and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) |
|
Funding Opportunity Title |
Limited Competition for the Continuation of the Clinical Centers for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (UC4) |
Activity Code |
UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-DK-12-504 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.847, 93.855, 93.856 and 93.865 |
FOA Purpose |
This Limited Competition Funding Opportunity Announcement (FOA) invites applications from the Principal Investigators of the six current Clinical Centers (CCs) for The Environmental Determinants of Diabetes in the Young (TEDDY) study, an ongoing epidemiological study of type 1 diabetes (T1D) etiology. The TEDDY study involves the rigorous investigation of TEDDY subjects, including data and samples, for the identification of infectious agents, dietary factors, or other environmental factors associated with onset of T1D and/or T1D associated autoimmune markers. The six current CCs have been involved in study design and data and biosample acquisition since the inception of the TEDDY consortium. The CCs have recruited participants and followed the subjects over the past 10 years. This FOA is a one-time solicitation to support the CCs to allow them to continue to retain, follow clinically, and collect biosamples from TEDDY subjects for an additional 5 years. |
Posted Date |
February 22, 2012 |
Open Date (Earliest Submission Date) |
June 17, 2012 |
Letter of Intent Due Date |
June 17, 2012 |
Application Due Date(s) |
(Extended to August 7, 2012 per NOT-DK-12-008), Originally July 17, 2012 , by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable. |
Scientific Merit Review |
October/November, 2012 |
Advisory Council Review |
January, 2013 |
Earliest Start Date(s) |
April 2013 |
Expiration Date |
(Extended to August 8, 2012 per NOT-DK-12-008), Originally July 18, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Background
An estimated one million Americans have T1D, making it one of the most common and serious chronic diseases in children. Data suggest that the incidence of T1D is increasing globally, particularly in the very young. Counteracting this trend is difficult because the etiology of the disease remains unclear.
It is known that there is a substantial genetic component to susceptibility to T1D. Certain HLA class II alleles confer high risk of disease and appear to contribute 40-45% of the total genetic risk. Other genes that provide more modest additional contributions to risk have also been identified. Most of the genes that confer risk are involved in immune system function or regulation, strongly supporting an autoimmune-mediated pathogenic mechanism of disease. Environmental factors also play a role since only about 1 in 15 children in the general population who carries a high risk HLA allele will develop the disease, and only one in five with both a high risk allele and an affected first degree relative (implies additional genetic risk) will develop the disease.
Previous epidemiologic studies suggest that viruses, nutrition, toxic agents and/or socioeconomic factors may contribute to disease risk. However, definitive identification of environmental factors that precipitate type 1 diabetes has proven difficult. Investigation of environmental determinants is confounded by the long interval between exposure and onset of clinical disease, and multi-factorial environmental and genetic interactions. Definitive studies of environmental influences in T1D will have to account for genetic susceptibility, begin observation of individuals at very young ages or in utero, follow a sufficient number of individuals long-term with frequent assessments, and use highly sensitive and specific methods to identify potential pathogens and other environmental influences. TEDDY was designed to systematically address each of these confounding factors in order to provide definitive correlates of disease progression in at-risk populations.
A competitive FOA was issued in 2002 to select CCs capable of recruiting and following subjects from birth to age 15, from the general population as well as T1D families. The FOA specified that the TEDDY consortium should involve multiple sites in the US and in Europe, but that the sites should collect information and specimens in a standardized manner to achieve greater statistical power than could be achieved at a single center. It also specified the creation of a central repository of data and biologic samples for subsequent hypothesis testing. It was also envisioned that the reposited data and biosamples would be available to the broader scientific community to pursue novel hypotheses in the future. Six awards to TEDDY CCs were awarded in January 1, 2003. The CC cooperative agreement awards were renewed under a limited competition FOA issued in 2007 and awarded in April 2008.
The TEDDY study has screened over 400,000 newborns to identify, recruit and enroll over 8,000 newborns at high genetic risk for T1D. Participants were enrolled either from the general population, including 7,700 neonates who have an expected 10 year T1D risk of 3%, or from T1D families (subjects must have a first degree relative with T1D), including 919 neonates who have an expected 10 year T1D risk of 10%. The participants were recruited from multiple CCs in the United States and Europe (Finland, Germany, Sweden). The participants are being followed very closely with islet autoantibody measurements every 3 months until age 4 years. After the age of 4, autoantibody positive subjects continue to be followed at 3 month intervals and autoantibody negative subjects are followed at six month intervals, up to diabetes onset or age 15. In addition to blood samples taken at each visit, the parents collect monthly stool samples in early childhood. Other samples are collected periodically including urine, nasal swabs, and nail clippings. The parents also complete questionnaires about diet, health and infections, and psychosocial stressors at each visit and record events in the child’s TEDDY Book. The first primary outcome measure is appearance of one or more islet cell autoantibodies: GADA, IAA, ZnT8, or IA-2A, confirmed at two consecutive visits; and it is expected that approximately 800 subjects will develop autoantibodies during the entire course of the study. The second primary outcome is development of T1D; and it is expected that 390-400 subjects will develop T1D in this cohort during childhood and adolescence. TEDDY is thus a complex project that requires extensive amounts of coordination of individuals and organizations that are nationally and internationally based. The TEDDY study completed enrollment in 2010 and, to date, 357 subjects are single autoantibody positive, 202 are double autoantibody positive and 96 subjects have developed diabetes.
