Part I Overview Information
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
Title: Neurological Emergencies Treatment Trials (NETT)
Network Statistical and Data Management Center (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-NS-06-008
Catalog of Federal Domestic Assistance Number(s)
93.853
Key Dates
Release
Date: April 28, 2007
Letters of Intent
Receipt Date(s): May 29, 2006
Application
Receipt Date(s): June 28, 2006
Peer
Review Date(s): August
2006
Council
Review Date(s): September
2006
Earliest
Anticipated Start Date: September 2006
Additional Information
To Be Available Date (Url Activation Date): Not applicable
Expiration Date: June 29, 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
2. NETT
Network Organization and Timeline
A. Statistical
and Data Management Center
B. Clinical
Coordinating Center
C. Clinical
Site Hubs
D. Proposed
NETT Timeline
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,
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
A. Supplemental
Application Information
B. Plan
for Sharing Research Data
C. Sharing
Research Resources
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
PURPOSE OF THIS RFA
In order to improve outcomes for patients with neurological emergencies through research aimed at new therapies and their more effective implementation, the National Institute of Neurological Disorders and Stroke (NINDS) seeks to develop a Neurological Emergencies Treatment Trials (NETT) Network, comprising three essential components: a Clinical Coordinating Center, a statistical and data management center, and a network of clinical sites. The purpose of this RFA is to request applications for the NETT Network Statistical and Data Management Center (SDMC). The SDMC will provide data management and biostatistical support for the NETT Network. Applications for a NETT Network Clinical Coordinating Center (RFA NS-06-002, release date November 1, 2005 - http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-06-002.html) and for 11 clinical sites to serve as “Hubs” for regional emergency department consortia are being sought in separate solicitations. Funding for two large, streamlined phase III clinical trials is included in the developmental phase of the NETT Network initiative. (Please note that in RFA-NS-06-002, the Statistical and Data Management Center was referred to by the acronym “SCC”.)
BACKGROUND
Fifteen million adults and children are seen in U.S. emergency departments annually for acute neurological disorders that vary in seriousness from trivial to life threatening. Most patients are initially evaluated and treated by emergency medicine physicians, not by specialists in neurological diseases. Optimal management in the first hours of neurological emergencies is often critical to recovery; the window of opportunity cannot be reopened later due to the unique vulnerability of the central nervous system.
In order to improve outcomes for patients with neurological emergencies through research aimed at new therapies and their more effective implementation, the NINDS seeks to develop the Neurological Emergencies Treatment Trials (NETT) Network with a single, unifying Statistical and Data Management Center. The goals of the NETT Network are: 1) to facilitate high-quality clinical trials in several different types of emergency neurological disorders afflicting adults or children; 2) to encourage collaboration between emergency medicine physicians and neurological disease specialists in trial design and execution; and 3) to facilitate the implementation of new therapies into clinical practice. Once established, the NETT Network is intended to serve as a resource for investigator-initiated clinical research in acute neurological disorders. Following the initial trials funded through this initiative during the development phase, subsequent trials will be funded through traditional NINDS peer-review mechanisms.
Objectives of Neurological Emergencies Treatment Trials (NETT) Network
Overall Goal: To develop and widely implement efficacious treatments for patients with a broad spectrum of neurological emergencies in order to decrease the morbidity and mortality associated with neurological disease.
Specific Objectives:
1. To create a clinical research network of emergency medicine physicians, neurologists, and neurosurgeons that will work together to develop in an efficient manner more and better treatments for patients with acute neurological disorders through execution of NINDS-sponsored clinical trials.
2. To conduct two large, streamlined phase III clinical trials involving neurological emergencies to demonstrate the capability of the Network and to stimulate general interest in the NETT Network regarding future collaborations.
Specific Aims:
1. To develop an infrastructure to carry out clinical trials in neurological emergencies that are relevant to the clinical practice of both emergency medicine physicians and neuro-clinicians by involving both types of physicians in collaborative clinical research.
2. To enhance the efficient conduct of clinical research in neurological emergencies by avoiding de novo creation of clinical trial infrastructure for each individual research project.
