stipend levels are effective
only for awards made beginning with FY 1991 funds; no retroactive adjustments
or supplementation of stipends with NRSA funds for awards made prior to
October 1, 1990, or with funds from FY 1990 is permitted. These stipends do
not apply to awards made under the Minority Access to Research Careers (MARC)
Honors Undergraduate Program.
The new stipend levels are to be used in the preparation of future NRSA
institutional training and individual fellowship applications. They will be
administratively applied to all applications now in the review process.
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS"
P.T. 42; K.W. 0783005
National Institutes of Health
Food and Drug Administration
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) are continuing to sponsor a series of workshops on responsibilities of
researchers, Institutional Review Boards (IRBs), and institutional officials
for the protection of human subjects in research. The workshops are open to
everyone with an interest in research involving human subjects. The meetings
should be of special interest to those persons currently serving or about to
begin serving as a member of an IRB. Issues discussed at these workshops are
relevant to all other Public Health Service agencies. The current schedule
includes the following:
I. SOUTHWEST WORKSHOP
DATES: February 4-5, 1991
WORKSHOP SITE:
Meridien Hotel
50 Third Street
San Francisco, CA 94103
SPONSOR:
University of California at San Francisco
Box 0400
San Francisco, CA 94143
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 1
REGISTRATION CONTACT:
Ms. Phyllis Colbert
Workshop Contact Person
University of California at San Francisco
Box 0400
San Francisco, CA 94143
Telephone: (415) 476-1881
TOPIC: "The Use of Human Subjects in Research: AIDS as a Model of
Complexity"
II. MIDEAST WORKSHOP
DATES: March 4-5, 1991
WORKSHOP SITE:
Friday Center
Laurel Hill Parkway
Chapel Hill, NC 27599-1020
SPONSORS:
University of North Carolina at Chapel Hill
300 Bynum Hall
Chapel Hill, NC 27599-4100
Shaw University
118 E. South Street
Raleigh, NC 27611
REGISTRATION CONTACT:
Mr. Al Dawson
Director
Friday Center
Laurel Hill Parkway
C. B. 1020
Chapel Hill, NC 27599-1020
Telephone: (919) 962-1106
TOPIC: "Interpreting the Federal Code for the Protection of Human Subjects"
III. MIDWEST WORKSHOP
DATES: April 11-12, 1991
WORKSHOP SITE:
Hyde Park Hilton
4900 Lake Shore Drive
Chicago, IL 60615
SPONSORS:
University of Chicago
970 East 58th Street
Chicago, IL 60637
Chicago State University
95th Street at King Drive
Chicago, IL 60628
REGISTRATION CONTACT:
Mr. Arnold L. Aronoff
Associate Director
Faculty and Administrative Services
University Research Administration
University of Chicago
970 East 58th Street
Chicago, IL 60637
Telephone: (312) 702-8669
TOPIC: "Cultural Diversity, Ethics, and Research: A Workshop on Human
Subject Protection"
NIH/FDA have planned national human subject protections workshops in other
parts of the United States. For further information regarding these workshops
contact:
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 2
Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Bldg. 31, Room 5B43B
Bethesda, MD 20892
Telephone: (301) 496-8101
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CLINICAL CORE CENTERS FOR ORAL HEALTH RESEARCH
RFA AVAILABLE: DE-91-02
P.T. 04; K.W. 0715148, 0710030, 0785035, 0745027
National Institute of Dental Research
Letter of Intent Receipt Date: April 2, 1991
Application Receipt Date: May 6, 1991
The National Institute of Dental Research (NIDR) seeks applications from U.S.
institutions to support Clinical Core Centers for Oral Health Research
(CCCOHR). Core center grants are intended to facilitate and stimulate
clinical research to improve oral health in adults, senior citizens, and
others at higher oral disease risk. This Request for Applications (RFA)
represents one step in the implementation of a major NIDR initiative, the
Research and Action Program for Improving the Oral Health of Older Americans
and Other Adults at High Risk.
Eligible institutions must have a base of high-quality, ongoing or pending
clinical oral health research projects that are of potential relevance to the
Research and Action Program initiative. The CCCOHRs will provide shared
resources to facilitate and expand these clinical research projects. This RFA
announces a single competition with an application receipt date of May 6,
1991.
RESEARCH GOALS AND SCOPE
The CCCOHRs will help develop state-of-the-art clinical research capacity in
dental schools and dental research institutions through supporting shared
resources and facilities to strengthen and expand clinical research relevant
to improving oral health in adults and high-risk populations. The CCCOHRs are
expected to provide a nucleus around which additional clinical studies, funded
through public or private sources, can be structured. The CCCOHRs will
facilitate the transfer of new scientific knowledge into improved methods for
preventing oral disease in adults and high-risk groups, and foster more
effective interdisciplinary collaborations among researchers and clinicians.
CENTER CHARACTERISTICS
Each CCCOHR must be a clearly defined organizational entity within a dental
school or dental research institution. Funding will support core research
resources and facilities. Each CCCOHR must include a minimum of three core
units, and each core unit must provide a shared resource enhancing research
productivity in at least two funded projects. Both administrative and
biostatistics core activities are mandatory. Laboratory cores, diagnostics
cores, and core support for unique clinical facilities (e.g., mobile units or
work-site based dental operatories), as well as other types of shared
facilities/resources to facilitate or expand ongoing clinical research, may be
supported.
Up to 20 percent of the total CCCOHR direct cost budget per year may support
pilot or feasibility studies. These are the only research projects that will
be directly supported by the CCCOHR. Each pilot or feasibility project may
cost no more than $25,000 per year; up to two years of support may be
requested.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included in the study populations
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 3
for clinical studies, a specific justification for this exclusion must be
provided. Applications without such documentation will not be accepted for
review.
FUNDING MECHANISM
The Centers will be supported by Center Core Grants (P30). Awards will be for
five-years and may commence as early as September 15, 1991. Applicants may
request up to $300,000 in direct costs for the initial year's budget.
Requested increases may not exceed four percent per year in each subsequent
year. Development of expanded funding for both CCCOHR activities and clinical
research projects from other sources (e.g., industry, foundations, or other
government agencies), is encouraged. A minimum of two awards is planned, if a
sufficient number of high-quality applications is received. Awards are
contingent upon the NIDR's receipt of appropriated funds for this purpose.
Policies governing research grant programs of the National Institutes of
Health will prevail. No more than one Core Research Center (P30) grant will
be awarded to any institution.
REVIEW PROCEDURES AND CRITERIA
Applications will be evaluated by a special review committee convened by the
NIDR Scientific Review Branch. Secondary review will be conducted by the
National Advisory Dental Research Council. Waivers of the receipt deadline
and budget limitation will not be granted.
Funding decisions will be based on recommendations of the initial review group
and the National Advisory Dental Research Council. Review will include
consideration of the scientific merit and relevance of the proposed pilot
projects, core units, and the ongoing clinical research projects the CCCOHR
will serve; the organization of CCCOHR-supported and independently supported
activities into a cohesive program likely to enhance and stimulate relevant
clinical research; total costs to the NIDR; and the availability of funds
appropriated for this purpose. Consideration will also be given to whether
complementary projects, supported from non-NIDR funds, contribute to the cost
effectiveness of the proposed Center. If projects have similar merit, but
vary in cost competitiveness, funding decisions are likely to favor more
cost-competitive projects.
