COLORECTAL CANCER SCREENING IN PRIMARY CARE PRACTICE

RELEASE DATE:  December 12, 2003

PA NUMBER:  PAR-04-036

EXPIRATION DATE:  June 24, 2005, unless reissued. 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH) 
 (http://www.nih.gov)
Agency for Healthcare Research and Quality (AHRQ) 
 (http://www.ahrq.gov) 

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.399, 93.226

LETTER OF INTENT DATES: 
January 23, 2004; September 22, 2004; January 24, 2005; May 23, 2005

APPLICATION RECEIPT DATES:
February 23, 2004; October 22, 2004; February 23, 2005; June 23, 2005

This PAR replaces PAR-02-042, which was published in the NIH Guide on 
December 20, 2001.

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PAR  

Colorectal cancer (CRC) is the second leading cause of cancer death in the 
United States. A growing body of evidence indicates that the number of 
individuals dying of colorectal cancer could be greatly reduced through 
appropriate screening. Although there is now general agreement that average-
risk adults aged 50 and older should be screened for colorectal cancer, 
national survey data show that less than half of eligible adults have ever 
been screened for this disease. Primary care practice is an important point 
of entry for colorectal cancer screening. The National Cancer Institute and 
Agency for Healthcare Research and Quality are interested in promoting 
research to improve colorectal cancer screening delivery, utilization, and 
outcomes in primary care practice. The objective of this Program Announcement 
is to encourage health services, social and behavioral, and outcomes 
researchers to develop innovative research projects to increase the knowledge 
base for enhanced translation of effective colorectal cancer screening 
techniques into community practice. Both R21 and R01 projects will be 
supported by this program.

RESEARCH OBJECTIVES

Screening tests in current use for the detection of adenomatous polyps and 
colorectal carcinomas include the fecal occult blood test (FOBT), flexible 
sigmoidoscopy, colonoscopy, and double-contrast barium enema (DCBE). These 
tests differ in their costs, risks, complexity of administration, and in the 
level of evidence to support their use. Results from three randomized trials 
demonstrate mortality reductions associated with FOBT screening ranging from 
15-33%. Evidence to support screening sigmoidoscopy primarily comes from 
three case-control studies demonstrating colorectal cancer mortality 
reductions ranging from 59-80%. The efficacy of DCBE and of colonoscopy in 
reducing colorectal cancer has been less studied. In general, FOBT is 
regarded as the least costly, most easily administered CRC screening test and 
colonoscopy as the most costly and complicated test. Because colonoscopy is 
the only screening modality that permits direct visualization of the entire 
colon as well as removal of precancerous and cancerous lesions, there has 
been debate as to whether colonoscopy should be considered the “preferred” 
colorectal cancer screening modality. The high costs, invasiveness, limited 
data on safety and efficacy, and restricted insurance coverage and provider 
availability associated with this modality have precluded most major expert 
groups from issuing screening guidelines that designate colonoscopy as a 
screening strategy that is preferable to FOBT, sigmoidoscopy, or DCBE. The 
recent change in Medicare reimbursement policy to extend coverage of 
screening colonoscopy to average-risk beneficiaries age 50 and older is 
contributing to increased use of this modality, and underscores the need for 
data to evaluate its acceptance, delivery, and utilization, especially in 
community practice.

Health services delivery refers to the activities of providers of care and 
utilization to the extent and kind of health services used by patients. 
Outcomes assessment involves an examination of the short-term results of 
and/or long-term impact of health services. Knowledge about delivery, 
utilization, and outcomes of colorectal cancer screening in primary care 
practice is limited. In particular, whether screening in community settings 
approximates outcomes as determined in controlled clinical studies is 
unknown. Data are needed on the sensitivity, specificity, and predictive 
value of various colorectal cancer screening approaches in community 
practice. Similarly, data on the acceptability of and adverse events 
associated with various screening strategies as delivered in community 
practice would make an important public health contribution.

Although increasing, screening rates for colorectal cancer remain relatively 
low in the U.S. Data from the 2000 National Health Interview Survey (NHIS) 
show that only about 43% of adults aged 50 or older reported having FOBT 
within the preceding year or colorectal endoscopy within the past 10 years. 
Analysis of NHIS data also indicates that higher income and educational 
attainment and having health insurance and a usual source of health care are 
all important factors associated with receipt of colorectal cancer screening. 
Little is known, though, about specific facilitators of or barriers to 
colorectal cancer screening delivery and utilization in primary care 
practice. What characteristics of the primary care setting influence 
providers to recommend colorectal cancer screening to their patients, and 
what factors influence patient decisions to comply? What factors facilitate 
the adoption of colorectal cancer screening guidelines by clinicians and how 
does this affect screening prevalence? What methods help physicians and their 
patients to make informed and shared decisions about the benefits and risks 
of colorectal cancer screening? Further research is needed to assess and 
inform interventions that will have the greatest potential for increasing 
colorectal cancer screening utilization and integrating colorectal cancer 
screening delivery into primary care practice. In addition, the extent to 
which implementation of organized approaches to colorectal cancer screening 
delivery influences colorectal cancer screening utilization has not been 
systematically documented. Moreover, whether diverse types of primary care 
practices, such as clinics, single or multi-specialty group practices, 
community health centers, or networks of primary care practices, are able to 
gather and systematically assess data on colorectal cancer screening 
delivery, utilization, and short-term outcomes in community practice remains 
to be demonstrated.

