and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)
Components of Participating Organizations
National Institute of Neurological Disorders and Stroke
(NINDS) (http://www.ninds.nih.gov)
Title: NINDS Cooperative Program in
Translational Research Resource Centers (U24)
Announcement Type
This is a reissue of PAR-05-158.
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-08-236
Catalog of Federal Domestic
Assistance Number
93.853
Key Dates
Release
Date: August 12, 2008
Letters of Intent Receipt Dates: Not Applicable
Application Submission Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url
Activation Date): Not
Applicable
Expiration Date: September 8, 2011
Due
Dates for E.O. 12372
Not
Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3.
Collaborative Responsibilities
4. Arbitration
Process
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Rapid tools development in recent years, decades of data acquisition on disease and physiological processes, and an evolving culture of collaborative science, establish an environment today that is conducive to successful therapy development. NINDS is committed to providing resources that will assist investigators with achieving therapy development goals and moving candidate therapeutics for neurological disorders into clinical testing. The goal of this FOA is to implement a program of cooperative agreements that will support milestone-driven resource-related projects focused on providing products and services needed to complete steps in the pipeline for the pre-clinical development of therapeutics. Each Translational Research Resource Center will serve a broad group of potential users and establish a national resource to support investigators engaged in therapy development for neurological disorders.
This FOA is one of five coordinated programs being released by NINDS to promote translational research, including NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-08-232), NINDS Cooperative Program in Translational Research Single-Component Projects (U01) (PAR-08-233), NINDS Cooperative Program in Translational Research Multi-Component Projects (U54) (PAR-08-234), and NINDS Cooperative Program in Translational Research Small Business Awards (SBIR [U44]) (PAR-08-235). The extramural research community may use these translational research initiatives flexibly and creatively, and in whatever combinations are necessary, to achieve the most rapid and effective development of investigational interventions for neurological disorders.
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.
As described below, this program supports pre-clinical translational research focused on the development of novel candidate therapies for clinical testing.
Scope of the Program:
The scope of this program includes only activities directly focused on pre-clinical therapy development necessary to begin clinical testing of candidate therapeutics that treat or prevent the primary insult or injury to the nervous system. Diagnostics or biomarker development and rehabilitation strategies are outside the scope of the program, and cannot be supported by a Translational Research Resource Center. Studies of disease mechanisms, basic studies, and clinical trials cannot be supported by a Translational Research Resource Center. Activities that can be supported potentially include any tasks in the pre-clinical development pipeline. However, Translational Research Resource Centers should not be focused on generic services, which are effectively made available through other sources. Instead, only products and services that are specific to neurology should be included. These might include screening, assays and animal models, efficacy testing, optimization of candidate therapeutics, production of candidate therapeutics, and other relevant products and services. Development tasks for drugs, biologics, and devices can be supported by a Translational Research Resource Center, and users can be any investigators developing therapies for neurological disorders.
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. These discussions also provide important information and guidance on how to develop an appropriate milestone plan, which is subject to peer review under this program. Pre-application consultation includes both an introductory call to discuss the scope and goals of the program and a conference call with NINDS staff. Pre-application consultation on translational research cooperative agreements require adequate lead time before an application receipt date in order for applicants to have sufficient time to consider advice and perspective from NINDS program staff. For this reason, the introductory call should be completed at least 10 weeks before a receipt date and the conference call at least 8 weeks before a receipt date.
Shortly after receipt, applications will be examined by NINDS Program Staff to determine if they are within the scope of this FOA. PDs/PIs for applications that are outside the scope will be asked to consider whether their proposed studies fall within the scope of other FOAs. Applications that are not within the scope of any existing FOAs will be withdrawn from further consideration.
Implementation:
The NINDS Cooperative Program in Translational Research Single Component Research Projects provides funding through the U01 cooperative agreements mechanism. As a cooperative agreement, implementation will involve participation of NINDS program staff in the planning and execution of these therapy-directed projects.
Milestones: Applications must include proposed yearly go/no-go milestones that are the subject of a special review criterion. During the execution of the project, NINDS staff will assess progress toward and achievement of milestones. Achievement of these milestones will be evaluated by NINDS prior to releasing funding for each year of the award. Guidance for preparation of milestone plans will be provided by NINDS in pre-application teleconferences and is available at http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm.
These U24 cooperative agreements support programs that provide essential pre-clinical development services to investigators who are actively engaged in the development of therapeutics for neurological disorders. NINDS recognizes that success in translational research for neurological disorders will require a breadth of support than cannot be made available through individual project awards. In addition to pre-clinical development projects, it is also necessary to support a pipeline of services that are necessary to move candidate therapeutics from the point of discovery through to clinical testing in humans. Translational Research Resource Centers will assist investigators with accomplishing goals that are required for therapy development but that are difficult or impractical to perform in individual labs. The provision of centralized resources and expertise will serve to stimulate the progress toward therapeutic intervention in humans for neurological disorders, and will provide for investigators an opportunity to apply advanced expertise and to obtain the highest quality products and services for their pre-clinical development programs.
A Translational Research Resource Center includes the scientific expertise necessary to optimally deliver the pre-clinical development services, and can include a significant research-project component in order to develop or refine the shared products and services.
