and Human Services (HHS)
EXPIRED
INSTITUTIONAL CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM
RELEASE DATE: March 20, 2003
PA NUMBER: PAR-03-083 (see replacement PAR-04-096)
(see addendum NOT-CA-04-008)
EXPIRATION DATE: April 1, 2004 (per addendum NOT-CA-04-008)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER(S): 93.398
LETTER OF INTENT RECEIPT DATE: May 1
APPLICATION SUBMISSION DATE: June 1
This Program Announcement (PA) replaces PAR-00-063, Clinical Oncology
Research Career Development Program, which was published in the NIH Guide on
February 17, 2000.
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE
The purpose of the National Cancer Institute (NCI) Institutional Clinical
Oncology Career Development Program, referred to in this PAR as the Program, is
to increase the number of medical doctors (M.D.'s, D.O.'s) and Nurses who are
motivated and properly trained to: (1) perform clinical oncology research that
develops and tests scientific hypotheses based on fundamental findings; 2)
design and test hypothesis-based clinical protocols and manage all phases (i.e.,
pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials,
and (3) communicate and collaborate with basic research scientists in order to
expedite the translation of basic/behavioral research discoveries into patient-
oriented therapeutic cancer research. The National Cancer Institute (NCI)
Institutional Clinical Oncology Career Development Program is intended to train
clinical researchers whose career focus will be on patient-oriented therapeutic
research and not on laboratory-based research. Clinicians seeking a career
development experience in laboratory-based research should refer to the NIH
Mentored Clinical Scientist Career Development Award or K08.
To achieve the purpose of this Program, 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
therapeutic cancer clinical trials research. For the purposes of this award
patient-oriented research is defined as research conducted with human subjects
for which an investigator directly interacts with human subjects.
RESEARCH OBJECTIVES
o Background: In 1991 the 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 nursing in general and oncology nursing in particular, in
clinical cancer research and care, the PA extended 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.
In view of the continuing commitment of the NCI to increasing the participation
of individuals from underrepresented minority groups in biomedical and
behavioral research and the critical need for more underrepresented minorities
in clinical oncology research, all competing applications for an Institutional
Oncology Career Development Program (K12)Grant are required in this latest
reannouncement of this Program to include a specific plan to recruit and retain
underrepresented minorities as trainees.
o Program: The award provides support to institutions for up to five
consecutive 12-month periods. Appointments of clinical candidates to the
program are provided in 12-month increments. 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.
MECHANISM OF SUPPORT
This PA will use the 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 up to
five years. Awards are renewable.
Awards will be administered under NIH grants policy as stated in the National
Institutes of Health Grants Policy Statement (Rev. 3/01) and described on
http://grants.nih.gov/grants/policy/nihgps_2001/. 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.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o Domestic
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
Foreign institutions are not eligible to apply.
INDIVIDUALS ELIGIBLE TO BECOME PROGRAM LEADER
The Program Leader is the Principal Investigator (PI), 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 principal
investigators.
ELIGIBLE CLINICIAN CANDIDATES
All candidates or trainees must currently be physicians holding the M.D. or D.O.
degrees, or be nurses with a Ph.D. degree; and must have completed the necessary
clinical training (i.e., completed residency and are board eligible) to engage
in clinical oncology research. Candidates must be able to spend a minimum of 75
percent effort conducting research and research career development, which
includes all relevant didactic activities 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 or who are current principal investigators
on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e.,
R21s) remain ELIGIBLE. However, former or current 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 are NOT ELIGIBLE unless approved by the
NCI.
SPECIAL REQUIREMENTS
Special NCI Programmatic Requirements
o Where there already exists an active Ruth L. Kirchstein (T32) National
Research Service Award Program 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. In those institutions with a Clinical
Research Curriculum (K30) Award, the didactic component of this proposal should
be linked with the K30 award.
o Institution: The institution must have substantial peer-reviewed basic and
clinical research support and faculty qualified in patient-oriented therapeutic
cancer research to serve as mentors in the proposed Program.
o Environment: The research environment should be one in which there are active
basic/clinical research collaborations that exemplify a dynamic two-way exchange
of information and ideas between basic and clinical scientists.
o Program:
1. Program Management: The PI must use an Advisory Committee (AC) to provide an
oversight function and annual evaluation of the Program as a whole. The
committee's responsibilities should include but are not limited to: selecting
physician and nurse candidates, assigning preceptors, approving each candidate's
research development plan, evaluating each candidate's progress, monitoring the
overall effectiveness of the program and recommending mid-course changes when
needed. A detailed description should be provided of the committee's
composition, function, and frequency of meetings. Plans for an annual evaluation
of the program by the Advisory Committee should be described.
