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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 Child Health and Human Development (NICHD), (http://www.nichd.nih.gov )
National Institute for Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)

Title: Rehabilitation Research Career Development Programs (K12)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-HD-06-010

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.853

Key Dates

Release Date: April 17, 2006
Letters of Intent Receipt Date(s): August 22, 2006
Application Submission Date(s): September 22, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): May/June 2007
Earliest Anticipated Start Date(s): July 1, 2007
Expiration Date: September 23, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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 Objectives

This Request for Applications seeks applications to coordinate the mentoring and career development of rehabilitation researchers selected by the sponsoring institution in one of the following domains: allied health professionals, clinicians involved in neurological rehabilitation, or engineers. The program will be responsible for identifying qualified candidates as scholars in the program and supporting them in appropriate research environments throughout the country.

The NICHD anticipates making three awards for K12 programs; one in each of the following academic disciplines:

Background

Despite the increasing population of individuals coping with chronic disabilities at various levels, the field of medical rehabilitation has not responded sufficiently to the need for research to validate approaches, optimize treatments, and incorporate new technologies and opportunities. Unprecedented opportunities exist to explore the biomedical, behavioral, and social bases for rehabilitative strategies and their application to appropriate populations. One of the earliest priorities of the NICHD s National Center for Medical Rehabilitation Research (NCMRR) has been the training of research scientists in the field of rehabilitation. There now exists critical masses of successful investigators in allied health, neurological rehabilitation (e.g., neurology, neuropsychology, neurosurgery, and physical medicine and rehabilitation), bioengineering, and related fields, who can recruit and train promising young rehabilitation researchers through national mentoring programs.

Through the career development programs described here, NCMRR and its NIH partners are seeking to attract and support a broad cohort of basic and clinical investigators for research on improving the lives of people with chronic physical disabilities. Research goals include the development of strategies to minimize tissue pathophysiology and secondary complications, to facilitate tissue plasticity and regeneration, to support behavioral and psychosocial adaptation, and to promote and integrate assistive technologies. Research is also needed to develop better treatments for clinical conditions such as chronic pain, weakness and paralysis, spasticity and tremors, problems with balance, coordination, and gait, and sensory and autonomic dysfunction. Behavioral and psychosocial studies are needed to promote cognitive rehabilitation and psychosocial support, understand the role of environmental factors, increase participation, and improve quality of life. Special research is also needed for understanding rehabilitative issues specific to pediatric populations. Children are more dependent on family and environmental factors and react differently to trauma, pharmacological compounds, and physical interventions. While the developing brain has a greater degree of vulnerability, it has higher potential for plasticity and recovery. Bioengineering research must continue to improve the use of orthotics, prosthetics, robotics, and other assistive devices for people with disabilities. Other opportunities include the innovative use of functional stimulation and brain imaging technologies. Rehabilitation also needs improved diagnostic and prognostic measures; better ways to assess function, impairment, and disability; and broader measures of participation, health care utilization, and quality of life.

Goals

The proposed institutional career development programs in these three areas are intended to promote networks with clinical and academic departments in order to provide a greater capacity for attracting and nurturing new investigators by building on current departmental resources and research infrastructure as well as national links among researchers and professional organizations.

Successful scholars trained under this program may seek advanced mentored development through individual K awards or proceed directly to developing independent research programs (e.g., R03, R21, or R01 grants).

The Institutional Career Development program shall be responsible for:

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Institutional Mentored Research Scientist Development Program (K12) award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed program.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NICHD intends to commit approximately $1.5 million total costs [direct plus facilities and Administrative (F & A) costs in FY 2007 to fund three new grants in response to this RFA. The NINDS plans to provide an additional $100,000 funding only for projects that are considered programmatically important to their mission.

An applicant may request a project period of up to five years and a budget for direct costs up to $600,000 in the initial year and up to $1.1 million direct costs annually for years two through five. Awards are anticipated to start in July, 2007.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

[Foreign institutions are not eligible to apply]

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. In addition, the individual should have a doctoral degree in the appropriate discipline and relevant experience in research, mentoring, and administration.

2. Cost Sharing or Matching

Not applicable

3. Other-Special Eligibility Criteria

Program Director: The Program Director must be a senior faculty member who is knowledgeable about medical rehabilitation research, has a record of success in laboratory and/or clinical investigation, and demonstrated skill in mentoring and career development. Up to 1.2 calendar months (i.e. 10% effort) is allowed, and the Principal Investigator may also be the Program Director.

