This Program Announcement expires on June 23, 2003, unless reissued.

COLORECTAL CANCER SCREENING IN PRIMARY CARE PRACTICE
 
Release Date:  December 20, 2001 (see addendum NOT-CA-03-012)
 
PAR NUMBER:  PAR-02-042 (see replacemnet PAR-04-036)
 
National Cancer Institute
 (http://cancer.gov)
Agency for Healthcare Research and Quality
 (http://www.ahrq.gov/)

Letter of Intent Date:     May 16, 2002, September 18, 2002, January 16, 2003, 
                           May 16, 2003
Application Receipt Date:  June 20, 2002, October 23, 2002, 
                           February 20, 2003, June 20, 2003

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAN $250,000 PER YEAR IN ALL YEARS.  MODULAR BUDGET INSTRUCTIONS ARE 
PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

Since AHRQ requires complete budget information in the pre-award 
administrative and budgetary review process, all applications being 
considered for funding by AHRQ will be requested to submit detailed budget 
pages prior to award.

PURPOSE

Colorectal cancer 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 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 Health Care 
Research and Quality are interested in promoting research to enhance 
understanding of colorectal cancer screening delivery, utilization, and 
outcomes in primary care practice. The objective of this Program Announcement 
is to encourage applications for exploratory/developmental grants (R21) 
designed to improve the delivery and uptake and evaluate the short-term 
outcomes of colorectal cancer screening in primary care practice.

RESEARCH OBJECTIVES

Background

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. For example, 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 colonoscopy 
and of DCBE in reducing colorectal cancer have 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. To date, the high costs, 
invasiveness, lack of data on safety and efficacy, restricted insurance 
coverage, and limited 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 likely to spur increased use of this modality, and underscores 
the need for data to evaluate its 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 use of health services by patients. 
Thus, delivery is assessed from the provider perspective and utilization from 
the patient perspective. Outcomes assessment involves an examination of the 
short-term results of and/or long-term impact of health services. Little is 
known about these factors for colorectal cancer screening in primary care 
practice. 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 1998 National Health Interview Survey (NHIS), 
an in-person household survey of a nationally representative sample of the 
noninstitutionalized U.S. population, show that only about 27% of adults aged 
50 or older reported having FOBT within the preceding two years and only 14% 
reported having a sigmoidoscopy within the past three years. Analysis of 1998 
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? 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 referral arrangements 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 might be particularly well-suited to undertaking the 
type of research outlined in this Program Announcement. In addition, health 
care organizations such as HMOs, community health centers, large clinics or 
networks of community-based practices, and Community Clinical Oncology 
Programs (CCOPs) 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 behavioral and health 
services research identified in the NCI Colorectal Cancer Progress Review 
Group report issued in April 2000 (http://osp.nci.nih.gov/cprgreport).  It is 
intended to support efforts in primary care practice to develop the 
capability for gathering 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 longitudinal data on the entire 
process of screening as well as repeat screening 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 collect data electronically. Moreover, 
because of the paucity of data on use of colonoscopy in community practice, 
sites that have the ability to collect 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 
Research, 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. Assuming 
the availability of funds and the successful completion of studies undertaken 
through this Program Announcement, it is anticipated that a future funding 
mechanism to support larger-scale studies of the diffusion and effectiveness 
of colorectal cancer screening as applied in broad populations and community 
settings will be offered.

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. Investigators should specify 
research objectives and plans that can be realistically achieved within the 
budget and time limits associated with the R21 funding mechanism.

1.  Develop appropriate interventions, mechanisms, or systems for monitoring 
the completion of and improving 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 the completion of or improving 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 risk for colorectal cancer is assessed in the primary care 
setting and propose strategies to improve patient 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 
obtaining 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, 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 perspective, 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.  Test the feasibility of innovative approaches to promoting colorectal 
cancer screening utilization in diverse populations that take into account 
multiple levels of intervention. 

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.

MECHANISM OF SUPPORT

This Program Announcement uses the National Institutes of Health (NIH) 
exploratory/developmental (R21) grant mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely 
that of the applicant.  The total project period for an application submitted 
in response to this PA may not exceed TWO years.  Though the size of award 
may vary with the scope of research proposed, it is expected that 
applications will stay within the budgetary guidelines for an 
exploratory/developmental project, direct costs are limited to $100,000 (four 
budget modules) per year unless the application includes consortium costs, in 
which case the limit is $125,000 direct costs (five budget modules) per year.  
These grants are non-renewable and continuation of projects developed under 
this Program Announcement will be through the traditional unsolicited 
investigator initiated grant program.  The earliest anticipated award date is 
January 2003.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and not-
for-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators. Faith-based organizations are also eligible to apply to this 
PAR.

