and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
PLANNING GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATION
Release Date: March 28, 2002
RFA: CA-03-009
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-02-006, which was published in the NIH Guide
on April 9, 2002.
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 planning grant applications
(i.e., P20s) to help researchers and faculty in Minority Serving Institutions
(MSIs) in collaboration with the researchers and faculty of NCI-designated
Cancer Centers (or other institutions with highly organized, integrated
research efforts focused on cancer) plan and implement focused collaborations
in cancer research, cancer research training and career development or cancer
education. The sole intent of the planning grant is to provide support for
cancer projects and programs for a limited duration of time to perform
feasibility studies and obtain preliminary data that will lead to the
submission of specific competitive grant applications traditionally supported
by the NCI and others.
Depending on prior experience, interactions and progress in planning,
applicants may apply for two-year or three-year P20 MI/CCP awards.
Applicants requesting three years of support must clearly describe a planning
stage, a priority setting stage, and an implementation stage. Applicants
requesting two years of support who have already identified areas of
potential collaboration through planning, must document prior planning
activities and clearly describe a priority-setting stage and an
implementation stage. Planning grants must be focused on one or two of the
targeted areas that work toward the following objectives:
1. Develop collaborative research project(s) with a minority investigator;
2. Develop collaborative training and career development program(s) between
MSIs and Cancer Centers designed to train minority students and scientists;
and
3. Develop collaborative education programs designed to motivate minority
students (e.g., high school, undergraduate, and/or graduate) to pursue cancer
research careers.
The final objective of the P20 must be the submission of specific competitive
research grant applications (e.g., R03s, R01s, projects on P01s, projects on
P50s); training and career development grant applications (e.g., T32s, K12s,
R25Ts); and or cancer education grant applications (e.g., R25Es) funded by
the NIH, NCI and other research funding organizations (e.g., American Cancer
Society).
The submission of a P20 application is not a requirement for either a
Cooperative Planning Grant for Comprehensive Minority Institution/Cancer
Center Partnership (U56) or a Comprehensive Minority Institution/Cancer
Center Partnership (U54) offered through the NCI..
OBJECTIVES
Background:
Minority-Serving Institutions (MSIs) [e.g., Minority Medical Schools,
Historically Black Colleges and Universities (HBCUs), Hispanic-Serving
Institutions (HSIs), Tribal Institutions (e.g., Colleges)] conduct high
quality programs for educating minorities, and they represent a rich source
of talent with appropriate cultural sensitivity and perspectives needed in
cancer research. However, MSIs have had difficulties developing and
sustaining independent programs in biomedical research, and there is a
paucity of minority scientists who are pursuing successful biomedical
research careers. Despite various initiatives by the community and the
National Institutes of Health (NIH), progress in realizing a significant
increase in the number of minority scientists who are competitive for NIH
research grants has been slow. More specifically, there remains a serious
shortage of funded minority scientists who can conduct independent cancer
research, who can focus research efforts on the disproportionate incidence,
mortality and morbidity rates in minority populations and who can bring the
cultural perspectives that are essential to the successful conduct of many
forms of research involving minority patients and populations.
The low involvement of MSIs in cancer research and lack of significant
training of minority scientists in cancer research must be addressed if we
are to develop a stronger national cancer research effort aimed at
understanding the disparities of cancer incidence and mortality in minorities
compared to majority populations. The prospect for identifying and training
minority students and faculty in areas of cancer research have not been fully
explored. One untried and potentially powerful approach for addressing these
difficult issues is to create and sustain collaborations between the
scientists and faculty of MSIs and Cancer Centers in ways that integrate and
take maximum advantage of their respective expertise and experience.
Three broad areas can be targeted for focused planning, development, and
implementation:
1. Cancer Research: Joint research projects may be in any area of basic,
clinical, prevention, control, behavioral, or population research. Joint
cancer research projects might focus, for example, on general areas of
environmental carcinogenesis, molecular epidemiology, and behavioral issues
related to cancer prevention, treatment and control. Successful planning
efforts and pilot research projects are expected to result in the submission
of competitive investigator-initiated research grant application (e.g., R03,
R01, project on a P01, project on a P50).
2. Cancer Research Training and Career Development: Cancer research training
programs are highly encouraged and must focus on joint programs organized and
conducted by the scientists and faculty of both the MSI and Cancer Center
that focus on the training of minority scientists. 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. Successful
planning activities and pilot training and career development programs should
result in the submission of multi-institutional training grants (e.g., T32,
R25T, K12).
