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: Established Investigator Award in Cancer Prevention & Control

Announcement Type
This is a reissuance of PAR-03-149, which was previously released July 8, 2003.

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

Program Announcement (PA) Number: PAR-05-145

Catalog of Federal Domestic Assistance Number:
93.393, 93.398, 93.399

Key Dates
Release Date: July 28, 2005
Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: New Date January 23, 2009 (per issuance of PAR-09-088) (Original Expiration Date: July 2, 2008 , changed to January 8, 2010 per NOT-OD-08-069 and September 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I. Overview Information

Part II. Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

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

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

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt, 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 Objectives

The objective of the NCI Established Investigator Award in Cancer Prevention and Control (K05) is to provide qualified researchers with protected time to devote to research and mentoring. The award is designed for established scientists who have already demonstrated a sustained, high level of research and mentoring productivity and who need K05 support to continue these activities. The award provides partial salary support for up to 5 years and for up to 50 percent effort. It is renewable for one additional 5-year period. Examples of cancer prevention and control research and mentoring activities supported by this funding opportunity include, but are not limited to, the following areas:

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the K05 award mechanism. The Established Investigator Award in Cancer Prevention & Control is a special NCI modification of the NIH Senior Scientist Award or K05 grant mechanism. As an applicant, the candidate is solely responsible for planning, directing, and executing the proposed project. In addition, the institution must demonstrate a commitment to the candidate and the candidate's goals for research, career development, and mentoring.

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 PHS 398 (Section III) instructions for budget information, providing only the total direct costs requested for each year and for the entire proposed period of support, and provide budget justification information.

2. Funds Available

Applications received in response to this program announcement will compete for funds in the general funding pool of NCI. No specific funds have been set aside for this announcement. The number and size of the awards will depend on the number of applications received, their relative scientific merit (as determined by the peer review process), their cost, and the general availability of funds for training and education grants.

The project period may be for up to 5 years (at least 3 years are required). Awards are renewable for one additional 5-year period if the candidate still meets the stated requirements.

Facilities and administrative (F&A) costs for grantee institutions and third party institutions will be budgeted and reimbursed at a rate of 8 percent of modified total direct costs, exclusive of tuition and fees, expenditures for equipment, and sub-grants and contracts in excess of $25,000.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit application if your organization has any of the following characteristics:

For-profit organizations;
Non-profit organizations;
Public or private institutions, such as universities, colleges, hospitals, and laboratories; and
Domestic Institutions.
Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research and mentoring are invited to work with their institution to develop an application. Applications from underrepresented racial and ethnic groups as well as from individuals with disabilities are encouraged. The following eligibility requirements also apply to individuals who wish to become K05 principal investigators.

Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. 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 under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Candidates must have a doctoral degree or its equivalent. Included in this category are individuals with health-professional doctoral degrees (e.g., M.D., O.D., Ph.D. in nursing or in clinical or health psychology) and individuals with non-clinical doctoral degree (e.g., research Ph.D.'s. in epidemiology, behavioral sciences, social psychology, and/or genetics).

Candidates must be able to commit a minimum of 25 percent time (but no more than 50 percent) time to the activities proposed in the award application. The remaining effort can be divided among other research, clinical, and teaching activities. 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. Candidates with VA appointments should consult NCI administrative staff to determine their eligibility for the K05 grant.

K05 awards are not transferable from one awardee to another.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Candidates should demonstrate a strong track record of mentoring new investigators.

Candidates for a K05 grant may not simultaneously submit or have pending an application for any other U.S. Public Health Service (PHS) senior level career award. However, current and former recipients of mentored and transitional career awards may apply for the K05 grant.

Candidates should be established cancer prevention and control researchers with strong track records of publications and a history of success in obtaining cancer prevention and control research support.

Candidates must have peer-reviewed, independent research support at the time of the award. This requirement may include having principal investigator (PI) status on funded NIH R01, P50, and/or P01 grants. Also included as eligible NIH support is status as a project leader on a peer-reviewed scientific subproject of a P50 or P01 grant. Other eligible support includes non-PHS peer reviewed research grants that are over $100,000 direct costs per year. Recipients of a K05 award may receive concurrent salary support from their career award and other competing NIH research grants. Small grants (R03s) or developmental grants (R21s) are not considered independent support for purposes of K05 eligibility, but the K05 awardee may draw also salary from these mechanisms.

One exception to the requirement for peer-reviewed, independent research support is made for scientists whose work is primarily theoretical. These individuals may apply for a K05 grant in the absence of research grant support, if institutional commitment includes stability of salary and research support and the candidate's records of publication, scientific leadership, and mentoring are strong.

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

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

Supplementary Instructions for applying for Career Awards are located in the PHS 398, Section III, starting on page 44.

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

3.A. Submission, Review, and Anticipated Start Dates

Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1 Letter of Intent
A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

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

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Appendices 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 dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt, applications will be evaluated for completeness by CSR and responsiveness to the program announcement by the NCI. Applications that are incomplete and unresponsive will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. 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 Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

In general, allowable costs on K05 grants must be consistent with NIH policy and the recommendations of peer reviewers. Allowable costs include the following items.

