Full Text PA-95-054

MENTORED CLINICAL SCIENTIST DEVELOPMENT PROGRAM AWARD

NIH GUIDE, Volume 24, Number 15, April 28, 1995

PA NUMBER:  PA-95-054

P.T. 34

Keywords: 
  Biomedical Research, Multidiscipl 
  Clinical Medicine, General 


National Institute on Aging
National Institute of Dental Research

Application Receipt Dates:  February 1, June 1, and October 1

PURPOSE

The Mentored Clinical Scientist Development Program Award (MCSDPA) is
an award to an educational institution to support career development
experiences for clinicians leading to research independence. Under
this award, newly-trained clinicians are to be selected and appointed
to this program award by the grantee institution.  In other respects,
the research experience of the candidates selected for support under
this award should resemble those supported by the individual Mentored
Clinical Scientist Development Award.

Applications for this award should propose a research plan which has
both intrinsic research importance and will also serve as a suitable
vehicle for learning the methodology, theories, and
conceptualizations necessary for a well trained independent
researcher.  The program should be designed to accommodate appointees
with varying levels of experiences.  For example, a prospective
candidate with limited experience in a given field of research may
find it appropriate to engage in a structured, phased developmental
program, including a designated period of didactic training followed
by a period of supervised research experience.  The entire program
should be comparable in scope and rigor to meeting the requirements
for an advanced research degree.

The NIH institutes and centers have modified this award to
accommodate the career pathways of researchers in fields related to
their missions.  For example, the National Institute of Dental
Research (NIDR) requires that all candidates must pursue a program
that includes didactic and supervised basic or behavioral research
experiences which result in the Ph.D. degree.  The NIDR provides
support under this program for the development of advanced clinical
knowledge and skills in either a recognized clinical specialty or
equivalent dental clinical discipline.  Therefore, the prospective
candidate must have a D.D.S. or an equivalent degree but need not
have started postgraduate training, such as in a clinical specialty.
Dentists who already posses advanced clinical knowledge and skills
are eligible for the MCSDPA under special circumstances, but are
encouraged to seek appointments to the Mentored Clinical Scientist
Development Award (K08).  All applicants and potential appointees are
strongly advised to contact the prospective NIH awarding component
for information about eligibility and the specific provisions of this
award.

This award replaces two comparable NIH career development program
awards for clinicians.  These are the Physician Scientist Program
Award (K12) and the Dentist Scientist Program Award (K16).
Institutions and departments that were eligible to apply for either
of these program awards are now eligible to apply for the MCSDPA
award.  Therefore, this Program Announcement (PA) supersedes all
previous K12 and K16 program announcements.  The NIH will no longer
accept competing applications for the old K12 and K16 awards.  The
new MCSDPA has been modified to incorporate the features of these
career development programs.  Existing policies and provisions will
remain in effect for current K12 and K16 awards until completion of
their non-competing years.

The NIH recently reviewed its career awards (K) used to develop the
research capabilities of clinicians and other scientists needed to
carry out the nation's research mission in the biomedical and
behavioral sciences.  This evaluation resulted in several changes:
(1) the total number of K mechanisms were reduced from 19 to six; (2)
the review criteria were refined to clarify the career development
goals of the K award; and (3) K award applications will be assigned
to initial review groups managed by the prospective funding institute
or center to which the application has been assigned.

HEALTHY PEOPLE 2000

The Public Health Service 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 Program Award, 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) from the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications will be accepted from departments or divisions from
domestic, non-Federal organizations, such as medical, dental or
nursing schools, or from comparable institutions of higher education
that have strong, well-established research and training programs.
The applicant institution must have adequate numbers of highly
trained faculty in clinical and basic sciences who have the interest
and capability to provide guidance to clinically-trained individuals
in the development of research independence.  The environment should
be one which will stimulate and increase the interactions between
basic scientists and clinical investigators.

Institutions with a MCSPDA may recruit and select candidates into
their programs on a local basis rather than submitting a separate
application on behalf of each prospective candidate.  In all aspects,
the program awards are intended to provide support for the
development of clinical scientists in the same manner and under the
same conditions as the individual Mentored Clinical Scientist
Development Award (K08).  Therefore, candidates for support under
this program award must have a clinical degree or its equivalent,
must have initiated internship and residency training (or its
equivalent), and must be provided with a mentor(s)  who has extensive
research experience and a record of providing the type of training
required under this award.  The candidate also must be willing to
spend a minimum of 75 percent of full-time professional effort
conducting research, career development, and/or research related
activities.

Minorities and women are encouraged to apply. Candidates appointed
under this program award must be U.S. citizens or noncitizen
nationals, or 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.