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 focus on minority students at earlier stages of their educational
experience (e.g., high school, undergraduate) and that would motivate them to
pursue careers in cancer research. A successful planning effort in this area
is expected to result in the submission of a competitive R25E application and
later to institutional commitments to make these curricula an inherent
component of their educational systems.
MECHANISM OF SUPPORT
This RFA will use NIH planning grant (P20) award mechanism. 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 (when appropriate). The anticipated award
date is April 2, 2003.
The Principal Investigators on behalf of the institutions are responsible for
the conduct of this planning grant enabling the success of the collaboration.
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 applications for review.
FUNDS AVAILABLE
NCI anticipates making up to six (three-pair) two-year awards and six (three
pair) three-year awards, and intends to commit approximately $4.0 million for
the first year of funding. The total annual directs cost budgets for the MSI
and the Cancer Center applications together are expected to range between
$50,000 and $250,000 each year depending upon prior progress in planning and
setting priorities. The amount requested should be specific to the stage of
development; for example, planning and priority-setting stages are not as
costly as the implementation stage. Third party contractual Facilities and
Administrative costs will not be counted toward the maximum combined direct
costs of $250,000. Applications exceeding the $250,000 direct cost limit will
be considered unresponsive to this 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 the collaboration for the full term of the award. The anticipated
award date is April 1, 2003. The total project period for applications
submitted in response to this RFA may not exceed three years.
ALLOWABLE COSTS
The P20 will provide support for:
1. Administrative costs for managing the planning effort, such as salaries
for key personnel, travel for key personnel, equipment, and supplies to
support an administrative structure.
2. Developmental costs for:
a. Initial Planning Stage: for workshops, seminars, retreats, and other
forms of communication to explore potential opportunities in cancer research,
cancer training and career development or cancer education.
b. Priority-setting Stage: for selecting the areas of greatest promise for
implementation as specific types of pilot projects or programs based on merit
and potential to result in a successful grant application.
c. Implementation Stage: for implementing pilot research projects or pilot
programs in training and career development or education for the explicit
purpose of obtaining preliminary data for the submission of a specific grant
application(s).
ELIGIBLE INSTITUTIONS
Applications will only be accepted from Minority-Serving Institutions (MSIs)
[eg., 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 from other
institutions that can demonstrate organized, highly integrated research
efforts focused on cancer. Minority-Serving Institutions 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 research and
education programs (e.g., Masters, and Ph.D. programs) are invited to
participate in this initiative. MSIs that offer only baccalaureate degrees,
and Tribal Institutions (e.g., Colleges) are encouraged to participate in
this initiative as full collaborators, especially in the development of
educational programs aimed at motivating students to enter careers in cancer
research. A partial list of eligible Minority-Serving Institutions can be
found at the following website address: http://www.sciencewise.com/.
Other institutions that meet the MSI qualifications may not be listed at this
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
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.
The Principal Investigators must be U.S. citizens, non-citizen alien
nationals, or permanent residents of the United States.
SPECIAL REQUIREMENTS
There are a number of Special Requirements and Provisions that each Minority
Institution/Cancer Center Collaboration planning grant application must
comply with:
1. Planning grants must be include one or two but not three of the following
targeted areas:
a) cancer research;
b) cancer research training and career development; or
c) cancer education.
2. When the Principal Investigator from the MSI or Cancer Center is a less
experienced scientist, there must be a written "Letter of Support" from a
senior member of the MSI/Cancer Center (e.g., Department Chair, Dean, Cancer
Center Director) that: a) identifies a mentor who will be responsible for
career and professional development of the individual, and b) that is fully
supportive of this activity to ensure appropriate institutional support and
provide the maximum chance of success.
3. Each collaborative planning activity must be submitted as a clear
partnership between the MSI and Cancer Center. This must be done by
submitting two separate planning grant 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 objectives 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 their common objectives.
4. Depending upon prior experience, interactions and progress in planning,
the two applications must clearly describe a collaborative planning process
outlining:
a) Initial Planning Stage (for those applicants requesting three years of
support) in which the participants must describe appropriate means of
communicating and identifying areas of potential collaborations.
b) Priority-Setting Stage for selecting the areas of greatest promise for
implementation as specific types of pilot projects or programs based on merit
and potential to result in a successful grant application, and
c) Implementation Stage of pilot project/programs in which preliminary
data is acquired for the purpose of submitting a specific competitive grant
application in one or two of the target areas mentioned above to the NCI or
other funding agencies.