APPLICATION PROCEDURES
Prospective applicants are advised to contact program staff early in the
planning phase of application preparation and to submit a letter of intent no
later than April 2, 1991. This letter should include the names of all key
personnel, identify the institution(s) or organizations participating, and
provide a descriptive title for each core unit and all proposed pilot or
feasibility studies. The letter of intent is not binding, nor a prerequisite
for acceptance of an application.
Applications should be submitted on Form PHS-398 (Rev. 10/88), available in
the business or grants office of most academic or research institutions or
from the Division of Research Grants, National Institutes of Health.
Requests for copies of the full RFA, all inquiries, and letters of intent
should be directed to:
Patricia S. Bryant, Ph.D.
Health Scientist Administrator
Extramural Program
National Institute of Dental Research
Westwood Building, Room 506
Bethesda, MD 20892-4500
Telephone: (301) 496-7807
The full RFA is also available from the E-Guide, the electronic version of the
NIH Guide for Grants and Contracts.
This program is described in the Catalog of Federal Domestic Assistance No.
93.1212. Awards will be made under authorization of the Public Health Service
Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and
administered under PHS grant policies and Federal Regulations 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.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 4
ONGOING PROGRAM ANNOUNCEMENTS
MINORITY INSTITUTIONS TRAVEL AWARD PROGRAM
PA: PA-91-17
P.T. 34, 48, FF; K.W. 1215018
National Center for Human Genome Research
Application Receipt Dates: See Sections A and B
The National Center for Human Genome Research (NCHGR) invites applications to
support students and faculty in minority institutions to attend scientific
meetings, courses, and workshops relevant to the Human Genome Program. The
Minority Institution Travel Award Program (MITAP) has been established to
increase the participation of students and faculty from minority institutions
in human genome research and research training programs. Under this program,
travel funds will be awarded through two mechanisms: (1) supplements to
active research grants that will support individuals and (2) conference grants
(R13) to support groups. Each is described below following the Background
section.
BACKGROUND
The NCHGR supports the Human Genome Program that has as its goal: completion
of a high-density genetic map of the human genome; construction of a
high-resolution physical map comprised of large overlapping contigs;
development of a "sequence-tagged site" map; development of technology to
reduce the expense of DNA sequencing significantly below current cost;
development of computer tools to manage and provide access to mapping and
sequencing data; examination of the legal, ethical, and social implications of
the Human Genome Program; and research training. These goals are discussed in
detail in the document, "A Five-Year Plan for the Human Genome Project,"
available from the Human Genome Management Information System, Oak Ridge
National Laboratory, Oak Ridge, TN 37831-6050; (615) 576-6669.
The NCHGR is committed to increasing the number of students and faculty in
minority institutions who will participate in accomplishing the goals of the
Human Genome Program and applying the results to biological, medical, and
biotechnological research. There are a variety of opportunities for research
and training that are available through the regular NCHGR grant program, the
minority supplement research program, the institutional training grant
program, and the individual postdoctoral fellowship program. The Minority
Institution Travel Award Program provides additional opportunities for
students at various stages of academic development and for faculty members who
are enrolled and employed, respectively, in minority institutions to
participate in the Human Genome Program.
A. SUPPLEMENTS TO ACTIVE RESEARCH GRANTS
Application Receipt Date: At least 3 months prior to date of meeting, course,
or workshop.
Any NIH grantee whose research is relevant to the Human Genome Program and is
interested in obtaining travel funds for students or faculty from minority
institutions to attend scientific meetings, workshops, or courses may request
supplemental grant support from the NCHGR.
DEFINITIONS, ELIGIBILITY, AND TERMS OF SUPPLEMENTAL AWARDS
1. Minority Institution. A minority institution is defined as an institution
in which the student enrollment is at least 50 percent minority. A minority
individual is defined as a member of any of the following groups: Black
Americans, Hispanic Americans, Native Americans (American Indians or Alsakan
Natives), Asian-Pacific slanders.
2. Student. The definition of student includes undergraduate, predoctoral,
or postdoctoral students enrolled or pursuing training at a minority
institution.
3. Faculty. A faculty member is defined as a full-time faculty member who is
employed by a minority institution and is interested in or engaged in
biomedical research.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 5
4. Scientific Meeting, Course, or Workshop. A scientific meeting in the
context of this program is defined as any national or international scientific
meeting, short course, or workshop relevant to the Human Genome Program.
5. Principal Investigator. Principal Investigators of active NIH grants
relevant to the Human Genome Initiative are eligible to submit supplemental
applications on behalf of a student or faculty member. The Principal
Investigator (or other designated senior investigator on the grant) is
expected to serve as a guide or mentor for the student or faculty member while
at the scientific meeting, course, or workshop.
6. Travel Funds. Travel funds include air and/or ground transportation, per
diem allowance, and registration fees or tuition associated with the meeting,
course, or workshop. The specific budget items must be justified in the
application.
7. Other Considerations. It is desirable that the student or faculty member
be accompanied by the Principal Investigator or designated senior investigator
when attending a scientific meeting. In the case of a workshop or a course,
this is not a requirement, although the Principal Investigator must
demonstrate that there will be some follow-up or informal discussions about
the scientific contents of the workshop or course with the student or faculty
member following completion of the activity. The Principal Investigator is
also encouraged to discuss the type of research and career opportunities that
are supported by the Human Genome Program and that are available through
universities, other institutions, and NIH.
8. Travel Report. In order to evaluate the effectiveness of this program,
the student or faculty member will be requested to prepare a brief report for
submission through the Principal Investigator. This report will be due 30
days after returning from the meeting, course, or workshop and is to be sent
to the program official whose name appears on the Notice of Grant Award. In
addition, the Principal Investigator must include the report in the annual
and/or final grant progress report.
METHOD OF APPLYING
Potential applicants are strongly encouraged to contact the NCHGR's program
official listed below prior to preparing an application.
The Principal Investigator must submit a supplemental grant application
through his/her institution on the standard form PHS 398 (Rev. 10/88) and
should include only the following: (1) face page--item 2 should give the
grant number of the active grant and specifically state "Minority Institution
Travel Award Program" (for example: RO1 AB12345-03, "Minority Institution
Travel Award Program"); (2) budget page; (3) complete curriculum vitae of the
individual for whom support is being requested; and (4) information addressing
the review criteria described below.
APPLICATION PROCEDURES AND REVIEW CRITERIA
Supplemental applications submitted in response to this announcement will be
reviewed for eligibility by the senior staff of the NCHGR using the following
criteria:
1. For Students:
o Completion of at least the sophomore year in college or enrollment
in a predoctoral or postdoctoral program (exceptions will be
considered if justification is furnished);
o Recommendation from one science faculty member or researcher other
than the Principal Investigator;
o A brief written statement describing reasons for attending the
meeting, benefits to be derived, and anticipated long-range
professional plans as they relate to biomedical research in general
and the Human Genome Program specifically.
