CLINICAL INVESTIGATOR AWARD FOR RESEARCH ON SPECIAL POPULATIONS

NIH GUIDE, Volume 21, Number 6, February 14, 1992



PA NUMBER:  PA-92-41



P.T. 34



Keywords:

  Cancer/Carcinogenesis 

  Diagnosis, Medical 

  Disease Prevention+ 

  Treatment, Medical+ 



National Cancer Institute



Application Receipt Dates:  June 1, 1992, October 1, 1992, February 1,

1993



PURPOSE



The Comprehensive Minority Biomedical Research Program, Division of

Extramural Activities, National Cancer Institute (NCI), announces the

availability of Clinical Investigator Awards for Research on Special

Populations.  The term "special populations" refers to those population

segments that may experience or are known to experience high cancer

rates and are underserved in terms of:  cancer prevention and control

programs (e.g., smoking cessation and health screening programs);

diagnostic and treatment modalities; study for special risk factors or

underlying biological differences; and access to routine medical care.

The definition of special populations includes: African Americans,

Alaska Natives, American Indians, Asian Americans, Pacific Islanders,

Hispanics, the elderly, and low-income groups.



The award will enable candidates to undertake three to five years of

special study and supervised research experience tailored to individual

needs with a sponsor (or sponsors) who is competent to provide research

guidance.  This award is intended to cover the transition between

postdoctoral research experience and an independent research career and

to acquaint the candidate with the often unique challenges and

circumstances involved in designing research protocols directed toward

improving the health of groups comprising a significant and often

disproportional percentage of individuals at risk from high cancer

morbidity and mortality rates.  It is anticipated that the experience

and results achieved by the awardee from this special grants program,

in the majority of cases, will provide the basis for successful

competition in the independent research support programs of the NCI.



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 (PA), Clinical Investigator Award for Research on Special

Populations, is related to the priority area of cancer research.

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



The award is designed to provide intensive, supervised research

experience on the above designated topics. Although the award is

primarily for individuals with an M.D. degree, applications will be

accepted from M.D.s and D.O.s who have a Ph.D. or an equivalent

research degree if special circumstances can be shown such as a Ph.D.

in an unrelated field or an intervening period of clinical training

since the completion of the Ph.D.  These applications will be

considered on a case-by-case basis.



If the candidate has less than three or more than seven years of

postdoctoral experience at the time of application, a strong

justification for an exception must be included in the application and

must be clearly indicated as such.



Candidates must have completed their clinical training by the time of

award, have documented competence in clinical activities, and have

research experience in the chosen area of interest.  Candidates must

provide evidence of a serious intent for research and academic careers

and an interest in medical issues associated with special populations.



Candidates from minority and non-minority institutions may apply.



Applicants for this Clinical Investigator Award may not submit a

concurrent application for an NIH Research Career Development Award

(K11), Academic Award (K07), First Independent Research Support and

Transition (FIRST) Award (R29), or a research project grant (R01).

However, an Awardee of this program may apply subsequently for a

research project grant or a FIRST Award.



The grantee institution must be a domestic nonprofit research

institution, school, or comparable institution with strong,

well-established research and training programs, adequate numbers of

highly trained faculty in clinical and basic science departments, and

development of independent research careers.



MECHANISM OF SUPPORT



Support of this program will be through the National Institutes of

Health Clinical Investigator Award (K08).  Applicants will be

responsible for the planning, direction, and execution of the proposed

project.  Except as otherwise stated in this PA, awards will be

administered under PHS Grants Policy Statement, DHHS Publication No.

(OASH) 90-50,000, revised October 1, 1990.



Conditions of the Award



Applicants may request three to five years of support.  Awards are

non-renewable and non-transferable from one awardee institution to

another.  Funding beyond the first year of the grant is contingent on

satisfactory progress during the preceding year.



Allowable costs may include:



o  Awardee's Salary:  a maximum of $50,000 per year for full-time

support; in addition, fringe benefits will be provided.  Institutional

supplementation is permitted.



o  Research Support:  a maximum of $10,000 annually for years 01 and 02

and $20,000 annually for succeeding years to provide the categories

listed below.



o  Equipment:  specialized research equipment essential to the proposed

program.  The available facilities should include most of the necessary

equipment.



o  Supplies:  consumable supplies essential to the proposed program.



o  Travel:  domestic travel essential to the proposed program.



o  Tuition for Training Courses:  if essential to the awardee's

individual research development program.



o  Other:  publication costs, patient costs, and other expenses

necessary for the research program.



