National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
The George M. O'Brien Urology Research Centers (U54) and Exploratory Centers for Interdisciplinary Research in Benign Urology (P20) serve to advance the NIDDK’s mission to support highly meritorious, innovative, interdisciplinary research in benign urologic diseases and disorders, and the training of the next generation of researchers. Critical to these broad goals is the ability to promote productive interactions between the U54 and P20 Centers, the institutional career development programs (K12), and the broader urology research and clinical communities. The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for a new Urology Centers Program Interactions Core (U24). The Interactions Core will serve as focal point for establishing productive collaborations within the Urology Centers Programs and between these Programs and other NIDDK urology training and scientific efforts and the broader research and clinical communities.
January 22, 2020
March 31, 2020
No late applications will be accepted for this Funding Opportunity Announcement
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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.
Despite advances in the clinical management of many genitourinary conditions, millions of Americans remain afflicted with benign diseases and disorders of the renal collecting system, ureters, bladder and urethra and the male reproductive organs (prostate, seminal vesicles, testicles, epididymis and penis). Contributing to the inability to adequately treat patients are the gaps in knowledge of the basic physiology, cell biology, and genetics of normal and abnormal urologic function; a lack of objective diagnostic criteria and tests for many benign genitourinary symptoms and conditions; inadequate in-depth characterization (phenotyping) of patients; and the paucity of epidemiological insights. Furthermore, this absence of a basic understanding of the mechanistic changes of the urogenital tract in disease also slows development of clinically-relevant models of benign genitourinary diseases and disorders.
To address these gaps the NIDDK’s George M. O'Brien Urology Research Centers Program was transitioned in 2012 to a Cooperative Research Centers Program (U54). This transition was prompted by a recognized need for more highly-interdisciplinary, integrated approaches and a lack of new research resources for the wider research community. The O’Brien Urology Cooperative Research Centers Program fosters broad basic, translational, and clinical research on questions of critical importance; develops resources to support the larger urologic community; engages new and established investigators from urology and other clinical and research disciplines; and promotes the training of junior scientists in the field of benign genitourinary diseases and disorders. The Exploratory Centers for Interdisciplinary Research in Benign Urology (P20) further enhance the infrastructure of the benign urology research community through establishing teams of diverse expertise and fostering projects that can mature into more comprehensive studies. The U54 and P20 Centers additionally collaborate with the two institutional career development programs (K12), the NIDDK Urologic Research (KURe) Career Development Program and the Urological Epidemiology (UroEpi) Program. All efforts are designed to improve prevention, diagnosis, and treatment of benign genitourinary diseases and disorders within the NIDDK’s mission.
Critical to addressing these broad goals is the ability to promote productive interactions between the various Centers, associated Career Development Programs, and the broader urology research and clinical communities. To support this the NIDDK has worked to increase collaborations, resource sharing, and enhanced training opportunities under the umbrella of the CAIRBU (Collaborating for the Advancement of Interdisciplinary Research in Benign Urology) effort. This includes a yearly CAIRBU meeting that brings together investigators and trainees from the NIDDK Urology Centers and training programs and other expertise inside and outside of the urology community.
This Funding Opportunity Announcement (FOA) seeks applications for a new Urology Centers Program Interactions Core. The Interactions Core will greatly enhance efforts to promote meritorious research, collaboration, resource sharing, and training and career development within the Centers Program and the larger urology community, as well as identify opportunities for synergistic interactions with other disciplines.
The Urology Centers Program Interactions Core (U24) will engage in broad and diverse efforts to enhance collaboration and resource sharing between the George M. O’Brien Cooperative Research Centers (U54), the Exploratory Centers for Interdisciplinary Research in Benign Urology (P20), the KURe and UroEpi career development programs (K12), and the urologic clinical and research communities all under the general framework of the CAIRBU efforts. The Core will additionally promote interactions between these NIDDK programs and investigators outside of the traditional urology field in order to introduce critical, new multi-disciplinary expertise into benign urologic research. All efforts will support the larger goals of fostering highly meritorious science, building interdisciplinary research teams, bringing new investigators to research on benign genitourinary diseases and disorders and training and career development of junior scientists. The synergy created through these collaborations is expected to advance our understanding of benign genitourinary diseases and disorders and build the community of urologic investigators well beyond the capacity of these individual programs.
