and Human Services (HHS)
EXPIRED
Department of
Health and Human Services
Participating
Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of
Participating Organizations
National Institute of
Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
Title: Specialized Programs of
Translational Research in Acute Stroke (SPOTRIAS) for Year 2007 (P50)
Announcement Type
This Funding Opportunity
Announcement replaces PAR-05-084 which was previously released April 8, 2005.
Update: The following update relating to this announcement has been issued:
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
Despite enormous research efforts including many clinical trials, tissue plasminogen activator (tPA) remains the only FDA-approved treatment for acute ischemic stroke. Clinical trials that demonstrated the efficacy of tPA showed an improved outcome when tPA was given within three hours of stroke onset. The requirement for administration within three hours of stroke onset has proven to be a major obstacle to the widespread use of tPA. Delays in the response to stroke by medical personnel and the risks inherent in the use of tPA, which require careful patient evaluation before treatment, contribute to the inability to extend its benefits to many stroke victims. Dramatic improvements in stroke outcomes could be achieved by reducing the time necessary to respond to and diagnose stroke and by identifying new interventions that could be safely and expeditiously administered to a wider range of patients.
The objective of the SPOTRIAS is to facilitate translation of basic research findings into clinical practice in settings where patients with acute ischemic and hemorrhagic stroke are evaluated and treated very rapidly after the onset of their symptoms. This program seeks to encourage clinical research directed toward improved treatments and treatment strategies for stroke. This translational program may include laboratory or technological research that is directly related to the proposed collaborative clinical research. Because of the importance of early treatment in translational research, SPOTRIAS will be established at institutions with a strong commitment to the rapid treatment of acute stroke patients and which have demonstrated an active collaboration between emergency medical services, emergency physicians, neurologists, and radiologists. Because of the emphasis on translational research, SPOTRIAS will be established at institutions with a strong commitment to bringing discoveries from basic stroke research to clinical practice.
Using its shared resources, a SPOTRIAS will add to the scientific information base and maintain state-of-the-art research that contributes to improved rapid treatment of acute ischemic and hemorrhagic stroke. Components of each SPOTRIAS will include a special stroke response group that treats patients in the emergency department, a biostatistical and data management core, and a human tissue core (blood and genetic samples). SPOTRIAS are expected to conduct a wide spectrum of research activities, and to contribute significantly to the development of specialized research resources, to the development of improved research model systems and to the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. The research supported through this program must have translational potential or significance, i.e., it must apply information developed in basic research laboratories to the design of clinical research that will test interventions or methods for improving the outcomes for patients with acute hemorrhagic or ischemic stroke. Translational research bridges the gap between the discoveries of basic scientists and definitive phase III trials of efficacy for specific treatments.
Projects encouraged within the SPOTRIAS include:
Beyond specific hypothesis testing projects, the network of SPOTRIAS will share several broad goals to:
Each SPOTRIAS and the network of SPOTRIAS is expected to conduct research that will have immediate impact on reducing disability and mortality in acute stroke by intervening as rapidly as possible after the onset of symptoms. It is expected that the national network of acute stroke research centers formed as a result of this PAR will lead to significant changes in the care of stroke patients. Examples are:
SPOTRIAS applications must fulfill the following requirements:
(1) Institutional Support. A statement must be provided that addresses how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPOTRIAS research effort will be given a high priority within the institution (relative to other research efforts and non-NIH supported programs). The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the SPOTRIAS Director, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution. The primary institution is strongly encouraged to demonstrate its commitment to SPOTRIAS by providing financial support to the Developmental Research and Career Development Programs on an awarded SPOTRIAS, as well as other programmatic needs identified as high priority on the original application. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, Hospital President , and Vice President for Research) should be attached confirming this commitment. In the case of a SPOTRIAS that involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must receive a formal written agreement(s) from the other participant organization(s). This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the Program.
