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COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP
Release Date: March 19, 2001
RFA: RFA-CA-02-005 (see replacement RFA-CA-03-010)
National Cancer Institute
National Center on Minority Health and Health Disparities
Letter of Intent Receipt Date: July 9, 2001
Application Receipt Date: August 13, 2001
This RFA is a reissue of RFA-CA-01-002, which was published in the NIH Guide
on April 25, 2000.
PURPOSE
The National Cancer Institute (NCI) and the National Center on Minority Health
and Health Disparities (NCMHD) invite cooperative agreement applications
(i.e., U54) for the implementation of Comprehensive Minority
Institution/Cancer Center Partnerships between Minority-Serving Institutions
(MSIs) and NCI-designated Cancer Centers (or groups of Centers) in order to
develop a stronger national cancer program aimed at understanding the reasons
behind the significant cancer disparities and impact on minority populations.
The lack of significant training opportunities for minority scientists in
cancer research and the low level of involvement of MSIs in competitive cancer
research have represented 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 NCI and
the NCMHD have created a potentially powerful approach that can help the MSIs
and Cancer Centers integrate and take maximum advantage of their expertise and
experience to get better and partner in areas that neither could do as well
alone. This new initiative, the Minority Institution/Cancer Center
Partnership (MI/CCP), offers two cooperative agreement assistance mechanisms,
a U56 for planning and developing a MI/CCP and a U54 for developing and
implementing a MI/CCP. It should be understood that a Cooperative Planning
Grant for Comprehensive Minority Institution/Cancer Center Partnership (U56)
is not a prerequisite to apply for a U54. (for U56 go to:
http://deainfo.nci.nih.gov/cmbs/index.htm. Both mechanisms are aimed at
helping MSIs and Cancer Centers to achieve the following long-term objectives:
to increase the cancer research capabilities at the MSIs; to increase the
number of minority scientists engaged in cancer research and other cancer-
related activities; and to improve the effectiveness of 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.
The U54 Comprehensive Minority Institution/Cancer Center Partnership must be
based on extensive planning and priority setting activities and must achieve
goals that are of clear mutual benefit. The partnership activities must be
predominantly focused on cancer research and one or more of the following
targeted program areas: cancer training and career development, cancer
education or cancer outreach to minority communities. Applicants are expected
to work toward the following objectives:
1. Build and stabilize the independent, competitive cancer research projects
and cancer research training and career development programs at MSIs;
2. Create stable, long-term collaborative relationships between MSIs and
Cancer Centers in the areas of cancer research, cancer training and career
development, cancer education and/or cancer 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 the Cancer Center research, training and
career development, cancer education and cancer outreach activities
specifically designed to benefit minority populations in the region the Cancer
Center serves;
4. Export successful approaches in addressing disproportionate cancer burden
in minority populations to other MSIs, Cancer Centers, and key networks
supported by the NCI (e.g., Cancer Genetics Network, Clinical Cooperative
Groups, Early Detection Research Network, and the Special Populations
Network).
OBJECTIVES
Background:
Since the War on Cancer was initiated, the disparities in cancer incidence,
morbidity and mortality in underserved racial and ethnic minorities have
continued to rise. For example, the incidence of colon and lung cancers in
Alaska Native and African-American men and women is higher than that of other
ethnic groups; five-year survival rates in Native American, African American,
Hawaiian, and Hispanic Americans are lower than those of Japanese and White
Americans; and patterns of prostate cancer among African American males
compared with White males, seen in the Southeastern U.S., particularly in
rural areas still remain higher http://www.nci.nih.gov/atlas. Clearly, more
research is needed that specifically addresses these and other disparities if
they are to be eliminated by 2010 (Presidents Initiative on Race and Health
Disparities).
Minority-Serving Institutions 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, they
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,
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 burden of cancer 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 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 U54 MI/CCP offers four broad areas to target for development:
1. Cancer Research: Joint cancer research projects must be the most
significant component of a U54 Comprehensive Minority Institution/Cancer
Center Partnership. Joint pilot and full 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 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, treatment and control. The expectation is that
successful pilot research projects will become full research projects and that
full research projects will become competitively funded grants (e.g., R03,
R01; project on a P01; project on a P50).