Deputy Director and Administrative Staff: A Deputy Director must have the expertise and experience essential to complement the Program Director. Up to 1.2 calendar months (i.e. 10% effort) is allowed. A recruitment officer must have demonstrated experience in the selection of scholars who will enhance participation in the program, giving full consideration to women, individuals from underrepresented racial and ethnic populations, individuals with disabilities, and individuals from disadvantaged backgrounds. A part-time administrative/clerical assistant whose duties are specifically designed to assist the Principle Investigator and/or the Program Director in the coordination and administration of the K12 program is also allowed. Limited funds are available for both the recruitment officer (up to 10% effort) and the administrative assistant (up to 50% effort).

Advisory Committee: Individuals selected must be scientists and clinicians who have interest and expertise in medical rehabilitation research.

Mentors: Mentors must be tenured faculty (or their equivalent) who have established records of research productivity and active grant support, preferably from the NIH, in areas of basic, applied, and translations research relevant to medical rehabilitation.

Candidate Scholars: As part of its recruitment efforts, the program should make every effort to broadly advertise career development opportunities and to provide information on prospective mentors. The program is required to seek out qualified women, individuals from underrepresented racial and ethnic groups, persons with disabilities, and individuals from disadvantaged backgrounds. In general, candidates should be no more than three years beyond their postdoctoral (therapists and engineers) or fellowship (clinicians) training when they enter this program. An individual who has previously served as Principal Investigator on an NIH research grant (e.g., R01, R21, R03), subproject of program project (P01) or contract (N01) may not be considered for further mentoring through this program.

Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be submitted on or before the receipt date described below (Section IV.3.A).

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): August 22, 2006
Application Submission Date(s): September 22, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): May/June 2007
Earliest Anticipated Start Date: July 1, 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Ralph Nitkin, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Rockville MD 20852 (for courier/express service or non-USPS delivery).
Telephone: (301) 402-4206
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01,
MSC 7510 Bethesda, MD 20892-7510
Rockville MD 20852 (for courier/express service or non-USPS delivery).
Telephone: (301) 496-1485
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

The Career Development program shall be responsible for:

The K12 award provides five years of funding to the applicant organization to support a national mentoring program. The Program Director, in consultation with the Advisory Committee, shall define the application process, review candidate scholars , make appointments to qualified individuals, and monitor progress.

While a consortium of any of the eligible organizations is allowed, the applicant organization must be the primary site for this institutional career development mentoring program. Any consortia arrangement plan must be clearly documented in the application, with respect to the specific individuals involved, the expertise and guidance to be provided not available at the sponsoring institution, the scientific advantages of off-site involvement, arrangement for the monitoring of the scholars progress, etc.

For each candidate scholar, the four to five year career development program consists of two phases.

In Phase I, the scholar receives two to three years of intense training in a basic science discipline with an established mentor scientist at the mentor s institution. In conjunction with the mentor, the scholar develops a research and career development plan, which will be reviewed annually by the program. Phase II begins with the transition to independent investigator status. The program will assist with placement in a sponsoring department and continue to monitor progress and provide support as necessary.

During Phase II (generally two to three years), individuals should be supported by independent research grants, departmental funds, and possibly even clinical duties but not directly from the K12 grant. It is expected that academic departments associated with this program will make a strong commitment to supporting individuals as they reach Phase II, including faculty positions and the provision for protected research time.

A. Principal Investigator

The Principal Investigator should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a national, multidisciplinary research-mentoring program. The Principal Investigator is responsible for appointing the Program Director and members of the Advisory Committee (see below), using their recommendations to determine the appropriate allotment of funds for career development. The Principal Investigator may not receive salary or fringe benefit support from the grant for this role per se, but may receive financial support for additional roles in the program (e.g., as Program Director).

