MENTORED CLINICAL SCIENTIST AWARDS IN NEPHROLOGY

Release Date:  May 1, 1998

PA NUMBER:  PAR-98-064

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases
National Kidney Foundation

PURPOSE

The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) wishes to
encourage nephrologists who are interested in a career in academic medicine to
apply for the Mentored Clinical Scientist Development Award (K08).  In
recognizing the importance of the K08 mechanism as a training vehicle for young
aspiring physician scientists, the National Kidney Foundation (NKF) will provide
a monetary supplement to as many as four K08 awards for each year of the award.

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.  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 202-512-1800).

ELIGIBILITY REQUIREMENTS

The candidate must have an M.D. (or D.O.) degree, or equivalent, must have
initiated postgraduate clinical training in nephrology, must identify a mentor
with extensive research experience, and be willing to spend at least 75 percent
of full-time in research and research related activities.

Applications may be submitted, on behalf of candidates, by domestic, non-Federal
organizations, public or private, such as medical, dental, or nursing schools or
other institutions of higher education.  Minorities and women are encouraged to
apply.  Candidates must be U.S. citizens or noncitizen nationals, or must have
been lawfully admitted for permanent residence and possess an Alien Registration
Receipt Card (I-151 or I-551) or some other verification of legal admission as
a permanent resident.  Noncitizen nationals, although not U.S. citizens, owe
permanent allegiance to the U.S.  They are usually born in lands that are not
states but are under U.S. sovereignty, jurisdiction, or administration. 
Individuals on temporary or student visas are not eligible.

Former principal investigators on NIH research project (R01), FIRST Awards (R29),
sub-projects of program project (P01) or center grants (P50; P60) are not
eligible.  A candidate for the K08 may not concurrently apply for any other PHS
award that duplicates the provisions of this award nor have another application
pending award.  K08 recipients are encouraged to apply for independent research
grant support during the period of this award.

MECHANISM OF SUPPORT

Awards in response to this program announcement will use the Mentored Clinical
Scientist Development Award (K08) mechanism.  Planning, direction, and execution
of the program will be the responsibility of the candidate and his/her mentor on
behalf of the applicant institution.  The project period may be for three, four
or five years.

Applicants from institutions that have a General Clinical Research Center (GCRC)
funded by the NIH National Center for Research Resources may wish to identify the
GCRC as a resource for conducting the proposed research.  If so, a letter of
agreement from either the GCRC program director or principal investigator should
be included with the application.

The NIDDK will provide a salary up to $75,000 plus fringe benefits.  The total
salary requested must be based on a full-time, 12-month staff appointment.  It
must be consistent both with the established salary structure at the institution
and with salaries actually provided by the institution from its own funds to
other staff members of equivalent qualifications, rank and responsibilities in
the department concerned. Under the terms of a K08 award, up to $20,000 per year
is allowed for tuition, fees, and books related to career development, research
expenses such as supplies, equipment and technical personnel, travel, and
statistical services including computer time.  Indirect costs are reimbursed at
8% of modified direct costs, or at the actual indirect cost rate, whichever is
less.  Additional information concerning income and fees may be obtained from the
NIH Guide for Grants and Contracts, Vol. 24, No. 15, April 28, 1995.

The NKF will select four successful candidates from those who submit applications
for receipt date October 1, 1998, February 1, 1999, or June 1, 1999, and meet the
award criteria stated under AWARD CRITERIA.  In addition to receiving a K08 award
from NIDDK, each of the four candidates will receive an additional $25,000 per
year toward their salaries from the NKF.  The NKF award will go directly to the
successful candidate's institution and will not include fringe benefits or
indirect costs.  If the NKF contribution and the NIDDK  salary allowance together
exceed the applicant's salary, the excess NKF award may be applied to other
components of the trainee's research program to support activities of direct
benefit to his/her continued development.  Such activities may include, for
example, costs of participating in relevant didactic training programs and
tuition costs for such programs, and/or participating in scientific meetings of
direct relevance to the trainee's research interest.  

The collaborative funding with the NKF is a one-time announcement.  If it is
determined to renew this joint training program, following a period of
evaluation, a new announcement will be made.  

RESEARCH OBJECTIVES

The purpose of this program announcement is to stimulate research training of
physician scientists in nephrology.  Examples of research topics that may be
encompassed in such training are: developmental biology of the kidney and urinary
tract; epithelial transport and structure of transport proteins; epidemiology of
renal diseases; diabetic nephropathy including mechanisms of renal injury, and
markers for early recognition of diabetic renal disease; polycystic kidney
disease; glomerulonephritis and tubulo-interstitial nephritis; growth failure in
children with chronic renal insufficiency; mechanisms of analgesic nephropathy;
acute renal failure including mechanisms of renal regeneration; cardiovascular
risk factors in end-stage renal disease; mechanisms for chronic renal allograft
loss; clinical trials in renal disease.  This list is intended to illustrate
types of relevant research training and is not all-inclusive.

