and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP
Release Date: March 28, 2002
RFA: CA-03-010
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
Letter of Intent Receipt Date: July 17, 2002
Application Receipt Date: August 14, 2002
This RFA is a reissue of RFA-CA-02-005, which was published in the NIH Guide
on April 9, 2001.
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE
The National Cancer Institute (NCI) invites 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 has
created a potentially powerful approach that can help MSIs and Cancer Centers
integrate and take maximum advantage of their expertise and experience to work
together in areas that are mutually beneficial.
This new initiative, the Minority Institution/Cancer Center Partnership
(MI/CCP) program, offers two cooperative agreement assistance mechanisms, a
U56 and a U54. The Cooperative Planning Grant for Comprehensive Minority
Institution/Cancer Center Partnership (U56) is to be used by those
institutions that are in the initial stages of planning for a comprehensive
partnership. The Comprehensive Minority Institution/Cancer Center Partnership
(U54) is to be used by those institutions who have had considerable prior
planning and evaluation and are ready to begin implementing a more broadly
focused partnership having inter-institutional cancer research projects and/or
cancer training and career development, education or outreach programs.
The sole purpose of the MI/CCP program is to provide support for various
collaborative activities that will lead to the submission of specific
competitive grant applications traditionally supported by the NCI and other
funding organizations.
This initiative for a U54 Comprehensive Minority Institution/Cancer Center
Partnership must be based on previous extensive planning and priority setting
activities and must achieve goals that are of clear mutual benefit. Partners
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/atlasplus/. 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.
Objectives and Scope
The U54 MI/CCP grant 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 are highly encouraged and 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 the
submission of competitive NCI education grant application (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.
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. As
an applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project will
compete with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated award date
is April 1, 2003.
The NIH U54 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award"
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 MI/CCP will provide support for:
1. Administrative costs (not to exceed 20% of the total direct costs per year
per partnership) for managing the partnership, such as salaries for key
personnel; equipment and supplies to support an administrative structure.
2. Planning and Evaluation should be constantly ongoing and the basis for
initiating and terminating the investment of resources into developmental
projects, programs, resources and recruitments below. This 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 cancer training and career
development, cancer education and/or cancer outreach programs(not to exceed
$100,000 in direct costs per year per project/program of the partnership for
no more than three years). These activities cannot be self-contained and must
have the potential to become long-term efforts (i.e. full projects as in
section b below or competitive grant applications)
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 of the partnership 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. Start-up packages for newly recruited investigators in areas prioritized
for development and stabilization.
FUNDS AVAILABLE
NCI anticipates making two (one pair) 5-year awards and intends to commit
approximately $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, 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 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, 2003.
ELIGIBLE INSTITUTIONS
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/.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
The Principal Investigators must be U.S. citizens, non-citizen alien
nationals, or permanent residents of the United States.
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to develop
an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH programs.
SPECIAL REQUIREMENTS
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 represent 50 percent of the proposed
activities.
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 not only complement each other, but 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 an 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
of the partnership or continue for more than three years. No full
project/program can exceed $250,000 in direct costs per year of the
partnership 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.
12. All recipients of U54 MI/CCP awards will be expected to participate in an
annual MI/CCP Workshop for the purpose of sharing information and strategies
sponsored by the Comprehensive Minority Biomedical Branch of the NCI. Travel
expenses for this purpose must be included in the applications from the MSI
and the Cancer Center.
13. If an application includes participation of Native American (American
Indian) or similar populations, a formal letter of support for the study from
the Tribal Nation Leader or equivalent must be included.
COOPERATIVE AGREEMENT 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 MI/CCP Workshop for the purpose of sharing information and strategies
to be organized by NCI. 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. The NCI Program
Coordinator will also:
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, 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/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 are
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.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD 20852 (express courier)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: springfs@mail.nih.gov
Nelson Aguila, D.V.M.
Program Director, CMBB, OCTR, ODDES, NCI
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD 20852 (express courier)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: aguilah@mail.nih.gov
Or
Brian Kimes, Ph.D.