B. Program Director and Administrative Staff

The Program Director has responsibility for the day-to-day administration of the program, and may receive up to ten percent support from the K12 grant. The Principal Investigator may also serve in the role of Program Director, and can receive appropriate remuneration for this role. The Program Director must be a senior faculty member who is knowledgeable about medical rehabilitation research, has a record of success in laboratory and/or clinical investigation, and demonstrated skill in mentoring and career development. In addition, a Deputy Director may be designated provided that individual has a complementary role to that of the Director. The Deputy Director may request an additional 1.2 calendar months (i.e. 10% effort from the K12 grant. The program may also incorporate a grant-supported part-time administrative/clerical assistant with responsibilities distinctly associated with this K12 program . In addition, limited funds may be provided for a well-qualified recruitment officer (up to 1.2 calendar months, i.e. 10% effort) to enhance participation in the program by women, underrepresented minorities, individuals with disabilities and individuals from disadvantaged backgrounds.

C. Advisory Committee

The Advisory Committee, chaired by the Principal Investigator, is a select group of scientists and clinicians who have interests and expertise in medical rehabilitation research. The committee may include potential mentors and advocates of the rehabilitation community, as appropriate. The Advisory Committee evaluates all applicants to the program, monitors progress of current candidates, and provides direct feedback to individuals as appropriate.

D. Mentors

Mentors shall be tenured faculty (or their equivalent) who have an established record of research productivity and grant support (preferably from the NIH) in areas of basic, applied, and translational research relevant to medical rehabilitation. Generally, they will be researchers and clinicians from allied fields, whose particular expertise is needed to support certain career research goals. Linkages to other departments should be encouraged, as they enhance the breadth of this mentoring program and the promotion of medical rehabilitation research in general. Although mentors must demonstrate a commitment to potential candidates and the overall goals of the program, they cannot receive salary, fringe benefits, or research support for this role from the K12 grant. However, provisions are made to support the research activities of particular K12 candidates within their laboratories, as described below. Mentors may be added to the roster of the program as appropriate, with NCMRR staff approval. It is expected that institutions that support candidates in Phase I make a strong commitment to supporting these candidates in Phase II when they seek positions as independent investigators.

E. Candidate Scholars

Prospective eligible scholars should be encouraged to contact potential mentors prior to formally applying to program, and should be strongly discouraged from remaining at the institution of their graduate training or residency. When possible, the program should support career development in those areas of research that would have the most impact on the emerging field of medical rehabilitation. Candidates selected as scholars must make a commitment to the program for four to five years, spanning both Phase I and Phase II. Upon entering the program, candidates should develop, in conjunction with their primary mentor, a long-range research and career development plan.

During Phase I, at least 9 calendar months (i.e. 75 %) of the scholar’s time/effort must be devoted to research activities supported by the program. Provided they are making appropriate progress as judged by the Advisory Committee, scholars may be renewed annually for up to the total allowable three years of Phase I support. Toward the end of the second year, scholars should be strongly encouraged to seek outside grant support and external funding as they transition to independent researcher positions in sponsoring institutions.

Phase II scholars will remain associated with the program for another two to three years, submitting yearly progress reports and attend annual meetings. However, they should develop independent and stable means of research support outside the K12 grant. It is expected that their departments provide at least 50 percent - and preferably 75 percent - protected time for research activities during this period. Total mentored support under the K12 program may not exceed five years. While it is expected that Phase II candidates will have their own travel funds, in the absence of adequate support they may request funds from the K12 program to attend the annual K12 workshop.

During Phase I or II, scholars may engage in brief research activities at another institution if it is directly related to the purpose of the award. Periods of leave from the program for greater than two months, whether for professional or personal reasons will be considered as unpaid leave and will require prior written approval from the NICHD.

Special Budgetary Requirements

The Administrative core may include salaries and support for a Program Director and Deputy Director (up to 1.2 calendar months, i.e. ten percent effort each), a part-time administrative/clerical assistant (up to 6 calendar months , i.e. 50 percent effort), and a recruiting officer (up to 1.2. calendar months, i.e. ten percent effort each). The Core may also include up to $15,000 per year for supplies, equipment, and other expenses specific to the administration of this program. Travel of Principal Investigator, Program Director, and Deputy Director to annual K12 meetings may also be included. The core may include up to $30,000 per year to cover modest expenses and travel for members of the Advisory Committee and other mentors participating in the annual workshops. Funds for prospective scholars should be listed under Other Expenses, with indication of the number of positions requested and to what extent these funds will be used for salaries.

