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discussion of the need for alternative approaches to obtaining informed consent, such as a process that would facilitate research during various clinical emergencies when informed consent cannot be obtained.

Other challenges include

  • the requirement expressed in 45 CFR 46, Subpart B,5 that sufficient data from preclinical studies and clinical studies of nonpregnant women and adults are needed to assess the potential risk of an agent or treatment to pregnant women and fetuses before research can proceed;

  • conflicts of interest of clinical investigators regarding the termination of pregnancy and the determination of viability;

  • innovative practices, such as maternal-fetal surgery; and

  • obtaining informed consent when the research offers only the prospect of a direct benefit to the fetus. A statement by the Committee on Ethics of the American College of Obstetricians and Gynecologists notes a concern that the recognition of distinct paternal rights before the birth of a child might undercut the mother’s autonomy. Therefore, if the research would be of direct benefit to the woman and the fetus, only the mother’s informed consent is required.

Regulations for Protecting Human Subjects of Research

Two issues that deserve focus because of the applicability of 45 CFR 46, Subpart B, are research at the threshold of viability and the ability of adolescent pregnant women to consent to research. In the 2001 revision to Subpart B, the term neonate was used as applied to research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates. Subpart B defines a viable neonate as one that, given the benefit of medical therapy, is able to survive after delivery to the point of independently maintaining a heartbeat and respiration. The National Human Research Protections Advisory Committee of the DHHS Office for Human Research Protections expressed concern about this definition, pointing out that, in fact, many neonatal patients are of uncertain viability and are kept alive for days, weeks, and perhaps months and that depending on how this definition is applied, some infants would now be considered premature under this definition (see Box 13-2 for a further discussion.)

Institutional review boards (IRBs) are struggling with how to apply the concept discussed in Box 13-2, particularly the differences between minimal risk and no added risk.

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Note that 45 CFR 46, Subpart B, applies only to research that is funded or supported by DHHS.



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