SECONDARY ANALYSES IN DIABETES, DIGESTIVE AND KIDNEY DISEASES

Release Date:  March 11, 2002

PA NUMBER:  PA-02-077 (This PA has been modified, see PA-05-094)

EXPIRATION DATE:  June 2, 2005, unless reissued.

National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK)  
  (www.niddk.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) invites applications to support the secondary analysis of 
existing data sets relevant to diabetes and endocrine and metabolic 
diseases, digestive diseases and nutrition, including obesity and 
eating disorders, and kidney, urological, and hematological diseases.  
The goal of this NIDDK program is to facilitate performance of short 
term projects that explore innovative approaches that are not readily 
supported by other funding mechanisms and that can be conducted using 
existing data sets.

RESEARCH OBJECTIVES

The specific objectives of this announcement on Secondary Analyses In 
Diabetes, Digestive And Kidney Diseases are to support the following: 
(a) research on secondary analyses of data related to the epidemiology 
of disease areas of NIDDK, (b) preliminary projects using secondary 
analysis that could lead to subsequent applications for individual 
research awards, (c) rapid analyses of new databases and experimental 
modules to inform the design and content of future studies, (d) the 
archiving of datasets to be made publicly available for research 
purposes related to diseases areas of NIDDK, including both 
epidemiological studies and multi-center clinical trials.  

Research that employs analytic techniques that demonstrate or promote 
methodological advances in patient oriented and epidemiologic research 
is also of interest.  International comparative analyses are 
encouraged.  Applications that are innovative and high risk with the 
likelihood for high impact would be especially encouraged.  

Background

Patient oriented and epidemiologic research projects, particularly 
multi-center projects, typically generate data with potential utility 
beyond the specific hypotheses and questions for which they were 
designed. Often data are not fully analyzed, especially when unexpected 
research questions emerge after the end of the project"s funding 
period. Analyzing such existing data sets can therefore provide a cost-
effective means to test specific hypotheses that have not been 
adequately examined. The further analysis of existing research data may 
also be prompted by a need to confirm new findings or to aid in the 
development of new research questions.  

Applicants may conduct secondary analyses using data from a variety of 
sources.  These would include investigator-initiated research 
activities, cooperative agreements, and contracts or from other public 
or private sources. Sources may be large, nationally representative 
data sets such as those of the National Center for Health Statistics or 
smaller, regional or locally based data sets. Also appropriate for 
secondary analyses are relevant cross-sectional and longitudinal survey 
data collected by Federal, State, and local government agencies. 
Secondary data analyses of these data may serve as an economical 
alternative to expensive and time-consuming new data collection 
projects.  Applicants may also secure access to other data sets that 
may or may not be in the public domain, such as those collected under 
research grant funds, sponsored by private entities, or originally 
collected for purposes other than research, such as health care 
administrative datasets.

In addition to the examination of specific research hypotheses, 
existing data sets may also be used to cross-validate exploratory 
analyses in ongoing studies, to test complex statistical models, and in 
special circumstances to provide comparison groups for experimental 
studies.  Meta-analysis, in which results from multiple studies may be 
compared or combined, is considered to be a form of secondary data 
analysis for the purpose of this program announcement.  Moreover, 
secondary analysis is appropriate for many types of data, including 
qualitative information, and may also cover the integration of 
quantitative and qualitative data.

The specific subject areas are restricted to those on which NIDDK 
conducts research, which include diabetes and endocrine and metabolic 
diseases, digestive diseases and nutritional disorders, including 
obesity and eating disorders, and kidney, urological, and hematological 
diseases.  All data analyses must concern patient oriented or 
epidemiologic research designed to elucidate the etiology, incidence, 
prevalence, natural history, pathophysiology, or response to therapy of 
the above mentioned disorders. 

Support for the creation of publicly archived data sets would be for 
information that could be applied to the subject areas of interest.  
Plans for archiving must include adequate dataset documentation and 
explanation so that it can be used by researchers not associated with 
the original study.  Provision for easy accessibility of archived 
datasets is required.

