Department of Health and Human Services
Participating Organizations
National Institutes
of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National
Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
Title: Announcement of a Limited
Competition for the Continuation of the Transfusion Medicine/Hemostasis
Clinical Trials Network (TMH CTN) [U01]
Announcement Type
This is a
limited competition RFA for previously released RFA-HL-02-001.
Request For Applications (RFA) Number: RFA-HL-06-108
Catalog of Federal Domestic Assistance Number(s)
93.839
Key Dates
Release Date: June
20, 2006
Letters of Intent
Receipt Date(s): July 17, 2006
Application Receipt
Date(s): August 17, 2006
Peer Review Date(s): January-February,
2007
Council Review Date(s): May 2007
Earliest Anticipated
Start Date(s): September 30, 2007
Additional Information
To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: August
18, 2006
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
Background
Clinical issues in transfusion medicine/hemostasis are sometimes focused on a large number of relatively rare diseases. For this reason, it is difficult to answer clinical questions of note due to the lack of a critical number of patients at any given institution. The NHLBI Workshop on Development of New Therapies for Rare Blood Diseases held on July 14, 1999, and a Working group on Clinical Research in Transfusion Medicine/Hemostasis that was convened on August 18, 2000, recommended the facilitation of clinical trials in this area with increased links to regulatory agencies such that therapeutic development could be fostered. Functioning clinical networks in Europe have fostered the collaborative approach to clinical problems and have been relatively successful. Similar networks for studies in the areas of transfusion medicine/hemostasis are not available in the U.S.
Research Goals
There is an urgent need to evaluate promising new therapies for hemostatic disorders such as ITP and TTP and to evaluate new blood products, especially platelets and platelet substitutes, and cytokines such as thrombopoietin. Each year, thousands of patients receive platelet transfusions or are treated for autoimmune hemostatic disorders and yet few have the opportunity to participate in clinical trials that would potentially result in improved patient care. There are several reasons why a Transfusion Medicine/Hemostasis Clinical Research Network would accelerate clinical research and translation of research to practice. Multi-center trials will reduce the number of patients needed at each clinical center and allow accrual to be completed more rapidly. Further, a common treatment protocol will reduce variables that contribute to patient outcome and allow valid comparisons between treatments. Finally, the Network approach will increase the number of comparative trials that are conducted by providing a framework for rapid initiation of important studies, a focus on randomized studies, and efficient use of pooled clinical expertise and data management resources.
The NHLBI seeks to continue support of the TMH CTN for an additional five years through this Limited Competition in order to implement studies that are currently in development and to take advantage of new research opportunities as they arise.
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 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 https://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".
This RFA is
a one-time solicitation. The NHLBI has not determined whether or how this
solicitation will be continued beyond the present RFA.
2. Funds Available
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:
1.B. Eligible Individuals
Eligible
principal investigators include individuals with the skills, knowledge, and
resources necessary to carry out the objectives of the TMH CTN and are invited
to submit grant applications to continue to participate in this network.
The grant application should provide evidence that the work proposed is
appropriate for the level of experience of the proposed Principal Investigator
and for that of other researchers.
2. Cost Sharing or Matching
Not applicable.
The most current Grants Policy Statement can be found at: https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Only
competing renewal applications funded as part of RFA-HL-02-001,
Transfusion Medicine/Hemostasis Clinical Trials Network will be considered.
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at https://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.
For each
Core Clinical Center (CCC), the Research Plan will include a detailed
description of the network study pipeline which will include ongoing trials,
trials ready for implementation, protocols in development, and future studies
at the proposal and conceptual stages. Only one application (the master
application) will contain the Research Plan (sections a. through d. outlined in
the PHS 398). Each of the other applications in the program will have the same
Research Plan as the master application and should specify “See the
application from Dr. X” (Principal Investigator for the master
application for the Research Plan), but will have unique Budget pages,
Biosketches, Resources, and Checklist. The Research Plan for the CCCs is
limited to 35 pages, and the Research Plan for the Data Coordinating Center
(DCC) is limited to 20 pages. The application from the DCC should include
a review of progress made by the TMH CTN, a plan to monitor and manage core and
non-core center performance, funding, and status within the Network.