3. To expedite recruitment by involving scores of emergency departments.
4. To involve a wide spectrum of investigators, including those at smaller hospitals and in non-urban settings.
5. To recruit a broad range of participants, particularly minorities.
6. To facilitate the transfer of research results to clinical practice, especially to community hospital settings, and the general endorsement by emergency medicine physicians.
7. To foster the development and testing of innovative telemedicine methods to involve off-site specialists in the care of neurological disorders in emergency department.
2. NETT Network Organization and Timeline
The basic structure of the NETT Network consists of a Statistical and Data Management Center, a Clinical Coordinating Center, and 11 Clinical Site Hubs. In addition, three key Committees will be established that will collaborate in the development of the network and the oversight of two clinical trials during the award period. In order to understand the interacting roles of each component, each will be described below.
2.A. Statistical and Data Management Center
This RFA is soliciting applications for the NETT Network Statistical and Data Management Center (SDMC). The SDMC will work with the network leadership to design and implement data entry systems, develop study forms, receive data from the Clinical Site Hubs, perform data checks/queries, undertake interim monitoring, analyses and reporting for the Clinical Coordinating Center, NINDS, and Data and Safety Monitoring Boards (DSMBs). Biostatistical analyses and trial reporting for the network trials will be done through collaboration with the Steering Committee.
The SDMC will coordinate central verification/adjudication of key trial outcomes. The staff of the SDMC will attend meetings with representatives of the Clinical Coordinating Center and the NINDS Scientific Program Director, participate in training sessions, and serve on the Steering Committee and on other subcommittees.
2.B. Clinical Coordinating Center
The NETT Network Coordinating Center will provide overall leadership for the project, including coordinating the activities of the 11 NETT Clinical Site Hubs, particularly recruitment, follow-up, and data quality. It will initiate investigator training and certification, supervise quality control measures, organize limited on-site monitoring, and coordinate meetings and teleconferences as appropriate among all study investigators. The Clinical Coordinating Center will develop and manage the trial protocols, monitor eligibility of participants, assure compliance with regulations and monitor the informed consent process, supervise and encourage recruitment, prepare blinded reports on adverse events, monitor study execution at sites, and arrange the supply of study medication for the trials. In addition, the Clinical Coordinating Center will collaborate with the SDMC in developing and implementing data management procedures. The Clinical Coordinating Center will be responsible for quarterly progress reports to the NINDS, the NINDS-appointed NETT Network Advisory Group, and one or more DSMBs.
During the initial development phase of the network, funding will be awarded to the NETT Network Coordinating Center to carry out two large, streamlined phase III clinical trials (see http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-06-002.html). High-visibility, high-interest clinical trials will be important in order to stimulate initial interest in the NETT Network and engender enthusiastic participation of emergency medicine physicians.
2.C. Clinical Site Hubs
Each of the 11 regional Clinical Site Hubs will coordinate activities at 2-10 emergency departments (or “spokes” in a hub-and-spoke model) involving 18-25 emergency medicine physicians, neurologists, neurointensivists, neurosurgeons, and other subspecialties as required depending on local circumstances. Typical Hubs are envisioned as regional academic medical centers or tertiary care facilities capable of providing research support for the “spokes.” Spokes may range from academic emergency centers to community hospitals, with the latter serving to expand patient access, to allow assessment of the intervention in a “real world” practice setting, and to facilitate dissemination of the research results. Depending on the specific trial design, the spokes could either enroll patients on-site, using the Hub for research support, or identify participants for transfer to the Hub for specialty care. The Hubs will provide clinical leadership and local neurological expertise, coordinate IRB activities and human subject protections, enter data, and manage contracts. Involvement of nonacademic-affiliated hospitals, non-urban hospitals, and hospitals serving minority populations will be considered in Hub selection.
2.D. PROPOSED NETT TIMELINE
Year 1: First 6 months
- Cooperative Agreements (U01) for the Clinical Coordinating Center (under RFA-NS-06-002) and Statistical and Data Management Center (under the current RFA) to be awarded.
- Trial protocol development and manual of operation finalization for two trials by the Clinical Coordinating Center and Statistical and Data Management Center.
