Full Text AG-97-004
NIH GUIDE, Volume 26, Number 3, January 31, 1997
RFA:  AG-97-004
P.T. 34, FF

  Clinical Trial 
  Public Health 

National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Office of Research on Women"s Health
Office of Research on Minority Health
Letter of Intent Receipt Date:  March 7, 1997
Application Receipt Dates:  April 18, 1997
The purpose of this Request for Applications (RFA) is to increase the
number of underrepresented minority investigators participating in
the clinical trial and observational study of the Women"s Health
Initiative (WHI) using the mechanism of the NIH Mentored Career
Development Awards.
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 RFA,
WHI Minority Investigator Career Development 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 202-512-1800).
In general, candidates should be an underrepresented minority
scientist or physician, in possession of a doctoral degree or
equivalent.  The NIH Career Development Grant Mechanisms are
described in the NIH GUIDE, Volume 24, Number 15, April 28, 1995.
All applicants are encouraged to contact one of the program officials
listed in this RFA regarding their eligibility for the K01 or K08.
Applications may be submitted by institutions on behalf of candidates
(1) the site of the clinical coordinating center or one of the 40
clinical centers that are participating in the Women"s Health
Initiative, or
(2) any other institution recognized as a minority institution or
with significant minority enrollment.
The candidate must identify a mentor at the site of the clinical
coordinating center or one of the 40 clinical centers that are
participating in the Women"s Health Initiative.  The mentor must have
extensive research experience and provide guidance for the awardee"s
development and research.  The candidate 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.  Research will be conducted primarily at the mentor"s
Awards in response to this RFA will use the K01 or K08 mechanism.
provide research scientists with an additional period of mentored
research experience as a way to gain expertise in a research area new
to the applicant or in an area which would demonstrably enhance the
applicant"s scientific career.  This award is generally reserved for
individuals interested in switching to a new research field, for
individuals who have interrupted their career because of illness or
pressing family care responsibilities, or for faculty at minority
institutions who wish to enhance their capacity for independent
award for clinicians who need an intensive period of mentored
research experience.
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.
The NIH will allocate approximately $300,000 during fiscal year 1997.
The actual amount may vary depending on the response to this RFA and
the availability of funds.  Three to four awards are anticipated.
The NIH Women"s Health Initiative is a  research study focused on the
major causes of morbidity and mortality in postmenopausal women.  It
is designed to test whether long term preventive measures will
decrease the incidence of  cardiovascular disease, breast and colon
cancer, and osteoporosis.  Over 160,000 women in 40 clinical centers
throughout the United States will be enrolled as participants in
either clinical intervention trials or in a long term epidemiologic
study.  Ten of the clinical centers are specifically recruiting
minority participants and all of the centers are committed to
optimizing the diversity of the populations recruited.  This project
is currently underway and will provide training opportunities in
epidemiology and clinical trials over the next decade and beyond.
The Women"s Health Initiative Policy Advisory Committee, a group that
provided advice to the Director of NIH during the initial years of
this project,  and the Special Populations Committee, composed of
scientists and clinicians within the study,  have both suggested that
the WHI would benefit from greater participation by minority
investigators in the scientific and clinical activities of the
Information on the background, current status and the participating
clinical centers of the WHI can be accessed on the World Wide Web at:
http://www.nih.gov/od/odp/whi or by contacting:
Nancy Morris
Women"s Health Initiative Project Office
National Institutes of Health
Federal Building, Room 6A-09
Bethesda, MD  20892
Telephone:  (301) 402-2900
Email:  Nancy_Morris@NIH.GOV
Career development awards to minority scientists to facilitate
participation in the WHI will  serve two purposes: first, to enhance
the research skills, training and development of the individual
awardees, and second, to enhance the diversity of the investigator
teams currently carrying out this project.  Scientists and clinicians
thus trained will be available to contribute to the next generation
of clinical investigations.
A.  Environment:  The institution must be one of the 40 clinical
centers or the clinical coordinating center participating in the
Women"s Health Initiative or a qualifying minority institution
willing to enter into an arrangement with one of the WHI centers.
The WHI institution will provide  a well-established research and/or
clinical career development program(s) and qualified faculty to serve
as mentors.  The WHI Clinical or Coordinating Center must be able to
demonstrate a commitment to the development of the candidate as a
productive, independent investigator. If  the minority institution
submits an application on behalf of a candidate a letter signed by an
institutional official  must indicate that the candidate has the
necessary research time available and that the institution has a
strong commitment to the career development of the candidate. 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 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 research-related and/or teaching pursuits consistent
with the objectives of the award.  The candidate must develop
knowledge in the clinical or biomedical sciences and research skills
relevant to his or her career goals. The candidate should include
relevant didactic and laboratory or field research experiences.
C.  Mentor(s):  The recipient must receive appropriate mentoring
throughout the three to five year program.  Where feasible, women and
minority mentors are encouraged to be involved as role models.
D.  Allowable Costs:
1.  Salary:  The NIH will provide salary and fringe benefits for the
K award recipient.  The awardee may receive up to  a maximum of
$50,000 per year plus fringe benefits for five years.
