Part I Overview Information


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 Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology and Neuroradiology (R25)

Announcement Type
Re-issue of RFA-NS-09-001.

Update: The following updates relating to this announcement have been issued:

Request for Applications (RFA) Number: RFA-NS-10-002

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.853

Key Dates
Release/Posted Date: June 10, 2009
Opening Date:  August 10, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not required
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s): September 10, 2009
Peer Review Date(s): November-December, 2009
Council Review Date(s): January 2010
Earliest Anticipated Start Date(s): May 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date: September 11, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The National Institute on Neurological Disorders and Stroke (NINDS) Research Education grant is a flexible and specialized mechanism designed to foster the development of neuroscience researchers through creative and innovative educational programs. The overall goal of the NINDS research training and research education programs is to ensure that highly trained scientists will make future advances that lead to a reduction in the burden of neurological disease.  These research education grants will create an opportunity for medical residents and fellows to participate in an intensive 9 to 24 months of mentored research education experience during residency and fellowship years. This opportunity will include the necessary research education and training for successful competition for independent mentored research awards and will facilitate the transition from fellow/resident to clinician-scientist.  In addition to collection of preliminary data to be used in future applications, participants in the program will develop laboratory research skills and the critical skills necessary to design and conduct research experiments and write competitive grant applications.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Education 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Application Due, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 Education Objectives

Definitions

Project Director/Principal Investigator (PD/PI). The Project Director/Principal Investigator is the person who writes this application and oversees the entire program. This person must hold a health professional degree (e.g., M.D., or equivalent), have an appointment in a Neurology, Neurosurgery or Pathology Department, have clearly demonstrated training/education/mentoring credentials in research and have a strong recent history of NIH funding.  If the sponsoring institution is a hospital affiliated with a medical school, the PD/PI must have an appointment in both the medical school and at the sponsoring institution. If multiple PD/PIs are designated, the role of each should be clearly described.

Mentors. The mentors will directly train and mentor the participants (residents and fellows) in this research education program. Mentors must have active, well-funded research programs, and conduct studies in either basic or clinical research related to neurology or neuroscience. Mentors should have a strong track record in the successful training of researchers (as evidenced by continuing success of the trainee in research) and dedication to the training of physician-scientists. Mentors can belong to any department or unit, but must conduct research that is directly relevant to the mission of NINDS.

Participants. The participants in the research education program are residents and fellows in neurology, neurosurgery, neuropathology or neuroradiology. Participants must begin this research education program during residency. These participants then have the opportunity to continue in this program during their first fellowship year. Participants must be dedicated to a career as physician-scientists and conduct research in an area that fits within the mission of NINDS. Participants are expected to apply for independent funding by the end of their involvement in this research education program.

RFA-NS-10-002 Grant. This grant is awarded as a result of the application submitted by the PD/PI.  The budget for the primary grant award will contain funds for the support of at least one resident in the first year. Funding for subsequent years will be in the form of Administrative Supplements.

Administrative Supplements. Support for residents and fellows in years 2 – 5 may be requested by submission of supplement applications. These brief applications, which are described in detail below, should be prepared by the prospective participant, not by the PD/PI of the primary grant. There is one submission deadline (receipt date) per year, September 10, in each of years 2 - 5 during which the primary grant is active. Supplement applications will be reviewed administratively and will undergo a selection process.  Awards will be made based on evaluation criteria and are subject to available funds (details for supplement preparation, submission, review and evaluation criteria are provided below).  It is anticipated that there will be more supplement applications than awards.

Overview of the research education program

The overall goal of NINDS's research training and research education programs is to ensure that highly trained scientists will be available to make future advances that will lead to a reduction in the burden of neurological disease.  There is critical need for additional physician-scientists with the medical training and research experience to conduct basic, clinical and translational research on the mechanisms, cure and treatment of neurological disorders. NINDS provides mentored career development awards (K08 and K23 mechanisms) to highly qualified physician-scientists who have early training and experience in research, and who generally have one or more significant, original research publications.  However, there is need for a mechanism to support the early training of clinicians during the residency/fellowship period in research and related skills, which would enable them to compete successfully for the mentored career development awards. This Research Education Program is designed to foster the development of neuroscience researchers through research training and educational experiences that will prepare clinicians to successfully compete for individual fellowships or mentored career development awards.

