and Human Services (HHS)
EXPIRED
RESEARCH GRANTS FOR CLINICAL STUDIES OF KIDNEY DISEASES
RELEASE DATE: April 15, 2003 (see correction NOT-DK-03-005)
(see reissuance PAR-04-065)
PA NUMBER: PAR-03-105
EXPIRATION DATE: After March 18, 2004, unless reissued.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
APPLICATION RECEIPT DATES: July 18, 2003; March 18, 2004
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.849
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAR
The Division of Kidney, Urologic, and Hematologic Diseases of the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a
longstanding and substantial interest in research concerning the prevention
and treatment of kidney disorders. This program announcement (PAR)
specifically encourages the submission of applications for pilot and
feasibility studies, clinical trials, and epidemiological studies related to
kidney disease research that are particularly innovative and/or potentially
of high impact. It is anticipated that applications for pilot and feasibility
studies may lead to full-scale clinical trials in the prevention, diagnosis
or treatment of kidney disease.
These grants may be used for trials that evaluate pharmacological, dietary,
surgical, or behavioral interventions for the prevention or treatment of
kidney disease. In view of the extent and severity of various co-morbidities
(i.e., cardiovascular disease, infections, and depression) observed in
patients with kidney disease, these grants may also assess interventions that
prevent or treat co-morbid conditions in the setting of renal disease. Pilot
epidemiological studies are also encouraged, especially related to kidney
disease, or co-morbid condition, prevention. It is anticipated that these
grants will in some cases serve as a basis of planning future multi-center
research project grant applications (R01) or for cooperative agreement (U01)
awards. Both new and experienced investigators in relevant fields and
disciplines are encouraged to apply for these grants.
RESEARCH OBJECTIVES
Background
Recent estimates of chronic kidney disease (CKD) in the US population,
obtained through analysis of the Third National Health and Nutrition
Examination Survey (NHANES III), indicate that it is a common medical problem
with an estimated prevalence of 11% in the adult US population. Most cases
of CKD observed in the US occur in the setting of diabetes, hypertension,
glomerulonephritis and polycystic kidney disease. With an increasing
incidence of CKD, the incidence of end-stage renal disease (ESRD) has also
been steadily increasing in the adult US population. US Renal Data System
(USRDS) data indicate that from 1992 2000 the number of patients with ESRD
has increased from 220 to 334 per million population. These increases in CKD
and ESRD rates reflect a marked increase in patient morbidity and mortality
related to underlying kidney disease, as well as a significant increase in
utilization of health care resources to provide appropriate care for affected
patients. The increasing rate of ESRD has also markedly increased waiting
time for cadaveric transplantation such that the rate of kidney transplants
per patient year on dialysis has steadily declined over the last decade.
Similarly, USRDS data indicate that the rates of the primary causes of CKD in
pediatric patients have increased over the last two decades. This increase
has been most evident in the near doubling of the incidence of
glomerulonephritis in African American children and children of other non-
Caucasian races. Rates of cystic, hereditary, and congenital diseases in all
racial groups have also almost doubled during this time period.
Acute renal failure in hospitalized patients is also a significant problem in
the US, ranging from 1-15% of hospitalized patients. Medical management of
acute renal failure has traditionally consisted of supportive care, with
renal replacement therapy implemented for the most severe cases. Despite
such interventions in acute renal failure, however, mortality rates in
affected patients remain very high (>50% in some series).
In view of these observations suggesting a marked and progressive increase in
CKD and ESRD in the US population, NIDDK has sponsored a number of large,
multi-center studies of specific kidney disorders. These studies include
prospective investigations in chronic kidney disease, dialysis access,
polycystic kidney disease, focal and segmental glomerulosclerosis, and acute
renal failure. In planning and performing these studies, however, it has
been apparent that the process for identifying appropriate interventions for
multi-center trials in kidney disease could be improved. This is
particularly evident in the current small number of clinical studies related
to kidney disease that could ultimately be expanded to large-scale clinical
trials.
The goal of this PAR is to provide flexibility for initiating preliminary,
short-term studies, thus allowing new ideas to be investigated in a more
expeditious manner without stringent requirements for preliminary data.
Additionally this PAR could facilitate Phase II clinical trials for projects
in which satisfactory preliminary data has been collected. Such support is
needed to encourage experienced investigators as well as new investigators to
pursue new approaches, underdeveloped topics, or more risky avenues of
research. If successful, these awards should lead to significant scientific
advances in the treatment of kidney diseases.
