MENTORED PATIENT-ORIENTED RESEARCH FOR UNDERREPRESENTED MINORITIES (K23)

RELEASE DATE:  October 7, 2002 (see modification NOT-CA-03-024)

PA NUMBER: PAR-03-006

EXPIRATION DATE: October 2, 2005, unless reissued.

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

This Program Announcement (PA) replaces PAR-00-042, which was published in the 
NIH Guide January 14, 2000.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Non-Competing Renewals
o Required Federal Citations

PURPOSE OF THIS PA 

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), announces the availability 
of the "Mentored Patient-Oriented Research for Underrepresented Minorities" 
award for career development of underrepresented minorities in clinical 
oncology. This award provides specialized study for individuals with a health 
professional doctoral degree (e.g. M.D., D.D.S., D.O., O.D., D.V.M., D.N.Sc., 
N.D. [Doctor of Naturopathy], Pharm D.), who are committed to a career in 
patient-oriented cancer research.   Individuals with a 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 certified to perform clinical duties should contact 
CMBB concerning their eligibility for a K23 award (SEE INQUIRIES). The 
purposes of this award are to:

o Encourage research-oriented underrepresented minority clinicians to develop 
independent research skills and gain experience in advanced methods and 
experimental approaches needed to conduct patient-oriented research,

o Capture those underrepresented minority health professionals with variable 
backgrounds in clinical practice and limited or no clinical research 
experience to re-direct their careers toward clinical cancer research by 
acquiring critical research skills in a mentored clinical research 
environment,

o Provide an opportunity for minority clinicians engaged in other clinical 
research areas for less than two years, to re-direct their research focus to 
clinical cancer research, and

o Increase the pool of underrepresented minority clinical researchers who can 
conduct patient-oriented studies, capitalizing on the discoveries of 
biomedical research and translating them to clinical settings.

This award will support the career development of underrepresented minority 
investigators who have made a commitment to focus their research endeavors on 
patient-oriented research. This mechanism provides support for three to five 
years of supervised study and research experience that may integrate didactic 
studies with clinically based research. Candidates must be clinically trained 
professionals who have the potential to develop into productive, clinical 
investigators with a focus on patient-oriented cancer-related 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 clinical 
investigator.  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.  

For the purposes of this award, patient-oriented research is defined as 
research conducted with human subjects (or on material of human origin such 
as tissues, specimens, and cognitive phenomena) for which an investigator 
directly interacts with human subjects. This area of research includes: 1) 
mechanisms of human disease; 2) therapeutic interventions; 3) clinical 
trials; and 4) the development of new technologies.

The NCI is especially interested in increasing the number of underrepresented 
minority clinicians trained to conduct high-quality, patient-oriented 
clinical research. Accordingly, this award forms an important part of the NCI 
initiative to attract talented underrepresented minority individuals to the 
challenges of clinical research. NCI intends to target a significant increase 
in funds for these entry-level career development awards. The K23 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 patient-oriented research. This initiative is 
consistent with the recommendations of the NIH Director's Panel on Clinical 
Research, and from the CMBB MD Working Group and the Institute of Medicine 
Committee on Addressing Career Paths for Clinical Research.

It is anticipated that candidates for this award may or may not have had a 
clinical research- intensive experience and will represent many different 
stages of career development.  Because of this, the NCI "Mentored Patient-
Oriented Research for Underrepresented Minorities" award places considerable 
emphasis on the experience and continued involvement and commitment of the 
mentor(s) during the candidate's development.  To ensure progression to 
independence, the prospective candidate should propose a period of study in 
which the mentor(s) 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 area of clinical 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 clinical research experience to be the most efficient 
means of attaining independence. A candidate with substantial previous 
clinical research experience may require a shorter award period and less 
specialized attention from the mentor in order to facilitate the transition 
to independence.

RESEARCH OBJECTIVES

Substantial national and local efforts have been made and are continuing to 
be made to reduce cancer morbidity and mortality in the general population. 
However, in spite of these efforts, projections made for 1999 were that 
1,221,800 cancers were expected to be diagnosed in the United States and 
563,100 Americans were expected to die of this disease.

Past patterns of cancer incidence and mortality predict that a 
disproportionate share of this increase in U.S. cancer incidence and 
mortality will be borne by minorities. Specifically, past and current SEER 
data show 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 Whites.

