Full Text DK-93-03


NIH GUIDE, Volume 21, Number 31, August 28, 1992

RFA:  DK-93-03

P.T. 34, FF

  Clinical Medicine, General 
  Biomedical Research, Multidiscipl 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  November 4, 1992
Application Receipt Date:  December 3, 1992


The purpose of this solicitation is to increase the number of
underrepresented minority clinicians who can conduct high-quality
independent research and provide leadership in the areas of diabetes,
endocrinology, metabolism and metabolic diseases (including cystic
fibrosis), nutrition, eating disorders, obesity, organ systems and
components associated with the gastrointestinal tract, renal and
urological diseases, and hematology.

This Request for Applications (RFA) is limited to the Clinical
Investigator Award (CIA/K08) and the Physician Scientist Award
(PSA/K11).  Each of these mechanisms is tailored to a particular stage
of the investigator's career.  Each is designed to equip the developing
physician-scientist to become an independent investigator capable of
designing and executing rigorous research protocols, carefully crafted
to examine a clearly stated and focused hypothesis.  Ideally, such
investigators should be able to integrate patient-oriented and
laboratory-oriented research methods to address specific questions.


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 RFA,
Career Development Awards for Underrepresented Minority Clinician-
Investigators, is related to the priority area of nutrition and
diabetes and chronic disabling disorders.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or 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 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.

Applicants for the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) CIA must:

o  Hold an M.D., D.O., or other appropriate clinical degree;

o  Have had approximately four to eight years of postdoctoral
experience, both clinical and research (a minimum of two years of
each), by the projected start of the award;

o  Not have been a Principal Investigator (PI) on a PHS-supported
research project; and

o  Commit at least 75 percent time to CIA activities.

Applicants for the NIDDK PSA must:

o  Hold an M.D., D.O., or other appropriate clinical degree;

o  Have completed at least one postgraduate year of clinical training
by the time the award is made;

o  Not have been a PI on a PHS-supported research project; and

o  Commit at least 75 percent time to PSA activities.

Potential candidates must be citizens or non-citizen nationals of the
United States or its possessions and territories or must have been
lawfully admitted to the United States for permanent residence at the
time of the application and must be a member of a minority group that
is underrepresented in biomedical or behavioral science.

Applicants applying for the CIA or the PSA under this solicitation must
have completed, by the time an award would be activated, a residency in
internal medicine, surgery, or pediatrics.


The mechanisms of support will be the Clinical Investigator Award (K08)
and the Physician Scientist Award (K11).  While these two mechanisms
are summarized in this announcement, detailed guidelines may be
obtained from the office of sponsored programs at most research
institutions or from the Office of Grants Inquiries, Division of
Research Grants, NIH, (301) 496-7441.

Awards will be administered under PHS grants policy as stated in the
PHS Grants Policy Statement.  This RFA is a one time solicitation.  The
total requested project period for applications submitted in response
to this RFA may not exceed five years.

Clinical Investigator Award

The CIA is offered to provide the opportunity for promising
clinically-trained individuals with demonstrated aptitude in research
to develop into independent investigators.  Provisions of the CIA

o  Five years of support, nonrenewable;

o  Salary up to $50,000 per year plus fringe benefits; and

o  Up to $20,000 per year for research supplies, equipment, technical
assistance, and travel.

Physician Scientist Award

The PSA is designed to encourage the newly trained clinician to develop
independent research skills and experience in a fundamental biomedical
or behavioral science.  This is a five year award that is divided into
two phases.  During Phase I, which may last two to three years, the
candidate is expected to develop independent research skills and
experience and may elect to work toward a Ph.D. degree.  The primary
sponsor must be an accomplished basic science investigator.  Phase II
entails intensive basic or clinical research activity, applying the
skills learned during Phase I.  Provisions of the PSA include:

o  Five years of support, nonrenewable;

o  Salary up to $50,000 per year plus fringe benefits; and

o  Up to $10,000 (Phase I) and $20,000 (Phase II) per year for research
supplies, equipment, technical assistance, and travel.

Grant funds awarded under the CIA and the PSA mechanisms are for
research development only and may not be used for the support of
clinical training or clinical services.  Such activities must be
supported from other funding sources.


Up to eight awards will be made in support of applications submitted
for this RFA, dependent upon the receipt of a sufficient number of
highly meritorious applications.  Although this program is provided for
in the financial plans of the NIDDK, the award of grants pursuant to
this RFA is also contingent upon the availability of funds for this


The proportion of physicians among all first-time PIs has been
declining since 1977, and the number of physicians and other
professional doctorates participating in NIH research training programs
has declined since 1975.  The limited number of minority clinicians in
research is a matter of critical concern.  The Institute of Medicine's
Committee on National Needs for Biomedical and Behavioral Research
Personnel, in their 1983 report, predicted that a potential no-growth
situation in medical schools would decrease the flow of qualified new
entrants into the field of clinical investigation, particularly in the
face of declining opportunities in the academic sector.  The
maintenance of such a flow, particularly for minority scientists, is
vital to the future of biomedical and behavioral research in this