2. For Faculty:
o A brief written statement indicating research interests, benefits
to be derived by attendance at the meeting, and long-range
professional plans as they relate to biomedical research in general
and the Human Genome Program specifically;
o Two letters of recommendation from the institution, including one
from the Dean or Department Chairperson.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 6
The original and six copies of the application should be submitted to:
Office of Scientific Review
Building 38A, Room 605
National Center for Human Genome Research
National Institutes of Health
Bethesda, MD 20892
Applications may be submitted at any time but must be submitted for a duration
to coincide with the end of the appropriate budget period of the grant. The
requested start date for the supplemental award should be at least 90 days
after the date of submission of the application.
FUNDING
Approved applications will be funded as supplements to active PHS grants
including individual research (RO1, R29, R37), program project (PO1), and
center (P30, P50) grants. R29 grants cannot be supplemented if the amount
requested will result in the total direct cost for the five-year period
exceeding the $350,000 limit. Funds awarded under this program are for the
sole purpose of facilitating participation of students and faculty from
minority institutions in scientific meetings, workshops, and courses relevant
to the Human Genome Program.
For more information about grant supplements, please contact:
Bettie J. Graham, Ph.D.
National Center for Human Genome Research
Building 38A, Room 613
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-7531
e-mail address: B2G@NIHCU.bitnet
B2G@CU.NIH.gov
The program official welcomes the opportunity to discuss this program with
interested applicants and Principal Investigators and encourages telephone,
e-mail, or written inquiries.
B. CONFERENCE GRANTS
Application Receipt Dates: February 1, June 1, and October 1
Individuals, organizations, institutions, or professional societies may apply
for conference grant funds to support students and faculty from minority
institutions attending scientific meetings, workshops, and courses relevant to
the Human Genome Program. The purpose of this initiative will be to provide,
in addition to support for regular attendance, enrichment activities that
would make the experience more meaningful for participants who are not
familiar with the Human Genome Program. Examples of enrichment activities
are: round-table discussions about the latest advances in genomic research,
in-depth discussions of selected posters presented at the meeting, and panel
discussions about research and training opportunities available at different
educational and research institutions. These examples are meant to be
illustrative and not to be all-inclusive. Applicants must demonstrate in the
application that the enrichment activities will be incorporated into the
overall activities of the meeting, workshop, or course and have the full
support of the meeting/ course organizer or council of the professional
society. It is expected that as a result of participating in this
comprehensive program, attendees would have a greater appreciation of the
Human Genome Program and the type of research it supports and the types of
research and career opportunities available through universities, other
institutions, and the NIH. The anticipated long-range outcome would be that
more students and faculty members from minority institutions would consider a
career in one of the research disciplines relevant to the Human Genome
Program.
MECHANISM OF SUPPORT
Support for this program will be through the conference grant mechanism (Rl3).
Allowable costs include air and ground transportation, per diem allowance, and
registration fees or tuition associated with the meeting, course, or workshop.
APPLICATION PROCEDURES AND REVIEW CRITERIA
Potential applicants are encouraged to contact the NCHGR program official
listed below prior to preparing an application.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 7
Applications in response to this announcement will be reviewed in accordance
with the usual NIH peer review procedures.
The following will be considered in evaluating applications:
o Overall scientific merit;
o Quality of the enrichment activities;
o Criteria for selecting participants; especially those who are
under-represented in the biomedical sciences in general and genomic
research specifically;
o Adequacy of recruitment plans;
o Potential for increasing the number of students and faculty at
minority institutions who are interested in pursuing a career or
research project in genomic research.
Following the initial review, applications will be considered by the
appropriate National Advisory Council.
METHOD OF APPLYING
Applications should be submitted at least 10 months in advance of the
conference/scientific meeting date and on Form PHS 398 (revised 10/88).
Application kits are available in most institutional business offices and from
the Office of Grants Inquiries, Westwood Bldg., Room 449; National Institutes
of Health, Bethesda, MD 20892.
Instructions for conference grant applications should be followed.
Applications will be accepted in accordance with the usual NIH receipt dates
(February 1, June 1, and October 1). It is essential that applicants type
"Minority Institution Travel Award Program" in item 2 on the face page of the
application form. The original and six copies of the application should be
submitted to the following office:
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
Telephone: (301) 496-7273
FUNDING
Applications will compete for available funds with all other approved
applications. Funding decisions will be based on recommendations of the
initial review group and of the appropriate National Advisory Council
regarding scientific merit and program relevance.
For more information about conference grants, applicants may contact:
Bettie J. Graham, Ph.D.
National Center for Human Genome Research
Building 38A, Room 613
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-7531
e-mail address: B2G@NIHCU.bitnet
B2G@CU.NIH.gov
The program official welcomes the opportunity to discuss this program with
interested applicants and encourages telephone, e-mail, or written inquiries.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 8
BIOTECHNOLOGY RESEARCH TRAINING
PA: PA-91-18
P.T. 44; K.W. 0710035
National Institute of General Medical Sciences
Application Receipt Dates: January 10, May 10, September 10
March 22, 1991 for 1991 only (T32 only)
Congress has significantly increased the support for biotechnology research
training for fiscal year 1991. Consequently, the National Institute of
General Medical Sciences (NIGMS) reannounces its predoctoral and postdoctoral
research training programs in the area of biotechnology. These programs
differ from existing NIGMS research training programs primarily in their
emphasis on engineering, mathematical, and physical research methods and
approaches to the analysis of biological processes. Consistent with the
Office of Technology Assessment's definition of biotechnology as "any
technique that uses living organisms (or parts of organisms) to make or modify
products, to improve plants or animals, or to develop microorganisms for
specific uses," these research training programs are designed to enhance
technological explorations leading to the development of new or improved
biotechnology products and services. Research training to be supported under
this announcement includes predoctoral (T32) institutional training grants,
individual postdoctoral (F32) fellowships, and senior (F33) fellowships.
The NIGMS currently supports predoctoral research training through National
Research Service Award (NRSA) institutional training grants in five major
programs: Cellular and Molecular Biology, Genetics, Molecular Biophysics,
Pharmacological Sciences, and Systems and Integrative Biology. In addition,
postdoctoral fellowship awards support interdisciplinary research training
with a strong emphasis on basic research. The Institute's goal in these
programs is to provide trainees with broad access to research opportunities
across disciplinary and departmental lines, while not sacrificing the
standards of depth and creativity characteristic of the best Ph.D. programs of
individual departments. Cooperative involvement of faculty members from
several departments as research mentors is considered evidence of such
breadth.
The enormous growth of the biotechnology industry has resulted in critical
shortages of experts in biochemical engineering, biocomputation,
macromolecular structure, protein engineering, immunogenetics, protein
chemistry, separation technologies, and other areas that coincide with the
major biotechnology research needs. NIGMS support for new biotechnology
programs is intended to help fill this need by providing research training
that focuses on the applications of engineering, physics, chemistry,
mathematics, and biology to those areas of biomedical research related to
biotechnology. Involvement of faculty from the physical and biological
sciences, as well as a curriculum that bridges these two disciplines, are
considered essential for biotechnology training programs. While there is also
an increasing demand for bioscientists trained in more classical areas, such
as biological chemistry, cell biology, enzymology, microbial ecology,
microbial physiology, molecular genetics, pharmacology/toxicology, physiology,
and virology, it is expected that these individuals will participate in the
more traditional training programs described in the preceding paragraph.
