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COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP
Release Date: April 25, 2000
RFA: CA-01-002
National Cancer Institute
Office of Research on Minority Health
Letter of Intent: June 8, 2000
Application Receipt Date: July 26, 2000
PURPOSE
The National Cancer Institute (NCI) and the NIH Office of Research on
Minority Health (ORMH) invite cooperative agreement applications (i.e., U54s)
for the establishment of Comprehensive Minority Institution/Cancer Center
Partnerships (CMI/CCP) between Minority-Serving Institutions (MSIs) and
NCI-designated Cancer Centers. Both MSIs with medical schools and MSIs with
more focused education and research programs (e.g., Masters and Ph.D.
Programs) are invited to participate in this initiative. The long-range goals
of the partnerships are to increase the cancer research capabilities at the
MSIs; to increase the number of minority scientists engaged in cancer
research and other related cancer activities; and to improve the
effectiveness of NCI-designated Cancer Centers in developing and sustaining
activities focused on the disproportionate incidence, mortality and morbidity
in minority populations in the region the cancer center serves. To achieve
these goals, CMI/CCP activities are expected to lead to the development of
long-term comprehensive partnerships that will strengthen competitive cancer
research, research training and career development, education and outreach
capabilities at MSIs and in Cancer Centers.
The purpose of this request for application (RFA) is to solicit cooperative
agreements (U54s) that would implement comprehensive partnerships between
MSIs and NCI-designated Cancer Centers (or groups of centers) that will
achieve goals that are of clear mutual benefit. The comprehensive
partnership must be predominantly focused on cancer research and one or more
of the following target areas: cancer research training and career
development, education or outreach programs to minority communities. The
partnership application must be based on extensive planning and priority
setting activities, whether supported by a CMI/CCP U20 cooperative planning
grant or not. CMI/CCP U54 applicants are expected to achieve the following
objectives in whole or in part:
1. Build and stabilize the independent and collaborative, competitive
research and research training projects and programs at MSIs;
2. Create stable, long-term collaborative relationships between MSIs and
NCI-designated Cancer Centers (or groups of centers) in the areas of cancer
research, research training and career development, education and/or outreach
that increase the emphasis on problems and issues relevant to the
disproportionate cancer incidence and mortality in minority populations;
3. Improve the effectiveness of Cancer Center research, education and
outreach activities specifically designed to benefit racial and/or ethnic
minority populations in the region the Cancer Center serves;
4. Export successful approaches in addressing disproportionate cancer
incidence and mortality rates in minority populations to other NCI Cancer
centers, as well as to other key networks supported by the NCI (e.g., Cancer
Genetics Network, Clinical Cooperative Groups, Early Detection Research
Network, and the Special Populations Network).
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, Comprehensive
Minority Institution/Cancer Center Partnership, is related to the priority
area of cancer. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications will only be accepted from MSIs, either in the United States or
in territories under U.S. jurisdiction, and from institutions that are
NCI-designated Cancer Centers (or groups of centers) that wish to develop
comprehensive partnerships. Minority-Serving Institutions are those in which
students of minority groups, who are underrepresented in the biomedical
sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan
Natives, Native Hawaiians, Pacific Islanders), comprise a significant
proportion of the enrollments AND that have a track record of commitment to
the special encouragement of minority faculty, students and investigators. A
list of the eligible Minority-Serving Institutions can be found at the
following website address: http://www.sciencewise.com/. A list of
NCI-designated Cancer Centers can be found at the following website address:
http://www.nci.nih.gov/cancercenters/
Each partnership must be submitted as two applications, one from the MSI and
one from the Cancer Center (or group of Cancer Centers), but with separate,
complementary budgets to achieve priorities, common goals and objectives.
Each Principal Investigator must be listed as a Co-Investigator on the
complementary application (See below for further instructions). Each
applicant should specify the Co-Investigator and partnering institution in a
cover letter.
The Principal Investigators must be U.S. citizens, non-citizen alien
nationals, or permanent residents of the United States.
Each MSI and Cancer Center is limited to participate in no more than ONE
Comprehensive Minority/Institution Cancer Center Partnership (U54)
application.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) cooperative
specialized center (U54) award mechanism. The U54 mechanism may support any
part of a full range of research development from very basic to clinical.
The U54 is a cooperative agreement, 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 activities. Under a cooperative agreement, the NIH's
purpose is to support and stimulate the recipient's activities by involvement
in and otherwise working jointly with the award recipient in a partner role.
NCI/ORMH staff will work cooperatively with the award recipients in a partner
role and do not assume direction, prime responsibility, or a dominant role in
the activity. Details of the responsibilities, relationships, and governance
of the activities to be funded under the cooperative agreements awarded for
this Program are discussed below under "Terms and Conditions of Award."
This RFA is a one-time solicitation. If it is determined that there is a
continuing program need, the NCI will either reissue this RFA for
re-competition or invite recipients of awards under this RFA to submit
competitive continuation cooperative agreement applications for review. If
the NCI does not continue the program, awardees will be able to submit grant
applications through existing investigator-initiated grant programs.
The Principal Investigators on behalf of the institutions are responsible for
the conduct of this activity with strong continuing commitments from the MSI
and the Cancer Center enabling the success of the partnership.
ALLOWABLE COSTS
The U54 will provide support for:
1. An Administrative Core activity (not to exceed 20% of the total direct
costs) for
a. Salaries of key personnel
b. Equipment and supplies to support an administrative structure
2. Planning and Evaluation Core activities that may include the costs for
a. Travel for key personnel
b. Travel and per diem for Program Steering Committee members
c. Workshops, seminars, retreats and other forums to strengthen, stabilize
and consolidate interactions and cooperation between the MSI and the Cancer
Center in areas of existing high priority; to merge existing cancer programs
of the MSI and the Cancer Center to consolidate collaborations; and to
identify new areas of opportunity and high priority as the partnership
evolves.
3. Developmental Core Funds for:
a. Pilot research projects or pilot programs in research training and career
development, education and outreach (not to exceed $100,000 in direct costs
per year per project/program or a duration of three years).
b. Up to three Full Projects/Programs per year in research, research training
and career development, outreach and education may be funded (not to exceed
$250,000 in direct costs per year per project/program or a duration of three
years) in areas prioritized for development and stabilization through
subsequent competitive funding (e.g., R01, K12, P01, SPORES, T32, R25). One
of one, one of two, or two of three Full projects/programs must be focused
primarily on research. The partnership would have the flexibility to
discontinue projects and start new projects based on the regular evaluation
of progress; the funding of Full projects/programs through other competitive
sources; and identification of new opportunities through formalized planning,
evaluation and priority setting activities.
c. Resources and infrastructure (e.g., tissue resources) that augment the
cancer research capability of the MSI, the collaborative research of the MSI
and the Cancer Center, and/or specifically enhance research focused on
minority issues. Shared infrastructure could be placed in either the MSI or
the Center or in both locations.
d. Support for research assistants and research associates in various stages
of their career development as independent scientists.
e. Start-up packages for newly recruited investigators in areas prioritized
for development and stabilization.
FUNDS AVAILABLE
This RFA is a one-time solicitation. NCI/ORMH anticipate making two (one
pair) 5-year awards and plan to set aside an estimated total of $2.5 million
(including direct costs and costs for facilities and administration) for the
initial year's funding of the program. An annual budget in the range of $1
million - 1.5 million in direct costs is suggested. Third party
sub-contractual F & A costs will not be counted toward the maximum combined
direct costs of $1.5 million. Applications exceeding the $1.5 million in
direct costs limit will be considered unresponsive to the RFA and will be
returned without further consideration. Funding in response to this RFA is
dependent upon the receipt of a sufficient number of meritorious
applications. Although this program is provided for in the financial plans of
NCI/ORMH, the award of grants pursuant to this RFA is contingent upon the
anticipated availability of funds for this purpose. Awards are not renewable.