Contributing to the cancer mortality of U.S. minorities is their limited 
access for treatment by physicians with appropriate cultural sensitivities. 
This factor is largely due to the small numbers of U.S. minority patient-
oriented clinical oncologists. Data from the American Medical Association for 
1994 show that of 11,224 U.S. oncologists, only 184 (1.6 percent) were of 
African American descent, 336 (3.0 percent) were of Hispanic descent, and 3 
(0.03 percent) were of Native American descent. Current statistics on medical 
specialties among U.S. medical school graduates do not portray a significant 
change in this situation. Specifically, of the total 1993 medical school 
graduates, only 0.9 percent had selected oncology as their area of 
specialization, and only 0.2 percent of graduates selecting an oncology 
specialization were underrepresented minorities. In 1994, only 11.2 percent 
of all medical school applicants were underrepresented minorities, a 
proportion that had not changed significantly from the value of 10.8 percent 
six years earlier.

A reduction in the overall cancer mortality rate in minority populations 
would substantially impact known cancer statistics. Cultural barriers to 
cancer diagnosis/treatment and to advice regarding preventive health care 
will take on added importance as the techniques of molecular epidemiology are 
increasingly applied to identify minority individuals and family members at 
high risk for cancer. As a result of this new technology, physicians will 
increasingly be called upon to deal with culturally sensitive issues such as 
prophylactic surgery for family members, and/or major changes in lifestyle, 
possibly even including childbearing. It is therefore imperative that a 
sufficient number of minority clinical oncologists be available so that 
access to care is not limited by the number of oncologists sensitive to 
cultural issues. Additionally, the clinical oncologist must have an 
understanding of the new technologies being developed that will assist in the 
diagnosis/treatment of cancers and the predictions of cancer risk. This 
understanding can best be provided by a research and career development 
experience in the development and/or application of these technologies.

MECHANISM OF SUPPORT 

Awards in response to this program announcement will be made through the 
Mentored Patient-Oriented Research (K23) mechanism.  Planning, direction, and 
the execution of the proposed training program will be the responsibilities 
of the applicant and her/his co-mentors on behalf of the applicant 
institution. 

The career development award will be made for a period of up to 5 years. Each 
award is non-renewable and non-transferable from one Principal Investigator 
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 (refer to "Non-Competing Renewals").  NIH Grant policies apply to 
these awards.

ELIGIBLE INSTITUTIONS 

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

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government or comparable institutions with 
well-established training programs in patient-oriented clinical oncology  
o Domestic 

Foreign organizations are excluded from submission to this announcement. 
Eligible institutions must also have active biomedical  research programs in 
oncology, including clinical trials with adequate numbers of highly trained 
faculty in clinical and biomedical science areas as they relate to cancer. 
They must also demonstrate a commitment to the development of the research 
careers of junior underrepresented minority health professionals in clinical 
oncology. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

This award is designed to provide an intensive, supervised research 
experience for underrepresented minority health professionals. The award is 
intended for individuals with a health professional degree to acquire 
research experience in patient-oriented clinical oncology. Individuals with a 
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 certified to perform clinical duties should contact 
CMBB concerning their eligibility for a K23 award (SEE INQUIRIES). 

Candidates must have completed their clinical training, including specialty 
and, if applicable, subspecialty training prior to receiving an award. 
However, candidates may submit an application prior to the completion of 
clinical training. 

Underrepresented minorities are defined as individuals belonging to a 
particular ethnic or racial group and determined by the grantee institution 
to be underrepresented in biomedical and behavioral research. NCI would like 
to point out that African Americans (Black), Hispanic Americans, Native 
Americans and Alaska Natives, and non-Asian Pacific Islanders are 
underrepresented in biomedical or behavioral research nationally. Awards will 
be limited to individuals who are citizens, non-citizen alien nationals, and 
permanent residents of the United States. Individuals on temporary or student 
visas are not eligible. 

Candidates for the award should have broad clinical training, must 
demonstrate competence in clinical activities, must document a serious intent 
for a research career in patient-oriented clinical oncology, and must 
document a sensitivity to cultural issues impinging upon the practice of 
medicine among the major U.S. ethnic populations. The candidates must be 
nominated by an institution on the basis of qualifications, interests, 
accomplishments, motivation, and their potential for a career in clinical 
oncology. Women and persons with disabilities are encouraged to apply as 
Principal Investigators. Evidence of the institution's commitment to the 
applicant's research development must be documented.

Candidates must have at least two mentors. One who is recognized as an 
accomplished clinical investigator and at least one additional mentor or 
advisor who is recognized as an accomplished independent basic science 
investigator in the proposed research area.  

Candidates must be willing to devote a minimum of 75 percent full-time 
professional effort in conducting research career development and clinical 
research.

