THE NCI CAREER DEVELOPMENT AWARD FOR QUANTITATIVE SCIENTISTS
RELEASE DATE: February 20, 2004
RFA Number: RFA-CA-04-016
EXPIRATION DATE: April 21, 2004
Department of Health and Human Services (DHHS)
National Institutes of Health (NIH)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.398
LETTER OF INTENT RECEIPT DATE: March 22, 2004
APPLICATION RECEIPT DATE: April 20, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this Request for Applications (RFA) is to solicit
applications to encourage doctoral level quantitative scientists to
develop and apply their skills to biomedical cancer research. This RFA
is specifically intended for quantitative scientists, whose skills have
not yet focused primarily on questions of health and disease and who
wish to become cancer researchers as independent investigators and/or as
leaders or co-leaders of interdisciplinary cancer research teams.
Examples of scientific and technical backgrounds considered appropriate,
but not all inclusive, for this award are as follows: physics,
mathematics, computer science, imaging science, informatics, statistics,
economics, chemistry, engineering, and nanotechnology. This K25 award
provides up to 5 years of salary and research support for a mentored
research career development experience in biomedical cancer research.
Quantitative scientists receiving an NCI K25 Award will become eligible
to apply for the NCI Transition Career (K22) Award, which would provide
3 years of protected time after completion of the K25 Award to develop
an independent research program in biomedical cancer research.
The NCI Career Development Award for Quantitative Scientists is not
intended to supersede participation of the National Cancer Institute
(NCI) in the existing omnibus NIH Mentored Quantitative Scientist
Research Career Development Award
(http://grants.nih.gov/grants/guide/pa-files/PA-02-127.html). Instead, this
RFA represents a pilot program that is intended to complement and expand
on the objectives of the NIH omnibus K25 program. This is achieved by
requiring (1) that the research career development experience takes
place at institutions that are NCI-designated Cancer Centers (P30s)
and/or are supported by NCI Integrative Cancer Biology Programs (ICBPs
or P50s) and (2) that a Mentoring Committee is in place to ensure that
the candidate is progressing successfully toward meeting his/her
proposed career development objectives. NCI-designated Cancer Centers
are responsible for broad-based coordination and integration of research
in academic and free-standing institutions and are therefore in a unique
position to match the background of a quantitative scientist to tailored
didactic and multidisciplinary research experiences needed for a
successful career in cancer research. Additionally, NCI-designated
Cancer Centers are characterized by scientific excellence and the
ability to integrate diverse research approaches that focus on the
problem of cancer. Consequently, the Cancer Centers represent ideal
environments for quantitative scientists to identify areas that will
bring their novel perspectives to bear on basic, clinical, prevention,
or behavioral research in, for example, the development of new tests,
devices, software, analytical tools, and innovative methodologies.
Finally, institutions that have successfully competed for Integrative
Cancer Biology Program grants are the ideal sites to nurture career
awardees in the kind of team science efforts that truly integrate the
quantitative and computational sciences with the biomedical sciences.
This initiative is consistent with the recommendations of the
Bioengineering Education and Training Panel which was convened as part
of the 1998 Bioengineering Consortium (BECON) Symposium (the symposium
Report is available at http://www.becon.nih.gov/becon_symposia.htm).
This initiative is also consistent with the recommendations of the 2002
BECON Symposium "Catalyzing Team Science"
Many of today’s health problems are too complex to be readily addressed
using a single discipline or even a multi-disciplinary approach. It has
become increasingly apparent that interdisciplinary approaches are
needed that integrate biological, clinical, behavioral and population
science research with the quantitative sciences in highly collaborative
team research settings. In 1998, BECON convened a 2-day symposium at the
NIH to identify scientific priorities in several categories of
bioengineering research and to propose strategies for addressing these
priorities. In the area of clinical medicine, the need to catalyze
multidisciplinary teams, to develop and document models of translational
research, and to provide incentives for translational research were
among the scientific priorities identified. NIH support for new
approaches to educate persons committed to translational research and to
create the intellectual infrastructure necessary for productive
translational research were recommended as strategies for addressing
these priorities. In the areas of education and training, the need to
increase the level of quantitative skills at all levels through K awards
was identified as a scientific priority.
