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 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 Cancer Institute (NCI), (http://www.nci.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 Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Eye Institute (NEI), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.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/)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov/)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov)

The following NIH Institutes and Centers do not participate in this program:
National Human Genome Research Institute (NHGRI); National Library of Medicine (NLM); National Center on Minority Health, Health Disparities (NCMHD); and the Fogarty International Center (FIC).

Title: Mentored Patient-Oriented Research Career Development Award (K23)

Announcement Type
This is a reissue of PA-00-004, which was previously released October 8, 1999.

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

Program Announcement (PA) Number: PA-05-143

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.271, 93.855, 93.856, 93.846, 93.286, 93.398, 93.865, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.113, 93.114, 93.115, 93.361, 93.867, 93.233, 93.837, 93.838, 93.839, 93.281, 93.853, 93.213, 93.389

Key Dates
Standard dates apply. See http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Release Date: July 22, 2005
Letters Of Intent Receipt Date(s): Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
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
AIDS Application Submission Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Additional Information To Be Available (URL Activation Date): Not applicable
Expiration Date: January 8, 2009 (per PA-09-043) - Previously: January 8, 2010 (per NOT-OD-08-069) - Originally: September 2, 2008

Due Dates for E.O. 12372
Not Applicable

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. 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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Career Objectives

The goal of the Mentored Patient-Oriented Research Career Development Award (K23) program is to ensure a future cadre of well-trained scientists working in POR areas who will become competitive for NIH research project (R01) grant support. The specific objectives of the Mentored Patient-Oriented Research Career Development Award are to:

For the purposes of this award, and in agreement with the recommendations of the NIH Director's Panel on Clinical Research, (http://www.nih.gov/news/crp/97report/index.htm), patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena for which an investigator directly interacts with human subjects). This area of research includes 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials; and 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition. Exemption 4 includes research projects involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. For additional information regarding Exemption 4, see PHS 398, Part II http://grants.nih.gov/grants/funding/phs398/phs398.html.

In 1995, a panel of academic physicians was convened (NIH Director's Panel on Clinical Research) by the then Director of NIH, Dr. Harold Varmus, "to review the status of clinical research in the United States and to make recommendations about how to ensure effective continuance". The Panel first developed a three-part working definition of Clinical Research, breaking down Clinical Research into three categories: patient-oriented research (POR), epidemiologic and behavioral studies, outcomes research and health services research. The Panel then formulated 10 recommendations that were presented to the Advisory Council to the NIH Director in December, 1996. In the area of training, the Panel recommended the initiation of new support mechanisms for young and mid-career clinical investigators (in POR).

In response to the recommendation of the Advisory Council in the area of training, the NIH in 1998 issued the initial program announcement (PA-98-052) titled “Mentored Career Development Award in Patient-Oriented Research”. That PA used the NIH K23 funding mechanism and was intended to provide junior clinical investigators protected time to initiate a research career in POR. This award has formed an important part of the NIH initiative to attract and retain talented individuals to the challenges of POR. NIH continues to recognize its value in developing a continuing supply of clinically-trained investigators in patient-oriented research. This initiative is consistent with the recommendations of the NIH Director's Panel on Clinical Research (http://www.nih.gov/news/crp/97report/index.htm) and the recommendations from the Institute of Medicine Committee on Addressing Career Paths for Clinical Research (http://www.iom.edu/event.asp?id=15129).

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 NIH K23 award mechanism. As an applicant, the candidate and his/her mentor(s) are 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.

Awards are for three-five years and are not renewable.

2. Funds Available

Allowable Costs:

Salary: The component NIH Institutes will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12month staff appointment requiring the candidate to devote a minimum of 75% of full-time professional effort to conducting patient-oriented research with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on 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 with 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 Institutes and Centers provide support ranging from $75,000 to $180,100 to help offset the full-time salary requirement of the candidate. Salary limits for NIH 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-05-143_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 additional PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K23. 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.

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 of the research 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 Institutes and Centers 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-05-143_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.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the participating ICs 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.

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. However, for the NIH K23 program, the following eligibility requirements apply to individuals who seek to become Research Career Award recipients (Principal Investigators).

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses 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 for this award must have a health-professional doctoral degree or its equivalent. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice. Candidates with Ph.D. degrees are eligible for this award if the degree is in a clinical field and they usually perform clinical duties. This may include clinical psychologists, clinical geneticists, social workers, speech and language pathologists, audiologists, and rehabilitationists. Individuals holding the Ph.D. in a non-clinical discipline but who are certified to perform clinical duties should contact the appropriate Institute concerning their eligibility for a K23 award. Candidates also must have completed their clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, candidates may submit an application prior to the completion of clinical training.

Candidates must identify a mentor with extensive research experience.

Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research career development and clinical research activities associated with this award. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K23 Award, i.e., the candidate's development into an independent investigator in POR. 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 Institute or Centers prior to preparing an application to discuss their eligibility, see http://grants.nih.gov/archive/grants/guide/contacts/pa-05-143_contacts.htm.

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

3. Other-Special Eligibility Criteria

A candidate for an NIH K23 award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K22, K23, K25), a research project grant (R01), or any PHS award that duplicates any of the provisions of the K23 award. Ineligible individuals include current and former principal investigators on NIH research project grants, comparable individual career development awards (e.g., K01, K07, K08, K23, K25) equivalent non-PHS peer-reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.

