and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov/)
Components of Participating Organizations
National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov)
Title: Identification of Factors Associated with Failure of
Arteriovenous Fistulas to Mature in Hemodialysis Patients (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-DK-07-007
Catalog of Federal Domestic Assistance Number(s)
93.849
Key Dates
Release Date: October
10, 2007
Letters of Intent
Receipt Date: November
20, 2007
Application
Receipt Date: December
13, 2007
Peer Review
Date(s): March-April
2008
Council Review Date: May 2008
Earliest Anticipated
Start Date: July
1, 2008
Expiration
Date: December
14, 2007
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) has a longstanding interest in supporting clinical
studies of patients with end-stage renal disease (ESRD). In 2004 in the US, over 300,000 ESRD patients were being treated by hemodialysis and another 100,000
patients either began or re-initiated this mode of renal replacement therapy. A
well-functioning vascular access is necessary for adequate hemodialysis therapy
to be delivered. Vascular access is not only expensive to place but is also
costly to maintain. For example, there were nearly 1.5 million vascular access
procedures performed in 2004, costing approximately $200 million (US Renal Data
System Annual Report, 2006). Although hospitalization rates for creation of
vascular access in ESRD have decreased significantly, with procedures performed
in the out-patient setting, hospitalization rates for access complications,
most notably serious hemodialysis vascular access infections doubled from
1994-2004 (US Renal Data System Annual Report, 2006). The highest rates of
infection are associated with vascular catheters, rather than with
arteriovenous fistulas (AVF) or grafts; a troubling observation in view of the
steady increase in the percentage of hemodialysis patients, approximately 50%,
which begin dialysis with a catheter access (US Renal Data System Annual
Report, 2006).
It has been long recognized that a mature AVF is the most reliable access for providing adequate blood flows for dialysis treatments. An AVF has a lower rate of infection, longer duration of use, and is associated with lower mortality than other access methods. This has resulted in clinical practice guidelines recommending AVF placement preferentially to other modes of vascular access, with the goal of reducing the number of vascular catheters used. As a result of these guidelines, and the Fistula First Initiative from the Centers for Medicare and Medicaid Services, many more AVF are being placed. However, recent studies suggest that impaired maturation, the failure of a new AVF to develop into a usable vascular access occurs in 20-50% of newly-created AVFs. Impaired AVF maturation has several serious consequences for hemodialysis patients, including prolonged use of vascular catheters (with attendant risk of sepsis) and the need for further invasive access procedures to create a more suitable permanent vascular access. Patient and physician frustration over a failed AVF is an additional contributing factor to vascular catheter use, as patients may be reluctant to undergo additional invasive procedures.
Several factors have been identified which may contribute significantly to impaired maturation of AVFs, including venous stenosis, accessory veins and impaired arterial or venous dilation, previous vascular procedures, details related to the surgical procedure, as well as circulating inflammatory mediators. The frequency with which these factors occur and their importance in contributing to impaired AVF maturation is not known. Moreover, the optimum approaches to manage these factors noted in a newly-placed AVF remain uncertain.
To address the problem of AVF maturation failure, the NIDDK will support a research consortium of 8 Participating Clinical Centers (PCC) and 1 Data Coordinating Center (DCC) to undertake a multi-center prospective observational cohort study investigating clinical factors which may be predictive and/or are associated with the failure of newly placed AVF to mature in patients with ESRD. The study would focus on evaluating AVF anatomy (i.e. vascular imaging, intra-operative assessment) and function (i.e. vascular reactivity, circulating factors, blood flow measures) with uniform measurements made across all participating clinical sites. The study would also collect information on additional vascular access morbidity related to failed maturation in a newly placed AVF, including catheter-related morbidity and the outcomes of subsequent hemodialysis access procedures. It is anticipated that, after a protocol development phase, at least 600 patients with newly-placed AVF will be required to assess factors and clinical parameters associated with failed maturation. The patient enrollment phase for the protocol would occur over two years of the study, with an additional year of patient follow-up, during which each PCC would enroll approximately 75-100 subjects. It is expected that the protocol will address methods to reliably assess fistula suitability for hemodialysis therapy. It is also anticipated that sub-studies within the main protocol could address the potential for newer vascular imaging methods or techniques to predict AVF outcomes. The final phase of the initiative will include study close-out and data analysis.
