GEORGE M. O’BRIEN KIDNEY RESEARCH CENTERS

Release Date:  October 1, 2001

RFA:  RFA-DK-02-028

National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)

Letter of Intent Receipt Date:  May 21, 2002
Application Receipt Date:       June 19, 2002

PURPOSE

This Request for Applications (RFA) invites investigators to submit research 
applications for the George M. O'Brien Kidney 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 kidney 
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 kidney 
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, epidemiology, immunology and pathology.  In 
addition, appropriate expertise will likely include a focus into topical 
areas, such as diabetic nephropathy or other endocrine and metabolic 
disorders; hypertension in kidney disease; hereditary renal disease; 
immunologic renal disease; acute renal failure and nephrotoxic cell injury.

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.

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 Request for 
Applications (RFA), GEORGE M. O’BRIEN KIDNEY RESEARCH CENTERS, is related to 
the of priority area of Chronic Kidney Disease, Diabetes, Disability and 
Secondary Conditions and Educational and Community-Based Programs.  Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and nonprofit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government.  Foreign institutions are not eligible for P50 
grants.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators.

To be considered eligible, applicant organizations must have: (1) a statement 
of institutional commitment that addresses how the institution will 
incorporate the O’Brien Kidney 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 Kidney 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.

NIDDK program staff listed under INQUIRIES should be consulted if there are 
questions regarding any of the above eligibility requirements for exclusion.   

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 
kidney 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 
April 1, 2003.

FUNDS AVAILABLE

The NIDDK intends to provide sufficient funds in FY 2003 to fund three (3) 
new and/or competing continuation center grants in response to this RFA.  
Three competing continuation applications are anticipated in response to this 
RFA.  New or competing renewal O’Brien Kidney Research Center applications 
may request maximum annual direct costs of $700,000 (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 $700,000, 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 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. 

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 progression of renal disease 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.

Based on the most current data, derived from the 2000 Annual USRDS Data 
Report as of the end of 1999, 344,094 patients were being treated for end-
stage renal disease (ESRD) and 89,252 new patients began ESRD treatment in 
1999.  The incidence of ESRD continues to mount, and is projected to rise 
over 170,000 by 2010.  Minority populations suffer a disproportionate share 
of kidney disease, especially diabetes (most common reported cause of ESRD) 
and hypertension, and ESRD continues to be a disease that affects African 
Americans (32 percent of treated ESRD patients) and Native Americans at a 
rate 3 to 5 times greater than the rate of Caucasian Americans.  The medical, 
social, and financial implications of this disease continue to make ESRD a 
major public health and public policy problem.  ESRD patients account for 
less than 1 percent of all Medicare Beneficiaries, but accrue almost 6% of 
the program expenditures, $12.7 billion in 1999.  

There is no cure for chronic kidney disease, and progression to kidney 
failure for many may be slowed if the disease is diagnosed and managed early.  
With considerable progress already being made in understanding the basic 
physiology and pathophysiology of the normal and affected renal systems, 
further unraveling of the mechanisms of those processes that lead to 
progressive deterioration in the function of these systems “is a work in 
progress.”  Nevertheless, major advances have been made in the management of 
their clinical consequences.  For example, sustained and intensified research 
efforts have lead to the refinement of renal dialysis; improved vascular 
access techniques and increased allograft survival have steadily improved 
during the last decade.  Also, prior racial differences between African 
Americans and Caucasians in one-year patient and graft survival have 
disappeared.

Another common form of kidney disease, which affects an estimated 5 percent 
of hospitalized patients is acute renal failure (ARF), secondary to ischemia, 
which remains an important clinical problem.  When ARF requires hemodialysis, 
the mortality rate increases to more than 60 percent, and ARF-associated 
medical expenses are estimated at $8 billion per year.  Although important 
advances have been made in understanding ARF in animals, translating that 
knowledge from experimental models to humans is complicated by its 
heterogeneity, and consequently has fallen far short of expectant goals of 
impacting on the morbidity and mortality of this disease.  

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
supports through the Division of Kidney, Urologic and Hematologic Diseases 
(DKUHD) seven George M. O’Brien Kidney Research Centers, two Centers of 
Excellence in Pediatric Nephrology, and four Interdisciplinary Centers for 
Polycystic Kidney Disease Research.  These Centers are part of an integrated 
program of kidney-related research support within the NIDDK.  Centers have 
provided a focus for increasing the efficiency and collaborative effort among 
groups of successful investigators at institutions with established 
comprehensive kidney research bases.  

The Specialized Center (P50) and the O’Brien Kidney Research Center, in 
particular, 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 Kidney Research Centers was 
to bring together investigators from relevant disciplines in a manner that 
would enhance and extend the effectiveness of research related to kidney 
disease and its complications.  More recently the overall goal of the O’Brien 
Kidney 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 ESRD.
  