As kidney disease occurs in variety of clinical settings, and is associated
with a number of co-morbid conditions, it is anticipated that applications
submitted in response to this PAR could address a number of different aspects
concerning the prevention, diagnosis, or treatment of kidney disease.
Relevant topics of study evaluating kidney disease in adults or children
could include (but are not limited to):
o Prevention, diagnosis, or therapy of chronic kidney disease, (and disease
progression) including studies of diabetic nephropathy, hypertensive
nephrosclerosis, polycystic kidney disease, or chronic allograft nephropathy;
o Studies assessing dialysis therapy, dialysis access, anemia of renal
disease, and nutritional or cardiovascular aspects of ESRD;
o Prevention, diagnosis, or therapy of glomerular disease, either idiopathic
or secondary glomerular involvement in a systemic process;
o Prevention, diagnosis, or therapy of acute renal failure, including that
observed following renal transplantation;
o Prevention, diagnosis, or therapy of co-morbid conditions associated with
reduced kidney function;
o Epidemiologic studies focusing on patients with reduced kidney function.
MECHANISM(S) OF SUPPORT
Support for this program will be through the NIH Exploratory/Development
Research Grant (R21), the Exploratory/Development Research Grant Phase 2
(R33), and the Phased Innovation Award (R21/R33 combined). The R33 is a newly
established NIH grant mechanism to provide a second phase for the support of
innovative exploratory and development research initiated under the R21
mechanism. Under the Phased Innovation Award (R21/R33), transition of the R21
to the R33 phase will be expedited and is dependent on completion of
negotiated milestones.
This PAR uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. Otherwise follow the instructions for non-
modular research grant applications.
Specific features of the Phased Innovation Award Mechanism (R21/33 Combined)
include:
o Single submission and evaluation of both a feasibility/pilot phase (R21) and
an expanded development phase (R33) as one application.
o Expedited transition of the R21 feasibility phase to an R33 development
phase. The award of the R33 funds will be based on program priorities, the
availability of funds and the successful completion of negotiated scientific
milestones as determined by program staff in the context of peer review
recommendations.
o Flexible budgets.
o Flexible staging of feasibility and development phases.
The use of the multiple mechanisms will allow projects to be submitted at
various stages of development. The R21 will provide support for projects in
early stages of development where there is little or no preliminary data
available and it is difficult to predict success sufficiently to develop an
extended R33 phase. The R33 will provide support for projects in which
feasibility has been demonstrated and thus are ready for extended development.
The combined R21/R33 will provide support for projects that require
feasibility demonstration, and the aims and milestones of the R21 are
sufficiently predictable to consider the extended R33 phase.
Responsibility for the planning, direction and execution of the proposed
research project will be solely that of the applicant. Except as otherwise
stated in this PAR, awards will be administered under the NIH grants policy as
stated in the NIH Grants Policy Statement, March 2001, available from the
internet only at http://grants.nih.gov/grants/policy/nihgps_2001/.
Under this PAR, applicants may submit either an R21 application, a combined
R21/R33 application (Phased Innovation Award application) or the R33
application alone, if feasibility can be documented, as described in the
SUBMITTING AN APPLICATION section of this PAR. The total project period for
an application in response to this PAR may not exceed the following durations:
2 years for the R21 phase; 5 years for the R33 phase; 5 years for a combined
R21/R33 proposal. In the combined application, the R21 phase may not extend
beyond 2 years. These awards are not renewable.
For R21 and combined R21/R33 applications, the R21 phase may not exceed
$275,000 direct costs for two years. R21 budgets can exceed this cap to
accommodate F&A costs to subcontracts to the project, in which case a non-
modular budget format must be used. R33 applications up to $500,000 may be
submitted with thorough budgetary justification. It is strongly recommended
that applicants contact institute staff at an early stage of application
development to convey critical information, such as potentially large budget
requests or to discuss programmatic responsiveness of the proposed project.
Early contact with institute staff is particularly critical relative to this
PAR because it uses a new grant mechanism (R33). Refer to the WHERE TO SEND
INQUIRIES section of this PAR for institute staff contacts.
To be eligible for the Phased Innovation Award, the R21 phase must include
well-defined quantifiable milestones that will be used to judge the progress
and success of the proposed research, as well as a credible plan for the R33
phase. The Phased Innovation Award must have a section labeled Milestones at
the end of the Research Plan of the R21 application. This section must
include well-defined quantifiable milestones for the completion of the R21
portion of the application, a discussion of the suitability of the proposed
milestones for assessing the success in the R21 phase, and a discussion of the
implications of successful completion of the milestones for the proposed R33
study.
