BUILDING INTERDISCIPLINARY RESEARCH CAREERS IN WOMEN'S HEALTH

Release Date:  September 7, 1999

RFA:  OD-99-008

Office of Research on Women's Health
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute of Child Health and Human Development
National Center for Complementary and Alternative Medicine
National Institute of Deafness and Other Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health Sciences
National Institute of Neurological Disorders and Stroke
Agency for Health Care Policy and Research

Letter of Intent Receipt Date:  October 11, 1999
Application Receipt Date:  December 10, 1999

PURPOSE

The Office of Research on Women's Health (ORWH) and cosponsors invite
institutional career development award applications for Building
Interdisciplinary Research Careers in Women's Health (BIRCWH) Career
Development Programs, hereafter termed "Programs."  Programs will support
research career development of junior faculty members, to be known as
Interdisciplinary Women's Health Research (IWHR) Scholars, who have recently
completed clinical training or postdoctoral fellowships, and who are
commencing basic, translational, clinical and/or health services research
relevant to women's health.

The goal of this initiative is to promote the performance of research and
transfer of findings that will benefit the health of women. The Programs will
accomplish this by bridging advanced training with research independence, as
well as bridging scientific disciplines or areas of interest. This will
increase the number and skills of investigators at awardee institutions
through a mentored research experience leading to an independent scientific
career addressing women's health concerns.

The NIH Institutes and Centers support biomedical and behavioral research and
research training.  The Agency for Health Care Policy and Research (AHCPR)
supports health services research and research training.  The cosponsors are
partnering with ORWH to expand support of the career development of
researchers in women's health within their respective missions.

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 Request for Applications (RFA),
Building Interdisciplinary Research in Women's Health, is related to several
priority areas.  Potential applicants may obtain a copy of "Healthy People
2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
non-Federal organizations, public or private, such as hospitals, medical or
other health professional schools, or other institutions of higher education. 
Foreign institutions are not eligible for this institutional career award. 
Applicant institutions must have the clinical specialties and subspecialties
and the clinical and research facilities sufficient to meet the purposes of
the BIRCWH program, namely, to bridge clinical or postdoctoral training with a
career in interdisciplinary basic, translational, clinical and/or health
services research relevant to women's health.  Racial/ethnic minority
individuals, persons with disabilities, and women are encouraged to apply as
Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Mentored Research
Scientist Development Program Award (K12) mechanism. The K12 awards will be
for a period of five years.  The anticipated award date is July 1, 2000.

Planning, direction, and execution of each component of the research and
career development program will be the responsibility of the IWHR Scholar with
the guidance of his or her mentor.

This RFA is a one-time solicitation.  ORWH has not yet determined whether or
how this program will be continued beyond the commitments expressed in the
present RFA.

FUNDS AVAILABLE

ORWH and cosponsors intend to commit approximately $4 million in total costs
(direct plus Facilities and Administrative) for the first year of support of
the entire program.  It is anticipated that up to eight awards will be made. 
K12 awards will be for up to $500,000 total costs (direct plus Facilities and
Administrative) per year, and will support a minimum of four IWHR Scholars.
Because the nature and scope of the research proposed in response to this RFA
may vary, it is anticipated that the size of awards also will vary.  Although
the financial plans of ORWH and cosponsors provide support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of applications of outstanding scientific
and technical merit.

