Full Text HD-94-022

UNINTENDED PREGNANCY IN THE UNITED STATES

NIH GUIDE, Volume 23, Number 18, May 13, 1994

RFA:  HD-94-022

P.T. 34

Keywords: 
  Pregnancy 
  Behavioral/Social Studies/Service 
  Sociology 


National Institute for Child Health and Human Development

Application Receipt Date:  August 19, 1994

APPLICANTS RESPONDING TO THIS RFA WILL BE ASKED TO USE A MODIFIED
(ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR
COMPLETING THE APPLICATION ARE IN THE APPLICATION PROCEDURES BELOW.

PURPOSE

This Request for Applications (RFA) invites applications for the
support of research on the meaning, measurement, and determinants of
unintended pregnancy and birth in the contemporary United States.
Two sets of research questions are at issue and applications may
address aspects of either or both. First, the RFA seeks to improve
the research base for understanding the meaning of unintended
pregnancy, as conventionally defined, as well as to build a
scientific base for improved measures.  Second, the RFA seeks to
improve and extend research on the determinants of unintended
pregnancy and birth at the cultural, societal, couple, and individual
levels.

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,
Unintended Pregnancy in the U.S., is related the priority areas of
family planning and maternal and infant health.  Potential applicants
may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State or local
governments, and eligible agencies of the Federal government.
Applications from minority individuals and women are encouraged.
For-profit organizations should note that no profit or fees may be
requested under financial assistance awards.  Foreign institutions
are not eligible for First Independent Research Support and
Transition (FIRST) (R29) awards.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01) and the FIRST (R29) awards.  This RFA is
for a single competition with the application receipt date of August
19, 1994.  The earliest possible start date for these grants is March
1995.  It is anticipated that four to six new and/or competing grants
will be awarded under this program, contingent upon receipt of a
sufficient number of meritorious applications and the availability of
funds.  $1,000,000 has been set aside to fund these awards for the
first year.  Because the nature and scope of the research proposed in
response to this RFA may vary, it is anticipated that the size of the
awards will vary also.  This RFA is a one-time solicitation.  Further
unsolicited competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.

Applicants should state the amount of time required to conduct
the proposed research.  Ordinarily, grants are supported for
one to five years.

RESEARCH OBJECTIVES

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 unintended
pregnancy in the contemporary United States.  The CPR is composed of
four branches that support research on all aspects of human
reproduction.  For more than two decades, the Demographic and
Behavioral Sciences Branch has supported research on social,
psychological, and behavioral aspects of pregnancy and childbearing,
including sexual behavior, contraceptive decision-making and
practice, and pregnancy outcome.  Recent initiatives related to this
program of research have included RFAs on childbearing motivation,
the effect of sexually transmitted disease on fertility-related
behavior, and the use of condoms to prevent HIV; a program
announcement inviting research on fertility and fertility-related
behavior, and a 1993 conference on "Negotiating the Paths to
Parenthood".

Despite the availability of safe, effective contraception, more than
half of all pregnancies in the U.S. are reported by these pregnant
women to be unintended.  Furthermore, half of all unintended
pregnancies end in abortion.  The proportion of pregnancies reported
as unintended is highest among unmarried women, women in their teens
and 40s, and poor women.  However, even among married women and women
in their twenties, from 40 to 60 percent of pregnancies are
unintended.  U.S. rates of unintended pregnancy and abortion are
among the highest in the industrialized world.

According to the conventions established by a series of national
fertility surveys conducted since the 1950s, "unintended pregnancy"
is defined as a pregnancy that is reported to have been unwanted at
any time ("unwanted") or to have occurred sooner than desired
("mistimed").  National estimates of unintended pregnancy and birth
are based on retrospective survey reports of a woman's attitude
toward pregnancy at the time she conceived.  Partner attitudes have
also been assessed, but rarely are included in the national
estimates.  Recently, the adequacy of these measures has come into
question.  This has resulted from research on childbearing motivation
that points to a high degree of complexity in the motivational and
intentional factors leading to pregnancy and birth, and evidence from
qualitative research studies suggesting that the questions may not
capture the appropriate dimensions of pregnancy timing and
wantedness.

