Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov/)
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
Office Dietary Supplements (ODS) (http://ods.od.nih.gov)

Title: Mentored Quantitative Research Development Award (K25)

Announcement Type
This is a reissue of PA-02-127 which was previously released July 10, 2002.

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

• December 12, 2008 - This PA has been reissued as (PA-09-039).
• September 18, 2008 - See Notice (NOT-MH-08-017) NIMH Policy Update for Career Awards.
• May 16, 2008 - See Notice (NOT-OD-08-069) Due to the upcoming receipt dates for several FOAs using these mechanisms, their expiration dates are being extended.
• October 10, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.
• September 20, 2006 - See Notice NOT-DA-06-013 NIDA Policy Update Mentored and Career Development (K) Awards.
• August 25, 2006 - See Notice NOT-NS-06-011 NINDS Guidelines for K25 Mentored Quantitative Research Career Development Award.

Key Dates
Release Date: December 2, 2005
Letters Of Intent Receipt Date(s): Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available (URL Activation Date): Not applicable
Expiration Date: January 8, 2009 (per PA-09-039) - Previously: January 8, 2010 (per NOT-OD-08-069) - Previously: May 8, 2009 (per NOT-OD-07-093) - Originally: February 1, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• The goals of NIH-supported research training and career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. NIH mentored career development awards provide mentored research experiences to gain additional expertise in a new research area or in an area that will significantly enhance an investigator’s research capabilities. It is expected that the mentored research and career development experience will lead to an independent and productive research career.
  
  
• The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease.
  
  
• The K25 award will provide support and protected time for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research.
  
  
• A K25 application may be submitted on behalf of the candidate (principal investigator) by a domestic for-profit or non-profit institution/organization, or a public or private institution, such as a university, college, hospital or laboratory. Foreign institutions are not eligible to apply.
  
  
• Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence, who hold advanced degrees in a quantitative area of science or engineering, and have demonstrated research interests in their primary quantitative discipline.
  
  
• Awards are not renewable, nor are they transferable from one principal investigator to another.
  
  
• Candidates must make a commitment of at least 75% of full-time professional effort to research and research career development activities specified in the application consistent with the overall purpose of the award. Receipt of prior support may impact on eligibility.
  
  
• A candidate must demonstrate and justify the need for a three, four, or five-year period of additional supervised research experience. Planning, direction, and execution of the proposed career development program and research project will be the responsibility of the candidate and mentor.
  
  
• The candidate should provide a plan and proposed timeline for achieving independent research support by the end of the award period.

• The total amount to be awarded and the number of anticipated awards will depend upon the quality, duration, and costs of the applications received as determined by the peer review process, available funds and program priorities.
  
  
• The candidate for this K25 award may not concurrently apply for or have an award pending for another NIH career development award. Up to two revisions of an application will be accepted.
  
  
• Applications must be submitted on or before the submission dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.
  
  
• Special Note: The participating NIH ICs may have distinctive guidelines, requirements, salary and research support levels provided under the auspices of this program announcement in order to accommodate the career development needs of researchers working in fields related to their specific research missions. Candidates are therefore strongly encouraged to contact the staff person in the relevant Institute or Center listed under Section VII prior to preparing an application to discuss issues of eligibility, program relevance, and to review the specific provisions of this program.
  
  
• See Section IV for application and submission information.
  
  
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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. 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

1. Research Career Objectives

A particular area of research is often invigorated by novel perspectives that may be provided by individuals trained outside that research arena. In an effort to advance research relevant to the mission of the National Institutes of Health (NIH; which includes basic biomedical, clinical biomedical, bioengineering, bioimaging, and behavioral research), the participating Institutes and Centers solicit applications for the Mentored Quantitative Research Career Development Award (K25). The K25 mechanism is meant to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. Examples of quantitative scientific and technical backgrounds considered appropriate for this award include, but are not limited to: mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry, and engineering. Potential applicants are strongly advised to contact the appropriate NIH staff member identified in Section VII (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm) to discuss their particular circumstances and quantitative backgrounds before developing an application.

