Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Title: NCI Mentored Clinical Scientist Award to Promote Diversity (K08)

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

• December 16, 2008 - This PA has been reissued as (PAR-09-050).
• September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

• The Comprehensive Minority Biomedical Branch (CMBB), Office of Centers, Training and Resources (OCTR), National Cancer Institute (NCI), announces the availability of Mentored Clinical Scientist Awards to Promote Diversity for career development of individuals from groups that have been shown to be underrepresented in health-related science who have obtained health professional doctoral degrees (e.g., M.D., D.D.S., D.O., O.D., D.V.M., D.N.Sc., N.D., Pharm.D.). This award provides specialized study for those who are committed to a career in laboratory or field-based cancer research (not patient-oriented research).
• The goal of the NCI CMBB K08 is to diversify the pool of laboratory or field-based cancer investigators. The NCI CMBB recognizes a unique and compelling need to promote diversity in laboratory and field-based research. The CMBB expects efforts to diversify the workforce in these areas to lead to the recruitment of the most talented researchers from all groups. Accordingly, this award forms an important part of the NCI initiative to attract talented underrepresented individuals to the challenges of cancer research.
• Candidates eligible for support under this award include individuals with health professional doctoral degrees who come from groups that have been shown to be underrepresented in science. Such candidates include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds. Detailed eligibility criteria are described in the full announcement (see Section III 1.B.).
• Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence and must have completed their clinical training, including specialty training, and, if applicable, subspecialty training prior to receiving an award. Additionally, candidates should have broad clinical training, must demonstrate competence in clinical activities, and must document a serious intent for a research career in patient-oriented clinical oncology.
• The K08 application may be submitted on behalf of the candidate by any Domestic, for-profit or non-profit institution/organization, or pubic or private institutions, such as universities, colleges, hospitals, and laboratories. Foreign institutions and organizations are not eligible to apply for this award.
• This mechanism provides up to $75,000 for salary plus benefits and up to $30,000 in research development support. The awards will be for a project period of 3 to 5 years of supervised study and research experience that may integrate didactic studies with clinically based research.
• The candidate must be able to commit a minimum of 75 percent of full-time professional effort conducting patient-oriented research and relevant career development activities. Planning, direction, and execution of the proposed career development program and research project will be the responsibility of the applicant and his/her mentors. Receipt of prior support may impact eligibility. Grants are non-renewable and cannot be transferred from one principal investigator (PI) to another.
• The total amount to be awarded and the number of anticipated awards will depend upon the quality, duration, and costs of the applications received as determined by the peer review process, available funds, and program priorities.
• The applicant for this K award may not concurrently apply for or have an award pending for another NIH career development award. Up to two revisions of an application will be accepted.
• See Section IV for application and submission information.
• Telecommunications for the hearing impaired is available at TTY 301-451-5936.

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. 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. Review Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This award will provide an opportunity for the underrepresented health professional that has been recently clinically trained, is a practicing clinician, or has limited laboratory or field-based research experience, to gain sufficient research expertise to pursue a career in laboratory or field-based biomedical cancer research. Candidates must have the potential to develop into independent investigators. The K08 mechanism supports a supervised research experience that integrates didactic studies with laboratory or field-based research. The proposed research must have intrinsic research importance as well as serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well-trained independent researcher.

The K08 mechanism provides the awardee, through multidisciplinary didactic training, the opportunity to obtain both the knowledge and the research skills necessary to compete for independent support in laboratory or field-based research. It is anticipated that candidates for this award may or may not have had a traditional research-intensive experience and will represent many different stages of career development. Because of this, the NCI "Mentored Clinical Scientist Award to Promote Diversity" places considerable emphasis on the experience, continued involvement and commitment of the mentor during the candidate's development. To ensure progression to independence, the prospective candidate should propose a period of study in which the mentor has carefully tailored the candidate's career development plan to build upon his/her previous training and background. For example, a candidate with limited experience in a given field of research and/or a unique cultural background may find a phased 5-year developmental program that includes a designated period of specialized didactic training and a more intensely supervised research experience to be the most efficient means of attaining independence. A candidate with substantial previous research experience may require a shorter award period and less specialized attention from the mentor in order to facilitate the transition to independence.

