NCI Transition Career Development Award to Promote Diversity

Program Announcement (PA) Number: PAR-05-011

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)

Announcement Type
This Program Announcement (PA) replaces PAR-03-101, which was published in the NIH Guide on April 09, 2003.

Update: The following updates relating to this announcement have been issued:

Catalog of Federal Domestic Assistance Number(s)
93.398

Key Dates
Release Date: November 2, 2004
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Dates http://grants.nih.gov/grants/funding/submissionschedule.htm
Expiration Date: This PA will expire on January 3, 2008 (New Date December 17, 2007 per PAR-08-047)
(now January 8, 2008 per NOT-OD-07-093)


Additional Overview Content

Executive Summary

The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, Training and Resources (OCTR), Office of the Deputy Director for Extramural Sciences (ODDES), National Cancer Institute (NCI), invites transition career development award applications from recipients of the NCI Mentored Career Development Award for Underrepresented Minorities or from advanced postdoctoral and/or newly independent research scientists representative of groups underrepresented in biomedical, behavioral, clinical, or social sciences. The purpose of the NCI Transition Career Development Award to Promote Diversity (K22) is to provide "protected time" for recipients to develop and receive support for their initial cancer research program. This award is intended to facilitate the transition of underrepresented postdoctoral research scientists from the mentored to the independent stages of their careers in cancer research. The unique feature of this award is that the individuals may apply without a sponsoring institution while they are still in a mentored position.

Awards in response to this program announcement will be made through the Transition Career Development Award (K22) mechanism for a total project period not to exceed 3 years. Planning, direction, and execution of the proposed training program will be the responsibilities of the applicant on behalf of the applicant institution. Grants are not transferable from one principal investigator to another and they are non-renewable.

This award will provide salary up to $75K annually plus fringe benefits and up to $50K, direct costs, for research and development expenses. The total salary requested must be based annually on a full-time, 12-month staff appointment requiring the candidate to spend a minimum of 75 percent effort conducting cancer research with the remaining effort being devoted to activities related to the development of a successful research career. Facilities and administrative costs will be reimbursed at 8 percent of modified total direct costs. It is expected that 10 grants will be funded per fiscal year.

Although applications may be submitted for peer-review without institutional representation, if approved for funding, applications must be resubmitted on behalf of candidates by: for-profit or non-profit organizations; public or private institutions such as universities, colleges, hospitals, and laboratories; units of State and local governments; or, domestic institutions or organizations. Foreign institutions are not eligible to apply.

Eligible candidates include recipients of the NCI Mentored Career Development Award for Underrepresented Minorities and/or candidates who are individuals representative of groups underrepresented in biomedical research, i.e., individuals belonging to particular ethnic, racial, and other groups determined by the grantee institution to be underrepresented in biomedical, behavioral, clinical, or social sciences, for example, first generation college students/graduates, socio-economically disadvantaged persons, disabled persons. Individuals with disabilities are defined as those with a physical or mental impairment which substantially limits one or more major life activity. Eligible candidates must:

•  Possess a research or health professional doctoral degree (or its equivalent) suitable for a productive research career;

•  Have been in or currently be in a "mentored" research postdoctoral position and have completed 2 years or more of research in this capacity at the time of the application, or be in a suitable independent position for less than 2 years with continuous previous postdoctoral research training at the time of the application;

•  Intend to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and treatment that has the potential for establishing an independent research program; and,

•  Be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award.

Each applicant may submit only one application in response to this PA.

Telecommunications for the hearing impaired: 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
    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
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

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

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. 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, despite these efforts, projections made for 2004 indicated that 1,368,030 cancers are expected to be diagnosed in the United States and 563,700 Americans are 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. Specifically, past and current Surveillance Epidemiology and End Results (SEER) data show that Hispanic Americans have excessive cancer incidences of the prostate, breast, lung and bronchus, colon and rectum, and cervix. Native Americans from New Mexico show excessive cancer rates for prostate, breast, colon and rectum, ovary, kidney, and renal pelvis cancers, with the incidence rate for gall bladder cancer being the highest of any racial group. Alaska Natives have the highest cancer incidence rates among any racial group for cancer of the colon and rectum. Finally, cancer mortality rates for all sites for African Americans are almost 1.4 times greater than for Caucasians.

