SURGICAL ONCOLOGY 

NIH GUIDE, Volume 21, Number 20, May 29, 1992

 

PA NUMBER:  PA-92-81

 

P.T. 34



Keywords:

  Cancer/Carcinogenesis 

  Oncology 

  Surgery 

 

National Cancer Institute

 

PURPOSE

 

The Division of Cancer Treatment (DCT) of the National Cancer Institute

(NCI) is seeking applications for investigator-initiated research

grants concerned with research in surgical oncology.  The Principal

Investigator must be a surgeon.  This Program Announcement (PA) is

designed to promote and develop a strong cadre of academic surgeons

involved in clinical research.  A PA is used to stimulate

investigator-initiated research projects in areas of special interest

to the National Cancer Program.

 

HEALTHY PEOPLE 2000

 

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, Surgical Oncology, is related to the priority area of

cancer.  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 202/783-3238).

 

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.  Applications from

minority individuals and women are encouraged. Applications from one or

more institutions (individual institutions, consortia, cancer centers)

with established clinical, laboratory, and statistical resources are

solicited.  Foreign institutions are not eligible for the First

Independent Research Support and Transition (FIRST) Award.  The special

eligibility criteria for the FIRST Award (R29) can be found in the

Guidelines for FIRST Award (version February 1991).  The Guidelines for

FIRST Award can be obtained from the Grants Inquiries Office, Division

of Research Grants, NIH (301-496-7441).

 

MECHANISM OF SUPPORT

 

Awards will be made as FIRST Awards (R29s), research project grants

(R01s) and interactive R01s in accordance with Public Health Service

(PHS) policies applicable to research project grants.  A description of

an interactive R01 application can be found in the NIH Guide for Grants

and Contracts (Vol. 21, No. 1, January 10, 1992) under PA-92-29.

Responsibility for the planning, direction, and execution of the

proposed research will be solely that of the applicant.  Awards will be

administered under PHS grants policy as stated in the Public Health

Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000,

revised October 1, 1990.

 

RESEARCH OBJECTIVES

 

Summary

 

The treatment of cancer has evolved as multi-disciplinary effort

involving, but not limited to, the disciplines of surgical oncology,

medical oncology, pediatric oncology, and radiation oncology.  The

disciplines of medical oncology, pediatric oncology, and radiation

oncology have developed strong cadres of academic investigators while

academic development in surgical oncology has not kept pace.  It is

felt that surgical oncology is not keeping pace because of an

insufficient number of surgical oncology research programs and an

insufficient number of surgeons undertaking research related to cancer.

Continued development of superior multi-disciplinary treatment of

cancer is the long-range objective of the DCT and the attainment of the

goal requires sufficient academic strength in investigative surgical

oncology.

 

Examples of relevant studies include mechanisms of metastases, effect

of surgery on tumor cell kinetics, and tumor host responses to surgery.

Preclinical and clinical research is encompassed in this program.

Categories of research include but, are not confined to, the following:

(1) pathophysiologic studies in laboratory models or in humans related

to surgery and cancer; (2) laboratory and clinical studies that examine

the biochemical, cytokinetic, immunological, and nutritional effects of

cancer surgery; (3) therapeutic studies in which surgery or a surgical

question is the primary treatment modality; (4) novel immunotherapy

procedures such as assessment of specific lymphokines stimulated cells

and autologous vaccines which require surgical input; (5) new surgical

techniques relevant to staging or care of patients; (6) studies to

identify prognostic factors relevant to the treatment of cancer

patients; (7) surgical supportive care; (8) regional chemotherapy or

hyperthermia or radiation in which a surgical approach to the treatment

site is a major aspect of the procedure.  This PA is not restricted to

the areas of surgical oncology research listed above.

 

Objectives

 

The aims of this initiative are two-fold:  (1) to promote academic

research in surgical oncology and (2) to stimulate development of

innovative surgical related clinical studies with laboratory

correlations so as to foster the development of interactions between

basic science laboratories and clinicians performing these clinical

trials.

 

STUDY POPULATION

 

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS

 

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 disease, 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, 1-4 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 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 is defined as 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

minorities.

 

If the required information is not contained within the application,

the application 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.

 

APPLICATION PROCEDURES

 

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

(rev. 9/91) and will be accepted at the receipt dates as indicated in

the application kit (February 1, June 1, and October 1).  Specific

application procedures for interactive R01 applications can be found in

the NIH Guide for Grants and Contracts (Vol. 21, No. 1, January 10,

1992) under PA-92-29.

 

Application kits are available at most institutional business 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 the announcement must be typed in item 2a on the face page of the

application.

 

Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research Resources

are requested to identify the GCRC as a resource for conducting the

proposed research.  In such a case, a letter of agreement from either

the GCRC program director or Principal Investigator must be included

with 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**

 

REVIEW PROCEDURES

 

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 of the Division of

Research Grants, NIH, in accordance with the customary NIH peer review

procedures.  Following scientific-technical review, the applications

will receive a second-level review by the appropriate national advisory

council.

 

AWARD CRITERIA

 

Applications will compete for available funds with all other approved

applications. 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

 

INQUIRIES

 

Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.

 

Direct inquiries regarding programmatic issues to:

 

Dr. Roy S. Wu

Program Director, Cancer Therapy Evaluation Program

Division of Cancer Treatment

National Cancer Institute

Executive Plaza North, Room 734

Bethesda, MD  20892

Telephone:  (301) 496-8866

FAX:  (301) 480-4663

 

Direct inquiries regarding fiscal matters to:

 

Ms. Carolyn Mason

Grants Management Specialist

National Cancer Institute

Executive Plaza South, Room 242

Bethesda, MD  20892

Telephone:  (301) 496-7800, ext. 59

FAX:  (301) 496-8601

 

AUTHORITY AND REGULATIONS

 

This program is described in the Catalog of Federal Domestic Assistance

No. 93.395, Cancer Treatment Research.  Awards are made under the

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

at 42 CFR Part 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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