Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New
August 16, 2024 - This RFA has been reissued as RFA-DK-19-022.
July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128
August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
RFA-DK-19-023, U01 Research Project – Cooperative Agreements
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
93.847
This Funding Opportunity Announcement (FOA) invites U01 applications for the establishment of a clinical consortium, composed of one Data Coordinating Center (DCC) and up to 10 Clinical Centers (CC), to conduct studies on diabetes mellitus, with an emphasis on Type 1 diabetes (T1D), that occurs after or as a consequence of one or more episodes of acute pancreatitis.
The Consortium will form multi-disciplinary teams composed of members from the CCs and DCC to undertake a prospective longitudinal observational study of the occurrence of diabetes that occurs during an acute pancreatitis episode or subsequently, with an emphasis on type 1 diabetes (T1D). The study will be designed to gain insight into the incidence, clinical evolution, etiology, type and pathophysiology of the T1D and other forms of diabetes that occurs during or after one or more episodes of acute pancreatitis. The teams will also undertake studies on the identification of immune and genetic risk factors and biomarkers which predict the development of T1D in a racially, ethnically, and geographically diverse population of subjects who have impaired glucose tolerance or diabetes mellitus after one or more episodes of acute pancreatitis due to various identifiable etiologies.
Applications for the Data Coordinating Center (DCC) will be submitted in response to a separate FOA: RFA-DK-19-023: Type 1 Diabetes in Acute Pancreatitis Consortium Data Coordinating Center (T1DAPC-DCC) (U01 Clinical Trial Optional).
To achieve the goal of a comprehensive characterization of diabetes with an emphasis on T1D that results or occurs after acute pancreatitis, each CC should include researchers and clinicians with multi-disciplinary expertise. CCs will be expected to share results freely within Consortium and to develop trans-consortium collaborative projects that make use of the combined expertise and technological capabilities present in all of the CCs.
In addition, a major collaborative effort within the Consortium will be the establishment of an annotated repository of bio-specimens (e.g., blood, saliva, urine, pancreatic and duodenal juice, stools and when feasible pancreatic tissue) to allow for the identification and validation of biomarkers for risk stratification, early detection, and to inform the development of future treatment strategies to prevent or reverse T1D after acute pancreatitis.
December 9, 2019
February 13, 2020
March 13, 2020. No late applications will be accepted for this Funding Opportunity Announcement.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
June/July 2020
October 2020
December 2020
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.
Background
Acute Pancreatitis (AP) results from acute inflammatory injury of the exocrine pancreas, due to duct obstruction, trauma, a genetic (hereditary) predisposition to inappropriate activation of intra-pancreatic proteases, or the toxic effects of alcohol, drugs, infectious agents, or metabolites. The disease ranges in severity from mild, self-limited illness from which most patients recover spontaneously within a day or two, to severe symptoms of the systemic inflammatory response syndrome, hemodynamic collapse, multi-organ failure, pancreatic tissue necrosis and/or infection, septic shock, and in 6-8% of patients, death. Acute pancreatitis is the most common gastrointestinal discharge diagnosis in the United States (US) where it accounts for over 300,000 hospital discharges per year. Currently, there are no approved drugs for the treatment of acute pancreatitis. Therefore, treatment is supportive, and surveillance for complications is essential.
Type 1 Diabetes (T1D) is classically described as a chronic auto-immune disorder in which pancreatic beta-cells are preferentially targeted for destruction by a thymus-derived lymphocyte (T-cell)-mediated attack. T1D has become appreciated as a disease which occurs as frequently in adults as in children and adolescents and which appears to be facilitated or induced by environmental factors which interact with the genome, metabolome, microbiome, and inflammasome of the individual. The geographic incidence of T1D varies greatly but has doubled over the last 30 years in several countries and now accounts for 5-15% of all diabetic patients in the US.
The pathophysiology of T1D is believed to involve proteins or protein fragments which serve as neo-antigens (i.e., post-translationally modified proteins) which in turn induce auto-reactive T cells to provoke a cascade of pro-inflammatory cytokines, resulting in the production of antibodies directed at a variety of beta cell proteins, including anti-glutamic acid decarboxylase (anti-GAD), anti-insulin (IAA), anti-insulinoma associated autoantigen 2 (anti-IA2A), and anti-zinc transporter 8 (anti-ZnT8A) antibodies. The hallmark of T1D is the presence of one or more of these anti-islet and anti-insulin antibodies, although years may elapse before overt diabetes develops in auto-antibody positive individuals, and some T1D patients appear to lack any of these auto-antibodies. The auto-immune process has been associated with antecedent viral infections and with other auto-immune diseases such as auto-immune gastritis, auto-immune thyroid disease, and celiac disease. For further information see Diabetes in America 3rd Edition, https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/diabetes-in-america-3rd-edition.
