Full Text HD-92-09


NIH GUIDE, Volume 21, Number 7, February 21, 1992

RFA:  HD-92-09

P.T. 34

  Human Reproduction/Fertility 
  Rehabilitation/Therapy, Physical 

National Institute of Child Health and Human Development (NICHD)

Application Receipt Date:  May 22, l992


The National Center for Medical Rehabilitation Research (NCMRR) of the
National Institute of Child Health and Human Development (NICHD)
invites research grant applications to develop new knowledge in the
areas of reproductive physiology, anatomy, and behavior that are common
to people with disabilities.  The goal of this Request for Applications
(RFA) is to restore, improve, and enhance reproductive function lost as
a consequence of injury, disease, and congenital disorder.  Basic,
clinical, and applied research applications that address these areas
are of high priority.  Interdisciplinary collaborative projects are
also encouraged that focus studies of human sexual functioning and
reproductive behavior on the development of interventions and devices
that will improve the quality of life in people with physical


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention goals of "Healthy People 2000," a
PHS-led national activity for setting priorities.  This RFA,
Reproductive Function in People with Physical Disabilities, is related
to the priority areas of nutrition, physical activity and fitness,
heart disease and stroke, cancer, and diabetes and chronic disabling
conditions.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-474-0, or Summary Report:  Stock
No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (Telephone:


Applications may be submitted by domestic and foreign public and
private, non-profit and for-profit organizations such as universities,
colleges, hospitals, laboratories, units of state local governments,
and eligible agencies of the Federal Government.  Women and minority
investigators are encouraged to apply.


This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
Project support may be requested for one to five years and may be
renewed according to the conventional procedures that pertain to PHS
grants.  The earliest anticipated award date will be September 1992.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed according to the customary NIH peer review


Applications submitted in response to this announcement will compete
for approximately $800,000 in grant money that has been made available
for this purpose in Fiscal Year l992.  It is expected that four awards
will be made.  The number of awards depends upon the overall scientific
merit of the applications and the availability of funds.



On November 16, l990, the President signed Public Law 101-613,
establishing a National Center for Medical Rehabilitation Research
within the National Institute of Child Health and Human Development.
The mandate of the NCMRR is to conduct and support research that
focuses on health-related improvement in human functioning at the
pathophysiological, physical impairment, functional impairment,
disability, and societal impact levels.  A task force of more than 100
clinicians and researchers with expertise in a wide range of medical,
biological, allied health, and social sciences was convened in 1990 to
assess medical rehabilitation research.  These experts conducted a
sweeping survey of research needs, challenges, and opportunities in
rehabilitation medicine (Report of the Task Force on Medical
Rehabilitation Research, l990).  Research on the improvement of
reproductive function in people with physical disabilities was
identified as a priority.  In response to this recommendation the NICHD
organized a conference on Reproductive Issues for Persons with Physical
Disabilities.  This RFA will implement the recommendations of both
panels concerning research on improvement of reproductive function in
people with physical disabilities


Advances in medical care have resulted in a longer life expectancy and
greater integration into society of people with physical disabilities.
High percentages of men and women with physical disabilities, such as
traumatic brain injury and spinal cord injury, are in the prime
reproductive years.  These individuals now lead independent lives and
may wish to establish successful personal relationships and have
children.  At the same time, major advances have been made in
reproductive technology and improvement in the management of high-risk
pregnancies enabling individuals to conceive and bear children who, a
few years ago, would have been considered infertile.  These medical
advances in the reproductive sciences along with the mainstreaming of
people with physical disabilities now provide an opportunity for
focusing research on improving reproductive success in persons with
disabling conditions.

This RFA invites scientists to submit grant applications for research
into the re-establishment, improvement, and management of reproductive
function in people with physical disabilities.  Little research has
been done on the needs of individuals with disabling conditions in
regard to their ability to establish successful intimate relationships,
conceive, bear, and parent children due to societal perception of the
reproductive needs of persons with disabilities.  Research is needed in
the areas of sexual identity among children with disabilities,
physiological and behavioral changes in sexual function as a result of
the disabling process, obstetrical care, and parenting issues.
Research applications are solicited that will address basic, clinical,
and applied research into the improvement of reproductive outcome and
that will improve the quality of life for people with disabling
conditions.  The list of research areas cited below is representative,
though not exhaustive, of the topics solicited by this announcement and
serves as a guide for potential applications submitted for this RFA.