Ineligible individuals include current and recent Principal Investigators on 
NIH research project grants (R01), and comparable career development awards 
(K01, K08, K07, K23).  Individuals who have not been Principal Investigators 
on the above types of grants in the last five years are eligible.  Former 
Principal Investigators of NIH Small Grants (R03) or 
Exploratory/Developmental Grants (R21), and sub-projects of a Program Project 
(P01), or Center Grant (P30), or Specialized Center Grant (P50) remain 
eligible. Current and former recipients of Clinical Associate Physician Award 
(CAP) support may apply for the K23 provided that they have had no more than 
3 years of CAP support by the time a K23 award is made. The combined total of 
CAP plus K23 support must not exceed 6 years. A candidate for the K23 award 
may not have pending and may not concurrently apply for a CAP award or any 
other career development award. K23 recipients are encouraged to apply for 
independent research grant support during the period of this award.

SPECIAL REQUIREMENTS

A.  Program:  

Up to five consecutive 12-month awards will be provided. 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 clinical investigator (e.g. 
acquisition of clinical trials 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 health professional to 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.

Under unusual and pressing circumstances, an awardee may submit to the 
awarding component a written request for 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. Further, 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.

Because of the focus on progression to independence as clinical 
investigators, candidates for the K23 should propose, together with their 
mentor(s), a period of study and career development consistent with the 
previous research and clinical experience of the candidate.  As appropriate, 
sensitivity to the candidate's needs related to his/her cultural, 
socioeconomic heritage should be considered.  For example, a candidate with 
limited experience in a given field of patient-oriented research may find a 
5-year phased developmental program that includes a designated period of 
specialized didactic training followed by a period of closely supervised 
training 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 may benefit from a 
program that focuses primarily on an intensive, supervised patient-oriented 
research experience. 

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 patient-oriented research. The 
candidate and the mentor are jointly responsible for the preparation of the 
plan for this program. The mentor must monitor the candidate's progress 
throughout the career development program and if necessary an advisory 
committee can be formed to assist with the development of a program that 
meets the candidates 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 candidate. Whereas the focus of the 
career development program is on the conduct of patient-oriented research, 
complementary laboratory research studies can be directly related to the 
patient-oriented research proposed in the application.

B.  Mentor(s): 

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

C.  Allowable Costs:

1. Salary:  The NCI 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.
 
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 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.  Institutional supplementation of salary must 
not require extra duties or responsibilities that would interfere with the 
purpose of the K23 award. Under expanded authorities, however, institutions 
may re-budget funds within the total costs awarded to cover salaries 
consistent with the institution's salary scale.

2.  Research Development Support:  NCI will provide generally up to $30,000 
per year for the following expenses: (a) tuition, fees, and books related to 
career development; (b) research expenses, such as supplies, equipment and 
technical personnel; (c) travel to research meetings or training; (d) 
statistical services including personnel and computer time. 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.

3.  Ancillary Personnel Support:  Salary for mentors, secretaries and 
administrative assistants is not allowed.

4.  Facilities and Administrative Costs:  These costs, which were formerly 
called indirect costs, will be reimbursed at 8 percent of modified total 
direct costs.

D.  Evaluation:  

In carrying out its stewardship of human resource related programs, the NCI 
will request 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.

E.  Other Income:  

Fees resulting from clinical practice, professional consultation, or other 
comparable activities required by the research and research-related 
activities of this award may not be retained by the career award recipient. 
Such fees must be assigned to the grantee institution for disposition by any 
of the following methods:

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

o 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.

o 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 that these activities remain incidental and 
provided that the retention of such pay is consistent with the policies and 
practices of the grantee institution.

o Usually, funds budgeted in an NIH-supported research or research training 
grant for the salaries or fringe benefits of individuals, but freed as a 
result of a career award, may not be 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.

F.  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 is required. 
To obtain prior approval, the award recipient must submit a letter 
countersigned by his or her department head and the appropriate institutional 
official to the NCI CMBB Program Director (see "Where To Send Inquiries") 
describing the plan.  A copy of a letter or other evidence from the 
institution at which 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 
prior written approval from the NIH Program Director 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.

G.  Termination or Change of Institution:

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 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 NCI shall notify the 
grantee institution and career award recipient in writing of this 
determination, the reasons thereof, the effective date, and the right to 
appeal the decision.

Awardees planning a change of institution must submit, in advance of the 
change, a written request for transfer to CMBB, countersigned by the 
appropriate institutional business official, describing the reasons for the 
change and including the new mentors' names and bio-sketches. The awardee 
must establish in this request 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. Additionally, the new mentors must have the 
appropriate research expertise to supervise the program and sufficient 
research support to ensure continuation of the research program to the end of 
the award (initial award).  CMBB Program Directors will review this request 
and may require a review by an initial review group and/or the appropriate 
National Cancer Advisory Board. Upon approval of this request, a new career 
award application must be submitted by the new institution far enough in 
advance of the requested effective date to permit review. The duration of 
support requested in the new application must be for no more than the time 
remaining within the existing award period.  