- Cooperative Agreements (U10) to be awarded to 11 Clinical Site Hubs (under RFA-NS-06-009).
- Approval of two trial protocols by the NETT Advisory Group and NINDS before implementation.
Year 1: Second 6 months
- Data entry systems developed and implemented by Statistical and Data Management Center, including site personnel training.
- IRB approval of trial protocols.
- Training of Hubs and Spokes in good research practices (if appropriate) and trial-specific aspects.
- Initial DSMB(s) meet.
Year 2: Patient accrual to begin.
Years 3-4: Patient accrual and follow-up in the trials.
Year 5: Trial close-out, data analysis, and preparation of papers for publication.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity will
use the cooperative
agreement (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. 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 anticipated award date is September, 2006.
2. Funds Available
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:
Foreign institutions are not eligible to apply.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
Cost sharing is not
required.
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
Not applicable
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)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-0088.
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.
See
Section IV.6.A. below for specific application information for the NETT
Statistical and Data Management Center.
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: May 29, 2006
Application
Receipt Date(s): June 28, 2006
Peer Review Date(s): August 2006
Council Review
Date(s): September 2006
Earliest
Anticipated Start Date(s): September 2006
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:
Robin Conwit, M.D.
Clinical Trials Group
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2181
Bethesda, MD 20892
Telephone: (301) 496-9135
FAX: (301)480-1080
Email: conwitr@ninds.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:
Chief, Scientific Review
Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Blvd.
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier
service)
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.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 NINDS. 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
6.A. Supplemental application information
For the development phase of the NETT Network, the goal is to establish a model of large, streamlined trials of clear clinical relevance and substantial interest to neuro-clinicians and emergency medicine physicians in order to demonstrate what the Network is capable of accomplishing. Two randomized clinical trials will be conducted as part of network development during the RFA period; the trials will be selected by the NETT Advisory Group, which will also approve the final protocols. Trial design is expected to be simple (i.e. streamlined), thus making the trials amenable to execution at community emergency centers. Selection of trials will consider both high prevalence neurological disorders and lower prevalence disorders with high morbidity. The public health importance, economic impact of the disease, scientific merit, feasibility for completion within the timeframe of the RFA, protocol quality and completeness, and budget will be considered in trial selection.
6.B. 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 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.
6.C. 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.
Section
V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
The following will be considered in making funding decisions:
Upon
receipt, applications will be reviewed for completeness by CSR and
responsiveness by NINDS. Incomplete and/or non-responsive applications will not
be reviewed. 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 NINDS 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.
Special Review Criteria for NETT Network Statistical and Data Management Center
The structure of the collaborative group described in this RFA is intended to promote the development of new clinical trial methodology by the interaction between the Statistical and Data Management Center and the Clinical Coordinating Center. Therefore, the review criteria for the SDMC emphasize innovative statistical and informatics approaches to the evaluation of treatments of neurologic emergencies. Expertise in neurologic emergency conditions is expected to reside in the Clinical Coordinating Center.
Review of applications for the SDMC will be based on the following specific criteria:
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?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection
of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed (see the Research Plan, Section E on
Human Subjects in the PHS Form 398).
Inclusion
of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).
Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data 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.
Program staff will be
responsible for the administrative review of the plan for sharing research
data.
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 http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant Progress
Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable
Section
VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the 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
(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 Principal
Investigator (PI) will have the primary responsibility for leadership and
implementation of the NETT SDMC. The SDMC PI has primary authority
and responsibility to work with the PI of the Clinical Coordinating Center and
study leadership committees to define research objectives and approaches,
and to plan, conduct, analyze, and publish results, interpretations, and
conclusions of the studies, and for providing overall scientific and administrative
leadership for the NETT statistical and data management activities. The
PI will oversee all aspects of the organization and execution of the SDMC as
approved by NINDS after peer review and review of the NETT Advisory Group.
Awardees have primary and lead responsibilities for the project as a whole, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for or by action of the NINDS, the NETT Steering Committee, NETT Advisory Group, and/or the DSMB.