The specific objectives of this RFA are to determine the natural history of AVF maturation in a broadly representative population of hemodialysis patients with the goal of identifying risk factors for impaired AVF maturation. It is anticipated that the initiative will also assess the utility of vascular imaging and other measurements to serve as a surrogate outcome in future trials of vascular access. The ultimate goal of this initiative is to enhance the knowledge base for vascular access management such that AVFs may be placed in patients having the greatest likelihood of successful use of this form of vascular access.
A Steering Committee will serve as the governing board for the Consortium; its actions and decisions will be determined by majority vote. Membership will include a Steering Committee Chair, the PCC and DCC PIs and the NIDDK Project Scientist. Responsibilities of the Steering Committee include:
The PCC PI will be responsible for implementation and oversight of the study protocol (s) at the site, including IRB submissions, quality control, patient enrollment and retention. The PCC will also be responsible for timely and accurate transfer of study data to the DCC, for the purpose of generating a single data set for all data collected for this initiative.
The DCC PI will be responsible for providing coordination, assistance, centralized data management, and analytical support for Consortium studies. The DCC responsibilities include statistical design and logistical support for the Consortium Steering Committee. Specifically, the DCC will provide assistance in the following areas:;
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the U01 Cooperative Agreement award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The NIH U01 is a cooperative agreement award mechanism. In the
cooperative agreement mechanism, the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH staff being substantially involved as a partner with
the Principal Investigator, as described under the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award". Plans for this cooperative agreement project beyond the
current funding opportunity are indefinite.
2. Funds Available
The NIDDK intends to
commit approximately $3.0 million dollars in FY 2008 to fund 7-9 new and/or competing continuation grants in response to this
RFA. An applicant may request a project period of up to five years and a budget for
direct costs up to $225,000 for a PCC award and $600,000 for a DCC award per year.
Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
Public/State Controlled Institution
of Higher Education
1.B.
Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution 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.
Individuals
applying as PI for a PCC should have expertise in the care of patients with ESRD
and clinical research. Individuals applying as PI for the DCC should have
expertise in clinical research, and a Masters Degree or Doctorate in Clinical
Epidemiology, Biostatistics, or related field. The PI of a DCC
application should also have experience in the field of kidney disease
research.
2. Cost Sharing or Matching
Not applicable
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
None
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letters of Intent
Receipt Date: November 20, 2007
Application
Receipt Date: December 13,
2007
Peer Review
Date(s): March-April 2008
Council Review
Date: May 2008
Earliest
Anticipated Start Date: July 1, 2008
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
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.
The letter of intent is to be sent by the date listed
at the beginning of this document.
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 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Dr.
Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive
applications will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Plan for Sharing Research
Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of
the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Data
sharing in this Consortium will have three components:(1) Data sets from
clinical centers will be shared within the Consortium during the clinical
study, becoming part of a common data set that will be maintained at the DCC
and that will be the basis for analysis of study endpoints, and ultimately
transferred to the NIDDK Data Repository after study completion. (2) The
Consortium will also publish their research results and share with the
scientific community and the general public. (3) The Consortium data set will
ultimately be transferred to the NIDDK Data Repository after the clinical study
has been completed and the primary data paper (s) published. Applicants should
indicate their willingness to comply with Consortium plans for both components
of data sharing.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NIDDK in
accordance with the review criteria stated below.
