INSTITUTIONAL CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM

Release Date:  February 17, 2000 (see replacement PAR-03-083)

PA NUMBER:  PAR-00-063 

National Cancer Institute

Letter of Intent Receipt Date:  May 1 every year
Application Receipt Date:       June 1 every year

This Program Announcement (PA) replaces PAR-99-077, Clinical Oncology 
Research Career Development Program, which was published in the NIH Guide on 
March 23, 1999.

PURPOSE

The purpose of the National Cancer Institute (NCI) Institutional Clinical 
Oncology Career Development Program is to increase the number of medical 
doctors (M.D.’s, D.O.’s) and doctorally degreed Oncology Registered Nurses 
who are motivated and properly trained to: (1) communicate and collaborate 
with basic/behavioral research scientists in order to expedite the 
translation of basic/ behavioral research information into patient-oriented 
cancer research; (2) perform independent clinical oncology research that 
develops and tests rational scientific hypotheses based on fundamental and 
clinical research findings with the potential for improving the medical care 
of cancer patients; and (3) design and test innovative clinical protocols and 
manage all phases (i.e., pilot/Phase I, Phase II, and Phase III) of clinical 
trials research.  To achieve this purpose, awards are made to institutions 
for up to five years for the development and implementation of training 
programs providing clinicians with all of the necessary information and 
training that will enable them to design, implement and manage all phases of 
cancer clinical trials research.  The distinguishing features of this career 
development Program are that a Program Leader in the institution together 
with an Advisory Committee selects the candidates and oversees the course of 
their training, and that candidates are likely to have more than one mentor 
as they are exposed to the basic sciences and to the many disciplines 
critical to the clinical sciences. 

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.  These areas of research include: 1) 
mechanisms of human disease; 2) therapeutic interventions; 3) clinical 
trials; and 4) the development of new technologies.  

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 PA, 
“Institutional Clinical Oncology Research Career Development Program,” is 
related to the priority areas of cancer and human resource development.  
Potential applicants may obtain a copy of "Healthy People 2000" at 
(http://odphp.osophs.dhhs.gov/pubs/hp2000). 

ELIGIBILITY REQUIREMENTS

Institution:  Applications may be submitted by domestic, for-profit and 
non-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Applicant organizations should have 
well-established research programs with adequate peer-reviewed grant support 
in cancer research and appropriate, highly qualified faculty in the clinical, 
behavioral and basic sciences as needed to meet the objectives of the 
proposed career development program. 

Program Leader/ Principal Investigator: The Program Leader/ Principal 
Investigator must be an established investigator in patient-oriented research 
and able to provide both administrative and scientific leadership to the 
Program.  Minorities, women and individuals with disabilities are encouraged 
to apply as program leaders/principal investigators.

Clinician Candidates: All candidates must currently be physicians holding the 
M.D. or D.O. degrees, or be doctorally prepared oncology registered nurses; 
and must have completed their clinical training (i.e., completed residency 
and are board eligible). Candidates must be able to spend a minimum of 75 
percent effort conducting research and research career development including 
taking courses during the period of the award.  

All clinician candidates must be citizens  or non-citizen nationals of the 
United States, or must have been lawfully admitted to the United States for 
permanent residence (i.e., in possession of a currently valid Alien 
Registration Receipt Card I- 551, or other legal verification of such 
status).  Non-citizen nationals are generally persons born in outlying 
possessions of the United States (i.e., American Samoa and Swains Island).  
Individuals on temporary visas are not eligible.

Clinician candidates who were former principal investigators on NIH Small 
Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) remain 
ELIGIBLE.  However, former principal investigators on NIH research project 
grants (i.e., R01s), FIRST Awards (i.e., R29s), sub-projects on Program 
Project Grants (i.e., P01s) or on center grants (i.e., P50s) and the 
equivalent are NOT ELIGIBLE.  Candidates who have been supported on NIH or 
non-NIH career development awards dedicated to training patient-oriented 
researchers are NOT ELIGIBLE.  However, while in general candidates who have 
been supported on other types of career awards are not eligible, if their 
training did not focus on clinical research and they can benefit from at 
least two years of additional training on a K12 Program, they are ELIGIBLE. 