2. Cancer Training and Career Development: Cancer training and career
development programs 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 disparities in minority populations. The NCI particularly
encourages training of minority scientists in clinical, behavioral and
population research; there is a huge deficit of minority scientists engaged in
these research areas, areas which are highly 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. For example, new
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 an MSI might be linked formally to doctoral training programs in
Cancer Centers. Clinical research training programs at MSIs might also include
rotations dealing with minority cultural issues for majority trainees and
clinical training programs at the Cancer Center might offer the use of current
methodologies for national and international electronic communication on
diagnosis and treatment of cancer for minority trainees. Successful
activities in this area may lead to the submission of a competitive training
grant application (e.g. T32, K12, R25T).
3. Cancer Education: Cancer education programs could focus on any effort to
augment existing or create new curricula in the MSI and/or the Cancer Center
that would apprise and culturally sensitize graduate and postdoctoral students
in research, medicine and public health of the need to reduce disproportionate
cancer burden in minority populations. A successful effort may result in an
NCI education grant (R25E) and later to institutional commitments to make
these curricula an inherent component of their educational systems.
4. Cancer Outreach: Cancer outreach programs may be defined as proactive
efforts 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 in the community to develop outreach 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 U54 MI/CCP could help communities develop activities such as:
(a) utilizing church networks to reach and educate the citizens of minority
communities about prevention, early detection and treatment of cancer; (b)
working 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) developing continuing education programs
for community health care providers to ensure that they are providing state-
of-the-art care and advice to their patients; and (d) training communities to
use and link their communities to the electronic information systems that can
educate individuals about cancer and help them make informed decisions about
their health.
SPECIAL REQUIREMENTS
SPECIAL REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY
INSTITUTION/CANCER CENTER PARTNERSHIPS (U54)
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 applying for no more than ONE
Comprehensive Minority Institution/Cancer Center Partnership application
(either a U56 or a U54).
2. Of the four areas being targeted by this initiative, (i.e., cancer
research, cancer training and career development, cancer education and cancer
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),
provisions for recruitment of new faculty, space and facilities for new
projects/programs, capital improvements, etc.
4. Each U54 MI/CCP activity must be submitted as a clear partnership between
the MSI and the Cancer Center. This must be done by submitting two separate
applications, one from the MSI and one from the Cancer Center. The Principal
Investigator of the MSI grant application must be the Co-Investigator of the
Cancer Center grant application and vice 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 applications should demonstrate
how the MSI and the Cancer Center requests both differ and 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 as a result of the partnership. For example,
both the MSI and Cancer Center benefit from a broader range of resources and
approaches than are available at any one institution, however, the MSI will be
exposed to state-of-the-art technology and have greater access to information
services while the Cancer Center benefits by having a greater diversity of
students, faculty and researchers participating in cancer related activities
and more access to minority patients for clinical protocols.
6. The direct costs of the two applications together cannot exceed $1.5
million per year. 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 used
for Administrative Core expenses.
8. There must be a common Planning and Evaluation Core shared between the MSI
and the Cancer Center(s) proposals with:
a. Internal Processes for workshops and other forums to identify areas of
new opportunity as well as for strengthening, stabilizing and merging existing
projects/programs. Internal processes must also have a evaluation and
prioritization process in place for reviewing internal proposals for Pilot and
Full projects/programs, recruitment of research associates, new investigators
and establishment of resources and infrastructure on the basis of their merit
and potential to contribute effectively to achieving high priority goals and
objectives.
b. External Processes, in which a Program Steering Committee evaluates
overall progress on an annual basis, make recommendations for establishing
priorities, changing direction and identifying areas of new opportunity to
accomplish mutual objectives more successfully. The evaluation and
recommendations 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.
