and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH) (http:/www.nih.gov)
Components
of Participating Organizations
National Institutes of Diabetes and Digestive and Kidney
Diseases (NIDDK) (http:/www.niddk.nih.gov)
National Institutes of Allergy and
Infectious Diseases (NIAID) (http:/www.niaid.nih.gov)
Title: Limited Competition: The Environmental Determinants of
Diabetes in the Youth (TEDDY) study ( U01)
Announcement Type
This is a reissue of RFA-DK-02-029,
which was previously released in January 22, 2002
Request For Applications
(RFA) Number: RFA-DK-07-500
Catalog of Federal
Domestic Assistance Number(s)
93.847, 93.848, 93.849, 93.855
Key Dates
Release Date: June 21, 2007
Letters of Intent Receipt Date(s): July 27, 2007
Application Receipt Date(s): August 29, 2007
Peer Review Date(s): Nov-Dec 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date: Add April 1, 2008
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: August 30, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of this funding opportunity announcement (FOA)
is to continue the support for the maintenance and further development of the
clinical centers that have been involved in the recruitment of subjects in The
Environmental Determinants of Diabetes in the youth (TEDDY) study. The Division
of Diabetes, Endocrinology and Metabolism, National Institute of Diabetes and
Digestive and Kidney diseases (NIDDK), invites applications for this limited
competition Request for Applications (RFA) from eligible applicants. The
program will fund, up to a maximum of 5 years, six U01 cooperative agreement
awards to conduct rigorous investigation for identification of infectious
agents, dietary factors, or other environmental factors that are associated
with increased risk of type 1 diabetes, with specific phenotypic manifestations
such as early age of onset or rapid rate of progression, or with protection
from the development of type 1 diabetes.
The CCs will continue to recruit, enroll and follow subjects, including obtaining informed consent from parents prior to or shortly after birth. The CCs will collect study data according to the TEDDY Protocol, obtain genetic and other samples from neonates and parents, and prospectively follow selected neonates throughout childhood or until development of type 1 diabetes. The CCs will continue to have full responsibility for identifying, recruiting, enrolling and following the necessary number of study participants to meet the study goals and bring the study to completion. The CCs will collect and transmit genetic and other samples and familial and clinical data as delineated in the Protocol and Manual of Operations.
Background
An estimated one million Americans have type 1 diabetes. Type 1 diabetes is one of the most common and serious chronic diseases in children and appears to be increasing globally, particularly in the very young. The etiology of the disease however remains unclear. There is a substantial genetic component to susceptibility to type 1 diabetes. High risk HLA class II alleles appear to contribute 40-45% of genetic risk and other genes have also been identified as providing more modest contributions to risk. However only about 1 in 15 children in the general population with the high risk HLA alleles and one in five with a first degree relative with type 1 diabetes and with the high risk HLA will develop type 1 diabetes. Thus, additional unidentified factors are important in the etiology of this disease. Epidemiologic patterns suggest that viruses, nutrition, toxic agents and/or socioeconomic factors may contribute. However, definitive identification of environmental factors that precipitate type 1 diabetes has proven difficult. Investigation is confounded by the long interval between exposure and onset of clinical disease and the multiple genes, and possibly multiple environmental insults, that interact in a complex manner. Numerous studies have investigated environmental influences but have yielded conflicting results, in part perhaps due to a failure to account for genetic susceptibility, a failure to begin observation of individuals at very early ages or in utero, and the inability to follow a sufficient sample of individuals long-term on a frequent basis incorporating methods that can detect potential pathogens and other environmental influences.
In response to a competitive RFA issued in 2002, awards to TEDDY CCs were approved in May 2002 and awarded in January 1, 2003. TEDDY is a consortium composed of six clinical centers U01s (U01 DK63821, Marian Rewers, Barbara Davis Center, Univ. CO, Denver, CO; U01 DK63829, U01 DK63865, U01 DK63836, U01 DK63863, and U01 DK63861).
The original RFA called for creation of Consortium of collaborating investigators following common protocol(s) to allow for a coordinated, multi-disciplinary approach to the complex problem of identification of infectious agents, dietary factors, or other environmental factors that are associated with increased risk of type 1 diabetes, with specific phenotypic manifestations such as early age of onset or rapid rate of progression, or with protection from the development of type 1 diabetes. In addition it specified that collection of information and samples should occur in a standardized manner to achieve greater statistical power than could be achieved at a single center. It also specified creation of a central repository of data and biologic samples for subsequent hypothesis based research. It was envisioned that this cooperative group would provide for rigorous testing of environmental factors as they emerged in order to derive appropriate definitive information about the pathogenesis of the disease process. It was also envisioned that the reposited data and biosamples would be available to the broader scientific community for retrospective analyses.
