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Posted on May 13, 2019 at 12:40 PM
This blog post made available by the American Journal of Bioethics. You can read this editorial and accompanying articles here.

by Sarah Wieten, Ph.D., Jacob Blythe, MA, & David Magnus, Ph.D.

In their target article, Beskow and Weinfurt investigate a lack of understanding by research participants about central concepts in biobanking and disagreement among experts about what this lack of understanding means for informed consent.

Beskow and Weinfurt designed and carried out “a national online survey in which participants were randomized to receive either the simplified or traditional consent form … After reading the form, participants completed the comprehension quiz. For each item answered incorrectly, they reviewed the corresponding consent form section and then answered another quiz item on that topic”.

We can see from the discussion of the authors’ methods that for Beskow and Weinfurt, truly informed consent is consent given by individuals who demonstrated that they understood the essential component topics of the research in question as previously identified by a panel of experts. For the authors, understanding these components requires scoring 100% on the quiz of essential information after explanation, a first attempt at answering a research question, and remedial explanation. On this conception of informed consent, the authors found that only about two-thirds of individuals could provide informed consent for their biobank.

As they acknowledge, Beskow and Weinfurt are in good company in finding empirically that participants often do not understand components of the research they are looking to participate in, even when various interventions are deployed to improve understanding.

The authors identify a tension they found in interviewing experts on how best to respond to these findings of imperfect understanding: “Although ≥70% of panelists previously agreed that these elements were essential for adequate understanding, >30% of Round 4 respondents said that individuals should still be allowed to enroll even if unable to answer corresponding quiz items correctly”. That is, many participants failed to meet the bar the authors and their panel of experts set for adequate understanding, and therefore for informed consent. Nonetheless, many of the interviewed experts did not think this was a reason to bar them from participating in the trial.

In their conclusion, Beskow and Weinfurt suggest that informed consent may need to be conceptualized differently, writing, “Our findings contribute to ongoing debates concerning ‘understanding’ in the context of informed consent … If thoughtful colleagues struggle with how to act upon the notion of understanding as an ethical requirement, perhaps viewing understanding as an ethical aspiration is more consistent with the range of values and considerations involved in making real-life decisions about research participation”.

They find that their empirical work points toward thinking of informed consent (including understanding as an important component) as aspirational. We agree that informed consent is best thought of as aspirational, meaning that at least some of the value of informed consent is in treating the participant as someone worth explaining things to, even if the explanation does not result in perfect or even adequate understanding. On an aspirational account of informed consent, empirical work that shows that participant understanding is imperfect does not count as evidence that informed consent is impractical and should be abandoned. Rather, this empirical work should be taken as evidence that communication and education are difficult and should be improved as much as possible, while allowing that not every participant will have knowledge of even the concepts experts think essential.

Taking informed consent as aspirational is not a new suggestion. In an often-cited 1966 paper, Henry K. Beecher examined 50 recent research projects and noted that 48 of these projects did not attempt to inform patients about the research they were participating in or ask their permission to be included. He writes, “Consent in any fully informed sense may not be obtainable. Nevertheless, except possibly, in the most trivial situations, it remains a goal toward which one must strive”. Later, he argues that “the ethical approach to experimentation in man has several components; two are more important than the others, the first being informed consent. The difficulty of obtaining this is discussed in detail. But it is absolutely essential to strive for it for moral, sociologic and legal reasons … Secondly, there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator”.

Beecher is often cited as an important historical figure in advocating for informed consent as an ethical standard in research. However, the aspirational nature of Beecher’s informed consent and his unwillingness to ask informed consent to do much of the moral work of regulating research (preferring an emphasis on intraprofessional regulation and the cultivation of virtuous investigators) are sometimes overlooked. Calls to recognize the aspirational, though potentially unachievable, goal of true informed consent have occasionally been proposed in the years following Beecher.

A growing chorus is calling for a rethinking of the role of informed consent in research. Perhaps the reason to “strive” for it has little to do with conveying information. In their commentary, Burgess and O’ Doherty see it as an activity to promote trust.

This function of informed consent is just one that has been identified by Dickert and colleagues. Others they discuss include providing transparency, allowing control and authorization, promoting concordance with participants’ values, protecting and promoting welfare interests, satisfying regulatory requirements, and promoting integrity in research.

These multiple functions play an important role in protecting research participants and demonstrating respect toward them. As several commentators have pointed out, this means that the context of the research matters for how we interpret what is required to fulfill the roles that informed consent plays. In biobanking research, should there be adequate oversight and data security, there may be little to no risk to being asked to participate. In other types of research, active elicitation of patient preferences may be necessary to truly demonstrate respect.

While Beecher might worry that such a broad range of functions asks too much of informed consent (when perhaps investigators themselves ought to, say, promote transparency and concordance with participants’ values), informed consent could still fulfill the various roles it plays while being aspirational when it comes to full understanding. That particular participants struggle to understand GINA (the Genetic Information Nondiscrimination Act) or the confidentiality protections in place to guard their data need not be a reason to think that informed consent is a flawed concept, or cannot fulfill the functions identified by Dickert and colleagues.

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