NIDDK MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD

Release Date:  March 5, 1999

PA NUMBER:  PA-99-069

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK)
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 usually 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 for-profit
and nonprofit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal Government. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
principal investigators.

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.

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 re-budget
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:

o  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.

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

o  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.

o  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.

o  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 re-budgeted.  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:

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

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

o  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 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, 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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is 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.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit.  Application kits are available at most institutional
offices of sponsored research, or may be obtained from the GrantsInfo,
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, Suite 6095, Bethesda, MD 20892-7910,
telephone 301-710-0267, email: [email protected].

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 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 and as modified in Vol.
25, Number 16, May 17, 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 Public Health
Service referral guidelines.  Applications that are complete will be evaluated
for scientific and technical merit by an appropriate peer review group
convened in accordance with NIH peer review procedures.  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
appropriate national advisory council or board.

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:  [email protected]

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:  [email protected]

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:  [email protected]

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:  [email protected]

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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