The K25 Award will support the career development of quantitatively trained investigators who make a commitment to basic or clinical biomedicine, bioengineering, bioimaging or behavioral research that is relevant to the NIH mission. This award provides support for a period of supervised study and research for productive professionals with quantitative backgrounds who have the potential to integrate their quantitative expertise with NIH-relevant research and develop into productive investigators. The K25 program is intended for research-oriented investigators from the postdoctoral level to the level of senior faculty.

The NIH is especially interested in increasing the number of scientists trained to conduct high-quality research that combines insights derived from, and cuts across, different scientific, technical, and biomedical areas. Accordingly, the Mentored Quantitative Research Career Development Award forms an important part of an initiative to attract talented individuals with highly-developed quantitative skills to the challenges of research relevant to the mission of NIH. This initiative is consistent with the recommendations of the Bioengineering Education and Training Panel which was convened as part of the 1998 Bioengineering Consortium (BECON) Symposium (the symposium report is available at http://www.becon.nih.gov/becon_symposia.htm).

The Mentored Quantitative Research Career Development Award is intended to increase the availability of high-quality, multidisciplinary, didactic training and research project guidance, in the context of a mentored research career transition experience. Candidates interested in cross-disciplinary research will become well grounded in behavioral, biomedical, bioimaging, or bioengineering research. At the completion of the award, candidates should have both the knowledge and the skills necessary to compete for independent research support from NIH, or to participate as leading members of multi-disciplinary research teams.

The specific objectives of the Mentored Quantitative Research Career Development Award (K25) are to:

• Encourage research-oriented quantitative scientists and engineers with little or no experience in biomedicine, bioengineering, bioimaging, or behavioral research to gain fundamental knowledge in these areas and develop relevant research skills, and to gain experience in current concepts, advanced methods, and experimental approaches that will allow them to conduct basic or clinical biomedical, behavioral, bioimaging, or bioengineering research, and to become independent investigators or play leading roles in multi-disciplinary research teams.

• Increase the pool of quantitative researchers who can conduct biomedical, behavioral, or bioengineering studies, capitalizing on the quantitative backgrounds of these investigators to inform new directions in biomedical, behavior and bioengineering research.

• Provide a unique opportunity for candidates holding degrees in quantitative science or engineering to embark on three to five years of special study, including course work, seminars, meetings, and mentored research, to achieve the career enhancement goals outlined above.

Because of the focus on a progression toward independence as a quantitative biomedical, behavioral, bioimaging, or bioengineering researcher, the prospective candidate for the Mentored Quantitative Research Career Development Award will require enhanced skills in the experimental, theoretical and conceptual approaches used in biomedicine, behavioral science, bioimaging or bioengineering. To satisfy this requirement, the candidate should propose a period of study and career development that is complementary to his or her previous research and experience. For example, a candidate with no or very limited experience in a given field of biomedical research may find a phased developmental program lasting for five years that includes a designated period of didactic training together with a closely supervised research experience the most efficient means of attaining independence. A candidate with, for example, more research experience in biomedicine may benefit from a program with greater emphasis on appropriate laboratory research with lower levels of supervision and direction. All programs should be carefully tailored to meet the individual needs of the candidate and must include (an) active mentor(s) who is (are) competent and willing to provide the appropriate research guidance.

Candidates should strongly consider incorporating into their training plan formal courses in relevant areas of biomedicine, behavioral science, bioimaging, or bioengineering; this program offers a unique opportunity to devote protected time to this activity.

The candidate must devote a minimum of 75% of full-time professional effort to the goals of this award. The remainder may be devoted to teaching or other research pursuits consistent with the objectives of the award. Both the didactic and research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.

All research career development programs must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. Applicants must justify the need for this award and provide a convincing case that the proposed period of support will substantially enhance their careers as independent investigators in their chosen area of quantitative research. The sponsoring institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator.

