CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION SCIENCES CAREER
DEVELOPMENT AWARD
RELEASE DATE: February 03, 2004 (see extension of expiration date NOT-CA-06-024 and NOT-CA-06-009)
PA NUMBER: PAR-04-055 (This PA has been reissued as PA-06-381)
EXPIRATION DATE: June 1, 2006, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI/NIH)
(http://www.nci.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.398
This Program Announcement (PA) replaces PAR-01-135, which was published
in the NIH Guide on September 4, 2001.
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 Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The purpose of the Cancer Prevention, Control, Behavioral and Population
Sciences Career Development Award (K07) is to support the career
development of investigators who have made a commitment to focus their
research endeavors on cancer prevention, control, behavioral and the
population sciences. This is achieved by providing protected time
through salary and research support for up to 5 years to individuals
with a health professional or science doctoral degree who are 1) already
proficient in GENERAL epidemiology, behavioral sciences, or other
relevant disciplines, and now want to make use of these proficiencies in
cancer-focused research careers in prevention, control, population
and/or the behavioral sciences, or 2) already trained in cancer
epidemiology, etiology, prevention, control and the behavioral and
population sciences but are not yet fully independent investigators.
Examples of relevant disciplines for this Program Announcement (PA)
include any aspect of human cancer prevention (modifiable risk factors,
new animal models and extrapolation of these models to human cancer,
genetic predisposition to cancer and detection of precursor lesions,
patient-oriented research focused on cancer prevention, and behavioral
research and behavioral intervention trials in cancer prevention),
epidemiology (biochemical, genetic, molecular), biostatistics, human
cancer genetics, clinical oncology, human nutrition, behavioral and
social sciences, health promotion, health services and health policy
research; and medical decision analysis, survivorship and quality of
life as they relate to cancer.
For the purpose of this PA, cancer control research is defined as "basic
and applied research in the behavioral sciences that independently or in
combination with biomedical approaches, reduces cancer risk, incidence,
morbidity, and mortality across the lifespan and over the entire process
of carcinogenesis from primary behavioral prevention in youth, to
screening, treatment, and survivorship" (Report of the NCI Cancer
Control Progress Review Group, 1998). Additionally, patient-oriented
research is defined as research conducted with human subjects (or on
material of human origin such as tissues, specimens, and cognitive
phenomena) for which an investigator directly interacts with human
subjects. This area of research includes 1) mechanisms of human
disease; 2) therapeutic interventions; 3) clinical trials; and 4) the
development of new technologies.
RESEARCH OBJECTIVES
Recognizing a need for training researchers in preventive oncology and
the lack of multidisciplinary curricula that would be needed for this
purpose, the National Cancer Institute (NCI) published in 1982 the
announcement titled "Preventive Oncology Academic Award" (NIH Guide for
Grants and Contracts, Vol. 11, No. 5, April 23, 1982). This award
(POAA) provided support for the development of institutional preventive
oncology curricula focused specifically on etiologic studies and primary
prevention of cancer. In 1985, the NCI made two significant changes in
the award. First, the emphasis on support for institutional curriculum
development was changed to support of research and career development of
individuals who wanted to make a transition to cancer prevention and
control research and to individuals already trained in cancer prevention
and control who were not yet fully independent investigators. Second,
the original focus on cancer etiology and primary cancer prevention was
expanded to include all cancer prevention and control sciences and
technologies from hypothesis development through demonstration.
In 1998, the National Cancer Institute completed major external reviews
of its programs in cancer prevention and control sciences. The
scientific experts who conducted these reviews identified the current
level of support for training in cancer prevention and cancer control
and the single discipline emphasis of these programs as being completely
inadequate to take advantage of the new opportunities for reducing
cancer incidence, morbidity and mortality. These experts recommended
that the NCI increase its current level of support of education/training
programs in cancer prevention and cancer control and generate new
opportunities for multidisciplinary training in these disciplines of
basic and clinical scientists in highly interdisciplinary and
collaborative environments. Similar recommendations regarding training
opportunities in cancer prevention and control have been made by other
NCI advisory groups. In 1999, the NCI published a new K07 PA
incorporating the recommendations made by these experts.