Candidates who are or have been former principal investigators on NIH
research projects (R01), FIRST Awards (R29), sub-projects of program
project (P01) or center grants (P50), or the equivalent, are not
eligible for appointment under this program.  Candidates may not
concurrently hold any other PHS award that duplicates the provisions
of this award. MCSDPA candidates are encouraged to apply for
independent research grant support during the period of support under
this award.

MECHANISM OF SUPPORT

Awards in response to this PA will use the K12 mechanism.  The
program award provides five years of support and is renewable.
Appointees may receive three to five years of support depending upon
the number of years of prior research experience, the need for
additional experiences to achieve independence, and the policy of the
NIH awarding unit.  Planning, direction, and execution of the program
will be the responsibility of the appointee and her/his mentor and
consistent with the goals of the program award.

RESEARCH OBJECTIVES

A.  Environment:  The institution must have well-established research
and clinical career development program and qualified faculty in
clinical and basic research to serve as mentors.  The appointee,
mentor and institution must develop innovative multi-disciplinary
programs to maximize the available research and educational
resources.

B.  Program Director:  The proposed Program Director should possess
the scientific expertise, leadership and administrative capabilities
required to coordinate and supervise an interdisciplinary research
and development program of this scope.  The Director should also be
experienced in the design and management of programs for developing
investigators, and should be able to demonstrate a superior record of
preparation of clinicians for independent research.  In addition, a
committee with representatives from the appropriate basic and
clinical science departments should be established to advise the
Program Director.

C.  Mentors:  Each candidate appointed on the program award must have
a primary sponsor who is recognized as an accomplished investigator
and is actively involved in basic or clinical research and who has a
successful record of providing the type of training required under
this award.  An assigned mentor will provide guidance for the
development of each candidate assigned to the program.  The mentor
must be committed to continue this involvement throughout the
appointee's total period of development under the award.

D.  Program: The program award provides five years of renewable
support.  The award is intended to support candidates who receive
three to five years support consisting of consecutive 12 month
appointments.  The support is often divided into two distinct phases-
-a basic science component and an intensive research experience under
the general guidance of a qualified mentor. The basic science
component must develop knowledge and research skills in scientific
areas relevant to the career development goals of the candidate and
must include relevant didactic and laboratory experiences.  In all
cases, the types of developmental experiences provided should be
consistent with the candidate's prior experience and needs.  At least
75 percent of the recipient's full-time professional effort must be
devoted to the program and the remainder devoted to developing other
clinical and teaching pursuits consonant with the objectives of the
award.

E.  Allowable Costs:

1.  Salary:  The NIH will provide salary and fringe benefits for the
candidate only.  The salary limits on career awards are not uniform
throughout the NIH and are determined independently by each component
of the NIH.  Therefore, prospective applicants should contact the
component to which the application is targeted to ascertain the
salary cap for appointees under the MCSDPA.  No compensation is
provided for the program director or the mentors.

The institution may supplement the NIH salary 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 for each candidate 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.

2.  Research Development Support:  Each appointee will be allowed 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; (d) statistical services including
personnel and computer time.  The NIDR will provide up to $15,000 for
research development support for each candidate.

3.  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.

F.  Evaluation:  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 candidates may be contacted
after the completion of their career development experiences 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.

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

H.  Special Leave: Candidates appointed to this program career award
may engage in research experiences at 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 three months.  For longer periods,
prior written approval of the NIH funding component is required.  To
obtain prior approval, the program director 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.

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 termination or relinquishment of an award.

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
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 reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

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

This is a generic program announcement for the NIH MCSDPA.
Therefore, it is strongly recommended that prospective applicants
contact the staff person in the relevant institute or center listed
under "INQUIRIES" early in the planning phase of application
preparation.  Such contact will help ensure that applications are
responsive to the career development goals of individual institutes
and centers.  It should be noted that not all NIH institutes and
centers use the MCSDPA as a means of recruiting clinicians into
research.

Applications are to be submitted on form PHS 398 (rev. 9/91) and will
be accepted on or before the receipt deadlines indicated in the
application kit (February 1, June 1 and October 1).  Forms are
available at most institutional offices of sponsored research and
from the Office of Grants Information, Division of Research Grants,
NIH, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301/435-0714.

The application must address the following issues:

(1) Provide information establishing the commitment of the applicant
institution, the program director, and the faculty mentors to
providing developmental experiences that lead to independence in
biomedical, behavioral, or clinical research.

(2) Summarize the immediate and long-term career objectives of the
program, explaining how the program and the MCSDPA will contribute to
their attainment.

