Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) invites cooperative agreement applications to expand the operational scope of the existing Human Pancreas Analysis Program (HPAP) to the study of pancreata recovered from tissue donors with Type 2 Diabetes (T2D) and related metabolic disorders. 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, with a program goal of further advancing research through a shared resource, by tasking the team with : 1) identifying, collecting and intensively characterizing primary pancreatic tissues from patients with T2D and related forms of islet dysfunction, as well as age-matched controls; and 2) analyzing, organizing and sharing the data resulting from the study of these tissues through use and expansion of the existing PANC DB open-access resource database. HPAP is a component of the Human Islet Research Network (HIRN), created in 2014 to support innovative and collaborative translational research to understand how human beta cells are lost in Type 1 Diabetes (T1D), and to find innovative strategies to protect and replace functional human beta cell mass.
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.
Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
Much remains to be learned about the contribution of specific components of the islet tissue environment to the tightly-regulated functioning of the human endocrine pancreas, to the capacity of the tissue to respond and adapt to metabolic and environmental challenges during the life of an individual, and to pathogenic processes involved in the development of a variety of metabolic disease types, disease subtypes, and disorders. Our inability to easily access the target organ in living individuals, or to extract meaningful biological information from cadaver donor pancreata, limits our knowledge of pancreatic tissue architecture, cell composition and function to studies in rodent models. This lack of knowledge about the basic working components of the human pancreatic tissue, and about how the islet tissue environment may vary within a diverse human population in both health and disease, significantly impairs our ability to develop therapeutic strategies that can address specific changes in islet composition or function that contribute to the development of a given metabolic disease state.
In 2016, NIDDK started filling in this substantial gap in knowledge in the specific context of T1D pathogenesis by creating the HPAP, a resource-generation and data-analysis component of the larger HIRN research network. 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 for a Pilot Phase of 3 years, and focuses on the collection and phenotyping of early stage T1D ( beta cell specific autoimmunity), recently diagnosed T1D, established T1D and matched control donor pancreata. Renewal of the current activity of HPAP with its focus on T1D pathogenesis is supported through a Companion Funding Opportunity (RFA-DK-18-015).
Research Goals and Objectives
This initiative proposes to leverage the investment that NIDDK has already made in creating HPAP, and to expand the operational scope of the program to include, as a priority, the deep phenotyping of human pancreata from donors with T2D and pre-diabetes. This HPAP-T2D initiative could also be used to analyze pancreata collected from donors with other metabolic conditions where changes in islet beta-cell composition, mass, and/or function are known to contribute to metabolic dysfunctions. The practical deliverable of this new effort would be to generate highly-informative, high-resolution datasets that will be made readily available to the diabetes, obesity and metabolic syndrome research community. The broader goal is to help investigators around the world formulate novel hypotheses about human disease pathogenesis and heterogeneity (that could be further explored or validated through future grant applications or other funding means) and to facilitate the development of innovative or more targeted therapeutic strategies for treating metabolic disorders and diabetes. This HPAP-T2D initiative will support one project that proposes to build upon the progress made by HPAP during its 3-year Pilot Phase and to expand HPAP’s original scope to:
Collect and extensively characterize pancreata recovered from individuals with T2D, pre-diabetes, insulin resistance, gestational diabetes,or metabolic conditions characterized by changes in islet beta-cell composition, mass or function (such as obesity, recent gastric bypass surgery and pregnancy).
Organize all functional, omics and image-based datasets derived from the study of HPAP-T2D tissues into the existing HPAP open-access database for direct access and use by the diabetes research community.