Current and former recipients of Clinical Associate Physicians Award (CAP) support may apply for the K23 provided they've had no more than 3 years of CAP support by the time of the K23 award. The combined total of CAP plus K23 support must not exceed 6 years.

K23 recipients are encouraged to apply for independent research grant support during the latter period of this award. K23 award recipients that obtain independent support during the K23 award period may hold concurrent research support, and under certain circumstances (see Allowable Costs above) salary support from their career award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Special Requirements

Each 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 in patient-oriented research. The sponsoring institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator in patient-oriented research.

Key elements for the award, in addition to information about the applicant candidate, include:

Environment: The applicant institution must have a well-established record of research career development activities and qualified research faculty to serve as mentors. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program with an emphasis on patient-oriented research that maximizes the use of relevant research, and educational resources, and qualified faculty as mentors in patient-oriented research.

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 the program, although up to 100% effort may be requested. The remainder of the applicant's time should be devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate is expected to develop knowledge, skills and expertise in POR relevant to her/his career goals. The candidate should include didactic, laboratory, interdisciplinary and field experiences in their career development plan as needed.

Mentor(s): The candidate must name a primary sponsor/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 in patient-oriented research. 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 co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. Appropriate mentors include, but are not limited to, NIH-supported investigators involved in POR.

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. 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 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/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Section VI.2. for additional information.

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.

Supplementary Instructions for Career Development awards 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 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 Time
Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not applicable.
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
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 (see Section VII), prior to submitting an application, to discuss issues of eligibility and review the specific provisions of this 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 dates described above (Section IV.3.A.) Upon receipt, applications will be evaluated for completeness by CSR and responsiveness to this announcement. Incomplete applications will be returned without review.

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

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement prior to award (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. The candidate is required to devote a minimum of 75% of full time effort to this program, and confirmation of the actual salary is required prior to the issuance of an award. Prospective applicants should contact the applicable NIH component to ascertain the maximum contribution to salary that each Institute will provide http://grants.nih.gov/archive/grants/guide/contacts/pa-05-143_contacts.htm.

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 allowed for this program must be carefully justified annually 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 ancillary personnel support such a 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 K23 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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), the following information must be included in the application.

Candidate

Describe the candidate's commitment to an academic career in patient-oriented research. Include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.

Statement(s) By Mentor(s)/Consultant(s)/Collaborator(s)

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 that clearly documents expertise in the proposed area(s) 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. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K23 award.

Career Development Plan

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 the program of study or to monitor the candidate's progress through the career development program.

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 regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in, and propose plans to receive, 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.

Research Plan

A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided.

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.

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 in patient-oriented research. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three recommendations. All sealed letters of reference should be attached to the face page of the application.

Budget for the Entire Proposed Period of Support

Allowable costs for the NIH K23 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-05-143_contacts.htm.

Follow the application instructions, provide 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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 resources sharing plan will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (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.

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, applications:

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

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 the following criteria in assigning the application's overall score, weighting them as appropriate for each application.

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

Career Development Plan

Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence, based on:

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. Nevertheless, a fundamentally sound research plan must be provided. For candidates who require substantial didactic training as part of their program, the research plan may cover less than the full period of the award.

Training in the Responsible Conduct of Research

Statements By Mentor/Co-Mentor(s)

Environment and Institutional Commitment

2A. Additional Review Criteria:

In addition to the above criteria, the following items will 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 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.

2B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development plan.

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. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps 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

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/archive/grants/policy/nihgps_2003/index.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.

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.

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.

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 that 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:

Usually, funds budgeted in an NIH supported research 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 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/archive/grants/policy/nihgps_2003/index.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 K23 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 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.

D. Changes in Research or Career Development Program

See http://grants.nih.gov/archive/grants/guide/contacts/pa-05-143_contacts.htm.

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, program staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff is strongly encouraged when either a change of institution or termination is being considered, see http://grants.nih.gov/archive/grants/guide/contacts/pa-05-143_contacts.htm.

A change of institution 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, and the qualifications of the proposed new mentor. 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 Principal Investigator is moving to another eligible institution, career award support may be continued provided:

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.

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 as required in the NIH Grants Policy Statement.

The Progress Report must include Sections a through f as described in the general PHS Form 2590 instructions, as well as Sections g through j as described in Section IV of the 2590 instructions. Evaluation of the awardee's progress will encompass the following:

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.

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:

Applicants should refer to the NIH Web site http://grants.nih.gov/archive/grants/guide/contacts/pa-05-143_contacts.htm for information regarding each IC's scientific/research contact for this K23 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-05-143_contacts.htm for information regarding each IC's grants management contact for this K23 program.

Section VIII. Other Information

Applicants are strongly encouraged to visit the following NIH Web site to gain a better understanding of the use of this program (K23) by the participating NIH Institutes and Centers: http://grants.nih.gov/archive/grants/guide/contacts/pa-05-143_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, June 12, 1998: 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, 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/guide/notice-files/NOT-OD-04-042.html). 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/archive/archive/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 that is available at 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: 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 (see http://escr.nih.gov/). It is the responsibility of the applicant to provide the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:

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

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

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (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 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply).

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 No. 93.398 at http://www.cfda.gov/, and is not subject to the intergovernmental review requirements of Executive Order 12372or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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: Please note that 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 Loan Repayment Program (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, because 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 research. For further information, please see: http://www.lrp.nih.gov.


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