RESEARCH OBJECTIVES

A need has been identified for expanded support for interdisciplinary research
bridging the completion of training with an independent career in research
addressing women's health.  This is described in the "Agenda for Research on
Women's Health for the 21st Century, A report of the Task Force on the NIH
Women's Health Research Agenda for the 21st Century," Volume 2, pp. 187-198,
Career Issues for Women Scientists, and pp. 223-228, Multidisciplinary
Perspectives; NIH Publication 99-4386 (1999). Therefore, ORWH has as one of
its priorities "facilitating research initiatives that foster
multidisciplinary collaborations."  Program grant awards from this RFA will
meet the specified need by providing clinical, health or life sciences, or
public health departments, centers, and institutes, both developing and
established, an opportunity to build national capacity for junior
investigators in women's health research, here defined as including research
on sex and/or gender differences, as well as research on factors that
contribute to disparities in health status or health outcomes for different
populations of women.  Investigators with established research programs
covering a broad range of basic and applied biomedical and behavioral science
or health services research, in the Principal Investigator's ("sponsoring")
and collaborating departments, centers, or institutes, form an intellectual
and technical research base for mentoring IWHR Scholars.  Mentors from
collaborating departments are encouraged to provide needed expertise and
resources, as long as the emphasis of IWHR Scholars' projects is on research
relevant to women's health. Projects may be basic, translational, clinical, or
health services research, but must be within the biomedical and behavioral
purview of NIH and/or the health services research purview of AHCPR.  Health
services research includes the study of the quality, appropriateness, outcomes
and effectiveness of health care services, as well as the cost, use and access
to health care services.

A number of research priority areas have been identified by the ORWH and
cosponsors as major research goals, based in part on the ORWH report cited
above.  The following should by no means be viewed as exhaustive, and are
intended only as examples:

o Biologic and molecular bases of sex and/or gender differences in
pharmacokinetics, pharmacodynamics and pharmacogenetics including hormone and
drug interaction, in drug-drug interactions, and in pharmacokinetics and
pharmacodynamics during pregnancy.

o  Kidney disorders including the impact of pregnancy, diabetes, and
hypertension on renal function; preeclampsia; causes of altered renal
hemodynamics during pregnancy; sex and/or gender differences in renal
transplantation, dialysis and acute renal failure; mechanisms of analgesic
nephropathy; effect of hormones and the menstrual cycle on renal function and
drug pharmacokinetics, and the effect of collagen vascular diseases on the
kidney.

o  Urologic and urogynecologic disorders including recurrent and chronic
urinary tract infections; vesicoureteral reflux during pregnancy; effect of
hormones on bladder function; interstitial cystitis; pelvic floor disorders
encompassing genital prolapse and consequent urinary incontinence; sexual
dysfunction; impact of bladder physiology of childbirth, exercise, diet,
obesity and hormone deficiency; and outcome measures for surgical, medical and
behavioral treatment of urinary incontinence, diabetes and bladder
dysfunction.

o  Prevention research: behavioral and cultural influences on risk and
lifestyle changes, including nutrition and exercise; addictive behavior
including alcohol, drugs and tobacco; obesity; type II diabetes;
cardiovascular diseases; cancer; and sexually transmitted diseases.

o  Gastrointestinal and digestive health and diseases, including the effect of
hormones and the menstrual cycle on the digestive system; irritable bowel
syndrome; functional bowel disorders and gut motility.

o  Obstetrical and gynecological research encompassing both pregnancy and non-
pregnancy issues, including the roles of infectious, inflammatory, and other
somatic diseases and disorders (such as oral infection) in adverse pregnancy
outcomes, prevention and management of pregnancy complications, reducing
morbidity and mortality from benign and malignant gynecologic diseases, and
promoting increased safety and acceptability of contraceptive options.

o  Natural history of menopause and the endocrinologic, biologic,
psychosocial, cultural, lifestyle and environmental determinants, concomitants
and/or sequelae; role of menopause in the chronic diseases of aging;
menopause-related pathophysiology; and the development of new strategies,
including complementary and alternative medicine, for alleviating the short-
term, clinical problems of the peri- and postmenopause and the prevention of
menopause-related diseases of old age.

o  Aging and development as a central factor in women's biological and
psychosocial health, functioning, and effectiveness of treatment.  Chronic
diseases, including those of aging, such as osteoporosis, arthritis,
degenerative joint disease, cardiovascular disease, or diabetes, that result
in disabilities; quality of life in women with chronic diseases.

o  Sex and/or gender differences in acute and chronic pain conditions or
syndromes, the perception of pain, and analgesic response.

o  Antecedents and consequences of women's multiple roles across the lifespan
(e.g., family, work, caregiving and volunteer roles).  The influence of
economics and competing roles on health behaviors and health outcomes.

o  The influence of environmental factors on women's health, including
genetic-environmental interactions in disease etiology; studies which focus on
critical windows for exposures during different periods of sexual development
and aging, e.g., in utero, childhood, puberty, pregnancy, lactation and
menopause.

