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 |
Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) |
Activity Code |
DP3 Type 1 Diabetes Targeted Research Award |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-11-350 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.847 |
FOA Purpose |
This FOA invites applications for ancillary studies using archived samples from selected type 1 diabetes clinical trials and studies. Ancillary studies are expected to generate scientific discoveries on disease mechanisms, disease pathogenic processes, and biomarkers of disease progression or clinical responses. |
Posted Date |
September 28, 2011 |
Open Date (Earliest Submission Date) |
November 7, 2011 |
Letter of Intent Due Date |
November 7, 2011; May 7, 2012 |
Application Due Date(s) |
December 7, 2011 and June 7, 2012, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
March 2012 and September 2012 |
Advisory Council Review |
May 2012 and January 2013 |
Earliest Start Date(s) |
July, 2012 and April, 2013 |
Expiration Date |
June 8, 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
There are two ways to access samples. One is through the NIDDK Central Repository (www.niddkrepository.org) which contains samples from the following type 1 diabetes clinical trials: Type 1 Diabetes Prevention Trial- 1 (DPT-1), and Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC samples collected though 2001). The second way to access samples is through one of the following NIDDK-funded consortia:
Type 1 Diabetes TrialNet, (http://www.diabetestrialnet.org/index.htm); or the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications DCCT/EDIC (samples collected before and after 2001), (http://www.t1diabetes.nih.gov/investigator/details.asp?ConsortiumID=36).
This opportunity is limited to research using samples from the clinical trials or studies listed herein. Funding or access to samples will not be provided for assay development or exploratory animal models research. Investigators should propose to test scientifically meritorious hypotheses related to the clinical trial’s goals. Applications should explain in what ways the study is meritorious, the assay technique is validated, and demonstrate that the laboratory is able to carry out the assays with the highest quality standards.
Applications that propose to use consortium-controlled samples must include in their application a document that clearly indicates that the consortium has granted approval for access to the samples. Applicants must apply to the consortium through the relevant ancillary studies application process (links below) with sufficient time for consortium review prior to the FOA receipt date (at least 6 weeks prior to receipt date). This letter must be included with the grant application for the application to be considered complete.
Studies using NIDDK Repository-held samples will be reviewed both for access approval and funding at the same time through this FOA. Applicants must visit the NIDDK Repository https://www.niddkrepository.org/niddk/jsp/public/sampleInstruction.jsp, register for a login and password, and make a preliminary application for access to samples. The Repository will then provide a standardized report which will indicate that samples are present in sufficient number and quantity or volume for the study. This report must be included with the grant application or the application will be considered incomplete and will be returned without review.
Nature of the Research Opportunity
The FOA is expected to promote scientific discoveries on disease mechanisms, disease pathogenic processes, and biomarkers of disease progression or clinical responses. Applicants must explain how the proposed research will take advantage of the associated clinical and phenotypic data, and why the proposed research specifically requires samples from the selected trial or clinical study. This FOA will provide funding to support scientific collaboration among assay providers from outside of the clinical trials networks and clinical and laboratory scientists and biostatisticians within NIDDK’s consortia listed above. Consortia member scientists are encouraged to submit applications, but they must also have documented access to consortium-controlled samples through the relevant process.
Applications should include:
Background and rationale for request of these limited, irreplaceable, and valuable clinical samples. Analysis of additional samples from other studies is allowed if it is well-justified and important for understanding the specific clinical studies listed below;
Specific objectives, including how the results would be integrated with other study results, and the impact of the results on understanding disease progression or response to treatment;
Assay details, including amounts and type of samples, assay variability and quality control, expected effect sizes and group differences, a statistical plan with calculations to demonstrate that the available samples are sufficient to answer the question;
Documentation from the relevant clinical consortia confirming that access to samples has been approved, or documentation from the NIDDK Repository that requested samples are available;
Budgetary information is required. It is expected that this FOA will generate applications with a wide range of budgetary requirements, from small studies utilizing few samples to larger studies with more expensive testing. Budgets should include repository charges (see the repository website https://www.niddkrepository.org/niddk/home.do for access charges by sample type).
Plans for sample management, including returning any unused specimens, plans for data sharing (data are expected to be shared with the consortium or the repository source, consistent with the goals of this program) and future directions.
See Section 6. Other Submission Requirements below for detailed application instructions specific to this FOA.
The following is a brief description of clinical trials and studies with opportunities for samples access and testing.