Indirect Costs - The indirect cost rate may not exceed eight percent of

the total allowable direct costs.  The grantee institution's share of

the fringe benefits may be paid as a direct cost (if not treated as an

indirect cost) on that portion of the salary provided by the Clinical

Investigator Award.



RESEARCH OBJECTIVES



o  To increase the number of physician-investigators in medical

oncology, surgical oncology, preventive oncology, and diagnostic and

therapeutic radiology and epidemiology, nutrition, and behavioral

medicine, as they relate to cancer, who are committed to investigate

the unique problems facing special populations.



o  To provide an opportunity for clinically trained physicians with a

commitment to research to develop as independent biomedical research

investigators.



STUDY POPULATIONS



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 in adequately represented in clinical

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

compelling rationale should be provided.



The composition of the proposed study populations 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

Section 2, A-D of the Research Plan AND summarized in Section 2, E,

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.



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.



APPLICATION PROCEDURES



The research grant application form PHS 398 (rev. 9/91) is to be used

in applying to this program.  These forms are available at most

institutional business offices, from the Office of Grants Inquiries,

Division of Research Grants, National Institutes of Health, Westwood

Building, Room 449, 5333 Westbard Avenue, Bethesda, MD  20892, and from

the NCI program director named below.



Submit a signed, typewritten original of the application, including the

Checklist, and four signed, exact photocopies, in one package to the

address below.  The photocopies must be clear and single sided.



DIVISION OF RESEARCH GRANTS

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892



At time of submission, send two additional copies of the application

to:



REFERRAL OFFICER

Division of Extramural Activities

National Cancer Institute

Westwood Building, Room 848

5333 Westbard Avenue

Bethesda, MD  20892



The receipt dates for all applications are found in the form PHS 398

instructions.  The title and number of this announcement must be typed

on line 2 of the application face page and the box must be checked YES.



Candidates must provide a description of the proposed research and

career development plan for the period of the award in Section 2 of the

application under the heading "Research Plan."  The candidate must be

prepared to commit full-time effort to the objectives of this award.

It is required that a minimum of 75 percent effort be devoted to the

research program.  The remaining 25 percent may be divided among other

activities such as teaching and clinical training pursuits only if they

are consonant with the program goals, i.e., the awardee's development

into an independent biomedical research investigator.



The reasons for a commitment to research in the problems facing special

populations with respect to cancer must be indicated.



The sponsor must provide:



o His/her concept of a development and research plan for the awardee.



o A current curriculum vitae with a complete bibliography and research

support.



o A letter indicating his/her evaluation of the proposed awardee and

his/her willingness to provide guidance and support.



Evidence of the commitment of the institution to the candidate's

research and development must be provided.



Adequate access to populations comprised of one or more of the groups

targeted by this award must be demonstrated.



REVIEW PROCEDURES



Upon receipt, applications will be reviewed initially by the Division

of Research Grants (DRG) for completeness and will be assigned on the

basis of Public Health Service referral guidelines.  Incomplete

applications will be returned to the applicant without further

consideration.



Applications will be reviewed for scientific and technical merit by an

appropriate peer review group convened by the relevant Institute or

Center.  Following scientific-technical review, the applications will

receive a second-level review by the appropriate national advisory

council.  Criteria for the initial review include:



o  The candidate's potential for a career in independent research.



o  The candidate's commitment to a research career.



o  The overall merit of the candidate's plan for research and the

development of research skills.



o  The quality of the candidate's clinical training and experience.



o  The institutions's ability to provide quality facilities, resources,

and opportunities necessary to the candidate's research development.



o  Presence of highly trained faculty in clinical and basic science

departments relative to the area of study.



o  The ability and plans of the sponsor (or sponsors) who will provide

the candidate with the guidance necessary for career development in

research.



The review group will recommend an appropriate budget for each approved

application.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered 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 to clarify any issues or questions from

potential applicants are encouraged and may be directed to:



Dr. Lemuel A. Evans

Division of Extramural Activities

Comprehensive Minority Biomedical Program

National Cancer Institute

Building 31, Room 10A04

Bethesda, MD  20892

Telephone:  (301) 496-7344

FAX:  (301) 402-0062



For information regarding budgetary/administrative issues related to

this PA, contact:



Ms. Carolyn Mason

Grants Management Specialist

National Cancer Institute

Executive Plaza South, Room 243

Bethesda, MD  20892

Telephone:  (301) 496-7800, Extension 59



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.398, Cancer Research Manpower.  Awards are made under the

authority 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

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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