NCI INSTITUTIONAL PRE-DOCTORAL RESEARCH TRAINING PARTNERSHIP AWARD
RELEASE DATE: October 10, 2002
RFA: CA-03-017
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
LETTER OF INTENT RECEIPT DATE: February 27, 2003
APPLICATION RECEIPT DATE: March 27, 2003
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 Eligible Program Directors
o Eligible Mentors
o Eligible Trainees
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
PURPOSE
As part of a broader pilot activity of the National Institutes of
Health (NIH), the Cancer Training Branch (CTB) of the National Cancer
Institute (NCI) invites applications to support the development of new
pre-doctoral training programs that are partnerships between extramural
institutions and unique areas of research within the components of the
NCI Intramural Program. The specific components of the NCI intramural
program selected for these partnerships represent unique strengths of
the NCI in terms of staff and resources for research and research
training, and represent high priority areas for research training.
The purpose of this RFA is to form partnerships between extramural
institutions and the NCI in order to enhance training opportunities at
these institutions for pre-doctoral students in high priority areas of
cancer research. Participation in this initiative is anticipated to 1)
expand opportunities for students and faculty at the respective
institutions for training and the conduct of research, 2) provide
greater access of trainees and researchers to unique aspects and
resources- for example, databases and study cohorts- of the NCI
Intramural Program; and 3) stimulate important new scientific
collaborations between extramural and NCI scientists and students.
RESEARCH OBJECTIVES
Background
While scientists at the NIH traditionally have participated in the
training of graduate students on an ad hoc basis, graduate programs at
universities have never been able to take full advantage of the
resources available on the NIH campus to help achieve their pre-
doctoral training objectives. To improve this situation, in July 2000,
the NIH implemented the Graduate Partnerships Program (GPP). The GPP
has the responsibility to formally link NIH intramural research with
universities in the training of pre-doctoral students in the biomedical
sciences and to facilitate the development, operation, and oversight of
University-NIH pre-doctoral training partnerships. As a first step,
the GPP created a website that comprehensively provides extramural
institutions and scientists descriptions of and access to the research
groups at the NIH. This website (http://gpp.nih.gov/Researchers/)
facilitates the development of ad hoc and formal arrangements between
extramural and intramural research groups with the GPP
serving as a broker and facilitator. In addition, the GPP
has expanded a prior model for University-NIH partnerships in
broad areas of research training. Currently, there are
nine of these partnerships: Johns Hopkins University (Biological
Sciences); George Washington University (Genetics); University of
Maryland (Biophysics); University of Pennsylvania (Immunology); Boston
University (Bioinformatics); University of Maryland (Hearing and
Communication Disorders); Oxford University, England (Biomedical and
Biological Sciences); Cambridge University, England (Health Sciences
Scholars Program); and the Karolinska Institute, Sweden
(Neurosciences). There are currently 24 pre-doctoral students in the
NCI Intramural Program participating in the GPP: 20 in the Center for
Cancer Research (CRC) and 4 in the Division of Cancer Epidemiology and
Genetics (DCEG). While these broad arrangements more aggressively
broker connections between graduate programs and intramural research
groups, they do not involve any NIH funding or formally integrate
extramural and intramural scientists in a specific training program,
such as those traditionally supported by institutional National
Research Service Awards (NRSAs) or T32s.
To explore other options for involving the NIH in graduate training, in
September 2000 a focus group of approximately 20 graduate school Deans
and others (mostly from the Graduate Research, Education and Training
{GREAT} Group) was constituted by Dr. Mary Delong (Director of the GPP,
OD, NIH) and convened at the NIH. A key recommendation of the focus
group was that NIH partnerships should be created that compete for
extramural training funds in a manner similar to applicants for
Institutional National Research Service Awards (NRSA). The NIH decided
that the best ways to pursue this new partnership concept would be to
ask institutes to develop pilot programs to explore its usefulness and
potential. Four ICs (i.e., NCI, NLM, NIHGR, and NIAID) are in the
process of developing RFAs to pilot the TU2 program.
Objectives and Scope
The objectives of this RFA will be accomplished by combining the
support for Ph.D. or equivalent degree (e.g., Dr.P.H., Sc.D.)
candidates and the program through a new specialized cooperative
training grant (TU2) guided by National Research Service Award (NRSAs)
policies and through Cancer Research Training Awards (CRTAs). The TU2
will support the didactic and research training of predoctoral
candidates, as well as other training related expenses of the program,
at the extramural institution; and CRTAs will support candidates for
their research training while in the NCI Intramural Program. Trainees
will be required to meet the dissertation requirements established by
their extramural home institution. In theory, the program has the
flexibility to afford the trainees the opportunity to move back and
forth between the extramural institution and the NCI Intramural program
during the entire period of their appointment. However, in this pilot
effort, it is expected that the laboratory component of the training
will occur mainly at the NCI.
The Division of Cancer Epidemiology and Genetics (DCEG) and the Center
for Cancer Research (CCR), both of which represent the NCI Intramural
Program, have selected a number of areas for possible training.
Interested extramural institutions may consult with NCI coordinators in
the areas described below to explore the possibility of developing a
partnership training program and submitting a grant application in
response to this initiative.