Recognizing that medical school curricula do not traditionally provide skills critical to the pursuit of an independent research career, this dedicated opportunity will provide experience in the design and conduct of research, as well as skills required for competitive application for independent funds.  It is expected that participants will conduct basic or clinical research in a well-funded (NIH or comparable) research laboratory and have one or more mentors with a superb track record in the training of physician-scientists. Hallmarks of these programs will be the immersion of participants in a significant research problem and an environment that provides high quality mentoring in all aspects of research and career management required for success as a physician-scientist. The immediate goal of this program is to prepare clinicians to successfully compete for individual fellowships or mentored career development awards. Such success will facilitate their transition from resident/fellow to physician-scientist, and will thus foster retention of a cadre of physician-scientists who will conduct research into the mechanisms of, etiology, and treatment of neurological diseases. 

Research Education Program structure. Applications will be accepted in response to this funding opportunity from accredited Medical Schools that propose outstanding opportunities for Neurology, Neurosurgery, Neuropathology and/or Neuroradiology residents and fellows (“participants”) to participate in an intensive, mentored research education experience during residency and fellowship training. The research education opportunity provided for each individual participant must occur for a minimum 9 month period; participants may be supported by this research education program for a maximum of 24 months. Initial research education/training must take place during a period of 6 - 12 months during residency. However, once a participant obtains 6 – 12 months of support from this program during residency, he/she may receive up to 12 months of continued support during fellowship. During any supported period, participants must devote a minimum of 80% of his/her professional time to this research education program. This 80% commitment by the participant should occupy 4 full days during the Monday through Friday workweek.  In general, supported time during residency should include at least one block of time with a minimum continuous duration of 6 months; support during residency may occur during a single PGY year or split between two PGY years. The time committed to this program during fellowship should be continuous.

This effort requirement also applies to neurosurgery residents. However, neurosurgeons who participate in the program for more than one year may commit a minimum of 50% effort to the program after the first year of support. This is consistent with the Career Development (K) award accommodation that allows neurosurgeons to devote a minimum of 50% of full time professional effort to research while supported by a K award.

Applications should describe in detail the participant activities and commitments not associated with this research experience (e.g. clinical duties, etc.), the time committed to these other activities, and when these activities will occur.

The structure of research experiences will be unique and should maximize resources and faculty at the applicant institution. All programs should include extensive laboratory and/or clinical research experience, including the collection of data that can be used by the participant in an application for independent funding. With the exception of training in experimental design and analysis, in responsible conduct of research, and in grant writing and presentation skills, it is expected that participants will engage in minimal coursework while participating in this research education program. Tuition is not an allowable expense from this FOA. Part of the supported research experience may include travel to one scientific meeting per year. In addition, all participants are expected to attend an NINDS workshop for either career development awardees or residents. Funds will be provided outside of this FOA for attendance at this workshop (additional details about this workshop will be provided by the NINDS Director of Training and Career Development).

Participants must begin this program during residency. This research education grant is intended to provide a means for participants to begin research education during residency and, if appropriate, continue this education during their fellowship period. Consequently, support for any individual participant must begin during residency. Participants must commit 80% effort (4 full days during the Monday through Friday workweek) for a minimum period of 6 months during residency to be eligible for continued support during a fellowship period.

Evaluation of program success. The primary indicator of success of these programs will be the ability of participants to successfully compete for individual fellowships or career development awards, and ultimately, the continuation of the participant’s research career. It is expected that applicants will publish original research papers that result from work done during this research education period, but the most important outcome of this research education program will be the successful competition for individual funding for continued career development by the participants. Programs will be evaluated primarily on this outcome measure.

