BASIC BIOBEHAVIORAL RESEARCH ON CANCER-RELATED BEHAVIORS

Release Date:  April 30, 1998

RFA:  CA-98-015

P.T.

National Cancer Institute

Letter of Intent Receipt Date:  July 14, 1998
Application Receipt Date:  August 11, 1998

PURPOSE

The Division of Cancer Control and Populations Sciences (DCCPS) of the National
Cancer Institute (NCI) invites research grant applications on the bio-behavioral
basis of cancer-related behaviors, especially those that increase cancer risk.

The exploratory/developmental (R21) grant mechanism is used for pilot projects
or feasibility studies to support creative, novel, high risk/high payoff research
that may produce innovative advances in science.  Historically, mechanisms
designed to stimulate and fund basic bio-behavioral research have not existed as
they have for basic biomedical research.  Thus, it has been difficult for
scientists to obtain funding for these activities through the traditional
investigator-initiated research project grant (R01) mechanism.

Because this Request for Applications (RFA) is designed to support innovative
ideas, preliminary data as evidence of feasibility are NOT required.  However,
the proposed work must be novel, hypothesis driven, and utilize pre-intervention
research designs in HUMAN populations.  Pre-intervention designs include basic
laboratory research and epidemiologic approaches which provide a scientific basis
for interventional studies. Although this mechanism is not designed to solicit
phase III intervention research (i.e., clinical trials), the potential
significance of the proposed research for future interventions will be a major
consideration in the evaluation.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA, Basic Biobehavioral Research on
Cancer-Related Behaviors, is related to the priority area of cancer.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:  Stock
No.017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents,Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.  New
investigators also are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) exploratory/
developmental (R21) grant mechanism.  Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the applicant.  The
total project period for an application submitted in response to this RFA may not
exceed two years.  These grants are non-renewable and continuation of projects
developed under this RFA will be through the traditional unsolicited investigator
initiated grant program.  The anticipated award date is April 1, 1999.

Though the size of award may vary with the scope of research proposed, it is
expected that applications will stay within the budgetary guidelines for an
exploratory/developmental project.

This RFA is one-time solicitation.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of support for
this program is $2.0 million.  Budgets are expected to average direct costs of
about $100,000 per year and should not exceed $200,000 total (direct and
indirect) costs.  Applications exceeding the suggested budget must be
appropriately justified.  It is anticipated that 10 to 12 new awards will be
supported through this RFA.

RESEARCH OBJECTIVES

Background

To date, much of cancer control research has emphasized the evaluation of health
behavior interventions and the application of such interventions in the
community. Indeed, cancer control was defined as the reduction in cancer
incidence, morbidity, and mortality through an orderly sequence from research on
interventions and their impact in defined populations to the broad systemic
application of the research results.  While such research has contributed to
reductions in cancer morbidity and mortality, the results of many large scale
cancer control intervention trials have been modest.

The limitations of traditional intervention-oriented cancer control research have
been recognized by two NCI working groups, the Working Group on Behavioral
Research in Cancer Control and the Cancer Control Working Group.  Both of these
reports highlighted gaps in fundamental knowledge about why certain people adopt
or fail to adopt behaviors that modify cancer risk, such as smoking, diet, and
physical activity.  Further, these reports emphasized the need for basic (pre-
intervention) research to elucidate the links between biology, behavior, and
environment as they pertain to cancer-related risk behaviors.  While such
research does not address behavior or disease outcomes per se, it enhances
knowledge of fundamental mechanisms and the determinants of cancer-related
behaviors.  This knowledge is necessary to develop more effective cancer control
interventions and to target such interventions to persons most likely to benefit.

Research Goals and Topics

This RFA is intended to solicit applications focused on the links between
biology, behavior, and environment as they pertain to cancer-related risk
behaviors.  New developments in genetics may lead to a greater understanding of 
cancer related health behaviors.  The next generation of behavioral research
should be built on this knowledge.  For example, evidence from twin and animal
studies suggests that cigarette smoking and nicotine dependence have significant
heritable components.  Such effects may be mediated by individual differences in
acute and chronic reactions to nicotine; however, this has yet to be investigated
extensively in human populations.  Research in this area is needed urgently
because it could lead to better interventions for both prevention and cessation
of nicotine use.  Likewise, investigators have begun to elucidate the genetic and
neurobiological basis of obesity and feeding behavior.