The rationale for using Developmental Core funds would have to be based on
these planning and evaluation processes.
9. In using Developmental Core funds to support pilot/full projects/programs,
each activity must be co-lead by individuals from both the MSI and the Cancer
Center. No pilot project/program can exceed $100,000 in direct costs per year
or continue for more than three years. No full project/program can exceed
$250,000 in direct costs or continue for longer than 3 years. 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.,
R03; R01; R25T; R25E; P50; T32; P01; K12). Third party facilities and
administrative costs are in addition to the direct costs requested.
10. Any new project/program and shared resources for development must be
totally new activities that do not overlap in purpose or intent with existing
grants and shared resources (e.g. P30; P50; National Center for Research
Resources’ Infrastructure Grants, National Institute of General Medical
Sciences Minority Biomedical Research Support Grants 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.
11. Successful Partnerships are expected to participate in exporting their
approaches to other NCI Centers, Networks and MSIs.
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 Program Coordinator. 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 direction of its activities and to ensure that the
necessary interactions are taking place. For partnerships including members
from other institutions, plan and extend meetings via teleconferencing,
videoconferencing or web conferencing (for more frequent meeting), 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 year.
e. Each partner will submit annual progress reports (including the PSC annual
meeting recommendation) to the NCI that describes 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 directed 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.nih.gov/od/ott/RTguide_final.htm. Procedures must be described,
that 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
The NCI Program Coordinator will be responsible for normal stewardship of the
award and may recommend the termination or curtailment of 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. In addition, the NCI
Program Coordinator will also have substantial scientific-programmatic
involvement during the conduct of this activity through technical assistance,
advice and coordination, as follows :
a. Serve as full participating and voting member 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, NCMHD, industry, private
foundations and federal funding agencies.
d. Ensure that activities proposed for 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. Assist the Program Steering Committee in the evaluation of new pilot and
full projects/programs when requested as replacements for ongoing activities.
l. Monitor institutional commitments and resources to ensure that the
partnership receives the maximum chance of stabilization and success.
m. Recommend the approval of new faculty recruits to ensure that they fall
within the bounds of the areas prioritized for development and stabilization.
n. Organize and recommend an 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.
o. Call additional meetings/workshops of the participants to address emerging
areas of high priority to the NCI and NCMHD and/or the problems of high cancer
incidence and mortality in minority populations.
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 projects/programs will be shared among the awardees and
the NCI Staff.
3. Collaborative Responsibilities of the Program Steering Committee
A Program Steering Committee (PSC) must be composed of the Co-Principal
Investigators of each partnership, NCI Program Coordinator, and up to six
external advisors with the scientific expertise necessary to provide
appropriate advice relative to the objectives of the U54 and for providing the
most objective advice. The PSC will meet once a year and serve as the primary
advisory board of the U54 Program and will have the responsibility of making
recommendations for establishing priorities, changing direction 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 is
to be used by the Principal Investigators to guide and direct the development
of the U54 program. The Principal Investigators and the NCI Program
Coordinator will each have one vote. The chairperson, who will be someone
other than the Principal Investigators or NCI staff, will be selected by the
PSC. Subcommittees with additional ad hoc advisors may 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 the 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 may be brought to
arbitration. An arbitration panel will be composed of three members -- one
selected by the Program Steering Committee (with the NCI member not voting), a
second member selected by NCI, 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.
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 and will 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.
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. Administrative costs (not to exceed 20% of the total direct costs per year)
for managing the partnership, such as salaries for key personnel; equipment
and supplies to support an administrative structure.
2. Planning and Evaluation may include the costs for travel for internal and
external activities (key personnel; travel and per diem for Program Steering
Committee members, workshops, seminars, retreats and other forums to
strengthen, stabilize and consolidate interactions and cooperation in areas of
existing high priority; to merge existing cancer programs into consolidated
collaborations; to identify new areas of opportunity and high priority as the
partnership evolves; and for reviewing pilots/full projects/programs,
recruitments and resources.