The NCI is especially interested in increasing the number of underrepresented clinicians trained to conduct high quality, laboratory or field-based research. Accordingly, this award forms an important part of the NCI initiative to attract talented individuals representative of groups shown to be underrepresented in biomedical science.

The purposes of these awards are to:

• Increase representation of underrepresented physician-scientists engaged in cancer research;
• Develop the research careers of recently trained underrepresented individuals who hold a health-professional degree or its equivalent, or who are doctorally-trained oncology nurses;
• Capture those underrepresented health professionals with variable backgrounds in clinical practice and limited or no investigative science experience to re-direct their careers toward cancer research by acquiring critical research skills in a mentored research environment; and
• Provide an opportunity for underrepresented clinicians engaged in other research areas for less than 2 years, to re-direct their research focus to cancer research.

Clinically trained underrepresented professionals who are interested in a career in patient-oriented research should apply for the "Mentored Patient-Oriented Research Award to Promote Diversity (K23), which can be found at PAR-06-222. A definition of patient-oriented research is provided in the K23 announcement, which is available on the NCI website at http://minorityopportunities.nci.nih.gov.

The CMBB will provide successful candidates with special opportunities to enhance their knowledge and understanding of the NIH/NCI peer review system and to develop the skills required for preparing competitive research project grants.

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

Section II. Award Information

1. Mechanism(s) of Support

Awards in response to this program announcement will be made through the Mentored Clinical Scientist Development Award (K08) mechanism. Planning, direction, and execution of the proposed training program will be the responsibilities of the applicant and his/her mentor(s) on behalf of the applicant institution.

The career development award will be for a period of up to 5 years. Each award is non-renewable and non-transferable from one principal investigator (PI) to another.

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

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs for each year and the entire proposed period of support and budget justification information.

2. Funds Available

Allowable Costs

Salary Support: The NIH will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12-month staff appointment. 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. For information regarding NIH policy on determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The NCI will provide up to $75,000 annually plus fringe benefits to offset the full-time salary requirements of the candidate. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08 award (e.g., patient care duties, administrative and teaching duties). Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-031.html

Mentored career award recipients in the last 2 years of career award support may reduce effort on the career award to a minimum of 50 percent and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a PI or subproject Director of the research grant. This new policy can be found at the following web site: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

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

Research Development Support: NCI will provide generally up to $30,000 per year for the following expenses: (a) tuition and fees, related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; (c) travel to research meetings or training; (d) statistical and computational services including personnel and computer time; and e) travel to an annual 2-day NCI awardee meeting and/or peer review related training expenses. All expenses must be directly related to the proposed research career development program. In exceptional cases, the Research Development Support costs may be as high as $50,000, but such costs will only be awarded in those cases where the need for such higher costs is well documented and adequately justified. Prospective candidates should contact the NCI component to which the application is targeted to ascertain the maximum contribution for research and development support.

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

The number of awards and the total amount of funding that NCI expect to award through this funding opportunity will depend on the number and quality of the applications. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit and non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic institutions
• Foreign institutions and organizations are not eligible to apply for this award.

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

1.B. Eligible Individuals

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

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

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

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

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

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

This award provides an intensive, supervised research experience for individuals representative of groups underrepresented in health-related science who have health professional degrees (e.g., M.D., D.D.S., D.O., O.D., D.V.M., N.D. [Doctor of Naturopathy], Pharm.D. degrees) or their equivalents, or are doctorally-trained oncology nurses to acquire research experience in laboratory or field-based cancer research. Individuals with the Ph.D. or other doctoral degrees in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, and rehabilitation are also eligible. Individuals holding the Ph.D. in a non-clinical discipline, but who are certified to perform clinical duties should contact CMBB concerning their eligibility for a K08 award (see "Section VII. Agency Contacts").

