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or through changes in insurance company liability policies. For example, grant supports could share part of the liability insurance costs for the time investigators spend in clinical research. Two changes in insurance company liability policies that would be helpful are known as “split positions” and “split assignments.” A split position involves two doctors each working half time and each paying half of a premium instead of a full one. A split assignment occurs when one doctor spends 50 percent of her or his time in clinical research and the other 50 percent of her or his time taking care of patients. In such a case it would be helpful if that doctor could pay half the full-time premium or if the premium could be significantly reduced.

All of these obstacles to research in this area contribute to the mood of the faculty and the culture of the institution, which are much more negative than they have been in the past. It is not surprising that students and residents who listen to clinical researchers in obstetrics and gynecology talk about liability issues, the difficulties involved in working with IRBs, and increased regulations become unenthusiastic about doing clinical research in obstetrics and gynecology.

LEADERSHIP CHALLENGES AND NEEDS

Preterm delivery is a complex problem, with genetic, immunologic, infectious disease, environmental, social, and psychological dimensions. It produces a syndrome that is hidden until its manifestation as preterm labor; however, the events responsible for preterm labor might have occurred at any time before its initiation, even as far back as the development of the mother as a fetus. Because of its complexity, few inroads into the prevention and treatment of preterm birth have been made. However, there have been successes in gaining a better understanding of some of the mechanisms implicated in preterm birth. These could lead the way to more treatment trials. Such trials, however, must be more specific and focused on smaller and more well-defined cohorts.

Despite the efforts of the research community to develop new strategies to prevent and treat preterm labor, they have been insufficient. At the federal level, the Advisory Committee on Infant Mortality, established to advise the DHHS secretary on the department’s programs to reduce infant mortality and improve the health of pregnant women and infants, called attention to the problem of preterm delivery and recommended the establishment of an interagency working group on low birth weight and preterm birth to stimulate multidisciplinary research, scientific exchange, and collaboration among DHHS agencies (ACIM, 2001).

NIH-sponsored individual research grants are an important component in progress, but more concerted and concentrated efforts must be made to build multidisciplinary investigative teams and develop new investigators



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