3. Developmental costs for:
a. Pilot cancer research projects or pilot programs (cancer training and
career development, cancer education and/or cancer outreach (not to exceed
$100,000 in direct costs per year per project/program for no more than three
years).
b. Up to three full projects/programs per year may be funded (not to exceed
$250,000 in direct costs per year per project/program for no longer than three
years) in areas prioritized for development and stabilization through
subsequent competitive funding (e.g., R01, K12, P01, P50, 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/programs and start new projects/programs 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/NCMHD 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. The maximum combined direct cost
budget of the MSI and the cancer center together is 1.5 million. Third party
sub-contractual facilities and administration costs will not be counted toward
the maximum combined direct costs of $1.5 million. Applications exceeding the
$1.5 million 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/NCMHD, 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/NCMHD will make a commitment for funding a partnership for the full
term of the award. The total project period for applications submitted in
response to this RFA may not exceed five years. The anticipated award date is
April 1, 2002.
ELIGIBILITY REQUIREMENTS
Applications will only be accepted from Minority-Serving Institutions (MSIs)
[e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving
Institutions (HSIs) and Tribal Institutions (e.g., Colleges)] 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. MSIs are defined as 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.
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. MSIs that offer only baccalaureate degrees,
and Tribal Colleges are also invited to participate in this initiative as sub-
contractual partners in Minority Institution/Cancer Center Partnerships. A
partial list of eligible Minority-Serving Institutions can be found at the
following website address: http://www.sciencewise.com/. Other
institutions that meet MSI qualifications may not be listed on the website but
they are also eligible to apply. A list of NCI-designated Cancer Centers can
be found at the following website address: http://www.nci.nih.gov/cancercenters/.
The Principal Investigators must be U.S. citizens, non-citizen alien
nationals, or permanent residents of the United States.
PREAPPLICATION TECHNICAL ASSISTANCE WORKSHOP
The NCI strongly encourages all potential applicants to attend a pre-
application Technical Assistance Workshop (TAW) on May 6-8, 2001. Since this
is a 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.
In addition, NCI encourages pre-application consultations with individual
partnerships either as telephone conference calls, videoconference meetings,
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 by email at kimesb@mail.nih.gov or by phone at
(301) 496-8537.
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 for inquiries:
Direct inquiries regarding scientific or programmatic issues to:
Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7018A
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 7000
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 Specialist
National Cancer Institute
6120 Executive Blvd.
EPS/243
Bethesda, MD 20892
Telephone: (301) 846-1015
Fax: (301) 496-8601
Email: bf18m@nih.gov.
Direct inquiries regarding review matters to:
Ms. Toby Friedberg
NCI Referral Officer
Division of Extramural Activities
6116 Executive Boulevard, Room 8109, MSC 8239
Rockville, MD 20852 (express service)
Bethesda, MD 20892-8239
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent (LOI) to program
staff members listed under inquiries by July 9, 2001 that includes a
descriptive title of the proposed 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 the 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 allows NCI staff to estimate the
potential peer review workload and plan the review.
SCHEDULE
Preapplication Technical Assistance Workshop Date: May 6-8, 2001
Letter of Intent Receipt Date: July 9, 2001
Application Receipt Date: August 13, 2001
Peer Review: October/November, 2001
Review by NCAB: February, 2002
Earliest Anticipated Award Date: April 1, 2002
NON-COMPETING CONTINUATION APPLICATION
For those applications that are funded, the NCI will provide special
instructions for submitting the Non-Competing Application.
APPLICATION PROCEDURES
The following procedures apply to both the MSI and the Cancer Center
applications:
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 August 13, 2001. 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 the
title "U54 MI/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 and the Co-Principal Investigator; this will allow the
NCI to assemble the two applications as one package for peer review. Submit
signed, typewritten originals of the cover letters, MSI application and the
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
NCI Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109
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 this U54 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
MI/CCP RFA. These instructions include all of the information needed by peer
reviewers of your applications.