As part of the initial
merit review, all applications will:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics? Are strategies proposed by the PCCs for recruitment and retention
well-described and feasible based on previous work at the institution? Is the
study design likely to provide data that is generalizable to the ESRD patient
population? Does the study design include meaningful clinical parameters and
factors for the study of vascular access?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)? Does the applicant present evidence of appropriate
training, experience and expertise in the field of kidney disease research? Has
the applicant participated in large clinical studies of kidney disease? In view
of the proposed overall number of study participants, does the applicant
provide a feasible plan for enrolling at least 75 subjects for the study, based
on the number of AVFs placed annually at the site and the previous experience
with studies of hemodialysis access? Does the applicant have experience with
clinical studies that have incorporated protocols for vascular access imaging?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support? For DCC
applications, is there evidence of previous experience and accomplishments in
the design and analysis of large-scale patient datasets related to kidney
disease, and of the availability of an adequate infrastructure to support the
appropriate storage, management and analysis of data generated by human
subjects research?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1. Award Notices
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.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
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. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.
2.A. 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 U01, 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.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal
Investigator will have the primary responsibility for defining the
protocols, approaches and details of the project within the guidelines of this
RFA. Each PI will be a voting member of the Consortium Steering
Committee, will participate in all Steering Committee activities, and will
follow the policies and procedures developed by the Steering Committee.
Each Clinical Center PI will have primary responsibility for implementation of
protocols (s) developed by the Steering Committee at their Center, and will be
required to provide primary study data to the DCC for management, quality
control and analysis. PI responsibility regarding Steering Committee
membership, protocol development and conduct are described under Collaborative
Responsibilities.
The DCC PI is expected to work cooperatively with Clinical Centers and sponsoring organizations in a multi-center study and oversee the implementation of and adherence to common protocols, as well as assure quality control of the data collected and its subsequent analysis. The DCC will schedule, organize and perform clinical site visits as required, during the conduct of the clinical trials. In addition to scheduling, organizing (including developing the agenda with the Consortium investigators) and attending regular meetings and monthly telephone conferences, the DCC will be expected to maintain close communications with the NIDDK Project Scientist and the PIs of the Clinical Centers. The DCC will perform analyses as outlined in the study protocols, and as suggested by the members of the Steering Committee, as well as propose original analyses to the collaborative group for their consideration. The DCC will prepare periodic reports on recruitment, quality control, study adherence, patient safety, and final results to the Steering committee, the NIDDK and the NIDDK-appointed external advisory committee (s). Additional interim analyses, as requested by NIDDK or an NIDDK-appointed data and safety monitoring board (DSMB) will also be prepared.
The DCC will establish, maintain and provide appropriate oversight to subcontracts for Central Laboratories, and other necessary adjuncts to the study. For all Central Laboratories the DCC will coordinate coding, shipping, and receipt in collaboration with study sites, and regularly monitor data quality control from the Central Laboratories.
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 DCC will work with the NIDDK Biosamples Repository and the PCCs to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. 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 tot he 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.
2.A.2. NIH
Responsibilities
An NIDDK 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 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 RFA, and/or a human
subject ethical issues that may dictate a premature termination.
Additionally, an NIDDK
Program Official will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice.
2.A.3. Collaborative
Responsibilities
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 PIs and the NIDDK Project Scientist. A Chair will be chosen from among the Steering Committee member (but not the NIDDK Project Scientist or DCC 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, 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 PI will be responsible for close coordination and cooperation with other Consortium investigators and with NIH staff. The 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.
2.A.4. Arbitration
Process
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 arbitration. An Arbitration
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 arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section
VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Dr. Catherine M. Meyers
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 641
Bethesda, Maryland 20892-5458
Telephone: (301) 594-7717
FAX (301) 480-3510
Email: [email protected]
Dr. John
Kusek
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 617
Bethesda, Maryland 20892-5458
Telephone: (301) 594-7717
FAX (301) 480-3510
Email: [email protected]
2. Peer Review Contacts:
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 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms. Carey
Beckley
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney
Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 725
Bethesda, Maryland 20892-5456
Telephone: (301) 594-8833
FAX: (301) 594-9523
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not
possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should think about how to structure informed consent statements and
other human subjects procedures given the potential for wider use of data
collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children
as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on
the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy
of Individually Identifiable Health Information:
The Department of Health
and Human Services (DHHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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