NINDS COOPERATIVE PROGRAM IN TRANSLATIONAL RESEARCH

RELEASE DATE:  July 26, 2002

PA NUMBER: PAR-02-139 (This PAR has been reissued, see PAR-05-158)

EXPIRATION DATE:  July 31, 2005

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators (PIs)
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

Recent discoveries across a broad range of research areas in the 
neurosciences offer promising opportunities for treatment of neurological 
disorders.  As part of its mission to reduce the burden of neurological 
disease, NINDS is committed to encouraging the "translation" of these 
discoveries into new treatments.  The goal of this PA is to implement a 
program of cooperative agreements that will support milestone-driven projects 
focused on the identification and pre-clinical testing of new therapeutics.  
The program will facilitate the effective review and research administration 
of translational research projects and will accelerate the translation of 
discoveries in basic research to treatment in the clinic.

This PA is one of three coordinated programs being released by NINDS to 
promote translational research, including "NINDS Exploratory/Developmental 
Projects in Translational Research" 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-138.html) and 
"NINDS Mentored Research Scientist Development Awards in Translational 
Research" 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-140.html).

RESEARCH OBJECTIVES

Definition of Translational Research:

Translational research is the process of applying ideas, insights, and 
discoveries generated through basic scientific inquiry to the treatment or 
prevention of human disease.

The scope of this program includes only activities directly focused on 
therapy development necessary to begin clinical testing.  Mechanistic or 
basic studies will not be supported, nor will clinical trials.  Projects will 
typically include either an assay that has demonstrated relevance to a 
neurological disorder, or candidate therapeutics that have a significant 
effect in a disease model.

Background:

Opportunities for discovery and progress in the treatment of neurological 
diseases have never been greater.  Remarkable advances have been made 
recently in our understanding of the molecular and genetic bases of disease, 
and the potential therapeutic opportunities offered by these scientific 
findings create an opportunity for basic, applied, and clinical scientists to 
combine and coordinate their efforts.  The realization of the potential for 
translating accumulated new knowledge will depend on the cooperation and 
partnering of public and private funding organizations, universities, 
academic medical centers, research institutes, contract research 
organizations, biotechnology companies, and pharmaceutical companies.  
Collaborative arrangements between drug and device companies and academic 
medical centers will be needed, with a spirit of sharing in the risks and 
rewards of the effort being inherent to the relationships.

By combining investigators from diverse fields of basic and clinical 
neuroscience, new perspectives and insights can be brought to bear on 
research findings.  To accomplish this will require that innovative 
clinicians join forces with basic biologists with an interest in applying 
their work to human disease.  These collaborations may be enhanced by the 
participation of applied scientists, such as epidemiologists and population 
geneticists, and the advice of chemists, physicists, and statisticians.  New 
and emerging technologies, such as combinatorial chemistry, high-throughput 
screening, and functional genomics will be needed to support the 
collaborations, and to bring the translational process to fruition.

The NINDS Cooperative Program in Translational Research is intended to 
catalyze the development of partnerships between basic and clinical 
investigators, and to stimulate agreements between the academic and 
industrial sectors, so that translational research in neuroscience can 
flourish as a cooperative, iterative process leading to new and effective 
interventions for neurological disorders.

Stages of Translational Research:

Translational research proceeds through a number of stages toward therapy 
development.  Specific project milestones can be defined based on these 
stages, and applications should include a linear timeline or flowchart of 
project tasks and milestones.  Early stages lead to the identification and 
characterization of candidate therapeutics, and late stages include 
preclinical development and submission of an Investigational New Drug (IND) 
or Investigational Device Exemptions (IDE) application to the Food and Drug 
Administration (FDA).  In many cases, early-stage projects will be unable to 
achieve an IND or IDE within a single project period.  

Implementation:

The NINDS Cooperative Program in Translational Research is implemented 
through three coordinated cooperative agreements mechanisms, and NINDS 
program staff will have a significant, although not dominant, role in the 
planning and execution of the supported activities.  It is intended for the 
extramural research community to use the translational research initiatives 
flexibly and creatively, and in whatever combinations are necessary, to 
achieve the most rapid and effective development of clinical interventions 
for neurological disorders.

Collaboration among awardees will be encouraged and facilitated by NINDS 
program staff.  Investigators working on the same disease will have the 
opportunity to share data, materials, and expertise.  It is expected that 
lessons learned and techniques developed within one disease community will be 
relevant to the efforts of other communities.  Relationships between academia 
and industry will be important, and NINDS program staff will assist with 
establishing them whenever possible.

