BASIC BIOBEHAVIORAL RESEARCH ON CANCER-RELATED BEHAVIORS

Release Date:  July 29, 1999

RFA:  CA-99-014

National Cancer Institute

Letter of Intent Receipt Date: October 21, 1999
Application Receipt Date: November 18, 1999 

This RFA is a reissuance of RFA CA-98-015, which was published on April 30, 1998.

THIS RFA 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 RFA.

PURPOSE

The Division of Cancer Control and Population Sciences (DCCPS) of the National
Cancer Institute (NCI) invites research grant applications on the biobehavioral
basis of behaviors which increase the risk of cancer, cancer-related morbidity,
or progression of cancer.

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. This request welcomes applications from a wide
range of activities related to cancer control, and encourages researchers from
conceptually related domains outside of the cancer control field to apply for
funding through this mechanism.

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), or at
http://www.crisny.org/health/us/health7.html.

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. 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. This RFA is a one-time solicitation. 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
July 1, 2000.

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. Budgets should not exceed $200,000 total
(direct and indirect) costs per year.

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://www.nih.gov/grants/funding/modular/modular.htm

For this RFA, funds must be requested in $25,000 direct cost modules. A feature
of the modular grant is that no escalation is provided for future years, and all
anticipated expenses for all years of the project must be included within the
number of modules being requested.  Only limited budget information is required
and any budget adjustments made by the Initial Review Group will be in modules
of $25,000.

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 per year. 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
interventions to modify health behavior 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 NCI working groups, including the Cancer Control Review
Group(http://deainfo.nci.nih.gov/ADVISORY/bsacacntrlmin.htm).  This report
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, this report emphasized the need for basic (pre intervention)
research to elucidate the links between biology, behavior, and environment as
they pertain to behaviors that may impact the risk of cancer, morbidity, and/or
the risk of cancer progression.  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 to solicit applications focused on the links between biology,
behavior, and environment as they pertain to cancer-related risk behaviors. For
example, while obesity increases the risk of developing cancer, particularly
hormone-dependent cancer, little work has been accomplished integrating
behavioral (including physical activity), hormonal and genetic factors in
determining obesity risk and subsequent risk of cancer. Work in this area may
allow for more individualized treatment interventions for a refractory health
problem. Likewise, interdisciplinary research in psychoneuroimmunology has
provided evidence of possible health impacts of brain-immune system
communication. These health impacts likely are mediated by behavioral mechanisms
(e.g.,smoking, diet) and mood (e.g., depression).

Little work has been done investigating the role of psychological states on the
immune system related to infectious disease and cancer, a significant source of
morbidity and mortality. Relationships between neuropeptides and cytokines
related to tumor development and growth are poorly understood. In addition, new
developments in genetics may lead to a greater understanding of cancer-related
health behaviors. For example, evidence from twin and animal studies indicate
that cigarette smoking and nicotine dependence may have significant heritable
components. Recent investigations have added to this knowledge base, with
indications that dopaminergic mechanisms may play a significant role as one of
many factors influencing tobacco use and nicotine dependence.  The next
generation of behavioral research should be built on knowledge gathered from
preinterventional studies in the areas above. Finally, as we work to integrate
biological and behavioral risk factors related to cancer, morbidity, and
progression, advances in measurement may go hand in hand. One goal of this RFA
includes research that will improve the quality of the data collected, including
the analysis of such data.

Despite the advances noted, there remain significant gaps in our knowledge about
the complex interplay of genetic, neurobiological, and environmental factors in
the initiation and maintenance of dietary practices, exercise habits and smoking.
Likewise, clinical implications of psychoneuroimmunology await more informed
preinterventional research.  A greater understanding of these basic biobehavioral
mechanisms would be valuable for the development of novel 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:

Psychophysiological and genetic processes linking psychiatric morbidity (e.g.,
depression), personality and health behaviors with risk of cancer, cancer-related
morbidity, and/or cancer progression;

Psychological influences on immune defenses against infectious disease among
cancer patients, including processes which may lead to a cancer diagnosis from
other disease processes (e.g, human papillomavirus (HPV) and cervical cancer);

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

Genetic determinants of individual differences in the reinforcing effects of
physical activity, food and alcohol intake, and smoking;

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

Processes underlying persuasion in response to cancer prevention messages,
including psychophysiological, cognitive, and motivational mechanisms;

Studies designed to understand processes underlying the relationships among risk
perception, cancer worry, distress, and health behavior.

