GEORGE M. O"BRIEN UROLOGY RESEARCH CENTERS
RELEASE DATE: May 8, 2002
RFA: DK-02-032 (Reissued as RFA-DK-07-004)
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute of Diabetes and Digestive and Kidney Diseases
(http://www.niddk.nih.gov/)
National Cancer Institute
(http://www.nci.nih.gov)
LETTER OF INTENT RECEIPT DATE: October 17, 2002
APPLICATION RECEIPT DATE: November 19, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
This Request for Applications (RFA) invites investigators to submit research
applications for the George M. O"Brien Urology Research Centers Program. The
emphases for this program are fourfold (1) to continue to attract new
scientific expertise into the study of the basic mechanisms of urological
diseases and disorders, (2) to encourage multidisciplinary research focused
on the causes of these diseases, 3) explore new basic areas that may have
clinical research application, and 4) generate *Developmental Research
(DR)/Pilot and Feasibility (P&F) studies of two years duration, which are
anticipated will lead to new and innovative approaches to study urological
disease, and the eventual submission of competitive investigator-initiated
R01 research grant applications.
The mounting complexities associated with the studies of disease processes
will likely require investigators who have training and expertise in
disciplines such as cell and molecular biology, biochemistry, physiology,
genomics and proteomics, developmental biology, tissue engineering,
epidemiology, immunology and pathology. In addition, appropriate expertise
will likely include a focus into topical areas, such as factors influencing
the development and progression of benign prostate growth, understanding
bladder urothelium responses to infections, effects of diabetes on lower
urinary tract, immunobiology and neurobiology of the lower urinary tract and
relationship to urological disease, factors influencing the development of
urolithiasis, genetics of urological diseases, factors influencing normal and
abnormal bladder urothelial biology, etc.
The major emphasis of these projects should be on understanding the normal
growth and development processes of the urinary tract and the development of
non-malignant disorders, e.g. benign prostatic hyperplasia, prostatitis,
urinary incontinence and dysfunctional voiding, urinary tract infections,
interstitial cystitis, pediatric bladder and developmental urological
disorders, erectile function, urinary tract stone disease, chronic pelvic pain
of bladder origin, as well as the urological malignancies.
Individual institutions with both basic and clinical research capabilities
are eligible to apply. Inter-institutional collaborative research
arrangements are also appropriate and encouraged. Coordination for such
arrangements must be evident and clearly meaningful and appropriate for the
research proposed.
*Generally DR/P&F proposals are expected to have limited preliminary data and
are reviewed based on the clear development of hypotheses and supporting
literature.
RESEARCH OBJECTIVES
Background
The application of human genomic information to improve clinical outcome is a
major challenge facing biomedical researchers today. Nevertheless, with the
elucidation of the human genome, there has been an explosion of new methods
and technologies that should allow for the routine discovery of new genes and
the identification of their biological relevancy. However, the understanding
of normal cellular processes and the development and progression of urological
diseases will require more than the delineation of an array of complex
protein-protein interacting pathways. These pathways are aberrantly modified
in disease states and reflected in the subtle protein changes in the cell.
Such changes in protein expression are likely to be translated into changes in
cell growth, differentiation, and/or apoptosis. In addition, because of the
complexity and heterogeneity of many of the urological diseases there is an
ever increasing need for the to utilize these new molecular approaches to well
characterized experimental animal models for the study the physiology and
neurophysiology of lower urinary tract function.
Prospective applicants are urged to consult the research priorities web pages
of both the NIDDK and NCI for additional urological research areas of interest
to the institutes: www.niddk.nih.gov/fund/fund.htm and
www.nci.nih.gov/research_programs/priorities/.
The O"Brien Research Center must be an identifiable unit within a single
university medical center, or within a consortium of cooperating institutions
with a university affiliation. The original intent of the O"Brien Research
Centers was to bring together investigators from relevant disciplines in a
manner that would enhance and extend the effectiveness of research related to
the urological disease and its complications. More recently the overall goal
of the O"Brien Urology Research Center has been expanded to bring together, in
a cooperative, multidisciplinary and integrative manner, basic science and
clinical investigators to enrich the effectiveness of research into causes,
treatment and cure of the many urological diseases which fall within the
purview of the NIDDK.