o  Allergic, immune and autoimmune diseases, in particular,
resistance/susceptibility genes, environmental influences, mechanisms of sex
and/or gender differences, immunological mechanisms, target organ influence,
role of innate immunity, development of surrogate markers, and immune therapy.

o  Drug abuse research, both human and animal, directed at identifying sex
and/or gender differences in the biological and behavioral mechanisms of abuse
and dependence; antecedents, pathways, risk and protective factors;
consequences of drug use and addiction, including interactions with HIV/AIDS;
and development of gender-based models of drug abuse prevention, treatment and
treatment services.

o  Oral influences on systemic health; oral health and manifestations of
disease, for example, temporo-mandibular joint disorders; and oral factors
which may influence transmission of HIV.

o  Health services research on the outcomes, effectiveness, and cost-
effectiveness of prevention and clinical treatment approaches.  Research on
the quality, outcomes or access to health care services among racial and
ethnic minorities.

o  Eliminating health disparities, including understanding and targeting the
origins of the variable burden of disease, disability and mortality among
people belonging to different ethnic and racial groups, living in different
parts of the United States, experiencing different socio-economic status, and
engaging in different patterns of behavior.

SPECIAL REQUIREMENTS

A.  Institutional Environment:  Applicant institutions should show commitment
to the Program's goals, and provide assurances that the institution intends
the Program and the supported IWHR Scholars to be an integral part of its
research endeavor (c.f. Environment, under "Review Considerations").  Research
facilities and training opportunities (see B, below) will be a critical part
of the environment.  Applicant institutions should provide a guarantee of 75
percent protected time for the IWHR Scholars for research.  As part of its
commitment to support of women's health research, the applicant institution
may choose internally to designate the Program as a Center, supported in part
by the K12 Program award.

B.  Program Composition:  Applicants must describe or propose a
multidisciplinary career development program that will maximize the use of
relevant research and educational resources.  The Program must have a strong
research base, comprising the investigations of established scientists who
will provide expertise, resources, and mentoring to the IWHR Scholars.  The
research base must be broad and relevant to current areas of research interest
and need in women's health.  The environment should be one which will
stimulate and increase the interactions among disciplines, which may include
basic, clinical, social and population sciences.  There should be an adequate
pool of junior investigators likely to benefit from mentored research career
development.  Of major importance, the Program must have a scientifically
sound and equitable procedure for selecting which IWHR Scholars and projects
are to be supported.  There must be documented evidence of an institutional
commitment to support the Program's human and tangible resources and its goal
of developing and retaining productive, independent investigators in areas of
women's health concerns.

C.  Principal Investigator: The Principal Investigator of a Program must be a
senior faculty member such as Dean, Department Chair, or Director of a
research center or interdisciplinary institute.  He/she should possess the
scientific expertise, leadership and administrative capabilities required to
coordinate and supervise a multidisciplinary research and development program
of this scope.  As an option, the application may request a coinvestigator to
serve as Program Director, with responsibility for some or all of the
day-to-day operations of the Program.  There are no specific requirements for
the Program Director, but if one is included, he/she should have experience
and qualifications complementing those of the Principal Investigator.

D.  Advisory Committee:  The Advisory Committee will be a group of scientists
from the sponsoring department, and other departments or institutions as
appropriate, with interests relevant to the Program's research programs.  It
may include mentors.  The two major functions of the committee are to evaluate
1) applications from IWHR Scholar candidates, and 2) the overall conduct of
the Program.  Specifically, the committee makes recommendations to the
Principal Investigator as to IWHR Scholar appointments, evaluates ongoing
research activities annually (including the interaction and integrated nature
of the Scholars' research experience), makes recommendations regarding their
continuation, and makes recommendations to the Principal Investigator
regarding priorities for use of the Core, if applicable.  The committee may
use institutional or outside consultants if needed.  Plans to include members
or consultants from outside institutions may be described, but such
individuals should not be named.  The committee is a formal part of the
structure of the Program.  It should meet regularly, and keep written minutes
which may be reviewed as part of a competing or noncompeting application.

