EXPLORATORY GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL

RELEASE DATE:  December 11, 2003

PA NUMBER:  PA-04-034

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov 
using the electronic SF424 (R&R) application. Accordingly, this funding 
opportunity expires on the date indicated below. A Replacement R21 (PA-06-351) 
funding opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI)  
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.399

This Program Announcement (PA) replaces PA-02-001, which was published in the 
NIH Guide on October 1, 2001.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

The Division of Cancer Control and Population Sciences of the National Cancer 
Institute (NCI) invites the submission of behavioral research applications in 
cancer control from investigators from a wide range of behavioral and social 
science disciplines who wish to focus their research on the behavioral 
aspects of the cancer control continuum from prevention to end of life care.  
The Exploratory Grant Program is designed to encourage the growth of a 
diverse cohort of scientists with a high level of research expertise in 
behavioral cancer control research. This exploratory grant is a 2-year award 
designed to encourage exploration of new ideas and new methodologies in the 
target area and to provide support for the collection of pilot data to be 
used as the basis for later R01’s. NIH Grants policies apply to these awards.
The Behavioral Research Program (BRP) at NCI also issues an R03 program 
announcement http://dccps.nci.nih.gov/smallgrants/.)  The two mechanisms, the 
R21 and the R03, are both considered “small grants” but are targeted to two 
different audiences. The BRP R21 targets new ideas and feasibility studies in 
areas new to seasoned investigators. The R03 is designed for new 
investigators. The R21 provides enough funding for a (small) collaborative 
team. The R03 guidelines until recently mandated a mentor relationship; this 
is still encouraged.  The R21 applications are reviewed in the large pool of 
CSR study sections where the applications are evaluated by behavioral and/or 
prevention scientists who may or may not have primary interests in oncology. 
The R03 applications are reviewed by NCI. Hence, the PI must use different 
strategies in presenting the research design and other sections of the 
applicants. The R21 is often used as a vehicle to provide rich pilot data for 
a later R01, and PI s are encouraged to think ahead to the next step, should 
their R21 hypotheses test favorably; there is a lesser emphasis on the 
continuation into the R01 for the R03 applicant.  In summary, seasoned 
investigators use the R21 mechanism to pursue new avenues of research with 
new populations; new investigators use the R03 to learn the factors involved 
in leading an investigation in an area they may have been working in since 
graduate school or as a post-doc.

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.  

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, 
communication and health promotion behavioral research through a program of 
exploratory investigator-initiated R21 grants. 

Because this developmental/exploratory grant mechanism is designed to support 
the collection of pilot data, and to allow an avenue for the exploration of 
new concepts and new methodologies, 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.  Feasibility of the proposed research and potential significance for 
ongoing research are major considerations in the evaluation.

This program is designed to encourage investigators from a variety of 
academic, scientific, and public health disciplines to apply their skills to 
behavioral research investigations in cancer prevention and control.  The 
research may occur in a variety of settings, such as hospitals, universities, 
cancer centers, communities, schools, health departments, and worksites.  It 
is appropriate to look at different populations within those settings and 
their interactions with cancer care health systems.

Investigators may choose any of the full range of scientific approaches to 
conduct their work.  Studies may contribute to: the design, implementation, 
or evaluation of intervention programs; the development and administration of 
descriptive baseline surveys; the testing, modification and validation of 
surveys or program materials for use in the proposed population groups, 
testing of recruitment, intervention or compliance procedures for 
participants; etc. Applications should include justifications of study 
designs, methods, and sample sizes. In addition, applicants should identify 
the theoretical framework used and clearly indicate the significance of the 
research and where it will lead.

Research Goals and Scope

The major goal of this initiative is to promote timely and innovative 
behavioral and culturally appropriate research approaches in cancer 
prevention and control. Studies may focus on: 1) Assessment (instrumentation 
methods, measurement development, particularly in new research populations); 
2) Intervention (feasibility of new and innovative approaches, 
appropriateness for use in populations disproportionately burdened with 
cancer or in populations involving 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) 
biological and psychological influences on cancer and 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 the potential efficacy of an 
intervention; it is also appropriate for testing new methodology in various 
applications.  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 yet been developed or validated. 

