EXPLORATORY GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL

Release Date:  September 7, 1999

PA NUMBER:  PA-99-163

National Cancer Institute

THIS 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.

PURPOSE

The Division of Cancer Control and Population Sciences and the Division of
Cancer Prevention of the National Cancer Institute (NCI) invite research grant
applications from interested investigators to conduct timely, innovative,
developmental, or methodological behavioral research in cancer prevention and
control through a program of exploratory investigator-initiated R21 grants.

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 advance in science.  The objective of
this Program Announcement (PA) is to encourage applications from individuals
who are interested in testing novel or conceptually creative ideas that may
produce innovative advances in the behavioral sciences.

This PA will expire two years from the first receipt date.  That is, the final
receipt date will be October 1, 2001.  NIH Grants policies apply to these
awards.

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 PA, Exploratory Grants for
Behavioral Research in Cancer Research, 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://odphp.osophs.dhhs.gov/pubs/hp2000.

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. Applications may be from a single institution or may
include arrangements with one or more institutions (e.g., consortia, clinical
trials cooperative group) if appropriate.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health
(NIH) exploratory/developmental grant (R21) mechanism.  Applicants will be
responsible for the planning, direction, and execution of the proposed
project.  All PHS and NIH grants policies will apply to applications received
and awards made in response to this program announcement.  Applicants may
request up to $100,000 per year in direct costs.  The total project period for
an application submitted in response to this PA may not exceed two years. 
These grants are non-renewable and continuation of projects developed under
this program will be through the traditional unsolicited investigator
initiated grant program.  Amended applications will be accepted.

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.

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

For this PA, 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.

RESEARCH OBJECTIVES

Background

The NCI supports behavioral research and other intervention studies related to
cancer prevention and control through research project grants.  Historically,
this research has emphasized evaluation of health behavior interventions or
disease outcomes, rather than the fundamental mechanisms of cancer-related
behaviors or pre-intervention research. However, with the exception of Small
Research Grants (R03), primarily targeted to new or previously unfunded cancer
prevention and control investigators, it has been difficult for behavioral
scientists to obtain funding for hypothesis development, methods development,
new intervention approaches, or feasibility studies.  It is expected that
these R21 grants will serve as a basis for planning future behavioral and
cancer control intervention research project grant applications (R01).  This
PA, therefore, is intended to stimulate innovative approaches to primary and
secondary cancer prevention, prevention of cancer associated morbidity,
quality of life, rehabilitation, and health promotion behavioral research
through a program of exploratory investigator-initiated R21 grants.

Because the exploratory grant mechanism is designed to support innovative
ideas, preliminary data as evidence of feasibility are NOT required.  However,
the applicant does have the responsibility for developing a sound research
plan with a strong theoretical or empirical basis.  Originality of the
approach and potential significance of the proposed research are major
considerations in the evaluation.

Research Goals and Scope

The major goal of this initiative is to promote timely and innovative
behavioral, and clinical research approaches in cancer prevention and control. 
Studies may focus on: 1) Assessment (instrumentation and methods development);
2) Intervention (feasibility of new and innovative approaches, appropriateness
for use in special populations or other clinical, organizational and community
settings), 3) Dissemination (applications, sustainability), and 4)
Surveillance (health services research and information data base linkage
studies to monitor progress toward cancer prevention and control).  These R21
exploratory/developmental award mechanism is appropriate for testing
innovative, timely and risk taking interventions in pilot studies for
feasibility or with small sample size to assess efficacy of an intervention. 
It is also appropriate for the psychometric evaluation of new measures or of
those adapted for use in special populations.

Research Issues

Examples of priority areas for innovative approaches to behavioral research in
cancer prevention and control which might need development or pilot work and
could be addressed by applicants are listed below. The list is illustrative
rather than comprehensive. It is expected that additional relevant and
important research topics will be identified by investigators responding to
this announcement.  Therefore, applicants are strongly encouraged to discuss
their ideas with NCI program staff.

