Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The purpose of this Limited Competition is to extend the Cure Glomerulonephropathy (CureGN) Network by continuing to support the Data Coordinating Center (DCC). The CureGN Network is a multicenter observational cohort study of glomerular disease patients with the goal of improving care for all glomerular disease patients. The operational components of the study include four multi-site Participating Clinical Centers (PCC) and a DCC. The CureGN Network, established in 2013, has recruited nearly 2,200 of 2,400 planned study participants and followed them with annual in-person clinic visits and interim telephone contacts. The DCC provides key leadership functions for this study in the areas of study organization, study design and implementation, overall management, data management and analysis, and biosample management. The CureGN PCCs will continue to follow-up previously enrolled participants under a separate FOA with a focus on clinical assessment of disease activity, developing novel methods for "virtual" study participation,and semi-quantitative assessment of histopathologic lesions. It is expected that a focus on disease features unique to glomerulonephropathy and outcomes relevant to the full range of patient experience, combined with carefully curated clinical and biochemical data, will uncover new predictors of the disease course, pathophysiologic processes, disease subtypes and novel treatment targets. The DCC will lead the study group to achieve the scientific goals of the next project period.
August 30, 2018
Open Date (Earliest Submission Date)
October 21, 2018
Letter of Intent Due Date(s)
October 21, 2018
Application Due Date(s)
November 21, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
No late applications will be accepted for this Funding Opportunity Announcement.
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.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date
November 22, 2018
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Primary glomerular diseases such as minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IGAN), and membranous nephropathy (MN) are associated with significant morbidity and mortality in both adults and children. In addition to progressive loss of renal function [resulting in approximately 10% of all incident end stage renal disease (ESRD) cases in the US], primary glomerular disease can result in nephrotic syndrome leading to increased risk of infection, venous thromboembolism, hypercholesterolemia, cardiovascular disease, toxicities associated with immunosuppressive therapy, increased hospitalization rate, decreased quality of life, and mortality.
Despite the significant disease burden associated with these glomerulopathies, relatively little is known regarding their natural history, various underlying pathophysiologic process, predictors of outcomes and response to the existing limited arsenal of therapies. A major hurdle to studying these processes in depth has been the rarity of these conditions relative to diabetic or hypertensive-associated chronic kidney disease (CKD). This has accordingly made it challenging for independent investigators to acquire sufficient cases to comprehensively study these glomerulopathies.
To facilitate the advancement of our understanding of the course, cause, and treatment of glomerular diseases in adults and children, the NIDDK established the CureGN multi-center Study in 2013. The original aims of this multi-center, prospective, observational study were to:
Recruit an observational multiethnic cohort of at least 2,400 adult and pediatric glomerular disease patients with biopsy-documented IgAN, FSGS, MN or MCD;
Describe the disease trajectories;
Estimate event rates for clinically meaningful outcomes and to identify clinical predictors of short- and long-term outcomes;
Identify and characterize clinical, histological, molecular, and genetic biomarkers that are linked to glomerular disease, disease outcomes, or that might be used to improve disease classification, or response to therapy;
Understand the genetic architecture of the four glomerulopathies, including epigenetic changes, and transcriptomic profile, and their impact on disease presentation and clinical outcomes;
Devise systems-based "-omics" approaches to clarify pathogenesis;
Describe the full range of the patient experience including, but not limited to Patient Reported Outcomes associated with primary glomerular diseases or disease progression and validate disease-specific instrument(s); and
Facilitate the development of translational and clinical ancillary studies that will leverage the cohort to advance the diagnosis and care of patients with glomerular diseases.
An initial cohort of about 2,200 participants has been recruited between 2013 and 2018. At the start of the next project period, it is projected that approximately 2,400 participants with MN, FSGS, IgA and MCD will be actively followed. Continued follow-up of this cohort will permit progress toward achieving the initial aims.
The CureGN study is expected to foster many ancillary studies through investigator initiated (R01) grants, career development (K) awards and to foster careers in both basic and clinical research of glomerular diseases. The study group will also actively collaborate with ongoing studies supported by the NIDDK as well as other funding sources. The study will continue to pursue collaborations with industry (e.g., pharmaceutical companies), other government agencies (e.g., FDA), and advocacy groups as appropriate to achieve the overarching goal of advancing the diagnosis, understanding of pathophysiology, development of predictive biomarkers and treatments needed to meaningfully improve the care of individuals with glomerular diseases.
