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: Career Development Award to Promote Diversity in Neuroscience Research

Announcement Type
This is a reissue of PAR-02-106.

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

Program Announcement (PA) Number: PAR-05-071

Catalog of Federal Domestic Assistance Number(s)
93.853

Key Dates
Release Date: March 18, 2005
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: New Date January 8, 2009 (per issuance of PAR-09-065) Original Expiration Date: December 2, 2008, changed to January 8, 2010 per NOT-OD-08-069)

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(s) of Support
    2. Funds Available

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

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

  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
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The purpose of the Career Development Award to Promote Diversity in Neuroscience Research is to support an intensive, supervised career development and scientific mentoring experience for promising junior investigators to obtain research independence during the performance period of the award. The proposed career development experience is expected to substantially contribute to the research capabilities of the applicant, and research should be in an area of interest to the NINDS. Presently, there is an underrepresentation of certain racial and ethnic minorities, individuals with disabilities, and individuals from disadvantaged backgrounds in biomedical and behavioral research careers. For example in surveys conducted by the Association of Neuroscience Departments and Programs (http://www.andp.org/), racial and ethnic minorities represented only 5-9% of the total U.S. tenure-stream neuroscience faculty from 1986 to 2003. It is envisioned that funding support from the Career Development Award to Promote Diversity in Neuroscience Research will bolster efforts to address this underrepresentation, and increase the total pool of well-trained researchers and health professionals who are competitively funded to conduct neuroscience research. The objective of the Career Development Award to Promote Diversity in Neuroscience Research is to increase the representation of racial and ethnic minorities, individuals with disabilities, and individuals from disadvantaged backgrounds in the neuroscience research workforce. To achieve this objective, the Career Development Award to Promote Diversity in Neuroscience Research will support an intensive, supervised research career development experience for underrepresented career neuroscientists that will provide them with the skills necessary to develop competitively funded and independent research programs.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Mentored Research Scientist Development (K01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm). 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

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 receipt of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Salary up to $85,000 per year plus related fringe benefits will be provided. A research allowance of up to $50,000 per year will be provided. The project period may be 3, 4, or 5 years and will depend upon the number of years of prior research experience, and the need for additional experiences to achieve independence. Awards are not renewable.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

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 programs.

Junior neuroscience investigators eligible for this award include only those individuals making the transition to an independent scientific career at the senior post-doctoral and junior faculty stages. For all individuals, the institution must demonstrate that the applicant will have the academic title, space and other resources necessary to apply for independent funding during the period of award (see Section 3 below ). In the case of a graduate student who is making the transition directly to a faculty position, a doctoral degree (Ph.D., M.D., D.Sc., etc.) must have been received by the time the K01 award is made.

For the purpose of this announcement, institutions are encouraged to identify candidates who will increase diversity within the neuroscience workforce on a national or institutional basis. The strength of an institution's description and justification for the appointment of an identified candidate will be judged along with all other aspects of the proposed experience (see review criteria in Section V.1.) As discussed, the NINDS is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

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 and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution are eligible for support under this program.

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

C. Individuals from disadvantaged backgrounds which 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 candidates 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. 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. Eligibility related to a disadvantaged background would be difficult to justify for individuals beyond the level of high school and undergraduate, and thus will be very difficult to justify for the career stages eligible under this announcement.

A person who has been principal investigator on a Public Health Service (PHS) research grant, career development award or who has had equivalent research support is not eligible for this award. The only exceptions to this rule are R03 and R21 grants. In addition, individuals who are in training status and are being supported by National Research Service Awards (NRSA) are eligible to apply, however, they may not activate the Career Development Award to Promote Diversity in Neuroscience Research until the NRSA research training program has been completed or terminated.

Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Non-citizen 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 for this award.

2. Cost Sharing or Matching

Cost sharing not required for this funding announcement

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

This award is intended for persons who plan to pursue careers in the neurological sciences and applies to all areas of research supported by NINDS.

The NINDS requires that applicant institutions demonstrate a commitment to providing the environment and resources needed for junior investigator applicants to pursue successful careers as independent academic researchers in neuroscience. It is anticipated that K01 awardees will apply for independent funding during the course of their award. Institutions sponsoring them must provide the resources required to do so.

The level of institutional commitment, as described above, will be considered during review.

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) 435-0714, Email: GrantsInfo@nih.gov.

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 mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not Applicable
Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required. However, applicants are encouraged to contact the program officials listed at the end of this announcement for any questions concerning the program.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

In order to facilitate the review of applications, the applicant should, at the same time, submit two copies of the application to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: nindsreview.nih.gov@mail.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the National Institute of Neurological Disorders and Stroke (NINDS).

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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

A recent NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject. The K-award recipient must be the named Principal Investigator on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). The policy is effective for competing research grant applications submitted for February 1, 2004 and beyond.

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.

The NINDS will provide up to $85,000 per year for salary support. The grantee institution may supplement the NINDS salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be provided from Federal funds unless specifically authorized by the Federal program from which such funds would be derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award, i.e., full-time commitment to supervised research and related activities. Individuals receiving salary support under the Career Development Award to Promote Diversity in Neuroscience Research are employees of the grantee institution and are subject to its established personnel policies dealing with professional status, title, salary, and related staff privileges and obligations. The salary proposed must be consistent with the established salary structure for full-time, 12-month staff appointments at the grantee institution.

Fringe Benefits are paid out of grant funds in proportion to the salary contribution. Practices related to payments of fringe benefits shall be consistent with grantee institution policies and not be altered for these awards.