Biotechnology training programs are NOT intended to duplicate those existing
programs.
PREDOCTORAL RESEARCH TRAINING GRANTS
Applications requesting support of PREDOCTORAL RESEARCH TRAINING in
biotechnology should accommodate the following considerations:
o Biotechnology research training should be an interdisciplinary
enterprise targeted toward the production of a new cadre of
scientists with facility and orientation to combine basic and
applied research. Because students entering the program will have
different backgrounds, biotechnology training programs should have
sufficient flexibility to accommodate a variety of candidates with
fundamentally sound preparation in, for example, chemical
engineering, biology, applied mathematics, chemistry, computer
science, biochemistry, or physics.
o Biotechnology research training should provide for a significant
amount of laboratory experience based on state-of-the-art common
methodologies (e.g., bioprocess engineering, plant and animal cell
culture technologies, biocomputing, macromolecular structure
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 9
analyses, hybridoma technology, molecular genetics, cell
fractionation, and separation technologies).
o To ensure formal mechanisms for multidepartmental organization and
truly inter- (or cross-) disciplinary training, and to make
provisions for academic and industrial collaborations in research
training, it is desirable that these training programs be
established at academic institutions with viable biotechnology
research programs (centers, institutes, or consortia). Scientists
from both the industrial and academic sectors should participate in
such research training programs. To ensure an appropriate balance
of basic and applied biotechnology research experiences and
perspectives, it is desirable that trainees participate in
internships in biotechnology industries or that an alternative
mechanism to such internships is available as an integral part of
the training program.
o It is expected that the Federal resources committed to the support
of biotechnology research training be augmented by cost-sharing
mechanisms, employing the university or state's resources, as well
as those of industries collaborating with these biotechnology
research and research training institutions.
The stipend level for predoctoral trainees is $8,800 per annum. In addition,
the applicant institution may request up to $1,500 per year for each
predoctoral trainee for essential direct support costs to the training
program. Tuition support for each trainee may be requested in accordance with
amounts charged to other graduate students. Indirect cost will be paid at 8
percent of total allowable direct costs less tuition.
Institutional training grants are made for project periods of up to 5 years
and are renewable. However, no single predoctoral trainee may receive more
than 5 years of support unless a special waiver is obtained.
INDIVIDUAL FELLOWSHIPS
POSTDOCTORAL FELLOWSHIPS in biotechnology are welcomed from applicants trained
in engineering, mathematical, or physical sciences who desire to bring such
approaches to biotechnology research or from biologists who wish to acquire
research training in biocomputation, protein engineering, macromolecular
analyses, or other areas related to biotechnology. Applications from
candidates seeking postdoctoral training in biotechnology industrial settings
are especially encouraged.
The stipend level for the individual postdoctoral fellowship ranges from
$18,600 to $32,300 depending on years of relevant experience subsequent to the
award of the doctorate degree. In addition, the applicant's
institution/organization may request an institutional allowance up to $3,000
per year for support of supplies, equipment, travel, tuition, fees, insurance,
and other training-related costs.
Individual postdoctoral fellowships are made for project periods of up to 3
years.
SENIOR FELLOWSHIPS will be supported for experienced investigators in the
biological, engineering, mathematical, or physical sciences who desire to
acquire experiences/training in areas more directly related to biotechnology.
The stipend level is currently $30,000 per annum for project periods of up to
2 years. The applicant's institution/organization may request an
institutional allowance up to $3,000 per year for support of supplies,
equipment, travel, tuition, fees, insurance, and other training-related costs.
More detail on the policies governing the institutional predoctoral training
Westwood Building, Room 449 grant, the postdoctoral fellowships, and the
senior fellowship awards can be found in the National Research Service Awards
Guidelines published in the NIH Guide for Grants and Contracts, Vol. 13, No.
1, January 6, 1984.
Application materials are available from the university business office or
from:
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Bethesda, MD 20892
Deadlines for receipt of all types of applications included in this
announcement are January 10, May 10, and September 10. For Fiscal Year 1991
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 10
ONLY there will be one additional deadline of March 22, 1991 for receipt of
applications for INSTITUTIONAL PREDOCTORAL RESEARCH TRAINING GRANTS.
Applications in response to this announcement for the March 22, 1991, deadline
should indicate in response to Item #2 on the 398 face page: BIOTECHNOLOGY
RESEARCH TRAININGi, PA-91-18.
The signed original and four copies of the application should be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applicants who are planning to submit for the March 22 deadline are strongly
encouraged to contact Dr. Christine Carrico at (301) 496-7707 as soon as
possible. To expedite the review process, in addition to the required copies
submitted to the Division of Research Grants, two copies of the application
should be submitted directly to:
Office of Review Activities
National Institute of General Medical Sciences (NIGMS)
Westwood Building, Room 9A18
Bethesda, MD 20892
For further information, please contact:
Dr. Christine K. Carrico, Ph.D.
Director, Pharmacological Sciences Program
National Institute of General Medical Sciences (NIGMS)
5333 Westbard Avenue, Room 919
Bethesda, MD 20892
Telephone: (301) 496-7707
BIOMEDICAL RESEARCH SUPPORT SHARED INSTRUMENTATION GRANTS
PA: PA-91-19
P.T. 34; K.W. 0735000, 1014001, 0735015
National Center for Research Resources
Application Receipt Date: March 26, 1991
BACKGROUND
The National Center for Research Resources (NCRR) is continuing its
competitive Biomedical Research Support (BRS) Shared Instrumentation Grant
(SIG) Program initiated in Fiscal Year 1982. The program was established in
recognition of the long-standing need in the biomedical research community to
cope with rapid technological advances in instrumentation and the rapid rate
of obsolescence of existing equipment. The objective of the program is to
make available, to institutions with a high concentration of Public Health
Service (PHS)-supported biomedical investigators, research instruments that
can only be justified on a shared-use basis and for which meritorious research
projects are described.
An eligible institution may submit more than one application for different
instrumentation for the March 26, 1991, deadline. However, if multiple
applications are submitted for similar instrumentation from one or more
eligible components of an institution, then documentation from a high
administrative official must be provided, stating that the multiple
applications are a coordinated institutional resource plan, not an unintended
duplication.
RESEARCH GOALS AND SCOPE
This program is designed to meet the special problems of acquisition and
updating of expensive shared-use instruments which are not generally available
through other PHS mechanisms, such as the individual research project, program
project and center grant programs, the Biomedical Research Technology Grant
Program, or the Biomedical Research Support (BRS) Grant Program. Proposals
for the development of new instrumentation will not be considered.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 11
ELIGIBILITY
The BRS Shared Instrumentation Grant Program is a subprogram of the BRS Grant
Program of NCRR. Awards are made under the authority of the BRS program and
are made to institutions only, not to individuals. Therefore, eligibility is
limited to institutions that receive a BRS grant award. Awards are contingent
on the availability of funds.
