Reissue of RFA-DK-14-004
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The Prevention of Lower Urinary tract Symptoms (PLUS) Research Consortium will use qualitative and quantitative strategies to conduct collaborative, transdisciplinary studies to establish the scientific basis for future intervention studies to promote bladder health and prevent lower urinary tract symptoms (LUTS) and associated bladder conditions such as bladder infections, urinary incontinence, voiding dysfunction, overactive bladder and interstitial cystitis/bladder pain syndrome in adolescent and adult women across the life course. This FOA is to invite applications for Clinical Research Centers to build on foundational work to establish a longitudinal cohort study with the intent of identifying plausible targets for future intervention studies. The consortium will also conduct a range of additional studies to facilitate the success of future intervention and implementation studies.
September 6, 2019
October 7, 2019
November 7, 2019
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.
Lower urinary tract symptoms (LUTS) are associated with a broad range of diagnoses including bladder infections, urinary incontinence, voiding dysfunction, overactive bladder and interstitial cystitis/bladder pain syndrome. These symptoms are common, costly and consequential for females from childhood to old age. Obesity, diabetes, metabolic syndrome, cardiovascular disease, sexual activity and vaginal childbirth have been associated with increased risk of LUTS. The prevalence of LUTS in the United States is expected to increase substantially over the next several decades as the population ages and the prevalence of risk factors (e.g., obesity and diabetes) increases, imposing an ever increasing medical and economic burden on the population. For the purposes of this FOA, the term bladder will refer to the entire lower urinary tract (bladder, urethra, pelvic floor) in women.
The goal of this FOA is to establish the knowledge and evidence base necessary to permit future studies of prevention of LUTS in adolescent and adult women. In general, prevention research takes a multi-factorial approach to include: epidemiologic studies to identify and assess risk and protective factors; to screen and identify individuals and groups at risk; to develop and evaluate interventions designed to reduce risk; and translate and disseminate effective preventive interventions into practice. Prevention research targets the full spectrum of factors responsible for disease manifestations, to include biologic factors, individual knowledge, beliefs and behaviors, the social and physical environment and health services. There are opportunities to further define and promote healthy bladder habits through focused research, which may lead to improvements in overall health and quality of life. Ultimately this research will inform public and health care professional education efforts.
The Prevention of Lower Urinary tract Symptoms (PLUS) Research Consortium was established by the NIDDK in 2015 to build the scientific foundation for future evidence-based intervention studies designed to prevent lower urinary tract symptoms (LUTS) and bladder conditions in adolescent and adult women. Foundational work to date includes development of a research definition for bladder health (http://doi.org/10.1089/jwh.2017.6786); terminology for bladder health research (https://doi.org/10.1002/nau.23985); and a conceptual framework for promoting bladder health and preventing LUTS in adolescent and adult women throughout the life course (https://doi.org/10.1002/nau.23787).
This Funding Opportunity Announcement (FOA), RFA-DK-19-015, will support up to seven Clinical Research Centers for a five-year funding period to conduct a longitudinal, observational cohort study and other studies necessary to add to the evidence base that will support future intervention studies.
The objectives for this FOA are 1) to design and establish a longitudinal national, population-based observational cohort to determine the state of bladder health in US adolescent and adult women and to monitor changes in bladder health over time; 2) to identify risk and protective factors that may enhance bladder health and are plausible targets for future intervention studies; 3) to design and conduct additional studies (using existing literature and databases, qualitative and quantitative methodologies including pilot intervention studies) that will facilitate successful intervention studies; and 4) to develop any new measures that will be necessary to determine short and long-term impact of future intervention studies.
To accomplish these objectives, the Prevention of Lower Urinary tract Symptoms (PLUS) Consortium will bring together researchers from diverse backgrounds (e.g., women's pelvic medicine, primary care across the life course, health behavior, preventive medicine, public health, epidemiology and biostatistics ) to design a longitudinal cohort study of bladder health in adolescent and adult women across the life course and assess novel promoters of bladder health or risk factors for LUTS such as knowledge about bladder function, lifestyle behaviors, toileting decision making and voiding behaviors . Additionally, the consortium will plan and perform studies that will inform future prevention intervention and implementation research. Such research may include systematic review the literature (including meta-analyses) to synthesize the evidence for potential risk and protective factors including biomarkers for bladder health or the range of conditions associated with LUTS described in this FOA; describe the relative importance of both modifiable (including diabetes, obesity, sexual activity and vaginal childbirth) and non-modifiable (age, sex, race/ethnicity) risk factors from completed epidemiological studies, or small pilot studies that test aspects (recruitment, retention or intervention strategies) for future intervention studies targeting normal adolescent and adult women and those with early LUTS.