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(s): July 17, 2006
Application
Receipt Date(s): August 17, 2006
Peer Review Date(s): January-February 2007
Council Review
Date(s): May 2007
Earliest
Anticipated Start Date: September 30,
2007
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:
Chief,
Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood
Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.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 https://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:
Chief,
Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood
Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: NHLBIchiefreviewbranch@nhlbi.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: https://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 NHLBI. 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 https://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 https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
6. Other Submission Requirements
A detailed categorical budget for the
initial budget period and the entire proposed period of support of five years
is to be submitted with the application.
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 https://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.
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 https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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, https://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:
One single overall score will be given for all the applications based on the scientific merit of the CCC applications and the DCC application as well as the overall synergy of the network. This score will reflect the progress of the network as well as its responsiveness to the network objective put forth in RFA-HL-02-001. The RFA states: “The objective of this RFA is to establish a Transfusion Medicine/Hemostasis Clinical Research Network that will accelerate research in the appropriate use of blood products and novel growth factors and in the treatment of hemostatic disorders, such as ITP and TTP. The network will standardize approaches to existing diagnoses and treatments, and evaluate new ones. The emphasis will be on clinical trials with a goal toward facilitating optimal therapy. Therapeutic trials may involve investigational drugs or blood products, including those already approved but not currently used, and those currently used. The network will emphasize the strength of the close collaborations between experts in transfusion medicine and those in hemostasis (and hematology) to potentially explore the role for other blood derived products such as granulocytes.”
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 NHLBI 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 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)?
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?
Specific considerations for each Core Clinical Center or Data Coordinating Center:
Core Clinical Centers (CCCs):
Data Coordinating Center:
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).
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 requires that
grant awardee 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 https://grants.nih.gov/archive/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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 above.
2.A.1. Principal
Investigator Rights and Responsibilities
The
Transfusion Medicine/Hemostasis Clinical Trials Network will be a cooperative
clinical network consisting of up to seventeen Clinical Centers (CC), a single
Data and Coordinating Center, and the NHLBI and include a Steering Committee,
Protocol Review Committee (PRC), Data and Safety Monitoring Board (DSMB) and
Clinical Research Skills Development Core(s).
The Principal Investigator(s) will have lead responsibilities in all aspects of the Network studies, including any modification of study designs; conduct of the studies; quality control; data analysis and interpretation; preparation of publications; and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. Principal Investigator(s) agree to the governance of the study through a Steering Committee.
The Clinical Center Principal Investigators will be responsible for proposing protocols, estimating their costs, participating in their overall development, recruiting subjects, conducting the research, assuring quality of subject care and protocol adherence, assuring the accurate and timely transmission of data collected in conjunction with the Data Coordinating Center, and disseminating research findings.
The Data Coordinating Center Principal Investigator will coordinate, administer, and support all Network clinical research activities. The DCC Principal Investigator will be responsible for oversight of protocol development, data collection, data safety and confidentiality, quality assurance, data analysis and distributed coordination.
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.
The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating center for a collaborative database; the submission of copies of the collaborative datasets to each principal investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NHLBI Program Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.
Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI. Awardees must follow NHLBI policy concerning third party agreements.
Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study in accordance with study protocols and governance. Within three years of the end of the period of NHLBI support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance and with the above paragraph. In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the three-year period following the end of the period of NHLBI support.
Upon completion of the project, awardees are expected to put
their intervention materials and procedure manuals into the public domain
and/or make them available to other investigators, according to the approved
plan for making data and materials available to the scientific community and
the NHLBI and ICRH, for the conduct of research at no charge other than the
costs of reproduction and distribution.
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
The NHLBI
will oversee the organization of the Network and thus will be substantially
involved with the awardees in a partnership. NHLBI will appoint the Network
Chairperson(s), all members of the Protocol Review Committee (PRC), and the
Data and Safety Monitoring Board (DSMB). The Network Chairperson(s) will be
responsible for ensuring that there are well-documented policies, procedures,
and bylaws to guide all aspects of Network activities and operations.
An NHLBI Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NHLBI Project Scientist will serve on the Steering Committee; he/she or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and other NHLBI staff) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.