5. The direct costs of the two applications together cannot exceed $250,000
per year. The amount requested should be appropriate to the stage of
development because the planning and priority-setting stages are not as
costly as the implementation stage, budget requests would be expected to
escalate progressively from year 1 to year 2 and 3 or year 2. If there are
third party subcontract costs, only the direct costs of the subcontract will
count against this cap.
6. The use of funds to support pilot projects and pilot programs must be for
totally new activities that do not overlap in purpose or intent with existing
funded grants (e.g., P30, P50, P01, R01, National Center for Research
Resources' Research Infrastructure Grants, National Institute of General
Medical Sciences' Minority Biomedical Research Support Grants, other peer-
reviewed funded program).
7. All recipients of P20 MI/CCP awards will be expected to participate in an
annual MI/CCP workshop sponsored by the Comprehensive Minority Biomedical
Branch (CMBB) of the NCI. Travel expenses for this purpose must be included
in the grant applications from the MSI and the Cancer Center institution.
8. If the 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 authority must be included.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and are we 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:
Direct inquiries regarding scientific 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 20895 (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
National Cancer Institute
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD 20895 (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 7001
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 peer 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
Direct inquiries regarding financial or grants management matters to:
Ms. Barbara Fisher
Grants Management Specialist
National Cancer Institute
Grants Administration Branch
1003 West 7th Street
Suite 300
Frederick, Maryland 21701
Email: fisherb@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 P20 collaboration
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 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 20895 (Express courier)
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) scheduled for June 3-4, 2002
Since this is an entirely new concept for the NCI and for the applicant
population, it will give staff the opportunity to clarify any perceived
ambiguities in the RFA and to help applicants to present their strongest case
for developing an application. If one is unable to attend the TAW, the
results of the workshop can be accessed at the Website:
http://minorityopportunities.nci.nih.gov.
In addition, NCI strongly encourages pre-application consultations with
individual collaborators either as telephone conference calls,
videoconferences or face-to-face meetings. In order to make these
arrangements contact Dr. Sanya A. Springfield by email at
springfs@mail.nih.gov or by telephone at (301) 496-7344 or Dr. Brian Kimes by
email at kimesb@mail.nih.gov or by telephone at (301) 496-8537.
SUBMITTING THE APPLICATION
The following procedures apply to both the MSI application and the Cancer
Center application, which are to be submitted as a collaborative effort:
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 one provide a title that is representative of your collaboration or
partnership. This title should be the same for both the MSI application and
the Cancer Center institution's application. For line 2 enter the title "P20
MI/CCP" and the number beginning with RFA-CA-03-009.
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 of the P20. The list all Key Personnel for the
Administrative Core and all Pilot projects/program in this application in
alphabetical. Follow the instructions provided in the Form PHS 398.
3. Table of Contents: The Table of Contents and Research Plan of the PHS 398
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
Total Initial Budget for all stages
Planning Stage (if applicable)
Priority-Setting Stage
Implementation Stage
Budget for Entire Proposed Period of Support
Total Entire Budget for all stages
Planning Stage (if applicable)
Priority-Setting Stage
Implementation Stage
Budgets Pertaining to Consortium/Contractual Arrangements
List of participating members of the MSI or the Cancer Center
Biographical Sketch and Other Support of:
a. Principal Investigator (not to exceed four pages)
b. Co-Investigator (not to exceed four pages)
c. All Key Personnel in alphabetical order of the MSI or Cancer Center
Resources
Collaborative Plan:
Special Introduction to revised application, if applicable (not to exceed
three pages)
a. Background
b. Letter of Support from the MSI/Cancer Center
c. Chronological Estimate of each Stage
d. Initial Planning Stage (as appropriate depending on prior experience)
e. Priority-Setting Stage
f. Implementation Stage (as appropriate depending on prior experience)
g. Human Subjects
h. Vertebrate Animals
i. Literature Cited
j. Consortium/Contractual Arrangements
Appendix
Checklist
Personal Data
4. Detailed Budget for Initial Budget Period as appropriate to the stage of
development: Use Form Page 4 of the Form PHS 398 application kit. It is
expected that requested costs in the first year will be less than costs in
the second or third years because planning and priority-setting are not as
expensive as the implementation of a project or a program. Separately break
out the budget into three sections using different Form Page 4s as follows:
a) Total Initial Budget for all Stages
b) Planning Stage (if applicable)
c) Priority-Setting Stage
d) Implementation Stage.
5. Budget for Entire Proposed Period of Support: Using Form Page 5 of the
Form PHS 398, follow the instructions in the Form PHS 398 application kit.
