Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK )
This Funding Opportunity Announcement will provide support for a Human Islet Research Enhancement Center that will supply the infrastructure needed to support research coordination, collaboration and dissemination of advances made by the NIDDK funded Human Islet Research Network (HIRN).
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.
This Funding Opportunity Announcement (FOA) requests applications for an organizational hub to serve as a Human Islet Research Enhancement Center (HIREC) for the Human Islet Research Network (HIRN). HIRN's overall mission is to support innovative and collaborative research into how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. To maximize scientific exchange and accelerate research, it is expected that all information, data, biomaterials, models, protocols, reagents, resources and methods developed by HIRN investigators will be shared in a timely way with other investigators in the network and with the research community at-large. The HIREC will provide the infrastructure needed to facilitate collaborations among HIRN investigators and to promote timely sharing of HIRN-generated data and reagents with the research community.
Background
The NIDDK Human Islet Research Network (HIRN)
In 2014 NIDDK established the Human Islet Research Network (HIRN) to support collaborative research in Type 1 Diabetes (T1D) with an overall mission to advance our understanding of how human beta cells are lost in T1D, and to find innovative strategies to protect or replace functional beta cell mass in diabetic patients. HIRN is configured as a modular network of small research consortia, each defined by a specific set of research priorities. The network structure is designed to facilitate interactions among communities of investigators that are organized around common biological and/or technological challenges, with the overall goal of finding innovative new approaches for the treatment, prevention and monitoring of T1D.
HIRN-Human Islet Research Enhancement Center (HIREC)
HIRN brings together investigators from potentially disparate fields to focus on compelling needs in Type 1 diabetes research. Central to the success of this effort is the ability to foster novel research synergies and rapidly share HIRN advances with the broader scientific community. The Human Islet Research Enhancement Center will be tasked with addressing these needs for the HIRN.
Objectives and Scope
The Human Islet Research Enhancement Center (HIREC) will consist of a single U24 award led by Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) with expertise in the management of resource-based operations that serve the biomedical research community, such as reagent-generating or service-providing consortia. The HIREC will be responsible for coordinating and enhancing collaborations among the five current HIRN consortia (see www.hirnetwork.org), and for outreach to the broader scientific community including attracting new talent to HIRN research and disseminating information about resources developed by HIRN to the external community. Given that the composition of the network may change over time as HIRN evolves, the HIREC should be designed with future flexibility in mind.
?Teams should be able to handle the following required functions of the Human Islet Research Enhancement Center:
Research coordination and collaboration:
Resource dissemination and outreach:
Meetings of the Human Islet Research Enhancement Center
The HIREC PD(s)/PI(s) must assist with logistics for (and participate in) the annual HIRN Investigator Scientific Retreats, and in the HIREC Steering Committee meetings and teleconferences. HIREC teleconferences will be held monthly. In addition, the HIREC PD(s)/PI(s) will meet at least once a year with the HIREC Program Officer, the HIREC Project Scientist and the HIREC Expert Scientific Panel to review progress of HIREC activities. In the application, budget requests must include costs for the PD(s)/PI(s) and up to three other members of the HIREC to attend the annual HIRN Investigator Scientific Retreat. All HIREC teleconferences will be organized by the HIREC. The HIREC will support costs of all HIRN-related meetings, except for costs for the HIRN investigative teams to travel and attend. The HIREC is also responsible for providing and maintaining a record of minutes of all HIREC meetings.
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-13-013.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Need help determining whether you are doing a clinical trial?
NIDDK intends to commit $1,500,000 in FY 2019 to fund ONE award.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
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)
Telephone: 301-594-7797
Email: [email protected]
In addition, applicants must provide the? ?f?o?l?l?o?w?i?n?g? ?i?n?f?o?r?m?a?t?i?o?n?:
Evidence of expertise working in collaborative environments
Evidence of expertise with the administrative management of resource-based operations that serve the biomedical research community, such as reagent-generating or service-providing consortia or , or organ procurement networks.
All instructions in the SF424 (R&R) Application Guide must be followed.
, with the following additional instructions:
Budget requests must include costs for the PD(s)/PI(s) and up to three other members of the HIREC project team to attend the annual HIRN Investigators Scientific Retreat.
Budget requests must include $30,000 Direct Costs per year to support travel of HIRN External Scientific Panel Members to the annual HIRN Investigators Scientific Retreat.
Budget requests must include at least $35,000 Direct Costs per year to provide for logistical support for the annual HIRN Investigators Scientific Retreat.
Budget requests should be structured to provide $?375,000 in direct costs plus associated institutional F&A as required to execute approximately 5 subawards of $75,000 per year from the HIRN opportunity pool fund.
Research Strategy: The applications sought in this FOA will propose to provide administrative infrastructure for a network of consortia.
?The applicant must outline how the center plans to manage the following responsibilities:
Research coordination and collaboration:
Resource dissemination and outreach:
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.
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.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDDK. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Does the proposed Center address the needs of the research network that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing basic research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel organizational concepts and/or management strategies for coordinating the research network the Center will serve? Are the strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable.
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable.
Not Applicable.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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, 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 Human Islet Research Network (HIRN) consists of five research consortia and this Human Islet Research Enhancement Center.
