National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
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.
This FOA invites new applications to participate in the Human Islet Research Network-Consortium on Human Islet Biomimetics (HIRN-CHIB). NIDDK will support the development of a microphysiological system (MPS) that allows the study of interactions between primary human islets or assembled islet spheroids (organoids made up of human beta/alpha/delta/other cells) and immune cells within a 3D microenvironment to mimic aspects of the autoimmune process and its regulation. The ultimate goal will be to create an in vitro human disease model(s) that could recapitulate some aspects of the complex pathophysiology of Type 1 diabetes (T1D), by using T1D patient-derived islets [created using induced pluripotent stem cells (iPSCs)] combined with autologous immune components. CHIB is already part of HIRN, whose overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans.
The need for high quality, well-characterized isogenic/patient-derived iPSC lines and standardized differentiation procedures for achieving maturation of beta cells and other pancreatic islet subtypes is a critical step for HIRN-CHIB. Expansion of islet chip capabilities such as multiplexed hormone sensing, instrumentation and systems engineering for robust control of fluidic and biochemical cellular microenvironments, the integration of bioanalytical systems, and incorporation of novel microfluidic systems that permit the controlled introduction of both stimuli and cells, coupled with the assessment of their impact on islet stress and function will be needed. CHIB will lay the groundwork for establishing reproducible and translatable MPS platforms that are capable of modeling key aspects of T1D pathophysiology. An essential feature of HIRN-CHIB will be a multidisciplinary approach that brings together basic science experts and physician scientists in stem cell biology, bioengineering, immunology, islet biology and T1D.
Funds from the NIDDK will be made available through the UG3/UH3 cooperative agreement award mechanism. The UG3 phase should include sensitive on-chip assays that measure normal islet function. The UG3/UH3 phase should use primary human tissues to help characterize both the maturity and adult function of iPSC-derived tissues, and by the end of the UH3 phase, assembly of an iPSC-based MPS model of T1D should be well-underway.
CHIB has focused on deriving engineered platforms that support the survival, maintenance and function of cadaveric human islets for periods of time up to 4 weeks. Interdisciplinary teams have combined technological advances and knowledge in islet biology, stem cell biology, and microengineering to accelerate progress in creating a human islet biomimetic or MPS. CHIB has generated a network of blood vessels around human islets in microdevices to deliver oxygen, nutrients and promote islet health, developed extracellular matrices that support islet function and survival, and continues to integrate robust, reproducible, and sensitive assays to monitor islet function (such as dynamic insulin secretion). These platforms will enable future investigations focused on how human islets and immune components interact, and provide insight as to how beta cells are lost in T1D. The Consortium on Modeling Autoimmune Interactions (CMAI), also part of HIRN, has been working on the development of "in vivo" humanized models of T1D, thus, the establishment of the in vitro platforms proposed here may support and complement research that is being advanced.
Research Objectives and Scope
UG3 Phase Objectives (up to 2 years)
The UG3 Phase should develop platform technology that allows the study of interactions between primary human islets/re-aggregated islet spheroids (organoids) and immune cells involved in the T1D inflammatory/autoimmune process, and its regulation within a 3D environment.
UH3 phase Objectives (up to 3 years)
HIRN-CHIB's long-term goal is to develop personalized chips for studying T1D. To work towards this goal, an MPS to study islet/immune interactions using an autologous T1D patient based platform will require:
All projects will be milestone-driven with clear go/no-go criteria that are quantifiable and milestones with a timeline, must be included in the application. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed UG3 and UH3 milestones and any changes supported by NIH staff or the NIH review panel. The Program Official and the applicant will negotiate and agree on a final set of approved UG3 milestones which will be specified in the Notice of Award. These milestones will be the basis for judging the successful completion of the work proposed in the UG3 stage and progress toward interim milestones in the UH3 stage. Only UG3 projects that meet their milestones will have an opportunity to move to the UH3 phase. UH3 milestones will be the basis for judging progress towards and completion of interim milestones in the UH3 phase.
Studies of interest for both the UG3 and UH3 phases will examine key cellular and environmental factors controlling autoimmune killing of human cadaveric islets/iPSC-generated islet cell populations. These studies could include the following but are not limited to:
All methods, reagents, resources, biomaterials (including cell lines), protocols, data and models developed by HIRN-CHIB are expected to be made available to the research community. Because individual UG3/UH3 projects will be coordinated through HIRN-CHIB, the timeline and processes for sharing within HIRN-CHIB, and with the community at-large will be established by the HIRN-CHIB NIDDK Project Scientist and the HIRN-CHIB PD(s)/PI(s). All participants are expected to adhere to these policies as a term of the award, consistent with achieving the goals of the program. Policy documents for HIRN-CHIB will be accessible in the HIRN website.