Transfer of support to other institutions with similar R25 programs. In some cases, participants who begin a research education program during residency may wish to change institutions for fellowship training. If the proposed fellowship training institution has an R25 program supported by this FOA, it may request supplemental support to continue the participant’s research education.

Prospective applicants are strongly encouraged to contact the NINDS Director of Training and Career Development early in the application preparation phase to discuss award provisions.  Such contact will help ensure that applications are responsive to the aims expressed in this announcement.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Education Grant (R25) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA. 

Research education grant support under this FOA is for new projects only; renewal (formerly “competing continuation”) applications and resubmission applications will not be accepted.

2. Funds Available

Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award may vary. Although the financial plans of the NINDS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Base (year 1) support for research education programs. The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of the award may vary among research education programs, applications must stay within the following budgetary guideline: direct costs requested in the initial application may be up to $70,000 per participant, annually. The grant submitted in response to this FOA will support salary plus fringe for 80% participant effort (4 full days during the Monday through Friday workweek), for a period of 6 to 12 months per participant. Salary support will be calculated as the duration of 80% research effort multiplied by the base salary level of the participant. It is anticipated that most programs will initially receive support for one new participant during the first year. However, applicants may request support for more than one participant in the first year if multiple outstanding potential participants are identified. Once a grant has been awarded, supplemental requests for support of additional participants may be submitted (see below). Support for participant travel to one meeting per year may also be requested.  

Supplemental requests for support in years 2 - 5.Support for participants in years 2 – 5 will be administered via administrative supplements. Requests for supplemental funding may be made for two purposes. 1) In years 2 – 5, supplemental funds may be requested to support new participants, who will begin during residency. These participants must be identified and a brief description of the research education program tailored for each participant must be described. These supplements will be awarded on a competitive basis, based on suitability of the proposed participants and available funds. Some programs may be poised to provide research education, training and mentoring to multiple outstanding residents. Although we anticipate that each program will support only 1 or 2 new participants each year, there is no limit to the number of participants a program may request support for. However, requests on behalf of outstanding candidates from institutions with fewer participants may be given preference. In all cases, supplements may be requested to support participant salary and fringe, plus travel to one meeting, and may not exceed $70,000 direct cost per participant. When requesting support for more than one participant in a single supplement application, the PI should clearly separate the materials submitted in support of each participant (see below for required materials).  Supplement requests will be reviewed administratively at NINDS. Awards will be competitive in the sense that it is anticipated that there will be more requests than awards made. 2) Supplements may be requested to continue the education/training during fellowship years of a participant who has completed at least 6 months of support under this FOA during residency. Each participant may receive up to 24 months of support via this funding mechanism over the course of their residency and fellowship years. Whereas these supplement requests will be examined to ensure the continuation of meritorious participants, these requests will not compete with supplement requests for new participants. All participants who begin this program during residency will receive additional support during a research fellowship year, subject to satisfactory progress and an appropriate training/education plan.

Submission and evaluation of supplemental requests. Applications will be evaluated administratively, and funds will be allocated, depending on availability of funds, based on evidence of the participant’s potential in research, the mentoring/training plan and the program’s record of success in transitioning residents and fellows to independent mentored funding. Supplement applications must be prepared using the PHS 398 forms. Applications should consist of a 3 page (maximum) description of the research education and research plan. The research education and research plan should be written by the prospective participant. Mentors must be chosen from those listed in the primary application. In addition to the 3 page description, supplement applications should include a curriculum vitae from the participant, and a letter of support from the proposed mentor that describes the mentoring, education and research plan for this participant. Applications for supplemental support to continue in the program in the fellowship year should include, in addition to the 3 page description of future research education and research plan, a brief (2 - 3 pages) description of progress made during the residency year. This description of future plans should also be written by the prospective participant.  Whereas the components of the supplement application (except for the letter of support from the proposed mentor) are to be written by the prospective participant, the administrative supplement must be submitted by the PD/PI of the primary grant and sent directly to the Chief, NINDS Scientific Review Branch, on paper forms. This application must be signed by the PD/PI of the primary R25 award and the signing institutional official responsible for administration of the award.