The Interactions Core will employ both proven and new and innovative approaches to addressing these roles. Specific activities in support of Core goals should include, but are not limited to:
Opportunity Pool Program: The Interactions Core will provide centralized administration (solicitation, submission and review)of the O’Brien Cooperative Research Centers (U54) Opportunity Pool Program.The U54 Centers have funds allocated for participation in an Opportunity Pool Program and are responsible for identification of candidates and co-development of applications. In addition, the InteractionsCore is responsible for administration of additional Opportunity Pool resources allocated to the Interactions Core through this FOA. This Interactions Core Opportunity Pool funds will enhance collaborations between U54 Center investigators, KURe (K12) fellows, and Exploratory Centers (P20) investigators with outside investigators who meet one of the following criteria: (a) early stage investigators or (b) established investigators not previously involved in genitourinary research. Topics aligned with currently funded U54 Urology O'Brien Centers should be funded by the appropriate U54 Center Opportunity Pool Program allowing the U24 funds to support research areas not supported by current U54 Centers. Both Opportunity Pool Programs are expected to increase the capacity of the urologic research community by leveraging resources within the Centers and enhance the base of investigators engaged in benign urologic research. Additionally, it is expected Opportunity Pool projects will generate preliminary data and collaborations that support development of future research grant applications, such as Investigator-Initiated R01s. Research investigating the relationships between biological and clinical characteristics are encouraged. Interaction Core Opportunity Pool Projects are limited to $100,000 in Direct Costs per year for up to a two-year funding period. Interactions Core activities will include but are not limited to development of standardized announcements for the solicitation of Opportunity Pool applications and administration of an objective peer-review process for assessing the merit of submitted applications. Final policies and criteria will be developed in consultation with the NIDDK and based on scientific priorities and available funds.
Interactions Core Travel and Professional Development Awards Program: The Interactions Core will be responsible for development and administration of a Travel Award Program and a Professional Development Award Program using allocated Core resources. The Travel Award Program should support travel of early stage investigators to attend educational enrichment scientific meetings held by the U54, P20 or K12 programs. The Professional Development Award Program should support short term sabbaticals for Urology U54 and P20 Centers Investigators to travel to other Centers or for outside investigators to travel to U54 and P20 Centers in order to learn new methods that will enhance benign urologic research and training. Final policies and criteria for the Travel and Professional Development awards will be developed in consultation with the NIDDK and based on scientific priorities and available funds.
The Interactions Core will operate in close collaboration with the NIDDK’s U54 and P20 Centers’ and KURe and UroEpi Programs’ investigators and NIDDK Program Staff. The Interactions Core will lead the CAIRIBU webinar/teleconferences and scientific meetings. The Interactions Core will provide logistical support for NIDDK on progress in addressing Core goals.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
The NIDDK intends to commit $750,000 in FY2021 to fund one award.
The application budget for the NIDDK Urology Centers Program Interactions Core must reflect the actual needs of the proposed study. The Core may request funds up to $600,000 in Direct Costs per year. Approximately $150,000 in Direct Costs of this request should be used in support of the Core’s Opportunity Pool, Travel Awards, and Professional Development Programs in combination.
The maximum project period is 5 years. The scope of the proposed project should determine the project period.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The Interactions Core Director (or one or more members of a Multi-PI team) is required to have a track record of research and administrative accomplishments and team building in the field of urologic disease. A record of establishing broad collaborations between diverse research fields in support of urologic research and training is a priority. The Core Director may not serve concurrently as the Center Director for a George M. O’Brien Urology Cooperative Research Center (U54) or a Exploratory Center for Interdisciplianry Research in Benign Urology (P20) or as a Director of a K12 career development program.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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)
The application should reflect theInteractions Core Director's (or one or more members of Multi-PI team) research and administrative accomplishments including team building across diverse research fields in benign urologyin the biosketches or research strategy.
All instructions in the SF424 (R&R) Application Guide must be followed.
The NIDDK Urology Centers Program Interactions Core Director will oversee all scientific and administrative activities of the Core. Support for the Director should be provided within the budget of the Interactions Core. The minimal level of effort for the Interactions Core Director is 6 person months (50%). As part of a Multi-PI application two Co-Directors may be proposed. Each of these Co-Directors must have a minimal level of effort of 4 person months (30%). Additional proposed Core personnel may be included in the budget request in order to address diverse Core activities. All personnel should be justified for their contributions to Core activities.
The Interactions Core budget must include a minimum of $150,000 in Direct Costs yearly for support of the Interactions Core Opportunity Pool Program and the Travel and Professional Development Awards Programs in composite. In addition, the Interactions Core budget must include funds to support development of the yearly CAIRIBU meeting and for travel of Interactions Core personnel and up to 8 invited guests to this meeting. Invited guests may include members of the External Expert Panel and key note speakers. Travel funds for Core personnel to attend additional scientific meetings including visits to U54, P20 or K12 Centers may be proposed. Funds to support the travel of members of the O’Brien Centers Program External Expert Panel to a yearly meeting in Bethesda should also be included. The External Expert Panel will include no more than 6 members.
Research Strategy: NIDDK Urology Centers Program Interactions Core applicants should describe broad and diverse efforts designed to enhance collaboration and sharing between the George M. O’Brien Cooperative Research Centers (U54), the Exploratory Centers for Interdisciplinary Research in Benign Urology (P20), the KURe and UroEpi career development programs (K12), and the urologic clinical and research communities. Interactions Core applicants should also describe proposed efforts to promote interactions between these NIDDK programs and investigators outside of the traditional urology field in order to introduce critical, new multi-disciplinary expertise into benign urologic research. All efforts should be described in the context of the Core goals to foster highly meritorious science and training and career development.