E.  Mentors:  Each IWHR Scholar appointed under the K12 award must have a
primary sponsor who is recognized as an independent investigator and who is
actively involved in basic, translational, clinical and/or health services
research relevant to this initiative, and who has a successful record of
providing research training of a type expected in this Program.  An assigned
mentor will provide guidance for the development of each IWHR Scholar assigned
to the program.  The mentor must be committed to continue this involvement
throughout the IWHR Scholar's total period of development under the award.

F.  Career Development Program:  The K12 award provides five years of funding
for the Program.  The Program will support IWHR Scholars for periods of two to
five years consisting of consecutive 12-month appointments.  The program may
be divided into two distinct phases if appropriate -- a basic and/or clinical
science training component and an intensive research experience under the
general guidance of a qualified mentor.  IWHR Scholars appointed under this
program should, as needed, receive formal didactic coursework to support their
career development, which may include, for example, biostatistics,
epidemiology, health economics, clinical evaluation sciences, and clinical
trials.  At least 75 percent of the IWHR Scholar's full-time professional
effort must be devoted to the K12 program per se.  The remainder of the
recipient IWHR Scholar's time may be devoted to developing other clinical or
academic pursuits consonant with the objectives of the award.

G.  IWHR Scholars:  The Scholar position is a junior faculty appointment, not
a fellowship.  Candidates for support as IWHR Scholars must have a clinical
doctorate or Ph.D. degree or its equivalent, must have completed any
postgraduate training normally expected for a faculty appointment in their
field (including clinical or postdoctoral fellowship training, or residency if
they have chosen not to subspecialize), 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.  Completion of clinical subspecialty training is not required of
candidates in general practice in their specialty; however, those who choose
to subspecialize must have completed their fellowship.  In order to
accommodate the needs of those interested in participating in this program who
may have had a career hiatus because of family responsibilities, uniformed
service, etc., there is no limit on time elapsed since completion of training. 
Support is in the form of a minimum of two consecutive 12-month appointments,
renewable in annual increments for up to five years total, and is contingent
upon satisfactory progress as reported to the Advisory Committee and to NIH in
the annual progress report of the Program.

Programs are encouraged to recruit members of underrepresented minorities,
women, and candidates with disabilities.  Candidates must be U.S. citizens or
noncitizen nationals, or must have been lawfully admitted for permanent
residence and possess an Alien Registration Receipt Card (I-151 or I-551) or
some other verification of legal admission as a permanent resident. 
Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to
the U.S.  They are usually born in lands that are not states but are under
U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary
or student visas are not eligible.

At the time support begins, IWHR Scholars may not have served as the principal
investigator or equivalent on an NIH research project (R01), Mentored Research
Scientist Development Award (K01), Mentored Clinical Scientist Development
Award (K08) or their equivalent, a subproject of a program project (P01) or
center grant (P50, U54), or equivalent PHS research grant awards. IWHR
Scholars may not accept or hold any other PHS award that duplicates the
provisions of this career award.

During the period of this award, IWHR Scholars are encouraged to apply for,
and may accept and hold, independent research grant support.

H.  Core facility:  With strong justification, a scientific Core facility may
be requested as part of the Program, within the total budget.  Such a Core
would provide skilled technical services to complement and extend the
capabilities of the mentors to promote the career development of the IWHR
Scholars.  Such a Core might provide scientific services such as, but not
limited to, assays, molecular biology or biostatistics.  Requests for a Core
must be justified in terms of cost-effective enhancement of the research
resources that will serve at least four IWHR Scholars' projects.  The Core, if
any, must be a new entity, not an extension or enhancement of an existing
facility.  The award may support professional direction of the Core lab, up to
50 percent effort, as well as technical assistance, supplies, equipment, and
appropriate costs of operation.  Institutional commitment to the Core must be
demonstrated, and may take the form of providing or renovating space, purchase
of required equipment, and/or support of personnel.