MECHANISM OF SUPPORT
BRS Shared Instrumentation Grants provide support for expensive
state-of-the-art instruments utilized in both basic and clinical research.
Applications are limited to instruments that cost at least $100,000 per
instrument or system. The maximum award is $400,000. Types of
instrumentation supported include, but are not limited to, nuclear magnetic
resonance systems, electron microscopes, mass spectrometers, protein
sequencer/amino acid analyzers, and cell sorters. Support will not be
provided for general purpose equipment or purely instructional equipment.
Proposals for "stand alone" computer systems will only be considered if the
instrument is solely dedicated to the research needs of a broad community of
PHS-supported investigators.
Awards will be made for the direct costs of the acquisition of new, or the
updating of existing, research instruments. The institution must meet those
costs (not covered in the normal purchase price) required to place the
instrumentation in operational order as well as the maintenance, support
personnel, and service costs associated with maximum utilization of the
instrument. There is no upper limit on the cost of the instrument, but the
maximum award is $400,000. Grants will be awarded for a period of one year
and are not renewable. Supplemental applications will not be accepted. The
program does not provide indirect costs or support for construction or
alterations and renovations. If the amount of funds requested does not cover
the total cost of the instrument, the application should describe the proposed
sources(s) of funding for the balance of the cost of the instrument.
Documentation of the availability of the remainder of the funding, signed by
an appropriate institutional official, must be presented to NCRR prior to the
issuance of an award. Requests for a multiple instrument purchase totalling
over $400,000 must specify and justify which instrument(s) should be supported
within the $400,000 ceiling.
Applicants proposing the direct purchase of an instrument that the institution
has secured or is planning to secure via a leasing agreement are strongly
encouraged to consult with their institutional sponsored projects office
regarding applicable PHS policy prior to executing the leasing agreement. If
the leasing agreement was executed more than one year prior to submission of
the SIG application, the applicant must provide strong justification for the
requested Federal funds. Further, the instrument must be considered
state-of-the-art at the time of submission of the SIG application.
A major user group of three or more investigators should be identified. A
minimum of three major users must have PHS peer-reviewed research support at
the time of the award; 50 percent of these grants must have been awarded by
the NIH. The application must show a clear need for the instrumentation by
projects supported by multiple PHS research awards and demonstrate that these
projects will require at least 75 percent of the total usage of the
instrument. Major users can be individual researchers, or a group of
investigators within the same department or from several departments at the
applicant institution. PHS extramural awardees from other institutions may
also be included.
If the major user group does not require total usage of the instrument, access
to the instrument can be made available to other users upon the advice of the
internal advisory committee. These users need not be PHS awardees, but
priority should be given to PHS-supported scientists engaged in biomedical
research.
ADMINISTRATIVE ARRANGEMENTS
Each applicant institution must propose a Principal Investigator who can
assume administrative/scientific oversight responsibility for the
instrumentation requested. An internal advisory committee to assist in this
responsibility should also be utilized. The Principal Investigator and the
advisory group are responsible for the development of guidelines for shared
use of the instrument, for preparation of all reports required by the NIH, for
relocation of the instrument within the grantee institution if the major user
group is significantly altered and for continued support for the maximum
utilization and maintenance of the instrument in the post-award period.
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 12
A plan should be proposed for the day-to-day management of the instrument
including designation of a qualified individual to supervise the operation of
the instrument and to provide technical expertise to the users. Specific
plans for sharing arrangements and for monitoring the use of the instrument
should be described.
If a grant award is made, a final progress report will be required that
describes the use of the instrument, listing all users, and indicating the
value of the instrumentation to the research of the major users and to the
institution as a whole. This report is due within 90 days following the end
of the project period.
REVIEW PROCEDURES AND CRITERIA
Applications are reviewed by specially convened initial review groups of the
Division of Research Grants (DRG) for scientific and technical merit and for
program considerations by the National Advisory Research Resources Council
(NARRC) of the NCRR. Approximately half of the applications will be reviewed
at the September 1991, NARRC meeting and the remainder at the NARRC meeting in
February 1992. Funding decisions on all applications received for the March
26, 1991, deadline will not be made until the program receives an
appropriation for FY 1992. The Council date will not affect funding
decisions.
Criteria for review of applications include the following:
o The extent to which an award for the specific instrument would meet
the scientific needs and enhance the planned research endeavors of
the major users by providing an instrument that is unavailable or
to which availability is highly limited.
o The availability and commitment of the appropriate technical
expertise within the major user group or the institution for use of
the instrumentation.
o The adequacy of the organizational plan and the internal advisory
committee for administration of the grant including sharing
arrangements for use of the instrument.
o The institution's commitment for continued support of the
utilization and maintenance of the instrument.
o The benefit of the proposed instrument to the overall research
community it will serve.
METHOD OF APPLYING
Copies of a more detailed announcement are being mailed to Program Directors
of BRS grants and to sponsored program offices at all institutions currently
receiving BRS grants. Interested investigators should obtain the complete
announcement prior to preparing an application.
Applications must be received by March 26, 1991. Applications received after
this date will not be accepted for review in this competition. The original
and four copies should be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
If appendix material is submitted, five collated sets must be included with
the application package. Identify each of the five sets with the name of the
principal investigator and the project title. This material will not be
routinely duplicated and will be used in a limited way by members of the
initial review group.
Two copies of the application and one copy of any appendix material should
also be addressed to:
Biomedical Research Support Program
National Center for Research Resources
National Institutes of Health
Westwood Building, Room 10A06
5333 Westbard Avenue
Bethesda, MD 20892**
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 13
Inquiries should be directed to the Biomedical Research Support Program Office
at (301) 496-6743.
This program is described in the Catalog of Federal Domestic Assistance number
93.337, Biomedical Research Support. Awards will be made under the authority
of the Public Health Service Act, Section 301 (Public Law 78-410, as amended;
42 USC 241) and administered under PHS grant policies and Federal Regulations
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.
**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
NIH GUIDE - Vol. 20, No. 1, January 4, 1991 - Page 14
------------------------- Full text of RFAs -------------------------
CLINICAL CORE CENTERS FOR ORAL HEALTH RESEARCH
RFA AVAILABLE: DE-91-02
P.T. 04; K.W. 0715148, 0710030, 0785035, 0745027
National Institute of Dental Research
Letter of Intent Receipt Date: April 2, 1991
Application Receipt Date: May 6, 1991
The National Institute of Dental Research (NIDR) invites
applications from domestic institutions for the support of
Clinical Core Centers for Oral Health Research (CCCOHR). The
CCCOHRs are intended to facilitate and stimulate clinical
research to improve oral health in adults, senior citizens, and
and other groups at high risk for oral diseases. Such groups
include individuals with systemic diseases or oral conditions
that increase the risk for oral diseases or tooth loss and
members of minority groups who have not shared the gains in oral
health seen in many segments of the U.S. population.
The CCCOHRs are intended to serve as focal points for
strengthening the nation's oral health clinical research
capability and facilitating the development of improved
approaches for preventing or treating oral diseases. They
represent one step in the implementation of a major NIDR research
initiative, the Research and Action Program for Improving the
Oral Health of Older Americans and Other Adults at High Risk.