(2) Access to acute stroke patient population. Each SPOTRIAS must have access to patients very soon after the onset of stroke. Standard care of stroke now includes intravenous tPA given to eligible ischemic stroke patients three hours or less after the onset of stroke symptoms. Three hours is an upper limit and basic research data would indicate that earlier treatment would have additional benefit. Testing treatments early after stroke onset allows more opportunity for the treatments to show a measurable benefit when less of the brain is irreversibly injured. For this reason, each SPOTRIAS will be required to treat at least twelve eligible patients each year of the grant with tissue plasminogen activator within two hours of the onset of their symptoms. In order to fulfill this requirement, patients that have hemorrhagic stroke or do not meet the strict requirements for tPA will have to be screened for eligibility. This will assure that ample early hemorrhagic and early ischemic stroke patients are available for clinical research studies. If a SPOTRIAS is not able to treat twelve patients with intravenous thrombolytic therapy within two hours of symptom onset each year, the SPOTRIAS will be terminated, the billing arrangement modified, and participation in the SPOTRIAS network limited. Terms for continuation of the SPOTRIAS that fails to treat the required number of patients may be modified to allow follow-up of patients already enrolled in SPOTRIAS studies and to complete any formal training obligations. Other cores and projects will be deleted.
(3) Involvement of Emergency Medicine: Emergency medicine must be fully integrated into the leadership of the SPOTRIAS and the patient access core. It is likely that many individuals representing different medical specialties, organizations and hospital departments will be part of a successful SPOTRIAS patient access core. These include: the emergency medical system, the hospital emergency departments, radiology facilities, intensive care units, patient coordinators, neurologists, neurosurgeons, radiologists, patient advocates, and patient educators. Central to the treatment of acute stroke is the emergency department where initial contact with most patients is made and the early diagnostic and treatment activities occur. Hence, involvement of the leadership of participating emergency departments in the patient access core as well as in the SPOTRIAS projects and the SPOTRIAS itself is a requirement. Naturally, the organization best suited to rapidly evaluate and treat stroke patients varies according to the local availability of resources, and therefore, a specific emergency physician role is not specified. What is required is clear evidence of involvement of emergency physicians that will ensure the most rapid possible treatment of stroke patients and the development of new procedures and treatment that are broadly applicable. This requirement is consistent with recommendations for organizing the rapid treatment of acute stroke patients that were published in the Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996 (http://www.ninds.nih.gov/health_and_medical/stroke_proceedings/contents.htm). These recommendations emphasize the importance of coordinating pre-hospital emergency medical care systems, emergency departments, and acute hospital care. A coordinated rural network or local network of cooperating hospitals may be part of the stroke care system if organized and lead by the SPOTRIAS.
(4) Research Projects. A minimum of three research projects, representing a balance and diversity of translational approaches.
(5) Shared Cores. Shared cores designed to support the proposed translational objectives of the SPOTRIAS (including the required human cancer tissue/specimen core for the particular organ site).
(6) A fellowship training and career development program (with a minimum required allocated budget of $50,000 in direct costs per year). The SPOTRIAS must demonstrate a consistent and significant commitment to a training program in translational acute stroke research. The NINDS is committed to the career development of clinically trained research scientists. The Institute supports several programs to advance the careers of clinician-scientists by: (1) encouraging the interest of outstanding physicians early in their career; (2) accelerating entry to independent research; (3) encouraging translational research; and (4) fostering research training by especially competent laboratories. SPOTRIAS will propose and carry out career development plans. SPOTRIAS will select candidates for career development who demonstrate potential for independent research careers or who are established investigators and are changing the direction of their research careers. In this selection process the SPOTRIAS will seek out and include qualified minorities, women, and persons with disabilities for inclusion in the career development program. After an individual is selected, a specific plan will be developed and facilitated by the leadership of the SPOTRIAS. A budget will be proposed for sustaining a significant activity in career development for a maximum of one year while applications for any further support are prepared. Further support would have to come from career development grants from NIH or other organizations. For example, the NINDS sponsors career development awards, minority career development supplements, and fellowships. For a description of these programs, please consult the NINDS training and career development website: http://www.ninds.nih.gov/funding/research_training.htm.
(7) Collaboration with the SPOTRIAS network. Each site is expected to share ideas and communicate with other centers in the SPOTRIAS network. SPOTRIAS will provide resources required for their centers to participate in annual three-day meetings of the SPOTRIAS network. This participation will include travel for up to ten individuals to Rockville, Maryland, or to an institution hosting a meeting. Included will be the SPOTRIAS Principal Investigator, the Principal Investigator for each SPOTRIAS project, the clinical coordinators, and the lead statistician. The SPOTRIAS will be responsible for advance planning to ensure the fullest possible attendance at the network meetings. Besides the annual meetings, monthly conference calls will be scheduled with the NINDS Program Director and the Principal Investigators of all the SPOTRIAS.
