Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
U01 Research Project – Cooperative Agreements
None
This FOA invites applications for continuation of the Collaborative Islet Transplantation Registry (CITR). Since 2001, this Registry has compiled and analyzed islet transplantation data with the intent to capture all clinical activity in North America as well as additional sites in other countries. Currently, data on both allo- and autotransplantation are collected. The registry will collect data and develop and maintain sophisticated databases to be used by the research community for publications and presentations. CITR will also prepare an annual report available to the public summarizing outcomes of islet transplantation and trends over time as well as conduct an annual CITR meeting for contributing sites. Collection and analysis of this information will contribute to identifying risk factors and key safety and efficacy determinants of successful therapy of islet transplantation as a treatment for patients with type 1 diabetes and pancreatectomy.
September 20, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 20, 2021 | October 20, 2021 | Not Applicable | March 2022 | May 2022 | July 2022 |
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
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 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.
Purpose and Research Objectives
This cooperative agreement is intended to maintain support for the Collaborative Islet Transplantation Registry (CITR). This Registry provides a compilation of the human islet transplantation experience from 1999 to the present. Collection of North American and international data is currently supported by NIDDK under the Special Statutory Program on Type 1 Diabetes Research. Data on pancreas donors, islet preparations, transplantation procedures and associated therapies, and recipient outcomes is obtained using standardized case report forms collected from islet transplant centers. Data is collected for both allo- and autotransplantation. This complex data is entered into a secure database for analysis by CITR and the research community. Results of comprehensive biostatistical analyses are communicated to islet transplant centers, the broader medical community, and the general public in an annual report and in scientific presentations/publications. CITR contributes to the assessment of islet transplantation as a therapeutic option for type 1 diabetes patients. Its data enables researchers to track and analyze successfully engrafted patients and those who experience graft failure. This effort is necessary to understand the factors contributing to success or failure of islet transplantation protocols and to develop approaches for continued improvements that will result in sustained graft function and therapeutic durability. As clinical islet transplantation evolves with a focus towards a longer lasting treatment, CITR will serve stakeholders considering islet transplant therapy by providing an evidence based approach for therapeutic decision making.
Background
The success of the "Edmonton Trial" in 1999 catalyzed the formation of many North American and international islet cell transplant programs. In 2001, NIDDK awarded a competitive contract to The EMMES Corporation, Rockville MD for support of the Collaborative Islet Transplantation Registry (CITR). Under subsequent NIDDK awards, the collection and analysis of islet transplant data was expanded beyond allograft therapy for type 1 diabetes to also include autograft therapy after pancreatectomy. In addition to establishing a comparator group,data is just beginning to be collected on pancreatectomy patients who have not received autograft therapy. Although initially funded by the JDRF (formerly known as the Juvenile Diabetes ResearchFoundation), international islet transplantation data collection is now solely funded by the NIDDK. CITR pools both retrospective and prospective data from participating programs and, as of March 2021, has 1419 registered islet allograft recipients, 1226 islet autograft recipients and 3406 islet preparations in its databases. CITR prepares a comprehensive annual report; current and past reports are available to the public and can be downloaded or requested in hard copy at www.citregistry.org. This website also contains detailed information concerning the Registry, participating transplantation sites and investigators, clinical protocols, etc. Scientific publications summarize key findings and results from additional focused analyses of the data. Results are also presented at major meetings on islet transplantation, diabetes and general transplantation.
The Registry has developed standardized case report forms and procedures that are the basis for data collection. Data reported to the Registry are abstracted from medical records, information routinely collected by investigators for reports required for U.S. Food and Drug Administration (FDA) regulated trials, as well as other research data. CITR utilizes a web based data entry and management system to capture data on donors and recipients. Donor and islet processing data are also obtained through a data sharing agreement with the United Network for Organ Sharing (UNOS). Through these data entry efforts, duplication is minimized and more consistent data defining terms and data fields are achieved. Approved requests for relevant statistical analyses are also conducted by CITR statisticians for the research community.
The CITR continues to improve procedures for data collection and analysis. In 2009, in response to requests by islet transplant centers, CITR expanded the database to accommodate data for a given islet recipient at any time point. This expansion allows islet transplant sites to have a single, comprehensive source database for all their own islet transplant activities, obviating the need for duplicate databases. This enhancement provides a unified data capture system for centers without this capacity and for data entry harmonization. This data entry system is available without cost in a customized version to all islet transplantation centers. CITR also developed a new database for islet autograft transplantation. Patients requiring an islet autograft typically have intractable pancreatitis or premalignant tumors that require complete pancreas resection. To prevent or minimize diabetes following pancreatectomy, select transplantation centers isolate the islets from the affected pancreas and re-infuse them intraportally. This endeavor may allow autograft vs. allograft islet transplant outcome assessment comparisons that enable evaluation of the impact of immunity and immunosuppression. To decrease missing data and to simplify data entry, CITR has decreased the number of data elements and has prioritized key data elements.