The Division of Cancer Epidemiology and Genetics (DCEG) invites applications
in the following areas of research training:
o genetic and molecular epidemiology
o environmental and occupational epidemiology
o nutritional epidemiology
o radiation epidemiology
o viral and infectious disease epidemiology
o biostatistics and methodologic research
DCEG carries out population-based and interdisciplinary research to
uncover the genetic and environmental determinants of cancer, and the
means of cancer prevention. Priority is given to accelerating and
broadening emergent scientific issues identified through clinical,
epidemiologic, and laboratory observations, including recent
discoveries in molecular genetics and cancer biology. Research
projects may involve biomarkers to assess precursor states,
intermediate outcomes, carcinogenic exposures, susceptibility states,
and mechanisms of carcinogenesis for the entire range of cancer organ
sites. The role of lifestyle factors (including diet and nutrition),
environmental pollutants, occupational exposures, genetic
predisposition, hormonal and other endogenous factors, infectious
agents, pharmacologic compounds, and ionizing and nonionizing radiation
is investigated. Particular emphasis is placed on the study of gene-
environment interactions.
DCEG has a firm commitment to training the next generation of cancer
epidemiologists and biostatisticians, and seeks partnerships with
academic institutions offering graduate education in epidemiology and
related areas in order to furnish opportunities for dissertation
projects at the National Cancer Institute.
For the DCEG, there are approximately 6 positions available for one or
a combination of the above six categories of research training.
The Center for Cancer Research (CCR) invites applications in the
following areas of research training:
Chemistry
Chemistry is a crucial component of the blend of disciplines that
constitute the Center for Cancer Research (CCR) at the National Cancer
Institute (NCI). Given the biomedical mission of the Institute, the
research is focused on areas of chemistry that have a direct impact on
that mission. While much of this research is fundamental chemistry
research, not unlike that found in many academic chemistry departments,
the general orientation is toward the biological sciences. As a
consequence, the chemically oriented laboratories of the NCI offer a
superb environment for graduate training in chemistry at the interface
with biology. The Program seeks to unite the chemistry groups in the
NCI into a Faculty that will provide a first class environment for the
training of doctoral candidates in biologically oriented chemistry. In
order to enhance the interdisciplinary nature of the Program, the
Faculty will also include biological scientists whose research requires
interaction with chemists. The partnership program will be a
competitive graduate program to pursue research in one of the chemistry
laboratories of the National Cancer Institute and is intended for
individuals who wish to obtain training in chemistry at the interface
of biology.
Bioinformatics and Computational Biology
As one of the pioneers in developing DNA sequencing, microarray
transcript profiling, proteomic profiling, laser-capture
microdissection, cell-based and tissue microarrays, and DNA analysis
microarrays, among other technologies, the NIH offers students exposure
to an unparalleled breadth and depth of expertise in the bioinformatic
disciplines. Increasingly, biomedical research relies on the computer
for both the exploration of existing databases and calculations focused
on biological phenomena. Advances in these in silico fields are
profoundly interconnected with the ongoing revolutions in genomics and
proteomics. This interrelationship is clearly evident in the Human
Genome Project, which has generated vast amounts of data.
New software tools, however, are needed to enable researchers to better
manage, correlate, analyze, and interpret such complex biological
information. In the field of cancer research, such tools will not only
lead to advances in basic research but also translate into the improved
diagnosis, prognosis prediction, prevention, and treatment of human
cancers.
The NIH and the NCI's Center for Cancer Research (CCR), therefore, have
increasingly focused on developing the bioinformatics needed to
transform the data produced by "omic" technologies into biomedical
knowledge through partnerships with applicant institutions seeking to
develop better software tools for managing complex biomedical
information and correlating it with diagnosis, prognosis prediction,
and treatment. These endeavors are highly interdisciplinary in nature
and most effectively undertaken by individuals who have a solid
background not only in biology, but also in statistics, data analysis,
engineering, computer science, or artificial intelligence. At present,
the CCR is particularly interested in encouraging collaborative,
interdisciplinary research aimed at achieving the following goals:
o Developing pattern-recognition algorithms designed to analyze
biological data, including artificial intelligence, support vector
machines, and self-organizing maps (SOMs).
o Using bioinformatics tools to identify genes that can be used to
diagnose cancer patients, predict their prognosis, assess responses to
therapy, and define tumor-specific therapeutic targets.
o Linking critical genes identified by individual investigators to
large, publicly available databases such as the protein structure
database and the NCI's small molecules database.
o Devising methods and web-based tools for unifying large databases
and for visualizing and clustering data, including multidimensional
scaling, principal component analysis, hierarchical clustering, K
means, and SOMs.
For the CCR, there are approximately 10 positions available, 5 for each
of the 2 categories of research training.
The total number of positions available (DCEG, CCR) is therefore 16.
The NCI facilitators for the DCEG and the CCR are respectively Dr.
Demetrius Albanes and Dr. Jonathan Wiest. Contact information for the
facilitators is provided under "WHERE TO SEND INQUIRIES". After having
first contacted the NCI extramural program director, potential partners
will be referred to the relevant NCI facilitator to explore the
possibility of submitting a grant application together.
The listing of available NCI mentors for each area with a description
of their research activities can be found at the following website:
http://cancertraining.nci.nih.gov/TU2
MECHANISM OF SUPPORT
This RFA will use the NIH TU2 cooperative agreement award mechanism.
This RFA is a one-time solicitation. Since this is a pilot program,
the decision to reissue this RFA in the future will be made after an
interim evaluation of the success and effectiveness of the RFA. Future
unsolicited, competing-continuation applications based on this
initiative will compete with all investigator-initiated Institutional
NRSA applications and will be reviewed according to the customary peer
review procedures. The anticipated award date under this RFA is
September, 2003.
The NIH TU2 is a cooperative agreement award mechanism in which the
Principal Investigator retains the primary responsibility and dominant
role for planning, directing, and executing the proposed project, with
NIH staff being substantially involved as a partner with the Principal
Investigator, as described under the section "Cooperative Agreement
Terms and Conditions of Award".