1. Enhancing Risk Communication, Comprehension, and Informed Decision-Making
Under Uncertainty: As new technologies are integrated into mainstream medical
care, patients are being challenged to make difficult decisions in the face of
uncertain risks and benefits.  Valid and reliable methods to evaluate
strategies to improve cancer risk communication, enhance comprehension, and
facilitate informed decision-making about options for cancer prevention,
screening and treatment are required.  These must be explored and evidence of
efficacy made available to address appropriate methodologic and research
questions for intervention studies in the future.

2. Integrating Preventive and Early Detection Services into Changing Health
Delivery Systems: The proportion of the insured population covered by a
managed care arrangement has increased, and continues to rise steadily. 
Increasingly, primary care providers, and physicians in particular, are
becoming part of larger organizations. Over three-fourths of physicians now
participate in managed care.  Behavioral research must respond to this change
in health care delivery by designing and testing innovative cancer prevention
and control interventions that can be integrated into health care systems in a
cost-effective manner. Appropriate methodology must be developed and tested
before doing this type of research.

3. Enhancing Survivorship of Cancer Patients: Due to advancements in early
detection and treatment, people are living longer with cancer, dramatically
increasing the number of cancer- affected life-years in our nation. There are
now over eight million cancer survivors in the U.S. This raises the question
of the quality of that extended survival time, including its effect upon
productivity, family functioning, and both medical and psychiatric
comorbidity.  New behavioral and psychosocial interventions targeted to this
population are needed to enhance functional health status (e.g., return to
work), improve coping and adjustment to the effects of cancer and its
treatment,  improve the delivery of palliative care, and promote health
behaviors that may reduce the risk of second malignancies. Instrument
development and innovative approaches for this population are needed before
research can proceed.

4. Promoting a Healthy Diet and Physical Activity: Nutrition and physical
activity play a central role in the initiation, promotion, and progression of
cancer. U.S. guidelines recommend diets that are low in fat and high in fiber,
fruits, and vegetables.  Yet, only a small proportion of the U.S. population
adheres to recommended guidelines for diet or participates in regular physical
activity.  Robust methods must be developed  to examine and explain the
determinants of changes in these behaviors. Innovative intervention designs
must be assessed for feasibility and acceptance before they can be targeted to
populations at high risk for cancer.

5. Prevention, Treatment and Control of Tobacco Use among Children, Teenagers,
and Adults: Innovative methods are needed to identify determinants of smoking
initiation and maintenance in U.S. children and teenagers, including high risk
groups.  Innovative strategies, with potential for broad public health
application,  to reduce prevalence among these population groups need to be
designed.  These methods and strategies must be tested for feasibility and
efficacy in different settings.

6. Improving the Outcomes of Genetic Testing for Cancer Susceptibility:
Breakthroughs in cancer genetics have created unprecedented opportunities for
individuals to learn whether they carry mutations in cancer-predisposing
genes. These include rare cancer genes that may confer an 80-90% lifetime
cancer risk (e.g., BRCA1) as well as more common, but less penetrant, genes
that interact with environmental and lifestyle factors (e.g., CYP2D6). Genetic
information has potentially far-reaching consequences for the psychological
well-being and medical care of individuals at high risk for cancer.  A better
understanding of the behavioral and social impact of disclosure of genetic
information is critical to designing optimal education and counseling
approaches. Efforts are also needed to develop and evaluate behavioral
interventions to test the feasibility of the intervention, acceptance by the
subjects etc. before they can be evaluated in research programs.

7. Prevention of Cancer: Testing of behavioral interventions to promote
adherence to life style or chemo-prevention interventions whose goal is the
prevention of cancer.  The longitudinal nature of cancer prevention trials
requires adherence to the activity or agent over a time frame of many years. 
The determinants of adherence may be different for specific sub-groups of the
population.  Evaluation of different approaches to ensure adherence to the
prevention protocol are appropriate for this mechanism of support.

8. Prevention of cancer associated morbidity: a limiting factor in successful
cancer therapy is often dose related toxicity or disease related symptoms. 
The development and validation of assessment measures for use in specific sub
groups or the development of new measures to assess the symptom of the outcome
of the interventions is encouraged.  The pilot testing of the feasibility and
efficacy of newly developed interventions that have a behavioral element as
one of the components and whose goal is to reduce cancer related morbidity are
encouraged.

