SMALL GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL

RELEASE DATE:  November 14, 2003
 
PA NUMBER:  PAR-04-020 (This PAR has been replaced, see PAR-06-073)

EXPIRATION DATE:  December 21, 2005 

Department of Health and Human Services (DHHS)

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

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.399 

APPLICATION RECEIPT DATE:  April 20, 2004; August 20, 2004; December 22, 
2004; April 20, 2005; August 22, 2005; December 20, 2005.

This Program Announcement (PAR) replaces PAR-02-037, which was published in 
the NIH Guide on December 13, 2001.

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations

PURPOSE OF THIS PAR 

The Division of Cancer Control and Population Sciences of the National Cancer 
Institute (NCI) invites behavioral research applications in cancer control 
from new investigators or established scientists refocusing their research 
interests to behavioral research in cancer. The Small Grants Program is 
designed to aid and facilitate the growth of a nationwide cohort of 
scientists with a high level of research expertise in behavioral cancer 
control research. Small grants are short-term awards to provide support for 
pilot projects, development and testing of new methodologies, secondary data 
analyses, or innovative studies that provide a basis for more extended 
research.

RESEARCH OBJECTIVES

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.
 
Investigators may choose any of the full range of scientific approaches to 
their work.  Studies may contribute to the design, implementation or 
evaluation of intervention programs, descriptive baseline surveys, 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. Proposals should include 
justification of study design, methods, and sample size. In addition, 
proposals should identify the theoretical framework used and clearly indicate 
the significance of the research and where it will lead.

Program areas that are focused on behavior and cancer and that would be 
considered relevant to meeting the goals of this PAR include but are not 
limited to:

Applied cancer screening – theory and methods development, effectiveness 
trials and related social, behavioral and health services research to promote 
the use of effective cancer screening tests in unscreened populations, as 
well as strategies for informed decision making regarding all cancer 
screening technologies in both community and clinical practice. 
http://dccps.nci.nih.gov/acsrb/priorities.html

Basic biobehavioral research - studies that examine mechanisms, principles, 
and theoretical underpinnings of cancer-related behavior change across ages, 
racial and ethnic groups, socioeconomic strata, and cancer diagnoses. 
Research areas include, but are not limited to: basic research in social, 
cognitive, and psychological processes (e.g., risk perception); biological 
mechanisms of psychosocial or behavioral processes related to cancer control 
(e.g., pyschoneuroimmunology); decision processes involved in cancer 
prevention, detection, and treatment; methodology and measurement in 
behavioral science research; development and testing of models and theories 
of health behavior; psychosocial and behavioral consequences of cancer risk 
assessment; understanding processes and mechanisms underlying health 
communication; genetic and environmental influences on health behaviors 
related to cancer control; mediators and moderators of adaptation and coping. 
For additional information go to: 
http://dccps.nci.nih.gov/bbrb/newsletter/03_spring/ and 
http://biobehavioral.cancer.gov

Applied health monitoring, methods and outcomes research - research related 
to evaluating patterns and trends in cancer -related behavioral risk factors, 
and determining the influence of those factors at the individual, societal 
and systems level on patterns and trends in measures of cancer burden, 
including incidence, morbidity, mortality and survival. Innovative approaches 
that address surveillance of cancer- related behaviors using newly available 
data, linkage between existing data systems to create enriched data systems 
for cancer surveillance, and contemporary statistical and economic methods 
are encouraged: http://appliedresearch.cancer.gov/

Health communication and informatics research- examines the use of human and 
mediated communication, including the use of new communication technologies, 
in cancer prevention, control and care, including persuasive communication 
campaigns, risk communication, information dissemination, social support, and 
coordination of care. Other examples may be found at: 
http://dccps.nci.nih.gov/hcirb/about.html.

Health disparities research - studies that seek to explain the impact of 
ecological, socioeconomic, ethnic or cultural factors on cancer incidence, 
morbidity, mortality and survivorship in underserved communities, that assess 
the influence of cultural factors in the medical community, or the variation 
in treatment based on sociocultural factors. More information may be found 
at: http://dccps.nci.nih.gov/od/healthdisp.html

Health promotion research - studies to change current behaviors and/or 
institute new behaviors, such as diet, physical activity, energy balance, 
virus exposure, sun exposure and other behavioral risk factors relevant to 
reducing incidence, morbidity or mortality from cancer or to improve 
maintenance, or investigate the causes of lack of maintenance, to diet, 
physical activity, energy balance or sun exposure prevention behaviors”. 
Other examples may be found at: http://healthpromotionresearch.cancer.gov

Survivorship - Studies that examine the adverse and / or positive effects of 
cancer diagnosis and treatment or aim to prevent or control negative 
outcomes, and / or enhance positive outcomes such as resilience among cancer 
survivors and their families. Pilot investigations focusing on the 
development, delivery, or evaluation of interventions that carry the 
potential to improve the length and quality of survival from cancer are 
encouraged. Survivorship studies may also include behavioral, clinical, or 
epidemiological research on the prevalence and control of post-cancer 
morbidity, second cancers, and chronic diseases other than cancer, instrument 
development specific to cancer survivors, and analyses of the economic cost 
of cancer survivorship. Other examples may be found at: 
http://survivorship.cancer.gov

