National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title
Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study (U01)
U01 Research Project – Cooperative Agreements
Reissue of RFA-DK-07-502
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The purpose of this Limited Competition is to extend the Chronic Renal Insufficiency Cohort (CRIC) Study. The CRIC Study is a multi-center, prospective, observational cohort study of men and women with chronic kidney disease (CKD). The study includes seven Clinical Centers and their satellites and a Scientific and Data Coordinating Center. The CRIC Study, established in 2001, recruited a total of approximately 3,600 study participants. The study was previously extended by a limited competition in 2008. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) plans to again extend the study for another five years through this Limited Competition Funding Opportunity Announcement (FOA). The primary objectives of this FOA are to continue to follow-up the originally recruited cohort of study participants, to better understand the risk factors for rapid decline in kidney function and cardiovascular diseases among persons with mild/moderate CKD, to examine in greater depth the morbidity suffered by patients with CKD and to explore the impact of CKD in elderly persons. Only organizations currently serving as grantees for this study are eligible to apply to this FOA.
September 6, 2012
Open Date (Earliest Submission Date)
October 14, 2012
Letter of Intent Due Date
October 14, 2012
Application Due Date(s)
November 14, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
July 1, 2013
November 15, 2012
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health is a Limited Competition FOA inviting cooperative agreement (U01) applications from organizations serving currently as grantees in the Chronic Renal Insufficiency Cohort (CRIC) Study. This FOA will primarily support continued follow-up of previously recruited study participants. It will also permit the investigators to study other areas of high priority research of the epidemiology of chronic kidney disease (CKD).
The CRIC Study, established in 2001, is an ongoing, multi-center, prospective, observational cohort study of men and women with CKD. Approximately 3,600 study participants were enrolled by seven clinical centers and their satellites. A Scientific and Data Coordinating Center (SDCC) provides overall scientific and administrative leadership and is the central unit for data collection and analysis for the study. An additional approximately 325 study participants with CKD and of Hispanic ethnicity were recruited into the study at one of the clinical centers through an investigator initiated (R01) ancillary study grant.
The objectives of the CRIC Study remain as they were described in the first FOA establishing this cohort study. They include: 1.) to examine risk factors for progressive CKD and cardiovascular disease, 2.) to develop predictive models to identify high-risk subgroups and 3.) to identify etiological factors as targets for future clinical trials and intervention.
The CRIC Study has been ongoing for about a decade. Since CKD is a chronic disease it is necessary to observe persons with this condition for a very long period of time in order to understand its treated natural history, including risk factors for the rapid decline of kidney function which leads to kidney failure and the occurrence of CVD, a co-morbid condition commonly seen in patients with CKD. The CRIC Study has reached a stage where longitudinal analyses are now being undertaken to take advantage of the strength of the prospective study design. However, further follow-up of the original cohort will provide unique opportunities to further characterize study participants, including identification of patterns of kidney function decline and ascertainment of additional outcomes related to CKD and CVD. A number of other areas of high priority research in CKD epidemiology have been identified over the course of the CRIC Study. One area of increasing public health and medical importance is the impact of reduced kidney function in older adults. The clinical significance of reduced kidney function in the elderly remains uncertain. Through continued follow-up of the original cohort and recruitment of additional older study participants the CRIC Study will be in a unique position to determine the relationship between level of kidney function and functional status, whether the relationship between outcomes and risk factors differ significantly by age, and how social support and functional status affect outcomes, particularly hospitalizations and mortality. One important observation from the CRIC Study is that hospitalizations not directly related to the current goals of the study (that is non-CVD-related) are common. The additional period of study resulting from this Limited Competition will provide an opportunity for the CRIC Study investigators to further explore the morbidity experienced by CKD patients including non-CVD-related hospitalizations, health resource utilization, cognitive impairment, use of long-term care facilities, among others. Finally, while the overall burden of CKD is substantial in the U.S. persons with Stage 2 and Stage 3a CKD termed "mild" and "moderate" make up a significant proportion of this pool of CKD. With additional recruitment of study participants with mild/moderate CKD the CRIC Study will be able to better characterize the patterns of kidney function change, determine whether characteristic patterns are associated with distinct clinical outcomes and explore the relationship between episodes of acute kidney injury and the rate of progression of CKD.
