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 I have observed or read descriptions of 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 as diverse as end-of-life care for Great Aunt Tillie to concerns about a NICU’s policies on perinates thinking about 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 this miscommunication strikes at the heart of the critique of the study.)  We all see what the study was 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 “Parents will be approached prior to delivery for informed consent, and their infants enrolled at delivery” (13). Further, the study protocol lists death as one of four adverse events possible from participating in the study (20). Yet, in the consent forms that the participating institutions used, death was never stated as being a possible risk of the oxygen intervention in the study.  To be clear, death is listed as a possible outcome –often with the statement that there is no increase in risk of death from altering oxygen intake levels. See, for example, the consent form.  Thus death is effectively seen as a “of course one can always die during a medical intervention” risk rather than a “we are checking for a link between Φ and death” risk.  It was precisely the second 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” (2).

The study itself called for the perinates to be held at one of two ranges of oxygen levels.  As 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 there is no predictable increase in risk for your baby” (3). What this, and similar language in consent forms used across the multi-site study, obscures is that while the oxygen saturation levels fall into the range that physicians would monitor it is now being controlled arbitrarily for research purposes, not for the level of patient care.  Further, the modified pulse-ox monitors would not show the level of oxygen saturation, just if it was in the pre-assigned range.  These children are not being treated with the standard of care; the effectiveness of the care levels 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;[1] indeed they find that “respect for autonomy requires much more than avoiding deception and coercion. It requires an attempt to instill relevant understanding.”[2]  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.”[3]  It seems clear that the risks and non-standard care being consented to was either not comprehended or was not thorough enough.

Turning away from Beauchamp and Childress’s principalism, we can 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 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 are asking to do something really nice.  We’ve all looked at it.  It seems okay to us.  And this is all normal.  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 that picture 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 level than the institution.  It is hard to see how in that interaction we would have a relationship full of care and concern which leads to a 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).[4]  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 included in the informed consent process, which was done on a vulnerable population by those who had power.  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 procedure to determine how they can truly protect their patients which become research subjects.  Anything less than that is to fail to respond to the ethical dimension of research in a clinical setting.