The NCI/ORMH will make a commitment for funding a partnership for the full
term of the award. The anticipated award date is March 1, 2001.
OBJECTIVES
Background:
Twenty-eight years have passed since the War on Cancer was initiated, and
during this period, the disparities in cancer incidence and mortality in
underserved racial and ethnic minorities have continued to rise. The
incidence of large bowel and lung cancers in Alaska Native and African
American men and women is higher than that of other ethnic groups. Five-year
survival rates by selective sites among racial or ethnic groups in the U.S.,
for example in Native American, African American, Hawaiian, and Hispanic
Americans, are lower than those of Japanese and White Americans. The cancer
mortality rates for lung, trachea, bronchus, and pleura for minority males
and females differ widely when measured by state economic area. Examples of
geographical differences are seen in a pattern of excessive prostate cancer
among African American males in the Southeastern U.S., particularly in rural
areas. High rates of esophageal cancer in the District of Columbia and in the
Coastal area of South Carolina appear to be related to alcohol consumption,
tobacco use and dietary deficiencies. More research is needed that
specifically addresses these disparities if they are to be eliminated.
Information about cancer incidence and mortality rates in different racial
and ethnic U.S. populations can be obtained at the following website address:
http://www.nci.nih.gov/atlas
Minority-Serving Institutions (MSIs) [e.g., Minority Medical Schools,
Historically Black Colleges and Universities (HBCUs), Hispanic-Serving
Institutions (HSIs), Tribal Colleges] conduct high quality programs for
educating minorities, and they represent a rich source of talent with
appropriate cultural sensitivity and perspectives needed in cancer research.
However, MSIs have had difficulties developing and sustaining independent
programs in biomedical research, and there is a paucity of minority
scientists who are pursuing successful biomedical research careers. Despite
various initiatives by the community and the NIH, progress in realizing a
significant increase in the number of minority scientists who are competitive
for NIH research grants has been slow. More specifically, there remains a
serious shortage of well-trained minority scientists who can conduct
independent cancer research, who can focus research efforts on the
disproportionate incidence and mortality rates in minority populations, and
whose cultural perspectives are essential to the successful conduct of many
forms of research involving minority patients and populations.
The NCI-designated Cancer Centers are geographically dispersed, research
intensive organizations with well-organized programs for training cancer
scientists. They engage in extensive outreach and education programs
designed to reduce cancer incidence and mortality in the communities they
serve. Cancer centers are the only organized units supported by the NCI that
conduct research; sponsor research training in the basic, clinical and
population sciences; provide information services; and develop and sustain
educational and outreach programs that benefit their communities. Yet, the
progress of cancer centers in focusing on research issues of particular
importance to cancer in minorities, in training minority scientists, in
reaching out to and partnering with different racial and ethnic minority
populations in their communities, and in bringing the benefits of cancer
research to these populations has been slow and often disappointing.
The low level of involvement of MSIs in cancer research and lack of
significant training of minority scientists in cancer research represent two
major obstacles to developing a stronger national cancer research effort
aimed at understanding the reasons behind the significant disparities of
cancer impact on minority populations. The potentials for identifying and
training minority students and faculty in areas of cancer research have not
been fully explored. One untried and potentially powerful approach for
addressing these difficult issues is to create collaborations and
partnerships between MSI's and NCI Cancer Centers that integrate and take
maximum advantage of their respective expertise and experience. MSIs and
Cancer Centers can help each other get better and collaborate in areas that
neither could do as well alone.
Through long-term comprehensive partnerships that are mutually beneficial to
MSIs and NCI-designated Cancer Centers, the objectives of NCI and ORMH are to
increase the participation of MSIs in the nation's cancer research and
research training enterprise; to increase the involvement and effectiveness
of the cancer centers in research and research training relating to
minorities; and to develop more effective research, outreach and education
programs that will have an impact on minority populations.
Within this objective, four broad areas are targeted for development:
1. Cancer Research: Cancer research projects must be the most significant
component of a Comprehensive Minority Institution Cancer Center Partnership.
Joint research projects may be in any area of basic, clinical, prevention,
control, behavioral or population research. Research projects conducted
primarily at the MSI may be in any area of cancer research, but research
projects conducted primarily at the NCI-designated Cancer Center must
specifically address areas of cancer disparity in minority populations.
Joint cancer research projects at MSIs might focus, for example, on general
areas of environmental carcinogenesis, molecular epidemiology, and behavioral
issues related to cancer prevention and control.
2. Cancer Research Training and Career Development: Cancer research training
and career development programs can be in any of the research areas above but
must focus on joint programs between MSI and Cancer Center(s) that place an
emphasis on the training of minority scientists and on educating majority
trainees to appreciate the issues and problems associated with cancer
incidence and mortality disparities in minority population. The need to
train minority scientists in clinical research and population research is a
recognized deficit in many areas of cancer research dependent for their
success on the cultural sensitivity of the researchers. These training
programs must represent true collaborations that function seamlessly across
the institutional boundaries of the MSI and the Cancer Center(s). For
example, new research training programs might provide graduate students in
MSIs the opportunity to fulfill their research requirements in cancer center
laboratories using state-of-the-art equipment and mentoring by cancer center
investigators; or masters programs in a MSI might be linked formally to
doctoral training programs in Cancer Centers. Clinical research training
might also include the use of current methodologies for national and
international electronic communication on diagnosis and treatment of cancer.
3. Cancer Education: Cancer education programs could focus on any efforts to
augment existing or create new curricula in the MSI and/or the Cancer Center
that would apprise and culturally sensitize graduate students and
postdoctoral students in research, medicine and public health of the need to
reduce disproportionate cancer incidence and mortality in racial and ethnic
minority populations. A successful effort may result in an R25 education
grant and later to institutional commitments to make these curricula an
inherent component of their educational systems.
4. Cancer Outreach: Outreach programs may be defined as proactive effort to
help minority communities develop and manage their own culturally sensitive
programs for educating their populations about cancer risk, early detection,
screening, prevention, and treatment. MSIs and Cancer Centers would be
expected to combine their expertise in working with minority leaders and
organizations to develop community education programs that effectively reach
individuals and physicians and that increase the recruitment and retention of
racial and ethnic minorities into clinical trials and prevention protocols.
The MSI Cancer Center Partnership could help communities develop activities
such as the following: (a) utilize church networks to reach and educate the
citizens of minority communities about prevention, early detection and
treatment of cancer; (b) work with civic organizations to develop programs
that encourage life-style changes important for cancer prevention and that
emphasize the importance of early detection and diagnosis; (c) develop
continuing education programs for community health care providers to ensure
that they are providing state-of-the-art care and advice to their patients;
(d) train communities to use and link these communities to the electronic
information systems that can educate individuals about cancer and help them
make informed decisions about their health.
SPECIAL REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY
INSTITUTION/CANCER CENTER PARTNERSHIPS (CMI/CCP)
There are a number of Special Requirements and Provisions that each
Comprehensive Minority Institution Cancer Center Partnership must comply
with:
1. Each MSI and Cancer Center is limited to participating in no more than ONE
U54 Comprehensive Minority Institution Cancer Center Partnership application.
2. Of the four areas being targeted by this initiative (i.e., cancer
research, cancer research training and career development, cancer education
and outreach), cancer research must be the major component.