Director, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7000
Bethesda, MD 20892-8347
Rockville, MD 20852 (express courier)
Telephone: (301) 496-8537
Fax: (301) 402-0181
Email: kimesb@mail.nih.gov
Direct inquiries regarding financial or grants management matters to:
Ms. Barbara Fisher
Grants Administration Branch
1003 West 7th Street
Suite 300
Frederick, Maryland 21701
Telephone: (301) 846-1015
Fax: (301) 496-8601
Email: fisherb@mail.nih.gov
Direct inquiries regarding review matters to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncidearefof@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed U54 partnership
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NCI staff to estimate the potential peer review workload and
plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD 20852
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: springfs@mail.nih.gov
PREAPPLICATION TECHNICAL ASSISTANCE WORKSHOP
The NCI strongly encourages all potential applicants to attend a pre-
application Technical Assistance Workshop (TAW) on June 4-5, 2002. 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://minorityopportunities.nci.nih.gov.
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.
SUBMITTING THE APPLICATION
The following procedures apply to both the MSI and the Cancer Center
applications:
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/01). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS
1. Face Page: Use Form Page 1 as instructed in the Form PHS 398 (rev. 5/01).
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-03-010. 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 Form Page 2 of the
Form PHS 398 and list the Principal Investigator first and next the Co-
Principal Investigator for the partnership application. Then list all Key
Personnel for the Administrative Core, Planning and Evaluation Core and
Developmental Core (all pilot/full projects/programs) and Resources inthis
application alphabetically. Follow the instructions provided in the Form PHS
398.
3. Table of Contents: NOTE: The Table of Contents and Research Plan of the
PHS 398 (rev. 5/01) application are not specifically tailored to the unique
objectives of the MI/CCP application. Therefore organize the Table of
Contents exactly as described below:
Face Page
Description, Performance Sites and Key Personnel
Table of Contents
Detailed Budget for Initial Budget Period:
a. Total Initial Budget for all Cores
b. Administrative Core
c. Planning and Evaluation Core
d. Developmental Core
Budget for Entire Proposed Period of Support:
a. Total Entire Budget for all Cores
b. Administrative Core
c. Planning and Evaluation Core
d. Developmental Core
Budgets Pertaining to Consortium/Contractual Arrangements
List of all participating members
Biographical Sketch(s) and Other Support:
a. Principal Investigator
b. Co-Investigator
c. All Key Personnel in alphabetical order
d. Program Steering Committee Members
Resources
Implementation Plan: (replaces Research Plan in PHS 398 application
instructions)
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
d. Scientific and Administrative Leadership
e. Administrative Core
f. Planning and Evaluation Core:
1. Internal Processes
2. External Processes
g. Development Core:
1. Pilot projects/programs
2. Full projects/programs
3. Resources and infrastructure
4. Recruitment(s)
h. Human Subjects
i. Vertebrate Animals
j. Literature Cited
k. Consortium/Contractual Arrangements
l. Intellectual Property
Appendix
Checklist
Personal Data
4. Detailed Budget for Initial Budget Period: Use Form Page 4 of the Form PHS
398 application kit. Separately break out the budget into three sections
using different Form Page 4s as follows:
a. Total Initial Budget for all Cores
b. Administrative Core: Denote the costs for personnel, supplies, travel
etc. needed to provide administrative oversight, coordination and cohesion of
the partnership.
c. 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.
d. 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 Page 5 of the Form
PHS 398, break out the total budgets separately for (provide justifications
for costs in future years only when there are specific items requested in
future years that exceed standard cost-of-living increases):
a. Total Entire Budget for all Core
b. Administration Core
c. Planning and Evaluation Core
d. Developmental Core Funds
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. List all participating faculty/members of the MSI or the Cancer Center
alphabetically by last name. Include for each their degree, department
affiliation or equivalent, and research or other interest (e.g., research
area, training, education, or outreach).
8. Biographical Sketches and Other Support: Use Biographical Sketch Format
Page and follow the instructions in the Form PHS 398 application kit for:
a. Principal Investigator
b. Co-Principal Investigator
c. All Key Personnel of the MSI or Cancer Center: 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.
d. Program Steering Committee Members
9. Resources: Using Resources Format Page, follow the instructions in the Form
PHS 398 application kit.
