National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This Funding Opportunity Announcement (FOA) invites cooperative agreement applications to continue the mission of the existing Human Pancreas Analysis Program (HPAP). This FOA will support one team of investigators with combined expertise in human pancreas physiology and pathophysiology; collection, processing and multimodal analysis of human pancreatic tissues; and biological database building, curation and management, that will be tasked to: 1) identify, collect and intensively characterize primary pancreatic tissues from patients with type 1 diabetes (T1D), beta cell specific autoimmunity, or rare forms of islet dysfunction that may inform understanding of the pathogenesis of T1D , as well as age-matched controls; and 2) analyze, organize and share the data resulting from the study of these tissues and expand the existing PANC DB open-access resource database. HPAP is a component of HIRN, created in 2014 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 human beta cell mass.
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.
Much remains to be learned about the causes and triggers of T1D in humans. Documenting the series of events that leads to beta cell dysfunction and loss, particularly during the early stages of life and the asymptomatic phase of human T1D, would provide critical insights into the origin of the disease. A molecular exploration of human pancreata could also help identify biomarkers highly specific for early T1D, develop means of controlling the regenerative capacity of the pancreatic compartment in individuals with T1D, and design therapeutic strategies to delay or stop the progression towards clinically overt T1D by slowing or preventing the development of beta cell-specific autoimmunity.
While it is now possible to identify individuals with or at highest risk for developing T1D prior to disease onset, T1D remains a particularly difficult disorder to investigate given our inability to access the target organ in living individuals. Current limitations include:
A deeper understanding of the origins and diversity of human T1D would be greatly facilitated by access to a collection of extensively phenotyped human tissues that could be shared with the research community to develop integrated (molecular, anatomical and functional) signatures of the developing, healthy, and T1D human pancreas at various stages of disease development from autoimmunity to overt clinical disease. In addition, a parallel exploration of pancreatic specimens collected from individuals with islet dysfunctions unrelated to T1D, or from individuals with conditions characterized by changes in beta cell mass, could facilitate the discovery of molecular signatures that are highly specific for beta cell dysfunction in T1D and the exploration of the regenerative capacity of pancreatic islets in individuals with T1D.
In 2016, NIDDK started filling in this gap in knowledge by creating the HPAP (RFA-DK-15-027), a resource-generation and data-analysis component of the HIRN. The mission of the HPAP is to apply a suite of technologies with single-cell resolution to the description of fixed pancreatic tissues and live cells, and to combine these measurements with a series of functional assays to obtain a high-resolution characterization of the human endocrine pancreas and its interaction with the immune system in a given tissue donor (https://hirnetwork.org/consortium/hpap). The primary function of the HPAP is to collect, analyze, and distribute the high value datasets resulting from this deep, extensive and systematic tissue phenotyping to the diabetes research community through a searchable community database called PANC DB (https://hpap.pmacs.upenn.edu/ ). HPAP is currently supported by Special Diabetes Program funds for a pilot phase of 3 years, and focuses primarily on the collection and phenotyping of stage 1 T1D (multiple antibodies), recently diagnosed T1D, established T1D and matched control donor pancreata. A Companion Funding Opportunity (RFA-DK-18-016) will support the expansion of the operational scope of the existing HPAP to the study of pancreata recovered from tissue donors with Type 2 Diabetes (T2D) and related metabolic disorders.
Research Goals and Objectives
The goal of this initiative is to build upon the progress made by HPAP during the 3-year Pilot Phase, and to continue to improve, develop and implement strategies for:
For this second phase of HPAP activities, investigators are asked to complete the following tasks:
1) Continue to assemble and phenotype a diverse collection of human pancreata:
A candidate HPAP team should propose and implement a strategy for identifying and collecting human pancreatic specimens from donors with stage 1 T1D, recently-diagnosed T1D, established T1D or other physiological conditions affecting pancreatic beta cell mass or function, as well as from age-matched healthy donors. HPAP should establish criteria for inclusion/exclusion of tissues into the HPAP collection with the goal of generating datasets that reveal unique aspects of pancreatic function/dysfunction associated with the development of T1D, interactions between various pancreatic tissue compartments and the immune system, or the capacity of the human endocrine pancreas to regenerate a functional beta cell mass.