The total project period for applications submitted in response to this
RFA may not exceed five years.
FUNDS AVAILABLE
NCI intends to commit approximately $1,000,000 total costs in FY 2003
to fund up to 5 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 $200,000 per year. Because the number of trainees on each
grant and their stipends may vary, it is anticipated that the sizes of
the award will also vary. Although the financial plans of 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.
ELIGIBLE INSTITUTIONS
Eligible applicant institutions are domestic institutions having any of
the following characteristics:
o For-profit or non-profit degree-granting organizations
o Not-for profit public or private institutions or academic
institutions that offer the Ph.D. and or equivalent health professional
degree
Eligible applicant institutions must have a generally strong research
program in any of the eligible area(s) proposed for research training,
as evidenced by the peer-reviewed and funded research of the scientists
at the institution who will serve as mentors.
This pilot initiative is intended for single extramural institution
partnerships and will not support a consortium of extramural
institutions.
ELIGIBLE PRINCIPAL INVESTIGATORS/INTRAMURAL PARTNERS
The intramural and extramural leaders of the partnership must be
established investigators. The extramural leader will be the PI of the
grant application and the intramural leader will be the intramural
partner (IP). Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged
to apply for NIH programs as principal investigators.
ELIGIBLE PRECEPTORS
Preceptors must be established investigators. Preceptors from the
extramural institution must have a track record of research
productivity and research support including current active research
support; and must have a successful track record in mentoring
predoctoral students. NCI Intramural preceptors must have a track of
research productivity and in mentoring investigators early in the
development of their research careers.
ELIGIBLE TRAINEES
Trainees must be U.S. citizens or non-citizen nationals or must be
lawfully admitted for permanent residence (i.e., possession of a
currently valid Alien Registration Receipt Card I-1551, or some other
legal verification of such status). Non-citizen nationals are
generally persons born in outlying possessions of the United States
(e.g., American Samoa and Swains Island). Individuals on temporary or
student visas are not eligible. Trainees must be able to pursue their
research training on a full-time basis, devoting at least 40 hours per
week to the program.
SPECIAL REQUIREMENTS
The applicant institution (s) must be able to demonstrate how a
partnership with the NCI Intramural Program will significantly
compliment and enhance their research training capability in ways that
otherwise would not be possible.
Program Steering Committee
Each Program must have a Program Steering Committee (PSC). The PSC
should include as voting members the PI and the IP, and four senior
core faculty (and mentors), two from the extramural institution and two
from the NCI Intramural Program. The PSC can add other members as
(non-voting) ad hoc participants whenever the situation requires. It
would be anticipated that representatives from the dissertation
committees for the individual trainees would be included on an as-
needed basis among the ad hoc participants. The NCI extramural program
director will serve as an ex officio with full authority to participate
in all discussions and ensure that the partnership is adhering to NCI
and NIH extramural policies. The PSC will be co-chaired by the PI and
the IP. The PSC must meet once a year. The PSC will function to
facilitate matching of predoctoral candidates previously admitted to
the graduate schools of the extramural institution with appropriate
extramural and intramural mentors; evaluate the progress of the program
in achieving its objectives and recommend midcourse corrections as
needed; approve of the extramural and intramural training plan for each
candidate; evaluate the progress of each candidate's training in terms
of benefiting from the unique opportunities offered by the partnership
and completing the training plan within the timeline originally
anticipated; ensure that each candidate in the intramural phase of the
Partnership Program continues to progress towards satisfying all of the
academic requirements of the extramural institution for a Ph.D. degree;
define areas of potential scientific collaboration between the
extramural scientists and NCI intramural scientists that will
strengthen the partnership in the future; and evaluate the special
marketing and recruitment efforts of the program and make
recommendations for improvement. A report documenting the deliberations
and decisions of the PSC must be provided annually with the Non-
Competing Grant Progress Report (PHS 2590).
Recruitment and Placement Plan
The Training Partnership must present a recruitment and placement plan
that augments and complements the extramural institution's normal
procedures for recruiting predoctoral candidates, and for
placing/matching candidates with mentors for their dissertation
training and research. It is expected that this plan will involve
special marketing efforts to inform potential candidates of this
special opportunity for training, and attract the highest quality
candidates possible for participation in this Partnership Program. It
is also expected that this plan will provide special opportunities for
the candidates to interact with potential mentors in the NCI Intramural
programs prior to selection of mentor(s). A Plan for recruiting
Minority Trainees must be provided and must follow current NRSA policy
Guidelines (See NIH Website noted under ALLOWABLE COSTS).
Special Administrative Requirements
o General
The NCI considers, as a condition of this NCI TU2 award, that the PI
and the business officials of the extramural institution understand the
official policies that govern Institutional National Research Service
Awards and will take full responsibility for conforming to the
reporting requirements of the NRSA program as required by Congressional
legislation. This includes timely and accurate submission of
Statements of Appointment (Form PHS 2271, available in an interactive
format at
https://grants.nih.gov/training/phs2271.pdf) for new and reappointed
trainees with correct stipend levels as approved by NIH; timely and
accurate submission of Termination Notices (Form PHS 416-17, available
at https://grants.nih.gov/grants/funding/416/phs416-7.pdf) when trainee
support is discontinued; and submission of the appropriate information
confirming citizenship status of trainees at the time of appointment
(The extramural institution is responsible for determining the
eligibility of trainees with regard to satisfying the necessary
citizenship requirements).
o Budget and Related Issues
Prior to developing budgets, applicants are strongly encouraged to
interact with appropriate Program Staff and Grants Management Staff
listed under "WHERE TO SEND INQUIRIES".