3. There must be written "Letters of Commitment" from the MSI leadership and
the Cancer Center leadership that are fully supportive of this activity and
that commit the additional resources necessary to ensure that these
partnerships will have the maximum chance of success. Additional resources
would include protected faculty time (i.e., release time with grant funds),
recruitment of new faculty, space and facilities, capital improvements, etc.
4. The CMI/CCP activity must be submitted as a clear partnership between the
MSI and the Cancer Center. This must be done by submitting two applications,
one from the MSI and one from the NCI Cancer Center (or Cancer Centers). The
Principal Investigator of the MSI grant must be the Co-Investigator of the
Center grant and visa versa. The overall priorities and objectives for
implementation of the two applications must be the same, but the actual
activities and budgets of the two grants should demonstrate how the MSI and
the Cancer Center requests complement each other in achieving these
priorities and objectives.
5. The two applications must clearly outline the mutual benefits to be gained
by the MSI and the Cancer Center (or Centers) as a result of the partnership.
6. The total direct costs of the two applications together cannot exceed $1.5
million. If there is a third party subcontract, only the direct costs of the
subcontract will count against this cap.
7. No more than 20% of the total direct costs of the partnership can be
devoted to Administrative Core expenses.
8. In using Developmental Funds to support Pilot or Full research projects or
Pilot or Full programs (research training and career development, education
or outreach), each activity must be co-led by individuals from both the MSI
and the Cancer Center.
9. Cancer research training programs must be joint programs designed to
function seamlessly across institutional boundaries and to share trainees,
faculty and mentors.
10. Research projects supported by the U54 and primarily conducted at the MSI
can be any research area relevant to cancer but research primarily conducted
at the NCI-designated Cancer Center must be focused on cancer disparity in
minority populations.
11. There must be a common planning and evaluation component shared between
the MSI and the Cancer Center(s) proposals:
a. A Program Steering Committee with NCI/ORMH staff as a voting member(s)
must meet once-a-year to evaluate progress and make recommendations for mid-
course corrections as needed. The progress must be in the form of a written
report and must be included as part of the Non-Competing Continuation
Application submitted to the NCI each year.
b. The partnerships must have a process in place for reviewing internal
proposals for Pilot and Full projects/programs, recruitment of new
investigators and establishment of infrastructure on the basis of their merit
and potential to contribute effectively to achieving high priority goals and
objectives and this process must serve as the basis for distributing
Developmental Funds. The rationale for using all Developmental Funds would
have to be based on careful planning and evaluation activities conducted by
the U54 CMI/CCP program. The expectation is that successful pilot
projects/programs will become full projects/programs and that full
projects/programs will become competitively funded grants (e.g., R01; R25;
SPORES; T32; P01; K12). No full project/program can exceed $250,000 in direct
costs or continue for a duration longer than 3 years
c. Other internal planning and evaluation methods for assuring progress of
the partnership.
12. Any new project/program and shared resources for development must not
overlap in purpose and intent with existing projects/programs and shared
resources funded by the NCI Cancer Center Support Grant, National Center for
Research Resources Infrastructure Grants, National Institute of General
Medical Sciences Minority Biomedical Research Support Grant or any other
peer-reviewed funded programs. Resources should augment the research
capability of the MSI, the collaborative research between the MSI and the
Cancer Center, and/or specifically support and enhance research focused on
minority issues. Resources can augment existing Cancer Center Resources, or
they can be entirely new resources, as long as they are tailored to the
common objectives and priorities of the partnership. Resources can be
located either at the MSI or the Cancer Center or divided but shared between
the MSI and the Cancer Center.
13. All recipients of U54 CMI/CCP Awards will be expected to participate in
an annual meeting sponsored by the Comprehensive Minority Biomedical Branch
(CMBB) of the NCI. Travel for this purpose must be included in the grant
applications from the both MSI and the Cancer Center institutions.
14. Successful Partnerships are expected to participate in exporting their
approaches to other NCI Centers and Networks and MSIs.
15. Once a U54 CMI/CCP grant is funded, specific guidelines for Non-Competing
Renewal applications will be provided to the grantees.
TERMS AND CONDITIONS OF AWARD
Cooperative agreements are assistance mechanisms and are subject to the same
administrative requirements as grants. The following Terms and Conditions of
Award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations in 45 CFR
Part 74 and 92 and administered under the NIH Grants Policy Statement.
The administrative and funding instrument used for this program is a
cooperative agreement (U54), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during performance
of the activity. Under the cooperative agreement, the NIH 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 activities in carrying out the
studies will be shared among the awardees and the NCI/ORMH Program staff.
These are summarized below:
1. Awardee Rights and Responsibilities
a. Awardees will have primary responsibility for the project as a whole,
including research design and conduct, data collection, data quality control,
data analysis and interpretation and preparation of publications, as well as
collaborations with other awardees. Awardees will retain primary rights to
the data developed under these awards, subject to government rights of access
consistent with current HHS, PHS, and NIH policies. However, awardees must
be committed to making the research tools and research materials they develop
available to the cancer research community.
b. Awardees agree to follow the advice and recommendations of the Program
Steering Committee, whenever possible, in meeting the intent of this
initiative.
c. Each partnership should plan regular meetings (no less than monthly) to
discuss the progress and directions of its activities and to insure that the
necessary interactions are taking place. For partnerships including members
from other institutions, plans to extend meetings via teleconferencing,
videoconferencing or web conferencing (for more frequent meetings) as well as
face-to-face meetings (semiannually or quarterly) should be described.
d. The Co-Investigators and other designated investigators will attend an
Annual Meeting to be organized by NCI staff in Washington D.C. In addition,
the Co-Investigators will be voting members of the Program Steering Committee
which meets once a year.
e. Each partner will submit annual progress reports to the NCI that describe
activities and accomplishments during the previous funding period as part of
the Non-Competing Continuation Renewal.
f. Intellectual Property. Each applicant must provide a detailed description
of the approach to be used for obtaining patent coverage and for licensing
where appropriate, in particular where the invention may involve
investigators from more than one institution. Procedures must be described
for resolution of legal problems should they arise. Your attention is drawn
to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions
were also published in the NIH Guide for Grants and Contracts (NIH Guide,
Vol. 19, No. 23, June 22, 1990).
All Awardees must adhere to the policy for distribution of unique research
resources produced with PHS funding, published in the NIH Guide for Grants
and Contracts (NIH Guide, Vol. 25, No. 23, July 12, 1996). The Guide can be
accessed electronically at http://grants.nih.gov/grants/guide/index.html. All
awardees must also adhere to the Principles and Guidelines for Recipients of
NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical
Research Resources (64 Federal Register 72090). The Principles and
Guidelines can be accessed electronically at
http://www.ott.nih.gov/policy/rt_guide_final.html. Procedures must be described,
which address how Awardees will approach such distribution/dissemination,
including acknowledgment of the terms of any related technology licenses or
sponsored research agreements which Institution may have.
Awardees shall include the following terms concerning intellectual property
rights, or provide an alternative plan. NCI acknowledges that some
commercial collaborators that are members of applicant partners, or who
provide agents to applicant partners, may require that Institution agree to
grant to them certain intellectual property rights, as described by the terms
below. If an Institution voluntarily agrees to the described terms, then
they should appear in the Institution's partner application. NCI recognizes
that Institutions' ability to access agents from commercial collaborators for
this effort may be limited absent such a voluntary agreement, or a
substantially similar independent agreement between Institution and
commercial collaborators providing agents. However, in no event will the
award of a cooperative agreement be dependent upon the described terms' being
part of an Institution's partner application. Rather, Institution's partner
application may provide Institution's own plan for accessing agents from
commercial collaborators. In no event, however, will an award be made absent
incorporation of either the terms below, or Institution's own plan.