An oversight committee composed of program staff will assess the 
responsiveness of applications, manage the development of collaborations and 
networks within the program, and assess progress toward and achievement of 
milestones.

NINDS will consider requests for administrative supplements to support new 
collaborations and networks among awardees, or for the exploration of new and 
important research questions in translational research.

Components of the Program:

Translational Research Conferences (U13)

Translational research conferences are used flexibly to meet the needs of 
research communities with translational research efforts at different stages 
of development.  All meetings must have a translational research focus, and 
be directly relevant to a clinical intervention for a neurological disorder.  
Multi-year conference plans must include annual milestones toward disease 
intervention.  The following objectives would be appropriate for conferences, 
but this list is not all-inclusive, and applicants are encouraged to use this 
support mechanism creatively to further the goals of translational research.

o Establish and implement collaborations between basic, applied, and clinical 
scientists.
o Compare experimental results, and identify and prioritize short-term 
research needs.
o Develop a comprehensive long-term strategy for translational research on 
the neurological disorder under study.
o Disseminate research priorities and results.
o Educate translational investigators and students.

Single-Component Translational Research Projects (U01)

These cooperative agreements support translational research projects that are 
focused on a single problem or approach in therapy development for a 
neurological disorder.  The research is focused on a neurological disorder, 
or a group of closely related neurological disorders.  NINDS strongly 
encourages collaboration or consultation between basic and clinical 
scientists.  Consortium agreements are permitted.  In some cases, Steering 
Committees and external advisory committees are appropriate.  Each research 
project will include the following common features.

o Translational Research Focus: The research project is dedicated to 
obtaining experimental results that will have a direct impact on clinical 
intervention for a neurological disorder.
o Milestones: Specific milestones of progress toward disease intervention 
must be met prior to funding of the next budget period.  NINDS program staff 
will consult with awardees on the evaluation of progress toward milestones.

Research project funding can be used to support the translational research 
process through an IND or IDE application to the FDA.  Projects may, however, 
collaborate on relevant Phase I, II, and III clinical trials that are 
supported with other NINDS funding mechanisms.

Multi-Component Translational Research Projects (U54)

These cooperative agreements will support research programs that take a 
multidimensional or comprehensive approach to therapy development.  Multi-
Component Translational Research Projects support interdisciplinary teams of 
investigators who are dedicated to translational research focused on a 
neurological disorder or a group of closely related neurological disorders.  
Any combination of scientific methods can be used to impact the treatment or 
prevention of the disease.

Multi-Component Translational Research Projects are appropriate for applicant 
institutions that are able to conduct high-quality, balanced translational 
research on a neurological disorder, and that will give the effort high 
priority and visibility within the institution.  Multi-Component 
Translational Research Projects are not only expected to conduct a wide 
spectrum of research activities, but also to contribute significantly to the 
development of specialized research resources, the development of improved 
research model systems, and the expansion of the research base through 
collaborative research with basic and clinical scientists in other 
institutions.  NINDS strongly encourages Multi-Component Translational 
Research Projects to be collaboratively designed and implemented, for example 
by including basic scientists working at the cellular and molecular levels, 
physicians experienced in patient-oriented research, and, in some cases, 
population scientists experienced in studying the patterns of disease. 
Each Multi-Component Translational Research Project will include the 
following common features.

o Translational Research Focus: Multi-Component Translational Research 
Projects are dedicated to obtaining experimental results that will have a 
direct impact on clinical intervention for a neurological disorder.
o Minimum Number of Components: Multi-Component Translational Research 
Projects must include a minimum of three components, which can be research 
projects or cores.
o Milestones: Specific milestones of progress toward disease intervention 
must be met prior to funding of the next budget period.  NINDS program staff 
will consult with awardees on the evaluation of progress toward milestones.
o Steering Committee: Each Multi-Component Translational Research Project has 
a Steering Committee to assist the program with overall management.  The 
Steering Committee will include the Multi-Component Translational Research 
Project PI, project leaders, and NINDS program staff.
o External Advisory Committee: Each Multi-component Translational Research 
Project has an advisory committee composed of experts not otherwise 
associated with the activity.

