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 301/710-0267. 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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