All posts by Katelyn M Edel

Informed Consent: An ethical requirement for all, or a moral choice for some?

In addition to autonomy, which is arguably the most well-known and prized construct in North American ethical discourse, informed consent also occupies an important role in the biomedical sphere. Informed consent, which is defined by medicine as being dually rooted in a patient’s ethical right to direct what happens to her body and in a physician’s ethical duty to involve the patient in her care, is even taught as a “practical application” in many medical schools. Below, I have included two case studies, from the University of Washington School of Medicine, that describe potential clinical encounters surrounding issues of informed consent.

The discussions that accompany these two case studies (also accessible through the link), describe informed consent as an ideal to obtain, with an emphasis on the probability of instances in which this obtainment is simply not possible. Most definitions of informed consent include a dimension about patient competency, making the mental ability to understand and process any provided information a requirement for voluntary choice about accepting or refusing treatment. For some, including the very young and the very old, this requirement, and a presumed lack of competency, is occasionally used as a mechanism to identify a decision-making proxy so that informed consent can still be secured. Proxies are often parents of infants, adult children of the elderly, or spouses, and these individuals are believed to have the patient’s best interests at heart.

As the readings this week explored the different dimensions of ethics, morality, culture, and choice, there were a few instances in which informed consent was overlooked, either blatantly or through more subtle mechanisms. In Adriana Petryna’s piece about globalized clinical trials and variability, she discusses the 1996 case of a drug called Trovan, manufactured by Pfizer, Inc. The industry team of Pfizer, upon hearing of a bacterial meningitis outbreak, took to Nigeria to administer the Trovan drug – an administration that ultimately killed 11 children. Petryna notes that the informed consent forms from this case were backdated, essentially making them null and void. The larger question here is whether or not informed consent falls under Petryna’s argument of “variability.” Do the contextual factors, like the meningitis outbreak and Pfizer’s premise of humanitarianism, discount the importance of informed consent? Is it ever appropriate, even in these outstanding circumstances, to strip someone of their right to make a decision about their own care?

From a more Western perspective, there was also a brief discussion in Rapp’s chapters about what it means to make decisions based on fully informed consent (p. 130). Rapp suggests that many of her informants were lacking a full understanding of the range of conditions that amniocentesis can detect, instead defaulting to the more common and easily constructed “Down’s Syndrome” as a catch-all. Does this challenge the notion of informed consent, on the grounds that women are perhaps not entirely clear about what a “positive result” may mean, including the social impacts of raising a child with a chromosomal abnormality? Is it wrong to expect a woman to make a decision without understanding all of the dimensions, or is it enough for a woman to decide, either instinctively or through counsel, with whatever information she feels she needs to make a decision? Below, I have included a commonly used informed consent form for amniocentesis. Does the document adequately outline the necessary information for an individual to make an informed choice about her care? Does there need to be an extended conversation about the nature of the amniocentesis test accompanying this document, thus allowing for a discussion of the ever-changing concerns shaped by a patient’s present moral landscape?

Informed consent is an important and necessary component in today’s medical world, at least within the United States. But for something that seems so straightforward, in practice there emerges a substantial amount of “gray area,” related to competency, the amount of information needed to ensure fully informed consent, and the place of informed consent in more variable, non-Western contexts. In cases of ambiguity, is it better to err on the side of caution and use informed consent as a moral vehicle to acknowledge a patient’s fundamental rights, or does the process become a hindrance that stalls the delivery of needed care from an expert provider? And, finally, does the necessity of informed consent vary from person to person, and across situations, or is it a non-changing entity crucial to public health, anthropological, and ethical intervention?