. "SECTION V Research and Policy: 13 Barriers to Clinical Research on Preterm Birth and Outcomes of Preterm Infants ." Preterm Birth: Causes, Consequences, and Prevention. Washington, DC: The National Academies Press, 2007.
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Preterm Birth: Causes, Consequences, and Prevention
In reviewing the clinical causes of prematurity, the adolescent pregnant woman is an important subpopulation of interest. There are two basic approaches to obtaining informed consent from an adolescent woman, particularly if the parent is not involved. The first are the so-called mature minor state statutes, and the second is emancipation. A mature minor is someone who is thought to be able to make decisions about clinical care, including sexually transmitted diseases and family planning, without parental involvement. An emancipated individual is one who qualifies as a legal adult, even though he or she is under the usual age for attaining legal adulthood. It is unclear whether the pertinent legal statutes and principles apply to research. State law often does not address research. Therefore, researchers must rely on the interpretation of legal counsel at a particular institution about the applicability of state law, which leads to a wide degree of variability (Campbell, 2004).
When the FDA adopted the informed consent regulations that apply to the pediatric population, the agency specifically chose not to adopt the section of the DHHS research regulations that covers waivers of informed consent. Although some IRBs have allowed adolescents to provide informed consent for research in situations in which the adolescents were thought to be mature enough to make their own decisions about treatment, drug research with this population requires parental permission.
Although there is no question that protecting human subjects is important and that oversight in this area is needed, it is also clear that there is a point at which the protection processes involved may impede the ability to do meaningful and important research if the IRB bureaucratic requirements become overwhelming. Inappropriate delays can deprive patients of beneficial research advances and increase the costs to the institution, NIH, and the individual researchers. This problem is especially relevant to research on preterm births and infants born preterm.
To address these issues, some institutions have formed a specific IRB subcommittee related to pregnancy and neonatology that comprises experts in pregnancy and neonatology who review research protocols only in those areas of study. This recent innovation has streamlined the process, but it is not known how common this practice is at universities that perform obstetric and neonatal research with many participants. However, concerns remain that the regulatory demands that have been imposed on clinical researchers over the last 5 to 10 years are making it extremely difficult to conduct large-scale, multi-institutional clinical care-related research on the problems of preterm birth and those encountered by infants born preterm.