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 Cancer Institute (NCI), (http://www.nci.nih.gov)

Title: NCI Mentored Career Development Award to Promote Diversity (K01)

Announcement Type
This Program Announcement (PA) replaces PAR-03-016.

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

• December 16, 2008 - This PA has been reissued as (PAR-09-052).
• September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.
• June 14, 2006 (NOT-CA-06-028) - Amendment to PAR-06-220 - change regarding the acceptance of revised (amended) applications.

Program Announcement (PA) Number: PAR-06-220

Catalog of Federal Domestic Assistance Number(s)
93.398

Key Dates
Release Date: March 8, 2006
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: January 8, 2009 (per PAR-09-052) - Originally: May 8, 2009 (per NOT-OD-07-093) - Originally: March 2, 2009

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

• The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, Training, and Resources (OCTR), National Cancer Institute (NCI), invites career development award applications (K01) from individuals representative of groups that have been shown to be underrepresented in health-related science who have been recipients of an NIH Research Supplement to Promote Diversity Award, any Ruth L. Kirschstein National Research Service Award (individual F31/F32 or institutional T32), or can demonstrate that they have been supported in a mentored capacity within any research grant equivalent to an NIH peer-reviewed research grant (e.g., American Cancer Society [ACS] research grant).
• The goal of the NCI CMBB K01 is to diversify the pool of independent cancer research investigators. The NCI and CMBB recognize a unique and compelling need to promote diversity in participation in cancer research and expect efforts to diversify the cancer research workforce to lead to the recruitment of the most talented researchers from all groups.
• The K01 mechanism establishes a pathway of recruiting, training and retaining underrepresented investigators into research fields that address problems pertinent to the biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment of human cancer and who can conduct independent competitive cancer programs. Accordingly, this award forms an important part of the NCI initiative to attract talented underrepresented individuals to the challenges of cancer research.
• The purpose of the K01 is to provide support and protected time (3, 4, or 5 years) for an intensive, supervised career development experience in the biomedical, behavioral, and/or clinical sciences leading to research independence. Awards are not renewable and they are not transferable from one principal investigator (PI) to another.
• The proposed career development experience must be in a research area new to the applicant and/or one in which an additional supervised research experience will substantially augment the research capabilities of the applicant. Planning, direction, and execution of the proposed career development program and research project will be the responsibility of the applicant and his/her mentors.
• Candidates eligible for support under this award include individuals with research or health professional doctoral degrees who come from groups that have been shown to be underrepresented in biomedical, behavioral, clinical, and/or social sciences. Such candidates include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds. Detailed eligibility criteria are described in the full announcement (see Section III 1.B.).
• Candidates must be U.S. citizens or non-citizen nationals, or individuals, lawfully admitted for permanent residence, who hold research or health-professional doctoral degrees or their equivalents and can commit a minimum of 75 percent of full-time professional effort conducting research and relevant career development activities specified in the application. Receipt of prior support may impact on eligibility.
• K01 applications may be submitted on behalf of candidates by domestic, for-profit or non-profit organizations and public or private institutions, such as universities, colleges, hospitals, and laboratories. Foreign institutions and organizations are not eligible to apply for this award.
• This mechanism provides up to $75,000 for salary plus fringe benefits and up to $30,000 for research development support annually.
• The applicant for this K 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.
• 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.
• See Section IV for application and submission information.
• Telecommunications for the hearing impaired is available at TTY 301-451-5936.

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
6. Other Submission Requirements

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Substantial national and local efforts have been made and are continuing to be made to reduce cancer morbidity and mortality in the general population. However, in spite of these efforts, projections made for 2005 were that 1,372,910 cancers were expected to be diagnosed in the United States and 570,280 Americans were expected to die of this disease. Past patterns of cancer incidence and mortality predict that a disproportionate share of this increase in U.S. cancer incidence and mortality will be borne by minorities.

A reduction in the overall cancer mortality rate in minority populations would substantially impact known cancer statistics. A major obstacle to developing a stronger national minority cancer research effort has been the lack of significant strategic training programs for students and scientists representative of minority populations in cancer research. Greater involvement of underrepresented candidates who possess the appropriate cultural perspectives is integral to a successful national minority cancer research effort involving more minority patients and populations.