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 minority students and scientists in cancer research. Greater involvement of minority candidates, who possess the appropriate cultural perspectives, is integral to a successful national minority cancer research effort involving more minority patients and populations. Prior to 2000, progress in realizing a significant increase in the number of competitive minority cancer researchers had been disappointing. This K22 mechanism establishes a unique pathway for recruiting and retaining advanced postdoctoral students and new investigators (who can conduct independent competitive cancer programs) from groups that are underrepresented in biomedical research into investigative fields that address problems pertinent to the biology, etiology, pathogenesis, prevention, diagnosis, control, and treatment of human cancer.

See Section VIII. Other Information – Required Federal Citations for policies relation to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the Transition Career Development Award (K22) mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed 3 years. Grants are not transferable from one principal investigator to another. Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report (refer to “Section VI.4. Reporting”). Awards are not renewable.

This funding opportunity uses just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants1.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

2. Funds Available

The NCI Transition Career Development Award to Promote Diversity (K22) will provide salary up to $75,000 annually plus fringe benefits. The total salary requested must be based annually on a full-time, 12-month staff appointment requiring the candidate to spend a minimum of 75 percent effort conducting cancer research with the remaining effort being devoted to activities related to the development of a successful research career. 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 NCI 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 K22. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale.

Research Development Support: Up to $50,000 per year will be provided 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, fees, and books related to career development; and (d) travel to research meetings or for training. The level of research development support may be negotiated downward with the acquisition of any independent grant support from any source.

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

Facilities and administrative costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. Total cost for successful proposals range from $140K - $156K/budget period. In anticipation of funding 10 grants/fiscal year, the CMBB intends to commit approximately $1.6 million/fiscal year.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

The institution must be able to demonstrate a commitment to the development of the research careers of junior underrepresented minority research scientists in biomedical cancer research.

1.B. Eligible Individuals

Applicants are encouraged to contact the NCI program staff listed under “Section VII. Agency Contacts, Scientific/Research Contacts” regarding their eligibility for this award prior to the preparation of an application. Recipients of the NCI Mentored Career Development Award for Underrepresented Minorities and/or candidates who meet the following requirements are eligible to apply:

•  Qualify as an underrepresented minority individual defined as individuals belonging to particular ethnic, racial, and other groups determined by the grantee institution to be underrepresented in biomedical, behavioral, clinical, or social sciences, e.g., first generation college students/graduates, socio-economically disadvantaged persons or persons with disabilities;

•  Possess a research or health professional doctoral degree (or its equivalent) that is suitable preparation for a productive research career;

•  Have been in or currently be in a "mentored" research postdoctoral position and have completed two years or more of research in this capacity at the time of the application, or be in a suitable independent position for less than 2 years with continuous previous postdoctoral research training at the time of the application. Exceptions to this condition will require explicit written permission from the NCI; and

•  Intend to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis and treatment that has the potential for establishing an independent research program.

Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence by the time of award. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although they are not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible for this award. Federal employees are ineligible for this program. Women and persons with disabilities are encouraged to apply as Principal Investigators.

2. Cost Sharing
Cost sharing is not required.

3. Other-Special Eligibility Criteria

The NCI Transition Career Development Award (K22) to Promote Diversity can be used by more advanced postdoctoral and newly independent minority candidates who need protected time to establish their initial cancer research program. Accordingly, the award provides up to three consecutive 12-month appointments to recipients who must devote a minimum of 75 percent effort to the proposed basic, clinical, or population science research program. The remaining 25 percent can be divided among other activities only if they are consistent with the program goals, i.e., the candidate's development into an independent investigator.

Candidates must devote at least 75 percent of their full-time professional effort to cancer-related research and peer review activities consistent with the objectives of this award. The candidate must develop advanced knowledge in the basic, clinical, prevention, or population-based sciences and the advanced research skills relevant to her/his cancer research field(s). Recipients of an NCI Transition Career Development Award to Promote Diversity (K22) must submit a competitive research grant application to the NIH/NCI, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support.