Salary: The award provides the recipient with annual salary support (up to the current Federal salary rate limit) for 25-50 percent effort plus fringe benefits. The award also provides $25,000 per year in research-related expenses. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. The total salary requested must be based on a full-time, 12-month staff appointment and the level of effort proposed. It 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 award will also provide fringe benefits on the calculated base salary at the established institutional rate.

Recipients of this award may derive additional compensation for effort associated with other federal sources or awards provided the total salary derived from all Federal sources does not exceed the current Federal salary rate limit and their total percent effort on all awards does not exceed 100 percent. Direct salary is exclusive of fringe benefits, indirect costs/ facilities, and administrative expenses.

Research Development Support: It is expected that candidates for a K05 award will have active, independent research support at the time of the award (see eligibility requirements). However, the K05 award provides additional funds up to $25,000 direct costs 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) statistical and computational services including personnel and computer time; and (d) travel to research meetings or training.

Ancillary Personnel Support: Salaries for secretaries, administrative assistants, and other ancillary personnel are not allowed.

Facilities and administrative (F&A) costs for grantee institutions and third party institutions will be budgeted and reimbursed at a rate of 8 percent of modified total direct costs, exclusive of tuition and fees, expenditures for equipment, and sub-grants and contracts in excess of $25,000.

Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such funds 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 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; and/or awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See 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 Supplemental Instructions in the PHS 398 for Research Career Awards (Instructions, Part 111, starting on page 44), the following information must be included in the K05 application:

Candidate

The candidate should describe current and long-term career objectives in cancer prevention and control research and in the mentoring of new investigators.

In addition to information about scientific and professional activities in the required biographical sketch, the candidate should provide narrative information documenting high-level scientific skills and a continuing commitment to a research career.

Since mentoring is an essential component of the K05 award, the candidate must also provide evidence of past mentoring as well as specific plans to mentor new investigators. This evidence should include information on the number of mentored individuals past, current and proposed; their scientific and professional backgrounds at the time of the mentoring experience, the candidate's role in their mentoring (i.e., research advisor, clinical mentor, etc.) and the specific scientific projects which served as vehicles for the mentoring. In order to judge the success of past mentoring and the likely impact of future mentoring, information in this section may list relevant research accomplishments and publications of past mentees (resulting from activities with the mentor as well as from the current positions of the past mentees).

Training in the Responsible Conduct of Research

Applications must include a description of a program to provide formal or informal instruction in the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, and 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 PHD-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Applications should document prior instructions in or proposed plans for instructions in the responsible conduct of research for the PI and mentees including subject matter of and duration of instruction. An award cannot be made without this information.

Justification for the Award

In justifying the need for the K05 award, it is important for the candidate to convey reasons for needing protected time to continue a vital research program and to continue to engage in the mentoring of new scientists. An explanation should describe how the salary support of the K05 will free up the candidate's time from patient care and/or administrative duties and thereby contribute to the development or expansion of the candidate's research program and an increased level of mentoring new investigators.

Research Plan

This plan should establish goals for the candidate's research as related to the support provided by the K05. The proposed percent effort commitment of the candidate to the research plan should be stated. The plan should distinguish between the candidate's ongoing research activities and those that would occur as a result of the K05 support.

The information in the research plan is not meant to duplicate the listing of current, recent and pending research support included in the candidate biographical information. It is intended, however, to provide summary information. The level of detail in the research plan on study design and methods is not expected to equal that in an R01 application. The plan should provide information for current and proposed research sufficient to understand major study hypotheses, research design(s), and methods. The section should contribute to appreciation of the significance of the candidate's research and the level of scientific productivity.

The research plan should also indicate how the proposed activities will contribute to the continued growth and refinement of the candidate's research skills and/or research directions.

Mentoring Plan

The mentoring plan for the K05 candidate should describe the settings from which mentees will be drawn. This description should include information on the availability of a pool of mentees with appropriate backgrounds and interests in cancer prevention and control research. The mentoring plan should provide evidence of the candidate's commitment to mentoring, as seen in previous mentoring activities. The mentoring plan should provide information on the candidate's past and proposed mentees sufficient to evaluate the quality of prior mentoring experience, including professional levels of mentees, the frequency and kinds of mentoring experiences received in interactions with the candidate, and the productivity of the mentoring relationship for the scientific development of the new scientist as judged by their publications and current research activities. K05 candidates should describe any financial and material support from their own funded research and research resources that will be available to their mentees. The candidate's proposed percent effort commitment to the mentoring plan should also be stated.

Environment and Institutional Commitment

Evidence should be provided of institutional commitment to enhancing the candidate's ability to be a productive, independent investigator. The K05 application should include a description of facilities and resources available to the candidate and their appropriateness for the candidate's proposed research and career enhancement activities and for the mentoring activities. In addition, letter(s) of commitment from institutional officials should demonstrate a commitment to providing the candidate with protected time for research and mentoring activities, including the percentage of time to be freed up by the institution if K05 funding is obtained and a description of the specific duties the candidate will be relieved of and how these duties will be covered by other institutional personnel and resources.