2. The Program must involve staff and clinical candidates representing at least
two clinical oncology disciplines such as medical oncology, surgical oncology,
radiation oncology, pediatric oncology, gynecologic oncology and oncology
nursing. Clinical candidates from non-oncology medical subspecialties may also
be represented in the Programs. However, these subspecialties should have
direct relevance to cancer (e.g., thoracic surgery, pulmonology) and the
individualized career development plans developed for these candidates must be
focused on clinical oncology research.
3. The Program must motivate and train candidates to: 1) perform clinical
oncology research that develops and tests scientific hypotheses based on
fundamental and clinical research findings; 2) design and test hypothesis-based
clinical protocols and manage all phases (i.e., pilot/Phase I, Phase II, and
Phase III) of cancer therapeutic clinical trials, and (3) communicate and
collaborate with basic research scientists in order to expedite the translation
of basic research discoveries into patient-oriented therapeutic cancer research.
4. Programs should have the flexibility to accommodate clinical
candidates with different levels of research experience and competence.
5. All competing applications for an Institutional Oncology Career Development
Program (K12) Grant are now required to include a specific plan to recruit and
retain underrepresented minorities in the Program. In addition, all future
Non-competing Grant Progress Reports must include a report on the recruitment
and retention of underrepresented minorities during the previous award period.
6. 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. Clinical candidates must commit a minimum of
75 percent effort to the 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).
7. The Program should include Core Requirements that each candidate is expected
to complete before meeting the Program's training objectives. All candidates
graduating from the program must complete all of these requirements either
directly or through combination with their past training experience. 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.
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
Phase I, Phase II and where possible Phase III clinical trials.
c. A basic research core component that provides a hands-on research experience
that adequately prepares the trainee for communication, coordination and
collaboration of clinical research activities with basic scientists. This
experience should 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.
Special Administrative Requirements
o Special Leave: Leave of a trainee to another institution, 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 up to one year, prior written approval of NCI staff
is required. To obtain prior approval, the trainee must submit a letter to the
NCI Grants Administration Branch with a copy to the NCI Program Director
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 for the leave and for the return of the
trainee to the Program. 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
grantee institution.
o 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. The NIH may discontinue
an award upon determination that the purpose or terms of the award are not being
fulfilled. In the event an award is terminated, the Director of the NIH shall
notify the grantee institution and career award recipients in writing of this
determination, the reasons therefore, the effective date, and the right to
appeal the decision.
o Change of Institution: The Clinical Oncology Career Development Program
(K12) cannot be transferred from one institution to another.
o Change of PI: If the PI moves to another institution or resigns from the
position, support of the award may be continued with NCI prior approval
provided:
1. The current PI or the awardee institution has submitted a written request for
change of PI, countersigned by the appropriate institutional business official,
to the NCI Grants Administration Branch with a copy to the NCI Program Director
describing the reasons for the change. The biosketch of the proposed new PI,
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 career development program to be conducted under the direction of
the new PI will remain unchanged; and that the new PI has the appropriate
research and administrative expertise to lead the program.
2. The request is submitted far enough in advance of the requested effective
date to allow the necessary time for review.
o Changes of Program: Awards are made to a specific institution for a
specific program under the guidance of a particular PI. Changes in any of
these parameters requires prior approval by the NCI.
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, support could be withheld or the award could be suspended or
terminated.
Budget and Related Issues
o Allowable costs:
1. Direct cost cap: No application may exceed $700,000 in direct costs per
annum. Applicants do not need to request prior permission to submit the K12
application unless the application is in addition to another K12 application
submitted by the same institution; in addition to another NCI K12 grant at the
same institution; or the requested direct costs per annum in any year exceeds
the current cap on NCI K12 grants.
2. Salary: Clinician research candidates may be provided salary support of
up to $75,000 each year based on a full-time,12 month staff appointment; 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 NIH 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: No more than $30,000 per individual
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. It is anticipated that the K12 trainees will
be working in a funded research environment. It will therefore be allowable to
use the research and development support provided by the K12 grant to augment
this support in order to be able to include the trainee in this research, but it
will not be allowable to use this to pay substantially for funded basic research
studies or clinical trials.
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. 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, Office 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 NIH-supported research or research training grant for
the salaries and/or fringe benefits of individuals, but freed as a result of a
K12 award, may not be rebudgeted and may not be used for any other purpose
without prior NIH approval.