In 1999, the NIH issued PA 99-087 titled Mentored Quantitative Research
Career Development (K25) Award." This K award was intended for
quantitative scientists whose research careers have not yet focused
primarily on issues of health and disease. The award was intended to
provide quantitative scientists a mentored biomedical research
experience that would allow them to conduct basic, clinical, behavioral,
bioimaging, or bioengineering research, and to become independent
investigators or play leading roles in multi-disciplinary research
teams. The K25 PA encouraged but did not require that career development
takes place in a multidisciplinary, translational team-oriented research
environment. The NCI Quantitative Scientist Career Development Award
will support career development exclusively within this type of research
The Cancer Centers Program of the NCI (see:
http://cancer.gov/cancercenters) provides the infrastructure that
supports the establishment of multidisciplinary and interdisciplinary
research programs through Cancer Center Support Grants (CCSGs or P30s).
NCI Integrative Cancer Biology Programs (ICBPs or P50s) are specifically
designed to create team research settings that integrate the biomedical,
quantitative, and computational sciences. Both NCI-designated Cancer
Centers and ICBPs represent ideal environments for quantitative
scientists to identify areas that will bring their novel perspectives to
bear on the basic, clinical, prevention, and behavioral cancer research.
The objectives of the NCI Career Development Award for Quantitative
Scientists are to:
o Encourage research-oriented quantitative scientists (e.g., physicists,
mathematicians, computer scientists, imaging scientists, informaticians,
statististians, economists, chemists, engineers, and nanotechnologists
with little or no experience in biomedical or health-related research to
pursue careers in biomedical cancer research;
o Engage NCI-designated Cancer Centers and NCI ICBPs to not only serve
as the sites for career development, but to take a proactive role in
selecting the best candidates to submit applications, matching
candidates to the most appropriate mentor(s) and research, and
monitoring performance of the mentors and the progress of candidates in
order to ensure successful career outcomes.
o Develop a cadre of quantitative scientists who can conduct biomedical
cancer research as independent investigators and/or as leaders or co-
leaders of interdisciplinary cancer research teams.
Because this career award will support the first experience of
quantitative scientists in applying their skills to biomedical cancer
research, these individuals may require an additional period of
protected time after completion of the NCI K25 Award to develop a
funding base for their research. To accommodate this potential need, the
eligibility requirements of the NCI Career Transition Award (K22)
will be expanded to include quantitative scientists who have been
supported by this K25 Award.
MECHANISM OF SUPPORT
This RFA will use the NIH K25 career development award mechanism.
Planning, direction, and/or execution of the career development plan of
the candidate according to the special requirements of this RFA will be
the responsibility of the applicant institution as implemented by the
mentor(s) and the Mentoring Committee. This RFA is a one-time
solicitation. Future unsolicited, competing-continuation applications
based on this project will compete with all investigator-initiated
applications and will be reviewed according to the customary NIH peer
review procedures. The anticipated award date is September, 2004.
Applications that are not funded in the competition described in this
RFA may be resubmitted as standard NIH K25 applications in response to
PA-02-027 or subsequent reissuances using the standard receipt dates for
NEW applications described in the instructions to the PHS 398
Applicants may request up to 5 years of support. Each award is non-
renewable and non-transferable from one Principal Investigator to
another. Funding beyond the first year is contingent upon satisfactory
progress during the preceding year, as documented in the required
progress report. NIH Grant policies apply to these awards.