This mechanism establishes a pathway of recruiting, training, and retaining underrepresented investigators in research fields that address problems pertinent to the biology, etiology, pathogenesis, prevention, diagnosis, control, and treatment of human cancer and who can conduct independent competitive cancer research programs.

The Mentored Career Development Award to Promote Diversity (K01) provides support for a sustained period of protected time for intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (R01) funding.

All 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 research. The sponsoring institution must be able to provide a signed statement establishing the eligibility of the candidate for this program and must be able to 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.

Section II. Award Information

1. Mechanism(s) of Support

Support for this program will be provided through the NIH K01 career development award mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution.

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.

Applicants may request 3, 4, or 5 years of funding support. Each award is non-renewable and non-transferable from one Principal Investigator (PI) to another.

Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report (PHS form 2590). See Section VI.3 Reporting. NIH Grant policies apply to these awards.

2. Funds Available

Allowable Costs

Salary: This award will provide salary up to $75,000 annually plus fringe benefits. The total salary requested must be based on a full-time, 12-month, staff appointment. The candidate must spend a minimum of 75 percent effort conducting cancer research studies, 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.

The 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. Because the salary amount provided by this award is based on the full-time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K01. Under expanded authorities, however, institutions may re-budget 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-06-031.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 percent and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a PI or Subproject Director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Ancillary Personnel Support: Salary support for ancillary personnel, such as mentors, secretaries, and administrative assistants, is not allowed.

Research Development Support: The NCI CMBB K01 will provide $30,000 per year for the following types of expenses: a) research expenses, such as supplies, equipment, and technical personnel; b) statistical services including personnel and computer time; c) tuition and fees, related to career development; d) travel to research meetings or for training; and e) travel to an annual 2-day NCI awardee meeting and/or peer review related training expenses.

Facilities and Administration Costs: Facilities and administrative (F&A) costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. F&A costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

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 NCI 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:

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

Foreign institutions and organizations are not eligible to apply.

The institution must have well-established basic, clinical, and/or prevention and population-based cancer research programs and qualified faculty to serve as mentors. The candidate, mentor, and institutional representative must be able to propose an appropriate cancer research/career development program that will maximize the use of relevant cancer research and educational resources. The institution must be able to demonstrate a commitment to the development of the research careers of junior underrepresented research scientists in biomedical cancer research.

1.B. Eligible Individuals

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

Accordingly, the NCI continues to encourage institutions to diversify their student and faculty populations and to identify candidates who will increase diversity on a national or institutional basis. Individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences from the following groups are encouraged to apply:

A. Individuals from racial and ethnic groups that have been shown by the NSF (see: http://www.nsf.gov/sbe/srs/women/start.htm) to be underrepresented in health-related sciences on a national basis;

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

C. Individuals from disadvantaged backgrounds, who are defined as:

• Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml . For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL); Loans for Disadvantaged Student Program; or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
  
  
• Individuals who come from a social, cultural, and/or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Candidates must have a research or health professional doctoral degree (or its equivalent) and must have been a recipient of an NIH Research Supplement to Promote Diversity Award, any National Research Service Award (individual F31/F32 or institutional T32 recepients) or can demonstrate that they have been supported in a mentored capacity within any research grant equivalent to an NIH peer-reviewed research grant (e.g., an American Cancer Society [ACS] research grant).

This award is designed to provide an intensive, supervised research experience for eligible underrepresented individuals who seek additional support in the basic, clinical, prevention, and/or population sciences in a mentored research environment. Successful candidates will be provided with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required to prepare other grant applications (e.g., those of the NIH R01, R21, and R03 mechanisms).

The candidate must be nominated by institutions on the basis of qualifications, interests, accomplishments, and motivation, and based upon the candidate's intent to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment that has the potential for establishing an independent research program.

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.

The candidate must have a mentor with extensive research experience who has an appreciation of the cultural, socioeconomic, and research background of the individual candidate and the candidate must be willing to devote a minimum of 75 percent full-time professional effort conducting research and research career development. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are in a fashion consistent with the goals of the K01 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 Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Potential candidates should contact the NCI Program staff to discuss their eligibility prior to preparing an application. See Section VII. Agency Contacts.