For the majority of the U.S. population, primary care is the main point of 
entry into the health care system. Provision of prevention and health 
promotion services, including cancer screening, is an important component of 
primary care practice. Even when the primary care physician does not him or 
herself deliver a health care service such as screening endoscopy or DCBE for 
the early detection of colorectal cancer, he or she may be responsible for 
recommending and facilitating referrals for this preventive service for 
eligible patients. For these reasons, this Program Announcement is directed 
toward enhancing understanding of colorectal cancer screening delivery, 
utilization, and outcomes in primary care practice. A variety of community-
based primary care organizations and networks are eligible to participate in 
research supported by this Program Announcement. Because of their multi-
practice organization and focus on conducting research in community-based 
primary care practice settings, primary care practice-based research networks 
or similar organizational structures for delivering and evaluating primary 
care may be well-suited to undertaking the type of research outlined in this 
Program Announcement. Health care organizations such as HMOs, community 
health centers, large clinics or networks of community-based practices, and 
Community Clinical Oncology Programs (CCOPs) also are encouraged to submit 
applications in response to this Program Announcement. 

Research Goals and Scope
 
This Program Announcement supports research to improve the delivery and 
uptake, and evaluate the short-term outcomes of colorectal cancer screening 
in primary care practice. It addresses the priorities for social and 
behavioral and health services research identified in the NCI Colorectal 
Cancer Progress Review Group report issued in April 2000 
(http://prg.nci.nih.gov/colorectal/finalreport.html). It is intended to 
support efforts in primary care practice to develop the capability for 
obtaining and evaluating patient, provider, practice, and clinical data 
and/or conducting interventions to assess and enhance colorectal cancer 
screening delivery, utilization, and outcomes. Such capability may entail 
establishing interfaces with specialty practices, particularly 
gastroenterologists, so that data on screening and follow-up procedures such 
as colonoscopy that are typically conducted by specialists are obtained. In 
addition, linkage to pathology laboratories to obtain data on colorectal 
lesions, particularly benign pathology, and/or to a high-quality cancer 
registry to obtain data on cancer outcomes may be required. Furthermore, 
development of the capacity to collect and evaluate longitudinal data on the 
entire process of screening (i.e., ever, repeat, follow-up) is encouraged. 
Priority will be given to applications involving 10 or more physician 
practices; that have access to large, diverse, or underserved population 
groups; in which there are established referral linkages to specialty 
practices (i.e., gastroenterologists, surgeons, or diagnostic radiologists); 
and in which clinical sites have the ability to obtain data electronically. 
Moreover, because of the paucity of data on use of colonoscopy in community 
practice, sites that have the ability to obtain and evaluate data on 
colonoscopy as a screening and/or follow-up modality are encouraged to 
incorporate this modality in their applications.

This Program Announcement is jointly sponsored by the Applied Research and 
Behavioral Research Programs, Division of Cancer Control and Population 
Sciences, National Cancer Institute (NCI), and the Center for Primary Care, 
Prevention, and Clinical Partnerships, Agency for Healthcare Research and 
Quality (AHRQ). NCI and AHRQ will work collaboratively and, contingent upon 
the availability of funds, anticipate sponsoring a meeting of grantees funded 
under this Program Announcement to facilitate future planning and program 
direction. 

Research topics to be supported are those falling within areas of clear 
importance to assessing the delivery, utilization, and short-term outcomes of 
colorectal cancer screening in primary care practice. These topics include, 
but are not limited to, those described below. If applying for funding under 
the R21 mechanism, investigators should specify research objectives and plans 
that can be realistically achieved within the budget and time limits 
associated with this mechanism. Preliminary data are not required for R21 
applications.

Investigators intending to use administrative claims as their primary data 
source should direct their applications to PA-04-012: Cancer Surveillance 
Using Health Claims-Based Data System.

1.  Develop appropriate interventions, mechanisms, or systems to monitor the 
completion of and improve compliance with colorectal cancer screening and 
follow-up. This includes tracking procedures such as sigmoidoscopy, 
colonoscopy, or DCBE for which patients may be referred to specialty 
providers. Development of interventions, mechanisms, or systems that utilize 
information technologies or computerized patient records to facilitate 
monitoring and to improve compliance with colorectal cancer screening is 
especially encouraged.

2.  Pilot or refine theories that could inform future interventions to 
enhance colorectal cancer screening utilization that consider diverse 
populations and primary care settings.

3.  Evaluate how the risk for colorectal cancer is assessed in the primary 
care setting and propose strategies to improve physician and patient informed 
and shared decision-making regarding colorectal cancer screening options.