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 
Kidney 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 kidney disease.  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 Kidney 
Research Centers program.  In the aggregate, the subprojects should continue to 
be directed to the development of fundamental knowledge leading to the 
understanding of kidney 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 Kidney 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 Kidney 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 cause renal disease.  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 kidney research experience who wish to 
apply their expertise to a problem in this area; and (3) established renal 
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.  For new Center applications an 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 Kidney 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.  

SPECIAL REQUIREMENTS

Annual O’Brien Kidney Research Center Workshop
O’Brien Kidney 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 Kidney 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 Kidney Research Center 
investigators and collaborators are to be budgeted for this purpose.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which was published in the Federal Register of March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide For Grants and Contracts, Vol. 23, No. 
11, March 18, 1994, available on the web at:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants an Contracts, June 5, 
2000 (Revised August 25, 2000), and is available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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. Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this RFA 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.

LETTER OF INTENT 

Prospective applicants are asked to submit, by May 21, 2002, a letter of 
intent that includes a descriptive title of the proposed research; the name, 
address, and telephone number of the Principal Investigator; the identities 
of other key personnel and participating institutions; and the number and 
title of the RFA in response to which the application may be submitted.

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 NIDDK staff to estimate the potential review workload and 
plan the review.

The letter of intent is to be sent to:

Chief, Review Branch 
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Room 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD  20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants. This version of the PHS 398 is available in an 
interactive, searchable PDF format.  Beginning January 10, 2002, however, the 
NIH will return applications that are not submitted on the 5/2001 version.  
For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: 
GrantsInfo@nih.gov.

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: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
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 time of submission, two additional copies of the application must be sent 
to:

Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD  20892-5452
(for express/courier service: Bethesda, MD  20817)

Applications must be received by the application receipt date listed in the 
heading of the RFA.  If an application is received after that date, it will 
be returned to the applicant without review. Supplemental documents 
containing significant revision or additions will not be accepted, unless 
applicants are notified by the Scientific Review Administrator.  

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 previously reviewed, but such applications must 
include an Introduction addressing the previous critique.

REVIEW CONSIDERATIONS

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.

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.

Specific criteria to be used in the evaluation of grant applications are 
listed below.  

a.  Individual Research Subprojects:

Within the O’Brien Kidney 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 kidney 
disease 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 Kidney 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 Kidney 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 Kidney 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 Kidney 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 renal disease.

c.3.  general quality of the pilot projects provided by the O’Brien Kidney 
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. 
This mechanism must include the use of appropriate consultants for review 
from the scientific community external to the center.  

c.5.  appropriateness of the budget relative to the needs and demonstrated 
capabilities of the O’Brien Kidney Research Center.

d.  Overall Program Organization and Capability:

d.1.  scientific qualifications and involvement of the O’Brien Kidney 
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 Kidney 
Research Center promote and facilitate scientific interactions between 
subprojects, pilot projects, etc., and effective use of the O’Brien Kidney 
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 Kidney Research Center programs;

d.7.  adequacy of tangible institutional commitments that will enable and 
facilitate the research objectives of the O’Brien Kidney Research Center 
(e.g., special facilities, recruitments, discretionary resources such as 
dollars and space);

d.8. written assurance that O’Brien Kidney 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 Kidney 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 Kidney Research 
Centers;

e.2.  willingness to interact with other O’Brien Kidney Research Centers and 
with the NIDDK in sharing information, in assessing scientific progress, in 
identifying new research opportunities and in establishing  scientific 
priorities.

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  Adequacy of plans to include both genders, minorities and their subgroups, 
and children as appropriate for the scientific goals of the research.  Plans 
for the recruitment and retention of subjects will also be evaluated

o  The reasonableness of the proposed budget and duration to the proposed 
subproject research.

o  The adequacy of the proposed protection of humans, animals, or the 
environment, to the extent that they may be adversely affected by the 
subproject and P&F research proposed in the application.

o The adequacy of the proposed plan to share data.  

Schedule

Letter of Intent Receipt Date:    May 21, 2002
Application Receipt Date:         June 19, 2002
Peer Review Date:                 October-November, 2002
Council Review:                   February 19-20, 2003
Earliest Anticipated Start Date:  April 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.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

M. James Scherbenske, Ph.D., 
Renal Physiology/Cell Biology and 
  Kidney Centers and SBIR Program Director
Division of Kidney, Urology, and Hematology
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 613
Bethesda, MD  20892-5458
Telephone:  (301) 594-7719
FAX:  (301)480-3510 
E-mail:  js255f@nih.gov

Direct inquiries regarding fiscal matters to:

Mrs. Mary K. Rosenberg 
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Blvd, Room 722
Bethesda, MD  20892-5456
Telephone:  (301) 594-8891
FAX:  (301) 480-3504
E-Mail:  mr239s@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.849.  Awards are under authorization of the Public Health Service Act, 
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 
241 and 285) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.   This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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