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Candidates for the award should have broad clinical training, must demonstrate competence in clinical activities, and must document a serious intent for a cancer research career. They may have variable academic/clinical appointments with little or no research experience or they may be experienced in other research areas with a desire to re-direct their research focus and acquire new research capabilities in laboratory or field-based cancer research. The candidates must be nominated by institutions on the basis of qualifications, interests, accomplishments, motivation, and potential for careers in laboratory or field-based cancer research. Women and persons with disabilities are encouraged to apply. Evidence of the institution's commitment to the applicant's research development must be documented and this documentation should be tailored to the candidate's experience and needs.

Candidates must identify a suitable sponsor (i.e., mentor) with extensive research experience who has an appreciation of the cultural, socioeconomic, and research backgrounds of the individual candidate and who fully recognizes the individual attention that minority candidates often need to pursue successful research careers. The mentor, with input from the candidate, will be responsible for the planning, direction, and execution of a tailored career development plan specific to the applicant's particular career development needs.

Candidates must be willing to devote a minimum of 75 percent professional effort conducting research and career development. The remaining 25 percent effort can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K08 Award, i.e., the candidate’s development into an independent investigator in laboratory-based research. The candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have U.S. Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Potential candidates should contact Program staff to discuss their eligibility prior to preparing an application. See Section VII. Agency Contacts.

2. Cost Sharing or Matching
Cost sharing is not required.

3. Other-Special Eligibility Criteria

A candidate for an NIH K08 award may not simultaneously submit or have an application pending for any other career award (e.g., K01, K07, , K22, K23, K25), a research project grant (R01), or any PHS award that duplicates any of the provisions of the K08 award. Ineligible individuals include current and former PIs on NIH Research Project Grants (R01) or comparable Career Development Awards. Former PIs of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21), and sub-projects of a Program Project (P01), Center Grant (P30), or Specialized Center Grant (P50) remain eligible.

K08 recipients are encouraged to apply for independent research grant support during the latter period of this award. K08 award recipients that obtain independent support during the K08 award period may hold concurrent research support, and under certain circumstances salary support from their career award and a competing NIH research project grant when recognized as a PI or subproject Director of the research project grant (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).

Program: Support will be provided for up to five consecutive 12-month awards. At least 75 percent of the recipient's full-time professional effort must be devoted to the goals of this award. For the purposes of this award, full-time professional effort provides protected time away from normal activities (e.g., standard patient care and on-call duties, and administrative and teaching assignments). The 75 percent effort includes activities consistent with development of the minority candidate into a competitive independent physician-scientist (e.g., acquisition of laboratory skills and didactic courses). The remainder (25 percent effort) may be devoted to clinical, teaching, or other research pursuits as long as they are consistent with the objectives of the award (i.e., to train a clinical scientist who can compete successfully for NIH support). Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.

Mentor(s): Each applicant must name a primary mentor who is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator, be sensitive to the individual needs of the minority candidate, have a proven record of success in training independent investigators, and demonstrate a strong, continuous commitment to the candidate throughout the period of training. Candidates may also nominate co-mentors in each area as appropriate to the goals of the program. Where feasible, women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. The mentors should have sufficient independent research support to absorb the costs of the proposed research project in excess of the allowable costs of this award.

Career Development: Because of the focus on progression to independence as researchers, candidates for the K08 should propose, together with their mentor, a period of study and career development consistent with the previous research and clinical experience of the candidate. As appropriate, sensitivity to the individual needs should be considered. For example, a candidate with limited experience in a given field of research may find a 5-year phased developmental program that includes a designated period of specialized didactic training followed by a research experience that is very closely monitored by the mentor necessary to insure that he/she will attain independence. A candidate with previous research experience and training may not require extensive additional didactic preparation, and a program that focuses primarily on an intensive, supervised cancer research experience may be appropriate.

All programs must be tailored to meet the individual needs of each minority candidate to provide the opportunity for him/her to gain the skills and knowledge necessary to carry out high quality cancer research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The mentor must carefully monitor the candidate's progress throughout the career development program. If necessary, an advisory committee can be formed to assist with the development of a program that meets the candidate's needs. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the minority candidate.