The sponsoring institution, once identified, must have well-established basic, clinical, and/or prevention and population-based cancer research programs. The candidate's proposed cancer research program should benefit from the relevant cancer research and educational resources that are available. The sponsoring institution must also demonstrate a commitment to the development of junior faculty as productive, independent investigators.

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 have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. See Subsection VI.2., V.1, and V.3 “ of this announcement for additional information”.

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

Applications must be prepared using Section IV, "Research Career Awards" (RCA), instructions to complete the PHS 398 research grant application (rev. 5/2001). These instructions can be obtained within the table of contents on the following website, http://grants.nih.gov/grants/funding/phs398/phs398.html.

The application must address the following issues:

Candidate

For applicants already in an independent position:

All Candidates

Research Plan

Previous Mentor's Statement

Environment and Institutional Commitment

Biographical Sketch

A biographical sketch is required for the candidate, including information on research projects completed and/or research grants participated in during the postdoctoral or mentored phase that are relevant to the proposed project.

Training in the Responsible Conduct of Research

Candidates must describe previous training in the responsible conduct of research or if the candidate has not had such training, must describe plans to receive instruction in the responsible conduct of research. These plans must detail the 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 K22 program announcement and the award limits of the NCI. Provide a detailed description, with justification, for all equipment, supplies, and personnel that are required to achieve the research objectives of this award.

3. Submission Dates
Applications must be submitted on or before the receipt dates listed below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not applicable .
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm


3.A.1. Letter of Intent
Not applicable.

3.B. Sending an Application to the NIH

Applications must be prepared using Section IV, "Research Career Awards" (RCA), instructions to complete the PHS 398 research grant application (rev. 5/2001) as described above. Submit a signed, typewritten original of the application, 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
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0715

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
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428

Appendices should be comprised of unbound materials with separators between documents.

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NCI. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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


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

5. Funding Restrictions
All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Award Criteria). Other general policies related to award funding restrictions include the following policies.

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 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, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment;

•  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.

Usually, funds budgeted in a 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 re-budgeted. 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 NCI.

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 NCI is required. To obtain prior approval, the award recipient must submit a letter to the NCI describing the plan, countersigned by his or her department head and the appropriate institutional official. 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 career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Effective for all competing research grants submitted for the February 1, 2004, deadlines and beyond, mentored career award recipients in the last 2 years of career award support may hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This new policy can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

In situations other than those supported in the concurrent support policy cited above, 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 a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.

Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.

Furthermore, the awardee must submit assurance of his or her intention to return to full-time professional effort (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.

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

Awardees planning a change of institution are urged to contact the NCI Program Director (name listed in Notice of Grant Award) to discuss the transfer and obtain instructions. The required paperwork must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested at the new institution must be no more than the time remaining within the existing award period.

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

6. Other Submission Requirements

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 Principal Investigator for the application.

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 and at http://www.ott.nih.gov/policy/rt_guide_final.html.

The adequacy of the data sharing plan and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information


1. Criteria
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 NCI on the basis of established PHS referral guidelines.

Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below.  Incomplete and/or non-responsive applications will not be reviewed.

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

•  Receive a second level of review by the National Cancer Advisory Board.

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 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.

The following review criteria will be applied:

For candidates (i.e., Principal Investigators) already in an independent position:

o Suitability of the position for the candidate to pursue an independent research career;

For all Candidates:

o Quality of the mentored period of cancer research training in terms of research experience(s), didactic experiences, and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate's ability to pursue an independent cancer research career in the chosen area of research (e.g., basic research; clinical or patient oriented research; or prevention, control, and population research);

o Scientific productivity during the mentored period of cancer research training;

o Commitment of the candidate to an independent cancer research career that will be focused on problems clearly relevant to cancer;

o Potential ability to successfully manage an independent research project;

o Ability of the candidate to interact and collaborate with other scientists;

o Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research.

