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://www.niddk.nih.gov)
Title: RFA-Announcement of a Limited Competition for the
Continuation of the Folic Acid for Vascular Outcome Reduction in Transplantation
(FAVORIT) Trial (U01)
Announcement Type
This is a limited competition RFA.
Request For Applications (RFA) Number: RFA-DK-06-502
Catalog of Federal Domestic Assistance Number(s)
93.849
Key Dates
Release Date: May
31, 2006
Letter of Intent Receipt
Date: June 23, 2006
Application Receipt
Dates: July 25, 2006
Peer Review Date: October/November 2006
Council Review Date(s): February 2007
Earliest Anticipated
Start Date: March 1, 2007
Expiration
Date: July 26, 2006
Due Dates for E.O. 12372
Not applicable
Additional Overview
Content
Executive Summary
This is an announcement for a Limited Competition to solicit a single grant
application from the Principal Investigator whose institution is currently
serving as the Operations Center for the Folic Acid for Vascular Outcome
Reduction in Transplantation (FAVORIT) Trial. This Limited Competition
will provide support for five years to Clinical Centers to continue
recruitment, treatment, and follow-up of study participants enrolled in the
trial. Support will also be provided for the Data Coordinating Center, the Central Laboratory, the Endpoint Adjudication Center, and the Operations Center.
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 Division of Kidney, Urologic, and Hematologic Diseases of the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a
longstanding and substantial interest in research on the care of patients with
chronic kidney diseases (CKD). CKD is a burdensome condition in the United States affecting between 8 and 10 million Americans. CKD patients are a very
high risk for cardiovascular disease (CVD). Among patients with kidney
failure treated with dialysis the cardiovascular mortality rate is up to ten
times that of the general age-matched population. The excess risk of CVD
in CKD patients is due in part to a higher prevalence of established
arteriosclerotic risk factors, including older age, hypertension, diabetes,
dyslipidemia, and physical inactivity. However, these established risk
factors do not account for the multi-fold increase observed in event rates for
persons with CKD. Unique risk factors related to CKD likely also
contribute to this excess CVD risk. These novel or unique risk factors
include elevated homocysteine levels. Mild to moderate
hyperhomocysteinemia has been shown to be an independent risk factor for CVD
outcomes in prospective observational studies of CKD patients including kidney
transplant recipients. Based on these observational studies it is
reasonable to hypothesize that lowering total homocysteine levels in patients
with CKD may reduce their burden of CVD outcomes. Kidney transplant
recipients are a suitable population for testing this hypothesis since they
have a high rate of both incident and recurrent cardiovascular disease and
continue to have an excess prevalence of hyperhomocysteinemia despite the
fortification of cereal grain flour with folic acid. Importantly, these
patients are able to normalize their total homocysteine levels with combined
folic acid, vitamin B12, and vitamin B6 treatment.
Based on an investigator initiated (R01) grant application which was subsequently converted to a cooperative agreement (U01), the NIDDK initiated the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. The primary objective of the FAVORIT Trial is to determine whether lowering total homocysteine levels in patients with CKD (kidney transplant recipients) will reduce their risk of CVD. The primary hypothesis is that, in stable kidney transplant recipients, treatment with a multivitamin containing high doses of folic acid (5.0 mg), vitamin B6 (pyridoxine, 50 mg) and vitamin B12 (cyancobolamin, 1.0 mg) will reduce the rate of pooled arteriosclerotic cardiovascular disease compared to a group of patients treated with a low dose multi-vitamin devoid of folic acid with estimated average requirement of vitamins B6 (1.4 mg) and B12 (2.0 mcg). The primary endpoint is combined clinical events and invasive procedures for cardiovascular, peripheral vascular or renovascular disease.
The trial s organizational and operational components include an Operations Center, Data Coordinating Center, Central Laboratory, Endpoint Adjudication Center, and Clinical Centers (recruiting sites) supported by a single grant. The target sample size is 4,000. A minimum of 4 years follow-up is planned.
The NIDDK seeks to continue support of the FAVORIT Trial for an additional five (5) years through this Limited Competition in order to complete recruitment, continue treatment and follow-up of study participants to promote adherence to the intervention, and to ascertain outcomes.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
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".
2. Funds Available
The participating IC, NIDDK, intends to commit a maximum of $3.9 million dollars (direct and facilities and administrative costs) in FY 2007 to fund a single grant comprised of a Operations Center, Data Coordinating Center, Clinical Centers, a Central Laboratory, and an Endpoint Adjudication Center.
The
application submitted in response to this RFA may request a project period of
up to five (5) years and a budget of $3.9 million dollars (direct and
facilities and administrative costs).
