Subject: NIH GUIDE - RFA HD-92-03 - V20(33) 09/06/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 06 Sep 91 15:16 EST

Hi Paul,
   Please post this to the NIH Listserver as:
      RFAHD-91-03.910906
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA HD9203 HD-92-03 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
RFA:  HD-92-03
 
THE DECISION PROCESS SURROUNDING THE CHOICE OF NORPLANT AS A
CONTRACEPTIVE BY U.S. WOMEN.
 
P.T. 34; K.W. 0750020, 0404000
 
National Institute of Child Health and Human Development
 
Application Receipt Date:  December 20, 1991
 
I. BACKGROUND INFORMATION
 
The Center for Population Research (CPR) of the National Institute of
Child Health and Human Development (NICHD) invites scientists to submit
grant applications for the support of research on behavioral aspects of
the adoption and utilization of NORPLANT by U.S. women.  CPR is composed
of four branches which support research on all aspects of reproduction
and related behaviors such as contraception and sexual behavior.
Applications submitted in response to this announcement will be assigned
to the most appropriate branch within the center.  Research on the
behavioral aspects of contraceptive use is an important part of the
program of the Demographic and Behavioral Sciences Branch.  Funded
research has included studies on the choice of and experience with
voluntary sterilization, contraceptive continuation, use of the
contraceptive sponge, and the effects of provider and partner
characteristics on contraceptive choice.
 
The recent Food and Drug Administration (FDA) approval of NORPLANT
provides an opportunity for observing the introduction and adoption
process in the U.S. of a new method of reversible contraception.
Initial research on the product indicates that it promises ease of use
and high efficacy, although it has a variety of side effects which may
trouble some unknown proportion of users or potential users.  The new
NIH initiative on women's health may be seen to underscore the
importance of studying the contribution of this new method to women's
continued reproductive health.
 
Most of the prior research on this contraceptive has been done in
developing countries.  (Liskin and Blackburn.  1987.  "Injectables and
Implants."  Population Reports, Series K Number 3.) As of now, there has
been little research on how U.S. women, with different contraceptives
available, will accept the method.  (Darney, Atkinson, Tanner,
MacPherson, Hellerstein and Alvarado.  1990.  "Acceptance and
perceptions of NORPLANT among users in San Francisco, USA."  Studies in
Family Planning.  21.3:152-160.)
 
In an era in which concern over sexually transmitted diseases and human
immunodeficiency virus has increased individuals' condom use, while not
decreasing use of other birth control methods, which individuals in
which situations are likely to adopt a new contraceptive that does not
protect against disease?  Will women continue to use condoms to protect
against infectious disease, even as NORPLANT protects them against
unintended pregnancy?  Is there a way to predict which individuals will
discontinue the method, and for which reasons?
 
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 RFA, The
Decision Process Surrounding the Choice of NORPLANT As a Contraceptive
By U.S. Women, is related to two of the priority areas:  health
promotion -- family planning; and preventive services -- maternal and
infant health.  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.
 
II.  RESEARCH GOALS AND SCOPE
 
Proposed research should include investigation into the decision
processes leading to consideration, adoption, continuation and
discontinuation of this method.  Research might include studies of the
awareness of NORPLANT's existence, through friends, media, or clinics;
and the availability of the method in the woman's geographic location.
The cost to the woman is also a factor, as it may vary, along with
women's eligibility for various subsidized services.  The woman's
perceptions of partners' and peers' acceptance of her use of this method
may be a component of her own decision process as well.  How health
service agencies present the method may have a bearing on which women
consider its use.  Different types of health service delivery systems
(public clinics or private sources, for example) may provide, or be seen
to provide, different access to the method, differing support for
potential users, and may serve very different clientele.
 