This RFA follows the Just-In-Time initiative for Career Awards published
in the NIH Guide, Volume 25, Number 10, March 29, 1996. Applications
submitted in accordance with PHS 398 (Rev. 05/2001), Section IV
(Additional Instructions for Preparing Individual Research Career Award
(RCA) Applications - "K" Series, are in compliance with the instructions
provided in the 1996 Guide Notice (See Supplementary Instructions
The NCI intends to commit approximately $700,000 in FY 2004 to fund four
new grants in response to this RFA. An applicant may request a project
period of up to 5 years and a budget for direct costs of up to $115,000
per year (excluding fringe benefits), which includes costs for Salary of
the candidate and Research Development Support (see section below on
Allowable Costs). Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial
plans of the NCI provide support for this program, awards pursuant to
this RFA are contingent upon the availability of funds and the receipt
of a sufficient number of meritorious applications.
An institution may submit an application on behalf of the candidate if
it has either of the following characteristics:
o It is an NCI-designated Cancer Center and is supported by an NCI
Cancer Center Support Grant (P30 grant) and/or
o Has pending an NCI Integrative Cancer Biology Program (P50)
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS:
To be eligible to apply for this award, candidates must be: (1)
doctorally-degreed individuals in the quantitative sciences (e.g.,
physics, mathematics, computer science, imaging science, informatics,
statistics, economics, chemistry, engineering, nanotechnology);(2)
experienced quantitative scientists, who have been committed to a
research career at either the postdoctoral, junior faculty or senior
faculty level at the sponsoring institution (these could be individuals
from the industry who will be trained at the sponsoring institution with
the intent of establishing collaborative research programs between the
sponsoring institution and the industrial sponsor after completion of
the program see below); (3) quantitative scientists with little or no
experience in applying their research to biomedical research; and (4)
individuals, who will devote a minimum of 75 percent full-time
professional effort to the Award. The remaining 25 percent can be
divided among other research, clinical, and teaching activities only if
these activities are consistent with the goals of the K25 Award, i.e.,
the candidate's career development as an independent cancer researcher
and/or as a leader or co-leader of an interdisciplinary research team.
If the candidate, who will be supported by the K25 award, is from
industry, there must be assurances from both the sponsoring institution
and the industrial sponsor guaranteeing protected time as required in
(4) above and stating the mutual commitment to develop collaborative
research in the future.
Only U.S. citizens or non-citizen nationals, or an individual lawfully
admitted for permanent residence who possesses an Alien Registration
Card (I-151 or I551), or some other verification of legal admission as a
permanent resident, are eligible for this award. Non-citizen nationals,
although not U.S. citizens, owe permanent allegiance to the U.S.; they
are usually born in the lands that are not States but under U.S.
sovereignty, jurisdiction, or administration. Individuals on temporary
or student visas are not eligible
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH
A candidate for this K25 award may not simultaneously submit or have
pending an application for any other PHS or non-Federal award that
duplicates any of the provisions of this award. Former or current
principal investigators on any NIH research grants (this does not
include NIH R03 or R21 grants or their equivalents) or non-PHS peer
reviewed research grants that are over $100,000 direct costs per year,
or project leaders on sub-projects of program project (P01) grants or
center grants (P50) are NOT eligible to apply.
Special Programmatic Requirements
1. The sponsoring institution, through the Cancer Center and/or ICBP,
must use a selection process that is broadly inclusive in selecting the
most motivated, highly qualified candidates representing the
quantitative sciences in the sponsoring institution to apply for the K25
2. The Cancer Center and/or the pending ICBP must play a significant
role in matching the selected candidate to the most appropriate
mentor(s) and research environment.
3. The candidate must have a mentor(s) who is a member of the NCI-
designated Cancer Center or a project leader of a pending ICBP. This
mentor(s) must have a strong research and training track record in
biomedical cancer research, experience in interdisciplinary team
research settings, and currently active independent support for
biomedical cancer research.
4. The candidate must have a Mentoring Committee (MC) appointed by the
senior leadership of the NCI Cancer Center and/or the pending ICBP. The
MC should be an appropriately qualified interdisciplinary group of
internal and/or external experts responsible for monitoring both the
performance of the mentor and progress of the candidate in achieving
his/her career objectives and becoming an independent investigator
and/or a leader or co-leader of a interdisciplinary research project.