2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Ineligible individuals include former and current PIs on NIH Research Project grants (R01), comparable Career Development Awards (e.g., K07, K08, K22, K23) or First Awards (e.g., R29). Former or current PIs on NIH Small Grants (e.g., R03) or Exploratory/Developmental Grants (e.g., R21), sub-projects on Program Project Grants (e.g., P01), Specialized Center Grant (e.g., P50), or Center Grant (P30) and their equivalents remain eligible.

K01 recipients are encouraged to apply for independent research grant support during the latter period of this award. K01 award recipients that obtain independent support during the K01 award period may hold concurrent research support, and under certain circumstances salary support from their career award and a competing NIH research project grant when recognized as a PI or subproject Director of the research project grant. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Special Requirements:

Program: The NCI Mentored Career Development Award to Promote Diversity (K01) can be used by postdoctoral candidates who need 3, 4, or 5 full years of mentored support. Accordingly, the award provides up to five consecutive 12-month appointments.

Candidates will participate in mentored research activities, which should include writing and submitting manuscripts for publication and presenting at scientific meetings. In addition, candidates will be expected to observe or participate (depending upon prior research experience and/or level of independence and without additional compensation) in the NIH/NCI peer review process, as well as to participate annually in workshops focused on preparing, writing, and submitting NIH grant applications; these activities will be coordinated and/or sponsored by the CMBB.

Candidate: Candidates must devote at least 75 percent of their professional effort to cancer-related research and peer review activities consistent with the objectives of this award. For the purposes of this award, full-time professional effort provides protected time away from normal activities (e.g., administrative, clinical, and teaching assignments). The 75 percent effort includes activities consistent with development of the minority candidate into a competitive independent scientist (e.g., acquisition of laboratory skills and didactic courses). The remainder (25 percent) may be devoted to teaching or other research pursuits as long as they are consistent with the objectives of the award (i.e., to train a research scientist who can compete successfully for NIH support). Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in the basic, clinical, prevention, or population-based cancer research field relevant to the career goals of the candidate.

Mentor: The application must include appropriate mentoring; that is, mentoring in preparation to become an independent scientist and mentoring to guide the candidate in an independent position in the development of a research program competitive for peer-reviewed research support. The mentor must be a senior or mid-level faculty member with research competence and/or experience appropriate to his/her role.

Candidates must identify a suitable sponsor (i.e., mentor) with extensive research experience who has an appreciation of the cultural, socioeconomic, and research backgrounds of the individual candidate. The mentor, with input from the candidate, will be responsible for the planning, direction, and execution of a tailored career development plan specific to the applicant's particular career development needs. Where feasible, women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Career Development: Because of the focus on progression to independence as researchers, candidates for the K01 should propose, together with their mentor, a period of study and career development consistent with the previous research and clinical experience of the candidate, and as appropriate, sensitive to the individual needs related to his/her cultural, socioeconomic heritage. For example, a candidate with limited experience in a given field of research may find a 5-year developmental program that includes a designated period of specialized didactic training followed by a research experience that is very closely monitored by the mentor necessary to insure that the candidate will attain independence.

Candidates with cultural and socioeconomic backgrounds that may isolate them from their peers or impede their progress should be given individual attention to ensure that they ultimately are able to perform and interact as effectively as any other candidate being trained in the institution as biomedical researchers. A candidate with previous research experience and training may not require extensive additional didactic preparation, and may benefit from a program that focuses primarily on an intensive, supervised cancer research experience. All programs must be tailored to meet the individual needs of each minority individual to provide the opportunity for him/her to gain the skills and knowledge necessary to carry out high quality cancer research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The mentor must carefully monitor the candidate's progress through the career development program.

If necessary, an advisory committee can be formed to assist with the development of a program that meets the candidate's needs and to monitor the candidate's progress through the career development program. The didactic and research components must develop new knowledge and research skills in scientific areas relevant to the career goals of the candidate.

Evaluation: In carrying out its stewardship of human resource-related programs, NCI CMBB 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.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions. Supplementary Instructions for Career Development Awards are located in the PHS 398, Section III, starting on page 45.

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

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

Applicants who will be using 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 PI for the application.