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

1. Mechanism(s) of Support

This funding opportunity will use the NIH K25 award mechanism. As an applicant, the candidate and his/her mentor will be jointly responsible for planning, directing, and executing the proposed project and career development activities.

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). The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs for each year and the entire proposed period of support and budget justification information.

The K25 project period may be for up to five years, with a minimum of three years required. Awards are not renewable and are not transferable from one principal investigator to another.

2. Funds Available

The total amount to be awarded by the participating ICs and the number of awards will depend upon the quality and merit of applications received, program priorities, and the availability of funds.

Because the nature and scope of the proposed research career development program will vary from application to application and the amounts provided by the participating ICs are not uniform, it is anticipated that the size and duration of each award will also vary. Awards include funds for salary, fringe benefits, and research development costs.

Allowable Costs:

Salary: The participating NIH ICs will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12-month staff appointment. The award requires the candidate to devote a minimum of 75% of full-time professional effort to conduct the research career development plan described in the application, the remainder may be devoted to teaching, or other research pursuits consistent with the objectives of the award. For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary.

NIH awarding ICs provide support ranging from ($75,000 to $180,100) to help offset the full-time salary requirements of the candidate. Salary limits on career awards are not uniform throughout the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted, to ascertain the possible maximum contribution to the candidate’s salary. See (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-87_contacts.htm).

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution’s salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the K25 award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution’s salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-023.html

Effective for all new competing research project grant applications, mentored career award recipients in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director on the research project grant. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html

Research Development Support: NIH ICs provide support ranging from ($20,000 to $50,000) per year for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Research development support limits on career awards are not uniform throughout the NIH. Therefore, prospective candidates should contact the NIH component to which the application is targeted to ascertain the maximum contribution for research and development support. See (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm).

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

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 and career development activities is invited to work with his/her mentor and sponsoring 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. However, for the NIH K25 program, the following eligibility requirements apply to individuals who seek to become Mentored Quantitative Research Career Development Award recipients (Principal Investigators).

Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who possess an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. 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.

Candidates must have an advanced degree in a quantitative area of science or engineering (M.S.E.E., Ph.D., D.Sc., etc.) and have demonstrated research interests in their primary quantitative discipline. They must identify a mentor with extensive behavioral, biomedical, bioengineering, or bioimaging research experience. Candidates must commit at least 75% effort to research and research career development and the remainder of the effort to other career development activities consistent with the overall purpose of the award.

Former principal investigators on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, K01, K08, K22 or K23 awards, or the equivalent are not eligible. Former principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), or SBIR/STTR (R41, R42, R43, R44) remain eligible. A candidate for the Mentored Quantitative Research Career Development Award may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. Mentored Quantitative Research Career Development Award recipients are strongly encouraged to apply for independent research grant support, either Federal or private, during the latter period of this K25 award.

The award is intended for research-oriented investigators at any level of experience, from the postdoctoral level to senior faculty level, who have shown clear evidence of productivity and research excellence in the field of their training, and who would like to expand their research capability, with the goal of making significant contributions to behavioral, biomedical (basic or clinical), bioimaging or bioengineering research that is relevant to the NIH mission

Candidates must identify mentor(s) with extensive and appropriate research experience for the proposed research development plan. The mentor must have basic or clinical biomedical research qualifications in the research area proposed, as well as experience as a research supervisor.

Candidates must commit a minimum of 75% of full-time professional effort conducting research career development and research activities associated with this award. The remaining 25% effort must be committed to other career development activities consistent with the overall purpose of the award, i.e., the candidate's development into an independent investigator. The candidate must have a full time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution .Candidates with VA appointments should contact the staff person in the relevant NIH ICs prior to preparing an application to discuss their eligibility. See (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm).

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

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

A candidate for an NIH K25 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K01, K07, K08, K18, K22, K23, K24) or any PHS award that duplicates any of the provisions of the K25 award. Current principal investigators on NIH career awards are not eligible.