At a minimum, HPAP activities should include the following activities:
2) Further develop and populate PANC DB:
HPAP will continue to be responsible for organizing and integrating all functional, anatomical and molecular data and metadata generated from the HPAP tissue analyses into the comprehensive and searchable community database PANC DB that will serve as an extensive source of information about the healthy and diseased human pancreas. The continuing development of PANC DB and its associated portal will continue to require the active involvement of a stellar computational group with demonstrated expertise in building and applying state-of-the-art analytical tools for the integration and visualization of datasets generated using different experimental modalities such as image-generating and multiple omics technologies. Whenever possible, the HPAP computational analysis team should leverage strategies and tools that are being developed or used for the multimodal phenotyping of other complex tissues rather than reinventing tools and approaches specific to the pancreatic tissue. HPAP applicants are strongly encouraged to use the Cloud-based platform (Blackfynn, https://www.blackfynn.com/ ?) currently being used as the computational backbone for PANC DB's data organization, curation, visualization and sharing. If HPAP applicants propose to use an alternative computational infrastructure for PANC DB, they will need to describe in details and convincingly what the added benefits of this new platform actually are, as well as a plan to incorporate and integrate all existing HPAP datasets to this new platform. Ideally, the information accessible through PANC DB will represent an extensive cellular and molecular analysis of all cell types present in the human pancreas to include exocrine and endocrine cell subtypes, intra- and inter-islet vascular and neuronal networks, pancreatic ducts and immune cells. As a resource, PANC DB should enable the scientific community to explore important aspects of pancreatic function and dysfunction, and should facilitate scientific endeavors such as exploring 3D structural and functional relationships at the cellular and organ-wide level, generating mechanistic hypotheses related to T1D pathogenesis or the regenerative capacity of the human endocrine pancreas, or identifying cell-specific biomarkers and candidate drug targets. In order to achieve these goals, the HPAP computational biology team should undertake most if not all of the following functions:
3) Improve on the existing HPAP workflow when necessary:
Applicants are encouraged to draw lessons from the pilot phase to propose changes to HPAP’s mode of operations if deemed desirable to increase the quality and/or value of HPAP’s resources and deliverables. Changes could include (but are not limited to):
When considering changes to existing HPAP protocols, experiments, analyses or resource-generation, investigators should carefully consider the value of the data already collected during the pilot phase and the importance of producing a consistent and comparable collection of datasets over time. Strong rationale should be given for dropping-off experimental protocols that were part of the original HPAP workflow. If new assays are proposed to complement the current workflow, investigators should indicate whether the new assays can and will be run on residual HPAP samples collected during the pilot phase.
4) Forge partnerships with relevant investigator communities and research programs:
HPAP will be responsible for leveraging the activities of relevant programs through the formation of strategic partnerships with existing efforts related to its mission. Such partners should include at least the following:
Other Special performance Requirements
The HPAP investigators may be asked to identify fixed and variable costs and establish procedures for negotiation of third party agreements or selection of subcontractors and develop processes to efficiently administer and manage same throughout the project.
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.
Renewal applications from RFA-DK-15-027
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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.
HPAP applicants should include in their research strategy:
Given the need for a multidisciplinary approach to HPAP's mission, applicants are strongly encouraged to structure their application as a multi-investigator (multi-PI) project, and to include a detailed Leadership plan in their application.
The following modifications also apply:
Upon completion or termination of the HPAP project, the awardee is responsible for making all HPAP data collections and tools broadly available (e.g., putting into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research, as appropriate. The data sharing plan should include a sustainability strategy to ensure access to HPAP data by the community once the project period expires.
Letters of Support: HPAP applications should identify the tissue source sites and provide supporting letters from these sites to demonstrate capacity and commitment to deliver the types and numbers of human pancreatic specimens described in the grant application.
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.
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.
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: Is the combination of phenotypic assays, multimodal analyses and number of human tissues to be analyzed likely to yield significant new knowledge regarding the development of human T1D? Is the sharing of the data with the research community likely to amplify the impact of the HPAP's data-generation and data-analysis effort, for example by stimulating hypothesis-driven follow-up studies?