"Institution agrees to grant to commercial collaborator: (i) a paid-up
nonexclusive, nontransferable, royalty-free, world-wide license to all
Institution Inventions for research purposes only; and (ii) a time-limited
first option to negotiate an exclusive, world-wide royalty-bearing license
for all commercial purposes, including the right to sub-license, to all
Institution Inventions on terms to be negotiated in good faith by the
collaborator and Institution. The collaborator shall notify Institution, in
writing, of its interest in obtaining such an exclusive license to any
Institution Invention within six (6) months of the collaborator's receipt of
notice of such Institution Invention(s). In the event that a collaborator
fails to so notify Institution, or elects not to obtain an exclusive license,
then the collaborator's option shall expire with respect to that Institution
Invention, and Institution will be free to dispose of its interests in such
Institution Invention in accordance with Institution's policies. If
Institution and collaborator fail to reach agreement within ninety (90) days,
(or such additional period as collaborator and Institution may agree) on the
terms for an exclusive license for a particular Institution Invention, then
for a period of six (6) months thereafter Institution shall not offer to
license the Institution Invention to any third party on materially better
terms than those last offered to collaborator without first offering such
terms to collaborator, in which case collaborator shall have a period of
thirty (30) days in which to accept or reject the offer.
Institution agrees that notwithstanding anything contained herein to the
contrary, any inventions, discoveries or innovations, whether patentable or
not, which are not Subject Inventions as defined in 35 USC 201(e), arising
out of any unauthorized use of the collaborator's agent and/or any
modifications to the agent, shall be the property of the collaborator
(hereinafter "Collaborator Inventions"). Institution will promptly notify the
collaborator in writing of any such Collaborator Inventions and, at
collaborator's request and expense, Institution will cause to be assigned to
collaborator all right, title and interest in and to any such collaborator
inventions and provide collaborator with assignment or other documents).
Institution may also be conducting other research using the agent under the
authority of a separate Material transfer Agreement (MTA) with the
collaborator. Inventions arising thereunder shall be subject to the terms of
the MTA, and not to this clause."
g. Protection of Proprietary Data. The ability to publish new results in a
timely and intellectually unconstrained manner is fundamental to the academic
enterprise. This need must be balanced with the legitimate requirements of
commercial collaborators to protect the proprietary or confidential
information that they provide concerning their proprietary agents. Commercial
collaborators also may require exclusive access to the raw and primary data
generated in studies of their agents. Therefore, NCI urges that the following
statement also be incorporated in Partner applications:
"Raw and primary data may be provided exclusively to the NCI, industrial
collaborators, and the FDA, as appropriate. This provision shall not affect
the investigators' right to disseminate their research findings through
publications or presentations."
2. NCI Staff Responsibilities
Program staff consists of the NCI Program Director and an additional
representative from the ORMH. The NCI/ORMH Program staff will have
substantial scientific-programmatic involvement during conduct of this
activity, through technical assistance, advice and coordination above and
beyond normal program stewardship for grants (which includes evaluating
progress), as described below. The NCI/ORMH staff will have substantial
involvement in identifying new areas of opportunity, recommend making mid-
course corrections on an annual basis and generally ensuring that the U54
CMI/CCP remains focused on the intent of this initiative. NCI/ORMH staff
will be involved in the following ways:
a. Serve as full participating and voting member(s) of the Program Steering
Committee.
b. Work closely with individual investigators and partners to facilitate
collaborations.
c. Assist the partnership efforts by facilitating access to fiscal and
intellectual resources provided by NCI, NIH, ORMH, industry, private
foundations and federal funding agencies.
d. Ensure that activities proposed for the development or implementation do
not overlap or duplicate activities supported by Cancer Center Support
Grants, Research Centers at Minority Institutions Infrastructure Grants,
Minority Biomedical Research Support Grants or other peer reviewed funding
mechanisms.
e. Interact with each partner, coordinate approaches between partners, and
contribute to the adjustment of projects/programs or approaches as warranted.
f. Provide assistance in reviewing and commenting on all major transitional
changes of an individual partner's activities prior to implementation to
assure consistency with the goals of this RFA.
g. Coordinate activities with other ongoing studies supported by NCI to avoid
duplication of effort and encourage sharing and collaboration in the
development of new clinically useful agents and methodologies.
h. Coordinate access to other resources from NCI including NCI sponsored
agents for pre-clinical and clinical testing, assistance in IND filing, etc.
i. Link the approaches developed from these partnerships to each other and to
other NCI Cancer centers and NCI-supported networks to ensure that
information is shared and utilized on the widest basis possible.
j. Help reprogram efforts within the peer reviewed scope of work, including
options to modify projects/programs when projects/programs are not making
headway relative to the time-line for achieving the objectives of the RFA.
k. Will assist the Program Steering Committee in the evaluation of new pilot
and full projects/programs when requested as replacements for ongoing
activities.
l. Terminate or curtail an investigator or project/program (or an individual
award) in the event the partnerships fail to evolve within the intent and
purpose of this initiative.
m. Monitor institutional commitments and resources to ensure that the
partnership receives the maximum chance of stabilization and success.
n. Prior approval of new faculty recruits to ensure that he/she falls within
the bounds of the areas prioritized for development and stabilization.
o. Organize and make final decisions on the agenda for an annual workshop
that engages all of the partnerships and other participants as needed. This
meeting will be held for all funded investigators to share progress and
research insights that may benefit all of the projects.
p. Call additional meetings/workshops of the participants to address emerging
areas of high priority to the NCI and ORMH and/or the problems of high cancer
incidence and mortality in minority populations.
The dominant role and prime responsibility for the activity reside with the
awardee(s) for the project as a whole, although specific tasks and activities
in carrying out the projects/programs will be shared among the awardees and
the NCI/ORMH Staff.
3. Collaborative Responsibilities of Program Steering Committee
A Program Steering Committee (PSC) must be composed of the Co-Principal
Investigators of each partnership, no more than two NCI/ORMH Program Staff,
and up to six external advisors with the scientific expertise necessary to
provide appropriate advice relative to the objectives of the U54 CMI/CCP.
The Co-Principal Investigators and the six external advisors are responsible
for providing the most objective advice. The PSC will meet once a year and
serve as the primary advisory board of the U54 CMI/CCP Program and will have
the responsibility to make recommendations for establishing priorities,
changing directions and identifying areas of new opportunity based on
continuing evaluation. The PSC's recommendations, in the form of a written
annual report, are to be submitted to the leaders of the MSI and the Cancer
Center and the NCI and used by the Principal Investigators in guiding and
directing the development of the U54 CMI/CCP program. The Principal
Investigators from the MSI and the Cancer Center and the NCI/ORMH Program
staff will have one vote. The chairperson, who will be someone other than
the Principal Investigators and NCI/ORMH staffs, will be selected by the PSC.
Subcommittees with additional ad hoc advisors can be established by the PSC
as necessary in order to meet its planning, priority setting and evaluation
responsibilities. Awardees generally will be expected to accept and
implement the recommendations of PSC; in those situations where the
recommendations are not feasible to implement, the Co-Principal
Investigators must provide a thorough explanation and rationale to the NCI.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within
the scope of the award), between award recipients and the NCI/ORMH may be
brought to arbitration. An arbitration panel will be composed of three
members -- one selected by the External Steering Committee (with the NCI/ORMH
member not voting), a second member selected by NCI/ORMH, and the third
member selected by the two prior selected members. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with the PHS regulations at 42 CFR
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH-supported biomedical
research projects involving human subjects, unless clear and compelling
rationale and justification is provided that the inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research.