The objective of the reissued K07 PA is to continue to provide a
mechanism to support specialized didactic study and mentored research in
scientific areas relevant to cancer prevention, cancer control, and
behavioral and population sciences research. Individuals lacking skills
in data management, statistics, epidemiology, study design, clinical
trial design, hypothesis development, etc., can be provided the
opportunity to participate in courses designed to overcome these
deficiencies. The scope of the research and didactic training may
extend from the development and experimental testing of hypotheses
including chemoprevention trials, through the stage of confirming
results using defined populations, to the development and demonstration
of technology as applied to epidemiology, cancer prevention, cancer
control, and the behavioral and population sciences as they relate to
cancer.
MECHANISM OF SUPPORT
This PA will use the NIH Cancer Prevention, and Control Career
Development (K07) Award mechanism. As an applicant, you will be solely
responsible for planning, direction, and execution of the proposed
program. Applicants may request from 3 to 5 years of support. The
actual length of the awarded project period will depend upon the number
of years of prior research experience and the need for additional
experience to achieve independence. Awards are not renewable.
This PA follows the Just-In-Time initiative for Career Awards published
in the NIH Guide, Volume 25, Number 10, March 29, 1996.
(http://grants.nih.gov/grants/guide/notice-files/not96-081.html).
Applications submitted in accordance with PHS 398 (Rev. 05/2001),
Section IV (Additional Instructions for Preparing Individual Research
Career Award (RCA) Applications - "K" Series
(http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing
_individual_CDA_app.htm) are in compliance with the instructions provided in
the 1996 Guide.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
To be eligible for an NCI K07 award, candidates must have a Ph.D.
degree, a health professional doctoral (M.D., Dr.PH., D.D.S., D.O.,
D.V.M., Pharm. D.) degree, or equivalent, or be a doctorally prepared
oncology nurse; and must have a research or academic appointment in the
sponsoring institution at the time of award. You must also be able to
devote a minimum of 75 percent of full-time professional effort to the
K07 Award. The remaining 25 percent effort can be divided among other
research, clinical and teaching activities only if these activities are
consistent with the goals of the K07 Award, i.e., the candidate's
development into an independent investigator in cancer prevention,
control, and the behavioral or population sciences.
Only U.S. citizens or non-citizen nationals, or an individual lawfully
admitted for permanent residence who possesses an Alien Registration
Receipt Card (I-151 or I-551), 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 lands that are not states, but are
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
programs.
A candidate for an NCI K07 Award may not simultaneously submit or have
pending an application for any other PHS career award (e.g., K01, K08,
K23), an NCI Transition Career Award (K22), a research project grant
(R01, R03), or any PHS or non-Federal award that duplicates any of the
provisions of the K07 award. However, K07 awardees may submit an
application for an NCI Transition Career Development Award (K22), and
are encouraged to actively seek independent support of their research
programs through investigator-initiated grants during the term 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) or center grants (P50) are NOT eligible to apply.
SPECIAL REQUIREMENTS
A. The sponsoring institution must have well-established research
programs in basic, clinical, and/or cancer
prevention/control/behavioral/population sciences. This research
environment should be one in which there are active research
collaborations that exemplify a dynamic two-way exchange of information
and ideas between laboratory and clinical and/or population research
settings.
B. Allowable Costs:
Salary: The K07 Award 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 with the remaining effort being 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 institution may supplement the NIH salary contribution up to a level
that is consistent with the institution's salary scale; however,
supplementation may not be from Federal funds unless specifically
authorized by the Federal program from which such funds are derived.
Because the salary amount provided by this award is based on the full-
time institutional salary, no other PHS funds may be used for salary
supplementation. Institutional supplementation of salary must not
require extra duties or responsibilities that would interfere with the
purpose of the K07. Under expanded authorities, however, institutions
may rebudget funds within the total costs awarded to cover salaries
consistent with the institution's salary scale.
