Full Text DK-92-05


NIH GUIDE, Volume 21, Number 15, April 17, 1992

RFA:  DK-92-05

P.T. 44

  Reproductive Disorders 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  June 1, 1992
Application Receipt Date:  August 6, 1992


The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), in cooperation with the American Foundation for Urologic
Diseases (AFUD), invites applications for a pilot fundamental
research training program in urologic sciences.  Proposed programs
are expected to provide postdoctoral research training in the basic
biological sciences related to the urologic disorders of interest to
the NIDDK.

Surveys of institutional training programs supported by the NIH have
shown that those programs that train physicians and post-doctoral
Ph.D.s concurrently produce more productive graduates than programs
designed exclusively for either clinicians or Ph.D.s.  Thus, Program
Directors will be responsible for designing and directing a urologic
research training program that integrates the training of physicians
and individuals holding a Ph.D. degree.

Each program will provide research training both for physicians who
have completed at least two years of surgical training in urology and
for individuals holding the Ph.D. degree trained in basic science.
The total program at an awardee institution will be supported by two
separate but linked awards from the NIDDK and coordinated support
from the AFUD.  Research training for physicians with clinical
training in urology will be supported through a Program Physician
Scientist Award (K12) and post-Ph.D. research training in
urologically related problems will be supported by a National
Research Service Award (NRSA) Institutional Training Award (T32).
The AFUD will provide supplementation to the stipends (trainees
supported by T32s) and salaries (participants supported by K12s)
according to the schedule given under "Description of Program" below.
Clinical training programs will not be considered for support in this


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,
Physician and Scientist Training Program in Urologic Research, is
related to the priority area of diabetes and chronic disabling
diseases.  Potential applicants may obtain a copy of "Healthy People
2000" through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202/783-3238).


The grantee institution must be a domestic university, medical
school, or comparable institution with a strong, well-established
program of research and training in areas related to urologic
disease.  To qualify for a K12 award, an institution must have an
adequate number of highly trained faculty in clinical and basic
science disciplines as well as the interest, capability, and
commitment to provide guidance to clinically trained investigators in
developing research independence.

The individual to be trained (T32) must be a citizen or non-citizen
national of the United States or have been lawfully admitted for
permanent residence (i.e., in possession of the Alien Registration
Receipt Card I-551 or I-151) at the time of appointment.  Individuals
on temporary or student visas are not eligible.


The training programs will consist of two NIH award mechanisms, the
K12 and the T32.  The AFUD will make separate awards to those
institutions holding the K12/T32 awards to supplement the salaries
(K12 participants) and stipends (T32 trainees).

Each training institution will submit a K12 application and a T32
application.  An applicant institution will receive both awards or
neither.  Holding both a K12 and a T32 will enable each grantee
institution to train both physicians (supported by the K12) and Ph.D.
degree holders (supported by the T32).

Responsibility for the planning, direction, and execution of the
proposed program will be solely that of the applicant.  The total
project period for applications is five years.


This program will support up to five institutions for a total funding
of five T32 awards and five K12 awards.  The number of awards made
will depend on receipt of a sufficient number of applications of high
scientific merit.  Up to $600,000 (total costs) will be allocated to
the support of this program in FY 1993, availability of funds



The urologic diseases affect a significant portion of both the
pediatric and adult populations.  Progress in the understanding and
treatment of these diseases is hampered by lack of a sufficient
number of research scientists and research clinicians in these areas.
Surveys have suggested that the combination of the long period of
residency training required for board certification in Urology and
the low stipends awarded for support in NRSA training programs
constitute a major obstacle to recruiting and training urologists for
research careers.  To facilitate the recruitment of individuals into
research training programs in urologic diseases, the DKUHD and the
AFUD have developed a joint program to supplement the NIH support
with designated funds from the AFUD.

