and Human Services (HHS)
EXPIRED
SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY
Release Date: November 28, 2000 (see replacement PAR-03-010)
PA NUMBER: PA-01-021
National Cancer Institute
Application Receipt Date: April 20, 2001, August 20, 2001, December 20, 2001,
April 22, 2002, August 20, 2002, December 20, 2002
THIS PROGRAM ANNOUNCEMENT (PA) USES THE MODULAR GRANT AND JUST-IN-TIME
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS
PA.
This Program Announcement (PA) replaces PAR-98-023 which was published in the
NIH Guide, Volume 27, Number 7 March 6, 1998.
PURPOSE
The Division of Cancer Control and Population Sciences of the National Cancer
Institute (NCI) invites Small Grant (R03) applications relating to cancer
epidemiology with a primary focus on etiologic cancer research. These are
short-term awards intended to provide support for pilot projects, testing of
new techniques, or development of innovative or high-risk projects that could
provide a basis for more extended research.
This PA will expire December 21, 2002, unless reissued. NIH Grants policies
apply to these awards.
RESEARCH OBJECTIVES
Investigators may apply for a small grant to support research on a topic
relevant to cancer etiology, which may lead to cancer control/prevention.
Investigations may include:
o Planning a complex epidemiologic investigation,
o Developing or validating a laboratory or statistical procedure that has
the potential for improving the quality of cancer epidemiologic research;
o Obtaining support to study a question relevant to cancer epidemiology in
special situations, such as the availability of special personnel for limited
time periods, rapidly evolving research or limited access to an important
resource;
o Analyzing previously collected data for epidemiologic purposes, such as
combining data from several studies to examine consistency or strength of
observed associations;
o Resolving methodologic problems, such as documenting the accuracy of a
customary procedure in preparation for use in epidemiologic research,
evaluating the effect of cancer diagnosis and/or treatment on risk factor
estimates derived from case-control studies; or
o Obtaining funding for investigations of urgent or emergent issues in
cancer epidemiology. Applications for support of dissertation research may
receive a small grant.
Applications for support of purposes other than those stated will be returned
to the proposed Principal Investigator without undergoing committee review.
Summary
This initiative permits a wide range of epidemiologic investigations to
enhance knowledge about the etiology of various cancers and means for their
prevention. It is intended to encourage:
o Less experienced investigators;
o Investigators at institutions without well-developed research traditions
and resources; or
o Experienced investigators for exploratory studies which represent a
significant change in their research direction
MECHANISM OF SUPPORT
Support of this PA will be through the small grants (R03) award mechanism.
The total budget may not exceed $100,000 in direct costs for the entire
project. The direct costs in any one year must not exceed $50,000. The total
project period for applications submitted in response to this announcement may
not exceed three years. The NIH has adopted a policy that limits the number
of amendments to two. The small grant is not renewable.
Specific application instructions have been modified to reflect MODULAR
GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and not-for-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, eligible
agencies of Federal government, and small businesses. Racial/ethnic minority
individuals, women and persons with disabilities are encouraged to apply as
principal investigators.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Dr. A. R. Patel
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., Room 239C, MSC 7395
Bethesda, MD 20892-7395
Telephone: (301) 496-9600
Fax: (301) 402-4279
Email: [email protected]
Direct inquiries regarding review issues to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities,
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Ms. Sara Stone
Grants Management Branch
National Cancer Institute
6120 Executive Blvd., Suite 243, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-9927
Fax: (301) 496-8601
Email: [email protected]
APPLICATION PROCEDURES
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.
Applications kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:
[email protected]. The title and Number of the PA must be typed on line 2 of
the face page of the application form and the YES box must be marked. For
those applicants with Internet access, the 398 kit may be found at:
http://grants.nih.gov/grants/forms.htm.
Applicants are strongly encouraged to call the program contacts listed in
INQUIRIES with any questions regarding adherence to the guidelines of their
proposed project to the goals of this PA.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $50,000 per year. The total direct costs must
be requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and
Administrative (F & A) costs] for the initial budget period. Items 8a and 8b
should be completed indicating the Direct and Total Costs for the entire
proposed period of support,
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page
(See http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages). At the top of the page, enter the total direct costs requested for
each year. This is not a form page.
o Under Personnel, list all project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of all personnel,
and the role on the project. Indicate whether the collaborating institution
is domestic or foreign. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual’s qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research tam. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.
o CHECKLIST - This page should be completed and submitted with the
application. If the F & A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied in
the calculation of the F & A costs for the initial budget period and all
future budget years.
The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further review.
Submit a signed, typewritten original of the application, including the
checklist, and three signed, exact, single-sided photocopies, in one package
to:
Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040-MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for Express/courier service)
Applications must be received by the receipt dates listed at the beginning of
this PA. 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 PA 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.
REVIEW CONSIDERATIONS
Applications will be reviewed for completeness by the Center for Scientific
Review and adherence to the guidelines to this PA by the National Cancer
Institute. Incomplete applications will be returned to the applicant without
further consideration.
Applications that are complete and adhere to the guidelines of this PA will be
evaluated for scientific and technical merit by an appropriate scientific
review group convened by the Division of Extramural Activities, NCI, in
accordance with the standard NIH peer review procedures. As part of the
initial merit review, all applications will receive a written critique, and
may undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under review,
will be discussed, assigned a priority score, and receive a second level
review by the National Cancer Advisory Board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score, weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.
1. Significance: Does this study address an important problem? 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?
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 method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
4. Investigator: 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 initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of the policy from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the internet
sites. Reviewers are cautioned that their anonymity may be compromised when
they directly access an Internet site
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of Healthy People 2010, a PHS-led national
activity for setting priority areas. This PA, Small Grants for Cancer
Epidemiology, is related to the priority area of cancer and chronic diseases.
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.
93.393, Cancer Cause and Prevention Research. Awards are made under the
authorization of the Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and administered under NIH grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency Review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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