Stipends: While in training, pre-doctoral candidates will receive
stipend levels as determined by current NRSA policies
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-028.html)
when at the extramural institution and stipend levels according to
CRTA policies (http://camp.nci.nih.gov/admin/crta)
when at the NCI. The stipend is provided as a subsistence allowance
to help trainees defray living expenses during the research training
experience. It is not provided as a condition of employment with
either the Federal Government or the awardee's institution.
The extramural training institution may not alter established stipend
levels. Further, stipend levels are not to be changed in the middle of
an appointment period. Stipends may be adjusted only at the time of
appointment or reappointment. Stipends must be based on the level
established for the current fiscal year of the grant. Finally, for
appointments of less than 12 months, the stipend will be based on a
monthly or daily pro-ration.
Student support at the extramural institution is expected to last from
one to three years and in the NCI Intramural Program from two to four
years. Unless there are exceptional circumstances requiring special
NCI approval, total support for an individual (the combination of NRSA
and CRTA support) is expected to last for no more than five years.
Appointments to students are for a period of one year, and are
renewable for up to five years based on adequate progress of the
student.
Tuition, Fees, and Health Insurance: The NRSA and CRTA mechanism will
offset the combined cost of tuition and fees for the trainee at the
following rate: 100 percent of all costs up to $3,000 and 60 percent
of costs above $3,000. Medical insurance will also be provided. Costs
associated with tuition, fees and health insurance are allowable only
if they are required for all individuals in a similar training status
at the institution regardless of the source of support. A full
description of the tuition policy is contained within the NIH Grants
Policy Statement at:
https://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm#_
Toc504812004
Training Related Expenses: Training related expenses of up to $10,000
per year per trainee may be requested to defray the costs of other
research training related expenses. Typically, these costs could
include staff salaries, consultant costs, equipment, research supplies,
travel costs for Steering Committee Members to meet once a year at
either the extramural institution or the NCI for purposes of assessing
the progress of the program; and trainee travel to scientific meetings
and between the extramural institution and the NCI as part of the
training program. Applicant institutions should contact the NCI
Extramural Program Director early in the application process to discuss
this budget category.
Facilities and Administrative Costs: While funded by NRSA, a
facilities and administrative allowance (indirect cost allowance) based
on 8 percent of the total allowable direct costs (this excludes amounts
for tuition, fees, health insurance and equipment) may be requested.
Stipend Supplementation: Supplementation or additional support to
offset the cost of living may be provided by the extramural grantee
institution during the extramural phase of the training program.
Supplementation does not require any additional effort from the
trainee. DHHS funds may not be used for supplementation under any
circumstances. Additionally, no funds from other Federal agencies may
be used for supplementation unless specifically authorized by the NIH
and the other Federal Agency.
Compensation: The extramural grantee institution may provide
additional funds to a trainee during the extramural phase of the
training program in the form of compensation (as salary and/or tuition
remission) for services such as teaching or serving as a research
assistant. A trainee may receive compensation for services as a
research assistant or in some other position on a Federal research
grant, including a DHHS research grant. However, compensated services
should occur on a limited, part-time basis apart from the normal
research training activities, which require a minimum of 40 hours per
week. In addition, compensation may not be paid from a research grant
supporting research that
constitutes the research training experience.
Educational Loans or G.I. Bill: An individual may make use of Federal
educational loan funds and assistance under the Veterans Readjustment
Benefits Act (G.I. Bill). Such funds are not considered
supplementation or compensation.
Concurrent Awards. An NRSA trainee may not an NRSA concurrently with
another federally sponsored fellowship or similar Federal award that
provides a stipend or otherwise duplicates provisions of the NRSA.
Tax Liability: Internal Revenue Code Section 117 applies to the tax
treatment of all scholarships and fellowships. Under that section,
non-degree candidates are required to report as gross income any monies
paid on their behalf for stipends, or any course tuition and fees
required for attendance. Degree candidates may exclude from gross
income (for tax purposes) any amount used for tuition and related
expenses such as fees, books, supplies, and equipment required for
courses of instruction at a qualified educational organization. The
taxability of stipends, however, in no way alters the relationship
between NRSA trainees and institutions. NRSA stipends are not
considered salaries. In addition, trainees supported under the NRSA
are not considered to be in an employee-employer relationship with the
NIH or the awardee institution. It is therefore, inappropriate and
unallowable for institutions to charge costs associated with employment
(such as FICA, workman's compensation, or unemployment insurance) to
the training grant. It must be emphasized that the interpretation and
implementation of the tax laws are the domain of the Internal Revenue
Service (IRS) and the courts. The NIH takes no position on the status
of a particular taxpayer, and it does not have the authority to
dispense tax advice. Individuals should consult their local IRS office
about the applicability of the law to their situation and for
information on their tax obligations.
Special NCI Programmatic Requirements
Pre-application Process. Potential applicant institutions must
initially contact the NCI Extramural Program Director listed in " WHERE
TO SEND INQUIRIES". This individual will clarify any issues regarding
the intent and purpose of the RFA and the process for exploring
potential training partnerships with NCI Intramural scientists.
Applicants will be referred by the NCI Extramural Program Director to
one of the NCI Intramural facilitators listed in " WHERE TO SEND
INQUIRIES". The NCI Intramural facilitator will assist in initiating
potential partnerships with potential IP's in either the Center for
Cancer Research (CCR) or the Division of Cancer Epidemiology and
Genetics (DCEG), and will assist in identifying alternative potential
partnerships if the initial contact is not productive. For those
situations where the initial contacts are not productive, an official
statement will be developed by the facilitator and the potential IP
stating the specific reason(s) for the lack of success in negotiating a
partnership. This statement will be provided to the potential
applicant institution and to the NCI Extramural Program Director. For
those situations where the negotiations are successful, the facilitator
will work with the applicant institution and the IP to develop the
conditions of the co-operative agreement.
o Post-award.
