SPECIALIZED PROGRAM OF TRANSLATIONAL RESEARCH IN ACUTE STROKE

Release Date:  May 10, 2001 

PA NUMBER:  PAS-01-092 (This PA has been modified, see PAR-05-084)
                       (see NOT-NS-03-020)


National Institute of Neurological Disorders and Stroke

PURPOSE

The Clinical Trial Group and the Neural Environment Group of the 
National Institute of Neurological Disorders and Stroke (NINDS) invite 
grant applications for Specialized Programs of Translational Research 
in Acute Stroke (SPOTRIAS).  The goal of the SPOTRIAS will be to reduce 
the disability of and mortality in stroke patients by promoting rapid 
diagnosis and effective interventions.  The intent of the SPOTRIAS is 
to support a collaboration of clinical researchers from different 
specialties whose collective efforts will lead to new approaches to 
early diagnosis and treatment of acute stroke patients.  Applicant 
institutions must be able to deliver rapid treatment for acute stroke 
and to conduct the highest quality translational research on the 
diagnosis and treatment of acute ischemic and hemorrhagic stroke.  
SPOTRIAS grants will require that a minimum number of stroke patients 
be treated two hours after the onset of their symptoms.  Another 
important function of SPOTRIAS is to establish a program to recruit and 
train of the next generation of stroke researchers.  

BACKGROUND

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 a improved outcome when tPA was given within 
three hours of stroke onset.  The requirement for administration within 
three hours of stroke onset has proven 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.  

RESEARCH OBJECTIVE

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.  Basic research will be included if it 
will add to the overall progress made by the collaborative 
translational program.  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.  

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, genetic samples, and any autopsy material).  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 3 trials of efficacy for specific treatments.  

Projects encouraged within the SPOTRIAS include:
o phase I and phase II studies to evaluate novel stroke treatments;
o development and testing of innovative systems for delivery of 
emergency medical services;
o development and evaluation of clinical tools useful for rapid stroke 
treatment;
o tests of potential biomarkers, surrogate outcomes, and clinical 
stroke scales useful in acute stroke research;
o development and evaluation of new treatments and practices within 
critical care units for patients immediately after initial emergency 
department management;
o tests of strategies for rehabilitation of acute stroke patients;
o long term quality-of-life research for patients treated early for 
acute stroke.

Beyond specific hypothesis testing projects, the network of SPOTRIAS 
will share several broad goals to:
o provide career development opportunities for new investigators who 
wish to pursue active research careers in translational acute stroke 
research; a training component will recruit promising junior physicians 
for further career development activities supported through the network 
and NIH grants.  The development of collaborative training within the 
SPOTRIAS network will be encouraged.  The success of trainees in 
obtaining independent research funding will be carefully considered on 
a yearly basis and at the time that any competing renewal are reviewed.
o share human tissue resources, including genetic material, that will 
benefit both basic and translational acute stroke research;
o develop collaborations in critical areas of research need with basic 
and clinical scientists within and across institutions;
o meet with other SPOTRIAS on a regular basis to share information, 
assess scientific progress in the field, identify new research 
opportunities, and promote inter-SPOTRIAS research collaborations to 
resolve areas of scientific controversy.

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 PA will lead 
to significant changes in the care of stroke patients.  Examples are:
o physicians early in their careers would be trained to react promptly 
to stroke and be given experience in the complex process of running an 
acute stroke treatment center;
o the acute stroke treatment centers would allow stroke fellows to 
develop clinical research careers by providing them access to stroke 
patients at the time when stroke can be treated;
o new treatments could be developed in phase one and phase two studies;
o therapies with little commercial interest could be developed;
o collaboration between SPOTRIAS on clinical research projects could 
occur;
o the emergency treatment of stroke could be further refined and 
developed;
o basic research could be more directly tied to the critical acute 
periods of stroke.
SPECIAL REQUIREMENTS

SPOTRIAS will fulfill several special requirements.

1)  There must be a core that provides 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.

2)  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/news_and_events/proceedings/stroke_proceedings/sayre.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.  

3)  No treatment protocol performed as part of the SPOTRIAS will delay 
for any amount of time, the delivery of standard care for acute stroke 
patients.

4)  Three or more translational research projects will be required at 
each SPOTRIAS, including at least one phase 1 or phase 2 clinical trial 
that will test an intervention intended to improve the outcome of 
patients who present very early after the onset of ischemic or 
hemorrhagic stroke.  In some cases, collaboration with a manufacturer 
will be required to provide therapeutic agents.  Each SPOTRIAS must 
monitor the safety of this phase 1 or phase 2 study, but overall data 
and safety monitoring will be done by an NINDS-appointed DSMB that will 
oversee the phase 1 and phase 2 studies in all SPOTRIAS in the network.

5)  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.  If the 
meeting is not hosted by NINDS in Rockville, MD, the host center will 
be chosen based on the number of patients treated within two hours of 
stroke onset.  No center would host a SPOTRIAS network meeting more 
than once.  