Cross-Cutting Themes

The following are relevant to all areas of priority behavioral research, and
therefore, are strongly encouraged as cross-cutting themes to be considered in
applications prepared in response to this Program Announcement.

1. Consideration of Race, Social Class, and Culture: To have the broadest
impact on cancer morbidity and mortality, behavioral research must take into
account the racial, cultural, and socioeconomic factors that influence
adoption of cancer prevention and control practices. This is especially true
since, for example, education and income are key predictors of cancer
screening. Special efforts are required to enroll these population subgroups
into cancer prevention and control studies.  The development and testing of
interventions with valid and reliable measurement tools that are practical and
culturally appropriate are needed.

2. Theory-Driven Research: There is a need to expand existing theories of
health behavior to take account of under served populations, new health care
technologies, and changes in service delivery. Ways must be found to explore
cognitive and emotional variables (e.g., risk perception, distress), which
receive insufficient attention in the dominant models of health behavior.
Researchers are encouraged to test theories both to guide intervention about
causal effects of interventions.  It is important to be able to identify the
effective components of behavioral interventions both for cost reasons and
dissemination into practice.

3.  Methods and measurement: Innovative methods, measurement and analysis
techniques are needed to provide a solid foundation on which to develop new
intervention methodologies (e.g., with populations in whom interventions have
not previously been effective).  Such research is essential to improve the
reach and effectiveness of interventions, particularly for underserved
populations and those at disproportionate risk for cancer.  Qualitative
approaches and research methods have potential value for understanding the
complexity of  health behaviors.  In addition, with the development of new
intervention approaches, study designs and statistical analysis must extend
from individual analysis to multiple levels of intervention impact, such as
communities and health care systems.  Understanding the success or failure of
these interventions will also depend on the ability to study the mechanisms of
intervention impact and dissemination, using validated assessments of the
processes of behavior change.

4. Research Settings: Behavioral research initiatives should span all phases
of cancer prevention and control research and take place in a variety of
settings.  Exploratory studies of novel approaches targeted at specific
research settings are encouraged.

5. Surveillance of Cancer Related Behaviors: New approaches to health services
research and information data base linkage are needed to monitor cancer
related behaviors, particularly in rural populations, ethnic/minority groups
and low socioeconomic groups.  Innovative approaches that address surveillance
problems using newly available data and modern statistical methods (e.g.,
analytical methods employing GIS, microsimulation or variance estimation for
age-adjusted rate trends) are strongly encouraged.

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:
https://grants.nih.gov/grants/guide/notice-files/not94-100.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 policy.

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 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/funding/children/children.htm

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:
grantsinfo@nih.gov.  For those applicants with internet access, the 398 kit
may be found at: https://grants.nih.gov/grants/funding/phs398/forms_toc.html

Applicants are strongly encouraged to contact the program staff listed under
INQUIRIES with any questions regarding their proposed project and the goals of
this PA.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $100,000 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 https://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 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:
https://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.

The PA 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 five 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)

Applications will be accepted on the standard application receipt dates for
investigator initiated research as indicated in the PHS 398 directions.  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 assigned on the basis of established PHS referral
guidelines.  An appropriate scientific review group convened in accordance
with the standard NIH peer review procedures will evaluate applications for
scientific and technical merit.  As part of the initial merit review, all
applications will 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 applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate national
advisory council or 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,
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.

INQUIRIES

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

For purposes of this program announcement, clarification of topics 1 - 6 under
the Research Issues section listed above should be directed to:

Sabra Woolley, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 232, MSC 7330
Bethesda, MD  20892-7330
Telephone:  (301) 435-1505
FAX: (301) 480-6637
Email:  sw215x@nih.gov

Clarification of topics 7 and 8 under the Research Issues section listed above
should be directed to:

Claudette Varricchio, D.S.N.
Division of Cancer Prevention
National Cancer Institute
Executive Plaza North, Room 300, MSC 7340
Bethesda, MD  20892-7340
Telephone: (301) 496-8641
Email: cv9h@nih.gov

Direct inquiries regarding fiscal matters to:

Bill Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone: (301) 496-7800
FAX:  (301) 496-8601
Email: ww14j@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 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 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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