Facilities and Administrative (F&A) costs requested by consortium participants will not be not included in the direct cost limitation. See NOT-OD-05-004.

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement is $1,100,000 for fiscal year 2010.  Future year amounts will depend on annual appropriations.  

NIH grants policies as described in the 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 grant 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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, 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.  In particular, applicants must be aware that all designated PDs/PIs should meet the eligibility criteria described above.  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

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education project. Appropriate institutional commitment to the project includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education project. The application should include a letter explaining the institutional commitment to the proposed research education program. This NINDS research education program will only be supported at an accredited Medical School (or an institution that is affiliated with an accredited Medical School). 

Participants: Applicants are required to describe who the intended participants are, and what eligibility and/or specific educational background characteristics are essential for participation in the proposed program. It is expected that participants will be trained in and conduct research in areas that are relevant to the NINDS mission. Support will not be provided for training in areas outside of the NINDS mission.  See also definition under Research Education Objectives (section I.1). 

Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Evaluation Plan: Applications must contain a plan for evaluation of the program.  Applications submitted without Evaluation sections may be delayed in the review process or not reviewed.

Number of Applications. Applicant departments may only sponsor a single application in response to this FOA.  Departments who received funding under RFA-NS-09-001 are not eligible.   

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals.  Renewal applications are not permitted for this FOA, but a mechanism for program renewal will be provided if needed.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.)  

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the 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” [Section 14 of the Research Plan Component in the SF424 (R&R)], 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.

Research Education Program

While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program.  The need for and use of multiple sites must be justified.   

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Allowable costs for this FOA include only the following: salary and fringe benefits for participants and travel to one scientific meeting per participant.

Unallowable Costs: Funds may NOT be used to support any of the following: salary for the PD/PI or faculty mentors participating in this research education program, experimental research costs, tuition of any kind, or administration of the program.  

Personnel: Support for the PD/PI and other faculty participating in this research education project are not allowable. This award is intended to cover salary and fringe benefits only for the participants in the research education program.

Other Program-Related Expenses: Support may be requested for participant travel to a conference or educational opportunity that will directly enhance the experience provided by this program and which will lead towards the stated goal of this award. Such requests must be justified.  All participants are expected to attend one NINDS workshop for either career development awardees or residents. Funds for attendance at this workshop will be provided outside of this FOA (additional details about this workshop will be provided by the NINDS Director of Training and Career Development).

Participant Costs: Participants are residents and fellows who benefit from the proposed research education program.  Participant costs must be justified as specifically required for the proposed research education program.  Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget. 

Some programs may be poised to provide mentoring and research education to multiple outstanding residents. Supplemental requests may be submitted for receipt by September 10 in each active year for support of additional participants in the next fiscal year.  Supplements may be requested to support participant salary and fringe, plus travel to one meeting, and may not exceed $70,000 direct cost per participant. Supplemental requests for direct support of mentors or research costs will not be considered. Applications will be evaluated administratively, and funds will be allocated, depending on availability of funds, based on evidence of the participant’s potential in research, the mentoring/training plan and the program’s record of success in transitioning residents and fellows to independent mentored funding (see above for details of supplement application and submission).

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens.  Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.

Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants are not allowable. A full-time participant is defined for the research education program as an individual supported for 5 days/week for a continuous, 12-month period.

Institutional Commitment: Evidence of institutional commitment to the research educational program is required for success in the review process.

A letter of institutional commitment may be attached at line item 16 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Application Due, Review, and Anticipated Start Dates
Opening Date: August 10, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not required
Application Due Date(s): September 10, 2009
Peer Review Date(s): November–December, 2009
Council Review Date(s): January 2010
Earliest Anticipated Start Date(s): May 2010

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays to view the application image.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA 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.

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 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 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 the NIH Grants Policy Statement.