MECHANISM OF SUPPORT

This PA will use the NIH R21 award mechanism. 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 PA may not exceed two years. 
Exploratory/developmental grants (R21) are limited to 2 years and 
$100,000 per year in direct costs.  Facilities and Administrative (F&A) 
costs will be awarded based on the negotiated rate at the time of the 
award. 

The grants cannot be renewed, however, a no-cost extension of up to one 
year may be granted prior to expiration of the project period. 
Investigators are encouraged to seek continued support after completing 
an exploratory/developmental grant project through a research project 
grant (R01).

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (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.

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

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. Investigators new to 
diabetes and digestive and kidney diseases are encouraged to apply. 
Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are encouraged to apply for NIH programs.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
two areas:  scientific/research, and financial or grants management 
issues.

o Direct inquiries regarding programmatic issues in digestive diseases 
and nutrition to:

James E.Everhart, MD, MPH
Chief, Epidemiology and Clinical Trials Branch
Division of Digestive Diseases and Nutrition
2 Democracy Plaza, Room 655
6707 Democracy Boulevard, MSC 5450
Bethesda MD 20892-5450
Telephone:  (301) 594-8878
Fax: (301) 480-8300
E-mail:  [email protected]

o Direct inquiries regarding programmatic issues in diabetes, 
endocrinology, and metabolism to:

Catherine C. Cowie, PhD
Director, Type 1 Diabetes Clinical Trials Program
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 691
6707 Democracy Boulevard, MSC 5460
Bethesda, MD  20892-5460
Telephone:  (301) 594-8804
Fax:  (301) 480-3503
E-mail:  [email protected]

o Direct inquiries regarding programmatic issues in kidney, urological, 
and hematological diseases to:

Paul W. Eggers, PhD
Program Director
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 615
6707 Democracy Boulevard, MSC 5458
Bethesda, MD  20892-5458
Telephone:  (301) 594-8305
Fax:  (301) 480-3510
E-mail:  [email protected]

o Direct inquiries regarding fiscal matters to:

Ms. Kathleen J. Shino
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 708
6707 Democracy Boulevard, MSC 5456
Bethesda, MD  20892-5456
Telephone:  (301) 594-8869
Fax:  (301) 594-9523
E-mail: [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].

SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS

All application instructions outlined in the PHS 398 application kit 
are to be followed, with the following requirements for R21 
applications:  

1.  R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" 
concepts, with direct costs requested in $25,000 modules, up to the 
total direct costs limit of $100,000 per year. 

2. Although preliminary data are not required for an R21 application, 
they may be included.

3.  Sections a-d of the Research Plan of the R21 application may not 
exceed 15 pages, including tables and figures.  

4.  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 assigned reviewers of the 
application and  will not be reproduced for wider distribution. The 
following materials may be included in the appendix:

o Up to 10 manuscripts, 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 also be stapled as sets.
O Original glossy photographs or color images of gels, micrographs, 
etc., provided that a photocopy (may be reduced in size) 

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 are 
restricted to $100,000 per year in direct costs and 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 five 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)

APPLICATION PROCESSING: Applications must be received by/or 
(postmarked) or mailed 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 PA 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.

PEER REVIEW PROCESS 

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.  

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 appropriate national advisory 
council or board

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

(1) Significance:  Does this study address an important problem?  If 
the aims of your 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?

(2) Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Do you acknowledge potential problem areas and 
consider alternative tactics? 

(3) Innovation: Does the project employ novel concepts, approaches or 
method? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies? 

(4) Investigator: Are you appropriately trained and well-suited to 
carry out this work? Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)? 

(5) Environment: Does the scientific environment in which your 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 address and consider each of these 
criteria in assigning your application"s overall score, weighting them 
as appropriate for each application. Your 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. 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

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)

DATA SHARING:  The adequacy of the proposed plan to share data

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

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 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 is 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," 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_20
01.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

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 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 the following website: 
http://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:
http://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.

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.

HEALTHY PEOPLE 2010

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 PA 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. 93.847, 93.848, and 93.849.  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 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, and 
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.
See comment 3
 
The PHS 398 specifies up to 10 manuscripts.

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