NIDDK MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD

Release Date:  May 11, 1998

PA NUMBER:  PAR-98-065

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Disease invites
applications for Mentored Research Scientist Development Awards (K01) from basic
scientists interested in pursuing research careers in the areas of diabetes,
endocrinology, metabolic disorders, digestive diseases, nutrition, obesity, and
kidney, urologic, and hematologic disorders.  The intent of these K01 awards is
to provide support for the critical transition period between postdoctoral
training and independent R01 funding for those non-clinical investigators whose
careers are vital for the future excellence of the NIDDK research endeavor. 
Candidates must justify the need for a 3-year period of mentored research
experience and provide a convincing case that the proposed period of support will
substantially enhance his/her career as an independent investigator.

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

Applicants must have a research or a health-related professional doctorate,
usually a Ph.D. degree, and have completed at least two, but not more than five,
years of postdoctoral research training prior to submission of the K01
application.  Postdoctoral work should have been in an area clearly relevant to
the mission of the NIDDK.  Applicants may not have been principal investigators
on peer-reviewed research project grants (R01s), or their equivalent, from the
NIH or other Federal or non-Federal sources.

The research proposed must be related to the areas of diabetes, metabolic
disorders, cystic fibrosis, endocrinology, digestive diseases, nutrition,
obesity, and kidney, urologic, or hematologic disorders.  Consultation with
program staff listed under INQUIRIES is strongly recommended to determine if both
the applicant and the proposed research are appropriate for this award.

The candidate must identify a mentor with extensive research experience, and must
be willing to spend a minimum of 75 percent of full-time professional effort
conducting research and research career development activities for the period of
the award.

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.  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. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply.

MECHANISM OF SUPPORT

The mechanism of support will be the Mentored Research Scientist Development
Award (K01) (NIH Guide, Vol. 24, Number 15, April 28, 1995; PA-95-049). 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 must be 3 years.

RESEARCH OBJECTIVES

The goal of the NIDDK K01 program is to ensure a future cadre of well-trained
Ph.D. scientists competitive for regular research project (R01) grant support.
The intent is to provide a final mentored period of support to facilitate the
transition of the candidate to independence and to allow him/her to accumulate
the data and expertise needed to apply for an initial R01 grant.

A.  Environment:  The institution must have a well-established research career
development program and qualified basic research faculty to serve as mentors. 
The institution must be able to demonstrate a commitment to the development of
the candidate as a productive, independent investigator.  The candidate, mentor,
and institution must be able to describe a multi-disciplinary career development
program that will maximize the use of relevant research and educational
resources.

B.  Program: The award provides 3 consecutive 12-month appointments.  At least
75 percent of the recipient's full-time professional effort must be devoted to
the program and the remainder devoted to other research-related and/or teaching
pursuits consistent with the objectives of the award.  The candidate must develop
knowledge in the basic sciences and research skills relevant to his/her career
goals.  The candidate may find it appropriate to include relevant didactic and
laboratory or field research experiences.

C.  Mentor(s):  The recipient must receive appropriate mentoring throughout the
3-year program.  Where feasible, women and minority mentors should be involved
as role models.

D.  Allowable Costs:

1.  Salary: The NIDDK will provide salary and fringe benefits for the K award
recipient.  Salary is limited to $50,000 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.  If full-time, 12-month salaries are not currently paid to
comparable staff members, the salary proposed must be appropriately related to
the existing salary structure.  Confirmation of salary is required prior to an
award being issued.

The institution may supplement the NIH contribution up to a level that is
consistent with the institution's salary scale; however, supplementation may not
be from Federal funds unless specifically authorized by the Federal program from
which such funds are derived. In no case may PHS funds be used for salary
supplementation.  Institutional supplementation of salary must not require extra
duties or responsibilities that would interfere with the purpose of the award. 
Under expanded authorities, however, institutions may rebudget funds within the
total costs awarded to cover salaries consistent with the institution's salary
scale.

2.  Research Development Support: The NIDDK will provide up to $20,000 per year
for the following expenses:  (a) tuition, fees, and books related to career
development; (b) research expenses, such as supplies, equipment, and technical
personnel; (c) travel to research meetings or training; and (d) statistical
services including personnel and computer time.

3.  Ancillary Personnel Support: Salary for mentors, secretarial and
administrative assistance, etc., is not allowed.

4.  Indirect costs: Indirect costs will be reimbursed at 8 percent of modified
total direct costs, or at the actual indirect cost rate, whichever is less.