The MC should perform these responsibilities at least once-a-year and
should make recommendations to the Mentor(s) and the Candidate for
improving career outcomes. A brief written Annual Summary (AS) of the
MC’s deliberations and any recommendations should be prepared each year.
The AS and statements describing how the mentor and candidate responded
to any recommendations should be included in the annual progress report
submitted to the NCI.
5. The Career Development Plan should include both didactic and research
requirements designed to enable the candidate to achieve his/her
objectives during the K25 award.
Budget and Related Issues
1. Allowable Costs:
a. Salary: The NCI Career Development Award For Quantitative
Scientists (K25) will provide salary up to $75,000, plus fringe
benefits. The total salary requested must be based on a full-time, 12-
month staff appointment requiring the candidate to devote a minimum of
75 percent of full-time professional effort to conducting cancer
research. The remaining effort should be devoted to activities related
to the development of a successful research career. The salary must be
consistent both with the established salary structure at the institution
and with salaries actually provided by the institution from its own
funds to other staff members of equivalent qualifications, rank, and
responsibilities in the department concerned. If full-time, 12-month
salaries are not currently paid to comparable staff members, the salary
proposed must be appropriately related to the existing salary structure.
The sponsoring institution may supplement the NIH contribution up to a
level consistent with the institution's salary scale. Supplementation
may not be from Federal funds unless specifically authorized by the
Federal program from which such funds are derived. Because the salary
amount provided by this award is based on the full-time institutional
salary, no other NIH funds may be used for salary supplementation.
Institutional supplementation of salary must not require extra duties or
responsibilities that would interfere with or detract from the purpose
of the award.
Effective for all competing research grant applications submitted for
the February 1, 2004, deadlines and beyond, mentored career award
recipients in the last 2 years of career award support may hold
concurrent support from their career award and a competing NIH research
grant when recognized as a Principal Investigator or subproject
Director. This new policy can be found at the following
b. Research Development Support: Up to $40,000 per year will be
provided for the following types of expenses: (a) research expenses,
such as supplies, equipment, and technical personnel; (b) statistical
services including personnel and computer time; (c) tuition, fees, and
books related to career development of the PI; and (d) travel to
research meetings or for training. The level of research development
support may be negotiated downward with the acquisition of any
independent grant support from any source.
c. Ancillary Personnel Support: Salaries for mentors, secretarial and
administrative assistance, etc. are NOT allowed.
d. Facilities and Administrative Costs: These costs, which were
formerly called indirect costs, will be reimbursed at eight percent of
modified total direct costs.
2. 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:
a. 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.
b. The funds may be used for health-related research purposes.
c. 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.
d. 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 and fees resulting from clinical
practice, professional consultation or other comparable activities,
provided these activities remain incidental, are not required by the
research and research-related activities of this award, and provided
that the retention of such pay is consistent with the policies and
practices of the grantee institution.
Usually, funds budgeted in an NIH supported research or research
training grant for the salaries or fringe benefits of individuals, but
freed as a result of a career award, may not be rebudgeted. The
awarding component will give consideration to approval for the use of
released funds only under unusual circumstances. Any proposed retention
of funds released as a result of a career award must receive prior
written approval of the NIH awarding component.
Special Administrative Requirements
1. Special Leave:
Leave to another institution, including a foreign laboratory, may be
permitted if the proposed experience is directly related to the purpose
of the award. Only local institutional approval is required if such
leave does not exceed 3 months. In general, leave without award support
may not exceed 12-months, should be requested only in unusual situations
and will require prior written approval of the NCI. Such leave does not
reduce the number of months of program support for which an individual
is eligible. To request prior NCI approval, the award recipient must
submit a letter to NCI describing the plan, countersigned by his/her
mentor 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 career award will continue during such leave.