Research Goals and Scope

This RFA invites applications to conduct research on the meaning,
measurement, and determinants of unintended pregnancy and birth in
the contemporary United States.  As noted above, two sets of research
questions are at issue and applications may address aspects of either
or both.  First, the RFA seeks to provide a richer understanding of
the meaning of unintended pregnancy, as conventionally defined, as
well as to build a scientific base for improved measures that may be
used in demographic surveys.  Second, the RFA seeks to improve and
extend research on the determinants of unintended pregnancy and birth
at the cultural, societal, couple, and individual levels.

An essential first step in interpreting data on unintended pregnancy
is to improve our understanding of how individuals, couples and
population groups differ in the extent to which pregnancy and
childbearing are viewed as intentional and the value placed on
planned childbearing.  For some, values surrounding sexual behavior,
contraception, and reproduction may emphasize aspects that are
irrelevant to or even in conflict with the concept of planned
childbearing.  A better understanding of the variability in
reproductive values within and across population subgroups is needed.

It has been suggested that there are a "continuum of intention" and a
"scale of wantedness" that underlie both conception and birth.
Previous research supported by NICHD points to the complexity of
fertility motivations and the possible presence of positive as well
as negative dimensions of motivation (hence, the potential for
ambivalent feelings about sexual behavior, contraception, and
childbearing).  Furthermore, changes may occur during and after
pregnancy in the reported wantedness and intendedness of a particular
birth.  Studies of gender differences in motivation and intention
regarding childbearing suggest that these concepts are equally
salient for men and women, but that important differences in the
nature of motivations exist.  Research is needed to extend these
insights to a variety of population groups and individuals at varying
times in their lives and to explore their relevance to our
understanding of the conventional measures of pregnancy intention.

Some of the excess of actual pregnancies and births over wanted
pregnancies and births may be accounted for by the measurement
techniques conventionally used to assess whether a pregnancy is
wanted, mistimed, or "on time."  Variations in question wording and
order, in time since the conception, and in emphasis placed on the
individual rather than the couple, may be associated with differences
in reported levels of intendedness.  Social desirability bias in the
responses to questions about pregnancy intentions may also distort
estimates.  Development and testing of improved measures of
unintended pregnancy and related concepts for use in demographic
surveys are within the scope of this RFA.  Applications for such
studies should reflect a solid grounding in previous research on
fertility motivation, unintended pregnancy, and survey methodology.

The second major goal of this RFA is to extend and improve scientific
research on the determinants of unintended pregnancy. Even if current
measures of unintended pregnancy are found to be flawed, the high
rates of abortion in the U.S. compared with elsewhere suggest that
some pregnancies are clearly unwanted.  About half of the pregnancies
aborted result from nonuse of contraception and the other half from
method failure or inaccurate or inconsistent use of a method.  This
RFA invites applications to conduct research on the influence of
cultural, societal, couple, and individual factors on the behaviors
that result in unintended pregnancies and births.

Among the most widely acknowledged, but least studied, influences on
reproductive behavior are cultural norms and values.  Research on
these influences is difficult because they are pervasive and often
inaccessible to the quantitative measures used in traditional
demographic research.  Ethnographic methods and comparisons with
other industrialized nations could provide important insights.  In
addition, studies may examine specific mechanisms through which norms
and values about reproductive behavior are shaped.  For example, it
is widely believed that media portrayals of sexual relationships and
sexual behavior influence the behavior of media consumers.  Well
designed research to examine these purported linkages is within the
scope of this RFA.

The proportion of pregnancies that are unintended is greatest among
poor women.  Several factors may account for this: differences among
socioeconomic groups in reproductive goals and values, differences in
the personal resources individuals and couples are able to bring to
achieving those goals, and differences in access to services and
other social, economic, and community supports.  Studies that propose
to provide insight into the mechanisms contributing to socioeconomic
differences in unintended pregnancy are appropriate for this RFA,
including those that examine issues of access to services.

Gender roles and male-female relationships are central to the
behaviors that result in unintended pregnancy.  Gender roles and
ideologies give shape to and define what individuals view as
appropriate sexual and reproductive behavior as well as the "scripts"
for heterosexual relationships.  A small research base exists linking
gender roles to behaviors related to unintended pregnancy; studies to
extend this base are needed.

Unintended pregnancy invariably occurs within the context of a sexual
relationship (however brief) between two individuals of opposite sex,
each bringing their own characteristics, beliefs, values and
attitudes to the relationship.  The occurrence of an unintended
pregnancy may be a function of each partner's characteristics, of the
similarity or differences between partners, or of characteristics of
the relationship that are independent of individual characteristics.
The vast majority of studies of sexual and contraceptive behavior
have taken the individual, not the couple, as the unit of analysis.
Applicants are encouraged to develop dyadic research designs, taking
into account the methodological challenges (such as selection bias)
associated with such designs.