o  characterize the effects of different types and locations of head
and spinal cord trauma on sexual function and reproduction

o  define neuronal populations responsible for the modification of the
sexual response in individuals with disabling conditions

o  develop neural, hormonal, or pharmacological interventions to
enhance or restore sensory and motor function involved in the sexual

o  characterize and define the causes of secondary complications in
sexual functioning associated with spinal cord injuries and traumatic
brain injury

o  characterize long-term posttraumatic changes that reduce fertility
in men and women with disabilities

o  identify physical and behavioral factors associated with successful
prosthetic use and effectiveness with prosthetic fitting

o  investigate methods for the improvement of yield in protocols
requiring repeated collection of semen by electroejaculation and its
effect on the well-being of men with disabilities

o  examine the effects of immobility and the compromised autonomic
nervous system on the vascular system, bioavailability of medications,
and endocrine regulation and how these affect fertility and the
production of viable gametes

o  identify the cause of autonomic dysreflexia in spinal cord- injured
men and women and develop intervention strategies to reduce its
incidence during sexual behavior and during pregnancy and delivery

o  evaluate changes in the menstrual cycle and in the sexual response
in women immediately post-injury and longitudinal studies in order to
develop appropriate intervention strategies and to assess their

o  characterize the best means of management of pregnant women with
spina bifida, spinal cord injury, multiple sclerosis, and other
disabilities and identify clinical issues that are unique to these

o  characterize the effect of impairment of sexual function on
psychosocial adaptation, emotional state, and establishment of intimate

o  identify the processes associated with gender identity in children
with disabilities such as spina bifida, cerebral palsy, muscular
dystrophy, and spinal cord injury

o  examine both the immediate and long-term changes in sexual behavior
after traumatic brain injury



National Institutes of Health (NIH) policy is that applicants for NIH
clinical research grants will be required to include minorities and
women in study populations so that research findings can be of benefit
to all persons at risk of the disease, disorder or condition under
study.  Special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
that disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial or ethnic group together with a rationale
for its choice.  In addition gender and racial or ethnic issues should
be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study.  This
information should be included on the grant application form PHS 398 in
Section 2, A-D of the research plan and summarized in Section 2, E,
(Human Subjects).

Applicants are urged to carefully assess the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial or ethnic minority populations (i. e., Native Americans
(including American Indians or Alaskan Natives, Asian/Pacific
Islanders, Blacks, Hispanics).

The rationale for limiting studies to one minority population group
should be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies on etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded. However,
every effort should be made to include human tissue from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, applicants
must discuss the relevance of research involving foreign population
groups to the United States' populations, including minorities.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed and the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.


Applications are to be submitted on form PHS 398 (rev. 9/91). This
application form is available in the business or grants and contracts
office at most academic and research institutions and from the Office
of Grants Inquiries, Division of Research Grants, NIH, Westwood
Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441.

The receipt deadline for applications prepared in response to this RFA
is May 22, l992.  Late applications will be returned to the applicant.
This is a one-time announcement.

The RFA label available in the PHS 398 must be affixed to the bottom of
the face page.  Failure to use this label could result in delayed
processing of the application in that it may not reach the review
committee in time for evaluation.

Check "yes" in line 2 on the face page of the application and type
"Reproductive Function in People with Physical Disabilities, RFA
HD-92-09."  The original and four copies of the application must be
sent or delivered to:

National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

In addition, two copies of the application must be sent under separate
cover to:

Laurance Johnston, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
Bethesda, MD  20892


Applications will be reviewed by staff of the NICHD for responsiveness
to the RFA.  Applications deemed non-responsive will be returned to the
applicant.  If an application is returned, the applicant has the option
to resubmit the application to the Division of Research Grants as an
unsolicited application during one of the three yearly review cycles
(February 1, June 1, and October 1).  If the application submitted in
response to this RFA is substantially similar to a grant application
already submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending application
or the new one.  Simultaneous submission of identical applications will
not be allowed, nor will essentially identical applications be reviewed
by different review committees.  Therefore, an application cannot be
submitted in response to this RFA that is essentially identical to one
that has already been reviewed.  This does not preclude the submission
of substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous

Responsive applications may be evaluated by a preliminary triage in a
peer review group to determine scientific merit relative to other
applications received in connection with this RFA.  Applications judged
to be non- competitive will be withdrawn and the Principal Investigator
and his/her institutional business official will be notified in such
instances.  Those applications judged to be competitive will be further
evaluated for technical and scientific merit by a review panel convened
for this purpose by the Division of Scientific Review, NICHD.

Review criteria will be those used by NIH to evaluate
investigator-initiated individual research grant applications,

o  Thorough knowledge of scientific literature in appropriate fields

o  Scientific, technical, or medical significance and originality of
proposed research

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research

o  Qualifications and research experience of the Principal Investigator
and staff, particularly but not exclusively in the area of the proposed

o  Availability of resources necessary to perform the research

o  Appropriateness of the proposed budget and duration in relation to
the proposed research

The second level of review will be by the NICHD National Advisory


The anticipated date of award is September 1992.  Awards will be made
on the basis of the quality of the proposed project as determined by
peer review, program balance among research areas, and level of funding
set aside for this RFA.


Requests for additional information and descriptions of proposed
research projects may be addressed to:

Danuta Krotoski, Ph.D.
Chief, Basic Rehabilitation Medicine Research Branch
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
Executive Plaza South, Room 450W
6120 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 402-2242

For fiscal and administrative inquires regarding this announcement,
potential applicants may write or call:

E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 501
6130 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 496-1303


This program is described in the Catalog of Federal Domestic Assistance
No. 93.929, Medical Rehabilitation Research.  Awards are made under
authorization of the Public Health Service Act, Title IV, 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.


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