Multi-Component Translational Research Project funding can be used to support 
the translational research process through an IND or IDE application to the 
FDA.  Projects may, however, collaborate on relevant Phase I, II, and III 
clinical trials that are supported with other NINDS funding mechanisms.

MECHANISMS OF SUPPORT 

This PA will use the NIH U13 Conference, U01 Research Project, and U54 
Specialized Center award mechanisms.  These are cooperative agreement award 
mechanisms in which the PI retains the primary responsibility and dominant 
role for planning, directing, and executing the proposed project, with NINDS 
staff being substantially involved as a partner with the PI, as described 
under the sections "Cooperative Agreement Terms and Conditions of Award."

The maximum that may be requested in support of conferences by the U13 award 
mechanism is $150,000 per year direct costs.

The total project period for an application submitted in response to this PA 
may not exceed five years.

This PA uses just-in-time concepts.

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution has any of the following 
characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the federal government  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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 programs.

SPECIAL REQUIREMENTS

Consultation with NINDS Program Staff:

Due to the unique requirements of the NINDS Cooperative Program in 
Translational Research, applicants are strongly encouraged to consult with 
NINDS program staff as plans for an application are being developed.  This 
early contact will provide an opportunity to clarify the applicant's 
understanding of program goals and guidelines, including the scope of 
projects within the program and the requirement that project objectives be 
milestone driven.

U13 Cooperative Agreement Terms and Conditions of Award:

These 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 policy statements.

The dominant role and prime responsibility for the activity resides with the 
awardees for the project as a whole, although specific tasks and activities 
in carrying out the studies will be shared among the awardees and NINDS 
Project Scientists.

1. Awardee Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of the conferences.

Awardees are responsible for identifying specific milestones toward disease 
intervention that will be achieved during the project period, when multi-year 
conferences are supported.

Awardees agree to participate in the overall coordination of NINDS research 
efforts in translational research.  This participation may include 
collaboration and consultation with other translational research awardees, 
and the sharing of information, data, and research materials.

2. NINDS Program Staff Responsibilities

Each project will have the support of one or more Project Scientists from 
NINDS program staff who are assigned an administrative role for the 
neurological disorder being studied and have expertise in the implementation 
of the NINDS Cooperative Program in Translational Research.

The NINDS Project Scientists will have substantial scientific-programmatic 
involvement during conduct of this activity, through technical assistance, 
advice, and coordination above and beyond normal program stewardship for 
grants.  They will work with conference organizers to determine the subjects 
to be discussed, to identify speakers, and to formulate an agenda.

An important part of the NINDS Cooperative Program in Translational Research 
is the coordination of research efforts across different funding mechanisms 
and research structures, and coordination among efforts aimed at different 
neurological disorders.  NINDS Project Scientists will have the primary 
responsibility for this overall coordination.

NINDS Project Scientists will be responsible for assessing the progress of 
multi-year conferences toward the accomplishment of specified milestones, and 
for recommending if further funds should be released to the project.

The program director will be responsible for normal stewardship of the award, 
and may also serve as a Project Scientist.

3. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award), between award recipients and NINDS may be brought to 
arbitration.  An arbitration panel will be composed of three members – one 
chosen by the awardee, a second member selected by NINDS, and the third 
member selected by the two prior selected members.  This special arbitration 
procedure in no way affects the awardee's right to appeal an adverse action 
that is otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

U01 Cooperative Agreement Terms and Conditions of Award:

These 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 policy statements.

The dominant role and prime responsibility for the activity resides with the 
awardees for the project as a whole, although specific tasks and activities 
in carrying out the studies will be shared among the awardees and NINDS 
Project Scientists.

1. Awardee Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of their studies.

Awardees are responsible for identifying specific milestones toward disease 
intervention that will be achieved during the project period.

Awardees agree to participate in the overall coordination of NINDS research 
efforts in translational research.  This participation may include 
collaboration and consultation with other translational research awardees, 
and the sharing of information, data, and research materials.

Awardees will retain custody of and have primary rights to data developed 
under these awards, subject to government rights of access consistent with 
current HHS and NIH policies.

2. NINDS Program Staff Responsibilities

Each project will have the support of one or more Project Scientists from 
NINDS program staff who are assigned an administrative role for the 
neurological disorder being studied and have expertise in the implementation 
of the NINDS Cooperative Program in Translational Research.

The NINDS Project Scientists will have substantial scientific-programmatic 
involvement during conduct of this activity, through technical assistance, 
advice, and coordination above and beyond normal program stewardship for 
grants.