This policy results from the NIH Revitalization Act of 1993 (Section 492B of
Public Law 103-43).
All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical
Research", which have been published in the federal register of March 20,
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contract, Volume
23, Number 11, March 18, 1994 available on the web at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted and supported by
the NIH, unless that are clear and compelling scientific and ethical reasons
not to include them. This policy applies to all initial (Type I) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as participants in
Research Involving Human Subjects "that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
PREAPPLICATION MEETING
The NCI/CMBB and the ORMH strongly encourage all potential applicants to
attend a pre-application technical assistance workshop (TAW) on May, 12-13,
2000 in New Orleans, LA. Since this is an entirely new concept for the NCI
and for the applicant population, it will give staff the opportunity to
clarify any perceived ambiguities in the RFA and help applicants to present
their strongest case for support. If one is unable to attend the technical
assistance workshop the results of the workshop can be accessed at the Web
site http://deainfo.nci.nih.gov/cmbs/index.htm. These results will be posted
by July 1, 2000.
In addition, NCI encourages pre-application consultations with individual
partnerships either as telephone conference calls or as face to face
meetings. In order to make these arrangements contact Dr. Sanya A.
Springfield by email at springfs@mail.nih.gov or by phone at (301) 496-7344
or Dr. Brian Kimes at by email at kimesb@mail.nih.gov or by phone at (301)
496-8537.
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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit by June 8, 2000, a letter of
intent (LOI) that includes a descriptive title of the proposed CMI/CCP U54
partnership, address, and telephone number of the Co-Investigators, the
identities of other key personnel and participating institutions, and the
number and title of the RFA in response to which application may be
submitted. Although a letter of intent is not required, is not binding, and
does not enter into the review of a subsequent application, the information
that it contains allow NCI staff to estimate the potential review workload
and plan the review. The letter of intent is to be sent to the program staff
members listed under INQUIRIES by the letter of intent receipt date.
APPLICATION PROCEDURES
The following procedures apply to both the MSI application and the NCI Cancer
Center(s) application:
Applications are to be submitted using the Form PHS 398 (rev. 4/98) using the
SUPPLEMENTAL INSTRUCTIONS provided below and at
http://deainfo.nci.nih.gov/cmbs/index.htm on or before July 26, 2000. A Form
PHS 398 application kit is available at most institutional offices of
sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, Phone: (301) 435-0714; FAX: (301)
480-0525; Email: grantsinfo@nih.gov. Forms are also available on the
following NIH website:
http://grants.nih.gov/grants/funding/phs398/phs398.html
NOTE: The RFA label available in the PHS 398 (rev. 4/98) application form
must be affixed to the bottom of the face page of the application and title
"U54 CMI/CCP" must be typed on line 2 of the face page of the application
form and the YES box must be marked. Type the RFA number on the label.
Failure to do so could result in delayed processing of the application such
that it may not reach the review committee in time for the review.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
A cover letter must be attached to the application clearly defining the MSI
or Cancer Center partner; this will allow the NCI to assemble the two
applications as one package for peer review. Submit signed, typewritten
originals of the of the cover letters, MSI application and the NCI-designated
Cancer Center application with their checklists, and three signed photocopies
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040
MSC 7710
Bethesda, MD 20892-7710 or
Bethesda, MD 20817-7710 (for express/courier service)
At the time of submission, two additional copies of the applications must be
sent to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062
MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
As noted above the instructions for the Form PHS 398 do not entirely apply to
the submission of a U54 CMI/CCP grant application. Accordingly, NCI strongly
recommends that you follow the SUPPLEMENTAL INSTRUCTIONS below which have
been adapted to accommodate the Form PHS 398 and the special needs of this
U54 CMI/CCP RFA. These instructions include all of the information needed by
peer reviewers of your applications.
SUPPLEMENTAL INSTRUCTIONS
1. Face Page: Use page AA as instructed in the Form PHS 398. On line 1
provide a title that is representative of your partnership. This title
should be the same for both the MSI application and the Cancer Center
institution's application. For line 2 enter the title "U54 CMI/CCP " and the
number beginning with RFA....Remember to affix the RFA label that comes with
the Form PHS 398 to the bottom of the Face Page.
2. Description, Performance Sites and Key Personnel: Use page 2 of the Form
PHS 398 and follow the instructions provided in the Form PHS 398.
3. Table of Contents: Organize the Table of Contents exactly as described
below:
Content Page Number
Face Page
Description, Performance Sites and Key Personnel
Table of Contents
Detailed Budget for Initial Budget Period:
a. Administrative Core
b. Planning and Evaluation Core
c. Developmental Core
Budget for Entire Proposed Period of Support
a. Administrative Core
b. Planning and Evaluation Core
c. Developmental Core
Budgets Pertaining to Consortium/Contractual Arrangements (e.g., more than
one MSI/Cancer Center is involved)
Biographical Sketches of Principal Investigator and the Co-Investigator (not
to exceed two pages for each individual)
Biographical Sketches of Key Professional Personnel of the MSI or Cancer
Center (not to exceed two pages for each individual)
Biographical Sketches of Program Steering Committee Members (not to exceed
two pages for each individual)
List of the participating members of the MSI or the Cancer Center
Other Support of Principal Investigator, Co-Investigator and Key Personnel
Resources
Implementation Plan for the Partnership:
a. Background and Objectives
b. "Letter of Commitment" from the Institution or Cancer Center
c. Chronological review of Planning and Priority-setting processes
d. Scientific and Administrative Leadership
e. Administrative Core
f. Planning and Evaluation
1) Internal Processes
2) Program Steering Committee
g. Proposed Pilot projects/programs to be supported with Developmental Funds
h. Proposed Full projects/programs to be supported with Developmental Funds
i. Proposed resources and infrastructure to be supported with Developmental
Funds
j. Proposed Recruitment to be supported with Development Funds
k. Human Subjects
l. Vertebrate Animals
m. Consortium/Contractual Arrangements
n. Intellectual Property
o. Checklist
4. Detailed Budget for Initial Budget Period: Use DD (Form page 4) of the
Form PHS 398 application kit. Separately break out the budget into three
sections using different Page 4s as follows: a) Administrative Core; b)
Planning and Evaluation Core; and c) Developmental Core.
a) For the Administrative Core, denote the costs for personnel, supplies,
travel etc. needed to provide administrative oversight, coordination and
cohesion of the partnership.
b) For Planning and Evaluation Core, delineate the costs separately for
Internal processes (e.g., workshops, retreats, committees, seminar series, ad
hoc consultants) and the Program Steering Committee. Internal processes
should include the process for evaluating and prioritizing the use of
developmental funds and the process for deciding which areas using
developmental funds should continue or be discontinued. External processes
should include the Program Steering Committee, which must meet once a year
and evaluate the progress of the partnership as a whole toward accomplishing
its objectives and make recommendations for changing direction or strategy to
accomplish mutual objectives more successfully. External processes could
also include special seminar series inviting experts who make presentations
to partnership participants that relate to the objectives of the partnership
and then serve as an ad hoc advisor in areas under development.
c) For the Developmental Core, separately delineate the funds being requested
for all Pilot projects/programs, Full Projects/programs, resources and
recruitment. Remember that individual Pilot projects/programs cannot exceed
$100,000 in direct costs and Full projects/programs cannot exceed $250,000 in
direct costs.
5. Budget for Entire Proposed Period of Support: Using page EE (Form page 5)
of the Form PHS 398, break out the total budgets separately for
Administration, Planning and Evaluation and Developmental Funds. Provide
justifications for costs in future years only when there are specific items
requested in future years that exceed standard cost-of-living increases.