4.  Develop innovative data collection approaches to enable evaluation of 
colorectal cancer screening delivery, utilization, and short-term outcomes in 
busy practice settings. Development of information technologies to facilitate 
the acquisition of complete, accurate data while minimizing disruption to 
busy practices is especially encouraged. Data elements of particular 
relevance could include patient sociodemographics; colorectal cancer risk 
factors; screening tests recommended and performed; follow-up tests 
recommended and performed; test results; adverse events associated with 
screening or follow-up tests; characteristics of tests performed; 
characteristics of performing providers; patient and provider knowledge, 
attitudes, and practices; characteristics of lesions identified, including 
cancer; and characteristics of the primary care practice setting, including 
use of office reminder systems.

5.  Develop and/or validate open source data collection instruments to assess 
patient and provider screening-related knowledge, attitudes, preferences, and 
practices that account for differences among population groups as well as 
among primary care practice settings.

6.  Develop measures, scales, and/or instruments to assess the utilization of 
and adherence to colorectal cancer screening over time that take into account 
the multiple available screening modalities and recommended screening 
intervals that vary by modality.

7.  Assess the feasibility and acceptability of conventional and emerging 
screening technologies from the patient and/or provider perspectives, in 
community practice.

8.  Determine the extent to which data collection procedures in community-
based practices for established screening modalities such as conventional 
FOBT and sigmoidoscopy can be readily adapted for new and emerging screening 
technologies such as colonoscopy, CT colonography, immunochemical FOBT, 
stool-based DNA marker testing, etc.

9.  Evaluate screening utilization and the efficiency and effectiveness of 
screening delivery in community practice, including screening and compliance 
rates by provider type, modality, and population group; time to completion of 
recommended screening and follow-up procedures; quality of procedures; or 
adverse events by provider type, modality, and population group.

10.  Determine the performance characteristics (i.e., sensitivity, 
specificity, and predictive value) in terms of ability to detect precancerous 
lesions and early-stage colorectal cancer, for various colorectal cancer 
screening modalities, as implemented in community practice.

11.  Identify factors that may influence performance characteristics for 
colorectal cancer screening procedures in community-based practices. Factors 
examined could include characteristics of different population groups, 
provider types, and practice organizations, or technical aspects such as test 
or equipment type.

12.  Develop innovative approaches to promoting colorectal cancer screening 
utilization in diverse populations that take into account multiple levels of 
intervention. Projects that address populations with compromised access are 
of particular interest.

13.  Develop innovative approaches that attempt to integrate the delivery of 
colorectal cancer screening with other preventive health services provided in 
the primary care setting.

MECHANISMS OF SUPPORT 

This PAR will use the NIH Research Project (R01) and 
Exploratory/Developmental (R21) award mechanisms.  As an applicant, you will 
be solely responsible for planning, directing, and executing the proposed 
project.  The total project period for an application submitted in response 
to this PAR may not exceed 2 years for an R21 application and 5 years for an 
R01 application. For an R21 application 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.  There is no 
dollar limit for R01 applications.

This PAR uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (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.  Otherwise follow the instructions 
for non-modular research grant applications.  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 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 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:

o Direct your questions about scientific/research issues to:

Carrie N. Klabunde, Ph.D.
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
EPN 4005; 6130 Executive Boulevard
Bethesda, MD  20892-7344
Telephone:  (301) 402-3362
FAX:  (301) 435-3710
Email: ck97b@nih.gov

Erica S. Breslau, Ph.D.
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
EPN 4098; 6130 Executive Boulevard
Bethesda, MD  20892
Telephone: (301) 435-2839
FAX: (301) 480-6637
E-mail: breslaue@mail.nih.gov

David Lanier, M.D., M.P.H.
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Policy and Research
540 Gaither Road 
Rockville, MD 20850 
Telephone: (301) 427-1567 
FAX: (301) 427-1595
Email: dlanier@ahrq.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
Telephone: (301) 496-3428
FAX: (301) 402-0275 
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 - 243
Bethesda, MD  20892
Telephone:  (301) 496-8634sa
FAX:  (301) 496-4801
Email: wolfreyc@mail.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PAR 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Carrie N. Klabunde, Ph.D.
Applied Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
EPN 4005; 6130 Executive Boulevard
Bethesda, MD  20892-7344
Rockville, MD 20852 (express/courier service)
Telephone:  (301) 402-3362
FAX:  (301) 435-3710
Email: ck97b@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 checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted by the receipt dates 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.

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.      

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1. Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2. Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3. Identify, in a cover letter sent with the application, the staff member 
who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

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)

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 dates listed on the first page of this program announcement. 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 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 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 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 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 applied to ALL applications 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 

Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
 
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

Letter of Intent Receipt Dates: January 23, 2004; September 22, 2004; 
January 24, 2005; May 23, 2005
Application Receipt Dates:  February 23, 2004; October 22, 2004; 
February 23, 2005; June 23, 2005
Peer Review Dates:  June 2004; March 2005; June 2005; November 2005
Council Review:  September 14, 2004; June 7, 2005; September 20, 2005; 
February 2006
Earliest Anticipated Start Dates: December 2004, July 2005; December 2005; 
April 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).  

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 
PAR 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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