Research Issues

The Behavioral Research Program (BRP) and the Office of Cancer Survivorship 
(OCS) support research on a range of topics, and applications in any of the 
areas mentioned below or in areas which bridge these topics are appropriate. 
The list is illustrative rather than comprehensive. It is expected that 
investigators responding to this announcement will identify additional 
research topics. 

1.  Enhancing Risk Communications, 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. Research on communication patterns as a measure of patient-
centered treatment, as well as redesign of existing communication process to 
impact client satisfaction, health status, and quality of life is encouraged. 
Research is also needed to understand the effects of media coverage and 
treatment of cancer-related topics on the knowledge, attitudes, and behavior 
patterns of both individuals and social groups.

2. 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. This raises the question of the quality of that 
extended survival time, including its effect upon productivity, the family 
functioning, and both medical and psychiatric comorbidity. There are now a 
number of under-studied cancer sites (e.g., liver, pancreatic, hemolytic 
cancers) and under-studied minority populations where survivors are of 
interest.  New behavioral and psychosocial interventions targeted to these 
populations are needed.  There has been little work done using the family or 
the extended family as the unit of analysis, and looking at the long-term 
effect of the cancer experience on that unit. Research is also 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 these populations are needed before 
research can proceed.

3. Promoting a Healthy Diet and Physical Activity:  

Nutrition and physical activity as keys to an energy balance strategy play an 
important role in the prevention of the initiation, promotion, and 
progression of cancer.  Only a small proportion of the U.S. population 
adheres to recommended guidelines for diet or participates in regular 
physical activity, and obesity is becoming a national disease. Refinement of 
current theoretical mechanisms of behavior change as well as a focus on 
developing new models is needed to examine and explain the determinants of 
changes in unhealthy behaviors. How individuals and groups maintain healthy 
behaviors is also of interest. 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.

4. Studying Prevention, Treatment and Control of Tobacco Use among Children, 
Teenagers, Young Adults 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 smoking prevalence among these 
population groups need to be designed.  These methods and strategies must be 
tested for feasibility and efficacy in different settings. 

5. Researching Biological Mechanisms of Psychosocial Effects on Disease:  

Our appreciation of the complex interplay between psychosocial factors (e.g., 
stress) and nervous, endocrine, and immune systems has substantially 
increased.  However our understanding and of this knowledge to the study of 
the development and control of malignant disease is limited.  Research that 
examines how interactions among environmental, psychosocial, immune, 
neuroendocrine, genetic, and other biological factors influence cancer 
biology, treatment and side effects, and/or outcome is needed. Research 
involving interactions among genetic, behavioral, and social factors in the 
development of cancer or cancer risk behaviors (smoking, physical activity, 
alcohol intake, nutritional intake, etc.) are of interest.  Such behavioral 
and social factors might include:  a) factors related to the social context 
such as poverty, cultural practices and social support and b) individual 
behavioral factors such as personality or coping style. The focus of this 
work must involve examining the complex interplay of these factors related to 
health. Interdisciplinary research and research that includes integrative 
conceptual models are encouraged.

6. Issues Involved in Cancer Screening Behaviors:

Social and behavioral research to promote the use of effective cancer 
screening tests, as well as strategies for informed decision-making regarding 
all cancer screening technologies, in both community and clinical practice is 
encouraged.  Particular areas of interest include the need to identify 
effective and appropriate messages related to cancer screening among 
subgroups (e.g., ethnic, gender, and income), and the development of methods 
for improving patient/provider communication and decision making about 
screening – particularly in the context of new and changing screening 
technology. Also of interest is research to incorporate risk assessment, 
genetic susceptibility, genetic risk information, and biological risk into 
screening programs. 