Under unusual circumstances, an awardee may submit a written request to
the awarding component requesting a reduction in professional effort
below 75 percent. Such requests will be considered on a case-by-case
basis during the award period. In no case will it be permissible to
work at less than 50 percent effort. The nature of the circumstances
requiring reduced effort might include medical conditions, disability,
or pressing personal or family situations such as child or elder care.
Permission to reduce the level of effort will not be approved to
accommodate other sources of funding, job opportunities, clinical
practice, or clinical training. In each situation, the grantee
institution must submit documentation supporting the need for reduced
effort along with assurance of a continuing commitment to the scientific
development of the awardee. In addition, the awardee must submit
assurance of his/her intention to return to full-time professional
effort (at least 75 percent) as soon as possible. During the period of
reduced effort, the salary and other costs supported by the award will
be reduced accordingly.
2. Termination of Grant
When a grantee institution plans to terminate an award, NCI must be
notified in writing at the earliest possible time so that appropriate
instructions can be given for termination. The Director of the NIH may
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 recipient in writing of this determination, the reasons therefore,
the effective date, and the right to appeal the decision.
3. Change of Institution
Due to the unique institutional environment requirements of this award,
individuals may not make a change of sponsoring institution.
4. Changes in Research Program
Individual awards are made for career development at a specific NCI-
sponsored Cancer Center in a specific integrated research environment.
Consequently, a change in the specified scientific area of the research
component of the career development program may be allowed only under
extremely extenuating circumstances. A scientific rationale must be
provided for any proposed changes in the aims of the original peer-
reviewed research plan. The new research plan will be evaluated by NCI
staff to ensure that the plan remains within the scope of the original
peer-reviewed research and career development program. If the new plan
does not satisfy this requirement, the award could be terminated.
A final progress report, invention statement, and Financial Status
Report are required upon termination or after completion of award.
5. Changes in Mentor(s)
Grantees may request a change in mentor(s). This request must be
submitted in writing to NCI staff, cosigned by an appropriate
institutional business official, and include from the grantee
1)justification for the change, 2) name(s) of the new mentor(s); 3) a
description of how the research expertise of the new mentor(s) will
contribute to the achievement of the research and career development
objectives of the peer-reviewed grant application. This request must be
accompanied by a letter from the proposed new mentor(s) 1) documenting
agreement to the change, 2)listing the current active support for
his/her/their research using the PHS Form 398 OTHER SUPPORT Format page,
3) a description of how his/her/their research expertise will contribute
to the achievement of the research and career development objectives of
the peer-reviewed grant application 4) if primary mentor, a mentoring
plans for the K-awardee.
In carrying out its stewardship of human resource related programs, the
NIH may begin requesting information essential to an assessment of the
effectiveness of this program. Accordingly, recipients are hereby
notified that they may be contacted after the completion of this award
for periodic updates on various aspects of their employment history,
publications, support from research grants or contracts, honors and
awards, professional activities, and other information helpful in
evaluating the impact of the program.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
o Direct your questions about scientific/research issues to:
Lester S. Gorelic, Ph.D.
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD 20892-8346
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8580
FAX: (301) 402-4472
o Direct your questions about peer review issues to:
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
o Direct your questions about financial or grants management matters to:
Ms. Kimmery B. Griffin
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
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 RFA
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.
Cancer Training Branch
National Cancer Institute
6116 Executive Boulevard, Suite 7025, MSC 8346
Bethesda, MD 20892-8346
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8580
FAX: (301) 402-4472
SUBMITTING AN APPLICATION:
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must have
a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number
as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling (866)
705-5711 or through the web site at http://www.dunandbradstreet.com/.
The DUNS number should be entered on line 11 of the face page of the PHS
398 form. The PHS 398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov.
In addition to the required information listed in the instructions for
Research Career Awards in the PHS 398, all applications MUST include the
following information in the respective sections:
o Provide information on research projects completed and/or research
grants participated in during the last 5 years that are relevant to the
o Provide Biographical Sketches for all members of the Mentoring
LETTERS OF REFERENCE
Three letters of reference must be provided from established scientists
familiar with the candidate's potential and capability to become a
successful independent investigator. These letters should be provided in
sealed envelopes attached to the front page of the application.