The short-term objective of the next project period of the CureGN Study to be supported by this FOA is to better characterize the courses and consequences of MN, FSGS, IgA and MCD glomerulopathies over a longer period and in substantially greater depth than achieved over the first 6 years of the study. The in-depth characterization of the biological and behavioral aspects of these glomerulopathies will require careful and extensive assessment of the study participants by both traditional and novel markers. The longer-term goals are for the collected data to provide the needed information to allow a more refined pathophysiologic based re-classification of some the glomerulopathies and/or subtypes, a more precise prediction of individual level outcomes and to help identify novel targeted treatments for individual patients.
The major objectives of the next five years of the study are to:
Continue implimentation of a common protocol to prospectively follow approximately 600 participants in each of the 4 disease groups: IGAN, FSGS, MCD and MN.
Retain enrolled participants and limit recruitment of newly-diagnosed participants to replace those who have withdrawn consent or have been lost to follow up. Follow-up of CureGN participants is anticipated to be ongoing until withdrawal from the study or death occurs.
Collect longitudinal phenotypic, clinical, patient-reported, genetic, biochemical, and tissue data.
Clinical data should include disease activity, associated non-renal outcomes and transplant/graft survival outcomes.
Tissue data should include histopathological and molecular/"-omics" analyses facilitated by the banking of blood, urine, physical slides or digital whole slide images, and physical biopsy tissue blocks.
Analyze these samples and data with both traditional and innovative approaches that integrate high levels of data (e.g. data reduction based approaches) as well as systems biology approaches, with the goal of uncovering novel disease features for disease subgroup classification, prognosis, delineation of pathophysiologic pathways, response to therapy, and the identification of novel treatment targets.
Identify fixed and variable costs and establish procedures for negotiation of third party agreements or selection of subcontractors (i.e. clinical sites, clinical/investigational pharmacies, clinical/research laboratories, drug distribution centers, biospecimen repositories, etc.), and develop processes to efficiently administer and manage same throughout the project.
Promote applications for subsequent ancillary studies to identify disease targets, develop biomarker-therapy combinations, and establish and validate Patient Reported Outcomes (PROs) and surrogate outcomes for disease progression, treatment efficacy, treatment toxicities, and remission.
Engage and involve multiple foundations and Patient Advocacy Groups through a Patient Advocacy Council (PAC) to help accelerate recruitment and strengthen patient engagement and retention.
Foster productive collaborations with scientists outside of the CureGN network.
Propose plans for collaborations set up as public-private partnerships (http://ppp.od.nih.gov). Such collaborations must include close interaction with the FDA on biomarker and surrogate outcome development. Collaborations with industry on pre-competitive items are encouraged.
The CureGN DCC will serve as the administrative center of the consortium. It will support consortial activities through:
Overall organization and management: The DCC will be responsible for the formation and communication of working groups and the Patient Advisory Council; the conduct of Steering Committee meetings (in person or by phone) and conference calls; development and archiving of study materials and work products; and development and maintenance of consortial policies and procedure manuals.
Study design and implementation: The DCC will collaborate with the PCCs to ensure execution of the study in keeping with the approved CureGN protocol and perform site monitoring to ensure protocol compliance and data integrity.
Data management and analysis: The DCC will coordinate data collection, management and cleaning; develop analytical plans, perform analyses and prepare study reports for the PCCs or other entities performing ancillary studies, in addition to preparing the final protocol for Observational Study Monitory Board (OSMB), External Expert Panel (EEP) and single/central Institutional Review Board (sIRB) review and approval. All data, whether derived through the central protocol or ancillary studies will be sent to the DCC for quality control and analysis. All data collection and analyses (i.e., questionnaires, biochemical measurements, pathological specimens, clinical data) will adhere to the standards of the Clinical Data Interchange Standards Consortium (CDISC) in order to facilitate biomarker, surrogate outcome, and therapy development in accordance with the FDA guidelines.