Finally, this RFA encourages the expansion of research linking
individual characteristics, psychology, and processes to unintended
pregnancy.

A large literature relevant to the determinants of unintended
pregnancy has developed over recent decades.  More recently, research
on the determinants of STD/AIDS risk behaviors has also been
supported, which may provide useful guidance for studies of
pregnancy-related behavior.  Applications submitted in response to
this RFA should demonstrate clear and substantial advances relative
to existing studies.  This may involve significant extensions of
existing approaches, the use of new models or methodologies, or the
extension of research to previously understudied populations that may
be expected, on substantive grounds, to differ from populations
addressed in previous research.

Applications may address any of the research goals described above.
If appropriate to the scientific aims of the proposed research,
applicants are encouraged to include qualitative as well as
quantitative methods, men and couples, individuals in their twenties
or older, and individuals belonging to ethnic or racial minorities.
Although the focus of this RFA is on the contemporary U.S.,
cross-national studies may provide valuable insights into the
conditions affecting unintended pregnancy among U.S. women.  If such
studies are proposed, the applicant must clearly demonstrate their
relevance to the issues posed by this RFA.

Studies proposing to examine the relationship between unintended
pregnancy and subsequent outcomes for the mother or child will not be
considered responsive to this RFA.

Investigators seeking to study unintended pregnancy as an outcome
should be aware of the underreporting of induced abortion typical of
most interview settings.  Applicants must effectively address
potential bias in self-reported pregnancy data or choose alternative
outcome measures.  If clinic-based samples are proposed, selection
bias in such groups should be addressed in relation to the research
objectives.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which  have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.  Investigators may obtain copies from these sources or
from the program staff or contact person listed below.  Program staff
may also provide additional relevant information concerning the
policy.

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

If the required information is not contained within the application,
the application will be returned.

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 agreement that do not comply with these
policies.

APPLICATION PROCEDURES

NOTE:  See Special Instructions below for Completion of Grant
Applications in response to this RFA.

Applications are to be submitted on form PHS 398 (rev. 9/91), which
is available in most offices of sponsored research and from the
Office of Grants Information, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449, Bethesda, MD
20892, telephone 301/435-0714.  Applications must be identified by
checking the "YES" box in Item 2a on the face page of the application
and typing in the words, "In Response to RFA HD-94-022."  The RFA
label available in 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 three copies of the application must be received by August 19,
1994.  Applications that are not received as a single package on the
receipt date or that do not conform to the instructions contained in
PHS 398 (rev. 9/91) application kit (as modified in, and superseded
by, the special instructions below, for the purposes of this RFA),
will be judged non-responsive and will be returned to the applicant.
Applications must be received by close of business August 19, 1994.
Late applications will not be accepted.  Applications must be sent or
delivered to:

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

It is extremely important for the timely review of an application
that two additional copies of the application be sent under separate
cover to:

Susan Streufert
Division of Scientific Review
National Institute of Child Health and Human Development
Building 61E, Room 5E03F
Bethesda MD  20892
Telephone:  (301) 496-1485

Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO
THIS RFA

The NIH has recently been designated a "reinvention laboratory" by
the Public Health Service.  An experiment is being conducted to
determine how to reduce the administrative burden in applying for an
NIH grant without compromising the information needed by the initial
scientific peer review group to assess the scientific merit of the
application and the reasonableness of the proposed budget.

The following are specific instructions for sections of the PHS 398
(rev. 9/91) application form that should be completed differently
than usual.  Some sections are modified and others in the application
should not be completed for the submission of the application, but
will be requested if the application receives a score in the fundable
range.  For all other items in the application, follow the usual
instructions on pages 9-32 of the PHS 398 booklet.

Form DD, Page 4.  Detailed Budget Page for Initial Budget Period:

Complete only selected portions of the Personnel section; do NOT
complete balance of this page (see Form EE, page 5 below).

o  Personnel.  Enter Names; and for each named person, enter Role on
Project and percent effort on project.  Do NOT complete remainder of
columns for personnel.