This Request for Applications (RFA) is for a single competition
with a receipt date of May 6, 1991. It may be reissued at a
later date.
BACKGROUND
In the early 1970's, a national survey (National Health and
Nutrition Examination Survey) assessed oral health in U.S. school
children and found unacceptably high levels of dental caries.
NIDR developed a targeted research program, the National Caries
Program, to address this problem. Subsequent NIDR surveys (1979-
80 and 1986-87) showed dramatic, continuing improvements in
children's oral health. Today, almost half the children between
5 and 17 years of age have no cavities in their permanent teeth.
In contrast, an NIDR survey of working adults and older adults
attending senior centers conducted in 1985-86 showed substantial
deficiencies in adults' oral health. Seniors had the worst
overall oral health status, with over forty percent missing all
their teeth. The survey also revealed marked variations among
sociodemographic groups. Thus, the oral health gains seen in
children were not being matched in adults and, in particular, in
those older Americans comprising the most rapidly growing
segments of the population.
In response to these findings, NIDR initiated planning activities
that integrated advice from scientists, public health experts,
and dental clinicians. These efforts provided the foundation for
an initiative to stimulate expanded basic and clinical research
to improve the oral health of adults and seniors, while enlisting
the participation of other public and private organizations and
dental practitioners in intensified, coordinated efforts to
improve adults' oral health.
Other observations identified additional groups remaining at high
risk for oral diseases. These included patients with systemic
diseases (e.g., diabetes), undergoing medical treatments (e.g.,
chemotherapy or radiation), or having oral conditions (e.g.,
xerostomia) which lead to oral diseases. Rural residents and
members of minority groups who were economically disadvantaged
also showed elevated risks for periodontal diseases, dental
caries, and other causes of tooth loss. These additional high-
risk groups are included in the NIDR's Research and Action
Program.
This RFA is intended to stimulate and enhance clinical research
that can benefit adults or these additional groups at high risk
of oral diseases. Many dental teaching and research institutions
have insufficient technical resources to conduct high-quality
clinical research or clinical trials in areas pertinent to
implementation of the Research and Action Program. The proposed
CCCOHRs will help to expand and improve the nation's clinical
oral health research capability.
Establishment of Core Research Centers was recommended by an
expert panel and highlighted in a 1985 report requested by
Congress on NIDR's use of Center and other large grant
mechanisms. A number of additional advisory groups, including
the National Advisory Dental Research Council, have reaffirmed
the need for expansions in clinical research and the use of core
centers to expedite translation of new knowledge from the
laboratory to the clinic.
In Fiscal Year 1989 NIDR issued its first RFA requesting Clinical
Dental Research Core Centers applications to facilitate a broad
array of clinical research in dental schools and research
institutions. Subsequently, two such Centers were funded. This
RFA differs from the prior request in that it focuses on
enhancing clinical research activities directly pertinent to
NIDR's Research and Action Program.
RESEARCH GOALS AND SCOPE
The CCCOHRs are intended to help develop state-of-the-art
clinical research capacity through supporting shared resources
and facilities (core units) that strengthen and expand relevant
clinical research. Limited funding (no more than 20% of the
total direct CCCOHR costs) also will be provided for the support
of designated pilot or feasibility studies. The CCCOHRs can
provide a nucleus around which additional clinical studies,
funded through government or private sources, can be structured.
Additional aims of the CCCOHR include:
o enhancing opportunities for translating new scientific
knowledge into improved methods for preventing and reducing oral
diseases in adults and other high-risk groups;
o encouraging more effective interdisciplinary collaboration
among researchers and clinicians with expertise relevant to this
initiative; and
o fostering the training of clinical research scientists by
providing improved opportunities for collaboration and expanded
environments for clinical research.
Several examples of appropriate CCCOHR activities are listed
below. However, their inclusion implies no priorities. The
needs for shared resources to enhance or expand ongoing,
meritorious clinical research projects and the content of such
projects at applicant institutions should determine the content
of applications. Examples of potential CCCOHR-supported
activities and collaborations include:
o developing and providing core resources to expand and
strengthen ongoing funded clinical research projects by, for
example:
- expanding biostatistical participation in implementing
projects;
- developing improved computer facilities for direct data
entry in field studies;
- providing improved facilities and methods for obtaining the
participation of high-risk, understudied population subgroups in
clinical studies;
- developing and providing laboratory services or facilities
to enhance ongoing research.
(Possible collaborations: biostatistics, public health,
medical specialties, epidemiology, laboratory sciences, and
behavioral/social sciences.)
o developing research opportunities utilizing health care
outreach activities in rural areas, medical clinics, minority
communities, nursing home settings, senior centers, work-sites or
other settings where individuals at high risk of oral disease can
be reached for participation in separately funded clinical
research projects. Core resources may not be used to support the
cost of delivering health care services, but may be used to
develop and utilize opportunities for implementing relevant
clinical field studies. (Possible collaborations: medicine,
public health, epidemiology, clinical dentistry, medical
specialties, nutrition, behavioral/social sciences).
o Conducting pilot or feasibility studies, such as:
- studies on methods to reduce oral complications associated
with cancer therapies in adults;
(Possible collaborations: epidemiology, clinical dentistry,
oncology, pharmacology, microbiology, behavioral/social sciences)
- studies on the behavioral, sociodemographic, or nutritional
characteristics of seniors with elevated rates of root caries;
(Possible collaborations: cariology, microbiology, epidemiology,
gerontology, nutrition, behavioral/social sciences)
- studies testing methods for assessing oral status, or the
effectiveness of interventions to prevent oral diseases in
medically compromised adult patients receiving drugs affecting
salivary function;
(Possible collaborations: internal medicine,
pharmacology, salivary research, microbiology, clinical
dentistry, behavioral/social sciences.)*
* Inclusion of the behavioral and/or social sciences in many
examples reflects their potential cross-cutting contributions.
For example, there may be a need to include such disciplinary
skills in assessing adherence to preventive or therapeutic
regimens; evaluating the effects of disease, or treatments for
oral conditions, on quality of life; or indicating how behaviors,
such as seeking dental care or engaging in effective personal
oral hygiene, modify treatment outcomes.
ELIGIBILITY
This competition is limited to U.S. institutions. Applicant
institutions must provide clear evidence of having a suitable
clinical research base to assure appropriate utilization of the
added resources which NIDR would provide through the CCCOHR.
This must include either: 1) meritorious ongoing clinical
research projects that are potentially relevant to the NIDR's
Research and Action Program and/or 2) the capability to develop
such clinical research, accompanied by firm funding commitments
which assure that appropriate clinical research projects will be
active at the time of a CCCOHR award. Institutions that have
already received a Clinical Research Core Center (P30) award from
NIDR are not eligible for this competition.
CENTER CHARACTERISTICS
Each CCCOHR must be a clearly defined organizational entity
within a dental school or dental research institution with a
Director responsible for management of the Center. Funding is
intended to support core research resources and facilities that
will accelerate the scientific productivity of, or enrich the
potential clinical "pay-offs" from, individually supported
clinical research projects pertinent to improving oral health in
adults and high-risk populations.