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.
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 or foreign
o Faith-based or community-based organizations
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
The NIH is interested in ensuring that the research resources developed
through this PAR become readily available to the research community for
further research, development, and application. It is the expectation that
this sharing will lead to beneficial knowledge for patients with kidney
disease. Data sharing will also allow more effective use of NIH resources by
avoiding unnecessary duplication of data collection, and thereby facilitate
the support of a larger number of research projects.
For the combined R21/R33 applications and the R33 applications submitted in
response to the PAR, a paragraph describing a data sharing plan should be
included at the end of the Research Plan section. This paragraph should
describe the procedures that will be implemented for data sharing, and
provide a timeline for making the data available to the general research
community. As the rights and privacy of subjects who participate in NIH-
sponsored research must be protected at all times, data sharing plans for
human studies should discuss how the rights and confidentiality of
participants will be protected. Data intended for broader use should be free
of identifiers that would permit linkages to the research participants and
stripped of variables that could lead to deductive identification of
individual participants. Costs associated with data sharing can be included
in the budget section of the application.
The scientific review group will evaluate the adequacy of the proposed plan
for sharing and data access. Comments on the plan and any concerns will be
presented in an administrative note in the Summary Statement.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAR 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:
Catherine M. Meyers, M.D.
Inflammatory Kidney Diseases Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 641
Bethesda, MD 20892-5458
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: [email protected]
o Direct your questions about peer review issues to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Blvd., Room 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817
Telephone: (301) 594-8897
FAX: (310) 480-3505
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Aretina Perry-Jones
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 745 MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8862
FAX: (301) 480-3504
Email: [email protected]
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
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS:
SPECIFIC INSTRUCTIONS FOR PREPARING THE COMBINED R21/R33 PHASED INNOVATION
AWARD APPLICATION:
The R21/R33 application must include the specific aims for each phase and
clear measurable goals (milestones) that would demonstrate feasibility and
justify transition to the R33 phase. Applications must include a specific
section labeled Milestones following the Research Plan of the R21 phase.
Milestones should be well described, quantifiable and scientifically justified
and not simply a restatement of the specific aims. A discussion of the
milestones relative to the progress of the R21 phase, as well as, the
implications of successful completion of the milestones for the R33 phase
should be included. This section should be indicated in the Table of Contents.
Applications lacking this information, as determined by the NIH program staff,
will be returned to the applicant without review. For funded applications,
completion of the R21 milestones will elicit an NIH expedited review that will
determine whether or not the R33 should be awarded. The release of R33 funds
will be based on successful completion of negotiated scientific milestones,
program priorities, and on the availability of funds. The expedited review may
result in additional negotiations of award.
The R21/R33 combined applications must be submitted as a single application,
with one face page. Although it is submitted as a single application, it
should be clearly organized into two phases. To accomplish a clear
distinction between the two phases, applicants are directed to complete
Sections a-d of the Research Plan twice: one write-up of Sections a-d and
milestones for the R21 phase and sections a-d again for the R33 phase. The
Form 398 Table of Contents should be modified to show sections a-d for each
phase as well as the milestones. There is a page limit of 25 pages for the
composite a-d text of all applications (i.e., section a-d and milestones for
the R21 phase plus sections a-d for the R33 phase must be contained within the
25 page limit for R21/R33 applications.)
In preparing the R21/R33 application, investigators should consider the fact
that applications will be assigned a single priority score. In addition, as
discussed in the REVIEW CONSIDERATIONS section, the initial review panel has
the option of recommending only the R21 phase for support. The clarity and
completeness of the R21/R33 application with regard to specific goals and
feasibility milestones for each phase are therefore critical.
1. Face Page of the application:
Item 2. Check the box marked "YES" and type the number and title of this
PAR. Also indicate that the application is submitted as an R21/R33.
Item 7a, DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT:
For the R21 phase of the combined R21/R33 application, direct costs are
limited to a maximum of $275,000 over two years and the award may not be used
to supplement an ongoing project. The requested budgets can exceed this cap
to accommodate for F&A costs to subcontracts to the project. Insert the first
year of R21 support in item 7a.
Item 8a, DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT:
For the R21 phase of the combined R21/R33 application, direct costs requested
for the proposed period may not exceed $275,000 for two years of support. The
statement in item 7a above pertaining to subcontract costs also applies here.