6. Budgets Pertaining to Consortium/Contractual Arrangements: Use this
category if more than one MSI or Cancer Center is being linked in the
partnership. In either case, the MSI or Cancer Center would have to serve
as the primary grantee and subcontract costs would go to the other MSI or
Cancer Center involved.
7. Biographical Sketches of the Principal Investigator and the
Co-Investigator (not to exceed two pages). Use Form FF (Form page 6) of the
Form PHS 398 and follow the instructions in the application kit.
8. Biographical Sketches of Key Professional Personnel of the MSI or Cancer
Center (not to exceed two pages for each individual). Use Form FF as above.
This section should include all professional individuals who serve in middle
leadership roles. The biographical sketches of those Co-Leaders of Pilot
projects/programs, Full projects/programs and resources, as well as any named
individuals who are going to be recruited, should be provided in the
appropriate sections of this application.
9. Biographical Sketches (not to exceed two pages for each individual) of
Program Steering Committee Members other than the Principal Investigators of
the MSI and Cancer Center and NCI/ORMH staff. Use form FF as above.
10. List all participating faculty/members of the MCI or the Cancer Center
alphabetically by name. Include for each individual their degree, department
affiliation or equivalent, and research or other interest (e.g., research
area, training, education, or outreach).
11. Other Support: Use Page GG of the Form PHS 398 kit for the Principal
Investigator, Co-Investigator and all other key professional personnel noted
in item 8 above.
12. Resources: Using Page HH, follow the instructions in the Form PHS 398
application kit.
13. IMPLEMENTATION PLAN FOR THE PARTNERSHIP
a. Background and Objectives:
This section should be the same for both the MSI and the Cancer Center U54
applications. It should (1) discuss the general rationale for and the mutual
benefits that the MSI and the Cancer Center expect to derive from the
partnership and the ways in which the MSI and the Cancer Center believe they
can help each other develop stronger cancer programs, (2) clearly outline the
immediate priorities of the partnership derived from a careful planning
process that relates to mutual benefits, (3) present focused objectives in
the areas of research, research training, education and/or outreach that the
partnership believes can be achieved during the grant period for each
priority, (4) present a projected time-line for achieving each objective and
(5) discuss other areas of opportunity that the partnership will consider as
the relationship between and potential of the partners to work together
evolves.
b. Letter of Commitment:
The MSI institutional leadership (e.g., Dean, President) and the Cancer
Center leadership (e.g., Center Director, Dean) should include a detailed
statement of their long-term commitment by noting the specific resources that
will be dedicated to the priorities of this partnership as outlined in the
Background and Objectives section above. These resources could be in the form
of protected time for faculty to participate in and focus on the objectives
of this grant, faculty appointments that will be made available in those
areas where recruitment will be needed, space that will be dedicated to this
effort, discretionary resources that will be made available to the Principal
and Co-Investigators and purchase of sophisticated equipment for critical
infrastructure needs. The letter should clearly explain how the MSI and the
Cancer Center would be responsible and accountable for following the progress
of this effort and doing what is needed to sustain it.
c. Chronological Review of the Planning and Priority-setting Process:
This section should be the same for both U54 CMI/CCP applications.
This section is to provide to the reviewers of your application a clear
indication that this partnership was derived from a careful planning and
priority-setting process based on each partner's strengths and weakness and
potential to complement each other and help each other become stronger in
areas of opportunity.
In chronological order present each process used in planning for and setting
the priorities and objectives for this application. Briefly describe the
nature of each planning activity (e.g., meetings of higher institutional
officials, planning committees, steering committees in areas of opportunity,
workshops of MSI faculty and Cancer Center members, retreats of MSI faculty
and Cancer Center members), its purpose, the individuals that participated
from the MSI and the Cancer Center, and its outcome.
d. Scientific and Administrative Leadership:
Briefly describe how the Principal and Co-Investigators were chosen in terms
of their qualifications and experience to provide leadership and cohesion for
this effort and to promote collaboration and cooperation in achieving the
common objectives as outlined in the Background and Objectives section above.
Also, if there are other mid-level leaders who will play a significant role
in determining the success of this partnership, provide the same information
for them.
e. Administrative Core: (no more than 10 pages)
Describe the leadership and specific functions of the administrative core to
provide the necessary regular day-to-day oversight, coordination, support,
and logistics services needed to make this partnership function effectively.
This might include organizing meetings, workshops, and retreats; documenting
the results of activities; providing critical secretarial services, etc.
f. Planning and Evaluation:
This section must be the same for each U54 application:
1) Internal Planning and Evaluation Activities:
Document each internal planning and evaluation activity (e.g., steering
committees, regular forums and seminars, workshops, retreats etc.) and
include the individuals from the MSI and the Cancer Center who will be
involved. This should include how the progress of the partnership will be
reported to institutional leaders and the Cancer Center Director and must
include a review and evaluation process for initiating and closing all pilot
and full projects and programs based on their merit and potential for
achieving the objectives of the partnership and their actual progress. This
process must also be used to determine which resources and infrastructure
needs of the partnership will be established and which kinds of recruitment
of faculty will be implemented.
2) Program Steering Committee:
Not including the Co- Principal Investigators and the NCI/ORMH staff,
describe how each Program Steering Committee member was chosen to provide
unbiased, rigorous, expert evaluation of progress, to provide recommendations
for improvement based on the objectives and priorities of the implementation
plan of the partnership and to provide insights and advice for taking
advantage of new objectives and initiatives as they emerge during the course
of the grant period.
NOTE: THE USE OF DEVELOPMENTAL FUNDS IN PARTS g., h., i., and j. BELOW IS
INTENDED TO BE VERY FLEXIBLE AND RESPONSIVE TO THE PLANNING AND PRIORITY
SETTING ACTIVITIES OF THE MSI AND THE CANCER CENTER DURING THE COURSE OF THE
GRANT
g. Proposed Pilot Projects/Programs:
Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 in
direct costs per year or continue for longer than three years, should be
provided in the following format:
1. Title
2. Names of the Co-Leaders from the MSI and the Cancer Center
3. One paragraph abstract stating the objectives of the project/program
4. One paragraph describing how this pilot project/program relates to the
overall priorities and objectives of the partnership as described in the
Background and Objectives section above.
5. Detailed budget page for initial budget period using page DD from the Form
PHS 398.
6. Biographical Sketches of Co-Leaders
7. Proposal (no more than two pages)
8. Describe what aspects of the pilot project/program will be conducted at
the MSI and the Cancer Center
9. Human Subjects**
**NOTE: (1) All NIH-supported biomedical or behavioral research projects
involving human subjects must consider appropriate inclusion of Gender and
Minorities and Children as noted on pages 16 and 17 and 27-33 of the Form PHS
398 instructions; (2) Research dealing with Human Subjects and Vertebrate
Animals must be accompanied by appropriate documentation as described on
pages 17 and 18 of the Form PHS 398 instructions; (3) Research components
involving clinical trials must include provisions for rigorous data
management, quality assurance, and auditing procedures. Funds should be
budgeted for these activities and should be justified. The proposed
provisions should not duplicate review and monitoring systems already in
place at the institution. For any cancer treatment protocol supported
directly or indirectly by the U54 CMI/CCP, informed consent forms, early
stopping rules and procedures to detect and monitor adverse drug reactions
(ADR) must be provided in the application, or in the case of protocols
subsequent to funding of a U54 CMI/CCP, to the NCI program director.
h. Proposed Full Projects/Programs:
Full Projects/Programs proposed for funding, which cannot exceed $250,000 in
direct costs per year or continue for longer than three years, should be
prepared in the following format:
1. Title
2. Names of the Co-Leaders from the MSI and the Cancer Center
3. One paragraph abstract describing the purpose and objective of the
project/program
4. One paragraph describing how the project/program relates to the overall
priorities and objectives of the partnership as described in the Background
and Objectives section above.