NINDS Project Scientists will be responsible for assessing the progress of 
the projects toward the accomplishment of specified milestones, and for 
recommending if further funds should be released to the project.

The NINDS Project Scientists will facilitate the establishment of contacts 
and collaborations between awardees of the NINDS Cooperative Program in 
Translational Research and other persons or organizations whose participation 
will assist with the accomplishment of project goals.  These persons or 
organizations may include the FDA, disease voluntary organizations, 
pharmaceutical companies, or research organizations that can provide 
essential services on contract.

An important part of the NINDS program in translational research is the 
coordination of research efforts across different funding mechanisms and 
research structures, and coordination among efforts aimed at different 
neurological disorders.  NINDS Project Scientists will have the primary 
responsibility for this overall coordination.

The program director will be responsible for normal stewardship of the award, 
and may also serve as a Project Scientist.

3. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award), between award recipients and NINDS may be brought to 
arbitration.  An arbitration panel will be composed of three members – one 
chosen by the awardee, a second member selected by NINDS, and the third 
member selected by the two prior selected members.  This special arbitration 
procedure in no way affects the awardee's right to appeal an adverse action 
that is otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

U54 Cooperative Agreement Terms and Conditions of Award:

These 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 policy statements.

The dominant role and prime responsibility for the activity resides with the 
awardees for the project as a whole, although specific tasks and activities 
in carrying out the studies will be shared among the awardees and NINDS 
Project Scientists.

1. Awardee Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of their studies.

Awardees are responsible for identifying specific milestones toward disease 
intervention that will be achieved during the project period.

Awardees are responsible for establishing an external advisory committee 
composed of experts not otherwise associated with the activity.

Awardees agree to participate in the overall coordination of NINDS research 
efforts in translational research.  This participation may include 
collaboration and consultation with other translational research awardees, 
and the sharing of information, data, and research materials.

Awardees will retain custody of and have primary rights to data developed 
under these awards, subject to government rights of access consistent with 
current HHS and NIH policies.

2. NINDS Program Staff Responsibilities

Each project will have the support of one or more Project Scientists from 
NINDS program staff who are assigned an administrative role for the 
neurological disorder being studied and have expertise in the implementation 
of the NINDS Cooperative Program in Translational Research.

The NINDS Project Scientists will have substantial scientific-programmatic 
involvement during conduct of this activity, through technical assistance, 
advice, and coordination above and beyond normal program stewardship for 
grants.

NINDS Project Scientists will be responsible for assessing the progress of 
the projects toward the accomplishment of specified milestones, and for 
recommending if further funds should be released to the project.

The NINDS Project Scientists will facilitate the establishment of contacts 
and collaborations between awardees of the NINDS Cooperative Program in 
Translational Research and other persons or organizations whose participation 
will assist with the accomplishment of project goals.  These persons or 
organizations may include the FDA, disease voluntary organizations, 
pharmaceutical companies, or research organizations that can provide 
essential services on contract.

An important part of the NINDS program in translational research is the 
coordination of research efforts across different funding mechanisms and 
research structures, and coordination among efforts aimed at different 
neurological disorders.  NINDS Project Scientists will have the primary 
responsibility for this overall coordination.

NINDS Project Scientists will have a single NIH vote on the Steering 
Committee.

The program director will be responsible for normal stewardship of the award, 
and may also serve as a Project Scientist.

3. Collaborative Responsibilities

A Steering Committee will make strategic decisions with regard to goals and 
research implementation, including the establishment of shared resources and 
the development of collaborations.  The Steering Committee will meet at least 
annually.

The Steering Committee will be composed of the project PI, and other 
investigators who are leaders of individual projects within the award or 
leaders of efforts at consortium sites, if applicable, and one or more NINDS 
Project Scientists.  The project PI and the project or consortium site 
leaders will each have one vote, and the NINDS Project Scientists will have a 
single NIH vote.  The project PI will serve as chairperson of the Steering 
Committee.

Awardees will be required to accept and implement the procedures approved by 
the Steering Committee.

4. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award), between award recipients and NINDS may be brought to 
arbitration.  An arbitration panel will be composed of three members – one 
chosen by the Steering Committee (with NIH not voting) or by the individual 
awardee in the event of an individual disagreement, a second member selected 
by NINDS, and the third member selected by the two prior selected members.  
This special arbitration procedure in no way affects the awardee's right to 
appeal an adverse action that is otherwise appealable in accordance with the 
PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR 
Part 16.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA 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:

o Direct your questions about scientific/research issues to:

Thomas Miller, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2139
Bethesda, MD 20892
Telephone: 301-496-1779
FAX: 301-402-1501
Email: tm208y@nih.gov

o Direct your questions about peer review issues to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3208
Bethesda, MD 20892
Telephone: 301-496-5980
FAX: 301-402-0182

o Direct your questions about financial or grants management matters to:

Rebecca Claycamp
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290
Bethesda, MD 20892
Telephone: 301-496-9231
Fax: 301-402-0219
Email: rc253d@nih.gov  

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION PAGE LIMITS: Applications submitted in response to this PA for 
Translational Research Conferences (U13) or Single-Component Translational 
Research Projects (U01) are limited to 25 pages for sections A through D of 
PHS 398.  Applications for Multi-Component Translational Research Projects 
(U54) are limited to 25 pages per component for sections A through D of PHS 
398.

SPECIAL INSTRUCTIONS FOR MULTI-COMPONENENT TRANSLATIONAL RESEARCH PROJECT 
APPLICATIONS: Since the PHS 398 application form is designed primarily for 
the traditional research project grant (R01) application, several sections 
have to be modified and expanded so that the form can be used to provide the 
information needed for a Multi-Component Translational Research Project 
application.

Prepare a detailed table of contents that will enable reviewers to find 
specific information readily.  Present the projects first and the core units 
last.  Identify each component by title, and assign each project a number and 
each core unit a capital letter that reflects the order in which the projects 
and core units are presented in the application, and provide the name of the 
investigator responsible for each component.

Applicants should prepare only a single face page for the entire application, 
not one for each component.  The title should be followed by "(U54)".

In the Key Personnel table provided, list the PI for the overall Multi-
Component Translational Research Project and the investigator responsible for 
each component project or core.  List the investigators in the same order in 
which their individual components are presented.  Under "Role on Project" 
state the investigator's role (e.g., "Investigator, Project 1", "Co-
investigator, Core B", or "Consultant, Project 3").

For the entire Multi-Component Translational Research Project, as well as for 
each project and core, prepare the standard "Detailed Budget for Initial 
Budget Period" and the "Budget for Entire Proposed Project Period."  Identify 
each budget page (e.g., "Composite", "Project 1", etc.).  Place the composite 
budget pages first, followed by the projects and cores.  All budgets 
(composite, projects, and cores) will be in this one section.  Individual 
project budgets should not be included with the project research plans.

Put the biographical sketch for the PI of the Multi-Component Translational 
Research Project first, followed by the other biographical sketches in 
alphabetical order.  Put all of the biographical sketches together in one 
section immediately after the budget section.  Biographical sketches are 
required for all key personnel and consultants who participate in the 
research projects and core units.

Present all Resources pages in one section.

The Research Plan of each research project or core should consist of a title 
page, Description (use form page 2 of form PHS 398 for this), and sections on 
Specific Aims, Background and Significance, Preliminary Studies/Progress 
Report, Research Design and Methods, Human Subjects Research (if 
appropriate), Vertebrate Animals (if appropriate), Literature Cited, 
Consortium/Contractual Arrangements (as appropriate), and Consultants, as 
described in the PHS 398 instructions.  The Specific Aims, Background and 
Significance, Preliminary Studies/Progress Report, and Research Design and 
Methods sections for each research project or core, taken together, should 
not exceed 25 pages.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

The title and number of the PA must be typed on line 2 of the face page of 
the application form and the YES box must be marked.

MODULAR GRANT APPLICATIONS: The NINDS Cooperative Program in Translational 
Research will not use modular grant procedures 
(http://grants1.nih.gov/grants/funding/modular/modular.htm).

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NINDS staff member who has agreed to 
accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact NINDS program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from NINDS staff that NINDS will accept your application 
for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the NINDS staff 
member who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types.  Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and four 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
Bethesda, MD  20817 (for express/courier service)

In order to facilitate the review of applications, the applicant should, at 
the same time, mail or deliver one copy of the application to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3208
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The Center for 
Scientific Review (CSR) will not accept any application in response to this 
PA that is essentially the same as one currently pending initial review 
unless the applicant withdraws the pending application.  The CSR 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.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness and adherence to program goals and objectives by NINDS.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.  Applications that are complete and 
responsive will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened by NINDS in accordance with the 
review criteria stated below.