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

H.  Change of Mentor:

When a mentor at the grantee institution is to be replaced, the institution 
must submit a letter documenting the need for substitution, the new mentor's 
qualifications for supervising the program, the level of support for the 
candidate's career development and a detailed statement from the new mentor 
that convincingly demonstrates the candidate's development will continue 
successfully without delay. The letter must also document that the specific 
aims of the research program will remain within the scope of the original 
peer-reviewed research program.  CMBB Program Directors will review the 
request and will notify the grantee institution of the results of the 
evaluation.

I.  Reporting Requirements:

If  an application is funded, additional reporting requirements for 
continuation of the project are listed in the section "NON-COMPETING 
RENEWALS".

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA 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:

Direct your questions about scientific/research issues to:

Ms. Belinda M. Locke
Program Director
Comprehensive Minority Biomedical Branch
National Cancer Institute, NIH
6116 Executive Boulevard, Room 7031, MSC 8350
Bethesda, Maryland 20892-8329
Rockville, Maryland 20852 (for express/courier service)
Tel:  301-496-7344
FAX:  301-402-4551
Email:  lockeb@mail.nih.gov

Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, Maryland 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncidearefof@mail.nih.gov

Direct your questions about financial or grants management issues to:

Ms. Barbara Fisher
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone: (301) 846-1015
FAX: (301) 846-5720
Email: fisherb@gab.nci.nih.gov

SUBMITTING AN APPLICATION:  Potential candidates are strongly encouraged to 
contact the program staff person listed under "WHERE TO SEND INQUIRIES". Such 
contact should occur early in the planning phase of application preparation. 
Such contact will help ensure that applications are responsive to the goals 
and policies of this announcement.

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.

Applications must be prepared using Section IV, "Research Career Awards"  
(RCA), instructions to complete the PHS 398 research grant application (rev. 
5/2001).  The PHS 398 and Section IV 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.

To identify the application as a response to this program announcement, check 
"YES" on item 2 of page one of the application and enter the title and number 
of this PA.

THE APPLICATION MUST ADDRESS THE FOLLOWING ISSUES:

CANDIDATE

o Describe the candidate's research background and note any cultural, 
socioeconomic, or ethnic issues, as appropriate, that have already effected 
or may effect the pace of the candidate's career development.
o Describe the candidate's commitment to a career in patient-oriented 
research (candidates interested in field or laboratory-based research should 
consider the "Mentored Clinical Scientist Award for Underrepresented 
Minorities" (K08)).  
o Provide evidence of the candidate's potential to develop into an 
independent investigator.  
o Indicate a minimum commitment of at least 75 percent effort to the research 
program.  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.
o Include three sealed letters of recommendation addressing the candidate's 
potential for a research career. Letters must be from individuals other than 
the designated mentors.

CAREER DEVELOPMENT PLAN

The career development plan should be a joint effort between the candidate 
and his/her mentor(s) and carefully tailored to the candidate's needs 
demonstrating an appreciation, as appropriate, of the candidate's cultural, 
socioeconomic and research background, and the particulars required to 
develop the candidate into an independent clinical investigator engaged in 
cancer research.  The Plan must include a description and consideration of 
the candidate's goals and prior research experience. A systematic plan must 
be described for obtaining the necessary theoretical and conceptual 
background, in addition to the research experience and skills necessary to 
launch an independent career in clinical research. Candidates must describe 
the availability of courses such as research design, biostatistics, 
epidemiology, and ethical and regulatory issues at their institution and the 
integration of these studies into their career development plan. Less 
experienced candidates may require a phased development period in 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 training in clinical research 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 
individual in achieving independence as a clinical researcher.

TRAINING IN RESPONSIBLE CONDUCT

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.

RESEARCH PLAN

Must include:

A description of the clinical research plan. The research plan must be 
described as outlined in PHS 398 form 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.

MENTOR'S STATEMENT

The application must include a statement from each mentor 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 cultural, 
socioeconomic heritage of the candidate, as appropriate, and enhance the 
candidate's research development toward independence.  

Similar information must be provided by any co-mentor. If more than one 
clinical and one research mentor are proposed, the respective areas of 
expertise and responsibility should be described.

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. 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 as 
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. 
 