Provide specific justifications for costs for each year requested appropriate
to the stage of development (e.g., total entire budget for all stages,
planning, priority-setting and implementation). Costs for each year would
include administrative costs and developmental costs as needed within the
$250,000 direct cost cap. A three percent cost of living escalation may be
included in future years
6. Budgets Pertaining to Consortium/Contractual Arrangements: Use this
category if more than one MSI or Cancer Center is being linked in a
collaboration. In this case, one of the MSI/Cancer Center institutions would
have to serve as the primary grantee and subcontract for the consortial
involvement of the other MSI/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, or education).
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. Key Professional 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, should be provided in the appropriate sections of this
application.
9. Resources: Using Resources Format Page, follow the instructions in the
Form PHS 398 application kit.
10. Collaborative 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 Introductory Statement for Revised Application (if applicable):
This section should be the same for both application the MSI and Cancer
Center and should be 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
summary statement. Include a chronological description of activities the
occurred 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:
This section should be the same for both the MSI and the Cancer Center P20
applications and must be limited to two to three pages. It should describe
the characteristics of the MSI and the Cancer Center that will contribute to
the planning effort. It should clearly denote the nature of the interactions
and deliberations that occurred and the individuals involved between the MSI
and the Cancer Center during the preparation of these applications.
When Cancer Centers are NOT NCI-designated Cancer Centers, there should be a
clear summary of the qualities of the institution that demonstrate that it
has a highly organized and integrated cancer research program comparable to
an NCI-designated Cancer Center.
B. Letter of Support:
This section should be different for each application. Two to three pages
are recommended. This letter of support would be required under the
following situations:
1) If the Principal Investigators of the MSI or Cancer Center are less
experienced individuals, this letter of support should be from a senior
member of the MSI or Cancer Center (e.g., Department Chair, Dean, Cancer
Center Director), respectively and should include a statement describing how
Principal Investigator will be provided with appropriate mentoring and the
necessary support to ensure the success of this collaborative planning
effort. This support could be in the form of protected time for junior
faculty to participate in and focus on the objectives of this grant and
discretionary resources that will be made available to the Principal and Co-
Principal Investigators.
2) If the nature of the potential application will require significant
institutional commitments to ensure its success, such a training program or
an education program must have the commitment both from institutional leaders
of the MSI (e.g., Dean, President) and the Cancer Center (e.g., Cancer Center
Director).
C. Chronological Estimates of Planning, Priority-Setting and Implementation
Stages:
This section should be the same for the MSI and the Cancer Center application
and must be limited to five pages. Each application should include a
chronological table listing the specific first year, second year, and third
year (as applicable) objectives that are expected to be achieved. Clearly,
applicants who have had minimal interactions and progress in planning should
apply for three years of support incorporating all three stages while those
who have had significant opportunity to plan should apply for two years of
support. For each objective, a brief statement should be made about the
separate contributions of the MSI and the Cancer Center in order to achieve
success. The final objective of the P20 must be the submission of a specific
grant application (R03, R01, T32, K12, R25T, R25E project on Program Project
Research Grant (P01) or Spore Grant (P50) to the NCI or other funding
agencies.
D. Initial Planning Stage:
This section should be the same for each application and limited to fives
pages.
For three-year applicants, clearly describe the kinds of planning activities
that the MSI and the Cancer Center will conduct to ensure a highly
interactive and integrated effort between their faculty and scientists.
Relate each planning activity (e.g., workshop, retreat, executive meeting) to
specific objectives above and name the specific faculty and interests (e.g.,
training, clinical oncology researchers, research in prostate cancer,
establishing new curriculum in nutrition, etc.) who will participate in each
activity.
For two-year applicants, this section should document the prior experience,
interaction and progress in planning.
E. Priority–Setting Stage:
Clearly describe how the specific projects/programs will be prioritized and
selected for implementation based on their merit and greatest potential for
success.
F. Implementation Stage:
Three-year applicants should use the general outline below including as much
information as possible about the following:
Proposed project/program area
Names of Co-leaders from the MSI and the Cancer Center
One paragraph abstract
One paragraph describing how this pilot project will relate to the overall
objectives of the collaboration as described in the Background section above.
Description of what aspects of the project/program will be conducted at the
MSI/Cancer Center
Two-year applicants should clearly describe the specific pilot
projects/programs to be supported. Pilots must have co-leadership by
individuals from the MSI and the Cancer Center. Each pilot project/program
should include the following specific information:
Title
Names of the Co-Leaders from the MSI and the Cancer Center
One paragraph abstract
Specific Aims
One paragraph describing how this pilot project will relate to the overall
objectives of the collaboration as described in the Background section
above.