Meetings of HIRN-CHIB
Program Director(s)Principal Investigators(s) of HIRN-CHIB must participate in an initial in-person meeting soon after awards are made, in the annual HIRN Investigator's Scientific Retreat held in the spring, in CHIB teleconference meetings to be held at least tri-annually thereafter, and in the in-person HIRN-CHIB Scientific Fall Retreat, to be held annually. All participants must be obligated to abide by the policies adopted by the majority vote of the HIRN-CHIB Steering Committee. In the application, research project budget requests should include costs for the PD/PI and up to two other members of the individual project to attend the annual HIRN Investigator's Scientific Retreat and the annual in-person HIRN-CHIB meeting.
Cells: The use of transformed or immortalized cell lines is discouraged, except for preliminary, proof-of-concept studies. The use of primary cells and organ explants in initial studies, progressing to pluripotent stem cells, e.g. iPSCs is encouraged. The current NIH guidance on stem cell usage can be found at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx
Collaborations: Collaborative interactions are a critical aspect of this FOA. The development of MPS(s) for modeling T1D will require extensive collaboration among tissue engineers, stem cell biologists, diabetes experts and clinicians. Additional funds may be made available at a later time to support collaborative studies with HIRN-Consortium on Beta Cell Death and Survival (CBDS), to validate or test new therapeutics/biomarkers for T1D, or with HIRN-CMAI, to facilitate complementary studies investigating islet cell/immune interactions in humanized animal models, and the cross-validation of T1D model endpoints with clinical measures in humans.
Applications that include the following types of studies will be considered non-responsive and will not be reviewed:
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.
NIDDK intends to commit $3 million per year in FY 2019 to fund 2-3 awards.
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
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: Provide the overall goals for hypotheses for the entire project period and identify separate Specific Aims to be accomplished in the UG3 phase and in the UH3 phase.
Research Strategy: The applicant must:
Include plans for collaboration among the scientific fields relevant to this FOA, i.e. T1D disease expertise, clinical expertise, tissue chip developers, stem cell biologists
Provide separate sections that describe both the UG3 and UH3 phases
Provide a description of the hypothesis to be tested in the UH3 phase of the study
Go/No-Go Transition Milestones for transition from the UG3 Phase to the UH3 Phase:
The applicant must:
Include clearly identified Go/No-Go transition milestones for completion of the UG3 phase at the end of Year 2 and transition to the UH3 phase for 3 years of additional funding.
A timeline (Gantt chart) including milestones is required for all studies. Yearly quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years.
Milestones and the timeline for each stage must be provided for each UG3 and UH3 section and include the following:
Provide detailed quantitative criteria by which milestone achievement will be assessed.
Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal.
Identify any impediments that could require an addendum to the research plan, milestones, or timeline with a discussion of alternative approaches.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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 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.
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.
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.
The UG3/UH3 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. Although a UG3/UH3 grant application is not required to have extensive preliminary data, background material or preliminary information, some preliminary data to inform feasibility is required; these data should be included if available. Appropriate justification for the proposed work can also be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge of understanding. Reviewers will assign a single impact score for the entire application, which includes the UG3 and UH3 phase.
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: In the project, is there a strong justification/rationale provided for transforming our understanding of normal human physiology of the pancreatic islet? Is there a potential translational benefit derived for the development and use of the proposed MPS? Is the MPS able to recapitulate normal biological indicators of islet function? Does the proposed disease model recapitulate aspects of a clinically relevant model of Type 1 diabetes? Does the application focus on critical gaps to address important questions or obstacles in Type 1 diabetes? Will successful completion of the research aims promote an understanding of Type 1 diabetes pathogenesis and advance the future development of diagnostics and interventions?
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: Is the Multi-PI leadership plan, if applicable, well-described, including plans for dispute resolution? Have project leadership and other key personnel demonstrated a track record of directing and conducting research activities related to creating and validating an MPS, creating and characterizing an iPSC-derived tissue, and have the expertise to create and validate clinically relevant on-chip assays, and models of type 1 diabetes? Are the collaborations, in particular, from disease experts, well-documented, including provision of letters of support? Does the application provide a feasible strategy for collaboration among the scientific fields relevant to this FOA, i.e. disease experts, clinicians, tissue chip developers, stem cell biologists?
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: Are the overall goals of the application conducive to generating significant multidisciplinary investigations that generate robust and reproducible protocols for generating iPSC derived tissues? Expanding islet chip capabilities such as multiplexed hormone sensing, instrumentation and systems engineering for robust control of fluidic and biochemical cellular microenvironments, the integration of bioanalytical systems, and incorporation of novel microfluidic systems that permit the controlled introduction of both stimuli and cells? Generating clinically relevant on-chip assays of function? Generating novel models for studies of type 1 diabetes that will advance basic and translational science and/or future therapy development?