BUDGET

The total direct costs requested must be consistent with this K23 program 
announcement and the award limits of the NCI.  Requests for tuition and fees, 
books, travel, research development support, etc., must be justified and 
specified by category.  Applicants seeking information on award limits should 
contact the fiscal representative listed in the INQUIRIES section at the end 
of this announcement.

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines  
may also use revised or AIDS dates, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the reference letters, the checklist, and three 
signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application 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)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 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 CSR 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.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  This 
policy is similar to and consistent with the policy for applications addressed 
to Center for Scientific Review as published in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for adherence to the guidelines of this PA by the NCI program staff.  
Applications not adhering to the guidelines of this PA, and those 
applications that are incomplete as determined by CSR or by NCI program 
staff, will be returned to the applicant without review.

Applications that are complete and adhere to the guidelines of this PA 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.  

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

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

REVIEW CRITERIA

The following review criteria will be applied:

CANDIDATE

o Quality of the underrepresented minority candidate's professional 
background that will represent an important addition to the cancer research 
community as a well-trained scientist; 

o Strength of the commitment of the underrepresented minority candidate to a 
patient-oriented cancer research career;

o Appropriateness of the dedicated 75 percent effort to the successful 
development as a cancer researcher;

o Strength of the letters of recommendation;

CAREER DEVELOPMENT PLAN

o Appropriateness of the content, phasing and duration of the 
underrepresented minority candidate's development plan in relation to his/her 
experience and background to become an independent investigator;

o Conformity of the plan to 75 percent effort devoted to research/research 
training;

o Adequacy of  considerations in the plan that tailors it to the individual 
needs of the underrepresented minority candidate's experience and background, 
as well as to any important cultural, ethnic and/or socioeconomic factors, as 
appropriate, that could effect the pace of the candidate's successful 
development; and

o Likelihood that the plan will contribute substantially to the achievement 
of scientific independence.

RESEARCH PLAN

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

o Scientific and technical merit of the research question, design and 
methodology;

o Relevance of the proposed research to the candidate's career objectives;

o Appropriateness of the plan to the stage of research development of the 
candidate as a vehicle to assure that the candidate achieves his/her career 
goals and objectives towards developing into an  independent scientist; and 

o Adequacy of the plan's attention to gender, children and minority issues 
associated with projects involving human subjects or justification for 
exclusion.

MENTOR/CO-MENTOR

o Evidence that the mentor(s) has participated in the development of the 
Career Plan, is sensitized to providing for the individual needs of the 
candidate and is willing personally to go beyond the traditional efforts that 
a mentor dedicates to a trainee in his/her research environment;

o Appropriateness of the mentors' research qualifications in the area of this 
application;

o Quality and extent of the mentors' proposed roles in providing guidance and 
advice to the candidate;

o Previous experience in fostering the development of researchers;
 
o Track record of research productivity and support; and

o Adequacy of the research support to the mentor to ensure that the proposed 
project can be conducted unimpeded for the proposed research.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

o Adequacy of research facilities and the availability of appropriate 
educational opportunities;

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

o 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 underrepresented minority candidate are 
being provided and that the candidate will be integrated with care and 
sensitivity into the institution's research programs; and

o 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).

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

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

BUDGET

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, applications 
will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans (including 
data safety monitoring plan), animals, or the environment, to the extent they 
may be adversely affected by the project proposed in the application.

INCLUSION:  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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

AWARD CRITERIA

Applications submitted in response to this PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review;

o Availability of funds; and 

o Relevance to program priorities;

NON-COMPETING RENEWALS

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

o 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; 

o A list of accomplishments such as publications, inventions, or project-
generated resources should be provided;

o A brief explanation of plans to address the specific aims during the next 
year of support;

o 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 must also address how weaknesses in the plan, as identified by peer 
reviewers in the Summary Statement, have been addressed and corrected.  
Include formal coursework, informal instruction in specific research skills, 
scientific seminars, etc..  In addition, a concise description of the 
candidate's participation in "other activities" during the report period 
should be included. The percent effort devoted to research/research training 
and to "other activities", respectively, must be clearly stated; 

o Description of similar activities for the next year of support with a clear 
indication of percent effort devoted to research/research training and other 
activities respectively;

o The mentor(s) report, briefly detailing 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.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: 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 (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: 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.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" for additional information:  
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:  
http://www.cancer.gov/clinical_trials/

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete 
copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research in now available online at:  http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Guidance 
for investigators and institutional review boards regarding research 
involving human embryonic stem cells, germ cells, and stem cell-derived test 
articles can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.html. Only research 
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry 
will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review.

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.

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 Cancer Research Manpower, and is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92 . 

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


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