TEDDY has succeeded in establishing an intrinsically collaborative, multi-disciplinary consortium composed of clinicians, epidemiologists, nutritionists, geneticists, immunologists, industry representatives, and patient advocates. The TEDDY consortium not only has made great progress towards achieving the original goals, but is also making substantial process improvements which can be applied more generally to enhance both the quality and utility of epidemiological studies involving children from birth. TEDDY’s accomplishments are in part due to its responsive infrastructure, clear and relevant scientific plan, and efficient quality assurance process. In addition to the study group and study leaders, The TEDDY consortium’s activities and plans are reviewed 2-3 times per year by a rigorous External Evaluation Committee comprised of experts across the many scientific disciplines relevant to TEDDY, such as genetics, infectious diseases, immunology, epidemiology and biostatistics.
The effective recruitment, retention, environmental exposure and endpoint rates seen in TEDDY demonstrate that it is highly likely that there will be a sufficiently large number of subjects 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. Case-control analyses are planned to investigate selected potential environmental determinants of risk and disease onset, in addition to longitudinal analyses.
Objectives and Scope
The overall objective of this solicitation is for the continuation of the TEDDY CCs. The specific goals of the TEDDY consortium in the next phase of the project are:
(1) to encourage novel approaches to identify infectious pathogens, dietary factors or other environmental influences that contribute to the pathogenesis of T1D in genetically susceptible individuals,
(2) to delineate environmental factors associated with the development and progression of T1D, and
(3) to establish a resource for studies of pathogenesis of T1D by creating a biologic specimen repository and clinical database.
The CCs are responsible for ensuring the transfer of all biosamples and data to the NIDDK central repositories according to an agreed-upon timeline. The applicants should therefore address these activities and provide past performance and future plans to continue fulfilling this objective. For example, retention rates and samples and data transmission compliance should be provided in the application.
The CC PD/PI will be a member of the TEDDY Steering Committee (SC). The SC is the main governing body of the network, and works with the NIDDK to oversee the implementation of the study. The CCs will be working closely with the TEDDY data coordinating center in a collaborative and interactive manner. The applicants should therefore address this function by providing past performance and future plans to continue fulfilling this objective. For example, the involvement of CC PD/PI and staff on TEDDY committees in the past and for the future should be provided in the application.
Ultimately it is anticipated that new information about etiology and pathogenesis of T1D emerging from this research effort will contribute to the development of strategies to prevent or delay T1D in children at increased genetic risk. Applicants should describe a testable hypothesis that can be addressed using TEDDY data, and discuss the implications of the results towards the better understanding of T1D etiology and implications for T1D prevention strategies.
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.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
Renewal The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIDDK intends to commit to the six awards utilizing a Special Type 1 Diabetes Program appropriation for a total cost of $30 million in fiscal year 2013 for a period of five years. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
The total project period for an application submitted in response to this FOA may not exceed five years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
Nonprofits Other Than Institutions of Higher Education
Governments
As this FOA is a limited competition opportunity, only the institutions that are the principal employers of the Program Director(s)/Principal Investigator(s) of the TEDDY Clinical Centers are eligible to apply in response to this FOA.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
Only the individuals currently serving as the Program Director(s)/Principal Investigator(s) for the Clinical Centers may apply for support under this FOA.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Budget Request
The Budget request is entered in the Estimated Project Funding section of the SF424 (R&R) Cover component only. Only the five-year total should be entered. A detailed budget is not required at the time of submission and will not be accepted. This FOA uses "Just-In-Time" information concepts (see SF424 (R&R) Application Guide). Detailed budget information will be requested as part of the Just-In-Time information.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:
The following items should be submitted as part of the Appendix:
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Since these awards will be issued with a 5-year budget and project period from the same fiscal year, the grantee will not have any authority for an automatic extension nor will one be permitted with NIH prior approval. Funds will not be available for expenditure beyond June 30th of the 5th fiscal year after the period of availability. Thus, extensions of the budget/project period will not be allowed.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.