(3) Describe the career development plans for prospective candidates.
Considering the program goals and the likely goals of prospective
candidates, describe a plan to provide the necessary basic science
background and research experiences considering the expected range of
prior research training in the applicant pool.  For example,
candidates with little previous research experience may require a
phased developmental period in which the first year or two of support
under this program award are comprised largely of didactic training
in the basic sciences.  For these candidates, a second phase would be
an intensive, supervised research experience to complete the five
year developmental program.  More experienced candidates may benefit
from moving immediately to a mentored research environment and a
shorter period of support under this program award.  The application
should contain a description of how the career development plan will
be tailored to the needs of the prospective candidates.

(4) Describe the pool of potential candidates including information
about the types of prior clinical and research training.  Also,
describe how  the appointments will be made to the MCSDPA.  Describe
the composition of the selection committee and the criteria to be
used for selection.  Describe plans to recruit candidates from racial
or ethnic groups that are currently underrepresented in biomedical,
behavioral, or clinical sciences.

(5) Describe to the extent possible the types of research experiences
available to the candidates.  The research experiences may include
either basic or clinical science approaches to biomedical or
behavioral problems.  Provide examples of potential experiences using
the format described in form PHS 398, including Specific Aims,
Background and Significance, Progress Report/ Preliminary Studies,
Research Design and Methods.

(6) Instructions in the responsible conduct of research.
Applications must include plans for instruction in the responsible
conduct of research, including the rationale, subject matter,
appropriateness, format, frequency and duration of instruction; and
the amount and nature of faculty participation.  No award will be
made if an application lacks this component.

(7) Renewal applications must include a detailed account of the
career outcomes of all candidates supported by this grant including
positions held, research involvement, publications, and other
evidence that this program award is meeting the objectives of the NIH
awarding component

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

To identify the application as a response to this PA, check "YES" on
item 2a of page 1 of the application and enter PA-95-054, Mentored
Clinical Scientist Development Program Award" and the name of the NIH
institute or center that you would like your application to be
assigned.

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

Division of Research Grants
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 reviewed for completeness by the Division of
Research Grants and responsiveness to the PA by the appropriate
institute or center staff.  Incomplete or nonresponsive 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 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 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 he appropriate national advisory council or
board.

The following review criteria will be applied:

Program Director

o  The program director's experience in managing career development
programs and success in preparing clinician investigators for
independent research careers;

Candidate(s)

o  Availability of high quality potential candidates,

o  Plans for recruiting and selecting candidates (including
minorities and women); and

o  Plan to identify candidates with a commitment to research and the
potential to develop as an independent researcher;

o  For renewal applications, the career success of candidates that
have terminated support under this award within the past 10 years.

Career Development Plan

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

o  Appropriateness of the content, the phasing, and the proposed
duration of the career development plan for achieving scientific
independence for the prospective candidates;

o  Consistency of the career development plan with prospective
candidate's career goals; and

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

Research Plan

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

o  Scientific and technical merit of the research questions, design
and methodology;

o  Relevance of the proposed research to the career objectives of the
potential candidate(s); and

o  Adequacy of the plan's attention to gender and minority issues.

Mentor

o  Appropriateness of the faculty mentors research qualifications in
the area of this application;

o  Quality and extent of the mentors proposed role in providing
guidance and advice to candidates;

o  Previous experience of the mentors in fostering the development of
researchers; and

Environment

o  Applicant institution's commitment to the scientific development
of the candidate(s) and assurances that the institution intends the
program and the supported candidate(s) to be an integral part of its
research program;

o  Adequacy of research facilities and training opportunities;

o  Quality of the environment for scientific and professional
development; and

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

Budget

o  Justification of budget requests in relation to career development
goals and research aims.

AWARD CRITERIA

The institute or center will notify the applicant of the board or
council's action shortly after its meeting.  Funding decisions will
be made based on the recommendations of the initial review group and
council/board, the need for research personnel in specific program
areas, and the availability of funds.

INQUIRIES

Written and telephone inquiries concerning this program announcement
are encouraged especially during the planning phase of the
application.  Below is a listing of NIH contacts for this career
development award:

Dr. Robin A. Barr
Office of Extramural Affairs
National Institute on Aging
7201 Wisconsin Avenue, Room 2C218, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9322
Email:  Barr@nihniagw.bitnet

Dr. James A. Lipton
Special Assistant for Training and Career Development
National Institute of Dental Research
Natcher Building, Room 4AN.18J
Bethesda, MD  20892
Telephone:  (301) 594-2618
Email:  liptonj@de45.nidr.nih.gov

Ms. Theresa Ringler
Grants Management Office
National Institute of Dental Research
Natcher Building, Room 4AS-55
Bethesda, MD  20892
Telephone:  (301) 594-4800
FAX:  (301) 480-8301

AUTHORITY AND REGULATIONS

The Mentored Clinical Scientist Development Program 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
described in the Catalog of Federal Domestic Assistance No. 93.121.
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 routing 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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