Although acute glucose intolerance has long been known as a complication of severe acute pancreatitis, this diabetogenic effect was thought to be a transient event, or the result of severe pancreatic necrosis and tissue loss. Recently, cohort studies and a meta-analysis of 24 published studies of 1,100 patients who survived one or more episodes of acute pancreatitis revealed that 30-40% of patients developed diabetes or impaired glucose tolerance within 3-4 years of even a single episode of acute pancreatitis. More surprisingly, the development of diabetes did not correlate with the severity of the index episode of acute pancreatitis.
Diabetes which occurs as a consequence of pancreatic exocrine disease has been termed pancreatogenic or type 3c diabetes based on a table of Classification of Diabetes published by the American Diabetes Association for several consecutive years. No studies have been published, however, in which the type or classification of diabetes which occurs after acute pancreatitis has been investigated. Recently, anecdotal evidence has emerged in which individual patients with documented pancreatitis-associated diabetes have been found to have anti-islet antibodies consistent with a diagnosis of auto-immune T1D.
The prevalence of diabetes occurring as a result of acute pancreatitis was assumed to be quite low until a recent report of almost 33,000 new-onset adult diabetic subjects who were identified in a general practitioner database of over 2 million persons in the United Kingdom. These investigators found that cases of diabetes occurring after acute pancreatitis were almost twice as common as diabetes occurring after the development of chronic pancreatitis, and that the diabetes which occurred after acute pancreatitis required insulin therapy in more than 20% of cases, which was more than twice as frequent as in patients with T2D. These observations suggested that the occurrence of diabetes after acute pancreatitis was far more common than previously thought, and that the diabetes was significantly more insulin-dependent than T2D. These observations suggest that a significant number of patients with diabetes which occurred after acute pancreatitis had T1D.
Acute pancreatitis is not regarded as an auto-immune process, but several aspects of the disease may be sufficient to provoke an auto-immune response. Acute pancreatitis often results in exuberant tissue damage due to the activation of proteolytic enzymes within the pancreas. Protein digestion and the breakdown of proteins are therefore central to the tissue damage of pancreatitis. The balance between inflammatory (auto-reactive) and anti-inflammatory (regulatory) T cells determines the extent to which auto-antibodies are produced against endogenous proteins and the severity of the subsequent injury (to the pancreas and other organs). In the case of T1D, the endogenous proteins and protein products of the pancreatic inflammation which might serve as neo-antigens include insulin, insulin fragments, or the digestion products of islet nucleic acids.
Given the close anatomical and physiological relationship of the exocrine and endocrine pancreas, exocrine pancreatic morphology and function have been studied in patients with diabetes for over 70 years. However, to date there have been no systematic clinical studies regarding the relationship between acute pancreatitis and the diabetes which develops after acute pancreatitis. The epidemiological, clinical and biochemical characterization of that relationship are the goals of the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC).
Research Objectives
The overriding objective of this research program is to undertake a prospective longitudinal observational clinical study to investigate the incidence, etiology and pathophysiology of diabetes following acute pancreatitis with a particular emphasis on the auto-immune processes that result in T1D. The incidence, timecourse, and relationship to pancreatitis severity, the roles of pancreatitis etiology, genetic and genomic risk factors, environmental and biological factors and potential biomarkers for the development of T1D are subjects of interest.
Through the acquisition of a cohort of well characterized patients monitored over time for diabetes onset and T1D-associated autoantibodies, and collected biospecimens (blood, saliva, urine, pancreatic and duodenal juice, stools and when feasible pancreatic tissue), the proposed clinical research consortium will provide the resources and collaborative opportunities necessary to identify the interrelationship between the exocrine and the endocrine pancreas in the development of post-pancreatitis diabetes.