6)  Between the annual meetings, conference calls with the NINDS 
Program Director and the Principal Investigators of all the SPOTRIAS 
will be scheduled quarterly.

7)  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 

8)  There will be a central facility in each SPOTRIAS for collecting 
and sharing relevant tissue and blood samples collected in the 
projects.  Particularly important will be samples for genetic studies.  
Some of the samples may be requested by other SPOTRIAS in the network.  
All such studies and the procedures for banking and sharing the 
specimens within the network will all be subject to approval by local 
Institutional Review Boards (IRBs) acting to protect human subjects 
from research risks.  Some SPOTRIAS may wish to share autopsy material.

9) A biostatistical and data management core will be required to 
collect and analyze the data for each of the clinical research 
projects.  For any phase 1 or phase 2 studies, reports summarizing 
patient safety, interim results, recruitment, and baseline description 
must be prepared for the NINDS-appointed DSMB as requested.  The 
medical safety monitor on the site must be in close communication with 
this center and appropriate safeguards to prevent bias will be 
established by this core.

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 
September 1, December 1, March 1 and June 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.

MECHANISM OF SUPPORT

Support of the SPOTRIAS program will be through the specialized center 
grant (P50) mechanism.  This mechanism supports any part of the full 
range of research and development from basic to clinical and 
intervention studies.  The spectrum of activities comprises a 
multidisciplinary attack on a specific disease entity or biomedical 
problem.  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. 

Applicants will be responsible for the planning, direction, and 
execution of the proposed SPOTRIAS program.  Awards will be 
administered under NIH grants policy as stated in the NIH Grants Policy 
Statement.

The total project period for applications submitted in response to this 
Program Announcement  may not exceed five years.  

The number of awards to be made and level of support to be provided 
depend on receipt of a sufficient number of applications of high 
scientific merit.  

FUNDS AVAILABLE

The maximum allowable direct cost per year for a SPOTRIAS will be 
$1,000,000. It is expected that approximately $1,400,000 total cost 
(direct plus the Facilities and Administrative (F&A) costs which vary 
depending on the applicant institution) will be available each year 
over a five year period for a SPOTRIAS.  It is anticipated that awards 
for ten new SPOTRIAS grants will be made over three years. It is 
estimated that four awards will be made in the first two years and two 
in the third.  A total of $ 5.6 million will be committed by the NINDS 
in FY 2002 and FY 2003 and $2.8 million in FY 2004 to fund applications 
of high scientific merit submitted in response to this Program 
Announcement.  Although this program is provided for in the financial 
plans of the NINDS, the award of grants pursuant to this PA is also 
contingent upon the availability of funds for this purpose. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, 
hospitals, clinics, laboratories, units of State and Local governments, 
and eligible agencies of the Federal Government.  Foreign institutions 
are not eligible for P50 grants.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as 
principal investigators.

INQUIRIES

Written, including electronic mail, and telephone inquiries concerning 
this PA are encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.

Direct inquiries regarding scientific or programmatic issues to:

Mary Ellen Michel, Ph.D.
Neuroscience Center, Room 2222, MSC 9525
6001 Executive Boulevard
Rockville, MD 20852 (courier)
Bethesda, MD 20892-9525
Phone: 301-496-1447
FAX: 301-480-1080
email: mm108w@nih.gov

Direct inquiries regarding fiscal matters to:

Gladys Bohler
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd.  Rm. #3290
Bethesda, MD  20892-9537
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  bohlerg@ninds.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent 30 days 
before the application receipt date (January 1 for the February 1 
receipt date, May 1 for the June 1 receipt date, or September 1 for the 
October 1 receipt date).  The letter of intent should include a 
descriptive title of the proposed research; name, address, and 
telephone number of the Principal Investigator; identities of other key 
personnel and participating institutions; and the number and title of 
the PA in response to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does 
not enter into the review of subsequent applications, the information 
allows NINDS staff to estimate the potential review workload and to 
avoid conflict of interest in the review.

The Letter of Intent is to be sent to:

Scott Janis, PhD
Program Analyst
National Institute of Neurological Disorders and Stroke
Neuroscience Center Room 2230
6001 Executive Blvd.
Rockville, Maryland  20892
Telephone:  (301) 496-9135
FAX:  (301) 480-1080
email:  janiss@ninds.nih.gov

SCHEDULE SUMMARY

SPOTRIAS applications may be submitted on February 1, June 1, and 
October 1.  Applications will be reviewed by the NINDS according to the 
usual review schedule of the NINDS Review Branch.  Secondary review by 
the National Advisory Council of the NINDS will follow.  

APPLICATION PROCEDURES

The research grant application form PHS 398 is to be used in applying 
for these awards. These forms are available at most institutional 
offices of sponsored research; from the Grants Information Office, 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, Suite 6095, Bethesda, MD  
20892-7910, telephone (301) 435-0714, email:  GrantsInfo@nih.gov.

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.