Research Plan

o Adequacy of the proposed research plan for developing an independent cancer research program as it relates to the basic, clinical, or patient-oriented and/or prevention control and population cancer research and commensurate with the candidate's level of research development;

o The originality and quality of the research hypothesis/question, design and methodology, judged in the context of the candidate's previous training and experience;

o Adequacy of plans 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. (See criteria included in the section on Federal Citations, below.)

Previous Mentor/Co-Mentor

o Strength of the previous mentor's statement describing the potential and capability of the candidate to become a successful independent investigator.

Institutional Environment and Commitment

o Clear commitment of the institution to ensure that a minimum of 75 percent of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a independent research career;

o Adequacy of research facilities and training opportunities;

o Quality and relevance of the environment for scientific and professional development of the candidate.

Training in the Responsible Conduct of Research

o Quality of the proposed/previous training in the responsible conduct

Budget

o Justification of the requested budget in relation to career development goals and research aims and plans; and

o Adequacy of the proposed budget items for the achievement of the career development and research objectives of the award.

3.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 Subject 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 Subject 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 (rev. 5/2001) will be assessed.


3.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.

3.C. Sharing Research Data

A data sharing plan is not required and reviewers will not factor in such a plan into the determination of scientific merit or the priority score.

3.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 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.

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. Award Criteria.

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, which is found at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm.

A formal notification in the form of a Notice of Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The Notice of Grant Award for successful candidates, will be sent to the sponsoring institution's Office of Sponsored Research via e-mail or paper copy.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General, at 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 at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

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

3. Award Criteria

The following will be considered in making funding decisions:

Candidates who have competed successfully for funding that do not have an institution at the time funding decisions are made will be notified by the NCI with a "Letter of Intent to Commit Funds." Candidates in a postdoctoral position will then have one-year from the date of the letter to find an institution that offers a position, preferably tenure-track, suitable for enhancing a research career. Candidates who have already identified positions will not receive the "Letter of Intent to Commit", but will be asked to submit the "Statement of Environment and Institutional Commitment" and to submit the Just-In-Time documents (detailed budget for initial budget period, detailed budget for entire project period, other support and checklist). For candidates who already have a position in a sponsoring institution, negotiation with the institution will begin without delay.

Negotiations will be initiated by asking the candidate's institution to submit a "Statement of Environment and Institutional Commitment" to the NCI. This statement will be evaluated by NCI staff using the following criteria:

•  Documentation of a strong, well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate;

•  Agreement of the institution's statement of commitment of equipment, physical and personnel resources with the peer-reviewed recommendation of needs;

•  Adequacy of the arrangements with the candidate to provide a permanent preferably tenure-track position, adequate facilities for conducting a research program, and additional resources conducive to the development of a research project and establishment of a successful research career.

For postdoctoral candidates, if the NCI approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to submit a completed PHS Form 398 application. For candidates who already have a position in a sponsoring institution, the NCI only needs to approve the Statement. After NCI approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated.

4. 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.

The Progress Report (PHS form 2590) will be evaluated based upon and should include:

Recipients of an NCI Transition Career Development Award to Promote Diversity (K22) must submit a competitive research grant application to the NIH/NCI, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support.

In addition to the information requested in the Application for Continuation Grant form PHS 2590 (Rev. 5/01), documentation must be provided with the Progress Report for the third year of the award showing that the awardee has submitted a competitive research grant (or equivalent) for funding. This documentation should minimally be a copy of the face page of the application with all required institutional signatures.

An award can be terminated prior to the end of the third year by the NCI if the candidate does not submit an R01 type grant application or equivalent for peer review before the end of the second year (refer to Section IV.5. Funding Restrictions).

In carrying out its stewardship of human resource related programs, the NCI 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 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:

Ms. Belinda M. Locke
Comprehensive Minority Biomedical Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7031, MSC 8350
Bethesda, MD 20892-8350
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: lockeb@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
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:

Ms. Kimery B. Griffin
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3196
FAX: (301) 496-8601
Email: griffink@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:
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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html.

Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (see the NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the Principal Investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials": at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/.

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. (See http://grants.nih.gov/grants/policy/data_sharing.)

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Human Embryonic Stem Cells (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 (see http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended by Public Law 99-158 (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.


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