Full Text PAR-95-081

CLINICAL RESEARCH SCHOLAR SUPPLEMENTS TO M01 GRANTS

NIH GUIDE, Volume 24, Number 28, August 4, 1995

PA NUMBER:  PAR-95-081

P.T. 04

Keywords: 
  Clinical Medicine, General 
  Grants Administration/Policy+ 


National Center for Research Resources

PURPOSE

The National Center for Research Resources (NCRR) announces the
Clinical Research Scholar (CRS) Program, a junior career development
program, for physicians and dentists who have the interest and
aptitude for careers in patient-oriented clinical research, but who
have had limited formal clinical research training or career
development.  The CRS Program is intended to support the candidate
for one year of course work and research activities to enhance the
career development of the individual.  The candidate should work
closely with an appropriate mentor who is a clinical investigator
supported by peer-reviewed grant(s).  The mentor must work with the
candidate in selecting appropriate course work to complement
laboratory and patient-oriented clinical research.  Applications to
the CRS Program are to be submitted as competitive supplements to
existing General Clinical Research Center (GCRC) grants (NIH Activity
Code:  M01).

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,
Clinical Research Scholar Supplements to M01 Grants, is related to
all 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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Only institutions with an existing GCRC grant funded by the NIH may
submit applications for CRS supplemental awards.

The candidate for the CRS supplemental award must have earned the
M.D. or D.D.S. degree or equivalent and completed at least two years
of residency training at the time of the award.  The candidate must
be a U.S. citizen or hold a permanent immigration visa.  The
candidate may not hold independent peer-reviewed grant support prior
to or concurrently with funding of the CRS application.

MECHANISM OF SUPPORT

The CRS Program is to be supported by competitive supplements to GCRC
grants (NIH Activity Code:  M01).

The one-year CRS award will provide salary support up to $42,500 and
associated fringe benefits.  The salary request must be commensurate
with institutional salary policies for individuals with comparable
experience.  Funds for supplies, domestic travel to scientific
meetings and other expenses may be requested up to a maximum total of
$5,000 for the year.  Applicable indirect costs will be provided.  It
is anticipated that approximately five to six CRS awards will be
made annually.

RESEARCH OBJECTIVES

Background:  In order to translate effectively unprecedented
scientific discoveries into diagnostic and therapeutic tools
benefiting patients of all ages, to further the development of
medical sciences and to develop future leaders in patient-oriented
clinical research, scientists with unusual interdisciplinary skills
including those for molecular biology, biological chemistry,
experimental design, and ethics are needed.  The National Academy of
Sciences and the Advisory Committee to the Director of the NIH have
identified and stressed the urgent need to select and develop
promising junior clinical scientists to become well-versed in the
basic principles of patient-oriented research through a combination
of courses and laboratory and clinical research.  This new program
offers support to address that need through work individualized to
meet the career goals of the candidate.

Program Description:  The CRS Program requires at least 90 percent of
time and effort for one year for participation in curriculum and
related clinical research activities designed to enhance the
patient-oriented clinical research skills of the participant.  The
courses should be relevant to diverse areas of patient-oriented
clinical research and could include an array of topics, such as
biostatistics, design of clinical trials, computer skills and
bioethics.  Courses relevant to more specific areas of clinical
research of particular interest to the candidate may also be
included.  The Program must also include a supervised
patient-oriented clinical research experience for the candidate.  The
application must detail how participation in the CRS Program will be
integrated longitudinally into a more comprehensive program of
activities intended to prepare the candidate for a career as an
independent patient-oriented clinical investigator.  A CRS candidate
must be nominated by the GCRC Advisory Committee at the applicant
institution on the basis of qualifications, interests,
accomplishments, motivation, and potential for performing quality
patient-oriented clinical research.  Three sealed letters of
reference for the CRS candidate must accompany the application.  A
mentor must be identified who will guide the career development of
the candidate and provide the necessary resources for a research
experience.

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
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, 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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  The single annual receipt date for the CRS
supplemental applications is October 1.  The earliest start date of
the award will be the following July 1.  There is no restriction on
the number of applications that may be submitted from the applicant
institution for each October 1 receipt date.  However, there must be
sufficient time remaining in the competitive segment of the parent
GCRC grant to accommodate the one year of this supplemental activity.

Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, 6701 Rockledge Drive, Room 3032 - MSC 7762, Bethesda, MD
20892-7762, telephone 301/710-0267.

Applications must follow the instructions provided in the form PHS
398 kit except for the following:

In Item 1 on the face page of the application, insert the name of the
CRS candidate in the title, e.g., GCRC-CRS-Pat Brown, M.D.  In Item
2, check the box marked "YES" and type the title and number of this
program announcement.

Under "Research Plan" Items a-d, substitute a narrative description
of the following topics (not to exceed 15 pages):

Candidate:

o  Include a signed statement from the CRS candidate describing
his/her clinical research objectives and career goals.

Mentor:

o  Provide a statement from the mentor detailing his/her role in
oversight of the candidate's career development program. Information
on the research qualifications of the mentor and previous experience
as a research mentor must be provided.

CRS Program:

o  Describe the process by which the CRS candidate was nominated by
the institutional GCRC Advisory Committee.

o  Describe the proposed career development plan for the CRS
candidate, taking into account his/her specific didactic and research
needs and goals.  The choice of courses for the CRS candidate must be
specified with a brief description of their content and duration.
Include a description of the plans for the CRS candidate upon
completion of the year-long CRS Program.

Research:

o  Provide a brief 4-5 page description of the patient-oriented
clinical research project on which the CRS candidate will work, that
includes:

a.  a summary of the project.

b.  a description of the research experience proposed for the CRS
candidate.

c.  a description of how the research experience will promote the
independent research capabilities of the CRS candidate.

This research plan must be developed in consultation with the mentor.
Attention must be paid to NIH policy on the inclusion of women and
minorities as subjects in clinical research, as well as all six
points listed under "Human Subjects" in the form PHS 398.

Environment:

o  Describe the relevant resources of the sponsoring institution,
including a description of any existing didactic multidisciplinary
program or programs for the development of clinical investigators and
resources for the conduct of clinical research.

o  Describe the record of the sponsoring institution in promoting the
development of clinical researchers.  Examples might include success
in obtaining Clinical Associate Physician and/or Minority Clinical
Associate Physician supplemental awards to M01 grants, relevant
training grants, career development grants, or other programs to
develop clinical researchers that are supported by the sponsoring
institution, foundations or other sources.

Provide, as part of the application, three sealed letters of
recommendation addressing the CRS candidate's potential for a career
as a clinical researcher.  For applicants who are not U.S. citizens,
the application must include evidence that the individual has been
lawfully admitted as a permanent resident.

The completed original application and three copies must be delivered
to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Suite 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for courier/deliver service)

At the time of submission, two additional copies must also be sent
to:

Clinical Research
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6030 - MSC 7965
Bethesda, MD  20892-7965

REVIEW CONSIDERATIONS

Applications will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the Office of Review,
NCRR, in accordance with the standard NIH peer-review procedures.
Following scientific-technical review, applications will receive a
second-level review by the National Advisory Research Resources
Council.

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 the appropriate national advisory council or
board.

Review Criteria

o  Qualifications and motivation of the CRS candidate to pursue a
career in clinical research.

o  Qualifications of the mentor to oversee the career development
plan of the candidate.

o  Quality and relevance of the proposed curriculum for enhancing the
research skills of the CRS candidate.

o  Appropriateness of the proposed patient-oriented clinical research
experience for enhancing the clinical research skills of the CRS
candidate.

o  Appropriateness of the plans for the CRS candidate's career
development upon completion of the CRS program.

o  Adequacy of existing resources of the sponsoring institution for
the proposed didactic and clinical research experiences of the CRS
candidate.

o  Record of the institution in promoting the development of clinical
researchers.

o  Appropriateness of the budget for the proposed activities.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to NCRR.  The following will be considered in
making funding decisions:  quality of the proposed project as
determined by peer review, availability of funds, and program
priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Harriet L. Gordon, M.D.
General Clinical Research Centers Program
National Center for Research Resources
One Rockledge Centre, Room 6030
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0790
Email:  HarrietG@ep.ncrr.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Mary Niemiec
Office of Grants and Contracts Management
National Center for Research Resources
One Rockledge Centre, Room 6086
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
Email:  MaryN@ep.ncrr.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.333.  Awards are made under authorization of the
Public Health Service Act, Title III, 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 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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