TEDDY has succeeded in establishing an intrinsically collaborative, multi-disciplinary consortium composed of clinicians, epidemiologists, nutritionists, geneticists, immunologists, industry representatives, and patient advocates that not only achieved the goals of the original FOA, but is poised to address the scientific challenges of the NIDDK and the scientific community in the future, thus improving both the quality and utility of epidemiological studies. TEDDY’s accomplishments are linked to its responsive, unique infrastructure, clear and relevant scientific plan, and focused quality assurance process. The TEDDY consortium has developed a protocol that was approved by a rigorous External Advisory Committee convened by the NIDDK and will follow a sufficiently large number of subjects to allow for analyses of gene-environmental interactions using both diabetes and islet autoimmunity as endpoints. The study population includes appropriate representation of both genders and the major racial/ethnic groups. Certain case-control studies are planned to investigate selected potential environmental determinants and there is provision for making study samples and data available to the broader scientific community to pursue novel hypotheses.
Data is being gathered from cohorts of newborns from the general population and newborn first-degree relatives of probands with type 1 diabetes. Newborns are identified to be at genetic risk for type 1 diabetes before long term follow-up. These cohorts are to be followed for 15 years for the appearance of various beta-cell autoantibodies and diabetes, with documentation of early childhood diet, reported and measured infections, vaccinations, and psychosocial stressors, as well as collection of biosamples for future analysis.
The TEDDY study is recruiting neonates both from the general population with a pre-determined type 1 diabetes risk of 3% and neonates with first degree relatives who have type 1 diabetes and who have a pre-determined type 1 diabetes risk of 10%. Thus, TEDDY proposes to study a total of 7,000 - 8000 -participants across six clinical centers worldwide (Finland, Germany, Sweden and three in North America). The participants are being followed with blood sampling every three months for islet autoantibody measurements until age 4 years and then every six months until the age of 15.
The Consortium has demonstrated organizational maturity as evidenced by its compelling multi-disciplinary, multi-institutional, clinical research protocol that provides pertinence, validity, reliability, and generalizability to an extent not possible with single-institutional or other observational studies. The Consortium has also demonstrated success in meeting challenging recruitment and retention goals and the special challenges of this complex study. The Consortium has established a broad and effective collaborative base of ongoing relationships providing expanded sources of relevant ideas and has streamlined the data submission and evaluation processes.
Objectives and Scope
The overall objective of this solicitation is to invite the clinical centers to complete the recruitment and continue the follow up of the subjects and to identify the environmental triggers of type 1 diabetes. The specific goals of the TEDDY consortium are
(1) to encourage novel approaches to identification of infectious pathogens, dietary factors or other environmental influences that contribute to the pathogenesis of type 1 diabetes in genetically susceptible individuals,
(2) to facilitate the recruitment of appropriate subjects and families for prospective studies to delineate environmental factors associated with the development and progression of type 1 diabetes, and
(3) to establish a resource for studies of pathogenesis of type 1 diabetes by creating a biologic specimen repository and clinical database. Ultimately it is anticipated that new information about etiology and pathogenesis of type 1 diabetes emerging from this research effort will contribute to the development of strategies to prevent or delay type 1 diabetes in children at increased genetic risk.
While the project period for applications solicited under this invitation will be five years, it is anticipated that there may be an opportunity for extension of the consortium to allow sufficient follow-up of the cohort under study for an appropriate duration to identify development of diabetes.
Study Design
The individual CCs and the DCC participating in the cooperative study have jointly developed the standardized protocol.
The Steering Committee (see below) will continue to develop a research plan and implement protocols based on consideration of the evidence to date about the real and potential relationship between type 1 diabetes and environmental triggers and taking into consideration technologies currently available for identification of pathogens and other environmental factors. This information will provide a rationale for development of priorities among the various "candidate" triggers and selection of the most relevant populations for study.