Areas for research training within this program are limited to those
that fall within the primary responsibility of the NIDDK.  These
areas are broadly defined as:  prostate growth control; prostate
development including benign prostatic hyperplasia (BPH); chronic
inflammatory urologic disorders such as prostatitis and interstitial
cystitis; the basic science and clinical aspects of urolithiasis;
physiology and pathophysiology of bladder function including voiding
dysfunctions such as urinary incontinence, enuresis and
vesicoureteral reflux; infections of the urinary tract; male sexual
function and dysfunction including the basic aspects of testicular
and epididymal function; and pediatric urology.  Institutions,
program directors, and individual applicants should contact the
appropriate staff at the NIDDK to ensure that the areas of the
proposed research training fall within the purview of the NIDDK.

Goals of Program

The goal of this pilot program is to ensure that investigators
trained in the sciences basic to the urologic diseases will be
available in adequate numbers in the appropriate research areas to
meet the nation's needs for research in urologic disorders and

Description of the Program

1.  Training to be Supported:  Candidates for the K12 must hold the
M.D. or equivalent degree (e.g., D.O.), must have completed the
general surgery requirement for urology, and should have two years of
urologic surgery training. K12 participants are expected to spend a
total of at least five years in the research training experience.
The research training should be divided into two phases.  Phase I
will occur prior to the Chief Resident year and generally will
consist of two years of uninterrupted training.  During Phase I the
participant will undertake course work, seminars, initial research
experiences and other educational experiences necessary to initiate
an intensive research program during Phase II.  The Chief Resident
year will generally separate Phases I and II and will not be
supported by this program.  The Program Director will be required to
develop criteria for determining when a participant has successfully
completed Phase I, and to provide an appropriately detailed Phase II
research plan and protocol for administrative review and approval by
NIDDK Staff.

Holders of the Ph.D. and other research degrees will be considered
candidates for support under the T32.  The emphasis of the T32 will
be to support specialized training in the basic sciences relevant to
the study of the genitourinary tract and urologic disorders and

2.  Program Requirements:  The proposed Program Director should be
designated as Program Director on both the T32 and K12 applications.
He/she should be able to demonstrate scientific expertise, leadership
and the administrative ability to coordinate and supervise an
interdisciplinary research program of this scope.  He/she should also
be able to demonstrate a superior record of preparing clinical
investigators for independent research in academic medicine.  A
committee consisting of representatives from the appropriate basic
and clinical science departments must be established to advise the
Program Director.  Graduates of this program are expected to occupy
positions in academic medicine and to be competitive for the R01 or
R29 research grants of the NIH.

The T32 training program must provide opportunities for individuals
to participate in supervised basic research experiences related to
urologic disorders, optimally in basic science departments.  It is
expected that Ph.D. trainees will generally receive two years of
support on the T32 institutional grant.

T32 trainees are required to pursue research training on a full-time
basis, devoting at least 40 hours per week as specified by the
sponsoring institution in accordance with its own policies.  Teaching
or other duties should be confined to those that are part of the
research training.

Each candidate appointed to the K12 must be essentially full-time
(75-100 percent) and have a primary sponsor recognized as an
accomplished investigator in basic science research to provide the
necessary guidance for the candidate's development and research plan.
In some instances the candidate may have a secondary clinical sponsor
for the Phase II research-intensive years.

Each year, the NIDDK will hold a steering and planning meeting with
all Program Directors to discuss training programs' progress and any
difficulties which may be associated with this new effort.  Starting
in year 02, these meetings will be expanded to enable T32 trainees
and K12 participants to present initial results of their current
research efforts.

3.  Recruitment of Trainees (T32) and Participants (K12):
Applications must include a well developed plan for the recruitment
of women and individuals from minority groups under-represented in
biomedical and behavioral research.  A primary objective of the K12
will be to provide for five years of intensive full-time research
training in urologic diseases for individuals who will have had two
years of training in general surgery and two years of training in
urologic surgery.  It is important therefore, to establish a pool of
candidates who are willing and able to commit themselves to five
years of research training.  A primary objective of the T32 is to
recruit Ph.D. scientists into research in areas of urologic
disorders.  Thus, it is necessary that applicant institutions develop
recruitment programs designed to meet the objective of increasing the
number of basic scientists investigating urologic disorders.