PROCESS FOR SELECTING THE CANDIDATE
o Describe the process (in the form of a self-contained document) that
will be used by the Cancer Center and/or the ICBP to identify and select
potential candidates to apply for the K25 award, and for matching the
candidate(s) to the most appropriate mentor(s) and research environment.
If candidate(s) from industry are being considered, describe the role of
the industry in this process. This document should be signed by an
institutional business official, and NCI Cancer Center Director and/or
the Director of a pending ICBP.
o Describe your commitment to a research career in the application of
the quantitative sciences to biomedical cancer research.
o Describe your immediate and long-term career objectives, explaining
how the award will contribute to their attainment.
o Describe all activities and professional accomplishments in the
quantitative sciences; and, if appropriate, in biomedical research.
Include all research experiences and mentors, any pertinent didactic
experiences and any other experiences designed to acquire critical
skills, techniques and scientific perspectives for pursuing an
independent research career in the chosen area of cancer biomedical
research (e.g., basic research, clinical, or patient-oriented research,
and prevention, control and population research).
o Describe and document your past scientific productivity (e.g.,
o Describe and document your ability to interact and collaborate with
o Establish the ability to make a commitment of at least 75 percent
effort to the career objectives of this award, including any current
duties that you will relinquish to pursue this career development
o Document prior instruction in or proposed plans for instruction in
the responsible conduct of research in terms of subject matter and
duration of instruction. An award cannot be made if an application lacks
o Describe in detail the composition of the MC appointed by the Cancer
Center and/or the pending ICBP if appropriate and the frequency of
meetings (note: the MC must meet at least once a year)
o Describe the process and the factors to be used in the process the MC
will use in overseeing the performance of the mentor, the effectiveness
of the mentoring plan, the progress of the candidate in meeting his/her
career didactic and research objectives and progress in becoming an
independent investigator and/or a leader or co-leader of a
interdisciplinary cancer research project.
o Describe how recommendations of the MC for midcourse corrections or
changes in the mentoring plan or research plan will be implemented.
o Describe the research plan in basic, clinical, cancer prevention or
cancer control research; or in behavioral or population sciences
research directly related to cancer. The research plan must be
described as outlined in form PHS 398 including sections on the Specific
Aims, Background and Significance, Progress Report/Preliminary Studies,
Research Design and Methods.
o Describe how the proposed plan extends the prior research experience
in the quantitative sciences (and, if applicable, biomedical research)
into new concepts and ideas in biomedical cancer research.
o Describe the equipment, specialized facilities and personnel
resources that will be needed to conduct the proposed research.
o Describe the plans for inclusion of women, minorities and children in
any clinical or population research activities.
o Describe the plans for protection of humans, animals, or the
environment to the extent they may be adversely affected by activities
proposed in the application.
CAREER DEVELOPMENT PLAN
o Describe a systematic multi-disciplinary plan incorporating
consideration of the candidate's goals and prior experience to obtain
the necessary theoretical and conceptual background and research
experience to launch an independent research career involving the
integration of the quantitative sciences and biomedical cancer research.
The career development plan must be tailored to the needs of the
individual candidate and the ultimate goal of achieving independence as
a researcher integrating the quantitative sciences with biomedical
cancer research. This plan should include a description of the core
didactic, biomedical research and quantitative sciences requirements
that each candidate will be expected to satisfy during the K25 award.
STATEMENT(S) BY MENTOR/CO-MENTOR(S)
o The application must include a statement from the mentor(s) providing
information on his/her basic or clinical biomedical research
qualifications in the research area proposed by the candidate; his/her
research support relevant to the candidate’s research plan; experience
conducting interdisciplinary cancer research in a team-oriented research
environment; and experience as a research supervisor. The mentor must
also provide a plan for mentoring the candidate that is tailored to
integrating an individual in the quantitative sciences into biomedical
research, and describe how this plan is likely to contribute to the
achievement of the objectives of the K25 award. The mentor(s) must
agree to provide annual evaluations of the trainee's progress to the MC
and to make midcourse corrections based on the MC’s recommendations.