Biosample management: The DCC will coordinate collection, tracking and shipping of biological samples (e.g. blood, urine, paraffin embedded biopsy tissue blocks, RNA, DNA) as they move from PCCs to internal or external sites for analyses or to the NIDDK Repository.
Community engagement: The DCC will facilitate collaboration with outside scientists and third parties through the development of ancillary studies policies and the management of an opportunity pool. The DCC will serve as the initial point of contact for public-private partnerships.
The CureGN DCC will consist of four components:
Administrative Core: The administrative core will support organization, implementation and management of the study; develop and publish pilot funding and enrichment opportunities supported by the Opportunity Pool.
Data Management Core: The data management core will oversee data collection, integration, management and cleaning; ensure data sharing.
Biostatistical Core: The biostatistical core will support the development of analytical plans for core and ancillary studies, perform interim analyses, and support the development of manuscripts for publication.
Biorepository Core: The biorepository core will support organization and management of physical biological samples (e.g. blood, urine, paraffin embedded biopsy tissue blocks, RNA, DNA) as well as the maintenance of the digital pathology repository.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Application Types Allowed
Renewal of applications from RFA-DK-12-014
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials
NIDDK has set aside $4,600,000 for the CureGN network renewal in FY2019. Of this set aside, NIDDK intends to commit up to $1,600,000 in FY 2019 to fund a single DCC. The award is contingent upon NIH annual appropriations and the submission of a sufficiently meritorious application.
Budget should not exceed $1,000,000 in direct costs for the first year. The application budget should accurately reflect the needs for the DCC.
Award Project Period
The total project period for an application submitted in response to this funding opportunity may not exceed five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Section III. Eligibility Information
1. Eligible Applicants
Only the current CureGN DCC awardee under RFA-DK-12-014 is eligible to apply under this FOA
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.
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.
Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
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.
Only the current UM1 Principal Investigators of the CureGN Data Coordinating Center are eligible to apply under this limited competition FOA.
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 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.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
Section IV. Application and Submission Information
1. Requesting an Application Package
Buttons to access the online ASSIST system or to download application forms 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:
Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
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)
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
, with the following exception:
For this specific FOA, the Research Strategy section is limited to 30 pages.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Attachments: The application must include the following documents, uploaded as a separate pdf file with the names indicated below.
Specific names provided for Other Attachments must be no more than 50 characters including spaces.
1. Clinical Protocol Synopsis: The filename "Clinical Protocol Synopsis.pdf" should be used. The synopsis is meant to supplement the information provided in the Research Strategy and should include the following information:
A description of the study population including CureGN subject eligibility, inclusion/exclusion criteria, and baseline characteristics
A report on the performance toward implementation of the protocol including visit compliance, biosample collection, submissions to the digital pathology repository, and retention rates for the study overall
A description of key study outcomes
A description of DCC network sites and local site leadership
2. Network Products: The filename "Network Products.pdf" should be used. The synopsis is meant to supplement the information provided in the Research Strategy and should include the following information:
A Table of ancillary studies approved by the CureGN Ancillary Studies Committee including ancillary study PI, ancillary study title, status (i.e. complete, active, pending funding, rejected), encumbered sample types;
A Table of publications and publication concepts approved by the CureGN Publications Committee including corresponding author, manuscript title, status (i.e. in development, submitted or in press);
A timeline of completed and proposed network milestones.
The NIDDK Technology Advancement Office must be consulted early in the process when an NIDDK-funded study enters into a collaboration agreement and the NIDDK Regulatory Specialist consulted early in the process when a protocol may be required to operate under an IND/IDE.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Briefly describe the Specific Aims for the CureGN Data Coordinating Center (DCC). The CureGN DCC Specific Aims should be congruent with those of the re-competing CureGN Participating Clinical Centers (PCC) and and should address opportunities to improve care for individuals with glomerular disease related to improving individual level disease trajectory and response to treatment, and implementing precision medicine approaches.
Research Strategy: This section should propose plans for organization and management of the CureGN network. Divide the Research Strategy into the follow sections:
Progress report: document progress toward goals in prior funding period.
