MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD IN ANESTHESIOLOGY, CLINICAL
PHARMACOLOGY, AND TRAUMA AND BURN INJURY

Release Date:  June 23, 1998

PA NUMBER:  PAR-98-084

P.T.

National Institute of General Medical Sciences

PURPOSE

The National Institute of General Medical Sciences (NIGMS) will accept
applications for the Mentored Clinical Scientist Development Award (MCSDA)
(K08) in the areas of anesthesiology, clinical pharmacology, and trauma and
burn injury research.

NIGMS will offer the K08 award to support the development of outstanding
academic physician scientists.  This mechanism provides support for a period
of supervised research and study for clinically trained professionals who have
the commitment and the potential to develop into productive, independent
investigators.  The award period will last three, four, or five years and must
include a plan to obtain and integrate a fundamental and theoretical
understanding of the chosen field with a period of intensive laboratory or
clinically oriented research.  The proposed research should have both
intrinsic importance and be a suitable vehicle for learning the skills
necessary to become an independent researcher.  The scope and nature of the
proposed research should also be suitable for potential development into an
independently funded research endeavor.

This award will support developmental experiences in either laboratory or
clinical research. Because of the focus on a progression to independence as a
researcher, the prospective candidate for the K08 award should propose a
period of development consistent with this goal and his or her previous
research and clinical experience.  For example, a candidate with limited
experience in a given field of research may find a phased developmental
program lasting for five years which includes a designated period of didactic
training and closely supervised research experience the most efficient means
of attaining independence.  A candidate with substantial previous research
experience may require a shorter award period appropriate for the transition
to independence.  In all cases, the candidate must provide evidence of
attainment of a broad understanding of theoretical aspects of the relevant
basic or clinical science, or s/he will attain the same during the course of
this award.

All applicants are strongly encouraged to contact NIGMS staff listed below to
discuss issues of eligibility and the specific provisions of this award as it
pertains to NIGMS programmatic interests.

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.  This PA, Mentored Clinical Scientist
Development Award in Anesthesiology, Clinical Pharmacology, and Trauma and
Burn Injury, is related to the priority area of human resource development. 
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. degree or its equivalent, must have completed
postgraduate clinical training and have secured a faculty appointment in an
appropriate research-intensive environment, 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.

Applications may be submitted, on behalf of candidates, by domestic,
non-Federal organizations, public or private, such as medical schools. 
Minorities and women are encouraged to apply. Candidates must be U.S. citizens
or non-citizen nationals, or must have been lawfully admitted for permanent
residence and possess an Alien Registration Receipt Card (I-551) or some other
verification of legal admission as a permanent resident.  Non-citizen
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), or the
equivalent, are not eligible.  A candidate for the K08 award 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.  The K08 recipient would be allowed to maintain the award if
other PHS support is procured, as long as the new support does not interfere
with the ability to meet the MCSDA requirements.

MECHANISM OF SUPPORT

Awards in response to this program announcement will use the K08 mechanism. 
Planning, direction, and execution of the program will be the responsibility
of the candidate and her/his mentor on behalf of the applicant institution. 
The project period may be for three, four or five years and will depend upon
the number of years of prior research experience, and the need for additional
experiences to achieve independence.  Awards are not renewable.

RESEARCH OBJECTIVES

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

B.  Program: The award provides three to five 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
clinical and teaching pursuits consonant with the objectives of the award. 
Both the didactic and basic science components must be designed to develop the
necessary knowledge and research skills in scientific areas relevant to the
career goals of the candidate.

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

D.  Allowable Costs:

1.  Salary:  NIGMS will provide salary for the K08 recipient at a maximum of
$75,000 per year.

The institution may supplement the NIGMS 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 MCSDA.  Under expanded authorities, however, institutions may rebudget
funds within the total costs awarded to cover salaries consistent with the
institution's salary scale.

The total salary requested must be based on a 100%, 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.

2.  Research Development Support: NIGMS will provide up to $20,000 per year
for:  (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; (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 NIGMS 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 clinical practice, 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. NIGMS will consider 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 NIGMS

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 NIGMS is required.  To
obtain prior approval, the award recipient must submit a letter to NIGMS
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 NIGMS 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, NIGMS 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:

The new institution submits an application to transfer the award, complete
with the requisite information concerning all aspects of the career
development plan, mentoring, and institutional support (as described elsewhere
in this notice);

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

The application to transfer an award is submitted at least 60 days prior to
the requested start date at the new institution to allow time for review by
NIGMS staff.

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 of March 18, 1994, Volume 23, Number
11.

NIH POLICY AND GUIDELINES ON THE 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

Investigators may obtain copies from these sources or from the program staff
or contact person listed below.  Program staff may also provide additional
relevant information concerning the policy.

APPLICATION PROCEDURES

All candidates are strongly encouraged to contact the staff person in the
relevant research area listed under INQUIRIES.  Such contact should occur
early in the planning phase of application preparation.  Such contact will
help ensure that applications are responsive to the career development goals
and policies of NIGMS.