MECHANISM OF SUPPORT

Support of this Program will be through the National Institutes of Health 
(NIH) Mentored Clinical Scientist Development Program award or K12 mechanism.  
Planning, direction, and, execution of the program will be the responsibility 
of the Program Leader/Principal Investigator and the Advisory Committee on 
behalf of the applicant institution. The project period is five years.  
Awards are renewable.

Awards will be administered under NIH grants policy as stated in the National 
Institutes of Health Grants Policy Statement, NIH Publication No. 99-8, 
October 1998.  However, the K12 award, as administered by the National Cancer 
Institute, is not subject to “Just-in-time” application procedures or to the 
Streamlined Noncompeting Application Process (SNAP).  The K12 remains under 
“Expanded Authorities” except that carryover of funds from one fiscal year to 
the next requires approval by the NCI.

RESEARCH OBJECTIVES

A.  Background:  In 1991 the National Cancer Institute (NCI) recognized the 
need for establishing formal training programs that would prepare the next 
generation of clinical scientists to participate more effectively in 
translational research. The NCI embarked on a pilot program initiative that 
would prepare clinical oncologists to be effective scientific partners  with 
basic/behavioral scientists in the movement of discoveries in the laboratory 
into patient research settings or the reverse process of taking observations 
in the clinic back into a laboratory research setting. These well-trained 
clinical oncology researchers would be expected to communicate, interact and 
collaborate with basic/behavioral scientists in the design and implementation 
of clinical trials that were hypothesis driven and based on an understanding 
of biological mechanisms.  This pilot program initiative was implemented 
through two successive RFAs in 1992 and 1997 and was founded on the following 
principles: (1) unlike career awards to individuals, these would be awards to 
institutions and the institution would appoint individuals to a formal 
training Program; (2) rather than having a single mentor, the individuals on 
the program would likely have more than one mentor as they are exposed to the 
basic sciences and to the many disciplines critical to the clinical sciences; 
(3) the Program would provide individuals with all of the information and 
training needed to design, implement and manage all phases of clinical trials 
research.

This initial pilot Program was highly successful and had generated 
considerable interest in the cancer research community.  It became clear that 
advertising the Program every five years as an RFA would not provide 
sufficient opportunity for this community to submit applications.  The 
conclusion was that NCI objectives would be better served by making this 
grant mechanism open to investigator-initiated applications on a regular 
basis using a Program Announcement (PA).  As a result, the NCI decided to 
establish the Clinical Oncology Research Career Development Program(K12) as 
an ongoing PA with a once-a-year submission date.  Additionally, due to the 
critical role of oncology nursing in clinical cancer the PA extends 
eligibility to include doctorally prepared Oncology Registered Nurses. The 
expectation of the NCI is that this kind of training program will greatly 
enhance and promote the multidisciplinary research approaches and team 
concepts needed for conducting clinical cancer research and for delivering 
optimum cancer patient care. 

The levels of salary and research support offered in the previous RFA’s and 
PAs have been increased in this PA to levels consistent with the support 
offered clinicians in the NCI in its individual career awards.

B.  Program:  The award provides support to institutions for five consecutive 
12-month periods.  Appointments of clinical candidates to the program are 
provided in 12-month increments.  These appointments may be as long as seven 
years. The program provides research career development opportunities in more 
than one clinical oncology research discipline (e.g., medical oncology, 
surgical oncology, radiation oncology, oncology nursing, etc.). Both the 
didactic and the research phases of the award are expected to develop the 
necessary knowledge and research skills in scientific areas relevant to the 
career goals of the candidate in clinical research.  Candidates lacking 
skills in data management, statistics, epidemiology, study design, clinical 
trial design, hypothesis development, drug development, etc. will be provided 
the opportunity to participate in courses designed to overcome these 
deficiencies.