Additional information concerning research objectives may be obtained in the
booklet The K Awards, from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301-710-0267, email: asknih@od.nih.gov, or
https://grants.nih.gov/training/careerdevelopmentawards.htm

In carrying out its stewardship of human resource related programs, the NIH may
begin requesting information essential to an assessment of the effectiveness of
this program.  Accordingly, recipients are hereby notified, that they may be
contacted after the completion of this award for periodic updates on various
aspects of their employment history, publications, support from research grants
or contracts, honors and awards, professional activities and other information
helpful in evaluating the impact of the program.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects.  Any exception will require a clear
and compelling rationale and justification that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," published in the Federal Register, March 28, 1994 (FR 59 14508-14513),
and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18,
1994.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (those under 21 years) must be included in
all human subjects research, conducted or supported by NIH, unless there are
scientific and ethical reasons not to include them.  This policy applies to all
applications submitted in response to this Program Announcement.  All
investigators proposing research involving human subjects should read NIH Guide
for Grants and Contracts, March 6, 1998 that is also available at:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard application deadlines as indicated in
the application kit.  Although applications for NIDDK K08 awards will be received
on a continuing basis for the K08 receipt dates listed in the form PHS 398, NKF
participation in this program will be restricted to those applications received
for the October 1, 1998, February 1, 1999, and June 1, 1999 receipt dates only. 


Application kits are available at most institutional offices of sponsored
research, or may be obtained from the Division of Extramural Outreach and
Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301-710-0267, email: asknih@od.nih.gov

Applications, accompanied by their scientific merit review, that meet the award
criteria may be forwarded by NIDDK staff to officials of the NKF.  Those
officials will be responsible for selecting the candidates for the NKF
supplement.

The application must address the following issues:

Candidate

Describe the candidate's commitment to a career in biomedical or behavioral
research.
Establish the candidate's potential to develop into an independent investigator.
Describe immediate and long-term career objectives, explaining how the award will
contribute to their attainment.
Letters of recommendation.  Three sealed letters of recommendation addressing the
candidate's potential for a research career must be included as part of the
application.

Career Development Plan

Describe the career development plan considering the candidate's goals and prior
experience.  Tailor the plan to the needs of the candidate and the ultimate goal
of independence as a researcher.
Detail plans to receive instruction in the responsible conduct of research. 
Plans must detail the proposed subject matter, format and duration of
instruction.  No award will be made if an application lacks this component.

Research Plan

Describe the research plan and the use of a basic or clinical science approach
to the problem.  The plan must follow the outline described in the form PHS 398
including sections on the Specific Aims, Background and Significance, Progress
Report/Preliminary Studies, Research Design and Methods.  The candidate should
consult with the mentor in developing the application.

Mentor's Statement

The application must include information on the mentor's research qualifications
and previous experience as a research supervisor.  The application must also
provide information to describe the nature and extent of supervision that will
occur during the proposed award period.

Environment and Institutional Commitment

The sponsoring institution must document a strong, well established research
program related to the candidate's area of interest with the staff and
environment capable of collaboration with the candidate.  A statement of
commitment to the candidate's development into a productive, independent
investigator must be included.

Budget

Provide budget requests according to the instructions in form PHS 398.

The program announcement title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked.

Mail the signed, original, single-sided application along with five exact,
single-sided copies and the collated sets of appendix materials to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health Service
referral guidelines.  An appropriate peer review group convened in accordance
with NIH peer review procedures will evaluate applications that are complete for
scientific and technical merit.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the top
half of applications under review, will be discussed, assigned a priority score,
and receive a second level review by the National Diabetes, Digestive and Kidney
Advisory Council.

Review Criteria

Candidate

Quality of the candidate's academic and clinical record;
Potential to develop as an independent researcher;
Commitment to a research career; and
Likelihood that the plan will contribute substantially to the achievement of
scientific independence.

Career Development Plan

Likelihood that the career development plan will contribute substantially to the
scientific development of the candidate;
Appropriateness of the content, the phasing, and the proposed duration of the
career development plan for achieving scientific independence;
]Consistency of the career development plan with the candidate's career goals;
and
Quality of the proposed training in responsible conduct of research.

Research Plan

o  Appropriateness of the research plan to the stage of research development and
as a vehicle for developing the research skills as described in the career
development plan;
o  Scientific and technical merit of the research question, design and
methodology;
o  Relevance of the proposed research to the candidate's career objectives; and
o  Adequacy of the plan's attention to gender and minority issues.

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address the adequacy of plans for including both
genders, minorities and their subgroups, and children as appropriate for the
scientific goals of the research, or justification for exclusion.

Mentor

o  Appropriateness of mentor's research qualifications in the area of this
application;
o  Quality and extent of mentor's proposed role in providing guidance and advice
to the candidate;
o  Previous experience in fostering the development of researchers;
o  History of research productivity; and
o  Record of research grant support, including active and pending awards.

Environment and Institutional Commitment

o  Applicant institution's commitment to the scientific development of the
candidate and assurances that the institution intends the candidate to be an
integral part of its research program;
o  Adequacy of research facilities and training opportunities;
o  Quality and relevance of the environment for scientific and professional
development of the candidate; and
o  Applicant institution's commitment to an appropriate balance of research and
clinical responsibilities.

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  Providing the aforementioned two criterion are met, NKF selection of candidate
to be supplemented will take into account regional distribution of applicant
institutions; and
o  Program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Charles H. Rodgers, Ph.D.
Division of Kidney, Urology and Hematology
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive MSC 6600
Bethesda, MD  20892-66000
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  rodgersc@extra.niddk.nih.gov

AUTHORITY AND REGULATIONS

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

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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