10. Implementation Plan
The Research Plan of the PHS 398 (rev. 5/01) application is not specifically
tailored to the unique objectives of the MI/CCP application. Therefore,
applicants should follow the outline below:
Special Introduction for Revised Applications (if applicable):
This section should be the same for both the MSI and Cancer Center
applications and limited to three pages. Include a summary of the additions,
deletions, and changes in the revised application, placing particular emphasis
on responses to the criticisms and issues raised in the previous summary
statement. Include a chronological description of activities conducted since
the original submission (meetings, research activities, etc.). 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 and limited to two to three pages. 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:
This section should be different for the MSI and Cancer Center application and
limited to two to three pages. The MSI institutional leadership (e.g., Dean,
President) and the Cancer Center leadership (e.g., Center Director, Dean),
respectively, 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 limited to five pages. It 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:
This section should be different for each application and limited to two to
three pages. Briefly describe how the Principal Investigator was chosen in
terms of the 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:
This section should be different for each application and limited to ten
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 and limited to five pages.
1. Internal Processes: Document each internal planning and evaluation activity
(e.g., regular forums and seminars, workshops, retreats etc.) in which the
objectives (or issues to be addressed) are identified, activities described,
and participating individuals from the MSI and the Cancer Center named.
(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
This section should be different for each application.
1. Pilot Projects/Programs:
Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 per
project/program in direct costs per year of the partnership or continue for
longer than three years, should be provided in the following format:
Title
Names of the Co-Leaders from the MSI and the Cancer Center
One paragraph abstract stating the objectives of the project/program
Specific Aims
One paragraph describing how this pilot project/program relates to the overall
priorities
Detailed budget page for initial budget period using Form Page 4 of the Form
PHS 398.
Budget for entire proposed period of support using Form Page 5 from the Form
PHS 398
Proposal (up to five pages), include experimental methods and design, and any
preliminary data and the role played by the MSI and Cancer Center
investigators in the collection of data.
Describe which aspects of the pilot project/program will be conducted at the
MSI/Cancer Center
Human Subjects**
Vertebrate Animals
Literature Cited
Consortium/Contractual
Consultants
**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 17 - 27 the Form PHS 398
instructions; (2) Research dealing with Human Subjects and Vertebrate Animals
must be accompanied by appropriate documentation as described on page 27 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 of the partnership or continue for
longer than three years, should be prepared in the following format:
Title
Names of the Co-Leaders from the MSI and the Cancer Center
One paragraph abstract describing the purpose and objective of the
project/program
Specific Aims
One paragraph describing how the project/program relates to the overall
priorities
Detailed budget for initial budget period using Form Page 4 from the Form PHS
398.
Budget for entire proposed period of support using Form Page 5 from the Form
PHS 398)
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.
Describe which aspects of the full project/program will be conducted at the
MSI/Cancer Center
Human Subjects**
Vertebrate Animals
Literature Cited
Consortium/Contractual
Consultants
**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 17 � 27 of the Form PHS 398
instructions; (2) Research dealing with Human Subjects and Vertebrate Animals
must be accompanied by appropriate documentation as described on page 27 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:
Title
Co-Leaders from the MSI and Cancer Center who lead the activity
The experience of key technical personnel, if applicable, who will be
responsible for the day-to-day operation.
Detailed budget for the initial budget period using Form Page 4 from the Form
PHS 398
Budget for entire proposed period of support using Form Page 5 from the Form
PHS 398
Biographical Sketches of Co-Leaders
Description of the resource/infrastructure and how it will further the
priorities
Commitment of space for the resource(s).
Justification for the location of the resource(s) at the MSI, the Cancer
Center or both.
4. Recruitment to be supported with Developmental Funds:
Individuals who are known:
Provide the biographical sketch of the individual.
Describe how the individual fulfills the priorities and objectives of the
partnership as described in the Background and Objectives section above.
Identify a mentor and describe a career development plan if the individual is
a less experienced investigator.
Describe the nature of the position that provides the necessary stability
(e.g., tenure track) and resources (e.g., space) to promote success.
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.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: 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:
NCI Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8041
MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE
WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries
(i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-
files/NOT-CA-02-002.html). This change in practice is effective immediately.