The NHLBI reserves the right to terminate or curtail the study (or an individual award) in the event of (1) failure to develop or implement a mutually agreeable collaborative protocol; (2) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (3) major breach of the protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (4) attaining of a major study endpoint before schedule with persuasive statistical significance; or (5) human subject ethical issues that may dictate a premature termination.
Additionally, a NHLBI Program Official will be responsible
for the normal scientific and programmatic stewardship of the award and will be
named in the award notice. The NHLBI Program Official will monitor subject
recruitment and study progress, ensure disclosure of conflicts of interest, and
ensure adherence to NHLBI policies.
2.A.3. Collaborative
Responsibilities
Awardee(s)
agree to the governance of the study through a Steering Committee (SC).
Steering Committee voting membership shall consist of the Principal Investigators
(or designated alternates) of the CCs and the DCC (i.e., cooperative agreement
awardees), the NHLBI Project Scientist, and the Network Chairperson(s). Each
full member will have one vote. The Network Chair(s) will plan Network
activities, oversee its functions and conduct SC meetings. The SC will develop
and ensure compliance with Network policies and procedures, identify and
prioritize topics for investigation, evaluate protocols proposed by the CCs,
develop consensus protocols for submission to the PRC, and ensure that studies
are properly conducted, monitored, and that study results are reported in the
scientific literature and disseminated in a timely manner. All major
scientific decisions will be determined by majority vote of the SC. The
SC has final responsibility for approving the protocol before review by the PRC
or DSMB. Subcommittees of the SC will be established as necessary and
would be expected to include a Publications and Presentations Subcommittee and
an Ancillary Studies Subcommittee. Awardee members of the Steering
Committee will be required to accept and implement policies approved by the
Steering Committee. Meetings of the Steering Committee will ordinarily be held
by telephone conference call or in the metropolitan Washington Area.
An independent Protocol Review Committee (PRC), established by the NHLBI, will provide peer review for each Network protocol. Because the PRC serves as an independent group advisory to the NHLBI, study investigators will not communicate with PRC members regarding study issues, except as authorized by the PRC's Executive Secretary. The independent PRC will be appointed by and be advisory to the NHLBI. It will consist of a chairperson and scientists with expertise in cardiac surgery, cardiovascular medicine, clinical research, clinical trial design, biostatistics, enabling technologies, outcome measures, and other areas of expertise as needed. The exact number and duration of protocols supported in the five-year program will depend on the nature and extent of the investigations proposed by the SC. The PRC will evaluate protocols proposed by the SC based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the Network and consistency with NHLBI missions and policies. The PRC will provide a written critique of each proposal and a final recommendation to the NHLBI. All study protocols performed by the Network must be recommended by the PRC and approved by the NHLBI before initiation.
A Data and Safety Monitoring Board will be appointed by the
Director, NHLBI to provide overall monitoring of interim data and safety
issues. Meetings of the Data and Safety Monitoring Board will ordinarily be
held in Bethesda, MD. An NHLBI scientist, other than the NHLBI Program
Official, shall serve as Executive Secretary to the Board.
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 (https://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement. NHLBI
policy requires that the Data Coordinating Center report quarterly on
recruitment in all Network Studies that propose to enroll more than 150
patients.
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:
George J.
Nemo, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive,
Bethesda, MD 20892-7950
Telephone: 301-435-0065
FAX: 301-480-1060
Email: nemog@nhlbi.nih.gov
2. Peer Review Contacts:
Chief,
Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express/
courier service)
Telephone: 301-435-0270
FAX: 301-480-0730
email: nhlbichiefreviewbranch@nhlbi.nih.gov
3. Financial or Grants Management Contacts:
Robert Vinson
NHLBI Grants Operations Branch
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7154
6701 Rockledge Drive
Bethesda, MD 20892-7924 (Express 20817)
Telephone: (301) 435-0166
FAX: (301) 480-3310
Email: vinsonr@mail.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).
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, https://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 (https://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 https://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 https://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 https://grants.nih.gov/archive/archive/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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://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 (https://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 https://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 https://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 https://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 https://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.
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NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
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