1. Participate in Steering Committee meetings (expected to occur in person at least annually and as teleconferences monthly or more frequently, as needed), site visits required by the NIDDK, and other regular telephone conference calls related to subcommittees,
2. Cooperate with other TEDDY investigators in the development and design or modification of research protocols, and cooperate in carrying out approved research protocols,
3. Abide by common definitions; common methods for patient recruitment, enrollment, and retention; and common protocols, procedures, tests, and reporting forms as chosen by majority vote of the Steering Committee,
4. Actively seek to implement each consortium-wide protocol approved by the Steering Committee and endorsed by the External Evaluation Committee (EEC) and the NIDDK,
5. Comply with study policies and quality assurance measures approved by the Steering Committee,
6. Agree to oversight of the study by an EEC.
7. Report all adverse events in accordance with procedures established by the Steering Committee and NIDDK policies,
8. Cooperate with other TEDDY investigators in the publication of study results and the eventual release to the scientific community of study procedures and other resources, and
9. Accept the Cooperative Agreement Terms and Conditions of Award in Section VI.2.Administrative and National Policy Requirements.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NDDK Advisory Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
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, 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.
Under the cooperative agreement, a relationship will exist between the recipient of these awards and the NIDDK, in which the performers of the activities are responsible for the requirements and conditions described below, and agree to accept program technical assistance, advice, and/or other coordination above and beyond normal program stewardship from a named NIDDK Project Scientist in achieving the project objectives.
Failure of an awardee to meet the performance requirements, including these special terms and
conditions of award, or significant changes in the level of performance, may result in the conduct of special site visits including if necessary, external (to the study) reviewers, a reduction of budget, withholding of support, suspension and/or termination of the award.
The PD(s)/PI(s) will have the primary responsibility for:
1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.
3. Designating Protocol Chairs. The Principal Investigators (for studies involving multiple coordinated awards) shall designate a single Protocol Chairperson (if the Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.
4. Implementing collection of data specified by the study protocol, by the Steering Committee. For a multi-center study, each awardee/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
5. Establishing procedures for data quality and completeness. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple awards, a plan for analysis of pooled data will be developed by the Steering Committee.
6. Submitting interim progress reports, when requested, to the NIDDK Program Director including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Director may require additional information from individual awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.
7. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.
8. Reporting of the study findings. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to the Government rights of access consistent with current HHS, PHS and NIH policies. The awardee must also be adherent to Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with awardees consistent with NIH and study policies.
9. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIDDK support; or special access to study results, primary data/summary information, or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party is permitted only after concurrence by NIDDK.
10. Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and steering committee policies on publications.
11. Maintaining confidentiality of information: The awardee(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of a company collaborating with the study.
12. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the
archival and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The PI or his/her designee will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution. In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. 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. Subsequently samples and data will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and,
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
13. The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If applicable, the PI or his/her designee will perform the mandatory study registration and reporting of study results to ClinicalTrials.gov. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at PRS Information: U.S. Public Law 110-85.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
1. Serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
2. For multi-center studies, participation in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serving as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
4. Substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:
a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
b. The NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
c. Reviewing procedures for assessing data quality and study performance monitoring.
d. The NIDDK Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participate in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
In addition, a separate NIDDK Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include.
Interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
Reviewing and approving protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.
The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; and (f) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
Making recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
Appointment of a Data and Safety Monitoring Board (DSMB) as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the DSMB.
Areas
of Joint Responsibility include
In addition to the interactions defined above, NIDDK Project Scientist and
Awardees shall share responsibility for the following activities:
1. Steering Committee.
A Steering Committee organized by the study investigator(s) will be the main governing body of the study.
The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.
A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIDDK (see item D2 below) and by interacting closely with the awardees during protocol development and implementation.
2. External Study Oversight.
An independent Data and Safety Monitoring Board will be established by the NIDDK for Phase III clinical trials or other high risk studies as appropriate. The Data and Safety Monitoring Board will review interim results periodically and provide guidance to the NIDDK.
Dispute Resolution:
Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Beena Akolkar, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 6105
Bethesda MD 20892
Tel: 301-594-8812
Fax: 301-480-3503
Email: [email protected]
Lisa M. Spain, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 6105
Bethesda MD 20892
Tel: 301-451-9871
Fax: 301-480-3503
Email: [email protected]
Kasia Bourcier, PhD
Program Officer
DAIT/NIAID
6610 Rockledge Dr, Rm 6615
Bethesda, MD 20892-6601
Phone: 301-451-3205
Fax: 301-480-1450
[email protected]
Dr. Kimberly Gray
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
PO Box 12233 MD EC-21 Research Triangle Park, NC 27709
Tel: (919) 541-0293
Fax: (919) 316-4606
Email: [email protected]
Dr. Gilman Grave
Chief, Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B-05
Bethesda, MD 20892-7510
Tel: 301-496-5593
Email: [email protected]
Francisco Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: 301-594-8897
Email: [email protected]
Christine Gill
Grants Management Specialist
Grants Management Branch, NIDDK
Democracy Plaza II, Room 733
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456 (express zip: 20817)
Telephone: 301-435-2816
Fax: 301-594-9523
Email:[email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
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 Part 52 and 45 CFR Parts 74 and 92.
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