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 NIH specialized center (P50) award mechanism, which
provides funding for multidisciplinary and multi-investigator approaches to the
investigation of specific and complex research problems requiring the
application of diverse expertise and methodologies. These grants differ from
program project grants in that they are more complex and flexible in terms of
the activities that can be supported. In addition to support for
multidisciplinary research projects, the P50 provides for career development,
pilot research projects, specialized resources and shared core facilities. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. Applicants may request support for a period of
up to five years. The maximum allowable direct cost per year for a SPOTRIAS
will be $1,500,000.
Direct costs are limited to $1.5 million in any one year. This limit applies to new grants, their non-competitive continuations, and any subsequent competitive renewals. Since the best scientific talent and resources are expected to be brought to bear on questions posed in each Center, and since these may not all be available at any single institution, projects constituting a given Center may be based at multiple institutions. In an effort to allow for such multi-institutional involvement Facility and Administrative (F&A) costs for consortium activity at collaborating institutions will not be counted against the $1.5 million limit to direct costs (but these costs should be delineated as instructed in form PHS 398 (see NOT-OD-05-004).
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
Applications received in response to this program announcement will compete for funds in the general funding pool of the NINDS. No specific funds have been set aside for this announcement. The number and size of the awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research.
A SPOTRIAS grant application may be submitted for up to 5 years of funding.
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-04-040.
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:
Eligible institutions may include Foreign components as full research projects, or cores, or as part of a research project or core, but Foreign institutions and organizations are not eligible to submit SPOTRIAS applications. SPOTRIAS may also use developmental funds to establish collaborative research efforts with foreign entities. Consortia agreements with Foreign institutions must include provisions that ensure adequate representation of women, minorities, and children in all research components that involve clinical trials or any other type of human intervention and must be in compliance with NIH policies.
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
Not applicable.
The most current Grants Policy Statement can be found
at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special
Eligibility Criteria
Foreign institutions are
not eligible for P50 grants.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and
Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering
System (DUNS) number as the universal identifier when applying for Federal
grants or cooperative agreements. The D&B number can be obtained by calling
(866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
The application should be
prepared in the format required by NINDS for research program projects. This
format is described at http://www.ninds.nih.gov/funding/ppg_guidelines.htm.
3.
Submission Dates and Times
Applications must be mailed 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 16, 2007
Application
Receipt Date(s): August 15, 2007
Peer
Review Date(s): October/November 2007
Council
Review Date(s): January 2008
Earliest
Anticipated Start Date(s): April
1, 2008
3.A.1.
Letter of Intent
Prospective applicants are asked to submit a letter of
intent 30 days before the application receipt date 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:
Scott Janis, Ph.D.
Neuroscience Center, Room 2191, MSC 9520
6001 Executive Boulevard
Rockville, MD 20852 (courier)
Bethesda, MD 20892-9520
Phone: 301-496-9135
FAX: 301-480-1080
Email: [email protected]
3.B.
Sending an Application to the NIH
Applications must be
prepared using the PHS 398 research grant application instructions and forms as
described above. Submit
a signed 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 (For express/courier use Bethesda, MD 20817)
At the time of submission, two additional copies of the application and all copies of appendix material must also be sent to:
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: [email protected]
3.C. Application Processing
Applications must be submitted
on or before the application receipt dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for completeness by CSR.
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. The NIH will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an introduction addressing the previous critique.
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 (see also Section
VI.3. Award Criteria).
Pre-award costs are
allowable. A grantee may, at their own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee’s ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission
Requirements
Plan for
Sharing Research Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants requesting
more than $500,000 in direct costs in any year of the proposed research must
include a plan for sharing research data in their application. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of
the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing
Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Award Criteria.
Section V. Application Review Information
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
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.
a. Research Projects
Within the SPOTRIAS concept of translational research (see definition in the Executive Summary and in Part II, Section I.1 above), reviewers will evaluate each research project using the five review criteria below and additional factors noted further below. Each criterion will be considered by the reviewers in assigning the overall merit score of the project, although a project does not need to be strong in all criteria in order to be viewed as meritorious.
1. Significance.
Does this study address an important translational research goal or barrier? Is it likely the study will be completed within the project period? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the impact of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If a project is ongoing, did it achieve its goals within the previous funding period; is scientific progress adequate?