Each CCCOHR must include a minimum of three core units. One unit
must be an administrative core. A biostatistics core unit is
also mandatory, unless an appropriate biostatistics unit is
already available to clinical investigators at the applicant
institution. The biostatistics component may be incorporated
into the administrative core. Other core resources proposed must
directly relate to ongoing and planned oral health clinical
research relevant to adults and high-risk groups.
Examples of potential core units include:
o Administrative Core: Funds for the Center Director and
administrative staff will be provided. This core unit should
ensure that CCCOHR participants are provided with shared support
services that enhance their research. The Director will be
responsible for monitoring the overall quality and the scope of
activities as they pertain to the objectives of the NIDR
Research and Action Program. The administrative core may provide
limited funds to facilitate improved accrual of patient
populations for pilot studies and for subsequent studies
supported through collateral funding. Costs associated with
information transfer and outreach programs also may be requested.
The core will convene an advisory panel of experts from outside
the applicant institution at least once a year to review Center
activities and provide a written report on the progress of the
Center. The Center Director will be expected to utilize panel
recommendations in monitoring and strengthening CCCOHR
activities. Pilot and feasibility studies also will be
administered through the administrative core and will remain
under the purview of the CCCOHR Director.
o Biostatistics, Experimental Design, Data Management and
Analysis Core: This core may provide the staff and other
resources needed to enhance programs of clinical research through
the application of epidemiology, sampling, biostatistics, and
related support methodologies. It should specifically foster and
strengthen biostatistician-clinical investigator interactions in
the design and conduct of clinical research.
o Diagnostics Core: May provide and develop methods and/or
instrumentation to detect early signs or markers of oral disease
or dysfunction and to monitor the efficacy of treatments.
o Laboratory Core: May provide resources and scientific
expertise to carry out adjunct studies on clinical trial patients
or general population samples. Examples of laboratory cores
could, for example, include: behavioral/social sciences,
pharmacology, microbiology, immunology, nutrition, or molecular
biology. The composition of the laboratory core(s) should
reflect the resource needs and added research opportunities
arising from ongoing clinical research activities.
o Unique Clinical Facilities Core: May provide resources to
facilitate research that cannot be carried out in conventional
health-care settings, such as the use of mobile units for
clinical studies involving elderly or physically disabled
individuals or work-site based dental operatories for preventive
interventions with employed adults.
The above list is not intended to describe the full range of
possible activities nor to direct applicants to these areas.
Inclusion of core units of all these types in a single proposed
center is not required nor even necessarily advisable. In
structuring CCCOHR proposals, applicants should consider their
institution's areas of special clinical research potential, its
profile of currently funded clinical research projects, and
determine which areas present the greatest need for shared
resources in addressing goals of the Research and Action Program.
Cores may provide support for personnel, including the necessary
expertise to direct cores, equipment, supplies, services,
facilities, and limited travel. In addition, they may provide
funds for the integration of activities with other research
centers in the same or related biomedical or behavioral/social
science areas. For institutions having General Clinical Research
Centers (GCRCs) funded by the NIH's National Center for Research
Resources, consideration should be given to planning and
coordinating CCCOHR activities to utilize the special inpatient
and outpatient research facilities and other research resources
(e.g., computers for data entry and data management and
additional biostatistical resources), the GCRC may provide.
Each core unit must serve at least two projects with independent
funding or firm funding commitments. This requirement is
essential because the CCCOHRs provide shared resources to
facilitate and expand ongoing research or planned research for
which independent budget support is already assured.
This award also will provide limited funds (up to 20 percent of
total direct CCCOHR costs) for pilot and feasibility studies.
These are the only research projects that will be directly
supported by this mechanism. Each pilot or feasibility project
may cost no more than $25,000 per year; up to two years of
support may be requested. Anticipated purposes for pilot and
feasibility studies include:
o developing enhanced clinical research methods and pre-testing
specific clinical research protocols to determine their
feasibility and potential value for larger studies, such as,
single or multi-site clinical trials;
o involving new investigators and dental faculty clinicians in
clinical research under the direction of experienced clinical
scientists;
o encouraging clinical researchers to develop interdisciplinary
collaborations permitting utilization of a fuller range of new
research techniques relevant to preventing or reducing oral
diseases in adults and high-risk populations.
Pilot projects to be carried out during Years 1 and 2 of the
grant period must be included in the application. In addition,
applicants should provide an overview of their plans for
potential pilot studies in Years 3-5 and should specify review
procedures to assure the relevance and scientific merit of these
studies. NIDR staff will determine during Year 2 of CCCOHR
grants whether the NIDR will arrange for additional peer review
of pilot studies for Years 3-5.
It is anticipated that following the completion of most pilot or
feasibility studies, investigators will apply for independent
support to extend preliminary findings. The CCCOHR will not
provide direct funding for ongoing research projects. These must
be funded through other sources or support mechanisms.
FUNDING MECHANISM
The Centers will be supported by Center Core Grants (P30) for a
period of five years, commencing as early as September 15, 1991.
Subsequent support will be contingent upon program needs, as
reflected in re-issuance of an RFA, and
successful competitive review. For the first year, applicants
may request up to $300,000 in direct costs. (Where indirect
costs are assigned to a subcontract and counted as direct costs,
the direct cost maximum of $300,000 may be exceeded by the amount
of the indirect costs assigned to the subcontract.) Applications
that exceed these limits will be returned without review.
Budget increases of no more than four percent per year may be
requested from the NIDR for each of the subsequent four years.
The development of expanded funding for both CCCOHR activities
and related clinical studies from other sources, such as
industry, foundations, or other government agencies, is
specifically encouraged.
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 Research Center (P30)
grant will be awarded to any one institution.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to
include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis
should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them. This policy is intended to apply
to males and females of all ages. If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear
compelling rationale should be provided.
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group. In
addition, gender and racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study. This information should be
included in the form PHS 398 in Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors are urged to assess carefully the feasibility
of including the broadest possible representation of minority
groups. However, NIH recognizes that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e., Native Americans (including American Indians
or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population groups
should be provided.
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited to
clinical trials.
The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
from women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
If the required information is not contained within the
application, the application will be returned.
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies. If the
representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
All applications for clinical research submitted to NIH are
required to address these policies. NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
DIRECTION AND LEADERSHIP
Strong and effective scientific leadership must be provided. The
application should specify provisions that will be made for
replacement of the Director with a suitably qualified
alternative should circumstances require. CCCOHR Directors will
be responsible for the organization and operation of the program
and for communication with the CCCOHR Advisory Panel and with the
NIDR on scientific and administrative matters. Directors will be
responsible for maintaining high-quality research efforts and for
ensuring effective collaboration among CCCOHR scientists. It is
essential that the various elements of the CCCOHR be interrelated
and that their utilization facilitates an enhanced quality and
quantity of clinical oral health research related to the aims of
NIDR's Research and Action Program.
REVIEW PROCEDURES AND CRITERIA
Applications will be evaluated by a special review committee
convened by the NIDR Scientific Review Branch. Prior to the
initial review, a triage mechanism may be used to screen out
applications that are noncompetitive or nonresponsive to the RFA.