C. Environment:  The institution must have a well-established research and 
clinical career development program, and faculty qualified in clinical 
research with an emphasis on patient-oriented research to serve as faculty 
for the program.  The research environment should be one in which there are 
active basic/behavioral/clinical research collaborations that exemplify a 
dynamic two-way exchange of information and ideas between laboratory and 
clinical scientists.  The research environment should also promote rapid 
translation of basic/behavioral/oncology research into clinical testing as 
well as stimulate new ideas and laboratory experiments, based on clinical 
observations and testing results.  Finally, the institution must demonstrate 
a commitment to the development of trainees as productive, independent 
investigators.

D.  Allowable costs:

1.  Direct cost cap: By NCI policy total direct costs cannot exceed $700,000  
per annum.  However, because NIH policy requires that any application 
exceeding $500,000 per year in direct costs receive permission from the 
funding institute before it can be accepted for review, any applicant 
planning to request more than $500,000 must submit the K12 application with a 
cover letter identifying the NCI Official by name who granted permission.

2.  Salary: Clinician research candidates may be provided salary support of 
up to $75,000 each year, plus fringe benefits commensurate with the applicant 
institution's salary structure for persons of equivalent qualifications,  
experience, and rank.  The institution may supplement the NCI contribution; 
however, supplementation may not be from Federal funds unless specifically
authorized by the Federal program from which such funds are derived.  In no 
case, may PHS funds be used for salary supplementation.  Institutional 
supplementation of salary may not require extra duties or responsibilities 
that would interfere with the purpose of this award.   The total salary 
requested must be based on a full-time, 12 month staff appointment.

Salary support for the Program Leader/Principal Investigator and 
participating faculty is not allowed.

3.  Research and Development Support: Up to $30,000 per candidate can be 
provided for the following types of expenses: (a) research expenses, such as 
supplies, equipment and technical personnel; (b) tuition, fees and books 
related to career development; (c) travel to research meetings or training; 
and (d) statistical services including personnel and computer time.  These 
costs must be specifically documented for each individual candidate and must 
be specifically and directly related to the candidate’s research activities.  
They cannot be pooled and used for advertising, recruiting or other programs 
unrelated or indirectly related to the research activities of individual 
candidates or trainees.

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

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

6.  The K12 grant, as administered by the NCI, is not subject to the 
Streamlined Noncompeting Application Process (SNAP).  In general this means 
that all reporting of budgetary information and program progress are provided 
in greater detail in an annual progress report.  While the K12 is subject to 
Expanded Authorities, the one exception to this is that carryover of funds 
from one fiscal year to the next must be approved by the NCI Grants 
Administration staff (see INQUIRIES).

7.  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:

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

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

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

Awardees may retain royalties and fees for activities such as scholarly 
writing, service on advisory groups, or honoraria from other institutions for 
lectures or seminars, provided these activities remain incidental and 
provided that the retention of such pay is consistent with the policies and 
practices of the grantee institution.

Funds budgeted in an NCI-supported research or research training grant for 
the salaries or fringe benefits of individuals, but freed as a result of a 
K12 award, may not be rebudgeted. 

E.  Special Leave:  Leave to another institution of a trainee, including a 
foreign laboratory, may be permitted if directly related to the purpose of 
the award.  Only local, institutional approval is required if such leave does 
not exceed 3 months.  For longer periods, prior written approval of NCI staff 
is required.  To obtain prior approval, the trainee must submit a letter to 
NCI Program staff describing the plan, countersigned by his or her department 
head and the appropriate institutional official.  A copy of a letter or other 
evidence from the institution where the leave is to be taken must be 
submitted to assure that satisfactory arrangements have been made.  Support 
from the award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires 
the prior written approval of the NCI and will be granted only in unusual 
situations.  Support from other sources is permissible during the period of 
leave.  Parental leave will be granted consistent with the policies of the 
NCI and the grantee institution.

F.  Termination: 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.

G.  Change of Institution:  The Clinical Oncology Career Development Program 
(K12) cannot be transferred from one institution to another.