Practically, and at a minimum, HPAP-T2D investigators are asked to complete the following tasks:
1) Assemble and phenotype a diverse collection of human pancreata relevant to T2D pathogenesis and heterogeneity:
HPAP-T2D should propose and implement a strategy for identifying and collecting human pancreatic specimens from donors with T2D and related metabolic phenotypes, as well as from age-matched healthy donors. HPAP-T2D should establish criteria for inclusion/exclusion of tissues into the HPAP-T2D collection with the goal of generating datasets that reveal unique aspects of pancreatic function/dysfunction associated with the development and/or heterogeneity of T2D. Given the limited funding provided through this initiative, investigators will need to focus their area of investigation to collect enough specimens to answer important biological questions with enough statistical power. For example, priority could be given to comparisons between diabetic and non-diabetic obese individuals, or to exploring certain aspects of disease heterogeneity (in relation to genetic risk, ethnic background, etc.). Efforts to minimize confounding variables in what will be a small donor pool should also be considered, for example by defining a donor age range for tissue collection.
At a minimum, HPAP-T2D activities should include:
Identify, coordinate and manage tissue source sites to acquire human pancreata from cadaver donors that are relevant to the mission of HPAP-T2D. The tissue source sites would be responsible for skilled and expedited autopsy, sample acquisition and processing, preservation, as well as collection and completion of proper documents, including consents. HPAP-T2D should ensure that the human sample collection and handling procedures comply with current NIH policies;
Collect whenever possible the de-identified medical records of the donors to include diabetes or pre-diabetes history, but also information about co-morbidities such as vascular disease, renal insufficiency, medications and overall health. At a minimum, all the information currently collected by the HPAP team on each and every tissue donor should be provided and shared through PANC DB under the formatted “Donor Summary” tab;
Process pancreata using protocols that allow for multiple analytical paradigms to be performed on the same specimen, including functional studies on subsets of live islets, sorted endocrine and immune cells, and a variety of molecular studies on fixed tissue. Ideally, this fine-processing step should be performed by a single team and at a single site, to minimize output variability. The proposed tissue-processing strategy should closely mimic the current HPAP protocol for systematic isolation of live islets from part of the tissue (to be used for functional studies of islets and transcriptomics analyses on sorted islet cell populations) and fixation of the rest of the specimen using a variety of procedures to allow for multiplexed analyses using antibody-based technologies (such as immunocytochemistry or imaging mass cytometry) and multi-omics analyses with single-cell resolution (such as sequential RNA FISH, single nucleus RNA-Seq, or single nucleus ATAC-seq);
Define and run a standard set of deep phenotyping experiments (molecular, functional and anatomical) to create a reference dataset that would be associated with each and every HPAP-T2D specimen. At a minimum, this set of experiments should include the major analyses currently being run within the existing HPAP, and following the same protocols, to ensure consistency and continuity between the datasets that were generated during the pilot phase of HPAP and those to be produced through this new production phase. The list of assays systematically run by HPAP are documented on the PANC DB portal (https://hpap.pmacs.upenn.edu/#research ) and includes experiments in histology (histological sectioning and staining), 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, imaging mass cytometry). The extensive profiling of immune cell populations currently being performed in HPAP, i mportant in the context of a focus on T1D pathogenesis, could be scaled back in HPAP-T2D and limited to the characterization of immune cell types that are involved in peri-islet inflammatory processes.
Identify what could be the specific needs for the HPAP-T2D and propose changes to HPAP’s existing suite of phenotypic assays as described on the PANC DB portal. Such changes could include (but are not limited to):
Introduction of new assays or technologies that may produce high-content data that complements in significant way the data already being generated by the HPAP suite of assays, or that may be important to implement in the specific context of T2D biology;
Technological improvements on existing assays to optimize throughput or sensitivity, or to significantly minimize the number of cells needed or the experimental cost;
Cancellation of assays that are concluded to be too costly in relation to the biological significance of the data being generated, or to be redundant with other assays in the pipeline;
Phenotypic characterization of tissue types, tissue compartments or cell populations not included in the initial program workflow;
Collection and archiving of relevant tissues other than the pancreas and its associated lymphoid organs, not necessarily for systematic analysis through HPAP, but for future analysis through collaborations as supported through other funding means.When considering changes to existing HPAP protocols, experiments, analyses or resource-generation, investigators should carefully consider the value of the data already collected by HPAP 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.