In addition to salary support, funds up to $50,000 direct costs in the aggregate may be requested for each year to support research and/or career development activities. The support for research activities is intended to enable the awardee to conduct research until regular research support can be obtained. Research costs include equipment, laboratory supplies, research assistants, and travel to scientific meetings and research workshops.

Career development costs may include travel, per diem, tuition, or fees for study at centers other than the grantee institution. Funds requested must be carefully justified for each year and must be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for mentors, secretaries and administrative assistants is not allowed.

Applicants may request up to 8% of direct costs for Facilities and Administrative Costs (F&A). F&A costs are not provided on tuition and related fees or on equipment expenditures.

6. Other Submission Requirements

A. Mentor

Candidates must name a primary sponsor (or mentor), who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. The mentor's role involves a substantial commitment of time on behalf of the candidate; therefore, persons with extensive administrative responsibilities (e.g., chairpersons, deans) should not be selected as mentors without adequate justification.

Candidates may choose more than one mentor; additional mentors may be at the candidate's institution or elsewhere within the United States, if a strong case is made for their contribution to the research career development of the candidate. The principal mentor should be in the candidate's home institution or be available locally. The typed name and signature of the principal mentor should appear at the end of the mentor's statement. "Per" signatures are not acceptable. Mentors are not funded for their role on the award. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

B. Duration of Award

The award provides three to five consecutive 12-month awards. Because of the focus on progression to independence as a researcher, candidates for the Career Development Award to Promote Diversity in Neuroscience Research should propose a period of study and career development taking into consideration their previous research experience. For example, a candidate with limited experience in the proposed field of research may find a phased developmental program lasting five years the most efficient means of attaining independence. This period could include a designated period of didactic training followed by a period of closely supervised research. A candidate with previous research experience in a related field may not require extensive additional didactic preparation and a program that focuses on an intensive, supervised research experience may be appropriate. All programs must be tailored to meet the individual needs of the candidate ensuring that he/she will gain the skills and knowledge necessary to carry out high quality health-related research. Awardees may not apply for another mentored award at the conclusion of their support.

C. Time and Effort

Recipients of this award must devote full time (at least 75 percent of a full time 12 month position) to career development activities, research, or other research-related activates relevant to their career goals. Activities such as participation in workshops, scientific meetings, or academic activities are encouraged if they contribute to the purpose of the award. The Career Development Award to Promote Diversity in Neuroscience Research will only support clinical practice or clinical training that is required to complete the scientific and/or career development objectives described in the application

D. Concurrent Application

At the time of application submission, a candidate for the Career Development Award to Promote Diversity in Neuroscience Research may not concurrently apply for any other PHS grant, nor may there be another application pending funding. However, awardees may apply for another PHS grant after the award is made. In fact, it is expected that awardees seek independent extramural research support (e.g. R01) by the end of the award period.

E. Training in the Responsible Conduct of Research

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions 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 regard 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.

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(Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

The following will be considered in making funding decisions:

Applications for this mentored research career development award will also be reviewed for the candidate's potential to develop into a productive neurological sciences researcher. Reviewers will consider:

1. Qualifications of the Candidate

2. Career Development Plan

3. Research Plan

4. Qualifications and Appropriateness of Mentor/Co-Mentor

5. Environment and Institutional Commitment

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

Quality of the proposed training in the responsible conduct of research.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data
Not Applicable

2.D. Sharing Research Resources
Quality of the proposed plan for sharing research resources.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

NGAs are sent via e-mail to the office of the Administrative Official named in item 14 on the Face Page of the PHS 398 application form, or may be retrieved by the institution through its NIH eRA Commons account. If a grantee is not e-mail enabled, a hard copy of the NGA will be mailed to the administrative official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 notice of grant award. 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).

A. Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation.  Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892.   Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

B. Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.  Only local institutional approval is required if such leave does not exceed 3 months.  For longer periods, prior written approval of the NIH funding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.) 

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the K01 award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50 percent effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

C. Termination or Change of Institution

When a grantee institution plans to terminate an award, the NINDS funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.

Career Development Award to Promote Diversity in Neuroscience Research awards are not transferable to another individual but may be transferred to another institution. In the latter case, the awardee must contact the responsible NINDS Program Director to fully discuss the circumstances of the transfer, and must subsequently provide a written justification and rationale for the transfer. The period of support requested can be no more than the time remaining within the existing original award project period. Further, no transfer will be allowed for awards with less than six months remaining in the project period. T he retention of such pay should be consistent with the policies and practices of the grantee institution.

D. Changes in Research or Career Development Program

Consultation with appropriate NINDS staff listed in Section VII. Agency Contacts, prior to proposing and implementing significant changes in the supported research or career development program is strongly encouraged.

Individual awards are made for career development at a specific institution in a specific research program.  A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

If it becomes necessary to replace a mentor due to extenuating circumstances, the institution must submit a letter from the proposed mentor and K01 awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for your continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. NINDS program staff will evaluate the request and will notify your institution of the results of the evaluation.

A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

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.

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:

David A. Jett, Ph.D.
OMHR
National Institute of Neurological Disorders and Stroke
NSC 2150
6001 Executive Blvd.
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-6035
FAX: 301-594-5929
Email: jettd@ninds.nih.gov

2. Peer Review Contacts:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

3. Financial or Grants Management Contacts:

James Washington
Grants Management Branch
National Institute of Neurological Disorders and Stroke
NSC 3248
6001 Executive Blvd.
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7449
Email: washingJ@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 (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 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.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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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