For this purpose the center director should clearly define criteria that is
used to select an investigator as a center grant participant. The O"Brien
Urology Research Center must also address the scientific information base and
provide focal points for sustaining and maintaining state-of-the-art research
that will contribute to improved detection, diagnosis, treatment and
prevention of the urological diseases and disorders. These centers are
expected to conduct a wide spectrum of research activities that will
contribute significantly to the development of specialized research resources,
the development of improved research model systems and the expansion of the
research base through collaborative research with scientists and clinicians in
other institutions locally and nationwide.
Interrelated, basic research subprojects, each with high scientific merit and
clear research objectives have been the hallmarks of the O"Brien Urology
Research Centers program. In the aggregate, the subprojects should continue
to be directed to the development of fundamental knowledge leading to the
understanding of urological disease processes and the design of curative or
preventive strategies. However, a new dimension to the centers program is
the requirement to include Research Development/Pilot and Feasibility (P&F)
project(s) as integral components of the centers concept (described below).
Core facilities that will benefit the overall centers program are likely
components of a center (described below).
Core Facilities
Core facilities in an O"Brien Urology Research Center are shared resources
that enhance productivity or in other ways benefit a group of investigators
working to accomplish the stated goals of the center. Cores should be
designed to furnish a group of investigators with a specific technique,
service, determination, or instrumentation in a manner that will enhance the
research in progress, consolidate manpower effort, and contribute to cost-
effectiveness by providing a service at lower cost and possibly higher quality
than if each investigator were to attempt the same activity individually.
Cores may be proposed in relation to any acceptable research activity of the
center, but usually fall into one of four categories: (l) provision of a
technology that lends itself to automation or preparation in large batches
(e.g., radioimmunoassay and tissue culture), (2) complex instrumentation
(e.g., electron microscopy or mass spectrometry), (3) animal preparation and
care, and (4) technical assistance and training (e.g., molecular biology).
Examples of possible core resources that would be considered within the scope
of this request for applications include the following:
o Molecular biology core to supply oligonucleotides and provide automated
DNA sequencing capability,
o Animal models core to develop, breed, and maintain animal models for
diseases of interest, which can be used to improve understanding of the
human forms of the disease,
o Tissue culture core for the harvest, cultivation, and handling of large
numbers of cells,
o Other cores needed to characterize gene transfer systems.
These cores are not listed in any particular order, nor should they be
construed to represent a comprehensive list of cores that could be fostered
under this program.
The establishment of and continued support for biomedical research cores
within an O"Brien Urology Research Center must be justified on the basis of
use by Center investigators. The minimum requirement is significant usage by
two or more principal investigators each with a Center project. A director
must be named for each core. The organization and proposed mode of operation
of each core should be described, with a plan for prioritizing investigator
use of the core as well as the criteria for determining core users or
potential users.
Each core must have in place a procedure to evaluate efficiency and to
maintain appropriate quality control. Limited developmental research is an
additional appropriate function of a core facility, so long as the research is
related directly to enhancing the function or utility of the core and is not
an undertaking that should be funded through other mechanisms. Teaching the
investigators and/or their staff members" new techniques and methodologies is
also an important function of the cores. The cores are not intended to
supplant investigator capabilities, rather, they are intended to enhance the
opportunities of investigators to learn and become proficient in the
technologies available through the core.
Developmental Research (DR)/Pilot and Feasibility (P&F) Projects
The DR/P&F program should provide modest support for innovative initiatives
with the potential to advance progress in understanding cellular and molecular
mechanisms that initiate or are involved in the progression of specific
urological diseases. This program is directed toward both
new/young and established investigators who wish to explore the feasibility of
a novel approach to a problem in this area. Investigators eligible for DR/P&F
funding fall into three general categories: (1) new investigators without
current or past NIH support as a principal investigator, and whose current or
previous support from other sources have been modest, (2) established
investigators with limited previous Urology research experience who wish to
apply their expertise to a problem in this area, and (3) established
urological investigators who propose testing innovative ideas that represent a
clear departure from their ongoing research directions. It is anticipated
that the majority of the recipients of DR/P&F funding will be from the first
category.