Attention should be given to the characteristics of women who adopt
NORPLANT and those who do not because of the unique characteristics of
this particular method of contraception.  Social, economic,
psychological and physiological or medical considerations that influence
the decision whether or not to adopt the method are important components
of such a study.  The individual's expectations of the method, through
her own information and her exposure to counseling, may influence both
her decision to use it and, later, her reaction to the method.  The life
cycle stage of the woman and, in some cases, the couple, must be taken
into consideration.  For example, married women who have not yet had
children may be more or less likely to consider this method than women
wishing to space births, or women not yet married.  Women whose
relationships end or change may be more or less likely to continue with
this method of contraception.  Women have had concerns about their
future fertility after they stopped using the pill and the IUD.  How do
those concerns affect adoption and continuation of NORPLANT?
 
The effect of use on women's well-being and sexual behavior, and the
dissemination of such information to other women is another component of
the decision-making process.  The incidence and prevalence of side
effects, and which side effects convince which women to discontinue the
method are also of interest.  Irregular menstrual bleeding is common
(60% of women) during the first year after NORPLANT insertion.  There
appears to be no harmful medical effect due to this bleeding, and after
the first year, it decreases.  A major question, since many of these
findings were based on studies of women in developing countries, is how
American women react to the inconvenience of irregular or increased
bleeding.  Another as yet unresolved issue is the effect of NORPLANT on
women's serum lipid levels, and whether or not that in turn affects
acceptability and continuation.
 
Another important question is how NORPLANT acceptability may vary among
groups of women for whom the method is clinically appropriate.  Various
groups have been suggested as most likely to use this method, among them
teenagers with one or more pregnancies, couples who do not desire more
children, HIV infected women, and women whose current dependence on
drugs mitigates against parenthood.
 
In sum, projects may take into consideration the decision making
continuum for individuals who wish to delay childbearing and for whom
NORPLANT is a clinically feasible method.  Factors to be weighed in the
research may include:
 
     o women's demographic characteristics
     o life cycle stage
     o social context
     o access to and utilization of various types of medical service
providers
 
This research will require longitudinal follow-up of women who do choose
NORPLANT as a contraceptive method, and may additionally involve
appropriate comparison groups.  The nature of the research encourages
cross-disciplinary applications that might effectively combine medical
and service delivery considerations with epidemiological, sociological,
psychological, anthropological and economic considerations.  Although we
encourage applications that include medical, epidemiological or service
delivery considerations along with behavioral considerations, the grant
will not provide payment for NORPLANT, its insertion or removal.
 
STUDY POPULATIONS
 
Any population proposed for study should include groups for whom this
contraceptive method is clinically feasible, and may include women,
their partners and service providers as well.  Samples should represent
carefully defined populations in specific localities so that the
findings of research can be considered applicable to similar groups
elsewhere.  Special attention should be given to the inclusion of
minorities in study populations.  NIH policy is that applicants for
grants and contracts are required to include minorities in study
populations so that research findings can be of benefit to all persons.
If minorities are not included or are inadequately represented, a clear
and compelling rationale should be provided.  The rationale for proposed
studies on single minority population groups should also be provided.
The application must include a description of the composition of the
proposed study population in terms of racial and ethnic group together
with a rationale for its choice.  In addition, racial and 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 in the form PHS 398 in Section 2, A-D of
the Research Plan AND summarized in Section 2,E, Human Subjects.
 
It is not expected that successful applications will address all of the
topics mentioned in this RFA.  It is expected that successful
applications will include women who do and do not select NORPLANT, and
will follow those who do accept the method for some period of time.  If
clinic based samples are proposed, selection biases in such groups
should be addressed in relation to the research objectives.
 
The proposed research must be well grounded in previous research on
contraceptive choice, side effects, and continuation.  Appropriate
theoretical frameworks for examining these processes must be proposed.
Since it is likely that the adoption process affects later experience
with the method and continuation of it, investigators may wish to design
studies capable of addressing these issues.
 
III.  MECHANISM OF SUPPORT
 
Applications submitted in response to this RFA will be funded through
the traditional individual research award (R01) program of the NIH.
This announcement is for a single competition with the application
receipt deadline of December 16, 1991.  The earliest possible start date
for these grants is August, 1992.  It is anticipated that four grants
will be awarded under this program contingent upon receipt of a
sufficient number of meritorious applications and the availability of
funds.  $700,000 has been set aside to fund these awards for the first
year.
 