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: Does the team have a convincing track record of accessing and processing human pancreatic tissues, including experience in skilled and expedited autopsy, sample acquisition and processing, preservation, as well as collection and completion of proper documents, including consents? Do PD(s)/PI(s) provide evidence of experience running the suite of phenotypic assays proposed in the application? Does the computational team have a convincing track record of collecting, curating, analyzing and sharing large and complex datasets through community portals or databases? Do PD(s)/PI(s) provide evidence of experience working productively in collaborative environments?
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: Will some of the proposed phenotypic and omics assays be applied for the first time to human pancreatic tissues, thereby increasing the likelihood of discovering new biological paradigms? What is the level of innovation of the proposed computational strategies for integrated analysis of various datasets generated from the same donor tissue?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? ?Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: Is the proposed plan for efficient collection, processing and documentation of cadaveric donor tissues appropriate and feasible? Are the investigators proposing at a minimum to perform the suite of phenotypic assays on human pancreatic cells and tissues that are required by this initiative, including experiments in histology, islet cell sequencing (RNAseq, ATACseq and whole genome bisulfite sequencing), islet physiology (calcium imaging, electrophysiology, oxygen consumption, perifusion studies for insulin and glucagon) and mass cytometry analysis (flow cytometry andimaging mass cytometry)? Are the estimated number and types of human pancreatic tissues to be processed and analyzed during the funding period adequate and justified? Is the plan for data sharing with the community and management of collaborations with non-HPAP investigators satisfactory?
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) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.
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 administrative and funding instrument used for this program will be the cooperative agreement U01, 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 and NIH staff, HPAP will determine criteria and processes for quality control of information and data to be posted for the research community, consistent with NIH policies and achieving the goals of the program as described in the Funding Opportunity Announcement. There will be an annual face-to-face meeting of HPAP and at least one other HPAP meeting (teleconference or face-to-face meeting) annually. These meetings could be combined with the annual meetings of the HPAC. The HPAP PD/PI, the HPAP Project Scientist, the HPAP Program Official and the Chair of the HPAP Expert Scientific Panel are expected to attend these meetings.
The HPAP Awardee agrees to the governance of the HPAP through a Steering Committee of the HPAC.
HIRN Trans-Network Committee (HIRN-TNC)
The HIRN-TNC will consist of: the PD/PI of the HIRN-AH and the Steering Committee Chairs and Project Scientists of the HIRN scientific consortia (CHIB, CTAR, CMAI, CBDS and HPAC); the TNC is not a governing body and does not cast votes.
The TNC will facilitate communication and foster collaboration across the different consortia.
The TNC will be responsible for organizing the yearly HIRN Scientific Investigator’s Retreat.
The TNC will meet by teleconference at least twice a year and will be organized by the HIRN-AH. Subcommittees of HIRN, as well as working groups for scientific planning may be established and require participation by HPAC members through in-person, electronic, or teleconference meetings, as appropriate. The HIRN-AH is responsible for providing and maintaining a record of minutes of all TNC meetings, which will be approved by the TNC.
Expert Scientific Panel (ESP)
An independent panel of 2-3 External Experts will be appointed by the NIDDK and meet by teleconference with the HPAC Project Scientist and the HPAC Project Officer at least once a year. The HPAC-ESP will be updated on progress and give feedback to NIH on adjustments and future directions for the HPAC research projects (including HPAP). 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 to the HPAC Steering Committee meetings as ex-officio, and to serve as the HPAC-ESP representative to the larger HIRN-ESP that will also meet once a year. The HPAC ESP Chair will be tasked with relaying the HPAC Steering Committee recommendations for new Opportunity Funds Initiatives to the HIRN-ESP. All HPAC-ESP members will also be invited to listen as ex-officio to HPAC Steering Committee meetings. Members of the HPAC-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-AH will support costs for teleconferences between the ESP and the HPAC Steering Committee, will arrange the HPAC-ESP and HIRN-ESP teleconferences, maintain a record of minutes, and support costs for the HPAC-ESP chair to participate in the annual HIRN Investigator Scientific Retreat.
Disagreements that may arise in scientific/technical matter or programmatic matters (within the scope of the award) between award recipients and the NIH 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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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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