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

ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE

Release Date:  October 4, 2001

PA NUMBER:  PA-02-005 (see replacement PA-04-017)

National Cancer Institute (NCI)
Agency for Healthcare Research and Quality (AHRQ)

This Program Announcement (PA) replaces PA-99-014, which was published in the 
NIH Guide on November 12, 1998.

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. 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 study sections requires complete budget information in their 
review, all applications assigned, after initial submission, to AHRQ for 
review and funding considerations will be requested to submit detailed budget 
pages prior to the study section review.

PURPOSE
 
The Division of Cancer Control and Population Sciences (DCCPS), National 
Cancer Institute (NCI) and the Agency for Health Care Research and Quality 
(AHRQ), invite investigator-initiated grant applications for research 
directed at increasing the knowledge base in the area of the economic aspects 
of cancer prevention, screening and care.  The goal of this program 
announcement is to generate new economic knowledge that will promote the 
optimal design of cancer prevention and control trial studies and 
interventions and will facilitate the formulation of effective health care 
policy related to cancer prevention and control.  NCI has an interest in 
economic and health services studies with particular emphasis on meeting the 
goals of the NCI Quality of Cancer Care Initiative 
(http://plan2002.cancer.gov/infquality.htm).  The overall goal of this 
Initiative is to enhance the state of the science on the quality of cancer 
care and inform federal decision making on care delivery, coverage, and 
regulation..  This initiative requests research applications on new methods 
development, the synthesis and extension of existing methods, and innovative 
data gathering strategies.  Applications that propose to implement actual 
data collection on a pilot or full-scale basis as well as analytical studies 
that use existing data and methodology may also be submitted.

This Program Announcement (PA) relates to the general health services and 
outcomes and effectiveness research supported by the AHRQ for a wide range of 
clinical conditions, including cancer.  For example, AHRQ is presently 
supporting research that supports improvements in health outcomes, 
strengthens quality measurement and improvement, identifies strategies to 
improve access, foster appropriate use, and reduce unnecessary expenditures, 
and methodologic advances in health services research, especially 
cost-effectiveness analysis.  Related research priorities are described in 
AHRQ Health Services Research Program Announcement PA-00-111, which is 
available on the WEB at:  
http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html

RESEARCH OBJECTIVES

Background

There is increasing interest in the collection and analysis of valid, 
accurate and reliable economic data related to specific disease entities and 
preventive, screening and treatment intervention related to specific disease 
entities.  For example, the 1998 Institute of Medicine report on Scientific 
Opportunities and Public Needs: Improving Priority Setting and Public Input 
at the NIH (see http://www.nap.edu/readingroom/books/nih/) recommends that, 
"In setting priorities, NIH should strengthen its analysis and use of health 
data, such as burdens and costs of diseases, and of data on the impact of 
research on the health of the public."  The DHHS panel on cost effectiveness 
in health and medicine (As summarized in Gold MR, et al.  Cost Effectiveness 
in Health and Medicine.  Oxford University Press, 1996) recognized that for 
purposes of health care program and policy evaluation economic data on 
diseases and health care interventions must go beyond the type of aggregate 
data needed for cost of disease studies to include longitudinal data on 
direct medical costs as well as data on time and productivity costs related 
to diseases and health care interventions.

Scope of Activity

This initiative supports research directed at increasing our understanding of 
economic aspects of cancer prevention, screening and care.  Cancer is a 
heterogeneous chronic disease characterized by innovation in treatment and 
care approaches.  Studies that cover the national population of all ages on 
an episodic basis fail to capture an adequate sample of cancer patients or 
the full scope and duration of cancer costs.  Studies that focus on a 
convenience sample of cancer patients in a single health care delivery 
setting or community can be criticized as lacking external validity.  Studies 
proposed in response to this PA will be expected to address these issues and 
propose innovative methods of overcoming these limitations.  

Examples of research topics that would be considered relevant to meeting the 
goals of this PA include:

1.  The economic burden to the individual cancer patient, family and society 
resulting from cancer and cancer treatment, including time costs, reduced 
employment opportunities and reduced access to health and life insurance.

2.   Economic factors at the individual, community and health system level 
that effect access to and outcomes following the use of cancer-related 
prevention, screening, diagnostic and treatment services.

3.  The cost and organizational structure of delivering cancer prevention, 
screening and treatment services in relation to various health care delivery 
settings and health care market structure conditions.

4.  Cost-utility, cost-effectiveness or cost-benefit of specific cancer 
prevention and screening trials and cancer prevention and control 
interventions.

5.  The interaction of cost, cost-effectiveness and other factors in decision 
making process related to the provision and delivery of cancer prevention, 
screening and treatment at the physician-patient, health system and health 
policy levels.

6.  The role of economic factors and financial incentives in determining the 
level of participation of patients, physicians and health care delivery 
systems in cancer prevention, screening and treatment clinical trials. 

7.  The identification, development and validation of data resources needed 
to support relevant and generalizable economic evaluation studies related to 
cancer prevention, screening and treatment. 

8.  Methodological studies on the measurement, evaluation and presentation of 
data on cost and cost-utility/effectiveness/benefit in relation to cancer 
specific issues.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health 
(NIH) research project grant (R01) or an exploratory/developmental grant 
(R21).  Applicants will be responsible for planning, direction and execution 
of the proposed project.  Awards will be administered under NIH grants policy 
as stated in the NIH Policy Statement. The total project period for an 
application submitted in response to this PA may not exceed 5 years for an 
R01 application and 2 years for an R21 application. Applicants without 
extensive preliminary data or who wish to explore the utility of claims-based 
data to address a specific question are urged to submit applications for this 
PA using the exploratory/developmental grant mechanism. Investigators are 
encouraged to seek continued support after completing an exploratory/ 
developmental grant project through a research project grant (R01). 

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and  JUST-IN-TIME" streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at:  
http://grants.nih.gov/grants/funding/modular/modular.htm.

For R21 submissions, applicants may request up to $100,000 direct costs (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.

ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and 
non-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators. 

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Martin Brown, Ph.D.
Applied Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 4005
Bethesda, MD  20892-7344
Telephone:  (301) 496-5716
FAX:  (301) 435-3710
Email:  mb53o@nih.gov

Yen-pin Chiang, Ph.D.
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
6010 Executive Boulevard, Suite 300
Rockville, MD  20852
Telephone:  (301) 594-4035
FAX:  (301) 594-3211
Email: ychiang@ahrq.gov

Direct inquiries regarding fiscal matters to:
 
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South - 243
Bethesda, MD  20892
Telephone:  (301) 496-8634
FAX:  (301) 496-4801
Email: wolfreyc@mail.nih.gov

Mabel Lam
Agency for Health Care Research and Quality
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone: (301) 594-1447  X1165

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format. Beginning January 10, 2002, the NIH will return 
applications that are not submitted on the 5/2001 version.  For further 
assistance contact GrantsInfo, Telephone 301/710-0267, Email: 
GrantsInfo@nih.gov.

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

This policy requires an applicant to obtain agreement for acceptance of any 
such application and any such subsequent amendment.  Refer to the NIH Guide 
for Grants and Contracts, March 20, 1998 at  
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award. It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, 
however, to use the 4/1998 revision of the PHS 398 for scheduled application 
receipt dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step instructions for 
Modular Grants available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Additional 
information about Modular Grants is also available on this site.

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 five signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS
 
Applications will be assigned based on established NIH referral guidelines.  
Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened in accordance with the standard 
NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, 
generally the top half of applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board. 

Review Criteria
 
The five criteria to be used in the evaluation of grant applications are 
listed below.
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
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 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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups, if applicable, and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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.  
Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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.

REQUIREMENTS FOR SHARING RESEARCH RESOURCES

NIH policy requires that investigators make unique research resources readily 
available for research purposes to qualified individuals within the 
scientific community when they have been published.  All investigators should 
read the Guidelines available at the following url address:  
http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm.  See also:  
NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps) and 
Sharing Biomedical Research Resources: Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 
(http://www.nih.gov/od/ott/RTguide_final.htm).  It is expected that 
biomaterials and other patentable research resources (examples could be, but 
are not limited to, vectors, embryonic cell lines, mutant mice, etc.) 
produced in projects funded by this initiative will be made available and 
distributed to the broader scientific community.

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, Economic Studies 
in Cancer Prevention, Screening and Care, is related to priority area of 
cancer control.  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, Cancer Control Research, 93.121, Oral Health Research and 93.226.  
Awards are made under authorization of the Public Health Service Act, Title 
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 
and 285) and administered under PHS grants policies and Federal Regulations 
42 CFR 52 and 67, Subpart A, and 45 CFR Part 74 and part 92.  This program is 
not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review. 

The PHS strongly encourages all grant 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.

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