Provide a statement of willingness by the Center to fully participate in the cooperative nature of the CureGN network as outlined in Section VI, "Cooperative Agreement Terms and Conditions of Award".
Describe administrative structure of the DCC and support of network activities (e.g. development of policies and protocols, working groups, study website, etc)
Discuss oversight and training to ensure adherence to the highest ethical, research and clinical standards, and any required regulatory standards.
Describe the formation and engagement of a Patient Advocacy Council with wide representation from relevant stakeholders (including patients and their care givers, patient advocacy groups and foundations) willing to inform CureGN research objectives, protocol development and participant retention and to serve as CureGN ambassadors to the larger community.
Describe engagement of junior investigators in the conception, execution, and presentation of network activities.
Describe the single/central Institutional Review Board (sIRB) or the process for its selection. Include a statement confirming that participating sites will adhere to the sIRB Policy (https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm) and describe how communications between sites and sIRB will be handled.
Describe approaches for study monitoring.
Discuss approaches for data quality monitoring
PCC site monitoring
investigator and study coordinator training.
Describe the strategy for enrollment completion and ensuring adequate representation of minority ethnic groups.
Describe the strategy to ensure maximum retention and continued follow-up of the enrolled participants, including type and frequency of measurements as well as relevant outcomes.
Discuss potential approaches to enhance the collection of important non-renal function-based outcomes such as cardiovascular events and immunosuppressive-related morbidity.
Describe approaches to capture outcomes of participants lost to follow up (e.g. use of USRDS records and/or death records).
Describe approaches for data collection, management, tracking and cleaning.
Describe the type and timing of data collected to be sent to the DCC for ultimate deposition to the NIDDK Repository and any processing that will occur prior to submission.
Provide a timeline for submission of all data to public databases (GEO and/or dbGaP).
Describe the analytical plan for baseline, interim, and long-term analyses.
Discuss how further follow-up of the primary cohort will lead to reclassification of glomerular disease patients or identification of sub-groups that will inform the care and management of these patients as well future clinical trials.
Describe approaches for the development of novel or non-classical outcomes (e.g. disease activity, remission/partial remission/relapse, treatment toxicity, graft survival, disease-specific patient reported outcomes).
Describe innovative analytic approaches that integrate high levels of data (e.g. data reduction-based approaches), as well as systems biology approaches. with the goal of uncovering novel disease features for disease subgroup classification, prognosis and the delineation of potential pathophysiologic pathways.
Provide sample size estimates and statistical power calculations appropriate for the proposed analyses.
Biorepository (organization and management of physical biological samples and maintenance of digital pathology repository)
Describe approaches for organization, management, and tracking of biosamples including parrafin embedded biopsy tissue blocks between sites and to the NIDDK Repository.
Describe the type, frequency, and estimated amounts of biological samples to be sent to the DCC for ultimate deposition to the NIDDK Repository during the next project period.
Describe the functions of the Digital Pathology Repository including capacity to scan and return slides to PCCs, data processing, quality control, storage, community access, and general analytic approaches.
Ancillary studies and Opportunity Pool
Describe how investigators outside the current grantees will be brought into the study group to meaningfully supplement expertise to inform study design, data analysis, and interpretation.
Discuss how ancillary studies, including those related to career development, will continue to be promoted and implemented consistent with study policies.
Propose a process for administration of an Opportunity Pool including development, solicitation, and award of pilot funding and enrichment activities.
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:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Resource (Biological Sample) Sharing Plan.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
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 Study
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
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
4. Submission Dates and Times
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.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Section V. Application Review Information
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 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).
Scored Review Criteria
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.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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:
Are the proposed specific aims and scientific questions valuable for improving patient care and clinical outcomes for glomerular disease patients? Does the proposed Center address the needs of the research network that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?
Will continued follow-up with the proposed study design have potential for significant insight into the causes, prognosis, complications and long-term outcomes of glomerular disease that can lead to improvement in the treatment of patients?
Are new opportunities for precision medicine likely to emerge? Will the DCC's support of the CureGN make substantial contributions to research on glomerular diseases? Will the samples and data repository generated from the CureGN cohort be of sufficient value to promote and support ancillary studies to expand the scope of the science for the glomerular disease community?
