Rory Kraft examines “a difference in the weighting of ethical standards.”

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I suppose that we should always be wary when the facts about an ethical dispute seem clear cut. I say this because it strikes me that the vast majority of clinical medical ethical “conflicts” which I have observed tend to come down to misunderstanding or a lack of shared information.

For this reason, my first inclination when coming across an emergent issue in bioethics is to try to determine a) which facts are in dispute and b) where miscommunication may have occurred. In situations ranging from end-of-life care for Great Aunt Tillie to concerns about a NICU’s policies on perinates, looking for these two aspects have gone far in my experience in resolving disputes.

Thus it was with increasing confusion that I looked at the ethical concerns surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT). Here, it did not seem that there were either facts in dispute or miscommunication between those seeing the study in very different lights. (This of course is not to say that there was no miscommunication in the study itself; indeed miscommunication is at the heart of the main ethical critique of the study.) We all see what the study involved, and how the consent forms were written. What we do not seem to agree on is how important the failings of those consent forms are. This is not a miscommunication, but a difference in weighting of ethical standards.

The protocol for the study itself (available here) states that “[p]arents will be approached prior to delivery for informed consent, and their infants enrolled at delivery” (p. 13). Further, the study protocol lists death as one of four adverse events possible from participating in the study (p. 20). Yet, in the consent forms that the participating institutions used, death was never stated as being a possible risk of randomized enrollment into the oxygen interventions in the study. To be clear, death is listed as a possible clinical outcome –often with the statement that there is no anticipated increase in risk of death from altering oxygen intake levels for research purposes. See, for example, the consent form for the University of Alabama at Birmingham (p. 4). Thus death is effectively represented as a “of course one can always die during a medical intervention” ordinary clinical risk rather than a “we are checking for a link between Φ and death” risk of enrollment in research. It was precisely the second type of risk that was being considered as a part of the study; as the SUPPORT protocol states the study is needed because we have previously seen a link between a “decrease in oxygen supplementation and/or death at 28 days after birth and at 36 weeks post menstrual age” (p. 2).

The study itself called for the perinates to be held at one of two ranges of oxygen levels. As is typical of many of the forms, the consent form for the Women and Infants Hospital of Rhode Island states, “all the treatments proposed in the study are standards of care at different hospitals across the country [so] there is no predictable increase in risk for your baby” (p. 3). What this and similar language in consent forms used across the multi-site study obscure is that, while the oxygen saturation levels fall into the range that some NICU clinicians would monitor without intervening, the oxygen saturation level in the study is being controlled primarily for research purposes, not primarily for patient care. Further, the modified pulse-oximeter monitors would not show the true level of oxygen saturation. These children are not being treated with the standard of care; the effectiveness of various possible types of care, at least some of which are not ordinarily seen in a NICU (e.g., holding the oxygen saturation level at 85-89%), are being studied through the use of these infants.

Beauchamp and Childress’s Principles of Bioethics is the beginning point for most discussions of clinical medical ethics. They firmly root the need for informed consent in their principle of respect for autonomy; indeed they find that “respect for autonomy requires much more than avoiding deception and coercion. It requires an attempt to instill relevant understanding.” (Beauchamp & Childress 2009, 118) Their description of an informed consent is even more illuminating here: “One gives an informed consent to an intervention if (and perhaps only if) one is competent to act, receives a thorough disclosure, comprehends the disclosure, acts voluntarily, and consents to the intervention.” (Beauchamp & Childress 2009, 120)  It seems clear that the risks and non-standard care being consented to in SUPPORT was likely either not comprehended—because it could not be comprehended from these forms—or the disclosure was not thorough enough.

Turning away from Beauchamp and Childress’s principlism, we can also see aspects of the SUPPORT study that are particularly troubling from a feminist bioethics perspective. When we look at the power dynamic implicit in the informed consent process, we see that it is the research authority itself – first the physician/researcher, then behind them the Institutional Review Board standing as proxy for the institution, and finally the U.S. Government – who is coming to a family with a soon-to-be-pre-term-perinate. This, or should I say these, authorities appear to be clinicians asking to do something uncontroversial. They seem to be saying, “We’ve all looked at this study’s design. It seems okay to us. And this is all pretty much normal clinical care here. In fact, it is kind of a shame we have to go through all this paperwork stuff. Just imagine what we can learn to help out others.”

While my portrayal is admittedly cynical, it captures the differences in power position that the physician/researcher and the mother/family of the perinate have. The soon-to-be parent (SUPPORT consents were done pre-birth) is at a much more vulnerable emotional and physical locale than the institution. It is hard to see how, in that power-laden interaction, we would have a relationship full of legitimate care and concern.  Instead of mutual respect and empathy we get the signing of flawed consent forms. Indeed we might worry that it is precisely because the parent(s) of the child are in the midst of decisions regarding the soon-to-be-pre-term-perinate that we should worry about the “social environments that constitute and sustain” the parent(s). (See Sherwin 2009 p. 149) In these instances, it is precisely the clinical institutional support which is providing support and sustaining the parent(s). It might always be wrong-making for the institution to ask for consent in that situation.

The most concise version of the concerns I and others have with SUPPORT is that the informed consent process was not sufficient. But stating it that simply minimizes the importance of the failing. Perhaps it is better to put it this way: there was insufficient-to-misleading information provided during in the informed consent process, which was aimed at a vulnerable population by those who should be perceived as having substantial power over that population. While certainly loaded language, I cannot look at the facts of the situation and find anything else. SUPPORT was flawed and the institutions and IRBs which approved it need to look again at their consent procedures to determine how they can truly protect their patients who become research subjects. Anything less than that is to fail to respond to the ethical dimension of research in a clinical setting.

Rory Kraft is Assistant Professor of Philosophy at York College of Pennsylvania, USA.

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This commentary was initially posted on July 17, 2013 on the IJFAB blog. A revised version is reposted here with permission of the author. Visit http://www.ifjab.org/blog/

Also see SUPPORT and What it Means to Do Bioethics, Alice Dreger