NIH GUIDE, Volume 21, Number 12, March 27, 1992

PA NUMBER:  PA-92-61

P.T. 34



  Disease Prevention+ 

  Disease Control+ 


National Cancer Institute


The National Cancer Institute (NCI) invites applications for studies

covering a broad range of research related to cancer prevention and

control.  The Division of Cancer Prevention and Control (DCPC), NCI is

mandated to conduct research on cancer prevention and control and the

surveillance and monitoring of the incidence, mortality, and morbidity

of cancer.  A priority for DCPC is to develop the means for effective

translation of the knowledge gained from research in prevention and

control into disease prevention and health promotion activities for the

benefit of the public.  The goal of these efforts is to achieve

significant reductions in cancer incidence, mortality, and morbidity

with a concomitant increase in cancer survival.


The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This program

announcement, Cancer Prevention and Control Research, is related to

priority areas of cancer, nutrition, tobacco, educational and

community-based programs, clinical preventive services, and

surveillance and data systems.  Potential applicants may obtain a copy

of "Healthy People 2000" (Full Report:  Stock No. 017-011-00474-0) or

"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202-783-3238).


Applications may be submitted by domestic and foreign, for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local government,

and eligible agencies of the Federal Government.  Applications from

minority individuals and women are encouraged.


The DCPC conducts a broad array of cancer control research and

application activities that emphasize validation, evaluation, and

demonstration.  The programs range from research on prevention,

screening and early detection, to methods for applying the most

effective regimens for cancer treatment, rehabilitation, and continuing


The primary research areas are:

o  Chemoprevention - pre-clinical and clinical studies related to the

identification and evaluation of agents including nutrients that may

inhibit carcinogenesis, i.e., initiation, promotion, transformation

and/or progression of the malignant process as presently understood.

Biomarkers or cancer occurrence may serve as endpoints.

o  Nutrition and Diet - Role of nutrients, foods or other dietary

components in cancer incidence.  Influence of dietary factors on the

modulation of cancer risk markers, early indicators of cancer risk or

intermediate endpoints.  Define biochemical and molecular mechanisms by

which dietary components may act as metabolic effectors that protect,

control, or increase cancer risk.  Absorption and metabolism of

nutrients and other dietary components associated with cancer risk and

prevention.  Dietary assessment in human intervention trials.

Development of biochemical or biological markers for dietary compliance

and exposure.  Improved nutritional and dietary assessment instruments

including nutrient data bases.  Development of reliable methods for

analysis of nutrients and other components in foods, body fluids, and


o  Screening and early detection of cancer - Research to significantly

reduce cancer morbidity and mortality through early detection including

identification of markers of risk, exposure, and pre-malignant events

of progression that can be used to identify sub-populations at

particularly high risk of developing cancer.  Research is also

encouraged in the use of artificial intelligence for image processing

as well as new imaging technologies related to early detection.

Research on quality control and quality assurance related to screening

and early detection is also encouraged.

o  Community Oncology - The primary objective is to stimulate research

that will provide a basis to reduce the time between research advances

in prevention, screening, early detection, patient management, and

continuing care and the application of those advances in community


o  Rehabilitation and Pain Management - Research that focuses on the

application of rehabilitative medicine and pain management for cancer


o  Cancer Control Applications - The development and testing of

intervention strategies to modify personal, social, and lifestyle

factors known to contribute to the development and/or increased risk of


o  Special Populations - Multidisciplinary intervention research aimed

at addressing and modifying the excessive cancer incidence and/or

mortality rates, lower cancer survival rates, or inadequate cancer

prevention and control services for minority, underserved and other

special populations.

o  Surveillance - Data collection, statistical analysis and

mathematical modelling, health services research and information data

base linkage studies are required to monitor progress toward cancer

control, particularly as it pertains to national goals.


The mechanism of support will be the individual research project grant

(R01).  Policies that govern research grant programs of the National

Institutes of Health will prevail.





NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements will be required to include

minorities and women in study populations so that research findings can

be of benefit to all persons at risk of the diseases, disorder or

condition under study; special emphasis should be placed on the need

for inclusion of minorities and women in studies of diseases, disorders

and conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale should be provided.

The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information should be included in the form PHS 398 in the

Research Plan section, 1-4, AND summarized in 5, Human Subjects.

Applicants/offerors are urged to assess carefully the feasibility of

including the broadest possible representation of minority groups.

However, NIH recognizes that it may not be feasible or appropriate in

all research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans (including American Indians or Alaskan Natives),

Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for studies

on single minority population groups should be provided.

For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including


If the required information is not contained within the application,

the review will be deferred until the information is provided.

Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.


Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the standard application deadlines

as indicated in the application kit.

Application kits are available at most institutional business and

grant/contract offices and may be obtained from the Office of Grants

Inquiries, Division of Research Grants, National Institutes of Health,

Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-

7441.  The title and number of this announcement must be typed in

Section 2a on the face page of the application.

The completed original application and five legible copies must be sent

or delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be reviewed for

scientific and technical merit by study sections or an ad hoc group

developed by the Division of Research Grants, NIH.  Following

scientific-technical review, the applications will receive a

second-level review by the appropriate national advisory council.


Applications will compete for available funds with all other approved

applications assigned to that ICD.  The following will be considered in

making funding decisions:

o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement


Requests for further information may be directed to the relevant

Program Director:


Dr. Winfred Malone

Telephone: (301) 496-8567


Dr. Carolyn Clifford

Telephone: (301) 496-8573


Dr. Barnett Kramer

Telephone: (301) 496-8544


Dr. Susan Nayfield

Telephone: (301) 496-8541


Dr. Thomas Glynn

Telephone: (301) 496-8520


Dr. George Alexander

Telephone: (301) 496-8589


Dr. Brenda Edwards

Telephone: (301) 496-8506

All the above Program Directors are located at:

National Cancer Institute

Division of Cancer Prevention and Control

Executive Plaza North

9000 Rockville Pike

Bethesda, MD  20892-4200

Written and telephone inquiries concerning the objectives and scope of

this program announcement and inquiries about whether or not specific

proposed research would be responsive, clarifying scientific content

and objectives of an application, size and focus of a research program,

organization of an application, and appropriate use of consultants are

strongly encouraged and should be directed to the relevant Program

Director at the above address and telephone numbers.  The Program

Directors welcome the opportunity to clarify any issues or questions

from potential applicants.

Direct inquiries regarding fiscal matters to:

Ms. Eileen Natoli, Team Leader, PC Team

Grants Administration Branch

National Cancer Institute

Executive Plaza South, Room 243

6120 Executive Boulevard

Bethesda, MD  20852

Telephone:  (301) 496-7800 ext. 56


This program is described in the Catalog of Federal Domestic Assistance

No. 93.399.  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 45 CFR Part 74.  This

program is not subject to the intergovernmental review requirements of

Executive Order 12372 or Health System Agency review.


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