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 Times

Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm. See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Letter of Intent Submission Date: Not applicable.
Application Submission 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 the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be submitted using the research grant application forms found in the PHS 398 instructions as described above. Submit a signed, typewritten original of the application, with three letters of reference in sealed envelopes on top and three signed photocopies in one package to:

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

At the time of submission, two additional copies of the application and all five (CD-ROM or paper) copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428

Applicants may, if they wish, submit appendix materials on CD-ROM disks. If appendix materials are submitted as paper copies, they should be comprised of unbound materials, with separators between documents.

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 date(s) 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 8 weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH 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 percent of full time effort to this program, and confirmation of the actual salary is required prior to the issuance of an award.

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 2 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 PI on a competing NIH research project grant (e.g., R01, R03, R15, R21, R34), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (e.g., P01, P50, U01).

Salary support for ancillary personnel, such as mentors, secretaries, and administrative assistants, is not allowed.

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.

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

6. Other Submission Requirements

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

CANDIDATE

• Describe the candidate's research background, and how it relates to the objectives and plans of the candidate -- note any issues, as appropriate, that have already affected or may affect the pace of the candidate's career development;
  
  
• Describe the candidate's commitment to a career in basic, clinical, and/or population-based cancer research; for example, candidates with clinical degrees (e.g., M.D.) may wish to consider the Mentored Clinical Scientist Award to Promote Diversity (K08) Award and candidates interested in patient-oriented research may wish to consider the Mentored Patient-Oriented Research to Promote Diversity Award (K23), as more appropriate alternatives relative to their stage of development and career goals;
  
  
• Present evidence of the candidate's ability to interact and collaborate with other scientists;
  
  
• Discuss the innovativeness and quality of the candidate's research efforts to this point in his/her research career;
  
  
• Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment;
  
  
• Provide three sealed letters of reference in which the following issues are addressed:
  
  
• The adequacy of the candidate's scientific background for the proposed research and career goals;
  
  
• The quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment);
  
  
• The candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries);
  
  
• Evidence of the candidate's originality and innovativeness in pursuing a research problem;
  
  
• VERY IMPORTANTLY, the candidate's special potential to develop, establish, and manage an independent research program.

MENTOR'S STATEMENT

• Include a signed statement from the mentor(s) with information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the mentor's research support as related to the candidate's research plan and the specific nature of the supervision and mentoring that the candidate will receive during the proposed award period. This information must detail how the career plan will build upon the candidate s unique research background, take into account unique needs of the candidate, as appropriate, and enhance the candidate’s research development toward independence.
  
  
• Provide similar information of any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
  
  
• Describe in this statement specifically whether all or parts of the research project being conducted by the candidate will remain as activities of that individual when the transition to an independent position is made or whether the candidate will be expected to develop an entirely new project in the independent position.

CAREER DEVELOPMENT PLAN

The career development plan should be a joint effort between the applicant and his/her mentor and carefully tailored to the candidate's needs, which should factor in any cultural, socioeconomic, and/or ethnic experiences that may impede the candidate's progress during his/her development as an independent research scientist engaged in cancer research.

• Present a systematic plan that covers the duration of this Program. This plan should incorporate the prior research training and experience of the candidate to provide a basis for the need for further career development to become an independent investigator focusing on research that is clearly relevant to cancer.
  
  
• The plan should provide a description of the research and training experiences that will occur during the proposed period of support, and the candidate must present a convincing case that, he/she will have a high probability of developing the research skills and abilities needed to work in a collaborative environment and to become a successful, independently supported investigator.
  
  
• Indicate a minimum commitment of at least 75 percent professional effort to research career development activities. The candidate should give a clear overall description of the types of research/research training activities that he/she will be involved in within the 75 percent effort versus an overall description of "other activities" and the percent effort involved.

RESEARCH PLAN

• Describe the research plan using PHS form 398 following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design, and Methods. The candidate must consult with the mentor regarding the development of this section. The research plan must be clearly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment. It must be clear as to whether all or parts of the Research Plan will remain as activities of the candidate when the transition to an independent position is made or whether the candidate will be expected to develop an entirely new project in the independent position.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

• A signed statement from the candidate and an institutional official establishing the eligibility of the candidate for support under this program. The statement must include clearly presented information on citizenship as well as the nature of the candidate’s disability, circumstances, background, or characteristics that confer eligibility under this program (see eligibility classes listed in Section III, Part 1.B.).
  