PLUS Consortium investigators will work collaboratively to devise a set of studies that will be reviewed by the External Experts Panel and approved by the NIDDK. Thus, all studies proposed in the applications will be a starting point for PLUS Consortium discussions regarding the research to be undertaken. It is unlikely that any proposed research will be undertaken exactly as planned, or at an individual site. Involvement of study participants and other potential stakeholders in the planning and execution of studies at the local and national level is anticipated.
It is also anticipated that the Consortium will establish a process from development of funding opportunity announcement(s) through application review, funding, tracking progress to completion and dissemination for pilot and feasibility studies proposed by either non- consortium or consortium investigators on research topics related to the goals of the PLUS Consortium.
The goals and objectives of the PLUS Research Consortium will be complementary to two other NIDDK supported multi-center collaborative networks studying the lower urinary tract, the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) and the Multidisciplinary Approach to the study of Chronic Pelvic Pain (MAPP) Research Network. When appropriate the PLUS Research Consortium will interact and work collaboratively with these networks.
Note that applications that include LUTS prevention intervention studies other than pilot and feasibility studies with the goal of evaluating methodologic considerations of intervention studies will be considered nonresponsive to the RFA and will be withdrawn and will not proceed to review.
The PLUS Research Consortium will be comprised of up to seven meritorious Clinical Research Centers and one Scientific and Data Coordination Center (SDCC). The SDCC and Clinical Research Centers investigators will work collaboratively for the planning, execution and analysis of PLUS Research Consortium studies.
Guidance for Clinical Research Centers
Bladder health and risk factors for conditions associated with lower urinary tract symptoms in adolescent and adult women across the life course will be investigated through a longitudinal, observational cohort study that will lay the ground work for evidence-based prevention intervention studies. A broad range of factors influencing bladder health including biologic factors, cognitive-behavioral factors, psychosocial factors, environmental factors and personal health including comorbid conditions and behaviors such as smoking, physical activity, dietary and fluid intake choices are within scope for this initiative.
To ensure that the PLUS Research Consortium has the necessary expertise for a longitudinal observational cohort study and future LUTS prevention interventions across much of the life course of adolescent and adult women, the Clinical Research Centers are required to bring expertise and experience from the spectrum of disciplines necessary to build the evidence base and the ability to recruit racially, ethnically and socio-demographically diverse participants across the life course from adolescents to older women. Participants must be able to provide their own information and complete self-reported questionnaires without assistance. Institutionalized older women are not within scope of this FOA.
Clinical Research Centers must demonstrate experience with the development of self-reported measures and specific expertise in the design and conduct of epidemiological and clinical research studies. As most PLUS Research Consortium studies will be conducted at all Clinical Research Centers (trans-consortium), each Clinical Research Center must present prior experience and future plans to recruit study participants with mild or minimal symptoms and control (without LUTS) participants across the life stages of interest to the PLUS Consortium. The record of successful recruitment of diverse populations can be in areas other than LUTS. Clinical Research Centers must also demonstrate previous experience with involvement of community members (target study participants and stakeholders) in planning and execution of research studies.
The primary focus of the first half of this project period will be to establish the longitudinal observational cohort study. Additional activities will be to support the planning and execution of selected qualitative and quantitative studies needed for design of successful intervention studies as soon as financial resources are available to the Clinical Research Centers in second half of project period. A broad range of research study designs may be proposed including surveys, qualitative research, observational studies, analyses of established large databases, case-control studies, and small clinical studies. It is anticipated that clinical studies will seek to characterize the biologic, psychosocial, cognitive-behavioral, cultural and environmental differences between normal adolescent and adult women and those with early LUTS.
