My exploration into informed consent in clinical practice focused on why it failed to protect patient autonomy as it was being played out. The reasons are fairly complex but, in a phrase, it is related to the information required to make a decision. The book describes this in detail, but the short version is that the patient’s values or preferences are essential and were not being brought into play. How would you bring them into play? Not so easy as a simple ask. As to why that is so, the book has an answer. A major part of the issue is that the info being presented to the patient can surface a particular set of preferences. It requires a substantial back and forth to ferret it out.
It is particularly difficult when we do not know all of the circumstances of the patient. Helping them sort out their own values is a big part of the literature on the subject of shared decision making. These goals are individualized and that makes the process challenging. We might be able to guess what most people want out of therapy. Unfortunately, particular circumstances require particular “calculations” about what is the best choice. The question before us is “Do we face a similar challenge in the research setting?"
I have not come across a comparison on this topic so this will be a bit of an adventure for me. One difference between the two situations includes this issue of goals for participation. In the research context there is at least some altruistic influence. I suppose some people participate to make a few dollars in healthy volunteer studies. Another exception are desperate and may get involved in novel therapies. So, they are looking for treatment. This seems to me to be similar to the typical therapeutic situation.
Is this difference enough to obviate the need to discover the patient’s values by an ongoing conversation surrounding that? This does not mean that there is no sharing back and forth. For example, it may be worthwhile to check on a patient/subject ‘s understanding of the information with a discussion. Perhaps they insist on considering the participation to be a primarily therapeutic endeavor. You might need to express this is not the case. You would have to explain equipoise if it is a new intervention being tested. If we knew it worked, we wouldn’t have to test.
How about people who are participating for altruistic reasons or even because they are curious? We have not intuitively at least challenged their choice to participate or not participate. Of course, in the research situation the choices are binary. The subject does not get to choose among many different alternatives. In this context it is either to participate or not participate. At least this is the typical situation. It is when participation is taking the place of an existing therapy that it once again takes on the features of a therapeutic choice.
It appears that there are times when the research situation is more like clinical practice. In that case a shared decision-making model makes sense. I have mentioned two such circumstances above. Otherwise the way we have been doing informed consent in clinical trials may be enough. More of that next time.
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