Applicants must furnish estimates of the time required to conduct the
proposed research.  Ordinarily, grants are supported for one to five
years; and since the nature of this study is longitudinal, it is
expected that grants will be for three to five years but no longer.  The
current policies and requirements that govern the research grant
programs of NIH will prevail (Code of Federal Regulations, Title 42,
Part 52 and Title 45, Part 74).
 
After projects have been funded, a meeting will be held to consider the
possibility of comparability in measures when feasible, considering the
varying research designs.  Further annual meetings will be held to
foster the sharing of information, data, and other experiences.
Principal and co-investigators will be encouraged to attend these
meetings, and funds ought to be included in the application budget for a
single two-day meeting per year in Bethesda, MD to discuss the research
with other investigators.
 
IV.  REVIEW PROCEDURES AND CRITERIA
 
Applications will be reviewed by NICHD staff for responsiveness to the
RFA.  Applications judged to be nonresponsive will be returned.  The
applicant may resubmit the application and have it assigned for review
in the same manner as unsolicited grant applications during the next
review cycle.  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
critique.
 
Responsive applications will be reviewed within six months of receipt.
They may be subjected to triage by a peer review group to determine
their scientific merit relative to the other applications received in
response to this RFA.  NIH will withdraw from competition those
applications judged to be noncompetitive and notify the applicant and
institutional business official.  Those applications judged to be
competitive will be further evaluated for scientific merit by a review
panel convened solely for this purpose by the Division of Scientific
Review, NICHD.  Criteria for the initial review include the significance
and originality of research goals and approaches; the feasibility of
research and adequacy of the experimental design; the research
experience and competence of the investigator(s) to conduct the project;
and the appropriateness of the project duration and cost relative to the
work proposed.  Following review by the Initial Review Group,
applications will be evaluated by the Institute's Advisory Council for
program relevance and policy issues before awards for meritorious
applications are made.
 
V. METHOD OF APPLYING
 
Applications must be submitted on form PHS 398 (revised 10/88) which is
available in most institutional business offices and from the Division
of Research Grants, NIH (301-496-7441).  Applications must be identified
by checking the "yes" box in Item No. 2 on the face page of the
application and by typing in the words, RFA HD-92-03 - The Decision
Process Surrounding the Choice of NORPLANT as a Contraceptive by U.S.
Women."  The RFA label available in form PHS 398 must be affixed to the
bottom of the face page of the original 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.  The
signed original and four copies of the application must be received by
December 16, 1991.  Applications must be sent or delivered to:
 
Grant Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
5333 Westbard Avenue
Bethesda MD  20892
 
It is extremely important for the timely review of applications that two
additional copies of the application be sent under separate cover to:
 
Laurance S. Johnston, Ph.D.
Acting Director
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
6130 Executive Boulevard
Bethesda, MD  20892
 
Applications must be received by December 20, 1991.  Late applications
will be returned.
 
VI. TIMETABLE
 
Application Receipt Date            December 20, 1991
 
Initial Review Date                 February 16, 1992
 
Review by NICHD Advisory Council    June, 1992
 
Anticipated Award Date              August 1992
 
Inquiries regarding this announcement may be directed to:
 
Susan F. Newcomer, Ph.D.
Demographic and Behavioral Science Branch
National Institute for Child Health and Human Development
Executive Plaza North, Room 611
Bethesda, MD  20892
Telephone:  (301) 496-1174
FAX:  (301) 496-0962
 
For questions concerning budget and fiscal matters, contact:
 
Melinda Nelson
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Rockville, MD  20892
Telephone:  (301) 496-5481
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.864, Population Research.  Awards will be made under the
authority of the Public Health Service Act, Title III, Section 301
(Public Law 78-410 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 the intergovernmental requirements
of Executive Order No. 12372 or to Health Systems Agency review.