The Partnership Program must satisfy all of the requirements of the NCI
Supplemental Policy for Institutional National Service Research Awards
(T32). The Supplemental policy may be found on the following website:
http://deainfo.nci.nih.gov/awards/supT32guideline.htm
Special NCI Administrative Policies
All grantees are expected to comply with the provisions as defined in
the National Research Service Award Guidelines. Institutions regularly
failing to provide timely submissions of Non-Competing Grant Progress
Report (PHS 2590); timely and accurate Statements of Appointment (Form
PHS 2271, available in an interactive format at:
https://grants.nih.gov/training/phs2271.pdf) and/or Termination Notices
(Form PHS 416-7, available at the following site:
https://grants.nih.gov/grants/funding/416/phs416-7.pdf); correct
stipends to trainees; or not providing the correct citizenship
information for trainees, will be considered by the NCI not to be in
compliance with the management requirements of the award. If any of
these circumstances become recurrent and serious problems, it will be
the policy of the NCI to issue provisional awards for the Non-Competing
Grant Progress Report (PHS 2590) until the situation(s) is fully
corrected; and the level of and/or future funding of the training
program could be jeopardized.
Recruitment of Minority Trainees
Although this is a general NIH requirement, the NCI, in order to
address the effectiveness of research approaches that investigate the
higher cancer incidence and mortality rates of minorities and various
ethnic and underserved groups, takes a very proactive interest in the
success of every grantee's recruitment efforts. Therefore, the required
specific recruitment plan by NIH for each training grant will be
monitored by NCI program staff for progress, and NCI staff will work
with each grantee to increase the effectiveness of the plan.
Allowable Costs
NCI TU2 grants support all of the traditional costs outlined in the
official National Research Service Award Guidelines
(https://grants.nih.gov/grants/policy/nihgps_2001/). These costs are
also summarized in this RFA under Special Requirements for Budget and
Related Issues.
Cooperative Agreement Terms and Conditions of Award
The following terms and conditions will be incorporated into the award
statement and will be provided to the PI as well as to the appropriate
extramural institutional officials at the time of award. The following
special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and
other HHS and NIH policies.
The administrative and funding instrument for this program will be the
Cooperative Agreement (CA) grant or TU2. The cooperative agreement is
an "assistance" mechanism (rather than an acquisition mechanism), in
which substantial NIH scientific and/or programmatic involvement with
the awardee is anticipated during the performance of the activity.
Under the CA, the NIH's purpose is to support and/or stimulate the
recipient's activity by involvement in and otherwise working jointly
with the award recipient in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardee(s) for the
project as a whole, although specific tasks and the activities in
carrying out the training will be shared among the awardee(s) and the
cooperating NCI Intramural Program's IP.
1. Awardee Rights and Responsibilities
The Principal Investigator (PI) will have the primary responsibility
for the oversight, administration and management of the NRSA-supported
part of the research training program according to the conditions of
this RFA. The PI will agree to accept close coordination, cooperation,
and participation with the NCI Intramural research staff as well as
with NCI Extramural program staff in those aspects of scientific and
technical management of the project as described under the NIH Staff
Responsibilities. The PI will:
o Recruit graduate students for the program, with special attention to
increasing the number of underrepresented minorities, and implementing
the special marketing recruitment measures to ensure that high quality
candidates are available.
o Ensure that there are adequate faculty at the extramural institution
and in the relevant NCI Intramural program with appropriate mentoring
skills and research experience to participate in the training program.
o Ensure that the didactic portion of the research training program is
appropriately rigorous so that students are grounded in the
fundamentals of the sciences appropriate to their research interests
and that it involves NCI intramural participants when they can
strengthen the program.
o Co-chair, in collaboration with the IP, the Program Steering
Committee (PSC) and ensure that it meets regularly to oversee the
progress of the program, evaluate its effectiveness, make
recommendations to improve its effectiveness and identify areas of
extramural/intramural research collaboration. Accept and implement the
recommendations of the PSC.
o Ensure that the research interests of the trainees are matched with
the research interests of the participating extramural and the NCI
intramural faculty.
o Ensure that there is a clear plan for each trainee regarding when
they transition from the didactic part of the program to the research
training part of the program.
o Ensure that the training plan developed for each trainee will
satisfy all of the requirements of the extramural institution for a
Ph.D. degree.
The PI will oversee all aspects of the partnership at the extramural
institution and the NCI Intramural program. The PI will be responsible
for reporting in the Non-Competing Grant Progress Report (PHS 2590) the
progress of the partnership that occurs both at the extramural
institution and the NCI Intramural Program.
2. NCI Staff Responsibilities
The NCI Intramural Partner will have the following rights and
responsibilities:
o Primary responsibility for administering and managing the intramural
research in support of the students' dissertation
o Work collaboratively with the PI and the PSC to ensure that there
are acceptable procedures for recruitment and selection of graduate
students to participate in the intramural research component.
o Work with the PI to ensure a smooth transition of the trainees from
the extramural institution to the NCI Intramural Research Program
o Ensure that intramural training is in compliance with the extramural
institution's requirements for doctoral degrees and ensure that every
graduate student selected for participation in the partnership program
will pursue a research project that will result in a doctoral
dissertation, will receive appropriate mentoring, and will be provided
with the resources to pursue the research.
o In conjunction with the PI and the PSC, develop policies for
monitoring the progress of graduate students, evaluating the
partnership training program and identifying areas for
extramural/intramural research collaboration.
o Co-chair the Program Steering Committee and accept its
recommendations
The IP in collaboration with the PI will oversee all activities at the
NCI and be responsible for providing the information related to the NCI
Intramural Program necessary for preparation of all progress reports
associated with the Non-Competing Grant Progress Report (PHS 2590).