I.  Allowable Costs:

1.  The Program structure may have these elements:
a) Administration:  Salary and fringe benefits for the Program Director, if
any, up to 10 percent effort, as well as a part-time secretary, may be
requested.  No compensation may be requested for the Principal Investigator. 
Travel to an annual Directors' meeting for the Principal Investigator or the
Program Director must be requested.

b) Core Facility:  Budgets may include salaries and fringe benefits for a Core
Director (up to 50 percent), other technical staff, supplies, animals,
equipment purchase and maintenance.  The sum of the budgets for Administration
and a Core facility may not exceed $100,000.

c) Facilities and Administrative costs:  Facilities and Administrative
(formerly, indirect) costs will be reimbursed at 8 percent of modified total
direct costs, or at the actual Facilities and Administrative cost rate,
whichever is less.

2.  As part of the Program budget, an application must request a minimum of
four IWHR Scholar positions, at least three of which must be for individuals
with a clinical doctoral degree.  Support for each IWHR Scholar position may
not exceed $100,000 total costs per year.

a) Salary:  The NIH will provide salary and fringe benefits for the IWHR
Scholar, within the statutory NIH annual salary cap, currently $125,900.  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 Program.

The total salary requested for each IWHR Scholar 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.

b) Research Development Support:  Within each IWHR Scholar's total award,
grant funds may be used toward the following expenses:  (1) salary as above;
(2) tuition, fees, and books related to career development; (3) research
expenses, such as supplies, equipment and technical personnel; (4) travel to
one training or scientific meeting per year; (5) statistical services
including personnel and computer time; and other project infrastructure
including relevant data sets.

Grant funds may not be requested for the following:  compensation for the
Principal Investigator or mentors, direct support of the mentors'
laboratories; compensation of administrative personnel normally paid from
institutional overhead charges; administrative activities such as public
relations, or health or educational services; travel of the Principal
Investigator, Program Director or mentors to scientific meetings; costs of
clinical care; and alterations and renovations.

In accord with directives included in the Labor, HHS, and Education Fiscal
Year 1999 Appropriations Bill enacted into law (Public Law 105-277) on October
21, 1998, funds provided for the awards made from this RFA must only be used
in compliance with the following directive:

"Sec. 511.  (a) None of the funds made available in this Act may be used for: 
(1) the creation of a human embryo or embryos for research purposes; or (2)
research in which a human embryo or embryos are destroyed, discarded, or
knowingly subjected to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498 (b) of
the Public Health Service Act (42 U.S.C. 289g (b)).

(b) For purposes of this section, the term "human embryo or embryos" includes
any organism, not protected as a human subject under 45 CFR 46 as of the date
of the enactment of this Act, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human gametes or
human diploid cells."

Per NIH policy, publications resulting from work supported by the award must
cite the grant number in a footnote.  The citation must include a disclaimer
that no Federal funds were used for the performance of in vitro fertilization
- embryo transfer, if any such activities may have been reported in the
publication.

J.  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, awardee institutions are
hereby notified that IWHR Scholars 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.

K.  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.

Program personnel supported by the K12 award 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- or AHCPR-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
or AHCPR career award must receive prior written approval of the institute
awarding component.

L.  Special Leave:  Candidates appointed to this program career award may
engage in research experiences at another institution, including a foreign
site, 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 awarding component is
required.  To obtain prior approval, the Principal Investigator must submit a
letter describing the plan, countersigned by the appropriate institutional
official, to the awarding component.  A copy of a letter or other evidence
from the performing 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 PHS funding component and will be granted only
in an unusual situation.  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.

M.  Termination:  The Director of the NIH may discontinue a Program award upon
determination that the purpose or terms of the award are not being fulfilled. 
For a Program cofunded by AHCPR, any such determination would encompass the
recommendation of the Administrator of AHCPR. In the event an award is
terminated, the Director of the NIH shall notify the grantee institution 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 and AHCPR that women and members of minority
groups and their subpopulations must be included in all NIH and AHCPR
supported biomedical, behavioral and health services 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 was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994, available on the web at:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

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:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 11, 1999, a letter of
intent that includes a descriptive title of the proposed Program, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of this RFA.  Although a letter of intent is not required, is not binding, and
does not enter into the review of a subsequent application, the information
that it contains allows NIH staff to estimate the potential review workload
and avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Donna L. Vogel at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

Prospective applicants are strongly encouraged to contact program staff at the
address listed under INQUIRIES early in the planning phase, to ensure that
applications are responsive to the goals of this initiative.