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 :
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Does the DCC effectively engage junior investigators? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical observational research? Do the investigators demonstrate significant experience with coordinating collaborative clinical and translational research?
If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, organizational structure, governance, and plans for conflict resolution appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Has the applicant team provided clear evidence of obtaining complete and high-quality data, participation in and initiating ancillary studies, membership in subcommittees of the Steering Committee and publications and presentations of the data as well as other key measures of success? Do the current study groups include the appropriate balance of clinical, population and translational expertise for optimal progress? Are any areas of expertise lacking? Is an adequate plan included to engage investigators beyond the immediate study group to inform future study designs and analyses? Have members of the DCC contributed successfully to the network's work products including ancillary studies and manuscripts?
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 novel management strategies, analytical strategies or resources in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies, analytical strategies or resources proposed? Does the description of the patient experience reach beyond standardized Patient Reported Outcomes to better characterize the full range of the patient experience? Have novel approaches to "remote" or "virtual" study participation been considered?
Have non-traditional kidney disease outcomes with unique relevance to nephrotic syndrome been appropriately considered and addressed? Have novel approaches to data collection been considered? Are unique uses for biopsy tissue blocks and the Digital Pathology Repository proposed? Is there sufficient emphasis towards achieving precision medicine within the GN domain (e.g. improve disease classification, predict individual level disease trajectory and response to treatment)?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 :
Has the DCC successfully met the objectives of the prior funding period? Are the proposed analytical strategies sufficiently robust to address the proposed specific aims and scientific questions?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Is the recruitment plan sufficient to reach recruitment goals? Has the DCC harmonized and catalyzed PCC approaches for recruitment, retention, biosample acquisition and data quality? Does the retention plan have a high likelihood of long term success? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed?
Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of human subjects? Will the study adequately address longer term direct and co-morbid outcomes (eg, remission, relapse, cardiac or vascular disease outcomes, infections)?
Have novel methods for "virtual" study participation and ecological momentary assessment been adequately considered?
Is the Digital Pathology Repository sufficiently robust to address the proposed aims? To support useful ancillary studies? Is the plan for collection of archival tissue biopsy blocks well-reasoned and appropriate? Have methods for (semi-) quantitative assessment of histopathologic lesions been appropriately addressed? Are the biological samples collected (type, amount, and frequency) sufficient not only for the needs of the CureGN study groups but also for use by the broader scientific community through the NIDDK Sample Repository?
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 children, 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 for this FOA :
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Additional Review Criteria
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 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 Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
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 children 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.
For Renewals, the committee will consider the progress made in the last funding period.
Additional Review Considerations
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 score.
Applications from Foreign Organizations
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).
Authentication of Key Biological and/or Chemical Resources:
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.
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.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Advisory Council. The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
Section VI. Award Administration Information
1. Award Notices
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 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.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General 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.
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
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 NIH policies. The awardee must also be adherent to Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with awardees consistent with NIH and study policies.
8. Agree that any third-party (including both industry and academia) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, Memorandum Of Understanding, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures. The NIDDK Program Official may consult with others at NIH including the NIDDK Technology Advancement Office.
9. Any involvement of a third party (including both industry and academia) in the study, including access to any study data; study results; using the name of the study; or the name of the NIH or NIDDK, is permitted only after written concurrence by the NIDDK Program Official who may consult with others at NIH including the 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 a company collaborating with the study.
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 Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time.
13. The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If trials conducted under this grant are applicable clinical trials subject to FDAAA, the sponsor or his/her designee will perform the mandatory study registration and reporting of study results to ClinicalTrials.gov. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at http://prsinfo.clinicaltrials.gov/fdaaa.html . In addition, grantees should be aware that clinical trials not covered by FDAAA may still require registration in an approved registry in order to be published, according to the guidelines issued by the International Committee of Medical Journal Editors (http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html ).
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIDDK Project Scientist 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 missions 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:
Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
Review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.
The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.
Areas of Joint Responsibility include:
In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:
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.
Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CR Part 16.
A final RPPR, 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.
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.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)