Surveillance research:  research related to evaluating patterns and trends in 
cancer incidence, morbidity, mortality and survival. Innovative approaches 
that address surveillance using newly available data, linkage between 
existing data systems to create enriched databases for cancer surveillance, 
or contemporary statistical and economic methods are encouraged, including 
ecologic studies of the cancer burden among various population groups 
according to geographic, socioeconomic, or systems-level factors. Research 
that links population-based data on cancer to data on risk factors or health-
related behaviors.  Research in developing statistical methodologies or 
statistical models appropriate for analyzing trends and for evaluating the 
impact of cancer control interventions as well as geographic, social, 
behavioral, genetic, and health care delivery factors on the cancer burden. 
http://surveillance.cancer.gov/

Tobacco control research - tobacco use etiology, prevention and cessation 
including, but not limited to, pilot studies that test strategies for 
improving utilization of current technologies in high risk individuals and 
populations; studies assessing the effect of various policies on tobacco 
initiation and use; secondary data analyses of existing datasets. Additional 
examples may be found at: http://tobaccocontrol.cancer.gov

Additionally, investigators may propose high priority secondary analyses in 
these areas.

Although the specific study proposed may attempt only to obtain preliminary 
data and/or conduct pilot studies in support of a future, more detailed 
intervention study, it is important that a long-term human cancer control 
hypothesis and supporting scientific justification be presented.

Applications not fitting one of the program areas stated above will be 
returned to the proposed Principal Investigator without undergoing peer 
review.

Summary
 
This program announcement is intended to increase the basic and applied 
scientific knowledge of behavioral cancer control research by facilitating 
and encouraging new investigators to conduct research in this area.

MECHANISMS OF SUPPORT 

This PAR will use the NIH small grants (R03) award mechanism. Applicants are 
solely responsible for planning, directing, and executing the proposed 
project.  The total budget may not exceed $100,000 in direct costs for the 
entire project.  The direct costs in any one-year must not exceed $50,000.  
The total project period for applications submitted in response to this 
announcement may not exceed three years.   Two revisions of a previously 
reviewed small grant application maybe submitted.  The small grant is not 
renewable.    

This PAR uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, because these applications are less than $250,000 in direct 
costs per year, they must 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/archive/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 institutions/organizations 
o Foreign institutions are not eligible to apply
o Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Eligible applicants must be either new investigators who have not previously 
been Principal Investigator (PI) on a NCI-funded cancer control research 
grant (R03, R01, U01, P01, R21), or established scientists refocusing their 
research interests to behavioral research in cancer.  Predoctoral 
investigators currently enrolled in an accredited doctoral degree program 
also are eligible to apply. 

Small research grants may NOT be used to supplement research projects 
currently supported by Federal or non-Federal funds, or to provide interim 
support of research project applications under review by the Public Health 
Service.  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 PAR and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

For detailed information about the Small Grants Program for Behavioral 
Research in Cancer Control, visit: 
http://dccps.nci.nih.gov/smallgrants/index.html

The opportunity to clarify any issues or questions from potential applicants 
is welcome.   

o Direct your questions about scientific/research issues to:

Veronica Chollette, RN, MS 
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, Suite 4100
Executive Plaza North
Rockville, MD  20892
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 435-2837
Email:  vc24a@nih.gov

o Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
Email:  ncirefof@dea.nci.nih.gov

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

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8634 
FAX:  (301) 496-8601
Email:  crystal.wolfrey@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 PA 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 by the receipt date(s) listed on the first page 
of this program announcement. 

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.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application and all 
copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Email:  ncirefof@dea.nci.nih.gov

Appendices should be comprised of single-sided, unbound materials, with 
separators between documents

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  
This change in practice is effective immediately.  This policy is similar 
to and consistent with the policy for applications addressed to Centers 
for Scientific Review as published in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before the 
receipt date(s)listed on the first page.  The CSR will not accept any 
application in response to this PAR 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 unfunded version 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

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCI.  Incomplete and/or non-responsive applications 
will not be reviewed.

Applications that are complete and responsive to the PAR will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the Division of Extramural Activities of the NCI in accordance 
with the review criteria stated below.  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 Receive a second level review by the National Cancer Advisory Board

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  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 these 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 PAR 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

RECEIPT AND REVIEW SCHEDULE

Application Receipt Dates: April 20, 2004; August 20, 2004; December 22, 
2004; April 20, 2005; August 22, 2005; December 20, 2005.

Peer Review Dates:  June 2004; October/November 2004; February/March 2005; 
June/July 2005; October/November 2005; February/March 2006.

Council Review Dates:  September 14, 2004; February 16,2005; June 7, 2005; 
September 20, 2005; February 2006; June 2006.

Earliest Anticipated Start Dates:  December 2004; April 2005; July 2005; 
December 2005; April 2006; July 2006

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 PAR 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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.