  
• The sponsoring institution must document a strong, well-established research and training program related to the candidate's area of interest and 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. The institutional statement also must commit to provision of release time from normal teaching or administrative duties necessary to meet the 75 percent effort requirement of this award. The institutional statement should clearly indicate activities included within the 75 percent protected time.
  
  
• Describe the resources and facilities that will be available to the candidate.
  
• Describe how the 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.

BIOGRAPHICAL SKETCH

• A biographical sketch is required for the candidate and mentor(s). For the candidate, include information on research projects completed and/or research grants participated in during the last 5 years that are relevant to the proposed project and demonstrate an uninterrupted involvement of research before submitting this application (see Section III. Eligibility Information).

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

• Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component.

BUDGET

• The total direct costs requested must be consistent with this K01 program announcement and the award limits of the NCI. Budget requests must be provided according to the instructions in PHS form 398, Section III Instructions for the Career Development Awards. The request for tuition and fees, travel, research development support, etc., must be justified and specified by category. Applications seeking information on award limits should contact the fiscal representative listed in Section VII. Agency Contacts.

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 (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

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

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

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the NCI in accordance with the review criteria stated below.

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

• 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;
• Receive a written critique; and
• Receive a second level of review by the National Cancer Advisory Board.

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

• Scientific merit of the proposed project 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 of program priorities, and
• Availability of funds.

Review Criteria

The goals of NIH/NCI supported career development programs are to help ensure that diverse pools of highly trained scientist 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

• Quality and breadth of the candidate's research, academic and/or clinical record, including publications, as a foundation for developing as an independent cancer researcher.
  
  
• Commitment of the candidate to an independent cancer research career in terms of effort and future plans that will be focused on problems clearly relevant to cancer.
  
  
• Appropriateness of the dedicated 75 percent effort to the successful development as a cancer researcher.
  
  
• Ability of the candidate to interact and collaborate with other scientists.
  
  
• Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research.

MENTOR/CO-MENTOR

• The application must include a signed statement from the mentor(s) including information on research qualifications and previous experience as a research supervisor. The applications must also include information to describe the mentor's research support related to the candidate's research plan and nature of the supervision that will occur during the proposed award period.
  
  
• Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.
  
  
• Evidence that the mentor has participated in the development of the Career Plan, is sensitized to providing any individual needs (i.e., because of his/her cultural, socioeconomic, and/or ethnic backgrounds) of the candidate, as appropriate, and is willing to go beyond the traditional efforts that a mentor dedicates to a trainee in his/her research environment.
  
  
• 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 during the entire period of the award.
  
  
• Previous experience in fostering and developing cancer researchers.
  
  
• History of research productivity and peer reviewed support.
  
  
• Adequacy of existing support for the proposed research project.
  
  
• Adequacy and clarity of the mentor's statement describing what aspects of the Research Plan will remain with the candidate when his/her transition is made to an independent position. This statement should also specifically describe whether all or parts of the research project being conducted by the candidate will go with the candidate when the transition to an independent position is made or whether the candidate will be expected to develop an entirely new project in the independent position.

CAREER DEVELOPMENT PLAN

• Appropriateness of the content and the proposed duration of the candidate's career development plan in relation to his/her experience, background, and stated career goals.
  
  
• Adequacy of considerations in the Plan that tailor it to the needs of the candidate's experience and background, including any important cultural, ethnic, and/or socioeconomic factors, as appropriate, that could effect the progress of the candidate's successful research career development.
  
  
• The need for the proposed research experience.
  
  
• Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence.
  
  
• Conformity of the plan to 75 percent effort devoted to research/research training activities.
  
  
• Adequacy of prior or proposed training in the responsible conduct of research.
  
  
• Likelihood of successful planning, writing and submitting of traditional grant applications.