The awardee will manage and conduct the NETT Network clinical trials in compliance with all established DHHS, NIH and NINDS policies and procedures. It is the grantee institution’s responsibility to ensure that all sites engaged in research involving human subjects have an appropriate OHRP-approved Assurance and an IRB approval of the research consistent with 45 CFR Part 46 and (2) to retain documentation of compliance with the requirements of 45 CFR Part 46.
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. The NINDS will name the Project Scientist for the NETT Network project. The Project Scientist’s function will be to advise the Steering Committee, the Publication Committee, and other subcommittees in carrying out the trials, including quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and coordination of efforts of all the project centers. The NINDS Project Scientist will have voting membership on the Steering Committee, and as appropriate, other subcommittees of the Steering Committee, including the Publications Committee. To the extent that the NINDS Project Scientist contributes to the scientific content of the trial, authorship may be shared in publications with other investigators in accordance with the same policies of the Publication Committee that apply to other investigators.
A second NINDS Program Official will administer the cooperative agreements and will be responsible for the fiscal management and programmatic stewardship of the program at the NIH. In addition, a Clinical Research Project Manager from the NINDS Clinical Trials group will serve as liaison to the Data and Safety Monitoring Board(s).
Other NINDS officials may, as appropriate, attend meetings and serve on study committees and work with awardees on issues coming before the Steering Committee or its subcommittees. However, in all cases, the NINDS will have only a single vote on study committees, either of the whole or on subcommittees.
The NINDS reserves the right to terminate or curtail the study (or an individual award) in the event of (a) a major breach in the protocol or substantial changes in the agreed-upon protocol with which the Institute does not agree or (b) human subject ethical issues that may dictate a premature termination or (c) failure to pursue the objectives stated in this Request for Applications or (d) substantial shortfall in recruitment and/or retention of subjects or (e) a recommendation to the NINDS by the DSMB to stop the trial.
2.A.3. Collaborative Responsibilities
NETT Network Committees
1. Network Advisory Group (NETT-AG) will be organized by NINDS and be composed of experts in Emergency Medicine and Neurology, both from within and outside of the NETT Network, and will include NINDS officials with expertise in clinical trials of neurological emergencies. It will serve as an oversight committee, giving final approval to the trial protocols, modifications to the protocols, the overall budget, and plans for analysis, and will forward reports and recommendations to NINDS.
2. NETT Network Steering Committee will consist of the Principal Investigator of the Clinical Coordinating Center (who will serve as the chair), Principal Investigator of the Statistical and Data Management Center, the NINDS Project Scientist, and selected representatives of the Clinical Site Hubs. The specific membership and charter of the Steering Committee will be proposed by the Clinical Coordinating Center and approved by the NETT-AG. The Steering Committee will approve the final protocols, supervise overall execution of the trial, generate and approve study policies, consider modifications of the protocol and operations, and plan and draft study-related publications. Each full member will have one vote. The Awardee will be required to accept and implement policies approved by the Steering Committee.
3. Data and Safety Monitoring Board (DSMB) will be appointed by NINDS to monitor safety and performance and to review interim analyses in the NETT Network clinical trials. Depending on the specific trials selected, more than one DSMB may be required. The NINDS will appoint and support the travel and other expenses of the members of the Data and Safety Monitoring Board, either directly or through a supplement to the Clinical Coordinating Center award.
2.A.4. Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have three
members: a designee of the Steering Committee chosen without NIH staff voting,
one NIH designee, and a third designee with expertise in the relevant area who
is chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
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:
Robin Conwit, M.D.
Clinical Trials Group
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room
2181
Bethesda, MD 20892
Telephone: (301) 496-9135
FAX: (301)480-1080
Email: conwitr@ninds.nih.gov
2. Peer Review Contacts
Chief, Scientific Review
Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Blvd.
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier
service)
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov
3. Financial or Grants Management
Contacts:
Mr. Gavin Wilkom
Grants Management
NINDS/NIH
Neuroscience Center, Room 3250
601
Executive Blvd.
Bethesda , MD 20892
Telephone: (301) 496-7460
Email: wilkomg@ninds.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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not
possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children
as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on
the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from the
publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy
of Individually Identifiable Health Information:
The Department of Health
and Human Services (DHHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the
HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. 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.
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NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
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