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

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

See also Section VI.2 for additional information

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

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

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times

Applications must be mailed on or before the receipt date described at http://grants.nih.gov/grants/funding/submissionschedule.htm.

See Section IV.3.A for details.

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

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

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity. .

3.B. Sending an Application to the NIH

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

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

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

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement prior to award (Section III).

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

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

An NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject. The K-award recipient must be the named PI on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.).

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

Research Development Support: The research development support costs allowed for this program must be carefully justified annually and must be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

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

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

6. Other Submission Requirements

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

CANDIDATE

• Describe the candidate's research background, and note any issues, as appropriate, that have already affected or may affect the pace of the candidate's career development.
• Describe the candidate's commitment to a career in laboratory or field-based cancer research (candidates interested in patient-oriented research should consider the Mentored Patient-Oriented Research Career Development Award to Promote Diversity [K23]).
• Establish the candidate's potential to develop into an independent investigator.
• Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment.
• Indicate a minimum commitment of at least 75 percent professional effort to research career development activities. The candidate should give a clear overall description of the types of research/research training activities that he/she will be involved in within the 75 percent effort versus an overall description of "other activities" and the percent effort involved.
• Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a research career must be included as part of the application. Letters must be from individuals other than the designated mentor(s).

MENTOR/CO-MENTOR(S) STATEMENT(S)

• The application must include a statement from the mentor(s) including information on their qualifications in the research area proposed by the candidate and previous experience as a research supervisor.
• The application must also include detailed information that describes the nature and extent of supervision that will occur during the proposed award period. This information must detail how the career plan will build upon the candidates unique research background, take into account the unique needs of the candidate, as appropriate, and enhance the candidate's research development toward independence.
• Any co-mentor must provide similar information and their respective area of expertise and responsibility should be described.

CAREER DEVELOPMENT PLAN

• The career development plan should be a joint effort between the applicant and his/her mentor and carefully tailored to the candidate's needs demonstrating an appreciation, as appropriate, of the candidates cultural, socioeconomic and research background and the particulars required to develop the applicant into an independent physician-scientist engaged in cancer research.
• Describe the career development plan incorporating consideration of the candidate's goals and prior experience. A systematic plan should be presented for obtaining the necessary basic cancer research background to launch an independent research career.
• The plan must include justification for the need for a 3-, 4-, or 5-year period of mentored research experience. Relatively junior candidates with little previous research experience may require a phased developmental period during which the first year(s) of the award are largely of a didactic nature followed by a period of intense, supervised research experience.
• Candidates with more experience at the time of the application may require a shorter development period that includes mostly additional basic research training with little or no didactic component.
• In any case, the career development plan must be tailored to the needs of the candidate and the ultimate goal of the candidate achieving independence as a researcher.

RESEARCH PLAN

A description of the research plan and the use of a basic science approach to a biomedical or behavioral problem as it relates to cancer. The research plan must be described as outlined in PHS form 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. The candidate should consult with the mentors regarding the development of this section.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

• The sponsoring institution must document a strong, well-established research and training program related to the candidate's area of interest and a high-quality research environment with staff capable of productive collaboration with the candidate.
• A signed statement from the candidate and an institutional official establishing the eligibility of the candidate for support under this program.
  • The statement must include clearly presented information on citizenship as well as the nature of the candidate's disability, circumstances, background, or characteristics that confer eligibility under this program (see eligibility classes listed in Section III, Part 1.B).
• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive independent investigator.
• The institutional statement also must commit to provision of release time from normal clinical, teaching or administrative duties necessary to meet the 75 percent effort requirement of this award. The institutional statement should clearly indicate activities included within the 75 percent protected time.

LETTERS OF REFERENCE

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator in laboratory or field-based research. All sealed letters of reference should be attached to the face page of the application.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

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

BUDGET

The total direct costs requested must be consistent with this K08 program announcement and the award limits of the NCI. Budget requests must be provided according to the instructions in form PHS 398, Section III, Instructions for the Career Development Awards (CDA). The request for tuition and fees, travel, research development support, etc., must be justified and specified by category. Applicants seeking information on award limits should contact the financial representative (see Section VII. Agency Contacts).