Form EE, Page 5.  Budget and Justification:

o   Budget.  Complete the budget section for all requested years of
support for all budget categories including total direct costs by
year and for all years.

o   Justification.  For the INITIAL BUDGET PERIOD, provide brief
justifications only for budget items that exceed the following dollar
amounts and/or meet the following criteria:

- Consultant Costs:  Exceeds $10,000 and/or consultant(s) are key
personnel.
-  Equipment:  Exceeds $15,000
-  Supplies:  Exceeds $15,000
-  Travel:  Exceeds $5,000
-  Other Expenses:  Exceeds $5,000
-  Consortium/Contractual:  Exceeds $10,000

o  For ADDITIONAL YEARS OF SUPPORT REQUESTED, briefly justify annual
changes that are more than or less than four percent increases from
the preceding years.

Form FF - Page 6. Biographical Sketch:  For each key investigator
provide a biographical sketch that does not exceed TWO PAGES and
includes the following information:

o  Name, Position Title, Education, as in the PHS 398 form.
o  Research and Professional Experience.  This section should be used
to highlight the investigator's scientific background and experience
relevant to the research proposed in this application.

Completing the section in the following sequence will facilitate
review of this application:
-  Previous research position(s) relevant to this application
-  Honors, including:  title and funding sources for all current and
relevant completed research on which investigator was Principal
Investigator, Co-Investigator, or Project Leader; and membership on
NIH review groups, councils, or program advisory committees and
length of service on each.
-  Complete references including titles and all authors for peer
reviewed publications representative of the investigator's research
career or pertinent to the research proposed in this application.

Form GG - Page 7 - Other Support:  Do not complete.  Information on
specific levels of support will be requested by the NICHD only from
applicants being considered for funding.

Form HH - Page 8 - Resources and Environment:  Complete selected
item(s) only if proposed research requires specialized unique
resources for which availability must be documented.

Research Plan (Booklet Pages 19-24):  Note:  Items 1 - 4 may not
exceed 20 pages.

o  Item 1- Specific Aims (typically less than one page):  List in
priority order the broad, long range objectives of the proposed
project and describe concisely and realistically the hypothesis to be
tested and what the specific research described in this application
is intended to accomplish.

o  Item 2- Background and Significance (typically 1 page):  The
background and significance has been established by the NICHD in
setting aside funds for the release of this RFA.  Use this section to
describe how the proposed research will contribute to meeting the
goals and objectives of the RFA and explain the rationale for the
selection of the general methods and approaches proposed to
accomplish the specific aims.

o  Items 3 - 6:  Complete as instructed on pages 21-23 of the PHS 398
booklet, noting the reduced page limit stated above.

o  Item 7 - Consultants/Collaborators:  Biographical sketches should
conform to the brief format described for Form FF, above.

o  Item 8 - Consortium, Contractual Arrangements (1 page only):
Provide a brief explanation (not to exceed one page) of the
scientific, fiscal, and administrative arrangements made with
collaborating organizations.

Appendix (PHS 398 Booklet - Page 24) A maximum of five publications,
manuscripts, submitted or accepted for publication, patents,
invention reports may be included.  Other than this change, complete
as instructed.

Forms II and JJ - Checklist:  Do not complete.  Information will be
requested by NICHD only from applicants being considered for funding.

If you or your business office have any questions regarding these
special instructions, call, FAX, or write Melinda Nelson at the
address listed under INQUIRIES.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for responsiveness by the
NICHD.  Applications judged to be nonresponsive will be returned.
The applicant may resubmit the application for review in competition
with unsolicited grant applications at the next review cycle.

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 in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.

Criteria for the initial review include:

o  the significance and originality of research goals and approaches;
o  the feasibility of research and adequacy of the experimental
design;
o  the research experience and competence of the investigator(s) to
conduct the project; and
o  the appropriateness of the project duration and cost relative to
the work proposed.

AWARD CRITERIA

The anticipated date of award is March 1995.  Scientific merit and
technical proficiency, as described in the application, will be the
predominant criteria for determining funding.

INQUIRIES

Written 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 to:

Susan F. Newcomer, Ph.D.
Demographic and Behavioral Science Branch
National Institute of Child Health and Human Development
Building 61E, Room 8B13
Bethesda MD  20892
Telephone:  (301) 496-1174
FAX:  (301) 496-0962
Email:  NewcomeS@HD1.NICHD.NIH.GOV

Direct inquiries regarding fiscal matters to:

Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 61E, Room 8A17
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  NelsonM@HD01.NICHD.NIH.GOV.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.864 (Population 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 990158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations, 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 23472, or to Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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