Detailed budget page for initial budget period using page DD from form PHS
398.
Pilot Research Proposal (up to five pages) that should include experimental
methods and design and any preliminary data with a brief description of
results and stating the role of the MSI and Cancer Center investigators in
the collection of data.
Description of what aspects of the project/program will be conducted at the
MSI and/or the Cancer Center
Human Subjects**
Vertebrate Animals
Literature Cited
**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 P20
MI/CCP, informed consent forms, early stopping rules and procedures to detect
and monitor adverse drug reactions (ADR) must be provided in the application,
or in the case of protocols subsequent to funding of a P20 MI/CCP, to the NCI
program director.
G. Human Subjects:
Follow the directions and instructions provided in the Form PHS 398
application kit.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01)
application form must be affixed to the bottom of the face page of the
application. 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. 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 collaborator; this will allow the NCI to assemble the two
applications as one package for peer review. Submit signed, typewritten
originals of the cover letters, the 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 cover letter and
application must be sent to:
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 that date, it will be returned to the applicant without
review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the Center
for Scientific Review (CSR) and responsiveness to ELIGIBILITY REQUIREMENTS
and responsiveness to the SPECIAL REQUIREMENTS AND PROVISIONS OF PLANNING
GRANT FOR MINORITY INSTITUTION/CANCER CENTER COLLABORATIONS 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 group 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 collaboration.
REVIEW CRITERIA
This initiative is quite broad in scope and equally emphasizes cancer
research, cancer training and career development and cancer education
objectives. 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 expand research, training and
career development opportunities for minority scientists and students.
Applicants can either apply for two or three years of support depending on
their previous experience, interactions and planning history, consequently
reviewers must evaluate the following:
1. Strength of the evidence that the researchers and faculty of the MSI and
the Cancer Center worked closely together in the preparation of the
application.
2. As applicable, the degree to which the letters of support from senior
faculty and/or institutional/center leaders address the need for mentoring of
inexperienced Principal Investigators or for specific institutional/center
commitments to ensure the success of the collaboration.
3. As applicable, the adequacy of provisions made for day-to-day oversight,
coordination, support and logistical services needed to make the
collaboration successful.
4. Initial Planning Stage:
For three-year applicants:
a. The adequacy of the different planning methods proposed by the MSI and
Cancer Center to fully explore areas of opportunity and to ensure highly
interactive and integrated efforts between individual scientists (e.g.,
research project) and/or between faculty and scientists (e.g., training
program, education program).
b. The adequacy and duration of the initial planning stage needed to
identify areas of potential collaboration.
For two-year applicants:
a. The quality and merit of the documented planning process used for
identifying areas ready for prioritization and/or for pilot testing.
b. The appropriateness and adequacy of the specific faculty and scientists
identified from the MSI and the Cancer Center to contribute effectively to
each aspect of this planning effort.
5. Priority-Setting Stage:
a. The adequacy of the experience and qualifications of the individuals
who will take part in prioritizing and selecting specific pilot
projects/programs for implementation.
b. The adequacy of the process used for selecting pilot projects/programs
for implementation based on their merit and their potential for successful
acquisition of preliminary data during the period of requested grant support.
6. Pilot Projects/Programs
For three-year applicants:
a. The potential of the Co-Investigators and the collaborative plan to
prioritize and implement specific pilot projects/programs.
b. The likelihood that potential pilot projects/programs will emerge from
this collaboration that will be successful as specific grant applications.
For two-year applicants:
a. The qualifications of the Co-leaders to implement the pilot
project/program.
b. The merit of the project/program and its feasibility to acquire the
necessary preliminary data to become competitive for specific grant support
(e.g., R03, R01, P01, P50, K12, T32, R25).
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 collaboration, as reflected by one
priority score will be assigned to the MSI and the Cancer Center
applications.
For three-year applications, the score will be based primarily on the
potential to develop projects/programs that will compete successfully for
specific grant support.
For two-year applications, the score should be based on the merit of the
specific programs proposed and their likelihood to compete successfully for
grant support with appropriate preliminary data.
RECEIPT AND REVIEW SCHEDULE
Pre-application TAW Meeting 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 each year.
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.
Each set of two applications from an MSI and a Cancer Center will compete for
funds with all other collaborations 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.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety monitoring plans for
clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the 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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