H.  Change of Program Director:  If the program director moves to another 
institution or resigns from the position, support of the award may be 
continued with NCI prior approval provided:

o  The current program director or the awardee institution has submitted a 
written request for change of program director, countersigned by the 
appropriate institutional business official, to the NCI Program Director 
describing the reasons for the change.  The biosketch of the proposed new 
program director, including a complete listing of active research grant 
support, is provided.  The information in the request establishes that the 
specific aims of the original peer reviewed research program to be conducted 
under the direction of the new program director will remain unchanged, and 
that the new program director has the appropriate research and administrative 
expertise to lead the program;

o  The request is submitted far enough in advance of the requested effective 
date to allow the necessary time for review.

I.  Changes of Program:  Awards are made to a specific institution for a 
specific program under the guidance of a particular program director.  
Changes in any of these parameters requires prior approval by NCI Program 
staff. 

A scientific rationale must be provided for any proposed changes in the aims 
of the original peer reviewed program.  The new program will be evaluated by 
NCI staff to ensure that the program remains within the scope of the original 
peer reviewed research program.  If the new program does not satisfy this 
requirement, the award could be terminated.

J.  Progress Reports:  An Annual Progress Report for the grant is required.  
This report should provide information about changes in the Program, a 
summary report of the evaluation of the Advisory Committee, and a description 
of the research and career progress of each candidate.  These Annual Reports 
will be closely monitored by NCI staff to ensure that the grant is achieving 
the goals of this Institutional Clinical Oncology Research Career Development 
Program.

Progress reports are submitted using the Form PHS 2590, which can be obtained 
at the following website address: 
http://grants.nih.gov/grants/funding/2590/2590.htm.   Forms are also available 
at most institutional offices of sponsored research. 

Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the 
application for continuation to contain the following information:

- Appropriate Face Page A as instructed in the Form PHS 2590.

- A budget page B that provides the salary and fringe benefits for each 
candidate or trainee by name or by position if no individual is filling the 
position at the time of the application.  Provide all other budgetary 
information (e.g., supplies, travel, technical help)by trainee name or by the 
position broken out specifically for each candidate and or trainee up to the 
$30,000 limit.

- A brief description of the Objectives and Goals of the Program

- A brief summary listing by name delineating which faculty, mentors and 
Advisory Committee members have left the Program and which new individuals 
have been added or are taking their places.  Include for each person their 
degree and department affiliation (or equivalent).

- Biographical sketches of

              i.  New faculty
             ii.  New mentors
            iii.  New Advisory Committee Members
             iv. New Trainees

- Progress of Individual Trainees: A brief paragraph for each candidate or 
trainee describing the research and didactic training experiences completed 
and ongoing, as well as the specific future plans for satisfying the Core 
Requirements of the Program.

- List of publications for each trainee resulting from their work in the 
Program.

- Summary information of the Program: A sample table can be obtained from the 
NCI program staff (see INQUIRIES)

- A Report from the Advisory Committee (AC) that is separately attached 
summarizing the actions of the AC during the last year, evaluating the 
performance of the Program in meeting its objectives and the intent of the 
NCI, evaluating the effectiveness of recruitment strategies (provide a 
separate evaluation for minority recruitment), and providing recommendations 
for improving the Program (e.g., new mentors, changes in Core Requirements, 
changes in recruitment strategies etc.)

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

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

SPECIAL REQUIREMENTS

1.  The Program Director must use an Advisory Committee to provide an 
oversight function and annual evaluation of the clinical research development 
program as a whole.  Clinical, basic and behavioral science departments, and 
oncology nursing departments participating in this program should be 
represented on the committee by clinical investigators from the various 
oncology disciplines such as medical oncology, surgical oncology, radiation 
oncology, oncology nursing and other oncology specialties as well as by basic 
and behavioral research investigators.  The committee's responsibilities 
might include: selecting physician and oncology nurse candidates, assigning 
preceptors, approving each candidate's clinical research development plan, 
evaluating each candidate's progress, and monitoring the overall 
effectiveness of the program.  A detailed description should be provided of 
the committee's composition, function, and frequency of meetings. A summary 
report of the actions of the committee meetings must be provided in the 
annual progress report of the grant.  Plans for an annual evaluation of the 
program by the Advisory Committee should be described.