Scope of Research
The CITR will continue to serve as a resource for the islet transplantation research community. It will compile and analyze clinical data on islet cell transplants within North America and participating international centers. Guidance and input for improvement of CITR activities will come from the NIDDK Program staff, Steering Committee, and External Evaluation Committee. CITR will address fundamental questions pertinent to continued improvement in outcomes following islet transplantation. Toward these goals, the CITR will:
a) Maintain the existing Registry database and refine or expand it as required. This database will have capabilities for storing data received by internet data entry case report forms, data uploaded through a project website or received through secured and password protected media. Currently the Registry supports data transfers from more than 30 clinical North American and international centers as well as UNOS. The database must be compliant with current federal regulations with an automated information system security profile, to include the systems security plan, a risk analysis and a contingency plan. All patient identifiable data is subject to the Privacy Act and DHHS regulations.
b) Maintain and refine existing data collection forms, involving additional expertise for this purpose as recommended by the External Evaluation, other standing committees and the NIDDK.
c) Design and conduct interim and final statistical analyses of study data and participate in the preparation of scientific publications and presentations. In addition, coordinate and support the preparation of publications derived from the analyses of data collected by the registry on topics of relevance identified by the scientific community.
d) Develop and implement specific SOP's regarding the receipt and exchange of data and assume responsibility for establishing and implementing data sharing agreements with other applicable sites and programs.
e) Train newly affiliated transplant centers in the use of the database.
f) Monitor clinical sites for quality assurance and quality control procedures that evaluate and, when necessary, improve the accuracy, timeliness and completeness of data provided by the clinical sites. This may require on site presence, with variable levels of software programming needed to produce uploaded data in an acceptable format from heterogeneous computer and software systems. CITR will make the necessary modifications and perform data transfer testing to assure data integrity.
g) Maintain and provide continued development of the CITR public and password protected website to foster communication of information pertinent to clinical islet transplantation.
h) Submit on an annual basis a report summarizing the results of the entire research calendar year data. This Annual Report will be in sufficient detail to comprehensively explain the results.
i) Notify NIDDK of adverse experiences for each clinical site including copies of adverse experience report forms and inform NIDDK of monthly site registration and data submission activity.
j) Maintain and develop the islet autograft database. It is noteworthy that although islet autograft activity is increasing, most data is collected from only a limited number of sites and is often incomplete due to loss of follow-up. Therefore, it is anticipated that the Program Director/Principal Investigator (PD/PI) will need to collaborate and interact with these selected sites to perform patient searches, contact patients and their current physicians to obtain fragmentary or missing data. These data will be entered into the CITR database and subjected to comparative statistical analyses with islet allo-transplantation.
k) Coordinate and provide statistical, technical, administrative, and logistical support for the activities of the Steering Committee, and Standing committees that are responsible for the overall scientific direction, management, and direction of the Registry. Currently the Steering Committee is composed of five members. Current Standing committees include; The Compliance committee (five members); Publications and Presentations Committee (six members); Data Monitoring Committee (five members); Data Managers/Transplant Coordinators Committee (six members).The above indicated membership refers to non-federal members. These responsibilities encompass preparation of rosters, scheduling of meetings and conference calls, preparation of materials, arranging travel and meeting logistics, and preparation of meeting summaries.
l) Organize and support an annual CITR meeting to be held in the Washington DC area. This meeting includes all clinical centers contributing data to CITR as well as other interested parties such as the FDA.
m) Collect data to evaluate outcome analyses of pancreatectomy alone versus pancreatectomy plus autoislet transplantation
n) Will begin collecting key elements of continuous glucose monitoring in diabetes trials, given the increasing use of this important diabetes treatment monitoring tool.
o) Make efforts to collect appropriate safety and efficacy data to monitor progress in areas related to diabetes cellular treatment modalities, such as stem cell derived beta cells/islets given they are becoming more commonplace.
See Section VIII. Other Information for award authorities and regulations.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIDDK intends to commit $800,000 in FY 2022 to fund one award.
Application budgets are limited to $500,000 Direct Costs per year. Budgets are expected to reflect the actual needs of the proposed project.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
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.
Letter of Intent
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 F. Connaughton, Ph.D,
Scientific Review Branch
National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofintent@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: The applicant should provide information on experience that is relevant to conduct operations associated with the Collaborative Islet Transplantation Registry, without duplicating information in biosketches. In addition the applicant should address how they plan to:
a) Maintain the existing Registry database and refine or expand it as required. This database will have capabilities for storing data received by internet data entry case report forms, data uploaded through a project website or received through secured and password protected media. Currently the Registry supports data transfers from more than 30 clinical North American and international centers as well as UNOS. The database must be compliant with current federal regulations with an automated information system security profile, to include the systems security plan, a risk analysis and a contingency plan. All patient identifiable data is subject to the Privacy Act and DHHS regulations.
b) Maintain and refine existing data collection forms, involving additional expertise for this purpose as recommended by the External Evaluation, other standing committees and the NIDDK.
c) Design and conduct interim and final statistical analyses of study data and participate in the preparation of scientific publications and presentations. In addition, coordinate and support the preparation of publications derived from the analyses of data collected by the registry on topics of relevance identified by the scientific community.
