This Program Announcement expires on October 2, 2003, unless reissued.


Release Date:  October 1, 2001
PA NUMBER:  PA-02-001 (see replacement PA-04-034)

National Cancer Institute


This Program Announcement (PA) replaces PA-99-163, which was published in the 
NIH Guide on September 7, 1999.
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 developmental and 
formative 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, research that 
aims to produce innovative advances in science.  The objective of this 
Program Announcement (PA) is to encourage applications from individuals who 
are interested in research in the behavioral aspects of the cancer control 
continuum from prevention to end of life care.



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.  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 
or measurement 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 
developmental and exploratory 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. 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, clinical, and culturally appropriate research approaches in 
cancer prevention and control. Studies may focus on: 1) Assessment 
(instrumentation methods, measurement development), 2) Intervention 
(feasibility of new and innovative approaches, appropriateness for use in 
populations disproportionately burdened with cancer, or other clinical, 
organizational and community settings, 3) Dissemination (applications, 
sustainability), 4) Surveillance (issues of inclusion of minority 
populations, data base linkage studies to monitor progress toward cancer 
prevention and control), and 5) psychological influences on cancer and the 
biobehavioral mechanisms underlying cancer related behaviors. This 
R21exploratory/developmental award mechanism is appropriate for testing 
timely  interventions in pilot studies for feasibility or using rigorous 
qualitative research methods to assess efficacy of an intervention.  It is 
also appropriate for the psychometric evaluation of new measures or 
culturally appropriate ones to be adapted for use in populations for whom 
measures have not been developed or validated. 

Research Issues

Examples of priority areas for exploratory 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. Genetic testing is one example of this.  
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 methodology 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 and end of life care, and 
promote health behaviors that may reduce the risk of second malignancies. 
Instrument development, observational studies, 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 an important 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.  Relatively little 
research has been published on key theoretical measures of constructs such as 
self-efficacy or perceived barriers when applied to fruit and vegetable 
consumption.  Little is known about measures appropriate for minority, low-
literacy or high-risk populations.  Innovative intervention designs must be 
assessed for feasibility and cultural competence 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.  Psychometric validation of new measures may be 
necessary before these are applied in larger studies. 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. 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 sociocultural impact of 
disclosure of genetic information is critical to designing optimal education 
and counseling approaches.  Innovative, process-oriented research that 
incorporates contemporary theories and methods from the social and behavioral 
sciences is needed.

7. Prevention of Cancer: Behavioral interventions to promote adherence 
chemo-prevention interventions need to be developed and tested.  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 and to understand the determinants of non-adherence 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 populations or the development of new measures to assess the 
outcome of interventions to limit disease related symptoms is encouraged, as 
is pilot testing of the behavioral component of such interventions.

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 Ethnicity, Social Class, and Culture:  The development 
and testing of interventions with valid and reliable measurement tools that 
are practical and culturally competent are needed.  Since little is known 
about the relative importance of sociocultural, economic, educational and 
other behavioral factors to the differential burden of cancer in the United 
States, special efforts are required to identify and reduce the risk, 
incidence and mortality of cancer among population subgroups.  In addition, 
we need to examine both system-wide as well as individual and group barriers 
to screening, medical treatment and adherence, and end of life care.

2. Underserved Populations:  Researchers are encouraged to extend behavioral 
theories to underserved populations, as well as develop new theories.  In 
addition, this PA encourages theory-based studies designed to test the active 
ingredients in interventions: what makes them work?  What makes them 
transferable to other populations or inhibits their dissemination?