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Carrie Klabunde, Ph.D.
Applied Research Program
National Cancer Institute, DCCPS
EPN 4005, 6130 Executive Boulevard
Bethesda, MD  20892-7344
Telephone:  301/402-3362
FAX:  301/435-3710
E-mail:  Ck97b@nih.gov

Helen Meissner, Ph.D.
Behavioral Research Program
National Cancer Institute, DCCPS
EPN 4102, 6130 Executive Boulevard
Bethesda, MD  20892
Telephone:  301/435-2836
FAX:  301/480-6637
E-mail:  hm36d@nih.gov

David Lanier, M.D., M.P.H.
Center for Primary Care Research
Agency for Healthcare Research and Quality
Room 210
6010 Executive Boulevard
Rockville, MD  20852
Phone:  301/594-1489
FAX:  301/594-3721
E-mail:  dlanier@ahrq.gov

Direct inquiries regarding fiscal matters to:
 
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
EPS 243
6120 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email:  crystal.wolfrey@nih.gov

Direct inquiries regarding review matters 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)
Telephone:  (301) 496-3428
Fax:  (301) 402-0275
Email:  ncidearefof-r@mail.nih.gov

LETTER OF INTENT 

Prospective applicants are asked to submit, four weeks in advance of the 
application receipt date as indicated on the first page of this PA, a Letter 
of Intent that includes a descriptive title of the proposed research, the 
name, address, and telephone number of the Principal Investigator, the 
identities of other key personnel and participating institutions, and the 
number and title of the PA in response to which the application may be 
submitted.  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 to Dr. Carrie Klabunde, at the address 
listed under INQUIRIES.

APPLICATION PROCEDURES

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 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.

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.

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES with any questions regarding the adherence to the guidelines of 
their proposed project to the goals of this PA.
 
All clinical trials supported or performed by NCI require some form of 
monitoring.  The method and degree of monitoring should be commensurate with 
the degree of risk involved in participation and the size and complexity of 
the clinical trial.  Monitoring exists on a continuum from monitoring by the 
principal investigator/project manager or NCI program staff to a Data and 
Safety Monitoring Board (DSMB).  These monitoring activities are distinct 
from the requirement for study review and approval by an Institutional Review 
Board (IRB).  For details about the Policy of the NCI for Data Safety 
Monitoring of Clinical Trials see 
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 to 
http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines.

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

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

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

To expedite the review process, at the time of submission, send two 
additional copies of the application to:  

Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8109
Rockville, MD 20852 (for overnight/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 402-0275

Applications must be received by the receipt dates listed at the beginning of 
this program announcement.  

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.

The Center for Scientific Review (CSR) will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application. The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS
 
Applications will be reviewed for completeness by the Center for Scientific 
Review and for adherence to the guidelines to this PA by the National Cancer 
Institute.  Incomplete applications will be returned to the applicant without 
further consideration.  Applications that are complete and adhere to the 
guidelines of this PA will be evaluated for scientific and technical merit by 
an appropriate scientific review group convened by the National Cancer 
Institute in accordance with the standard NIH peer review procedures.  As 
part of the initial merit review, all applications will receive a written 
critique, and may undergo a process in which only those applications deemed 
to have the highest scientific merit, generally the top half of applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Cancer Advisory Board. 

Review Criteria
 
The five criteria to be used in the evaluation of grant applications are 
listed below.
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.
 
1.  Significance.  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?
 
2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?
 
3.  Innovation.  Does the project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative? Does the project challenge 
existing paradigms or develop new methodologies or technologies?
 
4.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?
 
5.  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional 
support?

The initial review group will also examine: 

o  the appropriateness of proposed project budget and duration, 
o  the adequacy of plans to include both genders, minorities (and their 
subgroups), and children as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects, 
o  the provisions for the protection of human and animal subjects, 
o  the safety of the research environment,
o  the adequacy of the proposed plan to share instruments, measures, and/or 
data.   

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

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

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
It is the policy of the NIH that women and members of minority groups and 
their 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 AMENDMENT "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.

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are clear and compelling scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for 
Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at 
the following URL address:  
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 now 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.  It is 
not likely that data gathered under projects supported through this 
initiative will be used as a basis for federal regulation or action having 
the force and effect of law. However, should applicants wish to place data 
collected under this PA in a public archive, which can provide protections 
for the data (e.g., as required by the confidentiality statute applicable to 
AHRQ supported projects, 42 U.S.C. 299c-3c) and manage the distribution of 
nonidentifiable data for an indefinite period of time, they may.  The 
application should include a description of any 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.

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.  Reviewers are cautioned 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, Colorectal Cancer 
Screening in Primary Care Practice, is related to the priority area of 
reducing the incidence of and disability and deaths from colorectal cancer.  
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 No. 
93.399 (NCI) and 93.226 (AHRQ).  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies and Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  AHRQ awards are made under Title IX of 
the PHS Act and administered under AHRQ grant policies and Federal 
Regulations, 42 CFR Part 67, Subpart A. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.



Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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


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