5. Detailed budget for initial budget period using Page DD from the Form PHS
398.
6. Biographical Sketches of Co-Leaders
7. Proposal prepared in the same detail as any research, training or
education grant proposal following the specific instructions, page
limitations (no more than 25 pages) and guidelines provided in the Form PHS
398.
**NOTE: (1) All NIH-supported biomedical or behavioral research projects
involving human subjects must consider appropriate inclusion of Gender and
Minorities and Children as noted on pages 16 and 17 and 27-33 of the Form PHS
398 instructions; (2) Research dealing with Human Subjects and Vertebrate
Animals must be accompanied by appropriate documentation as described on
pages 17 and 18 of the Form PHS 398 instructions; (3) Research components
involving clinical trials must include provisions for rigorous data
management, quality assurance, and auditing procedures. Funds should be
budgeted for these activities and should be justified. The proposed
provisions should not duplicate review and monitoring systems already in
place at the institution. For any cancer treatment protocol supported
directly or indirectly by the U54 CMI/CCP, informed consent forms, early
stopping rules and procedures to detect and monitor adverse drug reactions
(ADR) must be provided in the application, or in the case of protocols
subsequent to funding of a U54 CMI/CCP, to the NCI program director.
i. Proposed Resources/ Infrastructure:
Resources and Infrastructure needs (e.g., minority tissue resource, minority
patient accrual core, clinical research management core) of the partnership
should be presented in the following format:
1. Title
2. Co-Leaders from the MSI and Cancer Center who lead the activity
3. The experience of key technical personnel, if applicable, who will be
responsible for the day-to-day operation.
4. Detailed budget for the initial budget period using page DD from the Form
PHS 398
5. Budget for entire propose period of support using page EE from the Form
PHS 398
6. Biographical Sketches of Co-Leaders
7. Description of the resource/infrastructure and how it will further the
priorities and objectives of the partnership (no more than one page)
8. Commitment of space for the resource.
9. Justification for the location of the resource at the MSI, the Cancer
Center or both.
j. Recruitment:
1. Individuals who are known:
a. Provide the Biographical sketch of the individual
b. Describe how the individual fulfills the priorities and objectives of the
partnership as described in the Background and Objectives section above
c. Describe the nature of the position that provides the necessary stability
(e.g., tenure track) and resources (e.g., space) to promote success.
d. Describe the location of the individual at the MSI or the Cancer Center
and how this location will best achieve the needs of the partnership.
2. Individuals who are planned for:
Describe the number and expertise of the individuals that the partnership
plans to recruit over the five-year period of this grant in order to
strengthen its capabilities (e.g., epidemiology, prostate cancer, breast
cancer, behavioral research, outcomes research, community outreach, molecular
genetics) in those areas needed to fulfill its priorities and objectives.
3. Budget:
The budget can provide salary and start-up packages for new recruitment.
Provide a five year budget plan that relates to the costs expected to be
incurred by this grant in years 1 through 5 using page EE of the Form PHS 398
for recruitment and plans to incorporate these individuals into the
permanent faculty of the MSI and/or the faculty/membership of the Cancer
Center.
k. Annual External Evaluation of Progress:
This planning activity is required to use a Program Steering Committee (PSC)
shared by the MSI and the Cancer Center to evaluate annual progress. An NIH
or NCI staff person must be voting members of this committee. Each year a
written report must be submitted to the NCI that summarizes the PSC’s
evaluation and its recommendations for improvement.
This section will be the same for the MSI and the Cancer Center grant
applications. Describe the expertise of the individual external advisors and
the rationale for their selection as a group that can effectively evaluate
this activity relative to its objectives and provide recommendations for mid-
course corrections as necessary.
l. Human Subjects:
Follow the directions and instructions provided in the Form PHS 398
application kit.
m. Vertebrate Animals:
Follow the directions and instructions provided in the Form PHS 398
application kit.
n. Intellectual Property - See instruction in the Form PHS 398 application
kit.
14. Checklist - See instruction in the Form PHS 398 application kit.
15. Appendix Materials
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness to ELIGIBILITY REQUIREMENTS and responsiveness to the SPECIAL
REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY INSTITUTION/CANCER
CENTER PARTNERSHIPS by the NCI. Incomplete and/or non-responsive applications
will be returned to the application without further consideration.
Applications that are complete and responsive to the RFA will be evaluated by
the appropriate peer review group convened by the Division of Extramural
Activities of the NCI. The initial review will first evaluate the
applications for meeting the criteria in the General Features below. Those
application that meet the criteria in the General Features (intent of the
RFA) will be further evaluated for scientific and technical merit in
accordance with the other review criteria stated below. As part of the
initial merit review, all applications will receive a written critique but
only those applications deemed to have the highest scientific merit,
generally the top half of the applications under review, will be discussed,
assigned a priority score, and receive a second level review by the National
Cancer Advisory Board (NCAB).
Both the application from the MSI and the application from the Cancer Center
will be reviewed together as ONE partnership.
Review Criteria
This initiative is quite broad in scope and can include objectives ranging
from cancer research to cancer training, to cancer education to cancer
outreach. Under these circumstances, the review criteria are not organized
under the traditional headings of Significance, Approach, Environment,
Investigator and Innovation typically used for NIH research grants.
Reviewers will have to use considerable flexibility in determining the merit
of a broad range of possibilities that can strengthen the research
capabilities of minority institutions, expand training and career development
opportunities for minority scientists and increase the effectiveness of
cancer centers in developing programs with the potential to reduce
disproportionate cancer incidence and mortality in minority populations.
1. General Features:
a. Strength of the evidence that MSI and the Cancer Center established
priorities and objectives for implementation after a careful and thorough
planning process and that they worked closely together in the preparation of
these applications.
b. Strength of the evidence that the MSI and the Cancer Center have clearly
identified the mutual benefits to be gained from this partnership.
c. Feasibility of achieving the priorities and objectives for this
partnership within the five-year grant period.
d. Degree to which this implementation plan, if fully successful, will result
in a stable cancer research capability for the MSI and/or result in the
significant, successful training of more minority cancer researchers.
e. Degree to which this implementation plan, if fully successful, will
enhance the ability of the Cancer Center through research and/or training and
education and/or outreach to more directly and successfully address the
disproportionate incidence and mortality rates in minority populations.
Those applications satisfying the criteria listed under “General Features”
will be evaluated according to the following criteria. Each criterion
includes additional guidance to reviewers.
2. Scientific and Administrative Leadership:
The adequacy of the qualifications and experience of the Co-Investigators
from the MSI and the Cancer Center to provide strong programmatic (e.g.,
scientific) and administrative leadership. If applicable, the adequacy of
the qualifications and experience of other key personnel in both the MSI and
the Cancer Center to successfully plan for and achieve the objectives of the
implementation plan of the partnership.
3. Letters of Commitment from the MSI and the NCI-designated Cancer Center:
The degree to which the letters of commitment from the MSI and the Cancer
Center address and fully support the priorities and objectives of the
implementation plan of the partnership. The level of authority of officials
committing to this joint effort at the MSI and the Cancer Center that gives
confidence that these commitments will be stable and long-lasting. Adequacy
of the plans to remain responsible and accountable for monitoring and
sustaining the priorities and objectives of this partnership. If applicable,
the adequacy of the resources (e.g., discretionary resources, space, faculty
positions, protected time for research, etc.) that the MSI and the Cancer
Center will provide to promote the successful achievement of the priorities
and objectives of this partnership.