Does the project utilize the current advances of cutting edge technologies? Are the tissue chip platforms, combined with iPSC derivatives being proposed suitable to capture features of normal islet function and is the MPS appropriate for modeling disease?
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 applicant included an adequate description and justification of the MPS and disease model? Are the technologies or experimental approaches state of the art or is there novel use of non-state of the art technology? Will the expected results lead to advances in technologies used in understanding the normal function of the human pancreatic islet, as well as, the pathophysiology of Type 1 Diabetes? Are the proposed approaches, tools, and technologies scientifically justified for the particular MPS and disease model? Does the application identify major technical risks, and are the proposed efforts to mitigate or address the risks clearly defined and feasible? Is the proposed transition plan to the UH3 phase complete and in a logical sequence to the elements of the phased UG3/UH3? Are the conceptual framework, testable hypothesis, design, bioengineered platform, microfluidics, biomechanics, iPSC source and differentiation protocols well-justified?
Milestones. Are appropriate, clearly-defined quantitative milestones provided for the UG3 and UH3 phases of the overall project? Are the UG3 and UH3 milestones feasible, well-developed and quantitative with regard to the specific aims within each phase? Is the overall timeline feasible for the UG3 and UH3 phases? Are the critical decision points (i.e. go/no go decision points) and timelines within the UG3 and UH3 phases appropriate? Are adequate criteria provided in the UG3 phase to assess milestone completion in order to make a decision to advance studies to the UH3 phase?
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?
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.
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.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, and other HHS PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement UG3/UH3, 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:
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 Awardee(s) and NIH staff, CHIB will cooperatively develop and implement processes to submit information and data to the HIRN-AH, 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 Funding Opportunity Announcement.
There will be an initial face-to-face meeting of HIRN and a minimum of 2 CHIB meetings (teleconferences or face-to face meetings) annually. One of these bi-annual meetings could be combined with the annual HIRN Investigator Scientific Retreat. Awardee(s), the CHIB Project Scientist, and the CHIB Program Official are expected to attend these meetings. A team will be established through this program to enable multiple, but coordinated, approaches to advance this area of research. If a single award is made, then CHIB will be governed by the PI and the NIH Project Scientist.
If multiple UG3/UH3s are funded, then CHIB Awardees agree to the governance of the study through a Steering Committee.
HIRN Trans-Network Committee (HIRN-TNC)
The HIRN-TNC will consist of: the PI/PD of the HIRN CC, the PI/PD of the HIRN DCC, and the Steering Committee Chairs and Project Scientists of the HIRN scientific topic consortia (CHIB, CTAR, CMAI, CBDS, and HPAP); the TNC is not a governing body and does not cast votes.
Expert Scientific Panel (ESP)
An independent panel of 2-5 External Experts will be appointed by the NIDDK and meet by teleconference with the CHIB Project Scientist and the CHIB Project Officer at least once a year. The CHIB-ESP will be updated on progress and give feedback to the CHIB PI/PD, Steering Committee and NIH on adjustments and future directions for the CHIB research projects(s). On an annual basis, and following input from the ESP members, NIDDK staff will appoint an ESP Chair who will be required to attend the annual HIRN Investigator Scientific Retreat, to participate in the CHIB Steering Committee meetings as ex-officio, and to serve as the CHIB-ESP representative to the larger HIRN-ESP that will also meet once a year. The CHIB-ESP Chair will be tasked with relaying the CHIB Steering Committee recommendations for new Opportunity Funds Initiatives to the HIRN ESP. All CHIB-ESP members will also be invited to listen as ex-officio to CHIB Steering Committee meetings. Members of CHIB-ESP may be asked, on an ad hoc basis, in the peer review of applications for new research applications that request "opportunity pool" funds. The HIRN-CC will support costs for teleconferences between the ESP and the CHIB Steering Committee, will arrange CHIB-ESP and HIRN-ESP teleconferences, maintain a record of minutes, and support costs for the CHIB-ESP chair to participate in the annual HIRN Investigator Scientific Retreat.
The successful development of disease models using microphysiological system platforms may require either substantial investment and support by private sector industries and/or may involve collaborations with other organizations such as academic, other government agencies, and/or non-profit research institutions not directly involved in CHIB. NIH recognized that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees shall understand and acknowledge the following:
Disagreements that may arise in scientific/technical matter or programmatic matters (within the scope of the award) between award recipients and the NIDDK may be brought to arbitration after first attempting to resolve the issue through the Steering Committee or its subcommittees, as appropriate. An Arbitration 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 awardee. This special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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Contact Center Telephone: 800-518-4726
Ann Jerkins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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