1. The Type 1 Diabetes TrialNet is an international network of investigators, clinical centers, and core support facilities that recruits patients and conducts research to advance knowledge about type 1 diabetes and to test strategies for its prevention and early treatment. TrialNet supports the development and implementation of clinical trials of agents aimed at preventing the disease in at-risk patients and slowing the progression of type 1 diabetes in new onset patients. The network’s Natural History Study enhances understanding of how the disease develops in individuals at risk and thus helps in the formulation of future trials. The Natural History study provides the basis for risk assessment and recruitment of at-risk subjects into clinical trials aimed at preventing the disease in susceptible individuals, see weblink for publications from TrialNet: (http://www.diabetestrialnet.org/publications/publications.htm) . TrialNet samples available under this FOA are described below. Applicants must apply for access to samples using ancillary studies application procedures: http://www.diabetestrialnet.org/researchers/ancillary.htm.
a) The TrialNet Natural History Study collects serum, RNA, plasma, and PBMC every 6 months from enrolled subjects at risk for disease, and a smaller number of control subjects. Samples from selected subjects within the Natural History study will be made available. Check the TrialNet website (link above) for specific information about the available collection, and for instructions on how to apply for access.
b) The Mycophenolate Mofetil-Daclizumab (MMF/DZB) clinical trial tested whether two immunosuppressive drugs used in combination, MMF and DZB, could stop the ongoing destruction of beta cells in new onset type 1diabetes patients, relative to MMF alone or placebo control. The clinical trial was stopped early when it became clear that the drugs were not able to stop the decline in C-peptide production (Diabetes Care. 2010 Apr;33(4):826-32.). Samples that potential collaborators may apply for include PBMC, whole blood RNA, and serum. Check the TrialNet website for specific information about the available collection, and for instructions on how to apply for access.
c) The Anti-CD20 trial tested the effects of the drug rituximab (anti-CD20) on progression of type 1 diabetes in new onset patients. This randomized, double-blind study used rituximab to deplete B cells and tracked the decline in C-peptide over 2 years (primary endpoint at 1 year). The study showed a statistically significant maintenance of C-peptide production at 1 year in type 1 diabetes patients that received the active drug compared to placebo (N Engl J Med. 2009 Nov 26;361(22):2143-52.), although the effect waned at the two years. Samples that potential collaborators may apply for includes serum, plasma, PBMC and whole blood RNA. Check the TrialNet website for specific information about the available collection, and for instructions on how to apply for access.
d) The CTLA-4-Ig trial tested the effects of the agent "abatacept" (CTLA-4-Ig, Orencia) on progression of type 1 diabetes in new onset patients. Abatacept interferes with the activation of T cells by binding to the molecules CD80/86 (expressed on antigen presenting cells) and blocking their interaction with the co-stimulatory receptor CD28 (expressed on T cells). This double-blinded, placebo control trial showed that abatacept, given monthly, delayed the decline of C-peptide (a measure of beta cell function) relative to placebo controls (Lancet. 2011 Jun 28). Samples that potential collaborators may apply for include serum, plasma, PBMC and whole blood RNA. Check the TrialNet website for specific information about the available collection, and for instructions on how to apply for access.
e) The GAD-alum trial (randomized, blinded, and placebo controlled) tested whether 2 or 3 spaced vaccinations using GAD protein in alum, relative to alum alone, could delay C-peptide decline in new onset subjects . GAD-alum was predicted to modulate the antigen-specific immune response to GAD antigen, through either response type skewing or induced regulation, and to thereby interfere with pathogenesis. The study showed no difference between either of the active drug dosing arms, and the placebo, in the primary or secondary outcome measures at 12 months (Lancet. 2011 Jun 28). Samples that potential collaborators may apply for include serum, plasma, PBMC and whole blood RNA. Check the TrialNet website for specific information about the available collection, and for instructions on how to apply for access.
f) The Anti-IL-1 beta (canakinumab trial) is currently in progress and will determine whether inhibition of the IL-1 inflammatory pathway can delay the decline of C-peptide in new onset T1D patients. This is a double-blinded, placebo controlled trial with the primary outcome at 1 year (expected in May, 2012). Samples that potential collaborators may apply for include serum, plasma, PBMC and whole blood RNA. Check the TrialNet website for specific information about the available collection, and for instructions on how to apply for access.
2. DPT-1: The Diabetes Prevention Type 1 (DPT-1) trial was a multi-center randomized clinical trial to determine if treatment with a common beta-cell auto-antigen (insulin) can delay the onset of Type 1 Diabetes Mellitus (Type 1 DM) in relatives of persons with type 1 diabetes. The protocol for high risk subjects used daily subcutaneous insulin injections and an annual course of intravenous insulin treatment (N. Engl. J. Med, 2002 May 30;346(22):1685-91), while the protocol for intermediate risk subjects used daily doses of insulin or placebo administered orally (Diabetes Care, 2005 May;28(5):1068-76.) There were over 100,000 relatives of persons with type 1 diabetes screened, and 711 subjects entered either the parenteral or oral arm of the study. Serum samples were collected and will be available from subjects who enrolled in the trial(s), some of whom later developed type 1 diabetes. Samples from a selection of subjects (over 10,000) who were autoantibody negative at screening are also available. A data set is available and applicants are urged to obtain and review the data to assist in their preparation of the application. Information for obtaining data and a samples availability report from this study is available on the NIDDK Repository Website: https://www.niddkrepository.org/niddk/home.do.