Catalog, annotate and store all residual (unused) pancreatic tissues and cells with methods that preserve bio-specimen integrity and will allow future experiments beyond the standard suite of phenotyping analyses supported by HPAP.
2) Contribute T2D-relevant datasets to PANC DB:
The HPAP-T2D team should work closely with the existing HPAP computational analysis team to ensure proper integration of HPAP-T2D datasets into PANC-DB. The two teams will be jointly responsible for organizing and integrating all functional, anatomical and molecular data and metadata generated from the HPAP-T2D tissue analyses into a comprehensive and searchable community database that will serve as an extensive source of information about the healthy and diseased human pancreas. Ideally, the HPAP-T2D 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. This resource 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 T2D pathogenesis or the disease diversity in the human population, or identifying novel candidate drug targets. In order to achieve these goals, the HPAP and HPAP-T2D computational biology teams should undertake most if not all of the following functions:
Share datasets with the research community as soon as they are generated and quality-controlled;
Develop and improve tools and protocols to efficiently extract, curate and incorporate all data resulting from the study of HPAP-T2D tissues into the HPAP database. The database should be flexible and extensible to manage and integrate multiple types of data, including genomics, proteomics and metabolomics data, but also complex image-based datasets;
Develop/adapt analysis tools for data integration, including for the co-registration of data of disparate but complementary nature (anatomical, functional and multiple omics);
Develop, maintain and enhance an open-access portal with user friendly interfaces to allow the research community easy access to the data;
Develop/adapt and share tools for on-line data mining, image analysis and visualization of data and metadata by the research community;
Work to incorporate datasets resulting from additional experiments performed on HPAP-T2D samples (such as through collaborations to further analyze HPAP-T2D cells and tissue sections), and link the HPAP database to relevant existing resources;
Work closely with the user community to build or make available any additional tool or feature that can facilitate the deposition, archiving, extraction, analysis or visualization of data;
Assist HIRN investigators in accessing and analyzing HPAP-T2D datasets through presentations, webinars, tutorials and hands-on workshops;
Advertise HPAP-T2D’s activities and resources to the scientific community worldwide through publications and presentations at international meetings;
Ensure that datasets and documentation are in a widely-adopted “standard format” for continuing data accessibility beyond the close out of the project
3) Forge partnerships with relevant investigator communities and research programs:
HPAP-T2D 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:
HPAP investigators: as noted above, renewal of the current activity of HPAP with its focus on T1D pathogenesis is supported through a Companion Funding Opportunity (RFA-DK-18-015). In addition to continuing their analysis of T1D-relevant tissues, the HPAP team will continue to be primarily responsible for the further development and improvement of PANC DB. The HPAP-T2D team should work closely with HPAP investigators to ensure standardization of assays and data, to facilitate the integration of HPAP-T2D datasets into the common database, and to leverage resources and minimize redundancy whenever possible (for example through the use of common age-matched controls between the two programs).
HIRN investigators: upon funding, the HPAP-T2D team will be integrated into the NIDDK-supported HIRN, whose overall mission is to better understand how human beta cells are lost in T1D, and to find innovative strategies to protect or replace functional beta cell mass in diabetic patients. The HPAP-T2D team will join the HPAP team and a group of investigators funded in response to the recent RFA on “High-Resolution Exploration of the Human Islet Tissue Environment” (RFA-DK-17-022) to form the ‘Human Pancreas Analysis Consortium” or HPAC. HPAP-T2D is expected to work closely with the HIRN Administrative Hub (HIRN-AH) to facilitate the organization and sharing of data and reagents generated by HPAP-T2D activities. In conjunction with the HIRN-AH, the HPAP should develop workshops and community outreach strategies to optimize community use of HPAP resources and to gather feedback from users. The HPAP-T2D team will be expected to work collaboratively with all of their HIRN colleagues and to contribute to an environment of sharing and trust across the network. All HPAP investigators will be expected to adhere to the sharing policies developed by the HIRN as a term of the award and to the Cooperative Agreement Terms and Conditions of Award. The NIDDK staff will designate a member of the HPAC to represent HPAP on the HIRN Trans-network Committee (HIRN-TNC) who will be expected to participate in all meetings of the HIRN-TNC. HPAC Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also participate in the annual HIRN Investigator Scientific Retreat. In the application, budget requests must include costs for the PD(s)/PI(s) and up to three other HPAP-T2D staff members to attend the annual HIRN Investigator's Scientific Retreat.