2.  These Institutional Clinical Oncology Career Development Programs  must 
involve staff and clinical candidates representing at least two clinical 
oncology disciplines such as medical, surgical, radiation, pediatric, 
gynecologic oncology and oncology nursing.

3.  The program must provide clinician candidates with the patient-oriented 
research skills that deal directly with aspects of cancer detection, 
diagnosis, prognosis, or treatment of cancer patients; and should provide the 
skills necessary for translating basic/ behavioral cancer research results 
into clinical experiments, procedures, and trials directly involving cancer 
patients in a clinical environment.  It will not be sufficient within the 
scope of this initiative to use human cells and other clinical materials in 
an isolated basic laboratory setting as the total research development 
program.  Basic laboratory/behavioral research experience is essential, but 
it must be properly integrated with patient-oriented clinical research, 
thereby affording the candidate actual experience in the application of their 
own basic research to clinical research.

4.  The program should have the flexibility to accommodate clinical 
candidates with different levels of research experience and competence (also 
see 6. below on Core Requirements).
  
5.  Appointments of clinical candidates to the program should be for a 
minimum of two years.  As long as a K12 has been renewed, individual 
candidates can be supported for up to seven years.

6.  The Program should include Core Requirements that each candidate is 
expected to complete before meeting the Program’s training objectives.  These 
requirements should include the following:

a.  A didactic core component (e.g. formal courses in clinical trial design, 
biostatistics, informed consent, Institutional Review Boards;  lecture 
series, seminars, and journal clubs) based on the experience and needs of 
each candidate.  In those institutions with a Clinical Research Curriculum 
(K30) Award, the didactic component should link with and incorporate the new 
didactic programs developed though the K30 award.

b.  A  clinical research core component that provides “hands-on” experience 
(e.g., protocol development; preparation of IRB applications; clinical trials 
management including patient accrual, analysis of outcomes) in all aspects of 
clinical trials. 

c.  A  basic research core component that adequately prepares the trainee for 
communication, coordination and collaboration of clinical research activities 
with basic scientists; ideally this would be linked to the core clinical 
research component.  
	
The expectation of the NCI is that candidates entering the Program with 
different backgrounds initially will satisfy many of the Core Requirements 
and that they will be provided with the additional didactic and research 
experiences over different periods of time in order to fully meet the 
objectives of the Program. 

7.  A minimum of 75 percent effort must be devoted to the basic/clinical 
research program.  The remaining 25 percent can be divided among other 
clinical and teaching activities only if they are consistent with the program 
goals, i.e. the candidate's development into an independent clinical oncology 
researcher.

8.  The institution must have a well-established research and clinical career 
development program, and faculty qualified in clinical research with an 
emphasis on patient-oriented research to serve as faculty for the program.  
The research environment should be one in which there are active 
basic/behavioral/clinical research collaborations that exemplify a dynamic 
two-way exchange of information and ideas between laboratory and clinical 
scientists.  The research environment should also promote rapid translation 
of basic/behavioral/oncology research into clinical testing as well as 
stimulate new ideas and laboratory experiments, based on clinical 
observations and testing results.

9. The institution must demonstrate a commitment to the development of 
trainees as productive, independent investigators.

10. Where there already exists an active institutional (T32) National 
Research Service Award (NRSA) supporting a surgical or other clinical 
oncology research training program, the applicant must address the 
relationship between the existing T32 and proposed K12 programs.  If there is 
significant overlap in the programs, the T32 award can be merged into the K12 
program or modified to remove areas of substantial overlap.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the 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 are provided 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 in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994. It is also available electronically at URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

Investigators may also a obtain copy of the policy from the program staff or 
contact person 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 
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.