The research grant application form PHS 398 (rev. 4/98), "Research Career
Award" section, is to be used in applying for these grants.  These forms are
available at most institutional offices of sponsored research and 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, E-mail:  [email protected].  The forms may also be downloaded
from the web at:  https://grants.nih.gov/grants/funding/phs398/phs398.html.

Application Instructions

The application must address the following issues under the headings for the
Research Career Award table of contents:

Modular Grant Application and Award procedures DO NOT APPLY.  Include all
information requested under "Section I: Basic Administrative Data."  Budget
requests must be provided according to the instructions in form PHS 398.  A
composite page DD for the entire Program budget request should be followed by
one page for the Scholars' costs and one for Administration and Core
laboratory (if applicable).  Provide page EE for the composite only.  The
requests for tuition and fees, books, travel, research development expenses,
etc., must be justified and specified by category.

"Section II: Specialized Information" should be modified as follows:

The section may begin with an overview of the proposed Program.

(1) The Candidate:  Describe in general terms the pool of potential candidates
including information about the types of prior clinical and research training. 
Do not name prospective Scholars.  Describe the criteria to be used for
candidate evaluation for selection as IWHR Scholars.  Describe plans to
recruit candidates, including those from racial or ethnic groups that are
currently underrepresented in biomedical, behavioral, or clinical sciences.

(2) Statement by Sponsor:  Summarize the immediate and long-term career
objectives of the Program, explaining how the Program will contribute to their
attainment.

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 research background and 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 phase of support under this
program award is composed largely of didactic training in basic and/or
clinical research sciences.  For these candidates, a second phase would be an
intensive, supervised research experience to complete a longer developmental
program.  More experienced candidates may benefit from entering immediately
into a mentored research experience of at least two years supported by 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,
and should distinguish the plan from fellowship training.

Describe the composition of the Advisory Committee, identifying by name and
role the internal members, and the desired expertise (but not the name or
affiliation) of external members, if any.

(3) Environment and Institutional Commitment to Candidate:  Provide
information establishing the commitment of the applicant institution, the
Principal Investigator, and Program Director, if any, and the faculty mentors
to providing developmental experiences that lead to independence in
biomedical, behavioral, clinical and/or health services research relevant to
women's health.  Include the specifics of institutional support.  There is no
dollar requirement, but significant commitment will be considered a strength. 
Letters from faculty mentors are not required unless they are collaborators
from other institutions.

(4) Research Plan:  For each faculty member proposed as a potential mentor,
provide a paragraph on his or her research relevant to the goals expressed in
this RFA, that may be the foundation of a IWHR Scholar's research experience
in the Program.  The research experiences may include basic, translational,
clinical, and/or health services research approaches to biomedical or
behavioral problems in women's health.  Lengthy, detailed protocols or plans
for specific experiments should not be included.  No limits are specified for
the number of proposed mentors; however, fewer than six may not provide
sufficient choice of projects, while more than 25 may dilute the focus on
women's health.  List up to five current or former students or fellows the
faculty member has trained.

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.

Note:  Page limitations on research project grant applications, as stated in
the guidelines and instructions for PHS Form 398, do not apply to these K12
applications, although applicants are encouraged to be concise.  Applicants
should ensure that all materials directly applicable to the  review criteria
(see below) are included in the body of the application, not in an appendix.

Submission Instructions

The RFA label available in the PHS 398 application form must be affixed to the
bottom of the face page of the application and must display the RFA number OD-
99-008. A sample modified RFA label is available at
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  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, "BIRCWH Career Development Programs," and number must be typed on line
2 of the face page of the application form and the YES box must be marked. 
Human subjects and vertebrate animals may be checked "NO" with an explanation
in the research plan that appropriate assurances will be provided when the
actual projects are known.