The NCI Intramural facilitators will have the following rights and
responsibilities:
o Working with the NCI Program Director, provide oversight of the
administration of the intramural component of the program.
The NCI Program Director will have the following rights and
responsibilities:
o Provide the same program administrative oversight as for any NRSA
Institutional Training Grant while trainees are at the extramural
institution.
o Serve as an ex officio member of the PSC.
o Oversee and approve the selection of candidates for the Program to
ensure that selection standards are fair and objective.
o Assess annual progress towards achieving Program objectives .
o Assess continued compliance of the program with intent of the RFA.
o Determine acceptability of the Program for continuation in each non-
competing year.
3. Collaborative Responsibilities
Each Partnership Program is required to have a Program Steering
Committee (PSC). The PSC should include as voting members the PI and
the IP, and four senior core faculty (and mentors), two from the
extramural institution and two from the NCI Intramural Program. The
PSC can add other members as (non-voting) ad hoc participants whenever
the situation requires. It would be anticipated that representatives
from the dissertation committees for the individual trainees would be
included on an as-needed basis among the ad hoc participants. The NCI
extramural program director will serve as an ex officio with full
authority to participate in all discussions and ensure that the
partnership is adhering to NCI and NIH extramural policies. The PSC
will be co-chaired by the PI and the IP. The PSC must meet once a
year.
The individual Program Steering Committees will have the following
responsibilities:
o Facilitiate the matching of predoctoral candidates previously
admitted to the graduates schools of the extramural institution to
appropriate extramural and intramural mentors.
o Evaluate the progress of each candidate's training in terms of
benefiting from the unique opportunities offered by the partnership,
their career development and completing the training plan within the
timeline originally anticipated.
o Ensure that each candidate in the intramural phase of the
Partnership Program continues to progress towards satisfying all of the
academic requirements of the extramural institution for a Ph.D. degree
o Approve the extramural and intramural training plan for each
candidate.
o Evaluate the progress of the program in achieving its objectives and
recommend midcourse corrections as needed
o Evaluate the special marketing and recruitment efforts of the
program and
make recommendations for improvement.
o Define areas of potential scientific collaboration between the
extramural scientists and NCI intramural scientists that will
strengthen the partnership in the future.
o Provide annually with the Non-Competing Grant Progress Report (PHS
2590) a report documenting the deliberations and decisions of the PSC.
Mentors from the NCI Intramural Research Program will serve in an
advisory capacity as ad hoc members of the mentee's dissertation
committee.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award), between the awardee and the NCI will
be brought to arbitration. The Arbitration Panel will consist of one
individual from the Extramural Institution, one individual from the NCI
Intramural Program, the Chief of the NCI Extramural Cancer Training
Branch, and one individual agreed upon by the other 3 members of the
panel. This special arbitration procedure in no way affects the
awardee's right to appeal an adverse action that otherwise can be
appealed in accordance with NIH regulations 42 CFR Part 50, Subpart D
and HHS regulation at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
four areas: programmatic, partnering, peer review, and financial or
grants management issues:
o The NCI Extramural Program Director listed below should be the
initial NCI contact for all potential applicant institutions. This
individual will clarify any issues you might about the intent and
purpose of the RFA and the process for exploring potential training
partnerships with NCI Intramural scientists. If a partnership has been
agreed upon and an application will be submitted, again contact the NCI
Extramural Program Director about the structure of the application and
the application procedure before submitting the application:
Lester S. Gorelic, Ph.D.
Cancer Training Branch
Office of Centers, Training and Resources
National Cancer Institute
6116 Executive Blvd, Suite 7025
Bethesda, MD 20892
Phone: (301) 496-8580
Fax: (301) 402-4472
e-mail: lg2h@nih.gov
o After contacting the NCI extramural Program Director above, initiate
explorations of potential scientific partnerships with either the
Center for Cancer Research (CCR) or the Division of Cancer Epidemiology
and Genetics (DCEG) through the following intramural Facilitators:
Potential Partnerships with the CCR:
Dr. Jonathan Wiest
Associate Director for Training and Education
CCR Office of the Director
Center for Cancer Research
National Cancer Institute
31 Center Drive
Suite 3A11
Bethesda, MD. 20852
Office: 301-451-9638
Fax: 301-496-0775
e-mail: wiestj@mail.nih.gov
Potential Partnerships with DCEG:
Demetrius Albanes, M.D.
Chief, Office of Education
Division of Cancer Epidemiology and Genetics
Executive Plaza South
Room 3044
Bethesda, MD 20892-7242
Phone: 301-496-1611
Fax: 302-402-3256
e-mail: albanesd@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
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncidearefof@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Mr. Bill Wells
Grants Administration Branch
Office of Management
National Cancer Institute
6120 Executive Blvd.
Room EPS 243
Bethesda, MD 20892
Phone: (301) 496-8796
Fax: (301) 496-8601
e-mail: ww14j@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed Partnership Program
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institution/ NCI intramural program(s)
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
Office of Centers, Training and Resources
National Cancer Institute
6116 Executive Blvd,
Bethesda, MD 20892
Phone: (301) 496-8580
Fax: (301) 402-4472
e-mail: lg2h@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://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.