All clinical trials supported or performed by NCI require some form of
monitoring. The method and degree of monitoring should be commensurate with
the degree of risk involved in participation and the size and complexity of
the clinical trial. Monitoring exists on a continuum from monitoring by the
principal investigator/project manager or NCI Program Coordinator to a data
and safety monitoring board (DSMB). These monitoring activities are distinct
from the requirement for study review and approval by an Institutional Review
Board (IRB). For details about the Policy of the NCI for Data Safety
Monitoring of Clinical Trials see
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II
clinical trials, investigators must submit a general description of the data
and safety monitoring plan as part of the research application. See NIH Guide
Notice on “Further Guidance on a Data and Safety Monitoring for Phase I and II
Trials” for additional information:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
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 and the Cancer Center institution's applications.
For line 2 enter the title "U54 MI/CCP " and the number of this RFA,
RFA-CA-02-005. 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 Sketch of the Principal Investigator (not to exceed two pages)
Biographical Sketch of the Co-Investigator (not to exceed two pages)
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 all 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: (not to exceed 25 pages)
Introduction to revised application (if applicable)
A. Background and Objectives
B. "Letter of Commitment" from the MSI or Cancer Center
C. Chronological Review of Planning and Priority-setting Processes
E. Scientific and Administrative Leadership
F. Administrative Core
G. Planning and Evaluation Core
1. Internal Processes
2. External Processes
H. Development Core
1. Pilot projects/programs
2. Full projects/programs
3. Resources and infrastructure
4. Research Associates/Assistants
5. Recruitment(s)
I. Human Subjects
J. Vertebrate Animals
K. Literature Cited
L. Consortium/Contractual Arrangements
M. Intellectual Property
Appendix Material
Checklist
4. Detailed Budget for Initial Budget Period: Use Form 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: Denote the costs for personnel, supplies, travel
etc. needed to provide administrative oversight, coordination and cohesion of
the partnership.
b. Planning and Evaluation Core: Delineate the costs separately for:
1. Internal processes (e.g., workshops, retreats, committees, seminar
series, and ad hoc consultants to strengthen, stabilize and merge existing
programs and the process for evaluating and prioritizing the use of
developmental funds and the process for deciding which areas using
developmental funds should be continued or be discontinued.
2. 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 to make presentations to partnership participants that relate
to the objectives of the partnership and then serve as ad hoc advisors in
areas under development.
c. Developmental Core: Separately delineate the funds being requested for
all Pilot projects/programs, Full Projects/programs, resources, research
associates 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 Form EE (form page 5)
of the Form PHS 398, break out the total budgets separately for a.
Administration Core, b. Planning and Evaluation Core, and c. Developmental
Core 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, one of the MSIs or Cancer Centers would have to
serve as the primary grantee and subcontract for the consortia involvement of
the other MSI or Cancer Center.
7. Biographical Sketches of the Principal 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 the Co-Principal 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.
9. 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.
10. Biographical Sketches of Program Steering Committee Members (not to exceed
two pages for each individual) other than the Co-Principal Investigators and
NCI staff. Use Form FF as above.
11. List all participating faculty/members of the MSI or the Cancer Center
alphabetically by name. Include for each their degree, department affiliation
or equivalent, and research or other interest (e.g., research area, training,
education, or outreach).
12. Other Support: Using Form Page GG of the Form PHS 398 kit, provide other
support only for the Principal Investigator, Co-Investigator and all other key
professional personnel at either the MSI or the Cancer Center.
13. Resources: Using Form Page HH, follow the instructions in the Form PHS 398
application kit.
14. IMPLEMENTATION PLAN FOR THE PARTNERSHIP
Special introductory statement for revised applications (if applicable):
This section should include a summary of not more than five pages of the
additions, deletions, and changes in the revised application, placing
particular emphasis on responses to the criticisms and issues raised in the
summary statement. The changes in the full text must be clearly marked by
appropriate bracketing, indenting, or changing the type setting, unless the
changes are so extensive as to include most of the text.