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted on the application receipt deadlines indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, Office of Extramural Research, National Institutes of
Health, 6701 Rockledge Drive, Room 6095, Bethesda, MD 20892-7910, Phone (301)
710-0267, FAX: (301) 480-0525, Email: [email protected].  Forms are also 
available on the NIH Website at: http://www.nih.gov/grants/oer.htm.

The application must address the following issues:

1.  Candidate

Describe the candidate's commitment to a career in clinical or
laboratory-based biomedical 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.

2.  Career Development Plan

Describe the career development plan incorporating consideration of the
candidate's goals and prior experience.  Where necessary, it must describe a
systematic plan to obtain both the necessary didactic training and research
experience to launch an independent research career.  Candidates interested in
clinical research must describe the availability of courses such as research
design, biostatistics, epidemiology, and ethical and regulatory issues at
their institution and the integration of these studies into their career
development plan.

Candidates with limited research training may require a phased developmental
period in which the first year(s) of the award are largely of a didactic
nature followed by a period of intense, supervised research experience. 
Candidates with more experience at the time of application may need a shorter
developmental period and may already have an adequate theoretical background. 
In any case, the career development plan must be tailored to the needs of the
individual candidate and the ultimate goal of achieving independence as a
researcher.

Candidates must 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.

3.  Research Plan

Describe the research plan and the use of a laboratory or clinical science
approach to a biomedical problem.  The research plan must be described as
outlined in 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 regarding the
development of this section, but the proposed research should derive from the
candidate's own background, research interests, and career goals.  The
proposed research should also be suitable for development into a project
capable of generating independent funding.

4.  Mentor's Statement

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

5.  Environment and Institutional Commitment

The sponsoring institution must document a strong, well-established research
and training 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.  The statement should indicate that the
candidate is in a tenure-track or analogous position.

6.  Budget

Budget requests must be provided according to the instructions in form PHS
398.  The request for tuition and fees, books, travel, research development
support, etc., must be justified and specified by category.

To identify the application as a response to this program announcement, check
"YES" on item 2 of page 1 of the application and enter "K08, Mentored Clinical
Scientist Development Award" and NIGMS as the institute where you would like
your application to be assigned for funding.

Submit a signed, typewritten original of the application with Checklist, and
five signed photocopies, in one package to:

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

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the Center for Scientific
Review.  Incomplete applications will be returned to the applicant without
further consideration.  Applications that are complete and responsive to the
program announcement will be evaluated for scientific merit and training
potential by an appropriate review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit review, all
applications will be discussed, assigned a priority score, and receive a
written critique.  The applications will then receive a second level review by
the National Advisory General Medical Sciences Council.

The following review criteria will be applied:

1.  Candidate

Quality of the candidate's academic and clinical record,

Potential to develop as an independent clinical or laboratory based
researcher;  and

Commitment to a research career.

2.  Career Development Plan

Likelihood that the career development plan will contribute substantially to
the scientific development of the candidate;

Probability of development of a competitive independent research program;

Appropriateness of the content and duration of the proposed didactic and
research phases of the award;

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

Quality of the proposed training in responsible conduct of research.

3.  Research Plan

Reviewers recognize that an individual with limited research experience is
less likely to be able to prepare a research plan with the breadth and depth
of that submitted by a more experienced investigator.  Although it is
understood that K08 applications do not require the level of detail necessary
in regular research grant proposals, a fundamentally sound research plan must
be provided.  In general, less detail is expected with regard to research
planned for the later years of the award, but the application should outline
the general goals for these years.  The following details should be provided:

The significance of the area of research in which the candidate proposes to
establish independence:

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;

Scientific and technical merit of the research question, design and
methodology;

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

Adequacy of the plan's attention to gender and minority issues associated with
projects involving human subjects.

4.  Mentor

Appropriateness of mentor's research qualifications;

Quality and extent of mentor's proposed role in providing guidance and advice
to the candidate;

Previous experience in fostering the development of researchers; and

History of research productivity and support.

5.  Environment

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;

Adequacy of research facilities and the availability of appropriate
educational opportunities;

Quality and relevance of the environment for scientific and professional
development of the candidate; and

Applicant institution's commitment to an appropriate balance of research and
clinical responsibilities.

6.  Budget

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

AWARD CRITERIA

Funding decisions will be made based on the merit of the proposal, the need
for research personnel in specific program areas, and the availability of
funds.

INQUIRIES

Written and telephone inquiries concerning this program announcement are
strongly encouraged especially during the planning phase of the application.

Direct inquiries regarding programmatic issues to:

Alison E. Cole, Ph.D.
Anesthesiology Program
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49K, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-1826
FAX:  (301) 480-2802
Email:  [email protected]

Rochelle M. Long, Ph.D.
Clinical Pharmacology Program
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49A, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-1826
FAX:  (301) 480-2802
Email:  [email protected]

Scott D. Somers, Ph.D.
Trauma and Burn Injury Program
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49J, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5560
FAX:  (301) 480-2802
Email:  [email protected]

For questions about grants management, contact:

Toni Holland
Grants Management Officer
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.50B, MSC 6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-5132
FAX:  (301) 480-3423
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.859.  Awards are made under the authority of Title III, Section 301 of the
Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42
USC 241).  The Code of Federal Regulations, Title 42 Part 52, and Title 45
part 74, are applicable to this program.  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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