Budget for the Entire Proposed Period of Support

This funding opportunity uses just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. The format for initial and proposed budget pages, which are provided in the PHS 398 grant application template should be followed (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Plan for Sharing Research Data
Not applicable

Sharing Research Resources

NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see 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 submitted for this funding opportunity will be assigned to the NCI on the basis of established PHS referral guidelines.

As part of the initial merit review, all applications:

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

Review Criteria

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In written comments, reviewers will be asked to evaluate applications in order to judge the likelihood that the proposed research and mentoring activities will have a substantial impact on the pursuit of these goals. 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 scientific review group will address and consider all aspects of each of these criteria as described below in assigning a score to the application.

Candidate:

What is the quality of the candidate's academic and research record, and track record as a leader of a productive research program? Is there evidence in the application of ongoing high-quality research in cancer prevention, control, behavioral, or population sciences? Is that research clearly related to the proposed K05 program? Does the candidate have a strong track record of obtaining research support in the cancer prevention and control, and a strong track record in mentoring or training of junior investigators?

Justification:

Is there evidence that the proposed program and protected time will relieve the candidate of existing clinical and/or administrative duties to permit additional time for research and mentoring?

Research Plan:

Is the research plan an appropriate vehicle for developing and refining skills and capabilities in cancer prevention, control, behavioral, or population sciences research? What is the scientific and technical merit of the ongoing and newly proposed research? What is the likelihood that the research will contribute significantly to the scientific knowledge base? Is the duration of the proposed program appropriate? Are adequate resources available to conduct the research program? Is the proposed level of effort committed to the Research Plan appropriate?

Mentoring Plan:

Does the candidate have the experience and potential to serve as a mentor to junior investigators in cancer prevention and control research? Is the mentoring plan adequate in describing how the candidate will mentor junior investigators? Has the candidate proposed an appropriate level of effort for the mentoring plan?

Environment and Institutional Commitment:

What is the quality and relevance of the environment for scientific and professional development of the candidate and trainees pursuing research in cancer prevention, control, behavioral, or population sciences? Is the applicant institution clearly committed to providing the candidate with adequate protected time for research, career development, and mentoring activities proposed in the K05 award?

Training in the Responsible Conduct of Research

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

2.A. 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 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 5 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, a determination will be made of the adequacy of the proposed protection.

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 award 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 data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and 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.

2.D. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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

A formal notification in the form of a Notice of Grant Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the 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:

A. Evaluation

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

B. Other Income

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

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

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

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

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

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

C. Special Leave

Leave to another institution, including a foreign laboratory, may be permitted if 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 NCI is required. This request must be countersigned by the appropriate business official at the grantee institution and at the new institution/facility. This request must include the reasons for the leave and must provide a description of the provisions that will be made to ensure that the awardee will be able to continue meeting the special requirements of this award, including for a suitable research environment and for opportunities to mentor junior investigators during the period of leave. Details on the process for submission of prior approval requests can be found at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm.

NCI staff will review the request and notify the principal investigator and the new grantee institution of the results of this evaluation. 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 K05 award will continue during such leave.

Leave without award support may not exceed 12 months. Leave without support requires the prior written approval of the NCI and will be granted only in unusual circumstances. Parental leave will be granted consistent with the policies of the NIH and the grantee institution.

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 K05 grant support for which an individual is eligible.

D. Termination or Change of Institution

Consultation with NCI program staff is strongly encouraged when either termination or a change of institution is being considered. When a grantee institution plans to terminate or transfer a K05 award, the NCI grants management specialist listed in this award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.

When a grantee institution plans to terminate an award, a relinquishing statement must be submitted by the institution. If the request also includes a change of institution, a transfer application must be submitted by the new institution. This package should be available to NCI staff at least 3 months prior to the transfer in order to allow the necessary time for administrative review.

A change of institution request normally will be permitted only when all of the benefits attributable to the original grant can be transferred. The K05 awardee must establish in the transfer application that the specific aims of the program to be conducted at the new institution are within the scope of the original peer reviewed research program including both research and mentoring aims.

The period of support requested may be no more than the time remaining within the existing award period. Review of materials submitted is usually carried out by NCI staff. However, depending upon the circumstances, the NCI may also require a review by an initial review group and/or the National Cancer Advisory Board.

NCI 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, NCI will notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

E. Changes in Career and Research Plan

A change in the scientific area of the research component of the award requires prior approval of the awarding NCI staff. 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 NCI staff 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.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually. Note that the instructions for career award applications must be followed for this program (see http://grants.nih.gov/grants/funding/2590/2590.htm). Financial statements must be submitted 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 progress will depend on the following:

A final Progress Report, Invention Statement, and Financial Status Report are required upon either termination of an award or when an award is relinquished as a recipient changes institutions.

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:

Mary C. Blehar, Ph.D.
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7019, MSC 8346
Bethesda, MD 20892-8346 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service )
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: mblehar@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Bill Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852-7150 (for express/courier service)
Telephone: (301) 496-8796
Email: wellsw@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://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).

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

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

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

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

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

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 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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