For proposed phase I and II trials: Is there adequate preliminary data from laboratory research or adequate rationale for proposed interventions based on prior clinical experience? Do proposed phase one or phase two studies have a clearly defined place in the process of advancing acute stroke treatment? Will the proposed projects likely add significant information important to further steps in the development of a clinical intervention?
2. 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? Is there clear evidence of co-leadership between both a basic biological and applied or clinical scientist in the conception, design, and proposed implementation of the project? Do the project co-leaders acknowledge potential problem areas and consider alternative tactics? If the project is ongoing and has changed research direction, is there appropriate rationale for the new approach?
For phase I and phase II trials: Are the phase one and phase two studies appropriately designed? Are there appropriate data collection procedures (considering the budget limitations) are a reasonable design?
3. Innovation.
Is the project original and innovative in the context of translational research? 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 organ site?
4. Investigators.
Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level and time commitments of the co-leaders and co-investigators on the project? Does the investigative team bring complementary and integrated expertise to the project?
5. Environment.
Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit form unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? If applicable, is there evidence of effective use of SPOTRIAS cores?
PAR Specific Review Criteria
For competing renewal applications, adequate progress should be demonstrated on projects that are ongoing. Any difficulties in achieving the previously proposed specific aims should be addressed and the new research goals should be logical extensions for the project. There should be clear evidence that such a project reached its anticipated human application(s) during the previous funding period and the continuation of the project will lead to new translational findings. It should also be evident that the investigative team, established a productive working relationship during the past performance period and contributed to the SPOTRIAS network and have published or submitted manuscripts describing their previous findings.
Applications for renewal of SPOTRIAS sites will be judged based upon:
1) the scientific contributions of the SPOTRIAS investigators during the previous grant award,
2) the strength of the proposed cores,
3) the previous, as well as the projected level of future contributions to collaborative research within SPOTRIAS network.
4) the scientific strength of the proposed research proposals.
For renewal applications, the Institute reserves the right to fund only those research proposals which are met with enthusiasm by peer review. At lease one of the three required research proposals must be approved for funding for the site to continue in the network. In cases in which a site is approved for renewal but one or more of their proposed research proposals are not funded, then the core budget will be adjusted accordingly. Non-funded proposals may be resubmitted as competitive supplements for review but their time for completion must not exceed the expiration date of the SPOTRIAS center(s).
b. Cores
1. Patient Access Core (this is a required component of a SPOTRIAS).
2. Biostatistical and Data Management Core (this is a required component of a SPOTRIAS).
3. Blood and Tissue Specimen Core (this is a required component of a SPOTRIAS).
4. Other Cores
c. Fellowship Training and Career Development Program
d. Overall Program Organization, Interaction, and Capability
1. Leadership
Are the scientific qualifications and involvement of the principal investigator as well as his/her scientific and administrative leadership capabilities and time commitment presented and sufficient for the requirements of the proposed SPOTRIAS?
2. Institutional Commitment
Is the institutional commitment for facilitating the research objectives of the SPOTRIAS (e.g., special facilities, recruitments, discretionary resources, such as dollars and space) documented and sufficient?
3. Integration within the SPOTRIAS and the Institution
Do the plans for integrating the activities of SPOTRIAS projects with proposed cores, as well as integrating SPOTRIAS research and cores with existing institutional resources give confidence and sufficient evidence that such efforts are likely to be effective? (Note that SPOTRIAS projects are not required to interact with each other.)
4. Hyper-acute Stroke Patient Population
Is the access to patients and populations for conducting current and projected therapeutic, prevention, detection, and control research adequate to ensure likely success of the goals of the program? (For competing renewal applications, documentation of accomplished translational goals, including evidence of human subject’s enrollment on clinical/population research studies during the past funding period should be provided.)
5. Planning and Evaluation of Activities
Are the plan(s) and/or track record(s) to evaluate the translational research productivity of existing projects and cores; discontinue activities of low productivity; initiate new activities in response to important translational research opportunities; establish collaborations; and utilize the advice of internal and external advisors presented and sufficient for the requirements of the proposed SPOTRIAS?