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 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 cancer research, cancer training and career development, cancer
education and/or cancer 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 the partners
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 leadership 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 Prior Planning and Priority-setting Processes:
This section should be the same for both the MSI and Cancer Center
applications and should provide a clear indication that this partnership was
derived from careful planning and priority-setting processes based on each
partner's strengths and weaknesses 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 day-to-day oversight, coordination, support, and
logistical 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 Core (This section must be the same for each
application):
1. Internal Processes: Document each internal planning and evaluation
activity (e.g., regular forums and seminars, workshops, retreats etc.) and
include the individuals from the MSI and the Cancer Center who will be
involved. (Face-to-face informal meetings between collaborators have been
found to be the most effective method of communication. In instances where
there is a problem of distance between partners, applicants are encouraged to
consider other methods of communication including e-mail, teleconferences, and
videoconferences). This should include how the progress of the partnership
will be reported to institutional leaders 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. External Processes: Program Steering Committee:
Excluding the Co-Principal Investigators and the NCI Program Coordinator,
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 PART G 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. Developmental Core
1. Pilot Projects/Programs:
Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 per
project/program 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 (no more than 2 pages)
(7). Proposal (up to five pages)
(8). Describe which 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,
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, to the NCI Program
Coordinator.
2. Proposed Full Projects/Programs:
Full Projects/Programs proposed for funding, which cannot exceed $250,000 per
project/program 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 (no more than 2 pages)
(7). Proposal prepared in the same detail as any research (R01), training
(T32) or education (R25) grant proposal following the specific instructions,
page limitations (no more than 25 pages) and guidelines provided in the Form
PHS 398.
(8). Describe which aspects of the full 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,
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, to the NCI Program
Coordinator.
3. 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 form page DD from the
Form PHS 398
(5). Budget for entire proposed period of support using form page EE from the
Form PHS 398
(6). Biographical Sketches of Co-Leaders (no more than 2 pages)
(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.
4. Research Associates/Assistants:
Individuals who are known:
(1). Provide the biographical sketch of the individual.
(2). Describe how the individual fulfills the priorities and objectives of the
partnership as described in the Background and Objectives section above.
(3). Describe the nature of the position that provides the necessary stability
and resources (e.g., space) to promote success.
(4). 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.
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.
5. Recruitment to be supported with Developmental Funds:
Individuals who are known:
(1). Provide the biographical sketch of the individual.
(2). Describe how the individual fulfills the priorities and objectives of the
partnership as described in the Background and Objectives section above.
(3). Describe the nature of the position that provides the necessary stability
(e.g., tenure track) and resources (e.g., space) to promote success.
(4). 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.
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.
H. Human Subjects:
Follow the directions and instructions provided in the Form PHS 398
application kit.
I. Vertebrate Animals:
Follow the directions and instructions provided in the Form PHS 398
application kit.
J. Literature Cited:
Follow the directions and instruction provided in the Form PHS 398 application
kit.
K. Consortial/Contractual Arrangements:
Follow the directions and instructions provided in the form 398 application
kit.
L. Intellectual Property:
Follow the directions and instructions provided in the Form PHS 398
application kit.
14. Appendix Materials:
Follow the directions and instructions provided in the Form PHS 398
application kit.
15. Checklist:
Follow the directions and instructions provided in the Form PHS 398
application kit
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the Center for
Scientific Review 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 applicant without further
consideration.
Applications that are complete and responsive to the RFA will be evaluated by
an 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
applications 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).
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 may 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.
General Features:
1. Have the MSI and the Cancer Center established priorities and objectives
for implementation after a careful and thorough planning process and have they
shown that they worked closely together in the preparation of these
applications?
2. Have the MSI and the Cancer Center clearly identified the mutual benefits
to be gained from this partnership?
3. Can the applicants achieve the priorities and objectives for this
partnership within the five-year grant period?
4. If fully successful, will the implementation plan result in a stable cancer
research capability for the MSI and/or result in the significant, successful
training of more minority cancer researchers?