Special Requirements:

Each research career development program must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career development program. It is anticipated that a K25 awardee will apply for independent funding during the latter period of this award, and that the sponsoring institution will provide the resources required for them to do so.

Key elements and common aspects that will be considered for each application include:

A. Candidate: The candidate should have demonstrated professional accomplishments consonant with his or her career status, and should have demonstrated experience or interest in pursuing research (including research outside of biomedicine, behavior, bioimaging, or bioengineering).

B. Career Development Program: The award provides three, four, or five consecutive 12-month budget periods. At least 75% of the recipient's full-time professional effort must be devoted to research and research career development activities. The remainder of the applicant’s time should be devoted to teaching or other research pursuits consistent with the career development objectives of the K25 award.

Both the didactic and the research components of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.

C. Mentor(s): The recipient must receive appropriate mentoring throughout the duration of the program. Candidates must name a primary mentor, who together with the applicant is responsible for planning, directing, and executing 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. Candidates may also nominate additional co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors and serve as role models.

D. Environment: The institution must have a well-established research and biomedical, behavioral, or bioengineering career development program, or have demonstrable ties to such programs. For example, if the mentor is based in industry and the career development program requires didactic activities at a nearby university, access to such activities must be described. The institution must also propose qualified faculty as mentors in the specific research area.

The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe an in-depth, multi disciplinary career development program (courses and research) that will maximize the use of relevant research and educational resources (whether at the institution or at a site with which there are demonstrable ties).

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 Grants Info, 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 Dun and Bradstreet (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.

See also Subsection VI.2. for additional information.

SUPPLEMENTARY INSTRUCTIONS for Career Development award applications are located in the PHS 398, Section III, starting on page 44.

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not applicable.
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity. However, applicants are encouraged to contact the scientific/research contact at the relevant awarding component listed in Sec. VII (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm) prior to submitting an application, to discuss issues of eligibility and review the specific provisions of the award.

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 five 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).

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.). and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. 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 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).

Citizenship: Prior to award, applicants must meet the citizenship requirements described in the Eligibility section of this announcement (Section III).

Concurrent Awards: Applicant must be aware of the NIH policies associated with other federally sponsored support.

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department. Confirmation of the actual salary is required prior to the issuance of an award. The candidate is required to devote a minimum of 75% of full-time effort to this program

An 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.).

Research Development Support: The research development support costs must be justified and 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 ancillary personnel support, such as mentors, secretarial and administrative assistants, is not allowed.

Pre-Award Costs: 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 K25 initial budget period of a new 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 award.

The incurrence of pre-award costs in anticipation of a 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
Using the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III), the following information must be included in the application.

CANDIDATE

• Discuss prior training and research experience and how these relate to the objectives and long-term career plans of the candidate. Explain how the award will contribute to their attainment.
• Discuss the candidate’s research efforts and professional accomplishments consonant with career status, including any publications that demonstrate the candidate’s experience and interest in pursuing research (including research outside of biomedicine, behavior, bioimaging, or bioengineering).
• Provide a description of the candidate's commitment to a career in quantitative biomedical, bioimaging, behavioral, or bioengineering research that is relevant to the NIH mission.
• Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• Include a statement that the candidate will commit at least 75% effort to this career development program. The mentor or department chair must agree that this amount of the candidate's time will be protected.

CAREER DEVELOPMENT PLAN

• Describe a systematic plan that shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences proposed during the K25 award period that utilize the relevant research and educational resources of the institution.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. A systematic plan to obtain the necessary theoretical and conceptual background and research experience to launch an independent research career in quantitative biomedicine, bioengineering, bioimaging or behavioral research must be proposed.
• Include a list of the specific course of study in which the candidate will engage, including specific coursework which is essential to gaining the required theoretical and conceptual understanding of biomedicine, behavioral science, bioimaging, or bioengineering, important to the candidate's short- and long-term research interests and the manner of integration of these studies into the career development plan.
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher in quantitative biomedicine, behavioral science, bioimaging, or bioengineering. Less experienced candidates may require a phased developmental period in which the first one to two year(s) of the award are largely didactic in nature that is followed by a period of intense, supervised research. Candidates with more experience at the time of application may need a shorter developmental period and may already have an adequate theoretical background.