6. Other Submission Requirements

The program description should be no more than 12 pages. Within that twelve page limit, the following must be included: a narrative description of the PD/PI record, a list of all mentors/trainers participating in this research education program, a description of the participating faculty records in research and training, the track record of the department in training (how many participants, their names, the level of training [resident, fellow, mentored K, other], how many trainees received individual awards, how many remain in research, and other details that will help the review committee determine the merit of the research training environment). In addition, a detailed outline of the program must be included.  The outline should include the timeline of participant training, including information on clinical and research education activities to be performed in all residency years (and fellowship years, if applicable). This outline should include topics such as the plans for oversight, specific mentoring plans regarding choice of project, guidance for project completion, plans for skills training (grant writing, etc.), goals for participant submission of an individual mentored award, and other strategies designed to foster participant success. In addition, the name, qualifications, mentor and very brief statement of project of the first participant in this program should be included, if known.

The application must also include (outside of the 12 page program description) a biosketch for each participating mentor and one table. The biosketch should include recent (within last 10 years) funding history, recent publication record, and a summary of the mentor’s record in the training of clinician-scientists, as well as non-clinician scientists. Normal biosketch page limits apply. The table should include a list of all trainees sponsored by the listed mentors over the last 5-10 years, and the outcome (subsequent position, independent funding), to the extent known, of this training. This table should list only the primary trainees of the mentor, not trainees who have done rotations or brief training sessions with the mentor. For each trainee, outcomes should be clearly listed (K award, other independent funding, non-research academic faculty, non-independent research faculty, private practice, etc.). Applicants are encouraged to use the template table found at http://www.ninds.nih.gov/funding/areas/training_and_career_development/r-25-template-instructions.htm for this listing. The table should be uploaded as a PDF attachment to Item 6 “Inclusion Enrollment Report” of Section 2. Research Plan Attachments of the PHS 398 Research Plan Component.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS 398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan (Research Education Plan for R25 applications) component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. 

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program.  A justification must be included for sites other than the applicant institution in the program narrative.   

2.  SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources):  Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.  

3.  SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI (or multiple PDs/PIs, if applicable) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. Mentors should not be listed as Key Personnel.

4.  Research & Related Budget:  Complete for each budget period requested.

A.  Senior/Key Person: complete for all senior/key persons associated with the research education program.  The PD/PI (or multiple PDs/PIs, if applicable) must be included here.

B.  Other Personnel: complete for all other personnel (including mentors, clerical and administrative staff) associated with the research education program.

C.  Equipment: self-explanatory.

D.  Travel: include here any travel funds requested for participants associated with the research education program.

E.  Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program.  If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program.    Allowable categories include only salary, fringe, and travel for participants in the program. See Section IV.2 for more information.

F.  Other Direct Costs: itemize as appropriate and allowed for the research education program.

K.  Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section E, itemize each category of support costs per participant and justify.

5.  PHS 398 Research Plan Attachments:

Part 4 of this section (Preliminary Studies/Progress Report): Not applicable

Part 5 of this section (Research Design and Methods) should be retitled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director/Principal Investigator (or multiple PDs/PIs, if applicable): Describe arrangements for administration of the program, provide evidence that the Program Director(s) is actively engaged in research and/or teaching in an area related to the mission of the NINDS, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.

Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NINDS, and provide evidence of the training record of each participating faculty member.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., research, courses, curricula, seminars, workshops).

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program.  Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.

If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.  If the applicant department has an active T32 institutional training grant for the training of clinician-scientists, a detailed explanation should be provided that describes the distinction between the intended participants for this research education program and the target population for the T32 training grant.

Diversity Recruitment and Retention Plan:  Provide a detailed diversity recruitment and retention plan for the research education program.  Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period.  Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below.  For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate. 

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A.   Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

B.   Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.   Individuals from disadvantaged backgrounds who are defined as:

1.     Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.     Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.  Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NINDS, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged.  Applications that lack an evaluation plan will not be reviewed.

