MENTORED PATIENT-ORIENTED RESEARCH FOR UNDERREPRESENTED MINORITIES (K23)

Release Date:  January 10, 2000 (see replacement PAR-03-006)

PA NUMBER:  PAR-00-042

National Cancer Institute

PURPOSE

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 a patient-oriented research career development award for minorities in 
clinical oncology. The purposes of this award are to:

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

o  Increase the pool of 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 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 for clinically trained professionals who have 
the potential to develop into productive, clinical investigators focusing on 
patient-oriented research. Clinically trained professionals or individuals 
with clinical degrees who are interested in further career development in 
biomedical research that is not patient-oriented, should refer to the 
Minorities in Clinical Oncology  Award (K08) (see 
http://grants.nih.gov/grants/guide/pa-files/PAR-00-040.html and 
http://deainfo.nci.nih.gov/cmbs/index.htm on the NCI website for details).

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 National Cancer Institute is especially interested in increasing the 
number of 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 minority individuals to the challenges 
of clinical research. NCI intends to target a significant increase in funds 
for these entry-level career development awards through 2003. 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 the recommendations from the Institute of Medicine Committee on 
Addressing Career Paths for Clinical Research.

This PA will expire two years from the first receipt date. NIH Grants policies 
apply to these awards.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2000", a PHS-led national 
activity for setting priority areas. This Program Announcement (PA) for 
Mentored Patient-Oriented Research Career Development Award for 
Underrepresented Minorities, is related to the priority area of cancer. 
Potential applicants may obtain a copy of "Healthy People 2000" or at 
http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

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 (M.D., D.C., D.D.S., D.O., O.D., 
 D.V.M., N.D. (Doctor of Naturopathy), Pharm.D. or its equivalent, or who are 
doctorally trained oncology nurses, 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 also 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. Candidates must identify a mentor with extensive 
research experience and must be willing to devote a minimum of 75 percent of 
full-time professional effort in conducting research career development and 
clinical research.

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. 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.

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State or local government, and eligible agencies of the 
Federal government or comparable institutions with well-established training 
programs in patient-oriented clinical oncology. 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 physicians in clinical oncology. Women and persons 
with disabilities are encouraged to apply as Principal Investigators.

Ineligible individuals include current and former Principal Investigators on 
NIH research project grants (R01), FIRST Awards (R29), comparable career 
development awards (K01, K08, K07, K23), sub-projects of program project (P01) 
or center (P30) grants, and the equivalent. Former principal investigators of 
NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) 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.

MECHANISM OF SUPPORT

Awards in response to this program announcement will be made through the K23 
mechanism. Planning, direction, and the execution of the proposed training 
program will be the responsibilities of the applicant and her/his mentors on 
behalf of the applicant institution. Awards are not renewable.

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. NIH Grant policies apply to these awards.

RESEARCH OBJECTIVES

A.  Background: 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 are 
that 1,221,800 cancers are expected to be diagnosed in the United States and 
563,100 Americans are expected to die of this disease.

Past patterns of cancer incidence and mortality predict that a 
disproportionate share of this increase in U.S. cancer incidence and mortality 
will be borne by minorities. Specifically, past and current 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/application of these technologies.

B.  Environment:   The applicant institution must have a well-established 
research and clinical career development program. It must also have faculty to 
serve as mentors qualified in clinical research with an emphasis on patient-
oriented research. The institution must be able to demonstrate a commitment to 
the development of the candidate as a productive, independent investigator. 
The candidate, mentor, and institution must be able to describe an in-depth, 
multidisciplinary career development program that will utilize the relevant 
research and educational resources.

C.  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. The remainder may be devoted to clinical, 
teaching, or other research pursuits consistent with the objectives of the 
award. 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.

Because of the focus on progression to independence as a researcher, 
candidates for the K23 should propose a period of study and career development 
consistent with her or his previous research and clinical experience. For 
example, a candidate with limited experience in a given field of research may 
find a phased developmental program lasting five years and including a 
designated period of didactic training followed by a period of closely 
supervised research experience as the most efficient means of attaining 
independence. A candidate with previous research experience and training may 
not require extensive additional didactic preparation, and a program that 
focuses on an intensive, supervised patient-oriented research experience may 
be appropriate. All programs must be tailored to meet the individual needs of 
the candidate to ensure that he/she will 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 may form an advisory committee to assist with the 
development of a program of study or to monitor the candidate's progress 
through the career development program. 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.

D.  Mentor(s):  Each applicant must name a primary mentor, who together with 
the applicant 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 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.

E. 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.
 
Most NCI awarding components will provide up to $75,000 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. Because the salary amount provided by this award is based 
on the full-time institutional salary, no other PHS funds may be used for 
salary supplementation. Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the purpose 
of the K23 award. Under expanded authorities, however, institutions may 
rebudget funds within the total costs awarded to cover salaries consistent 
with the institution's salary scale.

2.   Research Development Support: The NCI will provide generally up to 
$25,000 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.

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

G.  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.

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

H.  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 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 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.

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.

I.  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 biosketches. 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). Staff within NCI 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.

When a mentor at the grantee institution is to be replaced, the institution 
must submit from the proposed mentor a letter documenting the need for 
substitution, the new mentor's qualifications for supervising the program, and 
the level of support for the candidate's career development. 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. Staff within 
NCI will review the request and will notify the grantee institution of the 
results of the evaluation.

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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that women and members of minority groups and their 
subpopulations must be included in all NIH-supported biomedical and behavioral 
research projects involving human subjects unless a clear and compelling 
rationale and justification is provided to indicate 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 research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research", which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, 
Volume 23, Number 11 March 18, 1994 available on the web at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 clear and compelling 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

APPLICATION PROCEDURES

Potential candidates are strongly encouraged to contact the program staff 
person listed under 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 the individual 
institute or center.