The primary study design will be a longitudinal study of adults (age 18 years and older) who have experienced one or more episodes of acute pancreatitis in whom periodic glucose tolerance testing identifies subjects who develop impaired glucose tolerance (IGT) or diabetes after the onset of the acute pancreatitis over a period of at least three years. The type of diabetes which occurs after acute pancreatitis will be characterized using biomarkers of T1D (e.g., anti-islet and anti-insulin antibodies), T2D (e.g., measures of insulin sensitivity) and Type 3c diabetes (T3cD) (e.g., basal and post-test meal levels of pancreatic polypeptide and other biomarkers of T3cD) to determine the prevalence of T1D among all subjects with diabetes which occurs after or as a consequence of acute pancreatitis. Applicant teams should have expertise in Pancreatology, Endocrinology and Diabetology. Applicants must provide information regarding a) their capability to identify patients with Acute Pancreatitis (AP) and Recurrent Acute Pancreatitis (RAP) and their approach to ascertain the development of impaired glucose tolerance and diabetes and of the development of T1D in particular; b) their enrollment capacity to contribute to the collaborative efforts of the T1DAPC and c) proposed protocols and ancillary studies for post-award consideration by the Consortium Steering Committee.
Examples of possible additional objectives and ancillary projects include but are not limited to:
Organization of the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC)
The T1DAPC will consist of the following entities: the NIH, up to ten Clinical Centers (CCs), a Data Coordinating Center (DCC), an Executive Committee, a Steering Committee and its subcommittees, a Data and Safety Monitoring Board (DSMB), and other committees as needed. The responsibilities of each entity of the Network are described in the Terms and Conditions of Award.
Clinical Center applicants are encouraged to involve investigators interested in Pancreatology, Endocrinology and Diabetology. Clinical Centers will be responsible for proposing protocols, participating in their overall development, conducting the research, and disseminating research findings. For each investigational or therapeutic protocol, one Clinical Center will take the lead responsibility in conjunction with a protocol development subcommittee for drafting the protocol, although the Steering Committee will provide input and will be responsible for assuring development of a common protocol to be implemented by all of the CCs. All CC Program Directors/Principal Investigators (PDs/PIs) will be strongly encouraged to fully commit their center resources and efforts to the Consortium protocols and will disclose to the Steering Committee any institutional specific clinical studies that may overlap with the clinical activities of the T1DAPC. The CCs will continue to recruit subjects into any newly prioritized and approved studies and will conduct the clinical trials and longitudinal follow-up as described in the study protocols. No protocol parameters (eligibility, exclusion criteria) deviations will be allowed without the approval of the T1DAPC Steering Committe. All individual CCs will be required to participate in a cooperative and interactive manner with one another, with the DCC, and with the NIH in all aspects of the Consortium (see Terms and Conditions of Award). Only investigators who wish to continue to carry out the protocols of the T1DAPC, state their willingness to disclose other center specific clinical studies that may overlap the activities of the T1DAPC, agree to the use of a single centralized Institutional Review Board (IRB), and agree to be governed by the policies and procedures of the T1DAPC and its steering committee should apply under this FOA.
The NIDDK will be responsible for organizing and providing support for the T1DAPC and will be involved substantially with the awardees as a "partner," consistent with the Cooperative Agreement mechanism. A designated NIDDK Project Scientist, who will provide programmatic oversight, will monitor subject recruitment and study progress, ensure disclosure of conflicts of interest and adherence to NIDDK policies. The NIDDK will appoint Chairperson(s) of the Steering Committee and all members of the DSMB. An additional NIDDK Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Study Governance
Steering Committee. The Steering Committee will be the main governing body of the T1DAPC (see Terms and Conditions of Award). The Steering Committee will be composed of the PDs/PIs of each CC in the Network, the PDs/PIs of the DCC, the NIDDK Project Scientist and the NIDDK Program Official. Steering Committee co-chairs will be appointed by NIDDK. Each CC, the DCC, and the NIDDK Project Scientist will have one vote. The Steering Committee will have primary responsibility for the general organization of the Consortium and approval of publications and ancillary studies. The Steering Committee will be responsible for the conduct and monitoring of studies and reporting study results. Topics for investigational and treatment protocols will be proposed and prioritized by the Steering Committee. Other subcommittees of the Steering Committee will be established and will operate as necessary, such as publications, ancillary, protocol, pathology and radiology. All face-to-face Steering Committee, DSMB, and other necessary face-to-face meetings requiring the presence of NIDDK personnel will be held in the Washington, DC/Baltimore metropolitan area or other suitable venue.
Executive Committee. An Executive Committee will be comprised of Steering Committee Co-Chairs appointed by NIDDK, the PD/PI of the DCC, the NIDDK Project Scientist, and NIDDK Program Official. The Chair of the Executive Committee will be appointed by the NIDDK. The Executive Committee will be convened to prepare the agenda for the SC meetings and to effect management decisions needed between Steering Committee meetings, as required for the function of the Consortium. Other NIDDK and DCC personnel, as deemed necessary by the Project Scientists and Program Official, may also be included in this Commitee.