5. If fully successful, will the ability of the Cancer Center be enhanced
through research and/or training and career development and education and/or
outreach to more directly and successfully address the disproportionate cancer
burden 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.
1. Scientific and Administrative Leadership:
a. The adequacy of the qualifications and experience of the Co-
Investigators and other key personnel from the MSI and the Cancer Center to
provide strong programmatic (e.g., scientific) and administrative leadership.
b. 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.
2. Letters of Commitment from the leadership of the MSI and the Cancer Center:
a. The degree to which the letters of commitment from the leadership of the
MSI and the Cancer Center address and fully support the priorities and
objectives of the implementation plan of the partnership.
b. 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.
c. Adequacy of the plans to remain responsible and accountable for
monitoring and sustaining the priorities and objectives of this partnership.
d. 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.
3. Administrative Core:
a. The quality of an appropriate organizational and administrative
structure for effective attainment of U54 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
logistical services, contractual agreements, (if applicable), and internal
communication among investigators.
b. The qualifications, experience and time commitment of Co-Investigators
and key personnel in the services provided by the administrative core unit.
c. The appropriateness of the use of the administrative core services by
the budgeted activities and projects/programs.
4. Planning and Evaluation Core:
a. 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.
b. 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.
c. The appropriateness and adequacy of the specific faculty and others
identified who will participate together in each aspect of the planning and
evaluation effort.
d. 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.
e. 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.
f. 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.
4. Developmental Core:
a. Pilot Projects/Programs:
1. The qualifications of the Co-Leaders from the MSI and the Cancer
Center to develop the proposed project/program.
2. The merit of the proposed Pilot Project/Program, and the degree to
which it contributes to the priorities and objectives of the partnership.
3. Potential to develop into a Full project/program in three years or
less.
The options will be either to recommend support at the budget levels
recommended by review or to recommend no support because it has either: (1)
low merit; (2) low relevance to the objectives of the partnership and/or (3)
low potential to develop into a Full project/program.
b. Full Project/Programs
1. The qualifications of the Co-Leaders to conduct the project/program
as proposed;
2. The merit of the Project/Program and the degree to which the
project/program will fulfill the priorities and objectives of the partnership.
3. 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 budget levels recommended
by review or to recommend no support because it has either: (1) low merit; (2)
low relevance to the objectives of the partnership; and/or (3) low potential
to become funded through competitive peer review.
c. Resources/Infrastructure: (if applicable)
1. The degree to which the proposed resource/infrastructure proposed
will contribute to the overall priorities and objectives of the implementation
plan.
2. 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/programs and potential future funded grants.
3. The qualifications of key personnel to operate the proposed
resource/infrastructure activity, and the merit of the resource as proposed.
The options will be either to recommend support at the budget levels
recommended by review, 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: (1) low merit; and/or (2)
low relevance to the objectives and priorities of the partnership.
d. Research Associate/Assistant: (if applicable)
1. The quality of each specific individual recruitment proposed relative
to background and ability of the individual to contribute substantially to
strengthening areas of high priority to the implementation plan.
e. Recruitment: (if applicable)
1. The quality of each specific individual recruitment proposed relative
to background and ability of the individual to contribute substantially to
strengthening areas of high priority to the implementation plan.
2. 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.
5. Evaluation of Progress by the Program Steering Committee:
a. The adequacy of the plan for using the Program Steering Committee
effectively.
6. Intellectual Property: (if applicable)
a. 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.
7. Other Considerations:
The initial review group will also examine: (a) the appropriateness of the
proposed budgets and duration; (b) 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;
(c) the adequacy of plans for including children as appropriate for the
scientific goals of the research, or justification for exclusion; (d) the
provisions for the protection of human and animal subjects; and (e) 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 the 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 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 NCMHD; and (c) availability of funds.
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 sub- populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
policy that was published in the NIH Guide for Grants and Contracts, June 5,
2000 (Revised August 25, 2000), available at the following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned 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, 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/.
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.
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