A Translational Research Resource Center will employ one of two possible business models:
Each Translational Research Resource Center includes the following common features.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding
opportunity announcement (FOA) will use the U24 Resource-Related
Research Projects Cooperative Agreements award
mechanism. The applicant will be solely
responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
At this time, it is not known if this FOA will be reissued.
2. Funds Available
The total project period for an application submitted in response to this FOA may not exceed five years.
NINDS has not specified a maximum number of awards or a maximum total amount of funding that will be awarded under this FOA.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not
require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Resubmission applications will be accepted through this program. Such applications must include an Introduction addressing the previous peer review critique (Summary Statement).
Applicants may submit a renewal application.
Applicants may submit more than one application, provided that each application is scientifically distinct.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of
this funding opportunity must be typed in item (box) 2 only of the face page of
the application form and the YES box must be checked.
SPECIAL
INSTRUCTIONS
Overall Research Strategy for the Delivery of Pre-Clinical Services and Milestones:
Projects submitted under the U24 award mechanism must include an overall Research Strategy for the delivery of pre-clinical services. This Research Strategy must be based on a clearly stated project timeline that includes practical, achievable goals, and project milestones that address both the development and delivery of products and services. Milestones toward the achievement of program objectives are goals that create go/no-go decision points in the resource-related project, including quantitative success criteria (see http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm). The overall plan for the delivery of pre-clinical services should be included in Section 3 of the Research Plan.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review and Anticipated Start Dates
Application
Receipt Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review
Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council
Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated
Start Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A
letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for
Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix materials must be sent to:
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: [email protected]
3.C. Application Processing
Applications must be submitted on or before the application
receipt/submission dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or competing renewal award
if such costs: 1) are necessary to conduct the project, and 2) would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing
renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Research Strategy Page Limitations
Applications submitted in response to this FOA for Translational Research Resource Centers (U24) are limited to 12 pages for Section 3 of PHS 398.
Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year
Applicants requesting
$500,000 or more in direct costs for any year (excluding consortium F&A
costs) must carry out the following steps:
1) Contact the
IC program staff at least 6 weeks before submitting the application, i.e., as plans
are being developed for the study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.
Appendix Materials
All paper PHS 398 applications must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2.
Review and Selection Process
Applications submitted for this funding opportunity
will be assigned on the basis of established PHS referral guidelines to NINDS for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NINDS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious impact/priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
For applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs?
Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition to the above review criteria, the following criteria will be addressed and considered in determining scientific merit and score.
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
2. Administrative and
National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative
Agreement Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement, an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIH programmatic involvement with the awardees is anticipated
during the performance of the activities. Under the cooperative agreement, the
NIH purpose is to support and stimulate the recipients' activities by
involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the awardees for the project as a
whole, although specific tasks and activities may be shared among the awardees
and the NIH as defined below.
2.A.1. Project
Director/Principal Investigator (PD/PI) Rights and Responsibilities
The
Principal Investigator will have the primary responsibility 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 the data and software developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An NIH Project
Scientist will have substantial programmatic involvement
that is above and beyond the normal stewardship role in awards, as described
below.
The Translational Research Resource Centers will have the support of one or more Project Scientists from NINDS program staff who are assigned an administrative role for the group of neurological disorders being studied and have expertise in the implementation of the NINDS Translational Research Program.
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.
Additionally, an agency
program official or IC program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice. The assigned program director may also serve as an NIH
Project Scientist.
2.A.3. Collaborative Responsibilities
A Steering Committee will make strategic decisions with regard to
goals and research implementation, including the establishment and development
of collaborations. This role will include the solicitation, review, and
selection of proposals for collaborative projects in therapy development for
neurological disorders, and the selection and prioritization of projects that
will use products and services that are provided for a fee. Translational
Research Resource Centers may conduct studies through collaborations or on a
fee-for-service basis. The Steering Committee will meet at least annually.
The Steering Committee will be composed of the project PI, and at least three other investigators selected by the project PI who are associated with the Translational Research Resource Center, and one or more NINDS Project Scientists. The project PI and the other Steering Committee members selected by the Project PI 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.
The Steering Committee may, but is not required to, consult with outside advisors, or establish an Advisory Committee composed of outside experts not otherwise associated with the Translational Research Resource Center.
Awardee
members of the Steering Committee will be required to accept and implement
policies approved by the Steering Committee.
2.A.4. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An Arbitration
Panel composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
When multiple years are
involved, awardees will be required to submit the Non-Competing Continuation
Grant Progress Report (PHS 2590) annually and financial statements as
required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
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: [email protected]
2. Peer Review Contacts:
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: 301-496-9223
Fax: 301-402-0182
Email: [email protected]
3. Financial or Grants Management Contacts:
Tijuanna E. DeCoster, MPA
Chief Grants Management Officer
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3290, MSC
9537
Bethesda, Maryland 20892-9537
(Rockville, MD 20852 for express/courier service)
Telephone: 301-496-9231
Fax: 301-402-0219
Email: [email protected]
Section
VIII. Other Information
Required
Federal Citations
Vertebrate Animals:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and
local IRB rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule. Reviewers will consider the data sharing plan
but will not factor the plan into the determination of the scientific merit or
the impact/priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds and
(2) cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope of
this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigators NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of
Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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