7. Carryover of unobligated balances: Although the K12 is subject to Expanded
Authorities, the carryover of funds from one budget period to the next requires
prior written approval by NCI.
Special Reporting Requirements:
o 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.
o Progress Reports: An Annual Progress Report for the grant is required.
This report should provide information about changes in the Program, an
evaluation of the Program made by 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 the K12 initiative.
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. The procedure for
obtaining the face page for the application is described on the following
website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-066.html
Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the
application for continuation to contain the following information:
o Appropriate face page (Form Page 1) as instructed in the Form PHS 2590.
o A budget page (Form Page 2) 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.
o A brief description of the Objectives and Goals of the Program
o 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).
o Biographical sketches of
i. New faculty
ii. New mentors
iii. New Advisory Committee (AC) Members
iv. New Trainees
The biosketches for each trainee should include any Board Eligibilities or
Certifications. The biosketches for new faculty/mentors/AC members should
include a listing of all active research grant support for which they are the PI
or co-investigator.
o Progress of Individual Trainees: For each trainee, provide the start date
(month/year) of the appointment to the Program and the cumulative number of
years supported by the K12 grant; the names of the basic and clinical research
mentors; and a brief paragraph for each candidate or trainee describing the
basic laboratory and clinical research and didactic training experiences
completed and ongoing, the relationship between the two research training
experiences, and the specific future plans for satisfying the Core Requirements
of the Program. The individual reports should also include: 1) A list of
publications for the trainee resulting from their work in the Program; 2)
Descriptive titles of clinical trials developed and/or implemented by each
trainee and resulting from their work in the program, identifying the role of
the trainee in each of the trials; and 3) A listing of all active research
support for which a trainee is the PI, clearly showing the percent effort
commitment of the trainee and addressing potential overlap issues with the
research objectives of the K12-supported research. It is acceptable to describe
all of the career-related activities in which the trainee participates during
their appointment to the K12 program. However, it is important to differentiate
progress made on activities directly relevant to the Program from progress made
on other activities.
o A Report from the 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 and providing recommendations for improving the
Program (e.g., new mentors, changes in Core Requirements, changes in recruitment
strategies etc.).
o A separate report from the AC on progress made in recruiting underrepresented
minorities into the Program. Information must be included on successful and
unsuccessful recruitment strategies. The report should include the
following information on underrepresented minorities: 1) Candidates who applied
for admission within the participating department(s) relative to the Program; 2)
Candidates who were offered admission to the Program; 3) Candidates who were
appointed to the program.
o 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 (PI's, individual
candidates/trainees) 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.
o A final progress report, invention statement, and Financial Status Report are
required upon either completion of an award or relinquishment of an award.
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:
o Direct your questions about scientific/research issues to:
Lester S. Gorelic, Ph.D.
Office of Centers, Training and Resources
Cancer Training Branch
National Cancer Institute
6116 Executive Blvd., MSC 8346
Suite 7025
Bethesda, MD 20892-8346
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: [email protected]
o 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, MD 20852 (Express Mail)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Catherine Blount
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Blvd.
Bethesda, MD 20892
Rockville, MD 20852 (Express Mail)
Telephone: (301) 496-3179
FAX: (301) 496-8601
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this PA
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 plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Lester S. Gorelic, Ph.D.
Office of Centers, Training and Resources
Cancer Training Branch
National Cancer Institute
6116 Executive Blvd., MSC 8346
Suite 7025
Bethesda, MD 20892-8346
Rockville, MD 20852 (Express Mail)
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact Grants Info, Telephone (301) 710-0267,
Email: [email protected].
The instructions in the Form PHS 398 do not fully apply to the special needs
of this grant application. Therefore, follow the modified instructions below in
preparing an application for an NCI Institutional Clinical Oncology Research
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 Form Page 1 of the Form PHS 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-03-083 , 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 (Form Page 2 of Form
PHS 398): Complete as directed in the Form PHS 398. 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:
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)
- Principal Investigator
- 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. This
should include support from other training programs that relate to this
application (e.g. other K12 grants, K30 Awards, T32 Awards, R25T Awards)
i. Career Development/Training Plan (may exceed 25 pages; tables should be
included in the text, not as appendices)
(1) Introduction to Revised Application (when applicable, not to exceed 3 pages)
(2) Purpose and Objectives
(3) Description of Core Requirements
(4) Research Base/Resources and Facilities(Suggested tabular formats for this
information can be found under "Summary information on Program" on the following
website: (http://cancertraining.nci.nih.gov/research/clinical/k12full.html#app)
(5) Program Management
- Principal Investigator
- Recruitment Strategies (Including a separate plan for recruitment of
underrepresented minorities)
- 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 a minimum of 75% of
full-time professional effort to research and research career development.