The primary indicator of success of these programs will be the ability of participants to successfully compete for individual fellowships, career development awards or research grants, and ultimately, the continuation of the participant’s research career. It is expected that applicants will publish original research papers that result from work during this research education period, but the most important outcome of this research education program will be the successful competition for individual funding by the participants. Any additional criteria for self-evaluation should be specified in the application.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with 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 and further the advancement of the 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 the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable

(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 (e.g., 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

(d) Research education programs: These programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.  There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness of the proposed software dissemination plan.  Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.  The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to this FOA 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 initial merit 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 training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.  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 education program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. These criteria are not listed in any order of priority.

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by scholarship and responsiveness to the priorities and/or changing needs of the Institute in meeting its objectives.  Applicants are strongly encouraged to contact the Institute program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact. Reviewers will provide an overall impact 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 proposed research education program address the goals of this FOA and the scientific/education mission of the NINDS? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NINDS?

Investigator(s).  Are the mentors appropriately trained and well suited to carry out this work? Is the experience level of the PD/PI (or multiple PDs/PIs, if applicable) and other mentors appropriate to successfully carry out the proposed program?  Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Is there evidence that the Principal Investigator is actively engaged in research, can organize and administer the program based on his/her qualifications, capabilities and experiences?  Does the Principal Investigator have a strong, recent history of NIH funding? If there are multiple departments and multiple principal investigators involved, do the principal investigators from each department have strong, recent histories of NIH funding? Do the mentors in the program have strong, recent histories of NIH or equivalent funding? Do the mentors have a track record in the successful training of clinician-scientists?  Have trainees from this department and from this group of mentors been successful in competing for independent fellowship, career development and/or research funding? Do the department and mentors have a record of mentoring career development (K) awardees, and have those with K awards in this department obtained academic research appointments and/or had successful research careers?

Innovation.  Is the research education program original and innovative?  Does this program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program. If the applicant department has T32 training programs, did the applicant clearly describe 1) the distinction between this research education program and the T32 training programs and 2) the distinction between intended participants of this research program and the intended population that would constitute trainees in T32 training programs?.

Approach.  Is there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?  Is the mentoring program well-reasoned, well-integrated and likely to lead to success in reaching the goals of this FOA?  Does the program foster development of a combined clinical and research career for the participants? Are there appropriate opportunities for participants to interact with each other and multiple mentors? Is there a plan for appropriate oversight of the individual mentors, and the education of each participant, in basic and clinical research areas, to maximize the potential of participants to obtain individual funding and continue in a research career?

For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PD/PIs?

Environment.  Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Does the Department or institutional unit where the proposed program will take place have a record of successfully training physician-scientists and/or transitioning physicians to successful competition for NIH career awards or other individual research awards?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

Evaluation Plan: Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?

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.

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 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 Agent 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).

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).

Dissemination Plan: Is the dissemination plan strong and of high quality?

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the Institute, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

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 NIH 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 Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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 Institute to the grantee 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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution:  The research education program may not be transferred from one institution to another.

Change of Program:  Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

3. Reporting

Awards made in response to this FOA are not subject to SNAP.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.

Evaluation:  In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results:  Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Stephen Korn, Ph.D.
Director of Training and Career Development
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2186
Bethesda, MD 20892-9535
Rockville, MD 20852 (for Express/Courier Service)
Telephone:  (301) 496-4188
Fax:  (301) 480-1080
E-mail:  korns@ninds.nih.gov

2. Peer Review Contacts:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3201
Bethesda, MD 20892-9529
Telephone:  (301) 496-9223
Fax:  (301) 402-0182
E-mail:  nindsreview.nih.gov@mail.nih.gov

3. Financial or Grants Management Contacts:

Ms. Tijuanna DeCoster, MPA
Grants Management Officer
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3258
Bethesda, MD 20892-9529
Telephone: (301) 496-9531
Fax:  (301) 402-0219
Email:  Tijuanna.DeCoster@ninds.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
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 (45 CFR 46) 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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; 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-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 (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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Part 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 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/.


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