and Human Services (HHS)
EXPIRED
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected].
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: [email protected]
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
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