Crosscutting Themes

Although individual branches within the Behavioral Research Program or the 
Office of Cancer Survivorship concentrate on tobacco cessation, health 
promotion, communication, biobehavioral mechanisms, or survivor issues, the 
following are relevant to all areas of behavioral and social 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 
and underserved populations.  This includes racial/ethnic minorities, rural, 
elderly, immigrant, and under-insured populations.  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.  The 
medical system and its cultural components as they impact on cancer 
disparities are also of interest.

2. Methods and Measurement: 

Innovative methods as well as measurement and analysis techniques are a 
critical need within many domains of the behavioral and social sciences.  We 
encourage research that focuses on understanding the theoretical mechanisms 
of behavior change, and on developing new models as well as refining current 
theories.  We need to develop instrumentation methods and measurement that 
can be used to evaluate the impact of environmental and policy interventions 
and develop sociocultural/ecological perspectives as the context for behavior 
change. Qualitative research methods based on sound theoretical models have 
potential value for understanding the complexity of health behaviors. 

3. Levels of Analysis: 

We encourage increased attention to group as well as individual behaviors. 
Study designs, including intervention approaches and statistical analyses 
must extend from individual analysis to an emphasis on multiple population 
levels: communities, clinics, neighborhoods, etc.  Understanding the success 
or failure of interventions will also depend on the ability to study the 
mechanisms of intervention impact and dissemination.

4. Research Settings: 

Behavioral and social 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 as noted above. Exploratory studies 
of novel approaches targeted at specific research settings are encouraged. 

Summary
 
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 
factors. We also encourage inquiries into areas such as risk communication, 
communication inequality, and the impact of mass media on cancer-related risk 
behaviors.
 
MECHANISM OF SUPPORT 

This PA will use the NIH exploratory/development (R21) award mechanism.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project

The applicant may request a project period of up to two years with a combined 
budget for direct costs of up $275,000 for the two year period.  For example, 
the applicant may request $100,000 in the first year and $175,000 in the 
second year.  The request should be tailored to the needs of the project.  
Normally, no more than $200,000 may be requested in any single year.  These 
grants are non-renewable and continuation of projects developed under this PA 
will be through the traditional unsolicited investigator initiated grant 
program. 
 
This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular budget format.  This program does 
not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research, and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Sabra F. Woolley, Ph.D.
Health Promotion Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6130Executive Blvd., EPN Room 4078, MSC 7335
Bethesda, MD  20892-7335
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 435-4589
FAX: (301) 480-2087
Email:  sw215x@nih.gov

o Direct your questions about financial or grants management matters to:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Room 243
Bethesda, MD  20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7800
FAX:  (301) 496-8601
Email: wolfreyc@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form.  The PHS 
398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm. Application 
deadlines are also indicated in the PHS 398 application kit.

SUPPLEMENTARY INSTRUCTIONS:  All instructions for the PHS 398 (rev. 5/2001) 
must be followed, with these exceptions:

o  Research Plan

Items a - d of the Research Plan (Specific Aims, Background and Significance, 
Preliminary Studies, and Research Design and Methods) may not exceed a total 
of 15 pages.  No preliminary data is required but may be included if it is 
available.  Please note that a Progress Report is not needed; competing 
continuation applications for an exploratory/developmental grant will not be 
accepted.

Appendix.  Use the instructions for the appendix detailed in the PHS 398 
except that no more than 5 manuscripts, previously accepted for publication, 
may be included. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

For the NIH Exploratory/Developmental Grant (R21), applicants may request 
direct costs in $25,000 modules, up to a total direct cost of $275,000 for 
the combined two year award period.      

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA 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 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  As part of the initial merit review, all applications 
will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Those that receive a priority score will receive a second level review by 
an 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.  In 
the written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be judged 
likely to have 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.

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?

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?

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?

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)?

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?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

Clinical trials supported or performed by NCI require special considerations.  
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 or 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 for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  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: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling 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 clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program in the protection of human participants in 
research is available online at: http://cme.nci.nih.gov/

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92). All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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