and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|
Funding Opportunity Title |
Pilot Studies of Candidate Therapies for Chronic Kidney Disease (CKD) (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-DK-12-016 |
Companion Funding Opportunity |
None |
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) |
93.847 |
Funding Opportunity Purpose |
The purpose of this FOA is to advance the treatment of Chronic Kidney Disease (CKD) through pilot studies that seek to optimize critical elements of a full-scale randomized control trial design. Various treatments to slow or reverse progression of CKD have been tested in small trials with limited numbers of participants, but there still remain questions of the optimum agent(s), target population, dosing, data collection, and appropriate outcomes. This FOA solicits applications from investigators willing to collaborate on the design and conduct of pilot studies that will better inform the design of a full-scale randomized, controlled clinical trial(s) in CKD. |
Posted Date |
August 30, 2012 |
Open Date (Earliest Submission Date) |
October 19, 2012 |
Letter of Intent Due Date |
October 19, 2012 |
Application Due Date(s) |
November 21, 2012, 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) |
July 1, 2013 |
Expiration Date |
November 22, 2012 |
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 purpose of this FOA is to form a multi-center, collaborative study group that will carry out pilot studies that optimize critical elements of the study design of subsequent randomized trial(s) of new treatment(s) for CKD. This consortium may include industry participation (i.e., advisory, donation of drug, or other) and will communicate with the Food and Drug Administration (FDA) concerning its activities.
The following define elements of this FOA:
a. Each agent or non-pharmacologic maneuver must be off-patent or repurposed from its original use. Agents may be drawn from the following but are not limited to: allopurinol, pirfenidone, pentoxifylline, phosphate binders, spironolactone, vitamin D or from the NCATS list of repurposed drugs (http://www.ncats.nih.gov/research/tools/preclinical/npc/pharmaceutical-collection.html). Since angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are currently the standard of care for CKD patients, it is anticipated that all participants will be taking ACEI and/or ARB during pilot studies and the subsequent randomized trial(s).
b. Drug dosing/dose-ranging studies should be proposed to establish the toxicity and safety of specific therapeutic interventions. Within the study, protocols should be used to examine biomarker(s) for each drug proposed for study.
c. The target population for the pilot studies and for the future randomized controlled trial should be carefully defined with respect to such variables as: level of kidney function (eGFR), amount of urine protein excretion, age, co-morbidities of diabetes and hypertension, gender and racial/ethnic composition, future CKD biomarkers, and other factors deemed important by the investigators.
d. The investigators should demonstrate their ability to recruit a diverse population for the pilot trials and for any subsequent randomized trial. Pilot trials may be designed with a length appropriate to the purpose. If appropriate, participants may take part in more than one shorter-term study.
e. The sampling strategy and collection methods should be clearly defined.
f. Costs for all data and biological samples that will be deposited in the NIDDK Repository should be estimated in the application.
g. Renal and non-renal outcomes including measures of CKD progression should be specified. Alternative endpoint markers of progression should be acceptable to the FDA or should be qualified within this study.
h. Awardees will be contacted by NIDDK prior to award in order to set up tentative dates for weekly teleconferences immediately after award to develop study protocols. Within two months after the award, the successful awardees will meet face-to-face for two days to finalize the study protocol(s). All awardees must commit to joint recruitment and completion of all approved protocols.
A Steering Committee will serve as the governing board for the Consortium; its actions and decisions will be determined by majority vote. Membership on the Steering Committee will include a Steering Committee Chair (appointed by the NIDDK), the Participating Clinical Centers (PCC) and Data Coordinating Center (DCC) PD(s)/PI(s), a NIDDK Project Scientist, and other participating stakeholders, as appropriate. The FDA will be contacted to advise the steering committee concerning protocol development, and qualification of biomarkers and alternative outcomes.
The responsibilities of the Steering Committee include: Development of the common protocol(s) that will address points a-h above; Providing input on and approval of all studies developed by the Consortium members prior to or after study implementation; Review and approval of all data analyses, public presentations and publications of research conducted within the consortium; Development of policies and procedures for submission and approval of ancillary research applications using Consortium resources.
The responsibilities of each PCC are: local institutional review board (IRB) approval, recruitment of participants, collection of data according to the common protocol(s), timely transmission of data to the DCC, joint analysis, interpretation and publication of study data, and participation in steering committee meetings and annual meetings with the Data Safety and Monitoring Board (DSMB) and the NIDDK.
The responsibilities of the DCC include: standardization of data collection forms in accordance with the protocol(s), tabulation of collected data, analyses of data, coordination of PCCs including monthly meetings of the steering committee and other committees that are deemed necessary by the entire steering committee, publication of the annual progress report, and response to DSMB queries.
NIDDK will appoint an independent DSMB to monitor all study activities that impact participants. The DSMB will meet at intervals of not greater than 12 months to approve study protocols, review study progress, adverse events that occur in the course of the study, protocol changes suggested by the Steering Committee, and any other items relevant to the safety of participants and the successful completion of the study.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
It is anticipated that there will be 3 PCC awards and one DCC with a total budget of $1.5 million for the 4 applicants. Future year amounts will depend on annual appropriations. |
Award Budget |
An applicant may request a project period of up to 5 years and a budget for direct costs in the first year for a PCC up to $250,000 and for a DCC up to $350,000. Applicants should specify whether they propose to be a PCC or the DCC. |
Award Project Period |
The maximum project period is five 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
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.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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 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(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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:
Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
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 and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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 modifications:,
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.