Administration and Meetings
The PLUS Research Consortium Steering Committee will be composed of Clinical Research Center and Scientific and Data Coordinating Center PD/PI(s), the Steering Committee Chair, selected by the NIDDK and NIDDK Program Staff. The Steering Committee and sub-working groups will meet regularly by webinar to conduct PLUS Consortium studies, review progress, discuss results, interpret findings, and collaboratively develop manuscripts for peer reviewed publications. The Steering Committee Chair will lead the Executive Committee that will be comprised of the Chairman of the Steering Committee, PD/PI(s) of the SDCC, two PD/PI(s) from the Clinical Research Centers on 6-month rotations, NIDDK staff, and additional PLUS Consortium investigators and support personnel, as needed. The Executive Committee will make operational decisions for the PLUS Consortium between Steering Committee meetings by means of webinars. Crucial to PLUS’s commitment to a transdisciplinary process, all Consortium members convene for weekly All-Consortium webinars to gain cross-disciplinary feedback on work that is conducted in smaller groups and stay current on consortium activities. An in-person All Consortium Meeting will be held 4 times each year in the Washington DC area. Community members (target study participants and stakeholders) will be involved in webinar and in-person All-Consortium, Steering Committee and sub-working group meetings regularly depending on the needs of the consortium.
The first All-Consortium Meeting of the new project period will be September 20th through September 22nd, 2020 in the Washington DC area. All funded investigators will be expected to attend.
The NIDDK will assist PLUS Consortium investigators in the development of PLUS Research Consortium study protocols; will monitor the progress of projects and functioning of all consortium activities; will assist investigators in the analysis and interpretation of PLUS Research Consortium data; and will aid in preparation of manuscripts for publication. The NIDDK will continue to utilize the External Experts Panel (EEP) to monitor research efforts and advise the Institute on the progress of consortium studies.See Section VIII. Other Information for award authorities and regulations.
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.
NIDDK intends to commit $2,200,000 to fund up to 7 awards in FY 2020.
NIA intends to commit $100,000 to fund up to one award in FY 2020.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applications budgets are limited to $450,000 direct costs per year for each Clinical Research Center. Application budgets for the PLUS Clinical Research Centers must reflect the actual needs of the proposed research each budget year.
The maximum project period for this award is five years.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.”
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 F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Each Clinical Research Center should include expertise in the fields of 1) public health and or prevention science, 2) health behavior, 3) primary care (pediatric/adolescent health, family medicine, internal medicine, geriatrics, women’s health, or general gynecology), and 4) LUTS. A LUTS clinical expert can have a surgical, medical (e.g. infectious disease), nursing or physical therapy background. It is anticipated that the prevention and behavioral scientists may be drawn from research backgrounds unrelated to the lower urinary tract bringing expertise in human development, life-course trajectories and design of prevention interventions. Other expertise of value to PLUS are individuals with expertise in measurement development, epidemiology, community engagement and health education. Note that some of the required expertise may be represented by the same individual. Collectively, the Clinical Research Center team should include research expertise across the four life-stage groups: pre-reproductive, reproductive, post-reproductive and women over 65 years of age.
PLUS Clinical Research Centers are encouraged to involve junior faculty and new investigators in applications to allow for continuity of investigators to later stages of the consortium’s prevention research goals.
The Clinical Research Center PD/PI(s) biosketch should describe prior experience in developing and managing a transdisciplinary team.
Each investigator’s biosketch should describe:
Because all relevant expertise may not be present at a single institution, investigators may establish a transdisciplinary team through collaborations with researchers outside their own institution. Such arrangements must be highly justified and add important additional scientific capability to the PLUS Research Consortium and to meet the objectives in this FOA.
Investigators should not be listed as participants in more than one application.
All instructions in the SF424 (R&R) Application Guide must be followed.
The application should include a detailed Personnel Justification that outlines Clinical Research Center personnel and their respective roles in support of PLUS Consortium’s efforts during the five-year Project Period. All personnel should be highly justified for their respective contributions to the objectives of the FOA and scope of work for each year they are listed.
Based on a 12 month calendar year, the budget must show evidence that the Clinical Research Center PD/PI(s) each have a minimum of 2.4 person months per year for each project year and that key investigators each have a minimum of 1.8 person months per year for the first two years of the project period to dedicate to establishing and maintaining PLUS Research Consortium scientific and operational excellence. For the remainder of the project period, the budget should reflect key investigator contribution to the research efforts each year but must be at least 1.2 person months per year.