RESEARCH PLAN

Reviewers should recognize that candidates may have variable degrees of research experience. Those with more limited experience are less likely to prepare a plan with the breadth and depth of that submitted by more experienced investigators unless the mentor plays a significant role. All plans must include fundamentally sound research approaches, but reviewers should consider the applicant's research experience, background, as appropriate, and especially evidence that the mentor is committed and involved (see Mentor/Co-mentor below).

• Degree of relevance of the research plan to developing an independent cancer research program as it relates to the cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment.
  
  
• A sound research project that is consistent with the development plan for an independent career in cancer research and commensurate with the candidate's level of research development.
  
  
• Usefulness of the research project as a vehicle for enhancing existing research skills as described in the career development plan.
  
  
• The originality and quality of the research hypothesis/question, design, and methodology, judged in the context of the candidate's previous training and experience.
  
  
• Attention to and implications of what aspects of the project will remain with the candidate as an independent investigator, especially if the applicant proposes to transition to Phase II.
  
  
• Adequacy of plans for the provisions for the protection of human and animal subjects and the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects.
  
  
• Appropriateness of the mentor's research qualifications in the area of the proposed research.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

• Adequacy of research facilities and the availability of appropriate educational opportunities.
  
  
• Quality and relevance of the environment for scientific and professional development of the candidate.
  
  
• Degree of evidence that the applicant institution's commitment to the scientific development of the candidate is strong, as evidenced by it's willingness to ensure that any individual needs of the candidate, as appropriate, are being provided and that the candidate will be integrated with care and sensitivity into the institution's research programs; and assurances that the institution intends the candidate to be an integral part of the research program.
  
  
• Appropriateness of the applicant institution's commitment to ensuring that 75 percent of the candidate's time is dedicated to research career development and not to other activities unrelated to research, as evidenced by a clear listing of activities expected of the candidate within the 75 percent research effort and other activities that will be included in the remaining 25 percent effort.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

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

BUDGET

• Justification of the requested budget in relation to career development goals and research aims and plans.

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. The priority score should not be affected by the evaluation of the budget.

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 at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at 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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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 plans with the awardee before recommending funding of an application. The final version of the resource sharing plans 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 PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

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.

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.

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 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 assure that satisfactory arrangements have been made. Support from the K01 award will continue during such leave.

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

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

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate 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 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: 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 (see http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm). 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.

Change of Institution or Termination: Consultation with the applicable NIH program staff is strongly encouraged when either termination or a change of institution is being considered (see (http://grants.nih.gov/grants/guide/contacts/pa-06-001_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 NIH/NCI 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 (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. The 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 2590 instructions. The Progress Report (PHS form 2590) will be evaluated based upon and should include the following information.

• Demonstration of scientific progress toward the aims of the research should be presented. The candidate is responsible for a brief summary of the studies and results obtained during the prior funding period.
  
  
• A list of accomplishments such as publications, inventions, and/or project-generated resources should be provided.
  
  
• A brief explanation of plans to address the specific aims during the next year of support should be included.
  
  
• A short description of candidate's involvement in research/research training activities during the prior funding period in relation to the content and duration of the originally proposed Career Development Plan should be included; this description must address how weaknesses in the plan as identified by peer reviewers in the Summary Statement have been addressed and corrected. The description should also include formal coursework, informal instruction in specific research skills, scientific seminars, etc. In addition, a concise description of the candidate's participation in "other activities" during the report period should be included. The percent effort devoted to research/research training and to other activities, respectively, must be clearly stated.
  
  
• Description of similar activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities, respectively, should be included.
  
  
• The sponsor's report, briefly detailing the candidate's progress and performance during the prior year of support in terms of development into an independent investigator, should be included. Progress should be delineated in relation to the originally proposed Career Development Plan and Research Plan and this report should describe how weaknesses in these plans as identified by peer reviewers in the Summary Statement have been addressed and corrected. The sponsor should clearly substantiate that the candidate has at least 75 percent protected time toward research/research training.

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:

Belinda Locke
Comprehensive Minority Biomedical Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7031, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
FAX: 301-402-4551
Email: [email protected]

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone (301)-496-3428
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Kimery B. Griffin
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3196
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); and 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 (see the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, which is found at http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

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

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

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

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

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This funding opportunity 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 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 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov/.

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NIH Funding Opportunities and Notices

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