In summary, the next five year project period for the CRIC Study to be supported by this Limited Competition will focus on the following areas: 1.) continued follow-up and assessment of the originally recruited cohort, 2.) examine the relationship between reduced kidney function and outcomes in the elderly, 3.) expand the emphasis on the morbidity experienced by persons with CKD by assessing a more comprehensive set of outcomes, including non-CVD hospitalization and 4.) recruit, assess and follow-up of persons with mild/moderate CKD. In addition, it is anticipated that the CRIC Study will contribute community resources including data and biological samples consistent with NIH policies to advance further research in CKD.
In order to maintain high rates of follow-up and data collection from the originally recruited cohort and to retain the considerable investment in infrastructure at the Clinical Centers and the Scientific and Data Coordinating Center only those organizations currently serving as grantees (Clinical Centers or the Scientific and Data Coordinating Center) for the CRIC Study are eligible to apply to this FOA.
Application Types Allowed
Funds Available and Anticipated Number of Awards
NIDDK intends to commit $7.92 million dollars in FY 2013 for this program.
Application budgets are not limited, but must reflect actual needs of the proposed project according to the plans for the third project period of the CRIC Study.
Award Project Period
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Only organizations which are current grantees for the CRIC Study are eligible to apply for this FOA.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(Courier use 20817)
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 Application Guide must be followed with the following exceptions or additional requirements:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Special instructions for the Clinical Centers:
Applicants for Clinical Centers (CCs) should describe their individual center's accomplishments related to follow-up of study participants, completeness of data collection, including ascertainment of outcomes of direct interest to the study. Each CC application must describe their plans for retaining currently enrolled study participants. They must also provide a comprehensive plan for recruiting study participants with mild/moderate CKD. A plan to obtain hospitalization records to support ascertainment of events of key interest to the study must also be included. Each CC submitting an application in response to this FOA must include an outline of study protocols for the continued follow-up of previously enrolled study participants, a new study of mild/moderate CKD and an enhanced emphasis on assessing morbidity, including a more comprehensive assessment of causes of hospitalizations beyond those described in the original study protocol (cardiovascular disease-related). Plans for examining the impact of CKD in the elderly must also be described. Each CC must also show that they have been and will continue to be able to submit data to the SDCC and biological (blood and urine) samples to the Central Laboratory as approved by the CRIC Steering Committee.
Special Instructions for the Scientific and Data Coordinating Center (SDCC):
The application for the SDCC should describe the previous research accomplishments of the CRIC Study (publications and presentations) and describe its operational infrastructure (committees, procedures for communication and coordination, etc.) to carry out the study. Where appropriate, it should note what roles the SDCC have played and will continue to play in implementing study protocols. As before, it is expected that the PD/PI of the SDCC will carry out a significant leadership role in the study. The SDCC application should describe the aims of the proposed studies to be undertaken during the project period to be supported under this Limited Competition.
Other special requirements:
The CRIC Study will continue to be a collaborative effort that will require frequent interactions of awardees among themselves and with the NIDDK. Applicants must explicitly indicate their willingness to:
1. Participate in the Steering Committee meetings and teleconferences as needed.
2. Cooperate with other awardees in the implementation of the various study protocols and cooperate with other awardees in carrying out approved research protocols.
3. Comply with study policies and quality assurance measures approved by the Steering Committee.
4. Agree to oversight of the study by an NIDDK appointed External Expert Panel.
5. Transmit study data to the SDCC in a timely and accurate manner (Clinical Centers only).
6. Cooperate with other awardees in the publication of study results and the eventual release to the scientific community of study procedures, data (through the NIDDK Data Repository) and biological samples (through the NIDDK BioSample Repository), consistent with achieving the goals of the program and NIH policies.
7. Accept the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2"Cooperative Agreement Terms and Conditions of Award".
8. Continue to foster and conduct ancillary studies.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.
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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
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
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Review of Clinical Center applications will also be based on the following specific criteria:
1. Retention of study participants: Is there evidence that the Clinical Centers will be able to adequately follow-up previously recruited (the originally recruited cohort) study participants?