Scientific collaborators: residual HPAP-T2D cells and tissues are and will continue to be in limited supply following the thorough and systematic phenotyping that is the core mission of HPAP-T2D. In addition, the vast amount of data associated with any residual material makes it an even rarer and valuable commodity. For these reasons, the open sharing of residual HPAP-T2D cells and tissues with the broader scientific community is not the best or most efficient way to gather additional and meaningful biological information to complement the extensive analysis performed on each and every HPAP-T2D sample. Rather, the further exploration of these tissues will need to be carefully planned and justified in collaboration with the HPAP-T2D team, so as to optimize the biological significance and value to the community of any additional experiments, and to ensure that the resulting data can be efficiently added to and combined with the existing HPAP-T2D datasets. HPAP-T2D applicants should propose guidelines for candidate collaborators to approach the HPAP-T2D team and propose additional experiments, whether hypothesis-driven or hypothesis-generating. These guidelines should describe the process by which projects will be prioritized and selected, and should include a mechanism to ensure that all resulting data will be shared with the community through PANC DB.
Given the need for a multidisciplinary approach to HPAP's mission, applicants are strongly encouraged to structure their proposal as a multi-investigator (multi-PI) project.
Other Special Performance Requirements
The HPAP-T2D 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.
Application Types Allowed
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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.
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.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: HPAP-T2D applicants must include in their research strategy:
An estimated number of the human pancreatic specimens to be collected and characterized per year of operation and per tissue donor category (control, T2D, recently-diagnosed, obese, etc.). Ideally, the number of tissue samples per donor category should be sufficient to ensure that significant new biological knowledge specific to each donor category can be uncovered;
A strategy to coordinate the tissue source site(s) with the experimental site(s) to optimize the seamless integration of sample acquisition,tissue processing and tissue phenotyping;
A plan to implement the protocols needed for state-of-the-art phenotyping of the tissues as described above. At a minimum, the set of phenotypic assays currently run by the HPAP, as documented on the PANC DB community portal, should be proposed. These include 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 and imaging mass cytometry). Applicants can also propose additional assays that may be more specifically relevant to the study of T2D (as compared to T1D), shed light on aspects of disease biology that cannot be easily explored with the existing set of assays, or have the potential to yield novel biological knowledge by being applied for the first time to the human pancreas;
A strategy to analyze the data being generated through HPAP-T2D, including the meta-analysis of the multiple datasets being generated through the suite of functional, omics-based and imaging-based phenotypic assays, in order to collect as much new information as possible regarding human disease initiation, progression and heterogeneity;
A strategy for disseminating HPAP-T2D data to the research community in a timely fashion through PANC DB as described above. The ultimate goal should be to encourage and enable non-HPAP scientists to develop hypothesis-driven follow-up studies using other funding mechanisms. HPAP-T2D applicants should also describe how they plan to share summaries of their data analysis with the scientific community through the PANC DB portal;
A strategy to collaborate with the existing HPAP computational Biology team to integrate the newly-generated HPAP-T2D data with the existing HPAP datasets within PANC DB;
A plan to prioritize and manage requests for collaborations by non-HPAP investigators wanting to access residual HPAP-T2D cells and tissues to generate experimental data that would complement existing HPAP-T2D analyses;
A description of the team's expertise with accessing, processing and analyzing 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; collecting, curating, analyzing and sharing large and complex datasets through community portals or databases; working productively in collaborative environments.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Applicants are expected to register resources supported by this FOA with the NIDDK Information Network (dkNET) at https://dknet.org/ and use Research Resource Identifiers (RRID) assigned through dkNET in any publication supported by this FOA.