4.  NRSA Payback Requirement:  Before trainees can be appointed to an
NRSA training grant, they must sign an agreement that they will
fulfill the NRSA payback requirement.  Recipients agree to engage in
biomedical research and/or teaching for a period equal to the period
of NRSA support in excess of 12 months.  Recipients must begin to
undertake the obligated service on a continuous basis within two
years after termination of NRSA support.  Applicant organizational
officials responsible for recruitment of T32 trainees should
familiarize themselves with the terms of the service requirements and
must explain them to prospective training candidates before or at the
time an appointment at the institution is offered.

5.  Length of Training Periods and Stipends/Salaries for this
Program:  The period of training for Ph.D. T32 trainees in this
program will be two years with a third year possible under
exceptional circumstances.  The period of training for physicians
will be five years on the K12 award.  For physicians, the applicant
institution must define a specific timetable for integration of the
training requirements into the residency program.  The proposed
stipends/salaries are noted in the following example.  In the example
it is assumed that Ph.D.s have 0 years of postdoctoral experience at
the beginning of their T32 support.  K12 salary levels from the NIH
may not exceed $50,000 annually based on the respective institutional
determination or salary scale for persons of equivalent
qualifications, experience, and rank.  Information on other allowable
costs associated with the T32 and K12 programs may be obtained from
the general announcements of the T32 and K12 grant mechanisms
referenced under SPECIAL REQUIREMENTS.

The following example is of a program with two physicians supported
by the K12 award and four Ph.D.s supported by the T32.

YEAR       PARTICIPANT           BY        NIH       AFUD

01              #1   (Ph.D.)     T32      18,600     3,000
                #2   (M.D.)      K12      50,000         0

02              #1   (Ph.D.)     T32      19,700     5,000
                #2   (M.D.)      K12      50,000       500
                #3   (Ph.D.)     T32      18,600     3,000
                #4   (M.D.)      K12      50,000         0

03              #2   (M.D.)       Chief Resident Year
                #3   (Ph.D.)     T32      19,700     5,000
                #4   (M.D.)      K12      50,000       500
                #5   (Ph.D.)     T32      18,600     3,000

04              #2   (M.D.)      K12      50,000     5,500
                #4   (M.D.)       Chief Resident Year
                #5   (Ph.D.)     T32      19,700     5,000
                #6   (Ph.D.)     T32      18,600     3,000

05              #2   (M.D.)     K12       50,000    15,000
                #4   (M.D.)     K12       50,000     5,500
                #6   (Ph.D.)    T32       19,700     5,000

06*             #2   (M.D.)     K12       50,000    17,500
                #4   (M.D.)     K12       50,000    15,000

07*             #4   (M.D.)     K12       50,000    17,500

*Budgets for the 06 and 07 years are not to be included in the
present applications.  However, the narrative should include a
description of the training experiences during those years.

It is generally permissible for sponsoring institutions to supplement
AFUD and NIH stipends/salaries from non-Federal funds.

This program will support up to five institutions.  In year 01, one
M.D. participant and one Ph.D. trainee will be admitted; in year 02,
one additional M.D. and one additional Ph.D. will be recruited for a
total of four individuals in training per institution.  In years 03
and 04, one Ph.D. trainee will be admitted each year.  The Chief
Resident year will not be supported by the K12.  At the end of the
program, it is expected that each program will have trained four
Ph.D.s and two M.D.s.  To accommodate this level of training
activity, each application should request training slots as indicated
in the above table.


Applications must meet all NIH requirements for the NRSA (T32) and
K12 awards.  Applications must request funding for five years;
however, applicants should note that the training period for
physicians supported by this program will generally cover a total of
6 calendar years for each participant, including one of clinical work
not supported by this program.  The narrative section of the K12
application must describe the entire training experience for such
individuals even though the actual project period requested is only
five years.  In the event that a K12 award is not competitively
renewed at the end of the initial five-year project period, it is the
intention of the NIDDK, availability of funds permitting, to support
the completion of each enrolled participant's program under an
extension of the original terms of the award.

