and Human Services (HHS)
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Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) |
|
Funding Opportunity Title |
Planning Grants for Translating Chronic Kidney Disease (CKD) Research into Improved Clinical Outcomes (R34) |
Activity Code |
R34 Clinical Trial Planning Grant Program |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-DK-10-011 |
Companion FOA |
None |
Catalog of Federal Domestics Assistance (CFDA) Number(s) |
93.847 |
FOA Purpose |
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) encourages NIH Clinical Trial Planning Grant (R34) applications from institutions/organizations to test the effectiveness of interventions for the prevention, treatment and management of chronic kidney disease (CKD) that have a high likelihood of being widely adopted, and sustained in a wide range of health care settings and in individuals and communities at highest risk. The approaches to be tested must be based on interventions previously demonstrated to be efficacious in randomized clinical trials, and widely accepted throughout the chronic kidney disease CKD community. The proposed research must target chronic kidney disease and/or its complications. |
Posted Date |
September 15, 2010 |
Open Date (Earliest Submission Date) |
January 28, 2011 |
Letter of Intent Due Date |
January 31, 2011 |
Application Due Date(s) |
February 28, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
|
Advisory Council Review |
|
Earliest Start Date(s) |
September 30, 2011 |
Expiration Date |
March 1, 2011 |
Due Dates for E.O. 12372 |
Not Applicable |
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
The R34 submitted in response to this FOA should be designed to maximize generalizability and minimize bias in testing interventions which address barriers to implementation of evidence-based care for chronic kidney disease in populations and communities at highest risk. Studies should be designed within the context of the Chronic Care Model (or a similar comprehensive model): patient self-management support, delivery system design, decision support, and clinical information systems.
Relevant topics may include but are not limited to:
The primary outcomes of proposed studies must include objective measures of clinical status such as blood pressure, laboratory measures of metabolic control or nutritional status, change in kidney function or initiation of renal replacement therapy. Behavior change (such as changes in diet and/or physical activity patterns or behaviors) or knowledge acquisition may be included as secondary outcomes. Applications will not be considered responsive to this FOA if they fail to include objective clinical measures as primary outcomes.
Studies must be designed to translate interventions that have previously been shown to be efficacious in large randomized controlled clinical trials. It is not the intent of this FOA to support the development of initial efficacy trials or the development or dissemination of chronic kidney disease programs.
Applications must also propose to study the capacity of the tested approach to be widely disseminated, its sustainability once the research is concluded, and evaluate the cost of implementation in relation to the improvement in clinical outcomes. Applications must also include an evaluation of whether the intervention is delivered as intended (process assessment).
Studies addressing minority and other high-risk groups for chronic kidney disease are strongly encouraged but the intervention must be applicable to a broad segment of the at risk population. It is not the intent of this FOA to support research studies which replicate interventions previously shown to be efficacious in a different population (e.g., different age, gender, race/ethnic, co-morbid illnesses, SES). Studies of the development and validation of culturally appropriate patient education materials will be considered non-responsive to this FOA.
The design of the intervention and its analysis plan must be related to the research question(s) and the hypotheses to be tested. The study designs must emphasize the generalizability of the intervention.
Applications must provide a detailed description of the target population to be studied, a clear rationale for selection of the population, characteristics of the target population including age, gender, sex and race/ethnicity. Personnel with experience in recruiting CKD patients and the proposed recruitment strategies must be described. The sample size needed for the proposed study, including the assumptions used when estimating the sample size, should be detailed in relation to the analysis plan. Methods for assuring privacy and maintaining confidentiality must be included in the application. A data and safety-monitoring plan must also be described.
Studies may use study designs and methods methodology of biomedical, social or behavioral sciences, epidemiology, clinical trials, and health services and dissemination research. Interventions designed to result in behavioral change should be based on behavior change theory(ies) and must be described in the application.
Applicants must document the prior experience and expertise of the research team to conduct the proposed research study. Use of a multidisciplinary research team is strongly encouraged. The expertise may include, but not limited to, nephrologists, public health physicians, primary care physicians, epidemiologists, statisticians, clinical trialists, psychologists, health educators, sociologists, nurses, nutritionists and other health related professionals. The interdisciplinary nature of the research team should be fully described and justified.
Brief descriptions, as appropriate, of the process for biologic sample collection, storage and handling; the laboratory tests that are needed; physical facilities, data management and computer resources, and facilities for data retrieval and storage; and a plan for randomization of patients or settings (if applicable) for delivery of interventions into protocols should be provided.
Applicants are encouraged to consider use of patient, physician and other health care provider resources developed by the National Kidney Disease Education Program (NKDEP) (http://nkdep.nih.gov/).
NIDDK is sponsoring a Workshop on Translating CKD Research into Improved Clinical Outcomes on October 18-19, 2010 at the Natcher Conference Center. Additional information is available at http://www.ckdt2workshop.net.
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
In FY 2011, NIDDK intends to commit $1.45 million in support of 4 awards. |
Award Budget |
NIDDK intends to commit up to $225,000 direct costs per year and for a period of up to three years. A maximum of $450,000 direct costs may be requested. |
Award Project Period |
The maximum period is 3 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.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Governments
Other
Foreign (non-U.S.) components of U.S. Organizations are allowed.
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
registrations.
All Program Directors/Principal Investigators (PD/PIs) 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 four (4) 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 Project 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 PDs/PIs, visit the Multiple
Program Director/Principal Investigator 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. NIH will not accept any application that is essentially the same as one already reviewed.
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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive, and Kidney
Diseases (NIDDK)
6707 Democracy Boulevard
Room 752, MSC 5452
Bethesda, Maryland 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: 301-594-8897
Fax:301-480-3505
Email: fc15y@nih.gov
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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Appendix
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout 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.
Important
reminders:
All PD/PIs 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 fc15y@nih.gov 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.
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.
Significance
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? Is the proposed study based on interventions previously shown to be efficacious in randomized controlled clinical trials? Does the intervention strategy proposed have the ability to be translated into real world settings beyond the research environment, such as primary care, community, family or other patient care/support settings? Does the intervention have the potential to be disseminated and lead to an intervention that, considering costs and healthcare practice issues, can be sustained in real world settings?
Investigator(s)
Are the PD/PIs, 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Have the investigators demonstrated the ability to develop and implement a multi-disciplinary approach to improving clinical outcomes in CKD?
Innovation
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?
Approach
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 managed?
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? Has the target population been clearly described in terms of age,
gender race/ethnicity, and severity of CKD? Does the proposed primary outcome
include objective measures of clinical status? Is the sample size adequately
justified? Is the data analysis plan clearly described and appropriate? Does
the application include an evaluation of whether the intervention is delivered
as intended (process assessment)?
Environment
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.
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.
Vertebrate Animals
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.
Biohazards
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.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 the National Institute of Diabetes and Digestive and Kidney Diseases (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
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
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 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.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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.
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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Andrew Narva, M.D
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 644
Bethesda, MD 20892-5458
Telephone: 301-594-8864
Fax: 301-480-3510
Email:narvaa@mail.nih.gov
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive, and Kidney
Diseases (NIDDK)
6707 Democracy Boulevard
Room 752, MSC 5452
Bethesda, Maryland 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: 301-594-8897
Fax:301-480-3505
Email: fc15y@nih.gov
Charlette L. Kenley
Grants Management Specialist
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Room 711, MSC 5456
Bethesda, MD 20892-5456
Telephone: 301-594-8847
Fax: 301-594-9523
Email: kenleyc@mail.nih.gov
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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