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(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 NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
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.
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? Will the proposed study adequately inform an effective design of a randomized clinical trial of agent(s) that will slow, prevent or reverse progression of CKD?
Investigator(s)
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? Have these investigators demonstrated commitment to working together with other centers to design a common protocol, recruit participants, and implement the protocols that are not their own?
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? Are appropriate biomarkers and alternative outcomes proposed in the design of the study? If these alternative markers and outcomes have not been qualified by the FDA, does the application include plans to qualify or demonstrate their validity?
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? Does the proposed recruitment plan include a viable approach toward recruitment of
subjects with a broad range of eGFRs (and postulated rates of progression) for
the proposed pilot studies? Do they include backup plans in case the primary
recruitment plan fails? Have they documented how they would cooperate with
other centers in the consortium to accomplish the goals?
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?
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
Not Applicable.
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 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.l 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 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 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 OMB administrative guidelines, HHS 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 the primary responsibility for:
The PD(s)/PI(s) at each PCC and the DCC will have the primary
responsibility for working together to define the protocols, approaches and
details of the project within the guidelines of this FOA. Each PCC and DCC PD/PI
will be a voting member of the Consortium Steering Committee and will
participate in all Steering Committee activities, and will follow the policies
and procedures developed by the Steering Committee. A representative
from FDA will be designated to provide regulatory guidance in protocol,
biomarker, and surrogate outcome development.
PD(s)/PI(s) at PCCs Clinical Center will have primary responsibility for recruiting participants, collecting data, and providing study data to the DCC for management, quality control and analysis. PD(s)/PI(s) responsibility regarding Steering Committee membership, protocol development and conduct are described under Collaborative Responsibilities. 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 PD(s)/PI(s) will work with the NIDDK Biosamples Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. Biorepository costs should be included within each proposed budget.
The PD(s)/PI(s) at the DCC will be responsible for data
coordination of all trial sites, including data form changes, protocol changes,
oversight of all sub-contracts, quality control, assistance with retention of
study subjects, analysis of study results and close-out activities. In
addition, the DCC will coordinate with the NIDDK Repository to prepare the
collected data for eventual archiving and distribution. All samples and data
transferred to the Repositories will be under the custodianship of the NIDDK,
although the Consortium Steering Committee will have proprietary control of and
exclusive access to the samples and data for an agreed-upon period of time.
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 HHS, PHS, and NIH policies.
NIH staff have
substantial programmatic involvement that is above and beyond the normal
stewardship role in awards, as described below:
An NIH Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below.
The NIDDK Project Scientist will serve as a voting member of the Steering
Committee and will participate in all Committee activities, serving as a
resource with respect to the study design and implementation. The NIDDK will
select members of the DSMB that will carry out monitoring activities for the
consortium's activities, as stated above.
The NIDDK Project Scientist, together with the Steering Committee, will review the performance of each participating Center through consideration of the annual reports, sites visits, compliance with the Consortium procedures, meeting timeliness, adherence to uniform data collection procedures, and the timeliness and quality of data reporting. The NIDDK Project Scientist may contribute, through review, comment, analysis, and/or authorship, to reporting results of consortium studies to the investigator community and other interested scientific and lay organizations.
The NIDDK reserves the right to terminate or curtail any
study or any individual award in the event of (a) substantial shortfall in data
collection or submission, quality control, or other major breach or a study
protocol or Consortium policy and procedure, (b) substantive changes in a study
protocol that are not in keeping with the objectives of the FOA, and/or a human
subject ethical issues that may dictate a premature termination.
Additionally, an agency program official or IC program director will be
responsible for the normal scientific and programmatic stewardship of the award
and will be named in the award notice.
Areas of Joint
Responsibility include:
The Steering committee will be the governing board of the Consortium; its actions and decisions will be determined by majority vote. Voting members of the Steering Committee include a Steering Committee Chair, PCC and the DCC PD(s)/PI(s), the NIDDK Project Scientist; other stakeholders, if any, will not have voting status. A Chair will be chosen from among the Steering Committee member (but not the NIDDK Project Scientist or DCC PD/PI) or alternatively, from among experts in the field of clinical trials in kidney diseases who are not participating directly in the study. The Committee has the primary responsibility for determining the study protocol(s), monitoring the conduct of the study and reviewing data prior to reporting of study results. It will also be responsible for determining study policies in such areas as access to participant data, ancillary studies, publication and presentations, recruitment and quality standards. Each PD/PI will be responsible for close coordination and cooperation with other Consortium investigators and with NIH staff. The PD/PI will participate in regular (monthly) Steering Committee telephone calls and attend two Steering Committee meetings per year in the Washington DC Metro area.
The NIDDK Project Scientist (and other NIDDK scientists) may
work with awardees on issues coming before the Steering Committee and, as
appropriate, other committees, e.g. issues of recruitment, follow-up, quality
control, standards and methods, adherence to protocol, assessment of problems
affecting the study and potential changes in the protocol, interim data and
safety monitoring, final data analysis and interpretation, preparation of
publications, and development of solutions to major problems such as
insufficient participant participation. Regardless of the number of NIH
staff participating in technical advisory roles, the NIDDK will be limited to
one vote on the Steering Committee.
Each full member will have one vote. Awardee members of the Steering Committee
will be required to accept and implement policies approved by the Steering
Committee.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Dr. Michael F. Flessner
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: [email protected]
Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]).
Ms. Pamela Love
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 435-6198
FAX: (301) 594-9523
Email: [email protected]
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