This policy is similar to and consistent with the policy for applications
addressed to Centers for Scientific Review as published in the NIH Guide
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after the date, it will be
returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the 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 for
scientific and technical merit 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:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Those that receive a priority score will undergo a second level review by
the National Cancer Advisory Board.
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.
INDIVIDUAL SUBCOMPONENTS:
(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. 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 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.
(5) DEVELOPMENTAL CORE:
a. Evaluation Criteria for 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 score and recommend support at the recommended
budget levels or to Not Recommend for Further Consideration (NRFC) because it
has either: (1) low merit; (2) low relevance to the objectives of the
partnership; (3) low potential to develop into a Full project/program within
three years; and/or (4) low potential to become funded through competitive
peer review.
b. Evaluation Criteria for Full Research Projects
1. Significance: Does this study address an important problem consonant
with thte objectives of the MI/CCP program? If the aims of the application are
achieved, how will scientific knowledge be advanced? What will be the effect
of these studies on the concepts or methods that drive this field of cancer
research and/or research on cancer disparities?
2. Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
3. Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
4. Co-Leader: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
5. Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional support?
The options will be either to score and recommend support at the recommended
budget levels or to Not Recommend for Further Consideration (NRFC) 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. Evaluation Criteria for Full Programs (i.e., training and career
development, education, and/or outreach)
1. The qualifications of the Co-Leaders from the MSI and the Cancer
Center to develop the proposed program.
2. The merit of the proposed Full Program, and the degree to which it
contributes to the priorities and objectives of the partnership.
3. Potential to develop into a competitive rogram in three years or less.
The options will be either to score and recommend support at the recommended
budget levels or to Not Recommend for Further Consideration (NRFC) because it
has either: (1) low merit; (2) low relevance to the objectives of the
partnership; (3) low potential to become funded through competitive peer
review.
d. Evaluation Criteria for 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.
e. Evaluation Criteria for 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.
(6) EVALUATION OF PROGRESS BY THE PROGRAM STEERING COMMITTEE:
a. The adequacy of the plan for using the Program Steering Committee
effectively.
(7) 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.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data. (include if
appropriate)
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
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 quality of the seven individual sub-components, additional and other
review criteria as proposed in the MSI and Cancer Center U54 applications.
2. The extent to which the MSI and the Cancer Center applications together
satisfy the following General Features (i.e., overall intent of this
initiative):
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?
RECEIPT AND REVIEW SCHEDULE
Preapplication Technical Assistance Workshop Date: June 4-5, 2002
Letter of Intent Receipt Date: July 17, 2002
Application Receipt Date: August 14, 2002
Peer Review: November/December, 2002
Review by NCAB: February, 2003
Earliest Anticipated Award Date: April 1, 2003
NON-COMPETING CONTINUATION APPLICATION
For those applications that are funded, the NCI will provide special
instructions for submitting the Non-Competing Application.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
The set of two applications from an MSI and a Cancer Center will compete for
funds with all other partnerships in response to this RFA.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NCI require special considerations.
The method and degree of monitoring should be commensurate with the degree of
risk involved in participation and the size and complexity of the clinical
trial. Monitoring exists on a continuum from monitoring by the principal
investigator/project manager or NCI program staff or a Data and Safety
Monitoring Board (DSMB). These monitoring activities are distinct from the
requirement for study review and approval by an Institutional Review Board
(IRB). For details about the Policy for the NCI for Data and Safety
Monitoring of Clinical trials see:
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II
clinical trials, investigators must submit a general description of the data
and safety monitoring plan as part of the research application. See NIH Guide
Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II
Trials" for additional information: http://grants/guide/notice-
files/NOT-OD-00-038.html. Information concerning essential elements of data
safety monitoring plans for clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/
INCLUSION OF WOMEN AND MINORITIES IN 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 clinical research projects
unless a clear and compelling justification is provided indicating that
inclusion is inappropriate with respect to the health of the subjects or the
purpose of the research. This policy results from the NIH Revitalization Act
of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research in now available online at: http://cme.nci.nih.gov/
HUMAN EMBRYONIC STEM CELLS (HESC): Criteria for federal funding of research
on HESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using HESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the HESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This RFA
is related to one or more of the priority areas. 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, and is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. 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
described at: http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
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