2. Data and sample management: Is there an adequate plan to ensure accurate collection and timely transmission of study data to the SDCC and patient samples to the Central Laboratory as required by the approved CRIC Study protocol?
3. Recruitment of study participants with mild/moderate CKD: Is there a viable plan to recruit study participants with mild/moderate CKD? Are back-up or contingency plans provided and realistic?
4. Cooperative experience: Is there evidence of willingness to work cooperatively in this study?
5. Assessment of morbidity/hospitalizations: Does the applicant describe a plan to identify hospitalizations experienced by study participants and transmit necessary information to the SDCC?
Review of the Scientific and Data Coordinating Center application will be based on the following specific criteria:
1. The expertise, training, and experience of the investigators and staff, including the administrative abilities of the PD/PI and co-investigators, and the time they plan to devote to the effective coordination of the CRIC Study.
2. The administrative, supervisory, and collaborative arrangements for achieving the goals of the Clinical Centers and the NIDDK.
3. The appropriate facilities, equipment, and the organizational structure to effectively coordinate the CRIC Study activities in implementing the study protocols, supporting laboratory testing and data collection.
4. Plans for data analysis of previously collected data and newly acquired data to be collected under this limited competition.
5. Plans for fostering ancillary studies.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Select Agent Research
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).
Resource Sharing Plans
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) Genome Wide Association Studies (GWAS).
Budget and Period of Support
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. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
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 Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), 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 primary responsibility for:
1. Developing the research designs and study protocols, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment, assessment and follow-up, data collection and 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 and the External Expert Panel.
3. Implementing collection of data specified by the study protocol, by the Steering Committee. Each awardee/site is required to ensure that data will be submitted as completely and expeditiously as possible to the Scientific and Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the research study design strategy specifically developed for their individual study population.
4. 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) 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 awards, a plan for analysis of pooled data will be developed by the Steering Committee.
5. Submitting interim progress reports, when requested, 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.
6. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.
7. Reporting of the study findings. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to the Government rights of access consistent with current HHS, 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. Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NIDDK support; or special access to study results, primary data/summary information, or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party is permitted only after concurrence by NIDDK.
9. Study investigators are encouraged 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.
10. 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 a company collaborating with the study.
11. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the
archival and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The Program Director/Principal Investigator of the Scientific and Data Coordinating Center or his/her designee will coordinate with the NIDDK Data Repository to prepare the collected data for eventual archiving and distribution. In addition, if applicable, the Program Director/Principal Investigator or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, and storage 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 Steering Committee 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, http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
NIH staff will have substantial involvement in the project above and beyond normal stewardship and monitoring of the award, as described below:
1. Serve as the contact point for all aspects 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, Biostatistician or Analyst, 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. Participation in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serving 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. 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.
b. The NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of common research or clinical study protocols 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 designee 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) participate in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
In addition, a separate NIDDK Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include.
Interacting with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the 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 External Expert Panel, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
Reviewing and approving protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.
The NIDDK Program Official will monitor protocol progress, and may request that a 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; and (f) 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.
Making 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.
Appointment of an External Expert Panel as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the Panel.
Areas of Joint Responsibility include:
In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:
1. Steering Committee.
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 of operation, questionnaires and other data recording forms, establish and maintain data quality control among awardees, review progress, monitor accrual of study participants, 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 Principal Investigator(s), (including those of Scientific and Data Coordinating Center) and co-investigators as deemed necessary, and the NIDDK Project Scientist. 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.
The chairperson of the Steering Committee is the Principal Investigator of the Scientific and Data Coordinating Center. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Expert Panel established by the NIDDK (see item D2 below) and by interacting closely with the awardees during protocol development and implementation.
An Executive Committee, consisting of two Program Director(s)/Principal Investigator(s) of Clinical Centers, the Program Director/Principal Investigator of the SDCC, and the NIDDK Project Scientist, will continue under this Limited Competition. The Executive Committee meets by telephone on a weekly basis and serves as a decision-making body in the interim between Steering Committee meetings.
2. External Study Oversight.
An independent External Expert Panel has been established by the NIDDK. The Panel will review interim results periodically and provide guidance to the NIDDK.
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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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