Due to the short review cycle, applicant interviews or site
visits will not be conducted. Secondary review will be conducted
by the National Advisory Dental Research Council. Applications
must be received by May 6, 1991, so they can be reviewed and
considered for funding in Fiscal Year 1991. Applications judged
to be noncompetitive or nonresponsive to the RFA,
received after May 6,1991, or exceeding the budget limitation, will
be returned without review. Waivers of the receipt deadline and
budget limitation will not be granted.
Major factors to be considered in scientific review will include:
1 The combination of ongoing funded clinical research projects,
CCCOHR core units, and CCCOHR pilot/feasibility projects into an
effective and cohesive program that is conducive to stimulating
an expansion of high-quality clinical research relevant to
improving oral health in high-risk and adult populations.
2 The scientific merit and relevance of separately-funded
ongoing clinical research projects that will be served and
enhanced by CCCOHR resources.
3 The adequacy of plans to ensure efficient collaboration,
interaction, and dissemination of information among investigators
and effective monitoring of progress toward CCCOHR goals.
4 The scientific, clinical, and administrative qualifications;
experience and commitment of the Center Director; and his/her
ability to provide effective leadership.
5 Availability of a base of ongoing, meritorious clinical
research projects or projects with firm funding commitments
permitting optimal utilization of CCCOHR resources.
6 Demonstrable institutional commitment to the proposed CCCOHR.
7 The appropriateness, relevance, and scientific merit of
proposed pilot or feasibility projects to be conducted during the
first two years of the award.
8 The appropriateness, relevance, and scientific strengths of
the proposed core units.
9 The competence of individuals participating in core units and
pilot/feasibility studies and their commitment to the goals of
the CCCOHR.
10 The appropriateness of the budget.
11 The feasibility and relevance of plans for fostering training
in clinical research methodology for dental faculty and new
investigators through utilizing existing funded projects,
pilot/feasibility projects, and/or training grant mechanisms
supported by the NIH or by other public or private funds.
12 The availability of appropriate clinical and study
populations; the effectiveness of efforts to include women and
minorities in study populations, to the extent consistent with
the projected conduct of pilot and feasibility studies.
13 Appropriateness of provisions for the protection of human and
animal subjects.
Inclusion of projects or cores deemed to have limited scientific
merit or to be peripheral to the Center's objectives, may be
considered a reflection of the Director's judgment and may affect
the application's rating. Component projects devoid of merit
will be disapproved. Projects with only adequate merit, if not
deemed essential to success of the Center, may be recommended for
deletion.
In addition to scientific merit, program priorities, and program
balance, the total cost of the Center to the NIDR will be
considered by NIDR staff and the National Advisory Dental
Research Council in making funding recommendations. One
consideration will be the extent to which complementary projects,
supported from non-NIDR funds, contribute to the cost
effectiveness of the proposed Center. In circumstances where
projects have similar scientific merit, but vary in cost
competitiveness, the NIDR is likely to select the more cost-
competitive project for funding.
Following funding, interim peer review to evaluate progress may
be conducted by NIDR. Funding for subsequent years may be
contingent on successful outcomes of such reviews.
METHOD OF APPLICATION
Prospective applicants should communicate with program and grants
management staff of the NIDR Extramural Program as early as
possible in the planning phase of application preparation. These
communications may materially assist applicants in ensuring that
the proposed Core Research Center's objectives, structure, and
budget format are acceptable. At a minimum, prospective
applicants are urged to submit, on or before April 2, 1991, a
letter of intent referencing this RFA. This letter should
include the names of the Director and all key personnel including
consultants, identify the institution(s) or organizations
participating, and provide a descriptive title for each core unit
and all proposed pilot or feasibility studies. The letter should
be addressed to Dr. Patricia Bryant at the address indicated
below. This letter is not binding and does not constitute a
prerequisite for acceptance of an application. Submission of
letters of intent will facilitate planning for timely review of
all applications.
Applications should be prepared on Form PHS-398 (Rev. 10/88),
Application for PHS Grant may 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 the title "Clinical Core
Center for Oral Health Research" and the RFA number DE-91-02.
The RFA label available in the 10/88 revision of Form PHS-398
must be affixed to the bottom of the face page. Use the RFA
label provided in the Form PHS-398 application package.
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. Pagination must be
consecutive throughout the application. Each core unit and pilot
or feasibility project must be identified by number and Principal
Investigator. A consolidated budget for the complete CCCOHR for
the entire project period must be presented (use page 5, PHS-
398). Separate detailed annual and total budgets for the entire
project period for each project and core must be presented (use
pages 4-5, PHS-398). In addition, a summary table should be
included providing budget totals for each pilot project and core
unit, as well as the entire program, for all years of support.
Direct and indirect costs are to be indicated.
Both in planning and presenting the total project and each core
or pilot/feasibility project, specific attention should be given
to efforts to contain costs and assure cost-competitive
implementation of research goals. Funds may be requested for
professional, technical, and administrative personnel; consultant
services, including the costs associated with convening an
advisory committee; equipment; supplies; travel; patient costs;
minor renovations; and publication costs directly related to the
functions of the core units and not covered by the funded
research projects in the Center. A detailed summary must be
provided for all collateral support from non-NIDR sources for
studies which will be served by the Center or which complement or
expand NIDR-supported CCCOHR activities. Awardees will be
expected to update this information on an annual basis.
Under Section 2, Research Plans, describe the goals of the center
and explain how the proposed core resources and pilot/
feasibility studies will contribute toward achieving those goals.
Describe the administrative structure and define the
responsibilities of the Director, individual investigators,
advisory groups, and the proposed mechanisms for monitoring
scientific progress and for monitoring core units' contributions
toward expanding and strengthening clinical oral health research
efforts. Indicate the relationship of other funded or committed
projects to the proposed Core units or overall CCCOHR activities.
Each core unit should be presented as if it was a research grant
application; that is, the instruction pages 19-23 of Form PHS-398
should be followed. The 20-page limitation will apply to each
core unit. More succinct presentation is encouraged where
possible. Presentation of pilot or feasibility studies should
adhere to the format and length (8 page maximum) required for
NIDR Small Grant (R03) applications. Abstracts (page 2, Form PHS
-398) must be completed for the entire application and each core
resource, each funded or committed project that will utilize the
cores or collaborate with the CCCOHR, and each pilot or
feasibility study proposed for initiation during the first two
years of the award.
The original and four copies of the application must be received
by May 6, 1991, at:
Grant Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892-4500**
Applicants also must furnish two copies by May 6, 1991, 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
All inquiries and letters of intent should be directed to:
Patricia S. Bryant, Ph.D.
Health Scientist Administrator
Extramural Program
National Institute of Dental Research
Westwood Building, Room 506
Bethesda, MD 20892-4500
Telephone: (301) 496-7807
This program is described in the Catalog of Federal Domestic
Assistance No. 93.1212. Awards will be made under authorization
of the Public Health Service Act, Title III, Section 301 (Public
Law 78-410, as amended; 42 USC 241) and administered under PHS
grant policies and Federal Regulations 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.