The NIDDK is a focal point at the NIH for research on diabetes,
endocrinology, metabolism and metabolic diseases, including cystic
fibrosis; nutrition, eating disorders, obesity, organ systems and
components associated with the gastrointestinal tract; renal and
urological diseases and hematology.  Advances in knowledge in the
scientific areas served by the NIDDK requires a steady supply of
rigorously trained individuals.  To this end, the NIDDK wishes to
encourage research training and career development in areas related to
the mission of the NIDDK that utilize the most current scientific
disciplines such as molecular biology, cell biology, structural
biology, immunology, neurology, developmental biology, genetics,
biochemistry, organic chemistry, physiology, and epidemiology, to name
a few.  Applicants are encouraged to acquire proficiency in
technologies at the forefront of current biomedical and behavioral
research and should seek mentors in the areas served by the NIDDK.
Minority populations and women must be included in all proposed
clinical studies, unless sufficient justification is provided for their

Potential applicants are encouraged to read the guidelines for each
mechanism to identify the mechanism most appropriate for their needs
and experience.


Awardees will be asked to inform the NIH for each of five years
following the completion of the award about academic status,
publications, and research grants and contracts received.


It is NIH and ADAMHA policy that clinical research studies include
women and minorities 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 must be placed on the need for
inclusion of women and minorities in studies of diseases, disorders,
and conditions which disproportionately affect them.  This policy is
intended to apply to females and males of all ages.  If women or
minorities are excluded or inadequately represented in a clinical
research project, particularly in proposed population based studies, a
clear compelling rationale must 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 must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in form PHS 398 (rev. 9/91) in Item
4 (Research Design and Methods) of the Research Plan AND summarized in
Item 5, Human Subjects.  Applicants are urged to assess carefully the
feasibility of including the broadest possible representation of
minority groups.  However, the 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, and

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.

If the required information is not contained within the application,
the application will be returned to the applicant without review.

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 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.


Prospective applicants are asked to submit, by November 4, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the applicant, the
name of the sponsor, the names of all participating institutions, and
the number and title of the RFA in response to which the application is
being submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows NIDDK staff to estimate the potential review workload and to
avoid possible conflicts of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 496-7083
FAX:  (301) 402-1277


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for the K awards.  Special instructions for preparing CIA
and PSA applications can be found in the booklet "The K Awards,"
October 1991.  These forms and "The K Awards" booklet are available
from most institutional business offices and from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
5333 Westbard Avenue, Room 449, Bethesda, MD 20892 (telephone (301)

The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of an application such that it
may not reach the review committee in time for review.  In addition,
the RFA number and title, RFA DK-93-03, Career Awards for
Underrepresented Minorities, must be typed on line 2a of the face page
of the application form, and the YES box must be checked on the face

Applicants must submit a signed, typewritten original of the
application, including the Checklist, and three signed exact
photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application should
be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892

Applications must be received by December 3, 1992.  If an application
is received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application.  The DRG also will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of applications previously reviewed that have since been
substantially revised.  Such applications must not only include an
introduction addressing the previous critique, but also must be
responsive to this RFA.


Upon receipt, applications will be reviewed initially by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for responsiveness
to the program requirements and criteria stated in the RFA is an NIDDK
staff function.  If the application is not responsive to the RFA, NIDDK
staff will contact the applicant to determine whether it should be
returned to applicant or be held until the next regular receipt date
and reviewed in competition with all other unsolicited applications.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.
Applications may be subjected to triage by an NIDDK peer review group
to determine their scientific merit relative to other applications
received in response to this RFA.  If the number of applications is
large compared to the number of awards to be made, the NIDDK may
conduct a preliminary scientific peer review (triage) and withdraw
applications from further competition if they are not competitive for
the award.  The NIDDK will notify the applicant and institutional
official of any such action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit by an NIDDK initial review group (IRG).
Following this review, applications will be given a secondary review by
the National Diabetes and Digestive and Kidney Diseases Advisory
Council.  Applications not recommended for further consideration by the
IRG will not undergo secondary review.

The review criteria for applications received in response to this RFA
are the same as those for unsolicited K08 and K11 applications.
Generally stated, these include:

o  Applicant's potential for and commitment to a research career in the
areas specified by this RFA;

o  Scientific merit of the proposed research;

o  Potential of the proposed research in developing the applicant as an
independent investigator;

o  Qualifications, research expertise, and training experience of the
sponsor along with adequate institutional commitment to ensure
completion of the proposed training; and

o  Adequacy of the proposed means for protecting against or minimizing
such effects, for those applications involving activities that could
have an adverse effect upon humans, animals, or the environment.


Applications will compete for available funds with all other
recommended applications received in response to this RFA.  The
following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review;

o  Availability of funds; and

o  Program balance among the research areas of this RFA.


Letter of Intent:           Nov 4, 1992
Application Receipt:        Dec 3, 1992
Initial Review:             Feb/Mar 1993
Second Level Review:        May/Jun 1993
Anticipated Award:          Jul 1, 1993


Written and telephone inquiries about this RFA and the opportunity to
clarify any issues or questions from potential applicants are

Direct inquiries regarding programmatic issues to:

Lois F. Lipsett, Ph.D.
Director, Research Training and Career Development Programs
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 620
Bethesda, MD  20892
Telephone:  (301) 496-7433

Direct inquiries regarding fiscal matters to:

Ms. Kim Law
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 496-7467


This program is described in the Catalog of Federal Domestic Assistance
Nos. 93.847, 93.848, and 93.849. 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 66 and
45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency


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