The Consortium will jointly analyze data from its study populations. The consortium has developed a mechanism to solicit research proposals from investigators outside the Consortium who may have novel hypotheses about potential environmental influences on susceptibility to type 1 diabetes that can be tested using resources developed by the Consortium. TEDDY is collecting specimens that include sufficient material for measurements to be made based on hypotheses developed by the Steering Committee and also for storage of sufficient specimens that material will be available in the future when new technology or approaches to pathogen discovery may become available.
Study Components
1. Clinical Centers (CCs)
Up to six awards will be made for CCs that are responsible for the recruitment and evaluation of neonates and appropriate family members and for the long-term follow-up of study subjects.
CCs will continue to be required to submit genetic data and/or samples for genetic measurement on neonates screened for or enrolled in the study, samples for measurement of immunologic parameters, auto-antibodies, infectious agents or other factors, diagnostic and medical therapeutic data, blood, stool, and other samples as required by the protocol for testing or storage, samples for a DNA and/or cell line repository, as well as familial data and samples, as appropriate and required by the protocol, to the DCC. The CC must work in concert with the DCC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as has been established by the study protocol.
The Consortium will conduct analyses and will have exclusive access to data from its study populations for a period of time, in accordance to a timetable determined by the TEDDY Steering Committee in concordance with NIDDK. The Consortium will then be required to share data and patient specimens derived from collaborative studies with investigators outside the Consortium under policies and procedures to be determined by the NIDDK together with the Steering Committee and the External Advisory Committee. The Steering Committee has determined policies under which individual, center-specific projects, independently supported as ancillary research projects, may be conducted through the auspices of the DCC.
2. Data Coordinating Center (DCC)
There will continue to be a single DCC. A proposal for support of the DCC is being solicited under a separate Request for Proposal utilizing the contract mechanism. This center will be responsible for the collection, management and analysis of the genetic, immunologic, pathogen, and other laboratory and clinical data, and coordinating communication and research with the Clinical Centers. The DCC is encouraged to propose to use both existing and novel methods for data and sample collection, storage in a repository, and genetic analysis. The DCC played a key role in the logistics of the planning and development stage and will continue to manage logistics in the next phase of the project. In addition, the DCC will continue the data acquisition and transfer and continue to develop procedures for ensuring subject and control confidentiality and safety, develop procedures for quality control, training, and certification, develop and update the manual of operations, and supervise the orderly collection and transmission of data. The DCC will continue to oversee implementation and adherence to the study protocols, and assure quality control of the data collected.
The DCC will continue to coordinate movement of biologic specimens from the CCs to central laboratories for analysis and to the repository where samples will be stored for future analyses. The DCC will continue to maintain the system for identification of samples and linkage of samples to a central clinical database. In addition the DCC will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution.
The DCC will provide appropriate biostatistical, data management, and coordination and analytic expertise. The DCC will continue to generate appropriately detailed reports to the Steering Committee and to the External Advisory Board, and to the NIDDK staff (see below) at regular intervals, and will be responsible for the logistics and planning of the meeting of the Steering committee and its subcommittees.
3. Steering Committee
The primary governing body of the study will continue to be the Steering Committee
comprised of each of the Principal Investigators of the CCs and the DCC, the Chairperson of the Steering Committee and the NIDDK Project Scientist (described in detail under Terms and Conditions).
Representatives of other institutes and centers supporting and sponsoring the Consortium will serve as ex officio members of the steering committee.
The Steering Committee will continue to develop policies and procedures for the Consortium, including procedures for modification of the study design, for use of study samples and data, for approval of ancillary studies, for publication and presentation of results and for monitoring study progress, completeness and quality of data collection, and other performance measures.
4. Project Scientist
The NIDDK Project Scientist, will continue to assist the Steering Committee in carrying out the proposed studies (described in detail under Terms and Conditions). The Project Scientist will provide scientific support to awardees activities, including protocol development, quality control, interim data monitoring, final data analysis and interpretation, preparation of publications, and overall performance monitoring.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the NIH cooperative clinical research (U01) award mechanism of support, an "assistance" mechanism (rather than as "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
The NIH (U01) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
The total project period for an application submitted in response to this FOA may not exceed 5 years. This is a one time solicitation. While the initial project period will be five years, it is anticipated that there may be an opportunity for extension of the consortium to allow sufficient follow-up of the cohort under study for an appropriate duration to identify development of diabetes. The anticipated award date is April 2008.
2. Funds Available
The participating IC(s) NIDDK intends to commit
approximately 5
million dollars in FY 2008 to fund six
competing continuation cooperative
agreements in response to this FOA. An applicant may request a project period
of up to five years and a budget for direct costs
up to one
million dollars
per year.
Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the IC(s) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds. Designated funding levels are subject to change at any time prior to
final award, due to unforeseen budgetary, administrative, or scientific
developments. The anticipated start date for these awards is April 2008. Facilities and administrative
costs requested by consortium participants are not included in the direct cost
limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
As this FOA is a limited competition opportunity that involves a continuation of the cooperative agreements supporting The Environmental Determinants of Diabetes in the Youth (TEDDY) study), only the current U01 TEDDY awardees are eligible to submit applications.
1.B. Eligible Individuals
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 support.
2. Cost Sharing or Matching
This program does not require cost sharing. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Among the disciplines and expertise that may be appropriate for this program are: epidemiology, pediatrics, genetics, genomics, infectious disease, endocrinology and immunology.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
The Environmental
Determinants of Diabetes in the Youth (TEDDY) study (Limited competition (U01)
Foreign Organizations
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letters of Intent
Receipt Date(s): July 27, 2007
Application
Receipt Date(s): August 29,
2007
Peer Review Date(s): Nov-Dec 2007
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): April 1, 2008
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The
letter of intent is to be sent by the date listed at the beginning of this
document.
The
letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd.
Room 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies 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 Blvd.
Room 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]
Using the RFA Label: The RFA label available in the PHS 398 application instructions 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/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
The application may exceed the 25 page limit to a maximum of 45 page limit. The consortium's proposed protocol with the rationale for the protocol should be described in the application together with details on power of the study. The application should provide the center’s recruitment and retention goals, its plans to accomplish that mission, and present evidence of compliance to the protocol. It should specify the concrete research proposals of the consortium. It should outline the consortium's strategy for each category of investigation, including rationale and future plans; a clear sense of direction should be evident.
This application should include a clear description of the formal organizational structure of the consortium, including lines of authority and responsibility, with particular attention to the relationship of the organizational structure to the consortium's major objectives. The committees will have various research, quality control, and administrative mandates. Plans for interaction of the organizational elements should be described clearly. For each scientific committee the application should briefly summarize each committee’s progress to date, the major scientific goals, strategies, and broad research areas that the committee has been and will be concerned with; and identify the specific research questions that the committee plans to address.
Plan for Sharing Research
Data
The precise content of the data-sharing plan will
vary, depending on the data being collected and how the investigator is
planning to share the data. Applicants who are planning to share data may wish
to describe briefly the expected schedule for data sharing, the format of the
final dataset, the documentation to be provided, whether or not any analytic
tools also will be provided, whether or not a data-sharing agreement will be
required and, if so, a brief description of such an agreement (including the
criteria for deciding who can receive the data and whether or not any
conditions will be placed on their use), and the mode of data sharing (e.g.,
under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be
responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
All applicants must include a plan for sharing
research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
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 NIDDK in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria 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 an 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 or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: 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? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
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
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data will be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement (U01s) an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for all aspects of development and implementation of the protocols, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. Modifications of protocols will be approved by the Steering Committee. Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The collaborative protocol and governance policies will call for the continued submission of data centrally to the DCC for a collaborative database, the submission of copies of the collaborative data sets to each principal investigator upon completion of the study, procedures for data analysis, reporting and publication, and procedures to protect and ensure the privacy of medical and genetic data (if any) and records of individuals. The NIDDK Project Scientist, on behalf of the NIDDK, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee. The NIDDK expects that biologic samples and associated clinical data will be made available to the broader scientific community at an appropriate juncture to support further studies related to the prevention and etiology of type 1 diabetes and in studies to identify environmental factors and/or genes predisposing to type 1 diabetes. The study will be expected to put all study materials and procedures manuals in the public domain and/or make them available to other investigators. Awardees are encouraged to publish and to publicly release and disseminate results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and the NIDDK and other co-sponsors. However, one year beyond the end date of the project period of NIDDK support, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the Steering Committee.
Support or other involvement of industry or any other third party in any study performed by the Consortium may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to, and concurrence, by NIDDK.