E.  Evaluation:  In carrying out its stewardship of human resource related
programs, the NIDDK 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.

F.  Other Income: Fees resulting from professional consultation or other
comparable activities required by the research and research-related activities
of this award may not be retained by the career award recipient.  Such fees must
be assigned to the grantee institution for disposition by any of the following
methods:

The funds may be expended by the grantee institution in accordance with the NIH
policy on supplementation of career award salaries and to provide fringe benefits
in proportion to such supplementation.  Such salary supplementation and fringe
benefit payments must be within the established policies of the grantee
institution.

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks
should be made payable to the Department of Health and Human Services, NIH and
forwarded to the Director, Division of Financial Management, NIH, Bethesda,
Maryland 20892.  Checks must identify the relevant award account and reason for
the payment.

Awardees may retain royalties and fees for activities such as scholarly writing,
service on advisory groups, or honoraria from other institutions for lectures or
seminars, provided these activities remain incidental and provided that the
retention of such pay is consistent with the policies and practices of the
grantee institution.

Usually, funds budgeted in an NIH supported research or research training grant
for the salaries or fringe benefits of individuals, but freed as a result of a
career award, may not be rebudgeted.  The NIDDK will give consideration to
approval for the use of released funds only under unusual circumstances.  Any
proposed retention of funds released as a result of a career award must receive
prior written approval of the NIH awarding component.

G.  Special Leave: Leave to another institution, including a foreign laboratory,
may be permitted if directly related to the purpose of the award.  Only local,
institutional approval is required if such leave does not exceed 3 months.  For
longer periods, prior written approval of the NIH funding component is required. 
To obtain prior approval, the award recipient must submit a letter to the NIH
describing the plan, countersigned by his or her department head and the
appropriate institutional official.  A copy of a letter or other evidence from
the institution where the leave is to be taken must be submitted to assure that
satisfactory arrangements have been made.  Support from the career award will
continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the
prior written approval of the NIH funding component and will be granted only in
unusual situations.  Support from other sources is permissible during the period
of leave.  Such leave does not reduce the total number of months of program
support for which an individual is eligible.  Parental leave will be granted
consistent with the policies of the NIH and the grantee institution.

H.  Termination or Change of Institution: When a grantee institution plans to
terminate an award, the NIDDK must be notified in writing at the earliest
possible time so that appropriate instructions can be given for termination.  If
the individual is moving to another eligible institution, career award support
may be continued provided:

An application for continuing the award is submitted by the new institution;

The period of support requested is no more than the time remaining within the
existing award period; and

The new application is submitted far enough in advance of the requested effective
date to allow the necessary time for review.  Review will be carried out by staff
within the NIDDK and will focus on the likelihood that the original goals of the
project can be accomplished at the new institution given the change of
environment and possible change of mentor.

The Director of the NIH may discontinue an award upon determination that the
purpose or terms of the award are not being fulfilled.  In the event an award is
terminated, the Director of the NIH shall notify the grantee institution and
career award recipient in writing of this determination, the reasons therefor,
the effective date, and the right to appeal the decision.

A final progress report, invention statement, and Financial Status Report are
required upon either termination of an award or relinquishment of an award in a
change of institution situation.

INCLUSION OF WOMEN, MINORITIES, AND CHILDREN 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, unless a clear and compelling
rationale and justification is provided 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," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

Investigators also may obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

It is also the policy of NIH that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
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 on the application receipt dates of June 1 and October
1 1998 and February 1, 1999.  Application kits are available at most
institutional offices of sponsored research and may be obtained from the Division
of Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714,
email: grantsinfo@nih.gov.

To identify the application as a response to this program announcement, check
"YES" on item 2 of page 1 of the application and enter the number and title of
this program announcement.

Applications must include at least three sealed letters of reference attached to
the face page of the original application.  Applications submitted without the
required number of reference letters will be considered incomplete and will be
returned without review.

