The persistence of the therapeutic misconception
A recent paper in <a href="http://www.biomedcentral.com/bmcmedethics/
” target=”_blank”>BMC Medical Ethics shows that, in a small sample, a majority of research participants expressed a therapeutic misconception about the research in which they were involved. This isn’t necessarily news. The notion of therapeutic misconception has been around for a long time and Applebaum et al, in 1982, finally gave a name to it. Much has been written on therapeutic misconception since that time and interestingly, it seems to have become a pitfall of human participant research that many comment on.
There are two major ethical concerns with the TM. First, failure to appreciate correctly the risks and benefits of research participation raises concerns regarding the validity of informed consent. Indeed, understanding is an important requirement of informed consent, which itself is fundamental to ethical clinical research. Second, the presence of TM reflects the very real possibility that research participants will see themselves as patients and trust researchers as if the investigator’s role was that of the physician. The resulting concern is that patients will be susceptible to exploitation, as investigators might take advantage of such misplaced trust to enroll them in clinical research. The specific concern is that patients will view an invitation to enroll in research as a professional recommendation that is intended to serve their individual treatment interests.
Therapeutic misconception (TM), according to the authors of the BMC article, comes in two forms. In the first form, participants mistakenly believe that decisions regarding randomization in a study will be individualized to their needs and will “help” them and not cause potential harm, i.e. “The study doctor will make sure that I’ll get the better drug!” The second form of TM occurs when participants overestimate the degree of individual benefit that will come from enrolling in a study, i.e. “My doctor wouldn’t ask me to take part if she didn’t think participating would help me!” The existence of an “already-standing” relationship, especially a therapeutic or trusting one (doctor-patient, therapist-patient) can contribute to TM in a significant way.
This is arguably one of the most serious problems in human participant research, both clinical and non-clinical (and I’ll say later why the concept of TM is so important in non-clinical research as well). Why is this one of the most serious problems in research ethics? First of all, it’s pervasive. While this article was nicely conceptualized and well-written, it wasn’t saying anything new. More participants than not think that research, to some degree, may involve personal benefit and will certainly not cause them harm. Second of all, for a moment, just imagine the opposite case. Imagine if a patient coming in for surgery to bypass his diseased coronary arteries actually thought he was undergoing an intervention related to research, instead of a routine bypass surgery for therapy. The clinical team would, no doubt, work very hard to clarify the therapeutic value of the procedure and ensure that he demonstrated understanding that this wasn’t a “research study” before allowing him to consent to the surgery. As researchers, do we work as hard to ensure that human participants in research actually understand that research does not equal therapy? I don’t think so. I’m not sure why.
Most of the literature on therapeutic misconception addresses the phenomenon in the context of biomedical research. I think that the therapeutic misconception is just as pervasive in many other types of human participant research, from what I’ve seen and read. Students involved in educational research believe that their trusted professors wouldn’t expose them to a useless learning or teaching intervention as part of an educational study. They may, in turn, also believe that participation in a study by their professor will augment their knowledge or help them be in a position of advantage in terms of learning. Participants involved in qualitative interviews may believe that it is a form of beneficial talk-therapy. