NIH Guide, Volume 22, Number 14, April 9, 1993

PA NUMBER:  PA-93-070

P.T. 34



  Disease Control+ 

  Health Promotion 

  Disease Prevention+ 



National Cancer Institute

Application Receipt Dates:  June 1 and October 1 of 1993, 1994, and



The National Cancer Institute (NCI) invites applications for small

research grants (R03) in cancer prevention and control.  This program

announcement is designed to aid and facilitate the growth of a

nationwide cohort of scientists with a high level of research expertise

in the field of human cancer control intervention research.

New and experienced investigators in relevant fields and disciplines

(e.g., disease prevention and control, medicine, public health, health

promotion, epidemiology, social work, nursing research, nutrition,

health policy, health services research, and behavioral sciences, such

as psychology, health education, sociology, and community organization)

may submit applications to test ideas or do pilot studies.


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 PA,

Cancer Prevention and Control Research Small Grant Program, is related

to the priority areas of cancer, nutrition and tobacco.  Potential

applicants may obtain a copy of "Healthy People 2000" (Full Report:

Stock No. 017-001-00474-0) 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)



Eligible applicants include established researchers, new investigators,

qualified staff of public health and collaborating agencies, and

predoctoral investigators currently enrolled in an accredited doctoral

degree program.  Ineligible applicants are those who are or have

previously been Principal Investigator (PI) on an NCI funded Cancer

Control grant or contract for more than two years; previous recipients

(PIs) of a DCPC Small Grant; and foreign institutions.  Small grant

research support may NOT be used to supplement research projects

currently supported by Federal or non-Federal funds, or to provide

interim support of projects under review by the Public Health Service.


Support of this program will be the small grant (R03) funding

mechanism.  Total direct costs up to $50,000 are allowed.  The total

project period may not exceed two years.


This program is designed to encourage investigators from a variety of

academic, scientific, and public health disciplines to apply their

skills to scientific investigations in the field of human cancer

control intervention research.  The research may occur in a variety of

settings, such as universities, cancer centers, communities, schools,

health departments, laboratories, and worksites.

Investigators may choose any of the full range of scientific approaches

to their work.  Many studies and research designs may contribute to the

design, implementation, or evaluation of future phase III-V studies,

e.g., descriptive baseline surveys, testing, modification and

validation of surveys or program materials for use in the proposed

population groups, testing of recruitment or compliance procedures for

participants, and the like.  Applications should include justification

of study design and sample size, as well as clearly indicate the

significance of the research and where it will lead.

The following cancer control program areas are appropriate for Human

Intervention research grant applications:

o  Prevention - chemoprevention, diet and nutrition intervention


o  Screening and early detection - pilot studies of new methods;

application of the "NCI Guidelines for Early Detection."  In the area

of breast screening and detection, studies of breast self-examination

as a single modality will not be accepted.

o  Cancer control sciences - studies to change current behaviors and/or

institute new behaviors or health promotion interventions effective in

reducing incidence, morbidity or mortality from cancer.

o  Smoking prevention and cessation - pilot studies targeted at

improving utilization of current technologies in target populations or

organizations are encouraged.  Minor enhancements of existing

technology are not encouraged.

o  Applications research - in modifying, feasibility testing, and

adopting proven state-of-the-art intervention programs and strategies

from other research projects (e.g., screening, smoking prevention,

etc.) for use in special populations, state and local health agencies,

or other organizational and community setting.

In addition, planning, epidemiologic, and survey studies aimed at

developing cancer control operations research and evaluation studies

are appropriate for human intervention research grant applications.

o  Community oncology - improving the application of patient

management, pain and symptom management, rehabilitation and continuing

care research advances into community settings.

o  Applied epidemiology studies - using epidemiologic methods to

determine the association between exposure to an intervention and its

impact on disease.

Although the specific study proposed may attempt only to obtain

preliminary data and/or conduct pilot studies in support of a future,

more detailed Phase III-V study, it is important that a long-term human

cancer control hypothesis and supporting scientific justification be



Studies to determine the efficacy of chemotherapy, surgery,

radiotherapy and other primary treatment interventions are not

considered cancer control research under this PA.  Any laboratory

animal studies are not allowed.





NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women in

study populations so that research findings can be of benefit to all

persons at risk of the disease, disorder or condition under study;

special emphasis should be placed on the need for inclusion of

minorities 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 (rev.

9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5,

Human Subjects.  Applicants 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 Unites 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 must be provided.

For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies or 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.

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.


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

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

in this announcement.  Applications received after the October 1

receipt date will be returned to the applicant.

Application kits are available at most institutional office of

sponsored research and may be obtained from the Office of Grant

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

Westwood Building, Room 449, Bethesda, MD 20892, telephone (301)

710-0267.  The title and number of this announcement must be typed in

Section 2a on the face page of the application.

Note that the following additional page limitations (typewritten,

single-spaced) apply to the Research Plan of the application:

Research Plan (14 pages total; a suggested page distribution is as


o  Specific Aims - one page. Clearly state the cancer control

hypothesis and intervention to be studied.

o  Background and Significance - one page.

o  Progress Report and Preliminary Studies - if applicable, two pages.

o  Research Design and Methods - 10 pages.

Following the research plan, include the discussion of Human Subjects

and the literature cited.  Appendices are acceptable.  These page

limitations and others in the PHS 398 Application Instructions must be

observed or the application will not be accepted.

The completed original application and four copies must be sent or

delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**

Also send a copy of the application to the Ms. Helen Meissner at the

address listed under INQUIRIES when the grant is submitted.

Applications responding to this PA should include one round trip, two-

day meeting to Bethesda, MD in the budget.


Applications will be assigned on the basis of established PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by an appropriate review group of the NIH.


Applications will compete for available funds with all other approved

applications assigned to the National Cancer Institute. Funding

decisions will be based upon quality of the proposed project as

determined by peer review, availability of funds, and program balance

among research areas of the announcement.


Written and telephone inquiries are encouraged.  Direct inquiries

regarding programmatic issues to:

Helen I. Meissner, Sc.M.

National Cancer Institute

Executive Plaza North, Room 330

Bethesda, MD  20892

Telephone:  (301) 496-8520

Direct inquiries regarding fiscal matters to:

Ms. Eileen Natoli

Grants Administration Branch

National Cancer Institute

Executive Plaza South, Room 243

Bethesda, MD  20892

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 grant

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 Systems Agency review.


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