SUPPLEMENTAL INSTRUCTIONS
Potential applicants must interact with the NCI prior to the
preparation and submission of an application in response to this RFA.
Initial contact will be with the NCI extramural program director listed
in WHERE TO SEND INQUIRIES. Potential applicants will then be referred
to an appropriate NCI Intramural facilitator.
Instructions for preparing general Institutional National Research
Service Award Applications are on the NIH Website at:
https://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_NRSA_app.htm
The current NRSA policy Guidelines should be consulted as a resource
when preparing the application. These Guidelines are on the NIH Website
at:
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_4.htm#_
Toc504812031
1. Face Page (or Page 1): Complete as instructed in the PHS Form 398
(rev. 5/01). Enter RFA CA-03-017 and the title "Institutional
Training Partnership Award" on line 2.
2. Page 2: Complete as instructed in the PHS Form 398. Include as Key
personnel, the PI, the IP and all mentors from the extramural
institution and from the NCI Intramural Program.
3. Page 3: This will be the table of contents adapted from the NRSA
Substitute Page 3, PHS Form 398 (rev. 5/01) and organized as follows:
Table of Contents
Page Number
Face Page (Form Page 1)
Description and Personnel (Form Page 2)
Table of Contents (NRSA Substitute Form page 3)
Detailed Budget for Initial Budget Period (NRSA Substitute Form Page 4)
Budget for Entire Proposed Period of Support (NRSA Substitute Form Page 5)
Biographical Sketch of the PI
Biographical Sketch of IP
Biographical Sketches of Extramural Mentors
Biographical Sketches of NCI Intramural Program Mentors
Resources
Research Training Program Plan (A, B and C below not to exceed 25 pages)
A. Background
B. Program Plan
1. Objectives of the Training Program and the Unique benefits of the
Partnership
2. Training Plan
- Program Direction by PI and the IP.
- Proposed Training in Extramural and Intramural Environments
- Experience of Mentors
- Recruitment Plan – Applicant Pool
- Trainee Candidates
- Curriculum
3. Program Steering Committee
- Membership
- Responsibilities
- Benchmarks
C. Recruitment of Individuals from Underrepresented Racial/Ethnic Groups
D. Letters of Institutional Commitment
E. Responsible Conduct of Research
F. Human Subjects (See NRSA substitute page 3)
G. Vertebrate Animals
H. Consortium/Contractual Agreements
Checklist
Appendix
4. Biographical sketches: Provide biosketches for the PI (not to
exceed four pages), the IP (not to exceed four pages), the Extramural
mentors (not to exceed two pages per mentor), and the NCI Intramural
Program mentors (not to exceed two pages per mentor
5. Resources: Separately describe the resources available at the
extramural institution and the NCI Intramural Program and how these
resources will be integrated to create a unified partnership program
that will achieve the proposed training objectives.
6. Research Training Program Plan
o Objectives of the Training Program and the Unique Benefits of the
Partnership: Describe how this program will uniquely complement the
capability of the extramural institution and enhance the research and
research agenda of the extramural institution because of potential
collaborations that can be formed with the NCI Intramural Program.
Include a description of the types of scientists the program will
train.
o Proposed Research Training in the Extramural and NCI Intramural
Environments: Describe how the program is envisioned to provide
research training for pre-doctoral candidates through a combination of
extramural and NCI intramural mentoring . Describe how and when
trainees will transition from didactic training to research training.
o Experience of the Extramural and NCI Intramural Mentors in Training:
For each extramural and NCI intramural mentor, describe their most
recent mentoring experiences and successes in the last 5 years. For
extramural mentors, focus exclusively on pre-doctoral candidates; for
intramural mentors, experience may be limited to post-doctoral
mentoring. Provide no more than one paragraph per mentor.
o Recruitment Plan and Applicant Pool: Describe how the graduate
school (s) of the extramural institution recruits candidates. Provide
a qualitative and quantitative description of the typical applicant
pool and the number of graduate students accepted each year. Describe
any specific new steps the extramural institution will take to market
and recruit graduate students if the NCI Intramural Program becomes a
partner in the training of graduate students
o Trainee candidates: If there are existing graduate students ready
to enter the extramural institution's graduate program, identify those
who could take part in this program.
o Curriculum: Describe the curriculum or didactic experiences that
each trainee will be expected to complete as part of this program; and,
if applicable, how NCI intramural staff will enhance the didactic
training. Courses offered by the NIH may be used as part of the
planned didactic experiences.
7. Program Steering Committee (PSC): Provide the membership of the PSC
(remember that the PI and the IP must co-chair the committee and the
membership cannot exceed 6 members). Describe the role of the PSC
taking into consideration the SPECIAL REQUIREMENTS AND PROGRAM
CONSIDERATIONS noted above. Describe the benchmarks that the PSC will
use in selecting candidates, for approving the assignment of candidates
to extramural and intramural mentors, and for assessing the progress of
candidates in their completion of the Ph.D. degree or equivalent.
8. Letters of Institutional Commitment: A letter should be provided
with the application from an official at the extramural institution who
can represent the institutions commitment to this program (e.g., Dean
of the Medical School). A letter should also be provided to the
Scientific Director of the NCI Intramural Program by either the NCI
Director of the Division Cancer Epidemiology and Genetics or the
Director of the NCI Center for Cancer Research (or their
representatives) or both depending upon the nature of the training
program using intramural resources. This letter(s) should describe the
specific resources that will be made available to conduct the proposed
partnership program.
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:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
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.)
(https://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)
This change in practice is effective immediately. 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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by 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.
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. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and for responsiveness by the NCI program staff.