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 are to be submitted on the grant application form PHS 398 (rev. 
4/98) according to the instructions in Section IV, Research Career Awards, of 
the application kit for "Just-In-Time" procedures. Applications will be 
accepted on the standard application receipt dates indicated in the application
kit.  Application kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: grantsinfo@nih.gov.
For those applicants with Internet access, the 398 kit may be found at 
http://grants.nih.gov/grants/forms.htm.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site (see  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).

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

The application must address the following issues:

Candidate

o  A description of the candidate's commitment to a career in patient-oriented 
research.  Evidence of the candidate's potential to develop into status as an 
independent investigator.  A commitment of at least 75 percent effort to the 
clinical research program.  Three sealed letters of recommendation addressing 
the candidate's potential for a research career. The mentor's statement must 
not be included as one of the letters of recommendation.

Career Development Plan

o  The career development 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 and may already have 
had an adequate basic science background. In any case, the career development 
plan must be tailored to the needs of the candidate and the ultimate goal of 
the individual's achieving independence as a clinical researcher.

Training in the Responsible Conduct of Research

o  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:

o  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.

Mentors' Statements

o  The application must include a statement from the mentors including 
information on their qualifications in the research area proposed by the 
candidate and previous experience as research supervisors. The application 
must also include information to describe the nature and extent of supervision 
that will occur during the proposed award period.

o  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

o  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 necessary to meet the 75% effort requirement of this award. 
 
Budget

The total direct costs requested must be consistent with this K23 program 
announcement and the award limits of the NCI. Applicants seeking information 
on award limits should contact the fiscal representative listed in the 
INQUIRIES section at the end of this announcement.

Submit a signed, typewritten original of the application with Checklist, and 
five signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 B MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)
REVIEW CONSIDERATIONS

At the same time of submission, submit two additional copies of the 
application to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD  20852 (for express/courier service)

If an application is received after the deadline, it will be returned to the 
applicant without review. If the application submitted in response to this PA 
is substantially similar to a grant application already submitted to NIH for 
review but has not yet been reviewed, the applicant will be asked to withdraw 
either the pending application or the new one. Simultaneous submission of 
identical application will not be allowed, nor will essentially identical 
applications be reviewed by different review committee. An application, 
therefore, cannot be submitted in response to this PA which is essentially 
identical to the one that has already been reviewed. This does not preclude 
the submission of substantial revisions of applications already reviewed, but 
such applications must include an introduction addressing the previous 
critique.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the Center for Scientific 
Review. Incomplete applications will be returned to the applicant without 
further consideration. Applications that are complete and responsive to the PA 
will be evaluated for scientific and technical merit by an appropriate NCI 
peer-review group in accordance with the standard NIH peer review procedures 
and the review criteria stated below. As part of the initial merit review, all 
applicants will receive a written critique. Applications may undergo a 
streamlined review process. In this process, only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Cancer Advisory Board.

The following review criteria will be applied:

Candidate

o  Quality of the candidate's research, academic and clinical record in 
cancer;
o  Potential to develop as an independent clinical researcher focusing on 
patient-oriented research;
o  Commitment to a career in patient-oriented research in cancer.

Career Development Plan

o  Likelihood that the career development plan will contribute to the 
scientific development of the candidate.
o  Appropriateness of the content, the phasing, and the proposed duration of 
the career development plan for achieving scientific independence;
o  Consistency of the career development plan with the candidate's career 
goals and prior research experience.
o  Training in the Responsible Conduct of Research.
o  Quality of the proposed training in the responsible conduct of research.

Research Plan

Reviewers recognize 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. Nevertheless, a 
fundamentally sound research plan must be provided. For candidates who require 
substantial didactic training as part of their program, the research plan may 
encompass less than the full period of the award.

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 research plan to the stage of research development 
and as a vehicle for developing the research skills described in the career 
development plan;
o  Adequacy of the plan's attention to gender and minority issues associated 
with projects involving human subjects; and
o  Adequacy of plans for including children, as appropriate, for the 
scientific goals of the research, or justification for exclusion.

Mentor/Co-Mentor

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  History of research productivity and support; and
o  Adequacy of support for the proposed research project.

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  Applicant institution's commitment to the scientific development of the 
candidate and assurances that the institution intends the candidate to be an 
integral part of the research program; and
o  Applicant institution's commitment to an appropriate balance of research 
and clinical responsibilities, including the commitment of 75 percent of the 
candidate's effort to research and research-related activities.

Budget

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

AWARD CRITERIA

Funding decisions will be made on the basis of the recommendations of the 
initial review group and NCAB, program priorities, and the availability of 
funds.

INQUIRIES

Written and telephone inquiries concerning this program announcement are 
strongly encouraged, especially during the planning phase of the application. 
 

Direct inquiries regarding programmatic issues to:

Eric J. Bailey, Ph.D., M.P.H.
Comprehensive Minority Biomedical Branch
National Cancer Institute
6116 Executive Boulevard
Bethesda, MD 20892-7405
Rockville, MD 20852 (express/courier service)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: baileye@mail.nih.gov

Direct inquiries regarding fiscal matters 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) 496-8626
FAX: (301) 496-8601
Email: fisherb@gab.nci.nih.gov

Direct inquiries regarding referral matters to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8239
Bethesda, MD 20892-8239
Rockville, MD 20852 (for express/courier service)
telephone: (301) 496-3428
FAX: (301) 402-0275
Email: tf12w@NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.398 Cancer Research Manpower. Awards are made under authorization of the 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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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