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?


7 thoughts on “Informed Consent: An ethical requirement for all, or a moral choice for some?”

  1. Thanks for the post Katelyn! This issue of informed consent is indeed a thorny one. You mention some of the obstacles to obtaining informed consent, one of them being the patient’s mental competency. I think another important element to consider (which is tied to patient competency) is language. What happens when your patient is illiterate? Are there procedures for obtaining oral consent? With regards to my own research I have wondered are there ways to capture consent given in sign language (is this consent filmed)? What happens when there is no interpreter available to translate the informed consent form into the patient’s native language? The patient’s health literacy is also a factor, and you mention this in your post—there are issues around the meaning of “fully” informed consent. How does one know if their patient is fully informed? Do you give them a quiz to see how much they really know?

    In regards to the idea of fully informed consent: sometimes, even when an individual is fully informed, their consent is not freely given. For example, Petryna gives the example of clinical trails being conducted on prisoners. Perhaps (though most likely not) prisoners were fully informed about what was going to happen to them, yet they had no agency to refuse treatment. In clinical trials around the world today, the “treatment naïve” populations that are targeted are, more often than not, living in poverty. When clinical trials offer incentives or compensation for participation, does this not problematize the idea of informed consent? How much of a freely made choice is it to participate in a clinical trial when you’re in desperate need of money?

  2. Thanks for this post Katelyn! I think about this issue of informed consent a lot when it comes to TB case detection and treatment in Ghana. The role of NGOs is often to find and compel people to be tested for TB, as the gap between identifying potential patients and the number of patients who actually go for the test is large. However, there are many things that are done to gain people’s consent to be tested that are not particularly informed and seem less like consent than coercion. For example, patients who test positive for TB are supposed to be screened for HIV as well. This screening is not voluntary, and people are regularly not asked if they consent, or even informed that the procedure is taking place. If they are informed, it is generally right after they have been told that they have tuberculosis, and NGO and health staff told me that people will always say yes after that, because they have been told they will die from sickness otherwise. Additionally, NGOs frequently use tactics of fear in order to encourage people to take their TB medicine and to stop behaviors that limit the effectiveness of TB treatment, such as drinking and alcohol. How can we think about tactics like these as “informed consent?” Does it matter that consent closely tied with manipulation when it is for the patient’s “own good?” How do we think about the unequal power relationships that exist in these settings and the way that they affect consent?

  3. Thanks Katelyn!

    I think the question of informed consent is an important one and is something that most of us as researchers have to contend with in one way or another. My experience with the Internal Review Board for my own research was very difficult as I pushed for verbal consent as opposed to written consent because I had to explain the risk that people might take by signing a document in the particular context I was in.

    The interesting thing about informed consent is that we all know from our ethical research training is that it stems out of a particular history of scientists exploiting or even purposefully hurting people in experiments. The point of informed consent was to protect the interests of people who might be vulnerable to exploitation. So informed consent in a way already predetermines what those interests or risks are.

    Ideally, someone doing research already has enough knowledge to understand what aspects of their research constitutes risk for their research subjects or interlocuters. In anthropology this much more difficult to determine than it might seem. And yet at the same time, some of the readings show, and Whitney’s experience also confirms, that informed consent procedures are not always followed or are simply ignored and often with the justification of it being in the interests of the subjects/interlocuters or as Whitney put it, “for their own good.” The irony is that whether one is following the informed consent procedures or justifying ways to circumvent, or bend, or ignore it we are always determining their interests for them. I personally would want someone to follow those procedures but ultimately it seems like they are two-sides of the same coin. WE have the authority to determine interests as experts. But should we?

  4. Hi Katelyn,

    I do think Petryna offers a good example of ethical variability. What I take from that piece (and the edited volume by her and Kleinman called Global Pharmaceuticals) is that global inequalities exist and people living in poverty in third-world countries are affected unfairly. In her case, it would be that they are used as medical test subjects in a way that makes their life less important or valuable than those of the first-world citizens. The problem is exactly that there is no universal ethical standards or guidelines that regulate pharmaceutical companies’ behaviors in selecting and testing on human subjects. This kind of “variability” is used by the powerful pharmaceutical companies and acquiesced by governments to risk human lives that are deemed less valuable. “What could go wrong? If it goes wrong, well, so be it.”