Examples of preintervention study designs include, but are not limited to, basic
behavioral laboratory projects, retrospective studies (including case-control
approaches), cross-sectional and associational research, and other social science
methodologies (including survey research, focus groups).  Research plans could
incorporate behavioral measures, physiologic and genetic factors, or molecular
markers, as appropriate to the study question. In addition, projects that utilize
innovative settings or the new use of existing cohorts is encouraged.

Although not a formal sponsor of this program announcement, the National
Institute of Mental Health (NIMH) is interested in funding research on the basic
mechanisms by which behavior and cognition influence disease processes. 
Furthermore, the NIMH is interested in applications if the co-morbid condition
of interest is a mental disorder (e.g., depression or anxiety) or related
disability, or the research is aimed at  the prevention or treatment of these
disorders or related disabilities. Please contact Peter Muehrer, Ph.D., Health
and Behavioral Sciences Research Branch, NIMH, at 301/443-4708, Email: 
pmuehrer@nih.gov

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
subpopulations 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 (Section 492B of Public
Law 103-43).

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, available on the web at the following URL address:
http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html

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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (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://www.nih.gov/grants/funding/children/children.htm

LETTER OF INTENT

Prospective applicants are asked to submit, by October 21, 1999, 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 the program staff listed under INQUIRES.

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.

Applicants are strongly encouraged to call the program contacts listed in
INQUIRIES below with any questions regarding the responsiveness of their proposed
project to the goals of this RFA.

BUDGET INSTRUCTIONS

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://www.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 key 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 key 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 team.  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://www.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 RFA and will be returned without further review.

The RFA label available in the application form PHS 398 must be affixed to the
bottom of the face page.  The RFA label and line 2 of the application should both
indicate the RFA number.  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  20852 (for express/courier service)

Applications must be received by November 18, 1999.  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.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

These instructions apply to all applicants since the budget limit is $200,000.

FACE PAGE:Items 7a and 7b must 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
must be completed indicating the Direct and Total Costs for the entire proposed
period of support.

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.

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.

NARRATIVE BUDGET JUSTIFICATION- Use a Modular Grant Budget Narrative page. (See
http://www.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.

Under personnel, list key project personnel, including their names, percent of
effort, and roles on the project.  No individual salary information should be
provided.

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 key personnel, and the role
on the project.  The total cost for a consortium/contractual arrangement is
included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individuals qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team.  A biographical sketch is required for all key personnel,
following the instructions below. No more than three pages may be used for each
persona.  A sample biographical sketch may be viewed at:
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page; - List current
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;

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.  It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

Applications not conforming to these guidelines will be considered unresponsive
to this RFA and will be returned without further review.

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 will be used by the initial review group in which applications
receive a written critique and 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, 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 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.  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,
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.

Additional Review Criteria Specific to this RFA

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

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:  October 21, 1999
Application Receipt Date:       November 18, 1999
Review by NCAB Advisory Board:  May 2000
Anticipated Award Date:         July 1, 2000

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Michael Stefanek, Ph.D
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 211
Bethesda, MD  20892
Telephone:  (301) 496-8776
FAX:  (301) 435-7547
Email:  ms496r@nih.gov

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) 496-3179
FAX:  (301) 496-8601
Email: blountc@gab.nci.nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Rockville, MD 20852 (express courier)
Bethesda MD 20892-7399
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email:  tf12w@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.399.  Awards are made under 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 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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