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit a grant
application if your organization received a Notice of Grant Award (U01
DK61700) for the FAVORIT Trial.
1.B. Eligible Individuals
Institutions which served as the Operations Center, Data Coordinating Center, Clinical Centers, Central Laboratory, and Endpoint Adjudication Center are eligible to continue to collaborate and submit a single grant application in response to the RFA.
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
The objective of the continuation of the FAVORIT Trial is to complete
recruitment and to continue intervention and follow-up of the enrolled study
participants. Therefore, the single applicant for this RFA should be the
organizations which served as the Operations Center, the Data Coordinating Center, the Central Laboratory, and the Endpoint Adjudication Center during the previous project period.
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: GrantsInfo@nih.gov.
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.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
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
Letter of Intent Receipt
Date(s): June 23, 2006
Application
Receipt Date(s): July 25, 2006
Peer Review Date(s):
October/November 2006
Council Review
Date(s): February 2007
Earliest
Anticipated Start Date(s): March 1, 2007
3.A.1. Letter of Intent
The prospective
applicant is 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:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
Fax: (301) 480-3505
Email: fc15y@nih.gov
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:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
Fax: (301) 480-3505
Email: fc15y@nih.gov
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
None
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.
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may 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.
Sharing Research Resources
NIH policy requires that
grant awardee 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.
It is expected that patient samples and the final database be archived at the
NIDDK Biosample and Data Repository, respectively.
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 the 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?
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 Principal
Investigator and the collaborating 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?
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?
Progress in First Project Period: Has the progress and achievements made during the first funding period of the FAVORIT Trial justify continuation of the trial?
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 in Research: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups) as appropriate for the
scientific goals of the research will be assessed. (see the Research Plan,
Section E on Human Subjects in the PHS Form 398).
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 may 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 funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
It is expected that the complete, clean, documented database will be archived
at the NIDDK Data Repository at a mutually agreed upon time after the
completion of the trial.
2.D. Sharing Research
Resources
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 Principal Investigator will also receive a
written critique called a Summary Statement.
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 NoA. 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 ), 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 leading the conduct of the study as defined in the approved study protocol. He/she will also have the responsibility of coordinating the trial including the operation of the following units: the Operations Center, the Data Coordinating Center, the Biochemistry Laboratory and the Endpoint Adjudication Center. The Principal Investigator will work with the Data Coordinating Center to prepare interim and final reports on the conduct and findings of the trial. The Principal Investigator will be responsible for submitting Serious Adverse Events to the Food and Drug Administration (FDA) in accordance with the requirement of the Investigational New Drug (IND) Application that the trial is being conducted under. The Principal Investigator, in concert with the e Data Coordinating Center, is responsible for preparing an annual IND Report to be submitted to the FDA. The Principal Investigator will have the lead responsibility, in collaboration with the Data Coordinating Center and other FAVORIT investigators, to analyze the data and prepare scientific papers for publication.
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 NIH Project Scientist
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below.
The NIH Project Scientist will assist the FAVORIT investigators in the conduct of the trial including assessment of performance, including data quality. The Project Scientist will assist the investigators in data analysis and preparation of manuscripts for publication. The Project Scientist will also serve as a member of the Executive Committee (see 2A.3, Collaborative Responsibilities, below).
An independent Data and Safety Monitoring Board was
established by the NIDDK and provides oversight of the progress and safety of
the trial.
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.
2.A.3. Collaborative Responsibilities
The Principal Investigator will lead the effort of the Executive Committee, an administrative body which is responsible for decision making and monitoring the progress of the trial. The Executive Committee includes the Principal Investigator (head of the Operations Center), the lead investigators for the Data Coordinating Center, the Biochemistry Laboratory, the Endpoint Adjudication Center, the NIDDK Project Scientist, as well as several lead investigators of Clinical Centers and other members as needed. The investigators will meet annually in person and by telephone between this meeting to discuss progress of the trial, improve overall performance, and plan for analysis of the data.
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 Executive 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:
John W. Kusek, Ph.D.
Clinical Trials Program Director
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 617
Bethesda, MD 20892-5452
Telephone: (301) 594-7735
Fax: (301) 480-3510
Email: jk61x@nih.gov
2. Peer Review Contacts:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
Fax: (301) 480-3505
Email: fc15y@nih.gov
3. Financial or Grants Management Contacts:
Charlette Kenley
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room 723
Bethesda, MD 20892-5456
Telephone: (301) 594-8847
Fax: (301) 480-3504
Email: ck128k@nih.gov
Section VIII. Other Information
Required Federal Citations
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).
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.
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.
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.
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. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to 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 PA 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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