What Constitutes ‘Genuine’ Consent?

This week’s articles demonstrate the shortcomings present in clinical trials’ practices of recruiting and informing their human subjects. Fisher proposes that the commonly accepted ‘informed consent’ standard is one of the most important of these shortcomings, using case studies to demonstrate that many participants in these trials are still winding up unaware of many of the details about them, and thus facing unethical risks. Although we may be naturally drawn to putting responsibility on those who volunteer for trials in the name of agency, doing so does not allow for pressures unrelated to the specific trial, such as financial need, to be factored in to the measures of protection from unnecessary risks currently provided. When focus is placed only upon elucidating the relevant medical components of the trial to the patient, individuals are interested in the trial solely for reasons such as compensation or acquiring free drugs are left unprotected, since these concerns may be unimportant to them in the face of the former. Informed consent standards also neglect to factor in misinformation which can be distributed via advertisements with the goal of leading patients to make decisions before even signing up for the trial, rendering them impossible to ‘inform’ adequately at that point since they are already willing to consent. Federal regulation’s concern with the autonomous informed participant could seem mislead when viewed alongside such factors which influence one’s action in a less straightforward manner. Is it possible that advertising and other attempts to manufacture consent might pose an equal (if not greater) threat to autonomy than imposing restrictions beyond ‘informed consent’ upon peoples’ ability to participate in clinical trials?

However, if medical research has government approval use people as means to certain ends, are we justified in telling people they can’t use clinical trials as means to their own? Do we have the “right to serve as ‘guinea pigs’” mentioned in Epstein, and if so, how should we account for the ways our rights are compromised when we are manipulated into desiring this right in the first place? With medical research themselves ‘donning new hats’ as agents of persuasion, the answers to these question are becoming increasingly obscured.

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One Response to What Constitutes ‘Genuine’ Consent?

  1. shitangshuroy says:

    Your comment (and several other comments on the meaning of “informed consent”) raises an interesting question for me… which is more important: That one be informed when they give consent? Or that one have a reasonable opportunity to be informed (such as access to all relevant information in a clear fashion), whether they choose to use that opportunity or not? Let us assume the people in question also have the capacity for consent (e.g. they are literate).

    I will posit, perhaps controversially, that it is the latter which matters. Why? Let’s extend the discussion passed clinical trials: When I got an “Optimum Card” from Shopper’s, I frankly did not read the “Terms & Conditions”… Later, I find out that the card is used to monitor my shopping habits at Shopper’s. This was probably mentioned in the consent forms, but lazy me, I did not read it. So, does Shopper’s have a right to continue to monitor my shopping habits? From their point of view, they cannot be blamed for my not reading the information: they had the info on a sheet and numbers to call if I did not understand something. Indeed, even if I did not read all the “Optimum Card” info, I may still have been “informed” in another way… by not reading the info carefully, I knowingly exposed myself to risks… at the time of signing, I knew Shopper’s could use me in a way I might disagree with (like invading the privacy of my consumption), but- attracted by reward points and lacking time- I did not take the opportunity to inform myself of these risks. I am at fault here.

    A relevant reference: 2:25 to 4:35 of South Park’s “Human Centipad”: http://vimeo.com/24782590 (Viewer discretion advised)..

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