In addition, applicants should describe approaches for promoting Centers' activities, opportunities, and advances at outside scientific meetings; developing and support for yearly CAIRIBU meeting; administration of regular webinars/teleconferences; increasing interactions with outside professional and scientific organizations to further support the Core goals; and for developing and maintenance of a CAIRIBU website. Plans to identify and attend key Centers and Training and Career Development Program educational enrichment events should be described. Applicants should also describe plans for centralized administration and oversight of the O’Brien Centers (U54) Opportunity Pool Program and resources allocated to the Core for this Program. Plans for development and administration of the Interactions Core Travel and Professional Development Awards Programs should be detailed. These descriptions should include plans for soliciting, reviewing, and selecting the projects under the opportunity pool including plans for tracking of applications and awards.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Does the proposed Interactions Core address the needs of the research programs that it will coordinate? Is the scope of activities proposed for the Interactions Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs?
Specific to this FOA: Will the proposed efforts enhance collaboration and sharing between the NIDDK Centers Program (U54 and P20), the KURe and UroEpi training/career development programs, and the broader urology research community and investigators outside the traditional urology field? Will the synergy created through these collaborations advance our understanding of benign genitourinary diseases and disorders and build the community of investigators beyond the capacity of these individual programs?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Interactions Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing benign genitourinary 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 Interactions Core? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA: Does the proposed Core Director, or one or more members of a proposed Multi-PI team, have a track record of research and administrative accomplishments and team building in the field of benign urologic disease?
Does the application propose novel organizational concepts or management strategies in coordinating the research programs the Interactions Core will serve? Are the concepts or 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?
Specific to this FOA: Do investigators propose innovative strategies for promoting broad collaborations within U54, P20, K12 programs and external investigators; for development of agendas for yearly CAIRIBU meetings; for gaining visibility for the resources available through the U54 O'Brien Centers; for building links and tracking fruitful collaborations between investigators inside and outside of the CAIRIBU community; and for the administrative task of hosting webinars and the CAIRIBU website?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the Interactions Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the programs are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the programs? Are 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?
Specific to this FOA: Are adequate plans in place to enhance broad collaboration and sharing? Are plans in place for the promotion of Centers' activities, opportunities, and advances at outside scientific meetings? Is there a strategy for developing and support of the yearly Collaborating for the Advancement of Interdisciplinary Research in Benign Urology (CAIRIBU) meeting and the administration of regular group webinars/teleconferences? Are plans in place to develop and maintain a CAIRIBU website? Is an adequate strategy presented for administration of Opportunity Pool funds and Travel and Professional Development Awards?
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 institutional environment in which the Interactions Core will operate contribute to the probability of success in facilitating the research programs it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Interactions Core proposed? Will the Interactions Core 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 thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group(s) convened by the National Institute of Diabetes and Digestive and Kidney Diseases, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://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 https://www.hhs.gov/civil-rights/for-individuals/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.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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:
1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.
3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.
4. Implementing collection of data specified by the study protocol. For a multi-center study, each awardee/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
5. Establishing procedures for data quality and completeness. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee.
6. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.
7. Reporting of the study findings. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The awardee must also be adherent to Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with awardees consistent with NIH and study policies.
8. Any third-party (including industry, academia, and foundations) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.”
9. Any involvement of a third-party (including industry, academia, and foundations) in the study and network activities that includes access to any network study data and biosamples, or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
10. Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and steering committee policies on publications.
11. Maintaining confidentiality of information: The awardee(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK Program staff.
12. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archiving and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. Prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Central Repository to develop a Data Sharing Plan and prepare the collected data for eventual archiving and distribution. In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, storage, and sharing of study samples that are to be maintained in the Repository. All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the study’s leadership will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. Subsequently samples and data will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), as well as the NIDDK policy for data sharing in multi-center and large single-center clinical studies http://www.niddk.nih.gov/research-funding/process/human-subjects-research/Documents/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.
13. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the awardee is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIDDK Project Scientist with substantial involvement will:
1. Serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Project Coordinator, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or Project Coordinator will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
4. Have substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:
a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
b. The NIDDK Project Scientist or Project Coordinator may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
c. Reviewing procedures for assessing data quality and study performance monitoring.
d. The NIDDK Project Scientist or Project Coordinator may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to 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.
The NIDDK Program Official identified in the Notice of Award will:
Areas of Joint Responsibility include:
In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:
A Steering Committee organized by the study investigator(s) will be the main governing body of the study.
The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.
A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK, in consultation with the Steering Committee. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIDDK and by interacting closely with the awardees during protocol development and implementation.
Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare 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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Tamara G. Bavendam, M.D., M.S.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lan Tian, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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