Effective for all competing research grants 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 website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.
Research Development Support: Up to $30,000 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.
Ancillary Personnel Support: Salary for mentors, secretarial and
administrative assistance, etc., is NOT allowed.
Facilities and Administrative Costs: These costs, which were formerly
called indirect costs, will be reimbursed at eight percent of modified
total direct costs.
C. Evaluation:
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.
D. Other Income:
Fees resulting from clinical practice, professional consultation, or
other comparable activities required by the research and research-
related activities of this award may not be retained by the career award
recipient. Such fees must be assigned to the grantee institution for
disposition by any of the following methods:
o The funds may be expended by the grantee institution in accordance
with the NIH policy on supplementation of career award salaries and to
provide fringe benefits in proportion to such supplementation. Such
salary supplementation and fringe benefit payments must be within the
established policies of the grantee institution.
o The funds may be used for health-related research purposes.
o The funds may be paid to miscellaneous receipts of the U.S. Treasury.
Checks should be made payable to the Department of Health and Human
Services, NIH and forwarded to the Director, Office of Financial
Management, NIH, Bethesda, Maryland 20892. Checks must identify the
relevant award account and reason for the payment.
o Awardees may retain royalties and fees for activities such as
scholarly writing, service on advisory groups, or honoraria from other
institutions for lectures or seminars, 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, stipends, 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.
E. Special Leave:
Leave to another institution, including a foreign laboratory, may be
permitted if the proposed experience is directly related to the purpose
of the award. Only local institutional approval is required if such
leave does not exceed 3 months. For longer periods, prior written
approval of the NCI is required. To obtain prior 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.
Leave without award support may not exceed 12 months. Such leave
requires the prior written approval of NCI and will be granted only in
unusual situations. Support from other sources is permissible during
the period of leave. Such leave does not reduce the total number of
months of program support for which an individual is eligible.
Under unusual and pressing circumstances, an awardee may submit 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 (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.
F. Termination or Change of Institution:
When a grantee institution plans to terminate an award, the NCI Grants
Management Specialist listed on the Notice of Grant Award must be
notified in writing at the earliest possible time so that appropriate
instructions can be given for termination. If the individual is moving
to another eligible institution, career award support may be continued
provided that the following conditions are met.
o The awardee has submitted to the NCI a written request for a transfer,
countersigned by the appropriate institutional business official,
describing the reasons for the transfer and including the new sponsor's
name and biosketch.
o The awardee must establish in this request that the specific aims of
the research program to be conducted at the new institution are within
the scope of the original peer-reviewed research program, and that a new
sponsor has been identified who has the appropriate research expertise
and support to provide adequate guidance to the awardee and research
support for the awardee's research program.
o The awardee should contact the NCI Program Director listed in
INQUIRIES prior to submitting the request;
o The NCI Program Director has recommended approval of the request and
has forwarded the request for further evaluation to the Grants
Management Specialist listed on the Notice of Grant Award; and
o A completed transfer application has been submitted to the Grants
Management Specialist listed in the Notice of Grant Award far enough in
advance of the requested effective date to allow the necessary time for
review, establishing that all conditions of the initial award will be
met at the new institution including the presence of a qualified mentor,
and that the period of support requested does not exceed the time
remaining within the existing award period.
G. Changes in Research Program:
Individual awards are made for career development at a specific
institution in a specific research program. A change in the specified
scientific area of the research component of the career development
program requires prior approval of the NCI.
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 program. If the new
plan does not satisfy this requirement, NCI staff could recommend that
the award be terminated.
H. Termination of An Award
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.
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:
Dr. Lester S. Gorelic
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) 402-0181
Email: gorelicl@mail.nih.gov
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/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Kimery Griffin
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (express/courier service)
Telephone: 301-496-3196
FAX: 301-496-8601
Email: griffink3@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001) and instructions found
in Section IV, "Research Career Award." 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 website at http://www.dunnandbradstreet.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. Applicants are advised that these instructions are
provided under the section titled "Table of Contents" following the
tables providing individual PHS Form 398 pages. For further assistance
contact GrantsInfo, Telephone: (301) 710-0267, Email:
GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line
2 of the face page of the application form and the YES box must be
checked.