Despite these initial advances, there remain significant gaps in our knowledge
about the complex interplay of genetic, neurobiological, and environmental
factors in the initiation and maintenance of smoking, dietary practices, and
exercise habits.  A greater understanding of these basic bio-behavioral
mechanisms would be valuable for the development of novel pharmacologic cancer
control interventions and the targeting of such approaches to individuals most
likely to benefit -- and conversely, the development and targeting of behavioral
interventions to persons for whom these behaviors have a less significant
biological basis.  Opportunities for such research are numerous and include, but
are not limited to:

o  Psychophysiological response to smoking or eating (e.g., sensitivity,
metabolism) and relationship to cancer-related health behaviors;

o  Genetic determinants of individual differences in the reinforcing effects of
smoking, feeding-related behaviors, and/or physical activity;

o  Genetic, neurobiological and metabolic correlates of feeding-related
behaviors, obesity, and/or smoking;

o  Use of Ecological Momentary "real-time" Analysis or other related approaches
in the examination of the relationship between basic bio-behavioral factors and
cancer-related health behaviors;

o  Genetic and psychophysiological processes linking psychiatric co-morbidity
(e.g., depression) and personality with cancer-related health behaviors.

Examples of pre-investigational study designs include, but are not limited to,
basic behavioral laboratory projects, retrospective studies (including case-
control approaches), cross-sectional and associational research, and social
science methodologies (including survey research, focus groups).  Research plans
should incorporate physiologic  and genetic factors, or molecular markers for
these factors, as appropriate to the study question.  While assessment of
relevant neuroendocrine or immune parameters may be included in research plans,
studies in the area of psychoneuroimmunology (PNI) are not within the scope of
this RFA.

Laboratory animal studies are not considered responsive to this RFA.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
sub populations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided 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.

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

Investigators may also obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 14, 1998, a letter of intent
that includes a descriptive title of the proposed research, the name, address,
and telephone number of the Principal Investigator, the identities of other key
personnel and participating institutions, and the number and title of the RFA in
response to which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows NCI staff to
estimate the potential review workload and avoid conflict of interest in the
review.

The letter of intent is to be sent to:

Susan G. Nayfield, M.D., M.Sc.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza South, Room 214
Bethesda, MD  20892
Telephone:  (301) 594-7344
FAX:  (301) 435-5477
Email:  [email protected]

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/95) is to be used in applying
for these grants.  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 RFA label available in the PHS 398 (rev. 9/95) 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.  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.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, 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
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636
Bethesda, MD  20892-7399
Rockville, MD  20850 (for express/courier service)

Applications must be received by August 11, 1998.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness 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 NCI in
accordance with the review criteria stated below.

As part of the initial merit review, a process may be used by the initial review
group in which applications will be determined to be competitive or non-
competitive based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be competitive will be
discussed and be assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the Principal
Investigator and the official signing for the applicant organization will be
notified.

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 methods? 
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.  Research Team.  Has the investigator assembled the appropriate team to
conduct the proposed research?

6.  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 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.

Additional Review Criteria Specific to this RFA

o  How will the proposed research inform or lead to cancer-related behavioral
intervention trials?

o  How likely is it that this research will lead to subsequent investigator-
initiated research?

AWARD CRITERIA

Funding decisions will be based on scientific and technical merit as determined
by peer review, availability of funds, and programmatic priorities.

SCHEDULE

Letter of Intent Receipt Date:  July 14, 1998
Application Receipt Date:       August 11, 1998
Review by NCAB Advisory Board:  February 1999
Anticipated Award Date:         April 1, 1999

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Susan G. Nayfield, M.D., M.Sc.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza South, Room 214
Bethesda, MD  20892
Telephone:  (301) 594-7344
FAX:  (301) 435-5477
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Catherine E. Blount
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone: (301) 496-7800 ext. 262
FAX:  (301) 496-8601
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.399.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241
and 285) and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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