Co-mentors may be employed in any sector of the biomedical research
community (e.g., academia, industry, non-profit research institutions).
o Similar information must be provided by each co-mentor. When more
than one co-mentor is proposed, the respective areas of expertise and
responsibility of each should be described and distinguished from each
other as they relate to the Research Plan and the Career Development
Plan of the candidate.
STATEMENT(S) BY CONSULTANT(S), AND COLLABORATOR(S)
Signed statements must be provided by each consultant/collaborator
confirming his/her participation in the project and describing their
specific roles. Collaborators and consultants generally do not need to
provide their biosketches. However, information should be provided
clearly documenting the appropriate expertise in the proposed areas of
LETTERS OF REFERENCE
Three sealed letters of recommendation addressing the candidate's
potential for a research career in the quantitative sciences and
biomedical cancer research. The mentor's statement should not be
included as one of the letters of recommendation, although the mentor(s)
may submit a separate letter(s) of recommendation.
ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE
o Describe the existing depth and breadth of the funded biomedical
cancer research at the sponsoring institution, especially those
environments that are multidisciplinary and interdisciplinary, that will
meet, sustain and nurture the proposed Research Plan and the Career
Development Plan of the candidate and effectively integrate the
candidate into biomedical research.
o If not an NCI Cancer Center, describe the pending ICBP and
specifically how it will be linked to the career development of the K25
o By the sponsoring institution, provide assurance that the candidate
will be able to spend a minimum of 75 percent full professional effort
on the proposed career development plan/research, with the remaining 25
percent effort devoted to activities related to the development of a
successful research career. IF THE CANDIDATE COMES FROM INDUSTRY,
statements from both the sponsoring institution and the industrial
sponsor must be included AND there has to be a commitment to develop
collaborative research together after the candidate completes his/her
career development program. These statements must be signed by
appropriate officials representing the sponsoring institution and/or the
o Describe the steps the sponsoring institution will take to help career
progression of the candidate (i.e., to help the candidate become funded
as either an independent investigator or as a leader or co-leader of a
interdisciplinary research program) after the K25 award is completed.
TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH
o Candidates must describe plans to receive instruction in the
responsible conduct of research. These plans must detail the proposed
subject matter, format, frequency, and duration of instruction. No
award will be made if an application lacks this component.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
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 and
all copies of the appendix material must be sent to:
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)
Appendices should be comprised of single-sided, unbound materials, with
separators between documents.
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER
INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to
courier deliveries (i.e., FEDEX, UPS, DHL, etc.)
This policy is similar to and consistent with the policy for
applications addressed to Centers for Scientific Review as published in
the NIH Guide Notice
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
for responsiveness by the NCI. Incomplete and/or non-responsive
applications will not be reviewed.
Applications that are complete and responsive to the RFA 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 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 written critique
o Receive a second level review by the NCI National Advisory Board.
The following review criteria will be applied:
Process for Selection Of Candidates And Matching With Mentor(s).
o Adequacy of the process with regard to involving the Cancer Center
and/or the pending ICBP (and industry, when appropriate)
o Appropriateness and adequacy of the selection criteria for candidates
o Adequacy of the criteria for matching the candidate to the appropriate
mentor(s) and research environment
o Likelihood that the process has selected the best potential candidate
within the sponsoring institution and has matched the candidate to the
most appropriate mentor(s)
o Quality of the research and academic record.
o Potential to develop as an independent researcher and/or become a
leader or co-leader of interdisciplinary research teams.
o Strength of candidate’s commitment to a career in interdisciplinary
biomedical cancer research.