Submit the signed, original, single-sided application, along with five exact,
single-sided copies and five 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)

The application must address the following issues:

Candidate

o  Establish the candidate's commitment to a career in an area of biomedical or
behavioral research of importance to the NIDDK;

o  Establish the candidate's potential to develop into a successful independent
investigator.

o  Summarize the candidate's immediate and long-term career objectives,
explaining how the award will contribute to their attainment.

o  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

o  Describe the career development plan, incorporating consideration of the
candidate's goals and prior experience.  A systematic plan should be described
to obtain the necessary basic biomedical or behavioral science background and
research experience to launch an independent research career.  The career
development plan must be tailored to the needs of the candidate and the ultimate
goal of independence as a researcher.

o  Describe plans to receive instruction in the responsible conduct of research. 
These plans must detail the proposed subject matter, format, frequency, and
duration of instruction.  No award will be made if an application lacks this
component.

Research Plan

o  Describe the research plan and the use of a basic or clinical approach to a
biomedical or behavioral problem.  The candidate and mentor together must
describe the research plan as outlined in form PHS 398 including sections on the
Specific Aims, Background and Significance, Progress Report/Preliminary Studies,
Research Design and Methods.

Mentor's Statement

o  The application must include information on the mentor(s) including
information on research qualifications and previous experience as a research
supervisor.  The application must also include information that describes the
nature and extent of supervision that will occur during the proposed award
period.  The mentor must agree to provide annual evaluations of the applicant's
progress during the duration of the grant.

Environment and Institutional Commitment

o  The sponsoring institution must document a strong, well-established research
program related to the candidate's area of interest including a high-quality
research environment with staff capable of productive collaboration with the
candidate.  The sponsoring institution also must provide a statement of
commitment to the candidate's development into a productive, independent
investigator.

Budget

o  Budget requests must be provided according to instructions in form PHS 398 as
modified by the Just-In-Time Procedures instituted in 1996 (NIH Guide for Grants
and Contracts, Vol. 25, No. 10, March 29, 1996), including information on the
mentor(s)' pending and current research support as stipulated.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in accordance with
the standard NIH peer review procedures.  As part of the initial merit review,
all applications will receive a written critique and undergo a process in which
all submitted applications will be discussed, assigned a priority score, and
receive a second level review by the an appropriate National Advisory Council.

The following review criteria will be applied:

Candidate

o Commitment to an independent research career;

o Evidence of the capacity to develop as an independent investigator;

o Quality and breadth of prior scientific training and experience, including the
record of previous research training and support and publications.

Career Development Plan

o Likelihood that the career development plan will contribute substantially to
the scientific development of the candidate and the achievement of scientific
independence;

o Appropriateness of the research plan to the career goals of the candidate;

o Consistency of the career development plan with the candidate's prior research
and academic experience and the stated career goals;

o Clarity of the goals and scope of the plan and the need for the proposed
research experience; and

o Quality of the proposed training in the responsible conduct of research.

Research Plan

In general, candidates for this award will have had previous research experience
as postdoctoral fellows.  A sound research plan that is consistent with the
career development plan and candidates' level of research development must be
provided.

o Usefulness of the research plan as a vehicle for enhancing existing research
skills as described in the career development plan;

o Scientific and technical merit of the research question, design, and
methodology, judged in the context of the candidate's previous training and
experience;

o Relevance of the proposed research to the candidate's career objectives and to
the mission of the NIDDK; and

o Adequacy of the plans to include both genders, minorities, and children and
their subgroups as appropriate for the scientific goals of the research.  Plans
for the recruitment and retention of subjects will also be evaluated, when
applicable.

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
children as appropriate for the scientific goals of the research, or
justification for exclusion.

Mentor

o Appropriateness of the mentor's research qualifications in the area of research
proposed;

o Quality and commitment of the mentor to supervising and guiding the candidate
throughout the award period;

o Previous experience in fostering the development of researchers; and

o History of research productivity and support.

Institutional Environment and 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 willingness to develop an appropriate mix of research, 
teaching, and administrative responsibilities for the candidate.

Budget

o Justification of the requested budget in relation to career development goals
and research aims and plans.

AWARD CRITERIA

Applications will compete for available funds with all other approved career
development applications.  The following will be considered in making funding
decisions:

o  Quality of the proposed applications as determined by peer review
o  Availability of funds
o  Program priority

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Paul Coates, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8805
Email:  coatesp@extra.niddk.nih.gov

Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8876
Email:  podskalnyj@extra.niddk.nih.gov

Charles Rodgers, Ph.D.
Division of Kidney, Urologic, and Hematologic Disorders
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
Email:  rodgersc@extra.niddk.nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Donna Huggins
Grants Management Office
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 549-8848
Email:  hugginsd@extra.niddk.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.847, 93.848, and 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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