Submit a signed, typewritten original of the application, including the
Checklist, and three 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 (for express/courier service)

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

Scott F. Andres, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)

Applications must be received by December 10, 1999.  If an application is
received after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.  The
CSR will not accept any application that is essentially the same as one
already reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by program staff.  Incomplete and/or non-responsive
applications will be returned to the applicant without further consideration. 
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 NICHD on behalf of ORWH in accordance with the review criteria stated
below.  As part of the initial merit review, a process may be used by the
initial review group in which applications receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit will be discussed, assigned a priority score, and receive a
second level review by the appropriate national advisory council or board.

Review Criteria

Program Overall:

The probable impact of the Program award on enhancing the capacity of the
grantee institution to develop well-qualified new investigators, thus
enhancing women's health research locally and nationally.  This includes the
experience of the Principal Investigator/Program Director in preparing
clinical, basic and/or health services research investigators for independent
research careers.

Candidates:

o  Availability of an adequate pool of potential candidates;

o  Plans to identify, recruit, and select candidates (including minorities and
women), with a commitment to research relevant to women's health, and the
potential to develop as independent researchers.

Career Development Plan:

o  Likelihood that the career development plan will contribute significantly
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 candidates'
career goals and the multidisciplinary aims of the RFA; and

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

Research Plan:

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

o  Appropriateness of plans to comply with NIH policy on inclusion of women,
minorities and children.

Mentors:

o  Appropriateness of the faculty mentors' qualifications in the areas of
research relevant to this RFA;

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

o  Previous experience of the mentors in fostering the development of
researchers.

Core facility, if applicable:

o  Nature and quality of the optional Core facility:  technical merit,
scientific justification, evidence of cost-effectiveness, procedures for
quality control, allocation of resources among multiple users, qualifications
of the Core facility director and technical staff, and probable utility to the
research projects of the IWHR Scholars.

Environment:

o  Applicant institution's commitment to the Program's scientific development
of the IWHR Scholars, and assurances that the institution intends the Program
and the supported IWHR Scholars to be an integral part of its research
program;

o  Adequacy of research facilities including availability of a General
Clinical Research Center, if applicable, and training opportunities, including
demonstration of the research base;

o  Quality of the environment for scientific and professional development,
including opportunities for faculty positions that emphasize research; and

o Applicant institution's commitment to the appropriate balance of research
and clinical responsibilities, including guarantee of 75 percent protected
time for research.

Budget:

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

SCHEDULE

Letter of Intent Receipt Date:    October 11, 1999
Application Receipt Date:         December 10, 1999
Peer Review Date:                 April 2000
Council/Board Review:             May/June 2000
Earliest Anticipated Start Date:  July 2000

AWARD CRITERIA

Funding decisions will be based on scientific and technical merit as
determined by peer review, the need for research personnel in specific program
areas, and the availability of funds.

INQUIRIES

Written, e-mail, and telephone inquiries concerning this RFA are encouraged. 
The opportunity to clarify any issues or questions from potential applicants
is welcome.

Direct inquiries regarding programmatic issues and address the Letter of
Intent to:

Donna L. Vogel, M.D., Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Diane Watson
Chief, Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7150
Bethesda, MD 20892-7510
Telephone:  (301) 496-5001
Fax:  (301) 402-0915
Email:  [email protected]

Although the National Institute of Mental Health (NIMH) and the National Heart
Lung and Blood Institute (NHLBI) are not co-sponsors of this RFA, research
involving mental health or heart, lung and blood aspects may nonetheless be
relevant to the intent of the RFA.  NIMH and NHLBI support training and career
development related to women's health, including multidisciplinary training,
through their existing programs.
For NIMH, see: http://www.nimh.nih.gov/grants/rtcd.htm) or contact Mary C.
Blehar, Ph.D., Chief, Women's Health Program; telephone (301) 443-2847; E-
mail: [email protected].
For NHLBI, contact Teri Maniolo, M.D., M.H.S., Director, Epidemiology and
Biometry Program; telephone (301) 435-0707; E-mail: 
[email protected].

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.121.  Awards are made under authorization of Title III, Section 301 of the
Public Health Service Act (Public Law 78-410, as amended by Public Law 99-158,
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 (NIH) and 93.226 (AHCPR). 
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.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)