• Describe the professional responsibilities/activities (including other research projects) beyond the minimum required 75% effort commitment to the K25 award. Explain how these responsibilities/activities relate to the career development objectives of this award and will help ensure career progression to achieve independence as an investigator.
• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of a program of study or to monitor the candidate's progress through the career development program.

RESEARCH PLAN

Provide a sound quantitative biomedical, behavioral, or bioengineering research plan that is consistent with the candidate’s level of research development and objectives of his/her career development plan.

Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods. The candidate should consult with mentor(s) regarding the development of this section.

TRAINING IN THE 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 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.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

STATEMENT(S) BY MENTORS(S)/CONSULTANT(S)/COLLABORATOR(S)

• The candidate must name a primary sponsor (or mentor), who, together with the applicant and other mentors, is responsible for the planning, direction, and execution of the program. The candidate may also nominate co-mentors as appropriate to the goals 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.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: 1) information on his or her basic or clinical biomedical research qualifications and previous experience as a research supervisor; 2) a mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period; and 3) a plan for transitioning the candidate from the mentored phase of their career to the independent investigator phase during the project period of the award.
• The mentor or department chair must agree and provide a statement in the application documenting that the required amount of the candidate’s time will be protected.
• Mentors may be employed in any sector of the biomedical research community (e.g., academia, industry, non-profit research institutions).
• Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate.
• The mentor must agree to provide annual evaluations of the candidate’s progress for the duration of the award as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).
• Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

The sponsoring institution must define and document a strong, well-established research and training program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. This must include an indication of support for the proposed level of effort (at least 75%), commitment to the release time from other duties (e.g. teaching), as well as the availability of support and supervision during the award period. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K25 award.

• Describe the resources and facilities that will be available to the candidate.
• Describe how the institutional research environment of the institution is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• In a clear statement, provide assurances that the candidate will be able to devote a minimum of 75% of his/her effort in developing his/her research program, that the remaining percent effort will be devoted to activities related to the development of their research career, and that the candidate will be released from normal clinical, teaching or administrative duties. Candidates who will use the resources within a General Clinical Research Center (GCRC) during the course of the award should include a letter of agreement from either the GCRC program director or the principal investigator with the application.

LETTERS OF REFERENCE

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. All sealed letters of reference should be attached to the face page of the application.

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

Allowable costs for the NIH K25 program are not uniform throughout the participating Institutes; therefore the salary amounts as well as the research development costs vary. See (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm).

Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. Within the direct costs limitation for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Plan for Sharing Research Data
A plan for sharing research data is not required.

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 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.

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).
Not applicable.

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Will receive a written critique
• Will receive a second level of review by an appropriate national advisory council or board.

Applications will compete for available funds with all other approved research career development award applications. The following will be considered in making funding decisions:

• Scientific merit and quality of the proposed applications as determined by peer review
• Relevance of the proposed career development program prior training, and commitment of the applicant to becoming an independent researcher
• Relevance to program priorities
• Availability of funds

REVIEW CRITERIA

The goals of NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

• Candidate
• Career Development Plan
• Research Plan
• Training in the Responsible Conduct of Research
• Appropriateness of and statements by Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
• Environment and Institutional Commitment to the Candidate

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority.

CANDIDATE

• Potential to develop as an independent and productive quantitative biomedical, behavioral, bioimaging or bioengineering researcher or to play a significant role in multi-disciplinary research teams;
• Quality of the candidate's research and academic record;
• Commitment to meeting the K25 program objectives;
• Quality of the letters of reference from three well-established scientists evaluating the candidate’s potential to pursue a quantitative biomedical or bioengineering research career;
• Letters of reference submitted by mentor(s)/ co-mentor(s) will be considered independent of and in addition to the three required reference letters.