Data and Safety Monitoring Board (DSMB). An independent DSMB will be established by the NIDDK to review protocols and monitor subject safety and performance of each study. As a part of its responsibilities, the DSMB will submit recommendations to the NIDDK regarding the continuation of each study. The DSMB will be responsible for final approval of the Data and Safety Monitoring Plan developed by the DCC. All protocols or changes to protocols will be approved by single Institutional Review Board (sIRB) through reliance agreements at all participating centers, the Steering Committee, the T1DAPC Data and Safety Monitoring Board, and the NIDDK before initiation.
Other Special Performance Requirements
The T1DAPC will be a collaborative effort that requires frequent interactions of awardees among themselves and with the NIDDK Program Directors. Applicants are expected to:
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
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NIDDK intends to commit $2.7 million in FY 2020 to fund up to ten awards.
The maximum project period is five years.
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov
with the following exceptions or additional requirements:
For this specific FOA, the Research Strategy section is limited to 30 pages .
Facilities and Other Resources: There should be evidence of strong institutional support for the CC, including adequate space in which to conduct clinical and research activities and office space for staff. Institutional resources for patient care and follow-up including personnel, space, and special laboratory facilities should be described in the CC application.
SUPPLEMENTAL INSTRUCTIONS FOR CLINICAL CENTERS (CC):
Applications for the CCs will be assessed upon their clinical capacity to recruit, enroll, and retain patients in clinical studies and the investigators’ knowledge and expertise in the diagnosis and management of acute pancreatitis and diabetes and their complications. The CC application (including subcontract sites) must demonstrate how investigators will be able to submit data to the DCC and biospecimens to the NIDDK Repositories (supported by an independent contract from NIDDK) and to central laboratories and biological cores as approved by the Steering Committee. CCs must show how they will work in collaboration with the DCC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as established by the study protocol. CCs must also provide information regarding future plans for involvement with operational committees of the Consortium (e.g. Recruitment, Publications, etc.) and the establishment of uniform procedures and policies.
An organizational structure for the CC should be set forth in the application, delineating specific personnel (e.g., pathologists, radiologists, etc.) available to carry out the approved protocols. Each CC application may consider the addition of other scientific personnel who must be fully justified.
In order to maximize the impact and efficiency of the consortium, investigators are requested to state their willingness to present site-specific studies that may potentially conflict with the activities of the T1DAPC to the Steering Committee for comment and consideration as network-wide studies.
All proposed key personnel must demonstrate the capability to provide substantial scientific expertise (pancreatology/gastroenterology and diabetology) that is consistent with and aligns with the objectives of the T1DAPC. The final decision on the acceptance of the additional scientific personnel will be at the discretion of the NIDDK based upon consortium objectives and the availability of support. The PD/PI should state his/her general support of collaborative research and interaction with the NIDDK, the other CCs, and the DCC as described in the collaborative agreement.
The additional scientific personnel must demonstrate the capability to provide substantial scientific expertise that is consistent with and aligns with the objectives of the Consortium. The final decision on the acceptance of the additional scientific personnel will be at the discretion of the NIDDK based upon network objectives and the availability of support. The PD/PI should state his/her general support of collaborative research and interaction with the NIDDK, the other CCs, and the DCC through the Network concept.
All instructions in the SF424 (R&R) Application Guide must be followed.
Investigators must submit a complete, justified, individual budget for each year of support requested. All costs requested and all changes in budgets after the first year should be clearly identified and justified. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating site, if multiple sites or cores are proposed. (See Letters of Support in the PHS 398 Research Plan below).
No more than $175,000 in direct costs per year may be requested for support of PDs/PIs and travel. The cost of clinical coordinators, other research staff as well as the cost of patient enrollment, biorepository and laboratory assays are not to be included in the CC budget above. These costs will be determined on a per enrolled patient basis once the protocol is established and will be administered by the DCC via service contracts with the CC.
Research Strategy: The Clinical Center (CC) PD/PI should describe their willingness to collaborate with other members of the Consortium, the DCC, the T1DAPC Biobank, the DSMB and the NIDDK Central Repository. CC applicants (including sub awardee sites) should describe how they will be able to submit data to the DCC and biospecimens to the NIDDK Repositories (supported by an independent contract from NIDDK) and to central laboratories and biological cores as approved by the Steering Committee. CCs should show how they will work in collaboration with the DCC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as established by the study protocol.
CCs should also provide information regarding future plans for involvement with operational committees of the Consortium (e.g. Recruitment, Publications, etc.) and the establishment of uniform procedures and policies.