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 
must also be sent to:

Lillian M. Pubols, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center Suite #3208
6001 Executive Blvd.
Bethesda, MD  20892-9529 (For express/courier use Rockville, MD 20852)
Telephone:  (301) 496-9223
Fax: (301) 402-0182
e-mail:  LP28E@NIH.GOV

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NINDS. Incomplete or unresponsive 
applications will be returned to the applicant without further 
consideration.  

Applications that are complete and responsive to this PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NINDS in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in 
which only those applications deemed to have the highest scientific 
merit will be discussed, assigned a priority score, and receive a 
second level review by the National Institute of Neurological Disorders 
and Stroke Advisory Council.

Review Criteria

Overall Review Criteria

--The overall scientific objectives and hypothesis;
--The thematic cohesion of the program; the interrelationship of 
individual projects and cores;
--The administrative structure of the program, including any internal 
and external advisory committees;
--The principal investigator/program director’s scientific and 
administrative qualifications and his/her commitment to the program;
--The effective integration of specialists in emergency medicine into 
the leadership of the SPOTRIAS, its cores and individual projects.

Review Criteria for Individual Projects

(1) Significance

Does this study address an important problem?  If the aims of the 
application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods 
that drive this field? 

For proposed phase I and phase II trials:  Is there adequate 
preliminary data from laboratory research or an adequate rationale for 
proposed interventions based on prior clinical experience?  Do proposed 
phase one and phase two studies have a clearly defined place in the 
process of developing a new intervention?  Will the proposed projects 
be likely to add significant information important to further steps in 
the development of a clinical intervention?

(2) Approach

Are the conceptual framework, design, methods, and analyses adequately 
developed, well- integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and 
consider alternative tactics? 

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) and a reasonable 
design?  

(3) Innovation

Does the project employ novel concepts, approaches or methods?  Are the 
aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies? 

(4) Investigator
Is the investigator 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 (if any)?

Do the investigators demonstrate the capability to modify and refine 
projects to achieve the specific aims of the research proposed?  Will 
the investigators appropriately modify their projects in response to 
intermediate results of ongoing projects and in response to results 
from other centers in the SPOTRIAS network?

For phase I and phase II trials: Do the investigators demonstrate 
understanding that phase one and phase two trials provide limited 
preliminary data and are not definitive trials of efficacy?

(5) Environment
Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments 
take advantage of unique features of the scientific environment or 
employ useful collaborative arrangements?  Is there evidence of 
institutional support?

General Review Criteria for Cores:

- Quality of the facilities or services provided by this core 
(including procedures, techniques, and quality control) and criteria 
for prioritization of usage;

- Qualifications, experience, and commitment of the personnel involved 
in the core

Review Criteria for the Patient Access Core: 

- How well will the mission- critical patient access core exceed the 
minimum requirement to treat more than twelve patients with standard 
intravenous thrombolytic therapy within 2 hours of acute stroke onset 
in the manner approved by the FDA?  (The scientific merit of the entire 
project will be significantly reduced if this core is not likely to 
function well.)

- Does the applicant provide convincing evidence that within the 
SPOTRIAS there is 24- hour, seven day availability of a well- trained 
and organized stroke response system immediately available to all 
stroke patients with the full support and cooperation of departments of 
emergency medicine, radiology, neurology, and neurosurgery?

-   Is it clear that no project in the SPOTRIAS proposes a protocol, 
intervention or diagnostic test that delays the delivery of standard 
thrombolytic treatment for eligible ischemic stroke patients?  Will all 
patients be treated as rapidly as possible after stroke onset?

Review Criteria for the Biostatistical and Data Management Core

- Is the biostatistical and data management core appropriate for the 
proposed studies?  Is there evidence that biostatistical expertise will 
be available from the design to the reporting phase of all projects?

Review Criteria for the Career Development Core

- Is the proposed career development program likely to develop new 
leaders in the field of acute stroke research?  Are the plans for this 
program inclusive and adequately funded?  Are there appropriate links 
to NIH- funded career development programs? 

 Review Criteria for the Blood and Tissue Specimen Core

- Are the plans and facilities for storing and sharing any collected 
human blood or tissue specimens adequate?

Additional Review Criteria

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

- The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.

- The reasonableness of the proposed budget and duration in relation to 
the proposed research.

- The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the 
project proposed in the application.

AWARD CRITERIA

Applications recommended by the National Institute of Neurological 
Disorders and Stroke Advisory Council will be considered for award 
based upon (a) scientific and technical merit as determined by peer 
review; (b) program balance, and (c) availability of funds.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the updated "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on  August 2, 2000, available on the Internet at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.  
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

Although it is less frequent, childhood stroke is a significant problem.

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them. This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

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 that was published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and is available 
at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program 
staff listed under INQUIRIES. Program staff may also provide additional 
relevant information concerning the policy.

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.  Reviewers are cautioned 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 PAS, 
“Specialized Program of Transnational Research in Acute Stroke 
(SPOTRIAS)", 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 
No. 93.853. Awards are made under authorization of Sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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