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
MR/CSDA.  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 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:  Up to $20,000 per year may also be
awarded 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.
3.  Ancillary Personnel Support:  Salary for mentors, secretarial and
administrative assistance, etc., is not allowed.
4.  Indirect costs:  Indirect costs will be reimbursed at eight
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 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.
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 career award recipient.  Such fees must be assigned
to the grantee institution for disposition by any of the following
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.
H.  Special Leave:  Awardees from minority institutions not at a WHI
site are granted prior approval by NIH to spend the requisite time at
a participating center of the Women"s Health Initiative.  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.
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
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, Vol. 23, No. 11, March 18,
Applications kits are available at most institutional offices of
sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301/710-0267, email:  ASKNIH@odrockm1.od.nih.gov.
Applicants are advised to consult the NIH Guide, Vol. 25, No. 10,
March 29, 1996, and Vol. 25, No. 16, May 17, 1996 for additional
information concerning "just-in-time" procedures to be used in
completing mentored career award applications.
The application must address the following issues:
o  Establish the candidate"s commitment to a career in biomedical or
behavioral research
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
o  Letters of recommendation.  Three sealed letters of recommendation
attesting to 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.  It should describe a
systematic plan to obtain the necessary basic biomedical or
behavioral science background and research experience to launch or
re-initiate an independent research career.
o  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 as well as the amount and nature of faculty
participation.  No award will be made if an application lacks this
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. Although it is understood that this application does not
require the detail of regular research grant proposals, a
fundamentally sound research plan should be provided.  The research
will involve either the main study or an ancillary project being
carried out as part of the NIH Women"s Health Initiative.
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.
Environment and Institutional Commitment
o  The mentor"s 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  must also provide a statement of commitment to the
candidate"s development into a productive, independent investigator.
This statement will include a description of a multi-disciplinary
career development program that will maximize the use of relevant
research and educational resources.  If a minority institution is the
sponsoring organization a commitment to the candidate"s career
development as well as approval of leave should be documented.
o  Budget requests must follow "just-in-time"procedures described in
the NIH Guide, Vol. 25, No. 10, March 29, 1996, and Vol. 25, No. 16,
May 17, 1996.
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must
be marked.
Submit a signed, original of the application with Checklist, and
three signed photocopies, in one package to:
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Chief, Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, , Suite 2C212 - MSC 9205
Bethesda, MD  20892-9205
ATTN: WHI Minority Investigator Career Development Award
Applications will be reviewed for completeness by the Division of
Research Grants (DRG) and responsiveness to the RFA by the
appropriate WHI project office staff.  Applications that are complete
and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the
National Institute on Aging 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.
The following review criteria will be applied:
o  Commitment to an independent research career,
o  Potential to develop (or evidence of the capacity to develop) as
independent investigator,
o  Quality and breadth of prior scientific training and experience,
including, where appropriate, the record of previous research support
Career Development Plan
o  Likelihood that the 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
o  Appropriateness of the plan to update conceptual and theoretical
knowledge, and the proposed award duration,
o  Consistency of the career development plan with the candidate"s
prior research and academic experience and the stated career goals,
o  Relevance to the goals of the Women"s Health Initiative,
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 Plan
Candidates for this award will have had previous research experience
and in some cases will have been Principal Investigators in other
scientific fields.  A sound research plan that is consistent with the
career development plan and the candidate"s 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 research goals of the Women"s Health
Initiative, and
o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
o  Appropriateness of mentor"s research qualifications in the area of
this application,
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,
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 of environment for scientific and professional
development, and
o  Applicant institution"s willingness to develop an appropriate mix
of research, teaching and administrative responsibilities for the
The awarding component of the NIH will notify the applicant of the
national advisory 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.
Written and telephone inquiries concerning this RFA are encouraged,
especially during the planning phase of the application.
For general information about the Women"s Health Initiative, call:
Loretta Finnegan, M.D.
Women"s Health Initiative
National Institutes of Health
Federal Building, Room 6A-09
Bethesda, MD  20892
Telephone:  (301) 402-2900
FAX:  (301) 480-5158
Email:  loretta_finnegan@nih.gov:
For programmatic information about eligibility for career development
awards or about the interests of specific institutes, call:
Joan A. McGowan, Ph.D.
Musculoskeletal Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-43E, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  mcgowanj@ep.niams.nih.gov
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
FAX:  (301) 402-2945
Email:  rb42h@nih.gov
Joyce Rudick
Office of Research on Women"s Health
National Institutes of Health
Building 1, Room 201
Telephone:  (301)-402-1770
FAX:  (301)-402-1798
Email:  rudickj@od1tm1.od.nih.gov
Awards made in this program are described in the Catalog of Federal
Domestic Assistance No. 93.846, 93.866.  Awards will be made under
the authority of the Public Health Service Act, Title III, Section
301 (Public Law 410, 78th Congress, as amended, 42 USC 241) and
administered under PHS grant policies and Federal regulations 42 CFR
Part 52 and 45 CFR Part 74.  This program is not subject to
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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