Incomplete applications will be returned to the applicant without
further consideration. And, if the application is not responsive to
the RFA, CSR staff may contact the applicant to determine whether to
return the application to the applicant or submit it for review in
competition with unsolicited applications at the next appropriate NIH
review cycle.
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 (DEA) at
NCI in accordance with the review criteria stated below. As part of
the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have
the highest scientific merit, generally the top half of the
applications under review, will be discussed and assigned a priority
score
o Receive a second level review by the National Cancer Advisory
Board.
REVIEW CRITERIA
In the written comments, reviewers will be asked to discuss the
following aspects of your application in order to evaluate the
likelihood that the program will address the proposed research training
objectives:
o Merit of the objectives of the training program as a partnership
that will uniquely compliment and enhance the research training
capabilities of the extramural institution in ways that otherwise would
not be possible, and that will result in effective scientific
collaborations between the extramural institution scientists and those
of the NCI Intramural Program.
o Qualifications of the PI and the IP to provide administrative and
scientific leadership to the partnership training program
o Quality and experience of the extramural and NCI intramural
preceptors to serve as mentors
o Adequacy of the extramural and NCI intramural training environment
to achieve the objective of the partnership program and the adequacy of
the letters of commitment from the extramural institution leaders and
the NCI Intramural Program leaders.
o Adequacy of the membership and role of the Program Steering
Committee in monitoring the training program and identifying areas for
scientific collaboration.
o Adequacy of the existing recruitment plans of the extramural
graduate school and the specialized plans of the partnership program to
ensure that the appropriate number and quality of candidates needed to
conduct a successful training program.
o Quality and effectiveness of the PSC and its role as proposed to
evaluate the success of the partnership as a whole, monitor the
progress of individual candidates and stimulate collaborations between
the extramural institution and the NCI Intramural Program.
o Adequacy of the Resources and Environment available at the
extramural institution and the NCI Intramural Program to conduct a
successful training program.
ADDITIONAL REVIEW CRITERIA:
In addition to the above review criteria, your application will be
reviewed with respect to the following:
o MINORITY RECRUITMENT AND RETENTION PLAN: The NIH remains committed
to increasing the participation of individuals from underrepresented
racial and ethnic groups in biomedical research. As first announced
in 1989, all competing applications for institutional NRSA research
training grants must include a specific plan to recruit and retain
underrepresented minorities in the training program. If an application
is received without a plan or without a report on the previous award
period, the application will be considered incomplete and will be
returned to the applicant without review. Additional information on
this requirement was published in the NIH Guide to Grants and
Contracts, Volume 22, Number 25, July 16, 1993 (see
https://grants.nih.gov/grants/guide/notice-files/not93-188.html)
Although the success of efforts to recruit and retain minority trainees
is a factor in the assessment of the quality of the trainee pool, peer
reviewers will separately evaluate the minority recruitment plan after
the overall score has been determined. Reviewers will examine the
strategies to be used in the recruitment of minorities The review
panel's evaluation will not be a factor in the determination of the
priority score but will be included in an administrative note in the
summary statement. If the minority recruitment plan is judged to be
unacceptable, funding will be withheld until a revised plan that
addresses the deficiencies is received. Staff within the NCI, with
guidance from the Special Review Group evaluating NCI institutional
research training grant applications, will determine whether amended
plans submitted after the initial review are acceptable. Revised plans
will be monitored for their effectiveness each year by NCI staff.
o TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH: Every predoctoral
trainee supported by a TU2 institutional research training grant must
receive instruction in the responsible conduct of research (For more
information on this provision, see the NIH Guide for Grants and
Contracts, Volume 21, Number 43, November 27, 1992 or see
https://grants.nih.gov/grants/guide/notice-files/NOT92-236.html).
Applications must include a description of a program to provide formal
or informal instruction in scientific integrity or the responsible
conduct of research. Applications without plans will be considered
incomplete and may be returned to the applicant without review. Plans
must address the subject matter of the instruction, the format of the
instruction, the degree of faculty participation, trainee attendance,
and the frequency of instruction. The rationale for the proposed plan
of instruction must be provided.
o PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent that they may be adversely
affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated (See
Inclusion Criteria included in the section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o 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: February 27, 2003
Application receipt date: March 27, 2003
Peer Review Date: June-July 2003
Council Review: September, 2003
Earliest Anticipated Start Date: September, 2003
AWARD CRITERIA
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
REQUIRED FEDERAL CITATIONS
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 AMENDMENT
"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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories
in compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
A continuing education program in the protection of human participants
in research in now available online at: http://cme.nci.nih.gov/
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Guidance for investigators and institutional review boards regarding
research involving human embryonic stem cells, germ cells, and stem
cell-derived test articles can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.html. Only
research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s) to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA, "NCI Institutional Pre-Doctoral Research Training
Partnership Award", is related to the priority area of training .
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/
AUTHORITY AND REGULATIONS
NRSA Institutional Research Training Grants are made under the authority of
Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42
of the Code of Federal Regulations, Part 66, is applicable to this program. The
NRSA Institutional Training Grants are not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
CRTA awards are made under the authority of Section 405 (b) (1) (C) of the
Public Health Service Act, 42 USC 284 (b) (1) (C), as amended; and Section 413
(b) (3) of the Public Health Service Act, 42 USC 285a-2 (b) (3), as amended
pertaining to the National Cancer Institute. Awards are made under
authorization of Section 487 of the Public Health Service Act as amended
(42 USC 288) and administered under NIH grants policies described at
https://grants.nih.gov/grants/policy/policy.htm and under Title 42 of the Code
of Federal Regulations, Part 66.
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.
https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.