Applicants should document their ability to recruit patients, procure specimens prospectively, collect epidemiological and clinical data using previously developed Common Data Elements to contribute to the completion of one or several of the longitudinal clinical studies approved by the T1DAP.
Letters of Support: If parts of the costs of the application are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset StudyNote: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date 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 SF424 (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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
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 System for Award Management. 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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/ ) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Specific to this FOA:
Although Ancillary Study (AS) proposed may be considered preliminary until accepted by the consortium, does the AS proposed in the application (whether clinical trials or not) address an important problem in the field? Is the prior research sufficient or rigorous to support the proposed ancillary study projects?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
Do the Program Directors/Principal Investigators (PDs/PIs) and their institutions clearly state their commitment to this initiative?
Are the AS concept, design and implementation, grounded on the PD(s)/PI(s) training and expertise and track record on implementing clinical studies (whether trial or observational)?
Have the PDs/PIs and key personnel demonstrated the capability to provide substantial scientific expertise that is consistent with and aligns with the objectives of the Consortium?
Do the additional scientific personnel provide unique expertise that is suited to the scientific mission of the T1DAPC? Have the additional scientific personnel demonstrated an ongoing record of scientific accomplishments that are aligned with the T1DAPC scientific objectives?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
Specific to this FOA:
Does the application propose new ways to enhance recruitment and retention of patients in all stages of the studied diseases?
Is the proposed ancillary study novel to this field of research? Does it reinforce and expand the research objectives of the T1DAPC?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA:
Have the PDs/PIs shown how they will work in collaboration with the DCC to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as established by the study protocol?
Have the PDs/PIs described their ability to recruit patients, procure specimens prospectively, collect epidemiological and clinical data using previously developed Common Data Elements, to contribute to the longitudinal clinical studies planned by the T1DAPC as described in PHS 398 Research Plan of this FOA?
Has the applicant described in sufficient detail the number of potential patients eligible for a longitudinal clinical study of T1D in Acute Pancreatitis?
Has the applicant described the barriers and proposed solutions to fulfill the recruitment targets?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
Specific to this FOA:
Does the PD/PI provide evidence of strong institutional support for the CC, including adequate space in which to conduct clinical and research activities and office space for staff. Institutional resources for patient care and follow-up including personnel, space, and special laboratory facilities to contribute to proposed T1DAPC longitudinal study or to any of the AS they are proposing?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Future Patient Enrollment Potential
Are the CC patient recruitment, enrollment, and retention plans sufficient to contribute to the long term follow up of patients? Is there an appropriate and feasible strategy to optimize retention and follow-up of patients enrolled in the T1DAPC registry?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Not Applicable
Not Applicable
Not Applicable
Not Applicable
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:Applications will be assigned to 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 National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC).
. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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 Part 75, 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.
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 Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/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. 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 sites, a plan for analysis of pooled data will be developed by the Steering Committee.
6. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.
7. Reporting of the study findings. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIDDK 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.
8.Any third-party (including industry, academia, and foundations) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.
9. Any involvement of a third-party (including industry, academia, and foundations) in the study and network activities that includes access to any network study data and biosamples, or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office
10. Study investigators are required 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 an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK Program staff.
12. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archiving and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. Prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Central Repository to develop a Data Sharing Plan and 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, storage, and sharing 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 leadership 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, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), as well as the NIDDK policy for data sharing in multi-center and large single-center clinical studies http://www.niddk.nih.gov/research-funding/process/human-subjects-research/Documents/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.
13. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the awardee is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIDDK Project Scientists with substantial involvement will:
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 Project Coordinator, 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, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or Project Coordinator will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serve 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 mission and avoid unnecessary duplication of effort.
4. Have 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 NIDDK Project Scientist or Project Coordinator 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 Project Coordinator 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) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
The NIDDK Program Official identified in the Notice of Award will:
Areas of Joint Responsibility include:
In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:
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 Program Director(s)/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, in consultation with the Steering Committee. 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 and by interacting closely with the awardees during protocol development and implementation.
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 CFR Part 16.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Dana K. Andersen, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 410-868-0638
Email: andersendk@niddk.nih.gov
Maren Laughlin Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8802
Email: maren.laughlin@nih.gov
Jose Serrano M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8871
Email: js362q@nih.gov
Xiaodu Guo M.D., PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4719
Email: guox@mail.nih.go v
Eunica Haynes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-4018
Email: haynese@mail.nih.gov
This FOA is supported under the authority of P.L. 116-59, Continuing Appropriations Act, 2020, and Health Extenders Act of 2019; Section 1102. Diabetes Programs.