LETTER OF INTENT

Prospective applicants are asked to submit by May 1 of every year a Letter of 
Intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities 
of other key personnel and participating institutions, and the number and 
title of the PA in response to which the application may be submitted.   
Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NCI staff to estimate the potential review workload and avoid 
conflict of interest in the review.

The Letter of Intent is to be sent to the program staff listed under 
INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application Form PHS 398 (rev. 
4/98) using the modified instructions provided below and will be accepted 
once every year on June 1. Application forms can be obtained directly at the 
following website address: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Forms are also 
available at most institutional offices of sponsored research and from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, Phone: (301) 435-0714, FAX: (301) 480-0525, E-mail: GrantsInfo@nih.gov.

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 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).

The instructions in the Form PHS 398 do not fully apply to the special needs 
of this grant application. Detailed budgets must be provided in the 
application.  Therefore, please follow the modified instructions below in 
preparing an application for an NCI Institution Clinical Oncology Career 
Development Program(K12).  These instructions have been adapted to 
accommodate the Form PHS 398 and the special needs of the K12 grant:              

1.  Face Page:  Use page AA of the PHS Form 398.  On Line 1, include the 
title that best represents the nature of the training program.  On Line 2, 
provide the number of this Program Announcement beginning with PAR..., and 
the title “Institutional Clinical Oncology Research Career Development 
Program” of the Program Announcement.  The program Leader will be the 
principal investigator (PI) of the grant application.  

2. The Description/ Performance site(s)/ Key personnel (page BB of Form PHS 
398): Complete as directed in the Form PHS 398, page IV-2.  The information 
provided should include the P.I., Advisory Committee members, mentors and 
other faculty participating in the program.

3.  Table of Contents to be organized as follows: 

                               Content                                                              
Page Number  

         a.  Face Page
         b.  Description/Key Personnel
         c.  Table of Contents
         d.  Statement of Commitment
         e.  Detailed Budget Page for First Year
         f.   Budget for Entire Proposed Period of Support
         g.  Biographical Sketches (not to exceed two pages per individual)

              - Program Leader
              - Advisory Committee Members
              - Mentors
              - Other Faculty
              - Trainees (if available)

         h.  Other Support of the Principal Investigator and the Mentors that 
is specifically
              relevant to the purpose and objectives of this Program
          i.  Career Development/Training Plan (not to exceed 25 pages)

               i.  Introduction to Revised Application (when applicable, not 
to exceed 3 pages)
              ii.  Purpose and Objectives
             iii.  Description of Core Requirements
             iv.  Research Base/Resources and Facilities/ Mentors
              v.  Program Management

                   - Program Leader
                   - Recruitment Strategies
                   - Advisory Committee
                   - Individual Training Plans

          j.  Human Subjects
          k. Vertebrate Animals
          l.  Checklist
          m. Appendices

4.  Statement of Commitment: This statement should guarantee that all 
candidates participating in this Program will commit 75% of a full-time 
professional effort to research and research career development. 

5.  Detailed Budget for the First Year: Use Page 4 (or DD) of the Form PHS 
398 and provide detailed budget information with regard to Salary and Fringe 
benefits, supplies, travel etc. specified for each trainee by name or by 
position, if there is no one available to fill the position
Note there is an upper limit of salary of $75,000 plus fringe benefits and an 
upper limit for other costs of $30,000 per trainee.

6.  Budget for the Entire Proposed Period of Support: Follow instructions as 
provided in the Form PHS 398.

7.  Biographical Sketches: Provide biographical sketches using page FF 
provided in the Form PHS 398 kit.  Divide into five sections as follows: (1) 
Program Leader/Principal Investigator; (2) Advisory Committee Members; (3) 
Mentors; (4) Other Faculty; (5) Trainees (when available).