Insert sum of all years of requested support in item 8a
2. Page 2 - Description:
As part of the description, identify concisely the research team, the
fundamental research to be performed, its innovative nature, its relationship
to presently available knowledge or capabilities, and its expected impact on
the diagnosis, treatment or prevention of kidney disease or its complications.
3. Budget:
The application should provide a DETAILED BUDGET for Initial Budget Period
(form page 4), for each of the initial years of the R21 and R33 phases as well
as a budget for the entire proposed period of support (form page 5). Form
pages should indicate which years are R21 and R33. All budgets should include
a justification for each item requested.
4. Research Plan:
Item a, Specific Aims:
The applicants must present specific aims that the applicant considers to be
scientifically appropriate for the relevant phases of the project. The
instructions in the PHS 398 booklet for this section of research grant
applications suggest that the applicant state the hypotheses to be tested.
Furthermore for the R21 phase, preliminary data are not required, although
they should be included when available.
Item b, Background and Significance:
Elaborate on the innovative nature of the proposed research. Clarify how the
research as proposed in this project will result in a significant improvement
over existing approaches. Explain the potential of the proposed studies for
having a broad impact on a compelling area of kidney disease research. Clearly
identify how the project, if successful, would result in new capabilities for
the treatment, diagnosis, or prevention of kidney disease or its
complications.
Item c, Preliminary Studies/Progress Report:
While preliminary data are not required for the submission of the R21 phase,
this section should provide current thinking or evidence in the field to
substantiate the feasibility of the R33 phase. If limited relevant
preliminary data are available that would aid the review, they should be
described in this section. The R33 phase of the application need not repeat
information already provided in the R21 phase.
Item d, Research Design and Methods:
Follow the instructions in the PHS 398 booklet. In addition, for the R21
phase of combined R21/R33 applications only, the following information must be
included as a final section of Item d:
Applications must include a specific section labeled Milestones following the
Research Design and Methods of the R21 phase. Milestones should be well
described, quantifiable, and scientifically justified. The milestones should
not be a reiteration of the Specific Aims of the research project, but should
be tangible accomplishments. A discussion of the milestones relative to the
success of the R21 phase, as well as the implications of successful completion
of the milestones for the R33 phase and the page number of the milestones
section should be listed. This section should be indicated in the Table of
Contents.
Applications lacking this information, as determined by the Institute program
staff, will be returned to the applicant without review. For funded
applications, completion of the R21 milestones will elicit an Institute
expedited review that will determine whether or not the R33 should be awarded.
The release of R33 funds will be based on successful completion of milestones,
program priorities and on the availability of funds. The expedited review may
result in additional negotiations of award.
A paragraph describing a data sharing plan should be included at the end of
the Research Plan section of the R33 phase of the application, as described in
SPECIAL REQUIREMENTS.
SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R21 APPLICATION WHEN SUBMITTED
WITHOUT THE R33 PHASE.
MODULAR GRANT APPLICATION: R21 applications submitted without the R33 Phase
should be submitted in a modular grant format, unless exceeding the $275,000
two-year budgetary cap in order to accommodate F&A costs to subcontracts to
the project. The total project period for an R21 application may not exceed
two years. The modular grant format simplifies the preparation of the budget
in these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
1. Face page of the application:
Item 2. Check the box marked "YES" and type the number of this PAR. Also
indicate that the application is for an R21.
2. Page 2, Description:
As part of the description, identify concisely the research team, the
fundamental research to be performed, its innovative nature, its relationship
to presently available knowledge or capabilities, and its expected impact on
the diagnosis, treatment or prevention of kidney disease or its complications.
3. Research Plan:
Sections a d of the Research Plan of the R21 application may not exceed 15
pages, including tables and figures.
Item a, Specific Aims:
The applicants must present specific aims that the applicant considers to be
scientifically appropriate for the relevant phases of the project. The
instructions in the PHS 398 booklet for this section of research grant
applications suggest that the applicant state the hypotheses to be tested.
Furthermore for the R21 phase, preliminary data are not required, although
they should be included when available.
Item b, Background and Significance:
Elaborate on the innovative nature of the proposed research. Clarify how the
research as proposed in this project will result in a significant improvement
over existing approaches. Explain the potential of the proposed studies for
having a broad impact on a kidney disease research. Clearly identify how the
project, if successful, would result in new capabilities for the treatment and
prevention of kidney disease or its complications.