3. The Diabetes Control and Complications Trial (DCCT) recruited 1,441 type 1 diabetic participants who were randomly assigned to 2 treatment groups, intensive and conventional, for an average of 6.5 years of randomized treatment time. The DCCT ended in 1993 after demonstrating conclusively that intensive treatment reduced the development and progression of diabetic retinopathy, nephropathy and neuropathy, compared to conventional treatment. Subsequently, the Epidemiology of Diabetes Interventions and Complications Study (EDIC) recruited 96 percent of the living participants from DCCT for regular observational follow-up of metabolic and complications status, using similar methods as in the DCCT. The former intensive treatment group continues to exhibit the same reduction in the risks of diabetic complications, starting from a new baseline. This carry-over effect of prior glycemic exposure on the later course of complications (superimposed on the effect of concurrent glycemic exposure) has been called "metabolic memory". Serum, plasma and urine samples have been obtained annually since the DCCT baseline and stored frozen at -70 C. Samples collected through 2001 are available through the NIDDK Repository and may be applied for under this FOA. A data set is available and applicants are urged to obtain and review the data to assist in their preparation of the application. Information for obtaining data and a samples availability report from this study is available on the NIDDK Repository Website: https://www.niddkrepository.org/niddk/home.do
The ongoing DCCT/EDIC research group also welcomes proposals for collaborative studies from any investigator who believes he/she has a research idea that could utilize some of the stored sample collection (serum, plasma and urine) and clinical phenotypic data in an ancillary study. Any proposal would receive initial review by the relevant DCCT/EDIC committees, and would have to abide by the policies and procedures for data sharing and publications described here: http://www.niddk.nih.gov/patient/EDIC/edic.htm.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. NIDDK intends to fund an estimate of 5-10 awards, corresponding to a total of up to $3m, for fiscal year 2012. Future year amounts will depend on annual appropriations. |
Award Budget |
Application budgets are limited to $200,000 direct costs, per year. The total direct costs over a three year period should not exceed $600,000 direct costs, but need to reflect actual needs of the proposed project. |
Award Project Period |
The award project period shall not exceed 3 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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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 four (4) 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(s)/Principal Investigator(s) Policy and submission details in
the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R)
Application Guide.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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, with the following modification:
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.
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.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
In the Approach section of the Research Strategy, please make sure to include each of the following:
1. Sample selection: Justification for requesting these specific samples, and the advantage of these samples compared to other sources of similar samples. This section should explain how the proposed use relates to the design and outcomes of the study that produced the requested samples. The question being posed by the investigator must be appropriate to the source of the biospecimens, how they were collected, prepared, analyzed, and stored, their age, and the phenotypic and other accompanying data. Include detailed information about what samples are requested. If you will be combining the results from the proposed study with those obtained from other samples, be sure to explain how the requested samples will fit in with your overall study design.
2. Sample volume: Include a clear justification for the amount of sample being requested. In all cases, applicants should only request the minimum volume needed for the study.
3. Documentation of sample availability: in the Approach section, state whether the relevant NIDDK clinical consortium has approved access and confirmed the availability of the samples being requested, or whether the NIDDK Central Repository has confirmed that the requested samples are available. Documentation in the form of a Letter of Support from the consortium or a report from the NIDDK Central Repository should be attached as a letter of collaboration (not part of page limits).
4. Methodology: Relevant preliminary data demonstrating the applicant’s experience with the assay or technique that will be used with the requested samples. Describe how the requested samples will be used, including a description of the specific procedures by which the samples will be tested and analyzed.
5. Power and effect size: Describe the variability of the assay, the anticipated size of a detectable effect, and include a calculation of power that demonstrates that the number of samples requested us sufficient to answer the question.
6. Data analysis: Provide a detailed plan for data analysis. Include a brief summary of the team’s expertise and experience and evidence that they can handle the analysis proposed.
7. Data management: Describe how the accompanying phenotypic data as well as the data from sample analysis will be managed. For example, who will have the main responsibility for organizing, storing, and archiving the data? Who will maintain computer data files and make needed work files available to those who will analyze the data?
8. How will the privacy of information in the files be guarded and guaranteed?
9. Applicants are expected to return data derived from analysis of samples to the data coordinating center for the relevant NIDDK consortium, or the NIDDK Data Repository, along with appropriate quality measures. The plan should acknowledge the expectation to follow NIDDK instructions to return the phenotypic data and unused samples to the relevant NIDDK consortium or repository by one year after the period of award of this project.
10. Sample management: Explicitly address how the samples will be held, managed, and processed. For example, who will have the main responsibility for storing and testing the samples?
11. Plans for the next phase: Describe plans for follow up studies and, if relevant, further biomarker or assay development. If collaborations have been established for follow up, include these letters of collaboration.
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, NIH. Applications that are incomplete 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.
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
Not Applicable.
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 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:
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 NIDDK National Advisory Council. The following will be considered in making funding decisions:
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.
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
Not Applicable.
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]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Lisa M. Spain, Ph. D., Director
Immunobiology of Autoimmune Endocrine Diseases Program
Division of Diabetes, Endocrinology, and Metabolism
National Institute of Diabetes Digestive & Kidney Diseases (NIDDK)
Telephone: 301-451-9871
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]
Mary Kay Rosenberg
Grants Management Section Chief
Grants Management Branch, NIDDK
Democracy Plaza II, Room 745
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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NIH Funding Opportunities and Notices
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