The NIDDK has established Central Biosample, Genetic and Data Repositories for the archival and storage of data and biosamples. All samples and data transferred to the repositories will be under the custodianship of the NIDDK, although the study’s Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. NIDDK expects all baseline data from the previous funding period will be put into the public domain via the NIDDK central repository within one year of the conclusion of the funding period. The CCs will submit the samples and data to the NIDDK repository via the DCC and the study is expected to put all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIDDK, for the conduct of research at no charge other than the costs of reproduction and distribution.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
2.A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIDDK Project Scientist will have one vote on the Steering Committee and on all key study group subcommittees. Representatives of other institutes and centers supporting and sponsoring the Consortium will serve as non-voting ex officio members. The Project Scientists will have substantial scientific-programmatic involvement in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The dominant role and prime responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the Project Scientists.
The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIDDK cannot concur, (d) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (e) human subject ethical issues that may dictate a premature termination.
Additionally, an NIDDK Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
The Steering Committee, composed of each of the Principal Investigators of the CCs, and the DCC and the NIDDK Project Scientist, and the Chairman of the Steering Committee, will be the main governing board of the studies. Project Scientists from other institutes and centers will serve as ex officio members of the Steering Committee. This committee will have the primary responsibility for approval of the common protocols, facilitating the conduct of participant follow-up, monitoring completeness of data collection and timely transmission of data to the DCC, and reporting the study results. It will also be responsible for establishing study policies in such areas as access to patient data, ancillary studies, publications and presentations, and performance standards. Each member of the Steering Committee will have one vote and all major scientific decisions will be determined by a majority vote of the Steering Committee. A Chairperson will subsequently be chosen from among the Steering Committee members (but not the NIDDK Project Scientist). Subcommittees will be established for specific purposes as needed, such as for ancillary studies, publications and presentations, quality control, recruitment, protocol adherence, among others.
Each Consortium CC awardee agrees to the governance of the study through the Steering Committee. The Steering Committee voting membership shall consist of the Principal Investigators of the CCs and the DCC, and the NIDDK Project Scientist. Meetings of the steering Committee will ordinarily be held by telephone conference calls or be face to face.
The NIDDK Project Scientist (and the other cited NIH and CDC scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., to address issues of recruitment, intervention, follow-up, quality control, standards and methods, adherence to protocol, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment or retention. Regardless of the number of NIH and CDC staff participating in technical advisory roles, the NIH and CDC will be limited to one vote on the Steering Committee.
An independent External Advisory Board convened by the NIDDK and composed of experts in relevant medical, psychological, statistical, operational, and bioethical fields who are not otherwise involved in the study will be established to review periodically the progress of the study. The committee will oversee participant safety, evaluate study progress and results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Data Coordinating Center, the NIDDK Project Coordinator, and the Director of the Division of Diabetes, Endocrinology and Metabolism may participate as ex-officio, non-voting members of this Committee. Committee members will be appointed by the Director, NIDDK. The NIDDK named Project Coordinator will serve as executive secretary of the External Advisory Board.
The NIDDK expects that biologic samples and associated clinical data will be made available to the broader scientific community at an appropriate juncture to support further studies related to the prevention and etiology of type 1 diabetes and in studies to identify environmental factors and/or genes predisposing to type 1 diabetes. The NIDDK expects that the TEDDY study will put all study materials and procedures manuals in the public domain and/or make them available to other investigators via the NIDDK central repository according to the timetable determined by the steering committee in concordance with NIDDK.
Each
full member will have one vote. Awardee members of the Steering Committee will
be required to accept and implement policies approved by the Steering
Committee.
2.A.4. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Beena Akolkar, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 6105
Bethesda, MD 20892-5450
Telephone: (301) 594-8812
FAX: (301) 480-3503
Email: [email protected]
John Ridge, M.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 3027
Bethesda, MD 20892-7640
Telephone: (301) 496-7104
FAX: (301) 480-1450
E-Mail: [email protected]
2. Peer Review Contacts:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd.
Room 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]
3.
Financial or Grants Management Contacts:
Shelley Carow
Grants
Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 610, MSC 5456
Regular Mail: Bethesda, MD 20892-5455
Phone: 301-594-8853
FAX: 301/594-9523
Email: [email protected]
Victoria Connors
Grants
Management
DEA
National Institute of Allergy and Infectious Diseases
6700 B
Rockledge Drive, Room 2122
Bethesda, MD 20817
Phone: (301)
402 5065
Fax: (301)
493 0597
Email: [email protected]
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 FOA 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. All 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.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications are
encouraged. The periods of career award and LRP award may overlap providing the
LRP recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based on a
40 hour week) for two years to the research. For further information, please
see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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