Each DR/P&F study award is intended to provide a modest amount of support, not
to exceed $60,000 direct costs/year, for duration not to exceed two years,
which will allow an investigator the opportunity to develop sufficient
preliminary data to provide the basis for an application for independent
research support. DR/P&F study support is not intended for large projects by
established investigators, which otherwise would be submitted as separate
research grant applications. DR/P&F funds also are not intended to support or
supplement ongoing funded research of an investigator.
Each DR/P&F study proposal should state clearly the justification for
eligibility of the investigator under one of the above three criteria. A
proposed DR/P&F study should present a testable hypothesis and clearly
delineate the question being asked, detail the procedures to be followed, and
discuss how the data will be analyzed. The DR/P&F studies should be submitted
for review generally in the format of NIH research project applications (R01),
but with a 15-page limitation for the entire application.
The Administrative Core oversees the handling and implementation of any DR/P&F
program. Within this structure, each applicant institution must also establish
a mechanism to oversee the ongoing use of funds for the proposed DR/P&F
program. This mechanism must include the use of appropriate consultants
(described below) for review from the scientific community external to the
center. These same consultants may, if desired, review and assess other
activities of the center and may constitute the external advisory group to the
center. The external advisory committee need not be named in advance of the
application submission, only the mechanism for use of the proposed DR/P&F
program. The projects selected to receive these funds are to be described by
the Director in the DR/P&F section of the application.
Enrichment and Educational Program
The O"Brien Urology Research Center grant may budget for and provide limited
support for an optional enrichment program, whose description and budget may
also be included within the administrative core of the centers application.
It may provide support for visiting scientists, seminars, and research forums.
Limited travel support is allowable for center investigators to travel to
present scientific findings, learn new laboratory techniques, develop new
collaborations, or engage in scientific information exchange. In all cases,
the enrichment program should further the overall aims and objectives of the
center as well as of the scientific cores.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) P50 Specialized
Center award mechanism. This mechanism supports the full range of research
and development from basic to clinical and intervention studies. The
spectrum of activities comprises a multidisciplinary approach on a specific
urological disease process or biomedical problem. These grants differ from
traditional program project (P01) grants in that they are more complex and
flexible in terms of the activities that can be supported. In addition to
support for multidisciplinary research projects, support is also provided for
pilot research projects, specialized resources, and shared core facilities.
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. The total project period for
an application submitted in response to this RFA may not exceed five (5)
years. Awards will be administered under NIH grants policy as stated in the
NIH Grants Policy Statement.
Applicants from institutions which have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research. In
such a case, a letter of agreement from either the GCRC program director or
principal investigator should be included with the application.
This RFA is a one-time solicitation. The earliest anticipated award date is
July 1, 2003.
FUNDS AVAILABLE
The NIDDK and NCI intend to provide sufficient funds in FY 2003 to fund
five(5) new and/or competing continuation center grants in response to this
RFA. New or competing renewal O"Brien Urology Research Center applications
may request maximum annual direct costs of $750,000 (not to exceed $3.5
million for five years). For renewal applications, budgets requested for
research subprojects and core facilities are limited to 20% budget growth
over the most recent non-competing budget. Both new and renewal applications
must include budgets of $120,000 annually for Developmental Research/Pilot
and Feasibility (P&F) projects.
