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Posted on December 4, 2017 at 12:11 AM

This editorial is re-posted from the December 2017 issue of the American Journal of Bioethics. You can read more on this topic through the target article and open peer commentaries

by Tom L. Beauchamp, Ph.D.

The article in this issue of AJOB titled “Reframing Consent for Clinical Research: A Function-Based Approach” is a fresh and engaging way of thinking about how to handle several conceptual and moral problems about consent in clinical research. At times the authors seem entirely concerned with problems of informed consent, while at other times they are concerned with other forms of consent. As they note, they use the term “consent” in an unusually broad sense “from simply informing an individual that an activity involves research to providing a brief description of [a] study … to obtaining in-depth written consent.” My comments here will be confined more narrowly to what they say about informed consent. I will not consider other forms of consent (such as assent, implicit consent, presumed consent, and the like), and I will not consider single elements of informed consent such as disclosure and authorization.

The authors argue that “the standard view in research ethics is that the function of informed consent is to respect individual autonomy” [italics added]. They find this thesis too narrow on grounds that the standard view “omits several other distinct … functions that consent promotes,” namely the “seven distinct functions” featured in their analysis. They also judge that, in their conception of the standard view, there is an “assumption that individual autonomy alone can account for the ethical importance of consent.” This interpretation of the standard view does not show an adequate grasp of how its defenders conceive it. I will concentrate on what the view is and how it both differs and does not differ from the “function-based approach.”

It is correct to say both that the standard view has not emphasized a functional approach to informed consent and that if it makes a significant claim about the function of informed consent, the claim is that the function is “to respect individual autonomy.” The authors do not directly challenge the claim that respect for autonomy is an important function of informed consent; they say only that informed consent serves “other functions as well.” However, they indirectly challenge this claim by not including respect for individual autonomy on their list of the seven conceptually distinct functions of consent, which are 1) Providing transparency; 2) Allowing control and authorization; 3) Promoting concordance with participants’ values; 4) Protecting and promoting welfare interests; 5) Promoting trust; 6) Satisfying regulatory requirements; and 7) Promoting integrity in research.

It is puzzling that the authors entirely omit respecting autonomy from their list. Perhaps they think that a discussion of respect for autonomy is not needed because their theory implicitly retains several central dimensions of the requirements of this principle and therefore they have an appropriate link between the principle and their account of the functions of informed consent. For example, their functions 2–4 (allowing control and authorization; promoting concordance with participants’ values; and protecting and promoting welfare interests) are arguably functions of informed consent aimed at protecting the autonomy of subjects. Consider, for example, the authors’ second function of “control and authorization”: These notions are central to the concept of informed consent, whose basic meaning is autonomous authorization. That is, an informed consent conceptually is an individual’s autonomous authorization of a medical intervention or of participation in research. From this perspective, the gap between the authors’ theory of functions and the standard view about giving priority to the autonomy of patients and subjects is not as wide as these authors might seem to suggest. Indeed, on the interpretation I just offered, a “function-based approach” is not inconsistent with the standard view of informed consent even if the two approaches emphasize different aspects of informed consent.

In speaking of the “standard view in research ethics,” the authors seem to have in mind the historical fact that informed consent has, since at least the late 1970s, primarily been stated in terms of the obligation to respect autonomy and the elements of informed consent, rather than in terms of the functions of informed consent. If this is what the authors mean (or assume), it is correct. The standard view has long been framed in terms of the basic elements of informed consent, the meaning of “informed consent” as autonomous authorization, and the justification of requirements to obtain informed consent as grounded in the demands of the principle of respect for autonomy. This claim about justification can be stated as the view that obligations to solicit and obtain informed consent from patients and potential research subjects are demanded and justified by the principle of respect for autonomy. In the end, the core of the standard view is its autonomy-grounded framework of elements, obligations, and justification–and not in a claim about the functions of informed consent.

The elements in the standard view can be listed in a way parallel to way the functions are listed by the authors of the function-based account. The basic elements of informed consent in the standard view are 1) Competence (to understand and decide); 2) Voluntariness (in deciding); 3) Disclosure (of material information); 4) Recommendation (of a plan); 5) Understanding (of 3 and 4); 6) Decision (in favor of a plan); and 7. Authorization (of the chosen plan). This account, too, is not inconsistent with our authors’ function-based account of seven conceptually distinct functions, however different the emphases are in these theories. In my view, the theories should be taken as mutually supportive ways of thinking about the role(s) of informed consent in clinical research.

Viewed from another perspective, the standard view would be improved by being conjoined with a functional account that offers a different perspective from which to view informed consent—and a socially valuable one. For example, viewing informed consent from the perspective of promoting public trust in the research enterprise is critically important, as we have learned the hard way in cases such as that of the Tuskegee Syphilis Studies and Henrietta Lacks’ struggles with cancer. Although respect for the autonomy of subjects has the highest priority as a value underlying the institution of informed consent, functions such as maintaining public trust are high-priority considerations, especially for health centers committed to the treatment of patients who are also subjects in research. Accordingly, I commend the authors of “Reframing Consent for Clinical Research” for their significant contribution to the literature of informed consent.

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