5. Detailed Budget for the Initial Budget Period: Use Form Page 4 of the PHS
Form 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 that there is
an upper limit of salary of $75,000 plus fringe benefits, an upper limit for
other costs of $30,000 per trainee; and a required minimum 75% effort.
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 the Biographical
Sketch Format Page of the Form PHS 398. Group the biosketches into the
following five sections: (1)PI; (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 work with basic scientists on
projects in patient-oriented therapeutic cancer research.
b. Description of Core Requirements:
Describe separately 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. If there is an existing
institutional K30 program, explain how the K12 Program will link with and make
use of the K30 program to meet the objectives of the K12 core didactic
component.
Using specific, real or hypothetical examples, 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 (Refer to the following
website for a suggested format for providing this information:
http://cancertraining.nci.nih.gov/research/clinical/k12full.html)
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. Include in this description the
number and types of early to late phase clinical therapeutic clinical trials
being conducted in the institution and the general range of activities in these
trials.
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:
Principal Investigator: Describe the qualifications and role of the PI 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.
Plans for Recruitment of Underrepresented Minorities: Describe plans for
recruitment of underrepresented minorities (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/examples of 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 therapeutic research and collaborate effectively
with basic scientists in translating the discoveries of the basic scientists
into therapeutic clinical trials. If relevant to your K12 program, provide
examples of plans for short-term (2 years) appointments.
9. Human Subjects: Follow the instructions in Form PHS 398. You will need to
follow current NIH policy on providing in your application information on data
and safety monitoring. Refer to the following website for information on NCI
policies on data and safety monitoring for training awards:
http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines
10. Vertebrate Animals: Follow the instructions in Form PHS 398.
11. Appendices: Follow the instructions in Form PHS 398.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted by the receipt dates listed at the beginning of
this program announcement.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including 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 sent on or before the date(s) listed
on the first page of this PAR. 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.
Although there is no immediate knowledge of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
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 Receive a second level review by the National Cancer Advisory Board.
REVIEW CRITERIA
PRINCIPAL INVESTIGATOR: Qualifications (and track record for competing renewal
applications) of the PI to provide both scientific and administrative leadership
of the Program.
ADVISORY COMMITTEE: Quality (and track record for competing renewal
applications) of the Advisory Committee and appropriateness for performing its
critical functions in recruitment of candidates, assignment of mentors,
establishment and monitoring of individual training plans, and evaluating and
making mid-course corrections for the Program. Additionally, for competing
renewal applications, adequacy of addressing any concerns expressed in the
Summary Statement for the prior five year award.
PROGRAM/CORE REQUIREMENTS: Merit of the Program (and track record for competing
renewal applications), as defined in the didactic core requirements, basic
research core requirements, and clinical core requirements, to train patient-
oriented clinical scientists who can collaborate effectively with basic
scientists in translational research and conduct all phases (e.g., Phase I,
Phase II and Phase III) of hypothesis-driven, therapeutic cancer clinical
trials.
ENVIRONMENT: Quality, sufficiency and interactiveness of the basic and clinical
research of the institution to provide the environment necessary for the Program
to meet its goals and objectives.
MENTORS: Experience and quality of the mentors to ensure a successful outcome
of the Program.
CANDIDATES: Adequacy of the plans for (and track record for competing renewal
applications) recruiting high quality trainees, to ensure a supply of high
quality trainees for the Program representing at least two oncology disciplines.
Adequacy of the specific measures proposed or taken to recruit underrepresented
minority candidates to the Program. This does not include Continuing Umbrella of
Research Experiences (CURE) supplements to the K12 program.
INSTITUTIONAL COMMITMENT: The strength of the institution's commitment to the
Program, especially with regard to ensuring that each candidate will have
protected time to commit 75% effort to research career development.