The direct cost cap of $750,000, however, can be exceeded by the Facilities
and Administrative (F&A) Costs (previously referred to as "indirect costs")
on consortia subcontracts to other participating institutions. The budgets
of these consortia subcontracts may include the regular cost-of-living
increases (currently 3% per year). Because the nature and scope of the
research proposed may vary, it is anticipated that the size of each award
will also vary. Although the financial plans of the NIDDK and NCI provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds in FY 2003 and the receipt of a sufficient number of
applications of outstanding scientific and technical merit.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic
To be considered eligible, applicant organizations must have: (1) a statement
of institutional commitment that addresses how the institution will
incorporate the O"Brien Urology Research Center high within its institutional
priorities, (2) research subprojects, representing a balance and diversity of
research approaches, (3) a qualified principal investigator who is a
scientific leader in the field, (4) developmental/Pilot & Feasibility
programs and (5) appropriate shared resources to support the proposed
research of the O"Brien Urology Research Center. Although an application must
be submitted by a single applicant institution, subcontracted collaborative
scientific arrangements with scientists from other institutions may be
included if these arrangements are clearly delineated, and formally and
officially confirmed by signed statements from the responsible officials of
each institution. However, a full institutional commitment must come from
the applicant institution.
Support will not be provided for applications with research activities
focused exclusively on basic research, or clinical research or trials, or
epidemiological research, or malignant diseases of the urinary tract.
NIDDK program staff listed under INQUIRIES should be consulted if there are
questions regarding any of the above eligibility requirements for exclusion.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs
SPECIAL REQUIREMENTS
Annual O"Brien Urology Research Center Workshop
O"Brien Urology Research Center investigators will likely be expected to
participate in an annual or biennial workshop, organized and convened by the
DKUHD-NIDDK, to share research experiences with other O"Brien Urology Research
Centers, assess progress, identify new research opportunities, share
materials, establish interactions and research priorities and collaborations
that will maximize the impact of the research on reducing incidence and
mortality, and improving survival of ESRD patients. Travel funds for the
Principal Investigator and selected O"Brien Urology Research Center
investigators and collaborators are to be budgeted for this purpose.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Leroy M. Nyberg, Jr., Ph.D.,M.D.
Director, Urology Programs
Division of Kidney, Urology, and Hematology
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 627
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
FAX: (301)480-3510
E-mail: ln10f@nih.gov
o Direct your questions about peer review issues to:
Francisco O Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301)480-3505
E-mail: fc15y@nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Helen Ling
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 732
Bethesda, MD 20892-5456
Telephone: (301) 594-8857
FAX: (301) 480-4237
E-mail: hl12d@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Division of Extramural Activities
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Division of Extramural Activities
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is received
after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIDDK in accordance with the review criteria stated below.
As part of the initial merit review, all applications will receive a written
critique and undergo a process in which only those applications deemed to
have the highest scientific merit, generally the top half of the applications
under review, will be discussed, assigned a priority score, and receive a
second level review by the National Diabetes and Digestive and Kidney
Diseases Advisory Council.
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the IC. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the (IC) in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Diabetes and Digestive and
Kidney Diseases Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Support will not be provided for applications with research activities
focused exclusively on basic research, or clinical research or trials, or
epidemiological research, or malignant diseases of the urinary tract.
Specific criteria to be used in the evaluation of grant applications are
listed below.
a. Individual Research Subprojects:
Within the O"Brien Urology Research Center concept of research to be
performed, reviewers will evaluate each research subproject using the five
criteria listed below. Each criterion will be addressed and considered by
the reviewers in assigning the overall score project merit:
a.1. Significance: The importance of the research objective to human
urological diseases and its likelihood of completion within the project
period. Do these studies address an important problem? If the aims of the
application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive this
field?
a.2. Approach: The adequacy of the experimental design and methods to
achieve the research objectives. Are the conceptual framework, design,
methods, and analyses adequately developed, well integrated, and appropriate
to the aims of the subproject? Does the applicant acknowledge potential
problem areas and consider alternative tactics?
a.3. Innovation: Originality and novelty of the experimental design as it
relates to the proposed research subproject. Does the project employ novel
concepts, approaches or methods? Are the aims original and innovative? Does
the research subproject challenge existing paradigms or develop new
methodologies or technologies?
a.4. Investigators: The qualifications of the investigators to conduct the
proposed research and the appropriateness of the time commitments of each
investigator to the conduct of the subproject. Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator
and other researchers (if any)?