CAREER DEVELOPMENT PLAN

• Likelihood that the career development plan will contribute substantially to the candidate's scientific development;
• Appropriateness of the content and duration of the proposed didactic and research phases of the award;
• Consistency of the career development plan with the candidate's career goals and prior research experience.

RESEARCH PLAN

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K25 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals for these years.

• Appropriateness of the research plan to the candidate's stage of research development and as a vehicle for developing the research skills as described in the career development plan;
• Scientific and technical merit of the research question, design and methodology;
• Relevance of the proposed research to the candidate's career objectives;
• Adequacy of the plans to include both genders, minorities, and children and their subgroups as appropriate for the scientific goals of the research when human subjects are used. Plans for the recruitment and retention of subjects will also be evaluated, when applicable.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

• Quality and appropriateness of the proposed training in the responsible conduct of research.

STATEMENTS BY MENTOR/CO-MENTOR(S), CONSULTANT(S), and COLLABORATOR(S)

• Appropriateness of the mentor's research qualifications in the area of the proposed research;
• Quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate;
• Previous experience in fostering the development of independent investigators;
• History of research productivity and peer-reviewed support in the area of basic or clinical biomedical, bioengineering, bioimaging or behavioral research;
• Strength of the mentor’s statement.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

• Clear commitment of the institution to ensure that a minimum of 75% of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the overall purpose of the award and successful development of an independent research career.
• Strength of the institutional commitment to the career development of the candidate including a commitment to an appropriate balance of research and other responsibilities;
• Adequacy of research facilities and training opportunities, including faculty capable of productive collaboration with the candidate and access to utilize such facilities or opportunities in other institutions;
• Quality and relevance of the environment for the scientific and professional development of the candidate;
• Assurance that the institution intends for the candidate to be an integral part of its research program.

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development goals, research aims, and plans.

2.C. Sharing Research Data
A data sharing plan is not required.

2.D. 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 (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plan with the principal investigator before recommending funding of an application. The final version of the resource sharing plan negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

1. Award Notices

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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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 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).

The following related administrative policies apply to NIH Research Career Award ( K ) programs:

A. 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, recipients are hereby notified that they may be contacted after the completion of this award 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.

B. 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.

C. 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 three months. For longer periods, prior written approval of the NIH awarding 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 ensure that satisfactory arrangements have been made. Support from the K25 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%. 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% 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 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% effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

Consultation with the applicable NIH program staff responsible for the award is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

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.

In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the PI’s 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. Staff within the NIH funding component will review the request and will notify the institution of the results of the evaluation.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered. See (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm).

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

• A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NIH awarding institute.
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new sponsor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
• All conditions of the award are met at the new institution.
• The period of support requested is no more than the time remaining within the existing award

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: Note that the instructions for Research Career Development applications must be followed for this program http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements provided as required in the NIH Grants Policy Statement.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the PHS form 2590 instructions. Evaluation of the awardee’s progress will encompass the following:

• A demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
• A description of career development and research-related activities undertaken during the prior funding period.
• A list of accomplishments such as publications, scientific presentations, new collaborations, inventions, and project-generated resources made during the prior funding period;
• A brief description of plans to address the specific aims during the next year of support;
• A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities;
• An evaluation statement of the candidate’s progress, as required in the PHS 2590 continuation application instructions (item j. Sponsor’s Report).

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

1. Scientific/Research Contacts:

Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm) for information regarding each IC’s scientific/research contacts for this K25 program.

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:
Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm) for information regarding each IC’s grants management contact for this K25 program.

Applicants are strongly encouraged to visit the following NIH Web site to gain a better understanding of the use of this program (K25) by the participating NIH Institutes and Centers: (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-087_contacts.htm)

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 the scientific merit or the priority score.

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.

Additional information regarding the NIH Public Access Policy can be found at: http://www.nih.gov/about/publicaccess/index.htm

Additional information regarding the submission process can be found in the Public Access Policy Author’s Manual found at: http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm.

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.

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: (Be sure to cite any additional appropriate authorizations, regulations or policies below)
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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