3. Methods and Measurement: Innovative methods, measurement and analysis 
techniques are a critical need within many domains within the behavioral and 
social sciences, and 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. Research to develop, modify and validate questionnaires for use 
in minority populations is a priority for the National Cancer Institute. 
Qualitative 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 analyses must extend 
from individual analysis to multiple levels of intervention impact, such as 
communities.  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 may focus on any or 
all phases of the cancer control continuum, from prevention, detection, 
diagnosis and treatment, through survivorship, and end of life issues. 
Research activities may take place in a variety of settings.  Exploratory 
studies of novel approaches targeted at specific research settings are 
encouraged.  For example, little is known about environmental factors that 
affect fruits and vegetable consumption, and research settings could include 
worksite caterers, schools, vending machines, stores and restaurants, further 
work is need on nutritive approaches that improve quality of life for cancer 

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.

Research funded through this R21 mechanism is expected to increase scientific 
knowledge about health behaviors and health care practitioners" behaviors in 
a number of areas.  These areas include but are not limited to: tobacco 
cessation, sun exposure, cancer screening behaviors, diet, weight and 
physical activity factors relevant to in cancer risk reduction and treatment, 
communication patterns and technologies between health care practitioners and 
patients, cancer survivorship issues, socio-cultural factors in health 
behaviors and in health care practitioner behaviors, and basic bio-behavioral 


This PA 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 PA may not exceed TWO years.  These grants are non-
renewable and continuation of projects developed under this PA will be 
through the traditional unsolicited investigator initiated grant program.  
The earliest anticipated award date is December, 2002.

Applicants may request up to $100,000 direct costs (four budget modules). 

Though the size of the 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 that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at

Applications may be submitted by foreign and 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.  Faith-based organizations are eligible 
to apply for these grants.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as principal investigators. 

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Sabra F. Woolley, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 4078, MSC 7335
Bethesda, MD  20892-7335
Telephone:  (301) 435-4589
FAX:  (301) 480-2087

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

Direct inquiries regarding fiscal matters to:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., Suite 243
Bethesda, MD  20892  (for regular mail)
Rockville, MD  20852 (for hand-delivered mail)
Telephone:  (301) 496-8634
FAX:  (301) 496-8601


The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines ( as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format. Although applicants are encouraged to begin using the 
5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to 
accept applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/710-0267, Email:

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute or Center who agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of the 
original application as well as any subsequent revisions.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 


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 NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, 
however, to use the 4/1998 revision of the PHS 398 for scheduled application 
receipt dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step instructions for 
Modular Grants available at  Additional 
information about Modular Grants is also available on this site.

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.

Submit a signed, typewritten original of the application, including the 
checklist, and five signed, exact, single-sided photocopies, in one package 

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 assigned based on established PHS referral guidelines.  
Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened in accordance with the standard 
NIH peer review procedures.  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 five criteria to be used in the evaluation of grant applications are 
listed below.
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 
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 

The initial review group will also examine: 

o the appropriateness of proposed project budget and duration, 
o 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, 
o the provisions for the protection of human subjects, 
o the safety of the research environment,
o the adequacy of the proposed plan to share data.  

Award criteria that will be used to make award decisions include:

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.

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 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 
a complete copy of the updated Guidelines is available at 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.


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 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,” published in the NIH Guide for Grants and 
Contracts on March 6, 1998, and is available at the following URL address: 

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.


All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for 
Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at 
the following URL address:  A 
continuing education program in the protection 
of human participants in research is now available online at

All clinical trials supported or performed by NCI require some form of 
monitoring.  The method and degree of monitoring should be commensurate with 
the degree of risk involved in participation and the size and complexity of 
the clinical trial.  Monitoring exists on a continuum from monitoring by the 
principal investigator/project manager or NCI program staff to a Data and 
Safety Monitoring Board (DSMB).  These monitoring activities are distinct 
from the requirement for study review and approval by an Institutional Review 
Board (IRB).  For details about the Policy of the NCI for Data Safety 
Monitoring of Clinical Trials see  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on “Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials” for additional information:  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available to


The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at  
Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.


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 (see


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, Exploratory 
Grants for Behavioral Research in Cancer Control, is related to priority area 
of Cancer Control.  Potential applicants may obtain a copy of "Healthy People 
2010" at
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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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