Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

The American Journal of Bioethics, Volume 12, Issue 7, Page 1-2, July 2012.

The liberty of the woman is at stake in a sense unique to the human condition and so unique to the law. The mother who carries a child to full term is subject to anxieties, to physical constraints, to pain that only she must bear. That these sacrifices have from the beginning of the human race been endured by woman with a pride that ennobles her in the eyes of others and gives to the infant a bond of love cannot (...) alone be grounds for the State to insist that she make the sacrifice. Her suffering is too intimate and personal for the State to insist, without more, upon its own vision of the woman's role ….For years, Jehovah's Witnesses have posed a challenge to the medical profession. Bound by religious belief to refuse blood and blood products, they can frustrate physicians who, since World War II, have utilized transfusions when indicated in the course of treatment. (shrink)

Drawing on sociological and anthropological studies, the aim of this article is to reconstruct how obstetric technologies contribute to a moral conception of pregnancy and motherhood, and to evaluate that conception from a normative point of view. Obstetrics and midwifery, so the assumption, are value-laden, value-producing and value-reproducing practices, values that shape the social perception of what it means to be a “good” pregnant woman and to be a “good” mother. Activities in the medical field of reproduction contribute to “kinning”, (...) that is the making of particular social relationships marked by closeness and special moral obligations. Three technologies, which belong to standard procedures in prenatal care in postmodern societies, are presently investigated: informed consent in prenatal care, obstetric sonogram, and birth plan. Their widespread application issupposed to serve the moral goal of effecting patient autonomy. A reconstruction of the actual moral implications of these technologies, however, reveals that this goal is missed in multiple ways. Informed consent situations are marked by involuntariness and blindness to social dimensions of decision-making; obstetric sonograms construct moral subjectivity and agency in a way that attribute inconsistent and unreasonable moral responsibilities to the pregnant woman; and birth plans obscure the need for a healthcare environment that reflects a shared-decision-making model, rather than a rational-choice-framework. (shrink)

The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis of whether (...) they should be doing it in the first place. In a court of law, clinicians are generally judged based on the “reasonably prudent” standard: what a reasonably prudent practitioner in a similar situation would do. But this legal standard can have the effect of shifting the medical standard of care—enabling astandard‐of‐care sprawlwhere actions undertaken for the primary purpose of avoiding liability reset the standard of care against which clinicians will be adjudicated. While this problem has been recognized in the legal literature, neither current ethical models of care nor legal theory offer workable solutions.One of the best examples of the conflict between evidence‐based medicine and common clinical practice is the use of electronic fetal monitoring. Despite strong evidence and professional guidelines that argue against the use of EFM for healthy pregnancies, the practice persists. One of the main reasons for this is often assumed to be physicians’ concerns about liability. (shrink)

The “best interests of the patient” standard—a complex balance between the principles of beneficence and autonomy—is the driving force of ethical clinical care. Clinicians’ fear of litigation is a challenge to that ethical paradigm. But is it ever ethically appropriate for clinicians to undertake a procedure with the primary goal of protecting themselves from potential legal action? Complicating that question is the fact that tort liability is adjudicated based on what most clinicians are doing, not the scientific basis of whether (...) they should be doing it in the first place. In a court of law, clinicians are generally judged based on the “reasonably prudent” standard: what a reasonably prudent practitioner in a similar situation would do. But this legal standard can have the effect of shifting the medical standard of care—enabling a standard-of-care sprawl where actions undertaken for the primary purpose of avoiding liability reset the standard of care against which clinicians will be adjudicated. While this problem has been recognized in the legal literature, neither current ethical models of care nor legal theory offer workable solutions. One of the best examples of the conflict between evidence-based medicine and common clinical practice is the use of electronic fetal monitoring. Despite strong evidence and professional guidelines that argue against the use of EFM for healthy pregnancies, the practice persists. One of the main reasons for this is often assumed to be physicians’ concerns about liability. (shrink)

Decisions about continuing or terminating a pregnancy touch on profound, individualized questions about bodily integrity, reproductive autonomy, deeply held values regarding one's capacity for parenthood, and, in the case of a high-risk pregnancy, the risks one is willing to take to have a baby. So far as possible, reproductive decisions are made between a patient, in some cases her partner, and her medical provider. However, this standard framework cannot be applied if the patient lacks decision-making capacity. In this essay, we (...) discuss one such case that came before our clinical ethics team. We describe the challenges of respecting a patient's reproductive preferences when the patient cannot share what those preferences are, and we argue that decisions regarding reproductive health care should not be treated with exceptionalism. Rather, they should proceed under the normal processes of surrogate decision-making, including the application of substituted judgment. This approach enables us to take the patient's values into account when considering the questions implicated in reproductive health care, just as we do for other kinds of health care decisions in which a patient's deeply held values are salient. (shrink)