SUPPLEMENTARY INSTRUCTIONS
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:
BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT
o Within the limitation of $30,000 direct costs for research
development support, provide a detailed description, with justification,
for all equipment, supplies and personnel that will be used to help
achieve the career development and research objectives of this award.
THE CANDIDATE
o Describe the candidate's commitment to an academic career in cancer
prevention, cancer control, epidemiology, or the behavioral/ population
sciences as these disciplines relate to cancer prevention and control.
o Present evidence of the candidate's ability to interact and
collaborate with other scientists.
o Discuss prior training and how it relates to the objectives and
career plans of the candidate
o Discuss the candidate's research efforts to this point in his/her
research career.
LETTERS OF RECOMMENDATION
o Include three sealed letters of recommendation from well-established
scientists with the application addressing the above areas and any other
evidence that the candidate has a high potential for becoming an
independent investigator in cancer research. The mentor(s) may also
submit letters of reference, but these letters will be considered
independently of the three recommendations. All letters should be
attached to the front page of the application.
CAREER DEVELOPMENT PLAN
o Present a systematic plan that shows a logical progression from the
candidate’s prior research and training experiences to the training and
research experiences that will occur during the K07 award period to
independent investigator status. This plan must provide justification
of the need for further career development to become an independent
investigator. The candidate should consult with the mentor in the
preparation of this plan.
o Document prior instruction in or propose 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 this
component.
RESEARCH PLAN
o Describe the research plan using Form PHS 398 (rev. 5/01 or
subsequent revisions) following instructions for the Specific Aims,
Background and Significance, Progress Report/Preliminary Studies,
Research Design and Methods. The candidate should consult with the
mentor regarding the development of this section. A sound research
project that is consistent with the candidate's level of research
development and objectives of their career development plan must be
provided.
STATEMENT(S) BY MENTOR(S)/ CONSULTANT(S)/COLLABORATOR(S)
o The application must include a statement from the mentor providing:
1) information on their research qualifications and previous experience
as a research supervisor; 2) a mentoring plan describing the nature of
the supervision and mentoring that will occur during the proposed award
period and for ensuring that the applicant will be able to create a
niche for themselves in a specific area of research during the K07
award; 3) assurance that the applicant will be able to move at least a
portion of their K07-supported research to their first independent
research position. Information on the mentor’s active/pending research
support related to the candidate’s research plan should not be included
in this statement, but should be provided in the mentor’s biographical
sketch .
o Similar information must be provided by any co-mentor. If more than
one mentor is proposed, the respective areas of expertise and
responsibility of each should be described.
o Consultant(s)/Collaborator(s): Signed statements must be provided by
each consultant/collaborator confirming their 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 consulting/collaboration.
ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE
o Describe the resources and facilities that will be available to the
candidate.
o Describe how the research environment of the institution is
particularly suited for the development of the candidate's research
career and the pursuit of the proposed research plan.
o In a clear statement, provide assurances that the candidate will be
able to devote a minimum of seventy-five percent of his/her in the
development of his/her research program, with the remaining percent
effort being devoted to activities related to the development of their
research career.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application
deadlines, which are available at
http://grants.nih.gov/grants/dates.htm. Application deadlines are also
indicated in the PHS 398 application kit.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original
of the application, three original sealed letters of reference, and
three signed photocopies in one package to:
Center for Scientific Review (CSR)
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:
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)
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.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html).
This policy is similar to and consistent with the policy for
applications addressed to Centers for Scientific Review as published in
the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be mailed on or before the
receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of a substantial revision of an
unfunded version of an application already reviewed, but such
application must include an Introduction addressing the previous
critique.
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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NCI. Incomplete and/or non-responsive
applications will not be reviewed.