OVERLAP: The potential of this Program to overlap with other existing training
programs.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and priority
score.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (Se criteria included in the section on
Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans
to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria included in the section on Federal
Citations, below)
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be
used in the project, the five items described under Section f of the PHS 398
research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH: The appropriateness of topics,
format, amount and nature of faculty participation, and the frequency and
duration of instruction. Every trainee supported by this grant must receive
instruction in the responsible conduct of research. For more information on this
provision, see the NIH Guide for Grants and Contracts, Volume 21, Number
43,November 27, 1992, see http://grants.nih.gov/grants/guide/notice-
files/not92-236.html. Applications must include a description of a program
to provide formal or informal instruction in scientific integrity or the
responsible conduct of research. Applications without plans for instruction
in the responsible conduct of research will be considered incomplete and will
be returned to the applicant without review.
o Although the NIH does not establish specific curricula or formal requirements,
all programs are encouraged to consider instruction in the following areas:
conflict of interest, responsible authorship, policies for handling misconduct,
data management, data sharing, and policies regarding the use of human and
animal subjects. Within the context of training in scientific integrity, it is
also beneficial to discuss the relationship and the specific responsibilities of
the institution and the candidates appointed to the program.
o Plans must address the subject matter of the instruction, the format of the
instruction, the degree of faculty participation, trainee attendance, and the
frequency of instruction.
o The rationale for the proposed plan of instruction must be provided.
o Program reports on the type of instruction provided, topics covered, and other
relevant information, such as attendance by trainees and faculty participation,
must be included in future competing continuation and noncompeting applications.
The NIH encourages institutions to provide instruction in the responsible
conduct of research to all graduate students, postdoctorates, and research staff
regardless of their source of support.
NCI initial review groups will assess the applicant's plans on the basis of the
appropriateness of topics, format, amount and nature of faculty participation,
and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, so that the
review panel's evaluation of the plan will not be a factor in the determination
of the priority score. Plans will be judged as acceptable or unacceptable. The
acceptability of the plan will be described in an administrative note on the
summary statement. Regardless of the priority score, applications with
unacceptable plans will not be funded until the applicant provides a revised,
acceptable plan. Staff within the NIH awarding component will judge the
acceptability of the revised plan.
MINORITY RECRUITMENT AND RETENTION PLAN: The NCI remains committed to
increasing the participation of individuals from underrepresented minority
groups in biomedical and behavioral research. All competing applications for
this program must include a specific plan to recruit and retain underrepresented
minorities in the training program. In addition, all competing continuation
applications must include a report on the recruitment and retention of
underrepresented minorities during the previous award period. If an application
is received without a plan or without a report on the previous award period, the
application will be considered incomplete and will be returned to the applicant
without review.
Competing continuation applications and Non-competing Grant Progress Reports
must include a detailed account of experiences in recruiting individuals from
underrepresented groups during the previous funding period. Information must be
included on successful and unsuccessful recruitment strategies. The report
should provide information on the racial/ethnic distribution of:
o All clinician candidates who applied for admission or positions within the
department(s) participating in the Program
o Clinician candidates who were offered admission to or a position within the
participating department(s)
o Clinician candidates actually enrolled in the participating departments
o Clinician candidates who were appointed to the Program
For those trainees who were enrolled in the Program, the report should include
information about the duration of research training and whether those trainees
finished their training in good standing.
The success of efforts to recruit and retain minority trainees is a factor in
the assessment of the quality of the trainee pool and thus will be included
within the priority score. In addition, peer reviewers will separately evaluate
the minority recruitment plan and report (for competing renewals) after the
overall score has been determined. Reviewers will examine the strategies to be
used in the recruitment of minorities and whether the experience in recruitment
during the previous award period has been incorporated into the formulation of
the plan for the next award period. The review panel's evaluation will be
included in an administrative note in the summary statement. If the plan or the
record of minority recruitment and retention is judged to be unacceptable,
funding will be withheld until a revised plan (and report) that addresses the
deficiencies is received. Staff within the NCI will determine whether amended
plans and reports submitted after the initial review are acceptable.
BUDGET: Appropriateness of the budget and the requested period of support to
achieve the stated goals and objectives of the Program.
AWARD CRITERIA
Applications submitted in response to a 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
o Relevance to NCI priorities
o Acceptability of the plan for minority recruitment
o Acceptability of the proposal for instruction in the responsible conduct of
research.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects and others, and
the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA AND SAFETY 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 and Safety 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. Information
concerning essential elements of data safety monitoring plans for clinical
trials funded by the NCI is available:
http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines. Please refer to
the section titled "Training Grants" under Special Circumstances for specific
guidelines on data and safety monitoring for K12 grants for the initial award.
The Program must comply with all of the data and safety monitoring requirements
of individual NCI career awards during the funded project period.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
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 is 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. 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 at http://www.cfda.gov/
and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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