4. Administrative Core:
The quality of an appropriate organizational and administrative structure for
effective attainment of U54 CMI/CCP priorities and objectives that considers
arrangements for internal quality control of ongoing activities, the
allocation of funds, day-to-day oversight and management, support and
logistic services, contractual agreements, (if applicable), and internal
communication among investigators. The qualifications, experience and
commitment of Co-Investigators and key personnel in the services provided by
the administrative core unit, as well as their ability to devote the required
time and effort in providing services. The appropriateness of the use of the
administrative core services by the budgeted activities and
projects/programs.
5. Planning and Evaluation Activities:
The adequacy of the design of and quality of each of the internal planning
and evaluation processes proposed to achieve the objectives and priorities of
the implementation plan. The adequacy of the review and evaluation process
and criteria for initiating and closing pilot and full projects/programs
based on their merit and potential for achieving the objectives of the
partnership and on their actual progress. The appropriateness and adequacy of
the specific faculty and others identified who will participate together in
each aspect of the planning and evaluation effort. The adequacy of the
qualifications and experience of each proposed member of the Program Steering
Committee to evaluate and monitor the progress of the partnership in
achieving its priorities and objectives, to recommend mid-course changes in
approaches and tactics, and to help the partnership evaluate and take
advantage of new opportunities. If applicable, the appropriateness and
adequacy of the process and criteria for identifying and implementing the
resource and infrastructure needs of the partnership, and the
appropriateness and strategic adequacy of the actual and proposed recruitment
over the five-year period of the grant to strengthen the partnership's
capabilities in areas of high priority for implementation.
6. Method of Evaluating and Prioritizing the Use of Developmental Funds:
The adequacy of the experience and qualifications of the individuals who take
part in evaluating specific proposals (e.g., pilot/full projects, pilot/full
programs, recruitment) for using Developmental funds. The adequacy of the
criteria used for selecting pilot/full projects, pilot/full programs,
recruitment etc. for funding based on their merit and their potential to meet
the proposed priorities and objectives of the partnership. The adequacy of
the evidence based on any specific pilot/full projects, pilot/full programs,
recruitment, etc. proposed for support with Developmental Funds that the
process for allocating developmental funds works effectively.
7. Proposed Pilot Projects/Programs:
The qualifications of the Co-Leaders from the MSI and the Cancer Center to
develop the project/program. The merit of the Pilot Project/Program, and the
degree to which it contributes to the priorities and objectives of the
partnership. Potential to develop into a Full project/program in three years
or less. The options will be either to recommend support at the recommended
budget levels or to recommend no support because it has either: a) low merit;
b) low relevance to the objectives of the partnership and/or c) low potential
to develop into a Full project/program.
8. Proposed Full Projects/Programs:
The qualifications of the Co-Leaders to conduct the project/program as
proposed. The merit of the Project/Program and the degree to which the
project will fulfill the priorities and objectives of the partnership. The
potential to become a competitively funded project (e.g., R01, T32, R25) in
three years or less. The options will be either to recommend support at
recommended budget levels or to recommend no support because it has either:
a) low merit; b) low relevance to the objectives of the partnership; and/or
c) low potential to become funded through competitive peer review.
9. Proposed Resources/Infrastructure: (if applicable)
The degree to which the proposed resource/infrastructure proposed will
contribute to the overall priorities and objectives of the implementation
plan. The degree to which the proposed resource/infrastructure will provide
long-term stability to the activities of the partnership supported by current
pilot and full projects and potential future funded grants. The
qualifications of key personnel to operate the resource/infrastructure
activity, and the merit of the resource as proposed. The options will be
either to recommend support either at the recommended budget levels, or to
recommend support with specific modifications in the operation of the
resources, or to recommend no support and the development of a more
appropriate resource because of either: a) low merit; and/or b) low relevance
to the objectives and priorities of the partnership.
10. Proposed Recruitment: (if applicable)
The quality of each specific individual recruitment proposed relative to
background and ability to contribute substantially to strengthening areas of
high priority to the implementation plan. The quality of plans to recruit
individuals with the kinds of qualifications that will satisfy the most
important strategic needs in strengthening the future capability of the
partnership to fulfill its priorities and objectives.
11. Evaluation of Progress by Program Steering Committee:
The adequacy of the expertise and qualifications of each of the Program
Steering Committee members to provide appropriate evaluation and advice and
recommendations for making mid-course corrections based on the objective of
this planning effort. The adequacy of the plan for using the Program
Steering Committee effectively.
12. Intellectual Property: (if applicable)
The adequacy of the intellectual property plan (if applicable), including
provision for sharing of research tools/materials, and the accession of
agents from commercial collaborators.
13. Other Considerations:
The initial review group will also examine: the appropriateness of the
proposed budgets and duration; the adequacy of plans to include both genders
and minorities and their subgroups as appropriate for the scientific goals of
the research and plans for the recruitment and retention of subjects; the
adequacy of plans for including children as appropriate for the scientific
goals of the research, or justification for exclusion; the provisions for the
protection of human and animal subjects; and the safety of the research
environment.
Overall Evaluation and Scoring of Application:
The overall degree of merit for the partnership, as reflected by one priority
score that will be assigned to the MSI and the Cancer Center applications,
will be determined considering the following:
1. The extent to which the MSI and Cancer Center applications together
satisfy the General Features above (i.e., overall intent of this initiative).
2. Taken together, the quality of the individual sub-components as proposed
in the MSI and Cancer Center U54 CMI/CCP applications.
AWARD CRITERIA
Each set of two applications from an MSI and a Cancer Center will compete for
funds with all other partnerships in response to this RFA. Applications
recommended by the NCAB will be considered for award based upon (a)
scientific and technical merit as determined by peer reviewers; (b) the
program priorities of the NCI and the ORMH; and (c) availability of funds.
SCHEDULE
Preapplication Meeting Date: May 12-13, 2000
Letter of Intent Receipt Date: June 8, 2000
Application Receipt Date: July 26, 2000
Peer Review: October/November, 2000
Review by NCAB: February, 2001
Earliest Anticipated Award Date: March 1, 2001
NON-COMPETING CONTINUATION APPLICATION
For those applications that are funded, the NCI will provide special
instructions for submitting the Non-Competing Application or Progress Reports
each year.
INQUIRIES
Written, telephone, fax and e-mail inquiries concerning this RFA are
encouraged especially during the planning phase of these applications. Below
is a listing of program (i.e., scientific management), grants administration
(i.e. fiscal management) and review (i.e., management of peer review process)
staff of the National Cancer Institute who are available to for inquiries:
Direct inquiries regarding scientific or programmatic issue to:
Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 700
Bethesda, MD 20892-8347
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: springfs@mail.nih.gov
Or
Brian Kimes, Ph.D.
Director, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 700
Bethesda, MD 20892-8347
Telephone: (301) 496-8537
Fax: (301) 402-0181
Email: kimesb@mail.nih.gov
Direct inquiries regarding fiscal or budget matters to:
Ms. Barbara Fisher
Grants Management Specialists
National Cancer Institute
6120 Executive Blvd.
EPS/243
Bethesda, MD 20892
Telephone (301) 496-8626
Email: Bf18m@nih.gov.
Direct inquiries regarding review matters to:
Ms Toby Friedberg
Referral Officer
Division of Extramural Activities
6116 Executive Boulevard, Room 8062, MSC 8239
Rockville, MD 20852 (express service)
Bethesda, MD 20892-8239
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.398, Cancer Research Manpower. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations
42 CFR Parts 52 and 45 CFR Parts 74 and 92. This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Office of Extramural Research (OER) |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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