6. Collaborations
Is there evidence of tangible interactions with other SPOTRIAS centers? Are the abilities and availabilities of the investigators to interact with other SPOTRIAS and with the NIH/NINDS in sharing information, participating in committees, and collaborating on activities of mutual interest evident and sufficient? (For competing renewal applications, contributions and outcomes from annual SPOTRIAS meetings and other related SPOTRIAS or NIH/NINDS meetings during the term of the award.)
7. Progress (for Competitive Renewal Applications)
Overall Progress Report: List the progress and achievements specific to the application and relevant to translational research since the previous competitive review. Address the major scientific achievements in research on acute stroke and related topics carried out by Center personnel and by projects utilizing Center resources in the last funding period. Identify significant findings in acute stroke research that were facilitated or supported directly through Center resources. Include summaries of progress in achieving the major aims of the Center and its projects and highlight major publications. Describe how the presence of the Center has facilitated and improved translational acute stroke research at the Institution and with in the network of translational SPOTIRAS centers. When a project or optional core has terminated, include a final report with a summary of results and publications. If an optional core is continuing, include a progress report in that component write-up. Applicants should include tables detailing 1) Publications and grants (source, amount and title) resulting from each component funded by the SPOTRIAS, 2) Publications and grants (source amount and title) resulting from pilot projects, 3) Involvement in collaborative projects with other Centers including those funded by SPOTRIAS, and 4) minority enrollment into research projects or clinical trials and specifically, into any research projects addressing minority issues.
In addition to text summaries, applicants should also include summary tables detailing:
1. A list of all active Clinical trial protocols during the previous grant period being conducted in the Center including trial name, sponsor, number of patients enrolled and randomized, and dates. Detail separately currently active and completed trials and NIH and pharmaceutical industry sponsored trials. If multiple trials are selecting from the same patient population, describe process for determine trial eligibility and priority.
2. Collaborations with other acute stroke researchers, other Centers, cooperative studies, and with biotechnology and pharmaceutical companies. Identify non-SPOTRIAS sub-sites used to contribute patients to a SPOTRIAS study.
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 expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
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. Award Criteria.
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
TERMS AND CONDITIONS OF AWARD
The following terms and conditions will be incorporated into the notice of grant 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, and other HHS, PHS, and NIH grant administration policies.
1) The awardees for a SPOTRIAS will treat within two hours of onset of stroke symptoms a minimum of twelve eligible ischemic stroke patients during each year of the project with standard thrombolytic treatment as approved by the FDA. It is the intention of this announcement to facilitate the creation of SPOTRIAS at which more than twelve patients will be treated per year. Therefore if a SPOTRIAS should not be able to achieve this minimum level of performance, then funding will be severely reduced. Noncompliance with the terms of award may result in a reduction of the recommended budget, withholding of support, suspension, or termination of the award.
2) A condition of any award will be the periodic review of the clinical research projects which compose a SPOTRIAS by a Data Safety and Monitoring Board (DSMB) established by and reporting to the NINDS. This DSMB will review research progress in the entire SPOTRIAS as well as the phase I or phase II studies in the SPOTRIAS.
3) Information concerning the number of patients enrolled in each SPOTRIAS protocol, the completeness of follow-up, and other data necessary to assess research progress and to plan expenditure of funds shall be made available to the NINDS on a quarterly basis. The report shall include the number of males and females, and the different ethnic groups, in the study population. Reports are to be sent to the NINDS program administrator, summarizing progress, including data on patient accrual, completeness of data, and patient safety. These will be due March 1, June 1, September 1, and December 1 each year of the grant (or as mutually agreed upon with the NINDS program administrator).
4) The NINDS reserves the right to terminate or curtail a SPOTRIAS (or an individual project or core) in the event of (a) a major breach in a clinical 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 Program Announcement, or (d) shortfall in recruitment and/or retention of subjects or (e) a recommendation to the NINDS by the DSMB to a project.
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).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Scott Janis, Ph.D.
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2191
6001 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-9135
FAX: (301)480-1080
Email: [email protected]
2. Peer Review Contacts:
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: [email protected]
3. Financial or Grants Management
Contacts:
Maxine Davis-Vanlue
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3258
6001 Executive Blvd.
Bethesda , MD 20892
Telephone: (301) 496-5707
FAX: (301) 402-0219
Email: [email protected]
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.
Public 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 PA 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.
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 PAR is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the
Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. Awards are made under
the authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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