Applications that are complete and responsive to the PA, will be
evaluated for scientific and technical merit by an appropriate
scientific 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 selection process in which only those applications deemed to
have the highest scientific merit, generally the top half of
applications under review, will be discussed and assigned a priority
score
o Receive a written critique
o Receive a second level review by the National Cancer Advisory Board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate
applications in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as
appropriate for each application.
o Candidate
o Letters of reference
o Career Development Plan
o Research Plan
o Statements by former Mentor, Co-Mentor(s), Consultant(s), and
Collaborator(s)
o Environment and Institutional Commitment to the Candidate
o Research Plan
The application does not need to be strong in all categories to deserve
a high priority score. These criteria are listed in logical order and
not in order of priority.
CANDIDATE
o Commitment of the candidate to an academic career in cancer
prevention, cancer control, epidemiology, or to the behavioral or
population sciences as these disciplines relate to cancer prevention and
control.
o Ability of the candidate to interact and collaborate with other
scientists.
o Quality of the prior scientific training and experience, including
publications that establish the innovativeness of the candidate's
research and a high potential for an independent research career.
o Recommendations of three well-established scientists attesting to the
special potential of the individual to pursue an independent career in
cancer research. Letters of reference submitted by mentor(s)/ co-
mentor(s) will be considered independently of the three recommendations.
LETTERS OF REFERENCE
o Letters of reference on behalf of the candidate.
CAREER DEVELOPMENT PLAN
o Likelihood that the plan will contribute substantially to the
scientific development of the candidate, based on:
- Candidate's prior training and research experience;
- Appropriateness of the goals and scope of the plan to complement prior
training/research experience and achieve the stated training and
research objectives.
o Appropriateness of the proposed activities for the proposed award
period.
o Adequacy of prior or proposed training in the responsible conduct of
research.
RESEARCH PLAN
o Degree of relevance of the research plan to developing an independent
research program focused on cancer prevention, cancer control,
epidemiology, or the behavioral/population sciences as they relate
cancer prevention and control.
o Usefulness of the research plan as a vehicle for enhancing existing
research skills as described in the career development plan.
o The originality and quality of the research hypothesis/question,
design and methodology, judged in the context of the candidate's
previous training and experience.
STATEMENTS BY MENTOR/CO-MENTOR(S)
o Appropriateness of the mentor's research qualifications in the area
of the proposed research.
o Previous experience in fostering the development of cancer
researchers.
o History of research productivity and peer-reviewed support.
o Adequacy of active/pending support for the proposed research project.
o Strength of the mentor's statement.
ENVIRONMENT AND INSTITUTIONAL COMMITMENT
o Clear commitment of the institution to ensure that a minimum of
seventy-five percent of the candidate's will be devoted directly to
research, with the remaining percent effort being devoted to activities
related to the successful development of a research career.
o Adequacy of research facilities and training opportunities.
o Quality and relevance of the environment for scientific and
professional development of the candidate.
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 will be assessed. 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 requested budget in relation to
career development goals and research aims and plans.
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 program priorities.
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. See
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
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:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NCI require special
considerations. The method and degree of monitoring should be
commensurate with the degree of risk involved in participation and the
size and complexity of the clinical trial. Monitoring exists on a
continuum from monitoring by the principal investigator/project manager
or NCI program staff or a Data and Safety Monitoring Board (DSMB).
These monitoring activities are distinct from the requirement for study
review and approval by an Institutional review Board (IRB). For details
about the Policy for the NCI for Data and Safety Monitoring of Clinical
trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For Phase I and II clinical trials, investigators must submit a general
description of the data and safety monitoring plan as part of the
research application. See NIH Guide Notice on "Further Guidance on a
Data and Safety Monitoring for Phase I and II Trials" for additional
information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety
monitoring plans for clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "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 NIH, unless there are clear and compelling
scientific and ethical reasons not to include them. This policy applies
to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy And Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at:
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS: NIH
policy requires education on the protection of human research
participants for all investigators submitting NIH proposals for research
involvoing human subjects. You will find this policy announcement in
the NIH Guide for Grants and Contracts, dated June 5, 2000 at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS: Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp 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, 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
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.
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
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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.healthypeople.gov/.
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
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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