Upon completion or termination of the HPAP-T2D project, the awardee is responsible for making all HPAP-T2D 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-T2D data by the community once the project period expires.
Letters of Support: HPAP-T2D 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.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
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.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is 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 and number of human tissue to be analyzed proposed in the application likely to yield significant new knowledge regarding the development of human T2D?
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? 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 pancreatic tissues from human T2D donors, thereby increasing the likelihood of discovering new biological paradigms? What is the level of innovation of the proposed computational strategies for integrated analysis of diverse 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: 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, imaging mass cytometry)? Are the estimated number and types of human pancreatic tissues to be processed and analyzed during the funding period adequate and justified? Do applicants propose a convincing strategy to work closely with the existing HPAP computational biology team to integrate HPAP-T2D data with existing HPAP datasets through PANC DB? Is the plan for data sharing with the community and management of collaborations with non HPAP-T2D 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) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this FOA: Is the proposed scientific environment conducive to the seamless processing and analysis of human pancreatic cells and tissues in a timely fashion, so as to minimize delays between tissue processing and collection of meaningful biological data? Can we expect smooth interactions and efficient teamwork between the various components of the proposed program, including tissue procurement, tissue processing, data generation, data analysis and data sharing?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
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 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 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.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
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).
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.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK Review Branch, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review , recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Disease Advisory Council. The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
2. Administrative and National Policy Requirements
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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 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:
The HPAP-T2D Awardee will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies and tool-development efforts conducted under the terms and conditions of the cooperative agreement award.
The HPAP-T2D Awardee will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
The HPAP-T2D Awardee will retain custody of the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current HHS, PHS, and NIH policies. The datasets generated by HPAP-T2D are expected to be shared with the research community through PANC DB as soon as they are generated and quality-controlled.
All staff of the HPAP-T2D Awardee will maintain the confidentiality of the information received or generated in the context of HPAP activities, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the consortium as well as any confidential information received by third party collaborators.
The HPAP-T2D Awardee must analyze, publish and/or publicly release and disseminate results, data, tools and other products of HPAP-T2D activities in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
All staff of the Awardee will be required to participate in a cooperative and interactive manner with NIH staff, one another, the HIRN-AH and HIRN investigators in all aspects of HPAP-T2D activities.
The HPAP-T2D Awardee is expected to share data, materials, tools, methods, information and unique research resources that are generated by the project in accordance with the HIRN-AH policies in order to facilitate progress as appropriate and consistent with achieving the goals of the program.
The HPAP-T2D Awardee will submit a list of milestones and project deliverables to the HPAP-T2D Program Officer and the HPAP-T2D Project Scientist prior to the first HIRN meeting that follows issuance of award, and will update this list annually prior to the HIRN Investigator Scientific Meeting.
The HPAP-T2D Awardee agrees to work with the HPAC Steering Committees and the HIRN Trans-Network Committee (HIRN-TNC) to establish agreements that address the following issues: (1) procedures for data sharing among consortium members and data sharing with any third party (including both industry and academic partners); (2) procedures for safeguarding confidential information, including without limitation, any data generated by the consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing biospecimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications. The NIDDK Program Official may consult with others at NIH including the NIDDK Technology Advancement Office regarding these agreements and issues.
The HPAP-T2D Awardee agrees that third party collaborations (including both industry and academia) should be governed by a research collaboration agreement (e.g. CTA, RCA, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures and any policies and procedures developed by the HIRN-TNC. The NIDDK Program Official may consult with others at NIH including the NIDDK Technology Advancement Office regarding these collaboration agreements.
The HPAP-T2D Awardee must operate in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIDDK will designate program staff, including a Program Official and a Grants Management Specialist to provide stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.
The NIH will invite experts with relevant scientific expertise to provide feedback to the NIH on HPAP-T2D activities. The External Experts will meet to review the progress of the HPAP-T2D project and to advise NIH staff of opportunities that may enhance the operation and achievements of the HPAP.