a.5. Environment: The scientific environment in which the research work
will be done, and the unique features, if any, of the environment to support
the proposed work. Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
The scientific review group will also examine: the appropriateness of
proposed project budget and duration, the adequacy of plans to include both
genders and minorities and their subgroups, and children as appropriate for
the scientific goals of the research and plans for the recruitment and
retention of subjects, the provisions for the protection of human and animal
subjects, and the safety of the research environment.
b. Shared Resources (Cores)
b.1. adequacy of the proposed plan and/or track record to develop and
maintain appropriate cores and potential for the distribution of reagents,
tissues, transgenic animals within and outside the O"Brien Urology Research
Centers,
b.2. degree to which plans and/or track record indicate that shared resources
effectively and efficiently support (or will support) the research of the
O"Brien Urology Research Center in a manner that cannot be supported through
available national resources,
b.3. adequacy of the justification for each specialized resource relative to
its essential need for the conduct of O"Brien Urology Research Centers
subproject research or pilot projects and O"Brien collaborative subprojects,
b.4. adequacy of qualifications and performance (if applicable) of managers
of resources,
b.5. appropriateness of the requested budgets to conduct each resource
operation.
c. Developmental Research Program/Pilot & Feasibility (P&F) Projects
c.1. adequacy of the process for attracting new ideas for pilot studies
within and outside of the O"Brien Urology Research Center institution.
c.2. adequacy of the proposed process record for continuously reviewing and
funding a spectrum of pilot projects (e.g., research, technology development,
resources) for their quality and importance to research that will have an
impact on human urological diseases.
c.3. general quality of the pilot projects provided by the O"Brien Urology
Research Center to demonstrate the effectiveness of the process of funding
pilot projects,
c.4. established mechanism within the institution to solicit DR/P&F
applications and to oversee the use of funds for the proposed DR/P&F program.
c.5. appropriateness of the budget relative to the needs and demonstrated
capabilities of the O"Brien Urology Research Center.
d. Overall Program Organization and Capability:
d.1. scientific qualifications and involvement of the O"Brien Urology
Research Centers Principal Investigator, as well as his/her demonstrated
scientific and administrative leadership capabilities, adequacy of the time
commitment of the Principal Investigator,
d.2. adequacy of the planning and evaluation process to include: determining
research productivity of existing projects and resources, discontinuing
activities of low productivity, initiating new activities in response to
important research opportunities, establishing collaborations, and the use of
external advisors,
d.3. adequacy of access to patients and populations for conducting current
and projected therapeutic, prevention, detection and control research,
d.4. degree to which the organization and leadership of the O"Brien Urology
Research Center promote and facilitate scientific interactions between
subprojects, pilot projects, etc., and effective use of the O"Brien Urology
Research Center infrastructure (e.g., shared resources) in the conduct of
research,
d.5. effectiveness of and/or plans for promoting interdisciplinary
scientific interaction,
d.6. effectiveness of and/or plans for integrating O"Brien Center subproject
research and resources with existing O"Brien Urology Research Center programs,
d.7. adequacy of tangible institutional commitments that will enable and
facilitate the research objectives of the O"Brien Urology Research Center
(e.g., special facilities, recruitments, discretionary resources such as
dollars and space),
d.8. written assurance that O"Brien Urology Research Center interactions with
commercial entities will uphold the principles of academic freedom, including
the ability of the participating investigators to collaborate freely, and to
send and receive biomedical research materials without restriction to other
scientific researchers.
e. Interactions with other O"Brien Urology Research Centers
e.1. adequacy of plans (new application) or progress (competing renewal
applications) to promote and maintain communication and integration of
scientific subprojects of mutual interest with other O"Brien Urology Research
Centers,
e.2. willingness to interact with other O"Brien Urology Research Centers and
with the NIDDK in sharing information, in assessing scientific progress, in
identifying new research opportunities and in establishing scientific
priorities.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
subproject and P&F research proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 17, 2002
Application Receipt Date: November 19, 2002
Peer Review Date: March 2003
Council Review: May 2003
Earliest Anticipated Start Date: July 1, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html),
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.849 and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and
administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.