Individual scholars are eligible for up to $75,000 per year in salary, consistent with their institution’s salary scale; this may not be supplemented with other Federal funds unless specifically authorized by that Federal program. For each scholar, up to $10,000 per year in additional funds may be budgeted each year to defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by the scholar’s research in the laboratories of the established investigators who serve as mentors. In specific cases, grant funds may also be used for tuition and fees related to career development, in accordance with established policies of the sponsoring institutions for such positions. For each scholar, up to $3,500 per year in travel funds may be budgeted to attend annual program functions and other professional meetings. Total awards to individual scholars need not be equal across these different budget categories. Salary and research expenses are not appropriate for Phase II candidates; however, the K12 grant may provide travel funds to allow them to attend annual K12 meetings.

F. Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. 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, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

G. Evaluation

In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, awardee institutions are hereby notified that candidates may be contacted after the completion of their career development experiences for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Facilities and administrative costs on K12 awards are limited to eight percent of applicable direct costs.

Items that may NOT be supported with K12 grant funds include:

1. Direct salary, fringe benefits, or research support of the mentors beyond those laboratory expenses directly attributable to the scholar’s project;

2. Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges and not directly attributable to a specific award;

3. Salary and support for administrative activities such as institutional public relations or health and educational services;

4. Travel of the Principal Investigator, the Program Director, Deputy Director, or other established investigators to scientific meetings beyond those associated with and directly related to the administration of the Rehabilitation Research Career Development Program;

5. Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the candidate’s research;

6. Alterations and renovations

The above listing is not necessarily all inclusive. Any questions regarding allowable costs that may be charged to the K12 program should be directed to the NICHD Grants Management Contact listed in Section VII. 3.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

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

Applications that are complete and responsive to the RFA will be evaluated for mentoring potential, administrative oversight, and potential impact on the rehabilitation research community by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below:

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

Review Criteria

The application for a K12 institutional career development program must address the significance, approach, innovation, director/leadership and environmental aspects of the overall program.

The following specific areas must be adequately addressed and documented in the application:

1) Probable impact of the proposed career development program on the development of well-qualified medical rehabilitation investigators, advancement of rehabilitation research, and the application of basic research developments to significant clinical problems. Are the program design, methods, and strategy plans adequate to meet the intent of the program?

2) Scientific expertise, research experience, leadership, and administrative capabilities of the Principal Investigator.

3) Qualifications of the Program Director and Deputy Director (if proposed) and appropriateness of Administrative Staff.

4) Appropriateness of Advisory Committee and plans for oversight, evaluation, and feedback.

5) Commitment of a broadly-based and productive network of potential mentors to meet the needs of candidates and support the goals of the career development program, especially in research areas relevant to current NICHD interests and programmatic needs.

6) Evidence for the availability of a pool of prospective candidate scholars, who could benefit from participation in this program and are likely to develop into productive independent researchers.

7) Evidence of a sound and equitable evaluation and tracking system for evaluating candidates and monitoring their research progress and career development.

8) Availability of potential faculty positions at participating institutions for investigators mentored by this program with strong evidence of institutional commitment to these individuals as they become independent investigators.

9) If applicable, an adequate description and justification for any consortia arrangements for the scholars

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed career development goals may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the program proposed? Is each budget category realistic and justified in terms of the aims and methods?

Minority Recruitment and Retention Plan: Novel mechanisms for recruiting qualified individuals from under-represented racial and ethnic groups, individuals with disabilities and individuals from disadvantaged backgrounds, and for connecting them with potential mentors.

Training in the Responsible Conduct of Research: Appropriateness of guidelines for promoting mentoring, didactic interactions, career development, and education in the responsible and ethical conduct of research.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

Not Applicable

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Special Administrative Requirements (standard information for K programs)

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Suggest the author consider adding:

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:

Ralph Nitkin, Ph.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Rockville MD 20852 (for courier/express service or non-USPS delivery).
Telephone: (301) 402-4206
Email: [email protected]

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01,
MSC 7510 Bethesda, MD 20892-7510
Rockville MD 20852 (for courier/express service or non-USPS delivery).
Telephone: (301) 496-1485
Email: [email protected]

3. Financial or Grants Management Contacts:

Christopher Robey
Grants Management Team Leader
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A17K, MSC 7510
Bethesda, Maryland 20892
[Rockville MD 20852 for courier/express service or non-USPS delivery]
Telephone: (301) 435-6996
Fax: (301) 480-4783
E-Mail: [email protected]

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 (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.

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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices


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