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the NINDS advisory council
	
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them as 
appropriate for each application.  Your 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, you may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem?  If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
PI and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS: 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.

RESOURCE SHARING: A sharing plan for the distribution of unique research 
resources developed through Single-Component Translational Research Project 
or Multi-Component Translational Research Project activities should be 
included in the application.  The sharing plan should preserve research 
freedom and publication rights, while ensuring appropriate implementation of 
the Bayh-Dole Act (35 U.S.C. 200 et seq.) and dissemination of research 
resources.  A Federal Register Notice published on December 23, 1999, titled 
"Principles and Guidelines for Recipients of NIH Research Grants and 
Contracts on Obtaining and Disseminating Biomedical Research Resources: Final 
Notice," provides further information, and is available at 
http://www.ott.nih.gov/policy/rt_guide_final.html.  The application should 
include a request for the funds necessary to implement the sharing plan.

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:

U13 – Translational Research Conferences

o The importance of the translational research objective to the neurological 
disorder under study.
o The involvement of basic and clinical scientists in the conception, design, 
and proposed implementation of the conferences, as appropriate.
o The adequacy of proposed milestones for multi-year awards.
o The qualifications of the conference organizers and the proposed 
participants.
o The adequacy of the plans to seek out and encourage the participation of 
women, persons with disabilities, and underrepresented minorities.
o The participation of junior investigators and students in the conferences.
o The appropriateness of the proposed format and location of the conferences.
o The plans to distribute the results of the conferences, as appropriate.

U01 – Single-Component Translational Research Projects

o The importance of the translational research objective to the neurological 
disorder under study, and its likelihood of completion within the project 
period.
o The adequacy of the experimental design and methods to achieve the research 
objectives; including the involvement of basic and clinical scientists in the 
conception, design, and proposed implementation of the project.
o The adequacy of proposed project milestones, and the feasibility of 
achieving them.
o The qualifications of the basic and clinical investigators to conduct the 
proposed research, and the appropriateness of the time commitments of each 
investigator to the conduct to the project.
o The scientific environment in which the translational research work will be 
done, and the unique features, if any, of the environment to support the 
proposed work.
o 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.
o Appropriate plans for the rigorous management and quality control of 
research data or materials from human subjects.

U54 – Multi-Component Translational Research Projects

Individual Projects:

o The importance of the translational research objective to the neurological 
disorder under study, and its likelihood of completion within the project 
period.
o The adequacy of the experimental design and methods to achieve the research 
objectives; including the involvement of basic and clinical scientists in the 
conception, design, and proposed implementation of the project.
o The adequacy of proposed project milestones, and the feasibility of 
achieving them.
o The qualifications of the basic and clinical investigators to conduct the 
proposed research, and the appropriateness of the time commitments of each 
investigator to the conduct to the project.
o The scientific environment in which the translational research work will be 
done, and the unique features, if any, of the environment to support the 
proposed work.
o 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.
o Appropriate plans for the rigorous management and quality control of 
research data or materials from human subjects.

Core Resources:

o The degree to which plans indicate that core resources effectively and 
efficiently support the research activities in a manner that cannot be 
supported through available resources.
o Adequacy of the justification for each specialized resource as essential 
for the conduct of project research, or collaborative projects.
o The qualifications of core managers.
o The appropriateness of the requested budgets to conduct each shared 
resource operation.

Overall Program Organization:

o The scientific qualifications, scientific and administrative leadership 
capabilities, and adequacy of the time commitment of the PI.
o Adequacy of the planning and evaluation process to include: determining 
translational research productivity of existing projects and resources; 
discontinuing activities of low productivity; initiating new activities in 
response to important translational research opportunities; establishing 
collaborations; and the use of a Steering Committee and external advisors.
o The degree to which the organization and leadership of the project promote 
and facilitate scientific interactions and the effective use of core 
facilities.
o The effectiveness of proposed interdisciplinary interactions.
o The adequacy of tangible institutional commitments that will enable and 
facilitate the research objectives.

A single priority score will be assigned to the Multi-Component Translational 
Research Project application as a whole after discussing all of the review 
elements.  The score will be based on the overall quality of the research 
projects, the overall effectiveness and adequacy of core resources, and the 
overall program organization and capability.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants1.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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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 public 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
PA is related to one or more of the priority areas.  Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.853, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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