Item c, Preliminary Studies/Progress Report:
R21 applications should provide current thinking or evidence in the field to
support the project. If limited relevant preliminary data are available that
would aid the review, however, they should be described in this section.
Item d, Research Design and Methods:
Instructions for PHS 398 should be followed.
R21 appendix materials should be limited, as is consistent with the
exploratory nature of the R21 mechanism, and should not be used to circumvent
the page limit for the Research Plan. Copies of appendix material will only
be provided to the primary reviewers of the application and will not be
reproduced for wider distribution. The following materials may be included in
the appendix:
o Up to five publications, including manuscripts (submitted or accepted for
publication), abstracts, patents, or other printed materials directly relevant
to the project. These may be stapled as sets.
o Surveys, questionnaires, data collection instruments, and clinical
protocols. These may be stapled as sets.
o Original glossy photographs or color images of gels, micrographs, etc.,
provided that a photocopy (may be reduced in size), is also included within
the 15-page limit of items a d of the Research Plan.
SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R33 APPLICATION WHEN SUBMITTED
WITHOUT THE R21 PHASE.
Applications for R33 grants are to be prepared according to the instructions
provided in the PHS 398 booklet unless specified otherwise within items 1-4
below.
1. Face Page of the application:
Item 2. Check the box marked "YES" and type the number and title of this PAR.
Also, indicate that the application is for an R33.
2. Page 2 - Description:
As part of the description, identify concisely the research team, the
fundamental research to be performed, its innovative nature, its relationship
to presently available knowledge or capabilities, and its expected impact on
the diagnosis, treatment or prevention of kidney disease or its complications.
3. Budget:
The application should provide a DETAILED BUDGET for the Initial Budget Period
(form page 4) as well as a budget for the entire proposed period of support
(form page 5). Budget should include a justification of all items requested.
4. Research Plan:
Sections a d of the Research Plan of the R33 application may not exceed 25
pages, including tables and figures.
Item a, Specific Aims:
The instructions in the PHS 398 booklet for this section of research grant
applications suggest that the applicant state the hypotheses to be tested.
Item b, Background and Significance:
Elaborate on the innovative nature of the proposed research. Clarify how the
research as proposed in this project will result in a significant improvement
over existing approaches. Explain the potential of the proposed studies for
having a broad impact on kidney disease research. Clearly identify how the
project, if successful, would result in new capabilities for the diagnosis,
treatment or prevention of kidney disease or its complications.
Item c, Preliminary Studies/Progress Report:
This section must document that feasibility studies have been completed, and
progress achieved, equivalent to that expected through the support of an R21
project. The application must clearly describe how the
exploratory/developmental study is ready to scale up to an expanded
development stage. In the event that an applicant feels that some aspect of
the approach to be developed is too proprietary to disclose, applicants at a
minimum should provide a demonstration (results) of the capabilities of the
proposed approach, tool or technology.
Item d, Research Design and Methods:
Follow the instructions in the PHS 398 booklet. A paragraph describing a data
sharing plan should be included at the end of the Research Plan section of the
R33 application, as described in SPECIAL REQUIREMENTS.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
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
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies (5) of the appendix material must be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PAR 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 a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to this PAR 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:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of 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:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application. 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.
SIGNIFICANCE: Does this study 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?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator 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)?
ENVIRONMENT: 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?
SPECIAL REVIEW CONSIDERATIONS FOR R21 APPLICATIONS: Because the research
plan is limited to 15 pages, an exploratory/development grant application
need not have background material or preliminary information as one might
normally expect in an R01 application. Accordingly, reviewers should focus
their evaluation on the conceptual framework, the level of innovation, and
the potential to significantly advance our knowledge or understanding.
Reviewers should place less emphasis on methodological details and certain
indicators traditionally used in evaluating the scientific merit of the R01
applications including supportive preliminary data. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or, when available, from investigator-
generated data. Preliminary data are not required for R21 applications.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data for the
combined R21/R33 and the R33 applications submitted in response to this PAR.
This evaluation will be presented in an administrative note in the Summary
Statement, and will not factor into the numerical score.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research. This evaluation will be
presented in an administrative note in the Summary Statement, and will not
factor into the numerical score.
AWARD CRITERIA
Applications submitted in response to a PAR will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 "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 (http://grants.nih.gov/grants/guide/notice-files/NOT-
OD-02-001.html; a complete copy of the updated Guidelines are available at
http://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
http://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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
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 PAR 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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
PAR 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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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