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information

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

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

2. Review and Selection Process

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
• Receive a written critique; and
• Receive a second level of review by the National Cancer Advisory Board.

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

• Scientific merit of the proposed project as determined by peer review;
• Relevance of the proposed career development program, prior training, and commitment of the applicant to become an independent cancer researcher;
• Relevance to program priorities; and
• Availability of funds.

Review Criteria

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

CANDIDATE

• Quality of the candidate's professional background, that will represent an important addition to the cancer research community as a well-trained scientist;
• Adequacy of the candidate's research, academic and/or clinical record as a foundation for developing as an independent cancer researcher;
• Strength of the commitment of the candidate to a cancer research career;
• Appropriateness of the dedicated 75 percent effort to the successful development as a cancer researcher; and
• Strength of the letters of recommendation.

MENTOR/CO-MENTOR(S)

• Evidence that the mentor has participated in the development of the Career Plan, is sensitized to providing individual needs of the candidate and is willing to go beyond the traditional efforts that a mentor dedicates to a trainee in his/her research environment;
• Appropriateness of the mentor(s) research qualifications in the area of this application;
• Quality and extent of the mentor(s) proposed roles in providing guidance and advice to the candidate;
• Track record of research productivity;
• Previous experience in fostering and mentoring the development of researchers; and
• Adequacy of the research support to the mentor to ensure that the proposed project can be conducted unimpeded for the proposed research project.

CAREER DEVELOPMENT PLAN

• Appropriateness of the content, phasing, and duration of the candidate's development plan in relation to his/her experience and background to become an independent scientist;
• Conformity of the plan to 75 percent effort devoted to research/research training activities;
• Adequacy of considerations in the plan that tailor it to the individual needs of the candidate's experience and background, as well as to any important factors, as appropriate, that could effect the pace of the candidate's successful development; and
• Likelihood that the plan will contribute substantially to the achievement of scientific independence.

RESEARCH PLAN

• All research plans must include fundamentally sound research approaches, but reviewers should consider the applicant's research experience and cultural background, as appropriate, and especially evidence that the mentor is committed and involved (see Mentor/Co-mentor above);
• Reviewers should recognize that candidates may have variable degrees of research experience; those with more limited experience are less likely to prepare a plan with the breadth and depth of that submitted by more experienced investigators unless the mentor plays a significant role;
• Scientific and technical merit of the research question, design, and methodology;
• Relevance of the proposed research to the candidate's career objectives;
• Appropriateness of the plan to experience and stage of development of the candidate as a vehicle to assuring that the candidate achieves his/her career goals and objectives as an independent scientist; and
• Adequacy of plans for including women, minorities, and children, as appropriate, for the scientific goals of the research, or justification for exclusion.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

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

LETTERS OF REFERENCE

Strength of the letters of reference.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

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

BUDGET

Justification of the requested budget and duration in relation to the career development and research aims.

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both-genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates
Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

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

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

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

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

• 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 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 NIH awarding component.

Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130).

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K08 award will continue during such leave.

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

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

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

Changes in Research or Career Development Program: See Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, program staff could recommend that the award be terminated. Awardees should contact NCI program staff listed in Section VII of this announcement in consideration of any proposed changes in the specified scientific area of the research component of the career development program.

Change of Institution or Termination: Consultation with the applicable NIH program staff is strongly encouraged when either a change of institution or termination is being considered, see Section VII of this announcement for NIH/NCI program staff contact information. A change of institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project, and the qualifications of the proposed new mentor. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the PI is moving to another eligible institution, career award support may be continued provided that the following conditions are met:

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

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Note that the instructions for Research Career Development applications must be followed for this program, http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Non-competing Grant Progress Report

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

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

A final Progress Report, Invention Statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

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

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

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 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone (301) 496-496-3196
Email: [email protected]

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 institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance No. 93.398 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov/.

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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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