o Qualifications of the members of the Mentoring Committee to monitor
and provide advice to the candidate and the candidate’s mentor to ensure
that the candidate achieves his/her career objectives
o Adequacy of the factors that the Mentoring Committee will use in
monitoring the mentor and the progress of the candidate and making
Career Development Plan
o Likelihood that the career development plan will contribute
substantially to the candidate's scientific development
o Appropriateness of the content and duration of the proposed didactic
and research phases of the award.
o Consistency of the career development plan with the candidate's career
goals and prior research experience.
o Adequacy of the career development plan for producing a quantitative
scientist who can conduct biomedical cancer research as an independent
investigator and/or as a leader or co-leader of a team-oriented
interdisciplinary research project.
o Presence of the requirement for training in the responsible conduct of
Reviewers recognize that an individual with limited research experience
is less likely to be able to prepare a research plan with the breadth
and depth of that submitted by a more experienced investigator.
Although it is understood that K25 applications do not require the level
of detail necessary in regular research grant applications, a
fundamentally sound research plan must be provided. These particular
career award applications should reflect considerable input from the
mentor(s), since the candidate is not familiar with biomedical research.
In general, less detail is expected with regard to research planned for
the later years of the award, but the application should outline the
general goals and a timeline for achieving those goals over the grant
o Appropriateness of the research plan to the candidate's stage of
research development and as a vehicle for developing the research skills
as described in the career development plan.
o Scientific and technical merit of the research question, design, and
o Relevance of the proposed research to the candidate's career
o Adequacy of the plans to include both genders, minorities, and
children and their subgroups as appropriate for the scientific goals of
the research when human subjects are used. Plans for the recruitment
and retention of subjects will also be evaluated, when applicable.
o History of research productivity and support in biomedical cancer
o Appropriateness of the mentor's research qualifications in the area of
this application, particularly in interdisciplinary team-oriented
o Quality and extent of the mentor(s) proposed role(s) in providing
guidance and advice.
o Adequacy of prior experience in fostering the development of
researchers who can conduct research in a team-oriented research
o Merit of the proposed core requirements to successfully train a
quantitative scientist who can conduct biomedical cancer research in a
team-oriented interdisciplinary research environment.
Institutional Environment and Commitment
o Evidence that the institution is committed to the candidate's
scientific development and professional development. Assurance that the
institution intends for the candidate to be an integral part of its
o Adequacy of research facilities and training opportunities (including
access to such facilities or opportunities in other institutions).
o Quality and relevance of the environment for the candidate's goals and
objectives for scientific and professional development.
o Quality, strength and clarity of the Institution's commitment to the
candidate for 75 percent full-time, professional effort while supported
on this award.
o If the candidate comes from industry, adequacy of the statements from
both the sponsoring institution and the industrial sponsor to commit to
the development of collaborative research together after the candidate
completes his/her career development program.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See 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 in the sections
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 REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 22, 2004
Application Receipt Date: April 20, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: December 2004
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
Additionally, for applications submitted through a pending ICBP, the
ICBP must be awarded before the K25 application can be awarded.
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, June 12, 1998:
Clinical trials supported or performed by NCI require special
considerations. The method and degree of monitoring should be
commensurate with the degree of risk involved in participation and the
size and complexity of the clinical trial. Monitoring exists on a
continuum from monitoring by the principal investigator/project manager
or NCI program staff or a Data and Safety Monitoring Board (DSMB).
These monitoring activities are distinct from the requirement for study
review and approval by an Institutional review Board (IRB). For details
about the Policy for the NCI for Data and Safety Monitoring of Clinical
trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For Phase I and II clinical trials, investigators must submit a general
description of the data and safety monitoring plan as part of the
research application. See NIH Guide Notice on Further Guidance on a
Data and Safety Monitoring for Phase I and II Trials for additional
Information concerning essential elements of data safety
monitoring plans for clinical trials funded by the NCI is available:
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
a complete copy of the updated Guidelines are available at
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
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
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and
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, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s) to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
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
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
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information, the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can
be found at
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 RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance 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
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