    And thank you so much for providing the consent form! I’ve never seen one before but when I read it, and I imagine myself to be a pregnant parent (I know I can’t even compare to the experience of a real pregnant woman), the first question is already daunting. The whole form is full of misery, hopelessness, and, in some sense, a threat. For some reason, this form has a clear underlying tone to me: “Testing it or not is up to you. But seriously, terminate the pregnancy.” I don’t know if it contains enough information for someone to make a decision to take the test, but I shall say it has enough biased information to “force” the woman to make a decision before even taking the test.

  5. This is a great topic for us, as researchers, to explore. I want to echo Samee’s discussion of the historical background of informed consent in human subjects research, and its goals to protect people from harm. With that in mind, I do believe that informed consent is “crucial to public health, anthropological, and ethical intervention”, and that the majority of IRB mechanisms provide an important and meaningful contribution to the research process.

    Petryna’s piece on “Ethical Variability” brought up many of the issues surrounding the procurement of informed consent in vulnerable populations. One issue that I’ve actually struggled with considerably as a researcher is: is it unethical to supply populations with heath care and treatment that they wouldn’t have otherwise for the purpose of clinical trials? Can informed consent ever really be anything but coercive when people are forced to choose between temporary medical treatment or nothing? Katelyn asks if the process of informed consent becomes “a hindrance that stalls the delivery of needed care from an expert provider,” but we must also consider the implications of what happens when the intervention is inevitably removed, and what kind of lasting effects temporary interventions have on the health, social welfare, and economy of the populations that are left behind when the research concludes.

  6. Thanks Katelyn for your post! The issue of informed consent that you present in your blog and that we observe in the readings had me thinking about the ways in which we as social scientists encounter difficulties acquiring consent when conducting our fieldwork. Erin’s comments in particular had me thinking of the creative ways in which we access consent from our interlocutors and how technologies like a tape recorder would greatly serve our purposes in cases where gathering written consent is problematic. Then again I started wondering what the logistical implications would be if I were working with an illiterate population. Would my word that I gathered oral consent suffice the IRB requirements? Would it be inappropriate to get oral consent first, conduct an interview, and then go back for a signature for good measure? Where is the accountability in embracing this procedure? Would it be problematic if I had an interviewee stamp their thumb instead of writing out their signature? How would I go about confirming that they know enough about what this study entails before proceeding with my research?

    From my experience with IRB, I have had to write up consent forms well in advance of conducting fieldwork and carry printed forms with me at all times in both English and Spanish, along with my phone to record that I gathered consent in case a mishap occurred with my consent files. I recall I had to make amendments to these forms because some details started changing and it was an incredible pain to go through IRB review again but it was personally necessary to make sure that my questions were not endangering the population I was studying. The interesting thing about this process for me was that I had to think very critically about the questions that I was asking and focus on the language to make sure it was very explicit/ could not be misconstrued. I wonder if the protocol for IRBs across universities differ significantly or if they are mostly oriented to answer the same questions.

    When looking at the consent form you share, one thing that I found striking is that there was no contact information shared in case the informant decided they wanted to contact the researcher to withdraw their consent. I learned from my advisors in undergrad that I am always supposed to provide a return address or phone number for my informants to contact me in case they have further questions or would like to be exempt from the data set.

  7. Hi Katelyn,

    Thanks for your post! The ideal of informed consent does seem to be an ethical requirement in research, and yet how often is it actually attained? You brought up health literacy and language barriers, but what also comes to mind is financial incentive. For participants who are poor and need every penny, is their agreement to be in a study truly consent? Would they have consented if there wasn’t a financial need? Even if they were fully literate and genuinely knew what they were signing up for… And if it does count as informed consent, shouldn’t there be some other ethical standard that that violates?

    I think Lacey brought up the additional point of doing trials in populations that have no other treatment options. I feel like that involves a certain level of coercion, as does offering a monetary incentive to a population that is poverty-stricken.

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