The PD(s)/PI(s) will have the primary responsibility for:
Awardee(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
The Program Director/Principal Investigator (PD/PI) 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 (FOA) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
Awardees are responsible for their staff in maintaining confidentiality of the information as developed by the consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
Awardees must analyze, publish and/or publicly release and disseminate results, data and other products of the study 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 achieving the goals of the FOA.
Awardee(s) will be required to participate in a cooperative and interactive manner with members of the consortium including designated NIH staff (e.g., Program Official, Project Scientist).
Awardees must share data, materials, models, methods, information and unique research resources that are generated by the projects in concordance with HIRN policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, awardees will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other HIRN members.
Awardee(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing among consortium members and data sharing with industry 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 bio-specimens 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.
Awardee(s) agree that each industry collaboration 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 policies and procedures.
Awardees must agree to comply with the processes and goals as delineated within the FOA.
Upon completion or termination of the research project(s), the awardees are responsible for making all study materials and procedures 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. The data sharing plan should include a plan to accomplish this at the end of the study.
Awardee(s) agree to the governance of the project through a Steering Committee.
The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
Each full member will have one vote.
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 network subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
Awardees may be asked to scientifically review applications for special opportunity pool funds, as it is deemed appropriate
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 normal program 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 NIDDK will invite External Experts with relevant scientific expertise. The External Experts will meet to review the progress of the research projects and to advise NIH staff of scientific developments and opportunities that may enhance the achievement of the study goals.
An NIH IC Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:
The NIH Project Scientist will coordinate and facilitate the research projects, attend and participate in all meetings of the Consortium (Steering Committee), and act as (a) liaisons between the Awardee (Steering Committee) and the External Experts.
The NIH Project Scientist will be a member of the Steering Committee and, as determined by that committee, and its Subcommittees as needed. Only one NIH Project Scientist will vote on the Steering Committee. Other designated NIH program staff attending the steering committee meetings will be an ex officio (non-voting) member(s).
The NIH Project Scientist, and other designated NIH program staff will help the Steering Committee develop and draft operating policies.
The NIH Project Scientist and Program Official will review the scientific progress, cooperation in carrying out research, and maintenance of high quality research in each of the individual research project(s), and review the project(s) for compliance with operating policies developed by the Consortium (Steering Committee), and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the Consortium (Steering Committee). Review of progress may include regular communications with the PD/PI and NIH staff, periodic site visits for discussions with awardee research teams, fiscal review, and other relevant matters. The NIH retains the option of periodic external review of progress.
The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or Consortium policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or a human subject ethical issues that may dictate a premature termination.
The NIH Project Scientist and Program Official will review and approve applications of the Special Opportunity Funds to ensure that they are within the scope of Consortium research as described in the FOA and NIH guidelines.
The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist(s) and the Steering Committee 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 personnel involved.
The Project Scientist will have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientist will have the same access and privileges to any data generated by the grantee. The dominant role and primary responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist.
The NIH Project Scientist serves as a resource with respect to other ongoing NIH activities that may be relevant to HIRN studies to facilitate compatibility and avoid unnecessary duplication of effort.
The NIH Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of (a) common research protocol(s) and statistical evaluations of data and in the publication of results.
The NIH Project Scientist may review procedures for assessing data quality and monitor study performance.
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:
HIRN Trans-Network Committee (HIRN-TNC)
The HIRN-TNC will consist of: The Director(s) of the HIREC, NIDDK Project Scientists, and representative PIs chosen among the Awardees; the HIRN-TNC is not a governing body and does not cast votes.
The HIRN-TNC will review the progress of all NIH-funded HIRN special funding opportunity programs and make recommendations for improvement. Annual reports will be prepared for each special funding opportunity to coincide with one of the annual SC meetings;
The HIRN-TNC will be responsible for overseeing organization of the yearly Investigators Scientific Retreat.
The HIRN-TNC will have meetings that will be organized by the HIRN-HIREC. Any HIRN-TNC member may place items on the agenda. These should be communicated in advance of the meeting to the Project Scientist(s) who will distribute these to all members. The designated NIDDK Program Official(s) of HIRN may be asked to participate in order to provide additional information and to summarize actions that are taken.
Steering Committee (SC)
The Steering Committee (SC) composed of the PD(s)/PI(s) of the award and the NIH Project Scientist will be the main governing board for the U24. Each full SC member will have one vote. All major scientific and policy decisions will be determined by voting policies as established by the SC at the initial meeting. This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project. The SC activities and decisions will consider the advice of the External Experts.
NIDDK staff, in concert with the SC, will have the option to redirect research activities within the HIREC grant if it is considered beneficial to the overall program.
The SC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the expertise of the Steering Committee when necessary.
There will be an initial meeting and HIREC Steering Committee meetings annually. These meetings will incorporate participation and recommendations of the External Experts when determined appropriate by NIH staff.
The SC, including the Project Scientist(s), is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
The HIREC awardee agrees to the governance of the U24 through the SC.
The NIH Project Scientist(s) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees.
External Consultants
An independent panel of External Experts will be established by the NIDDK. The External Experts will review periodically interim progress of the U24 and report to NIDDK staff. Members of the panel of External Experts may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special "opportunity pool" funds.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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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