8.  Career Development/Training Plan:

a.  Purpose and Objectives:

Briefly describe the background, purpose and objectives of this 
career development Program.  This description should identify two or more 
clinical oncology disciplines represented in the Program and a discussion of 
the strategies to be used to ensure that the representation in each 
discipline in the mentor population and the trainee population will satisfy 
the intent of this NCI requirement. The description should clearly show how 
the purpose and objectives of the Program will meet the broader objectives 
and intent of the NCI to prepare candidates who can design and implement all 
phases of clinical trials and who can effectively participate in 
translational research projects involving human clinicians and basic 
scientists.

b.  Description of Core Requirements:

Describe the core didactic, core clinical research and core basic 
research experiences that each clinician candidate or trainee must complete 
to satisfy the overall Core Requirements of the Program.  Describe how 
individualized trainee career development plans will be developed that take 
into account past experiences and competencies before providing new 
experiences and skills by the Program.  Describe any certification, degree or 
other form of recognition, if any, that trainees will receive after 
completing the Core Requirements.

c.  Research Base/Resources and Facilities/Mentors (consult NCI Program Staff 
in the INQUIRIES section below for a suggest format for providing this 
information)

Research Base: Describe the existing funded laboratory and 
patient-oriented research activities and the interactive nature of the 
research environment that will meet and sustain needs of this Program

Resources and Facilities: Describe the research infrastructure, 
patient populations, facilities etc. that are available and accessible to 
this Program.

Mentors: Describe the pertinent research experience and track 
record in training cancer clinician scientists of each mentor participating 
in the Program.

d.  Program Management:

Program Leader: Describe the qualifications and role of the 
Program Leader to provide scientific and administrative leadership and 
coordination of the Program.

Recruitment Strategies: Describe the selection criteria for 
candidates recruited to this Program.  Describe the various strategies that 
will be used to ensure that the different clinical oncology disciplines 
represented by the Program are included and to ensure an adequate candidate 
pool.  Address the nature of any other competing institutional Programs that 
might limit the number of candidates and describe the strategies for 
addressing this competition.  Describe plans for recruitment of under-
represented (e.g., African Americans, Hispanic Americans, Native Pacific 
Islanders, Native Americans and Alaskan Natives) and how these strategies 
will be implemented.

Advisory Committee (AC): Describe how the AC will function in 
providing oversight of the development, implementation and evaluation of 
recruitment strategies; in the recruitment and selection of candidates; in 
the evaluation of special curricula and/or links to curricula developed 
through a K30 grant (if present); in the monitoring and evaluation of each 
candidate’s progress with recommendations for changes in the training plan, 
if necessary, or termination of a candidate who is not making adequate 
progress; and in monitoring and evaluation of the overall effectiveness of 
the Program.

Individual Training Plans: Provide brief summaries of the 
individual training plans that the Program will employ or has been able to 
achieve (for competing renewal applications) in preparing candidates to 
design, implement and participate in patient-oriented research and 
collaborate effectively with basic scientists in translational research.      

9.  Human Subjects: Follow instructions in Form PHS 398 application kit.

10. Vertebrate Animals: Follow instruction in Form PHS 398 application kit.
11. Appendices: Follow instructions in Form PHS 398 application kit.

The completed original application and three legible copies must be sent to 
or delivered to:

CENTER FOR SCIENTIFIC RESEARCH
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 must also be sent 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 (express/courier service)

Applications will be accepted once every year on June 1.  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 the 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 
applications will not be allowed, nor will essentially identical applications 
be reviewed by different review committees.  An application, therefore, 
cannot be submitted in response to this PA which is essentially identical to 
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

Upon receipt, applications will be reviewed for completeness by the Center 
for Scientific Review (CSR) and by the NCI for adherence to the guidelines.  
Applications that are complete will be evaluated for scientific and technical 
merit by an appropriate peer review group convened by the NCI in accordance 
with the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
process in which 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.