d) Develop and implement specific SOP's regarding the receipt and exchange of data and assume responsibility for establishing and implementing data sharing agreements with other applicable sites and programs.
e) Train newly affiliated transplant centers in the use of the database.
f) Monitor clinical sites for quality assurance and quality control procedures that evaluate and, when necessary, improve the accuracy, timeliness and completeness of data provided by the clinical sites. This may require on site presence, with variable levels of software programming needed to produce uploaded data in an acceptable format from heterogeneous computer and software systems. CITR will make the necessary modifications and perform data transfer testing to assure data integrity.
g) Maintain and provide continued development of the CITR public and password protected website to foster communication of information pertinent to clinical islet transplantation.
h) Submit on an annual basis a report summarizing the results of the entire research calendar year data. This Annual Report will be in sufficient detail to comprehensively explain the results.
i) Notify NIDDK of adverse experiences for each clinical site including copies of adverse experience report forms and inform NIDDK of monthly site registration and data submission activity.
j) Maintain and develop the islet autograft database. It is noteworthy that although islet autograft activity is increasing, most data is collected from only a limited number of sites and is often incomplete due to loss of follow-up. Therefore, it is anticipated that the Program Director/Principal Investigator (PD/PI) will need to collaborate and interact with these selected sites to perform patient searches, contact patients and their current physicians to obtain fragmentary or missing data. These data will be entered into the CITR database and subjected to comparative statistical analyses with islet allo-transplantation.
k) Coordinate and provide statistical, technical, administrative, and logistical support for the activities of the Steering Committee, and Standing committees that are responsible for the overall scientific direction, management, and direction of the Registry. Currently the Steering Committee is composed of five members. Current Standing committees include; The Compliance committee (five members); Publications and Presentations Committee (six members); Data Monitoring Committee (five members); Data Managers/Transplant Coordinators Committee (six members).The above indicated membership refers to non-federal members. These responsibilities encompass preparation of rosters, scheduling of meetings and conference calls, preparation of materials, arranging travel and meeting logistics, and preparation of meeting summaries.
l) Organize and support an annual CITR meeting to be held in the Washington DC area. This meeting includes all clinical centers contributing data to CITR as well as other interested parties such as the FDA.
m) Collect data to evaluate outcome analyses of pancreatectomy alone versus pancreatectomy plus autoislet transplantation
n) Will begin collecting key elements of continuous glucose monitoring in diabetes trials, given the increasing use of this important diabetes treatment monitoring tool.
o) Make efforts to collect appropriate safety and efficacy data to monitor progress in areas related to diabetes cellular treatment modalities, such as stem cell derived beta cells/islets given they are becoming more commonplace.
Renewals
For Renewals, progress made in the last funding period should be identified. Specific considerations may include the number of annual reports, presentations, publications, and number of active sites, changes in data collection to decrease the amount of missing data as well as other operational aspects.
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:
When involving human subjects research, clinical research, and/or NIH-defined 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.
Note: 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.
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" (https://cde.nlm.nih.gov/home/) 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.
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.
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.
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).
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 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: To what extent does the application address the needs of CITR? How appropriate is the scope of activities proposed for CITR to meet those needs? .
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: For multi-PD/PI projects, are plans for conflict resolution appropriate for CITR? Does the applicant have experience overseeing selection and management of sub-awards, if needed?
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: How novel are the proposed organizational concepts, management strategies, or statistical analyses related to the operations of CITR? How innovative are the applicant's plans for conducting the Research Strategy?
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?
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?
Specific to this FOA: How well-reasoned and appropriate are the operational plan and organization structure to accomplish the goals of CITR?
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: To what extent will the CITR benefit from unique features of the Institutional environment, infrastructure, or personnel?
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 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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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.
Vertebrate Animals
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.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
For Renewals, the committee will consider the progress made in the last funding period. Specific considerations may include the number of annual reports, presentations, publications, and number of active sites, changes in data collection to decrease the amount of missing data as well as other operational aspects.
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
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.
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 Diseases Advisory Council (NIDDKAC). The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient'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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.
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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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. 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.
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.
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.
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 recipients 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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Through the Recipient, Steering Committee and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the Coordinating Center (CC), determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the FOA.
Executive Committee (EC)
Steering Committee (SC)
The Steering Committee (SC) composed of the CITR PI, or Contact PD/PI(s) in the case of multi-PD/PI grants, selected PIs from sites contributing data to CITR and the NIH Project Scientist(s) will be the main governing board of the U01. Each full SC member will have one vote. All major scientific and policy decisions will be determined by (voting policies as established by the SC at the initial meeting). This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project. The SC activities and decisions will consider the advice of the External Consultants [External Experts].
External Consultants
An independent panel of External Consultants will be established by the NIDDK. The External Experts will review periodically interim progress of the U01s and report to NIDDK staff. Members of the panel of External Experts may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special “opportunity pool” funds.
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)
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
Thomas L. Eggerman, M.D., PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8813
Email: eggermant@mail.nih.gov
Peter J. Kozel, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4721
Email: kozelp@mail.nih.gov
Christina Coriz
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8848
Email: corizc@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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