An NIDDK Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIDDK Program Official as follows:
The NIH Project Scientist will coordinate and facilitate the activities of the HPAP-T2D, attend and participate in all meetings of the HPAP-T2D, and act as a liaison between the Awardee and the External Experts.
The NIH Project Scientist and Program Official will review the progress of HPAP-T2D activities, and review the project for compliance with operating policies developed by the HPAC Steering Committee and the HIRN-TNC. Based on this review, the Project Scientist in conjunction with the Program Official may recommend to the NIH to continue funding, or to withhold or restrict support for lack of scientific progress or failure to adhere to policies established by the HPAC Steering Committee and the HIRN-TNC. Review of progress may include regular communications between the Principal Investigator and NIH staff, periodic site visits for discussions with awardee research teams, fiscal review, and other relevant matters. The NIH retains the option of organizing periodic external review of progress.
The NIDDK reserves the right to terminate the HPAP-T2D award in the event of (1) A substantial shortfall in accomplishing the management goals and responsibilities stated in the funded application, (2) A failure to meet HIRN or NIH policies and procedures, (3) Substantive changes in the management of the HPAP-T2D that are not in keeping with the objectives of the FOA.
The NIH will enlist additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist in carrying out the goals and aims of the approved studies. The NIH will have one vote for any key committees, regardless of the number of NIH consultants involved in the project.
The NIH Project Scientist will have substantial scientific programmatic involvement in coordination and performance monitoring of HPAP-T2D activities. The dominant role and primary responsibility for these activities resides with the awardee, however, specific tasks and activities in carrying out the HPAP-T2D functions will be shared among the awardee and the NIH Project Scientist.
The NIH Project Scientist serves as a resource with respect to other ongoing NIH activities that may be relevant to HPAP-T2D operations to facilitate compatibility and avoid unnecessary duplication of effort.
The NIH Project Scientist may review procedures for assessing and monitor the performance of the HPAP-T2D.
The NIH Project Scientist may be a co-author on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
Areas of Joint Responsibility include:
Through the Awardee and NIH staff, HPAP-T2D 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-T2D and at least one other HPAP-T2D meeting (teleconference or face-to-face meeting) annually. These meetings could be combined with the annual meetings of the HPAP and/or the HPAC. The HPAP-T2D PD/PI, the HPAP-T2D Project Scientist, the HPAP-T2D Program Official and the Chair of the HPAP Expert Scientific Panel are expected to attend these meetings.
The HPAP-T2D Awardee agrees to the governance of the HPAP-T2D through a Steering Committee of the HPAC.
On an annual basis, and following input from the HPAC Steering Committee members, NIDDK staff will appoint a HPAC Steering Committee Chair who will be in charge of facilitating the HPAC Steering Committee meetings and teleconferences. In collaboration with the HIRN-AH and the NIH Project Scientist, the Chairperson is responsible for coordinating the Steering Committee activities, for preparing meeting agendas and for chairing meetings.
The Steering Committee, including the Project Scientist, is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
The NIH Project Scientist may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees.
The HPAC-Steering Committee will be composed of the Principal Investigators/Program Directors for each HPAC Cooperative Agreement Award (CAA), or by CAA representatives (one per CAA) chosen by the Principal Investigators/Program Directors in the cases of multi-PI grants, and the NIH Project Scientist. Only the CAA PI/PD or multi-PI CAA representatives and the NIH Project Scientist will be voting members of the Steering Committee and will attend all meetings of the Steering Committee. Each full member will have one vote. Other designated NIH program staff attending the steering committee meetings will be ex officio (non-voting) members. The HPAC Steering Committee will meet at least twice a year.
All major scientific and policy decisions will be determined by voting policies as established by the Steering Committee 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. Steering Committee activities and decisions will consider the advice of the External Experts.
The NIH Project Scientist will help the Steering Committee develop and draft operating policies.
NIDDK staff, in concert with the Steering Committee, will have the option to redirect research activities being pursued within the CAAs if it is considered beneficial to the overall program.
The Awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and Subcommittees. Awardees must serve on HPAC subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
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.
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.