For specific information on the T32 application format, applicants
should request the announcement "National Research Service Awards for
Institutional Training Grants (T32): Information Statement, October
1, 1990" and the booklet "Suggestions for National Service Award
Institutional Training Grant Applications, NIDDK, 1991." Copies are
available from Charles H. Rodgers, Ph.D. (see INQUIRIES below).

For specific information on the K12 application, applicants should
request from Dr. Rodgers the booklet, "K Awards."



NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 must 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 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 the form PHS 398 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
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.

If the required information is not included in the application, the
application will be returned.

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


Prospective applicants are asked, but not required, to submit a
letter of intent to apply to this RFA.  This letter should include
the name, telephone number and mailing address of the Program
Director, the names of other key personnel, the name of the applicant
institution and the number and title of the RFA.  Such a letter of
intent is not binding and it will not enter into the review of any
application subsequently submitted, not is it a necessary requirement
for application.  Letters of intent are requested solely for planning
purposes.  The NIDDK staff will not provide responses to such
letters. Letters of intent to this RFA, must be received no later
than June 1, 1992, and are to be addressed to:

Dr. Robert D. Hammond
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 603
Bethesda, MD  20892


Separate T32 and K12 applications must be submitted on form PHS 398
(rev. 9/91) following the guidelines for each specific type of award.
These forms are available at most institutional business offices;
from the Office of Grants Inquiries, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892, telephone 301/496-7441; and from the program
administrator named below.

The RFA label available in the form PHS 398 must be affixed to the
bottom of the face page of each application.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.  In
addition, the RFA title and RFA number:  DK-92-05, must be typed on
page 1, line 2a of each application form and the YES box must be

Submit a signed, typewritten original of each application, including
the checklist, and three signed photocopies, in one package to:

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

At the time of the submission, two additional copies of each
application must also be sent to:

Dr. Robert D. Hammond
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 603
Bethesda, MD  20892


Applications will undergo an initial review by an NIDDK Initial
Review Group.  The T32 and K12 applications will be reviewed
according to the established review criteria for each type of award.
These may be obtained from the announcement "National Research
Service Awards for Institutional Training Grants (T32):  Information
Statement, October 1, 1990," and from "K Awards."  Both documents may
be obtained from the staff listed under INQUIRIES.  In addition, the
T32 and K12 applications from a given institution will be reviewed
together to evaluate the proposed integration and overall quality of
potential research experiences for preparing clinical and basic
scientists to undertake careers in all areas of urologic research
supported by the NIDDK.

Subsequent to review by the Initial Review Group, applications will
be reviewed by the NIDDK National Advisory Council.


The anticipated date of award is July 1, 1993.  The following will be
considered in making funding decisions:

o  Quality of the proposed program as determined by peer review
o  Availability of funds
o  Program balance among all applications funded.

Timetable For Review and Funding

Letter of Intent Receipt Date:  June 1, 1992
Application Receipt Date:       August 6, 1992
Initial Review Group:           October/November 1992
Advisory Council Review:        January/February 1993
AFUD Review:                    February/March 1993
Start Date of Program:          July 1993


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome:

Inquiries regarding program issues may be directed to either of the

Leroy M. Nyberg, Jr., Ph.D., M.D.
Director, Urology Program
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-05
Bethesda, MD  20892
Telephone:  (301) 496-7133
Fax:  (301) 402-0223

Charles H. Rodgers, Ph.D.
Director, Manpower and Training Programs
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-11
Bethesda, MD  20892
Telephone:  (301) 496-7573
FAX:  (301) 402-0223

Direct inquiries regarding fiscal matters to:

Nancy Dixon
Supervisory Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 639
Bethesda, MD  20892
Telephone:  (301) 496-7467


This program is described in the Catalog of Federal Domestic
Assistance No. 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 45
Part 74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency


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