Review Criteria:

Purpose and Objectives:

- adequacy in representing the required two or more oncology 
disciplines among mentors and the trainee population
- clarity of the Program’s objectives
- adequacy in meeting the NCI intent to prepare candidates who can 
design and implement all phases of clinical trials research and effectively 
lead a translational research project involving clinician and basic 
scientists
- track record of the institution in the development of trainees as 
productive independent clinician investigators
- adequacy of the commitment of the institution assuring that 
candidates will spend a minimum of 75% of a full-time professional effort in 
research or research-related career development

Core Requirements:

- quality of the process for evaluating each candidate’s need relative 
to all core didactic and core research training requirements
- adequacy of the nature and duration of the core basic and clinical 
research requirements 
- adequacy of the nature and duration of specialized core didactic 
training/curriculum (e.g., biostatistics, clinical trials design, informed 
consent etc.)

Research Base/Resources and Facilities/Mentors:

- adequacy of the funded research laboratory and patient-oriented 
research base to support a career development Program
- adequacy of the multi-disciplinary interactions present to provide 
the proper example of a translational research environment
- adequacy of the available research infrastructure, access to 
technologies and methodologies and patient populations to support a career 
development Program
- quality of the mentors’ research experience and productivity and 
their track records in training basic and patient-oriented researchers.

Program Management:

- adequacy of the Program Leader’s qualifications to lead and 
coordinate the Program
- recruitment:

- adequacy of the strategies for attracting and the criteria for selecting 
the best clinician candidates
- adequacy of the trainee pool to meet the needs of the Program
- adequacy of the strategies for recruiting minorities

- Advisory Committee:

- appropriateness of the experience of the membership
- adequacy of the AC’s involvement as a quality control in:

i. selecting candidates for participating in the program
ii. establishing appropriate training plans for each candidate based on the 
Core Requirements of the Program
iii. monitoring the progress of candidates and making midcourse corrections 
to improve the quality of the candidates’ experiences
iv. terminating candidates for evident lack of performance or potential
v. monitoring and evaluating the overall performance of the Program
 
- the quality and completeness of the individual training plans relative to 
the Core Requirements and objective of preparing candidates who can design
and implement all phases of clinical trials research and effectively lead a
a translational research project involving clinician and basic scientists.

5.  (For competing renewal applications): quality/success in achieving the 
research career development objectives of this Program and meeting the NCI’s 
intent

6.  Appropriateness of the budget to achieve the objectives of the Program as 
proposed.

The initial review group will also examine:   the adequacy of plans to 
include both genders and minorities in their subgroups as appropriate for the 
scientific goals of the research and plans for the recruitment and retention 
of subjects; the adequacy of plans for including children as appropriate for 
the scientific goals of the research, or justification for exclusion; the 
provisions for the protection of human and animal subjects; and the safety of 
the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other scored 
applications submitted in response to this PA.  Following the initial review 
for scientific and technical merit, the initial review must be concurred with 
by the National Cancer Advisory Board (NCAB).  The NCI will notify the 
applicant of the NCAB’s action.  Final funding decisions are made by the NCI 
based on the quality of the proposed Program, as determined by peer review, 
the availability of funds, and priorities of the NCI.

NONCOMPETING RENEWAL APPLICATIONS

The procedures for submission of a new or a competing renewal application are 
not applicable to applications for a noncompeting renewal of an award.  
Noncompeting renewal applications for the K12 grant, as administered by the 
NCI, are not subject to the Streamlined Noncompeting Award Process (SNAP) and 
require detailed reporting of budgets and progress.  The general requirements 
for reporting progress annually are outlined in this PA under RESEARCH 
OBJECTIVES in the part of section D (Allowable Costs) that refers to Progress 
Reports.

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic and scientific issues to:

Dr. Lester S. Gorelic
Cancer Training Branch
Office of Centers, Training and Resources
National Cancer Institute
6116 Executive Blvd.
Suite 7011, MSC 8346 
Bethesda, MD 20892-8346
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: lg2h@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Catherine Blount
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Blvd.
Bethesda, MD 20892
Telephone: (301) 496-3179
FAX: (301) 496-8601
Email: cb136g@nih.gov

Direct inquiries regarding review issues to:

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