Each Clinical Research Center should allocate funds for the logistical expenses for all investigators, appropriate research staff and up to 2 community members to each in person All-Consortium Meeting.
Research Strategy: An application for a Clinical Research Center should:
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.
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.Delayed Onset Study
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.
Common Data Elements for Data Sharing
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.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this FOA: If successful, would the proposed research provide new and significant findings that will support future intervention studies? Does the proposed research broadly address relevant factors in the PLUS Conceptual framework? Are conceptual models aligned with proposed research?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this FOA: Is appropriate research and clinical expertise represented at the Clinical Research Center and its collaborating institutions (if any)? Do the proposed Clinical Research Center(s) and other listed personnel have relevant research and/or clinical experience and expertise to conduct the proposed studies (public health and or prevention science, health behavior, primary care (pediatric/adolescent health, family medicine, internal medicine, geriatrics, women’s health, or general gynecology), and LUTS expert)? Have investigators demonstrated successful transdisciplinary research collaborations and evidence that they can plan and execute qualitative and quantitative research? Have investigators demonstrated meaningful use of community members in design and execution of research studies? Has PD/PI(s) demonstrated evidence of developing and maintaining transdisciplinary research collaborations in local and geographically dispersed settings? Is a plan in place to allow regular meetings of funded researchers and staff at the respective site to address administrative and scientific issues, progress, and planning? Are personnel sufficiently justified for their roles in support of PLUS Consortium efforts for each year of the five-year project period they are proposed to participate?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this FOA: Does the proposed scientific plan, if successful, have the potential to significantly increase and enhance our foundation of knowledge to support future LUTS prevention of bladder health intervention studies with subsequent implementation research? Does the application present novel approaches to understanding of interpersonal, institutional and societal/community factors.? Have innovative interpersonal, institutional and community/societal factors been considered?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
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?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA:
Has the Clinical Research Center demonstrated the ability to successfully recruit relevant racially, ethnically, and socio-demographically, diverse populations with the ability to sample across the life-stages (adolescents to older women) and across the spectrum from bladder health to chronic LUTS? Does the application include a realistic plan for inclusion of community members (target study participants and key stakeholders) in the design and execution of research studies at the local and national level? Are the PLUS Research Consortium’s major scientific objectives for this project period adequately addressed? Has the applicant presented viable research plans for societal/community, institutional, interpersonal and individual factors – from conceptual model to observational study and beyond to additional studies (qualitative, quantitative or literature review) that will be necessary to support successful intervention studies? Will the research plan provide insights into the most important populations to target for future primary or secondary prevention interventions? Are all proposed studies collaborative, multi-site (i.e., Trans-PLUS) in design or potential?
Does application reflect sufficient expertise to address potential requirements of the PLUS Consortium, including the coordination of biosample collection, storage, quality control and distribution (e.g. serum, DNA, and urine)? Does the research plan describe 1) The roles, responsibilities of the key investigators with a leadership plan, 2) Collaboration across the consortium on the planning, implementation and analysis of all types of research efforts, 3) Integration, communication, resource and data sharing across the consortium and ultimately provide relevant materials to the NIDDK Data and Biorepositories as appropriate, and 4) Collaboration between investigators within a Clinical Research Center and between the Clinical Research Center and its collaborating institutions (if any) as well as across the entire consortium?
Is there language in the application indicating willingness to share data and resources within the PLUS Research Consortium and ultimately provide relevant materials to the NIDDK Data and Biorepositories, consistent with the goals of the program?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
In addition, for applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Renewals, the committee will consider the progress made in the last funding period.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:
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.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable 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:
The NIDDK Program Official identified in the Notice of Award will:
1. Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
2. Review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.
3. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
4. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
5. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.
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 CR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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Contact Center Telephone: 800-518-4726
Tamara G. Bavendam, M.D., M.S.
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Marcel Salive, M.D.
National Institute on Aging (NIA)
Ryan Morris, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lesa McQueen, M.Sc.
National Institute on Aging (NIA)
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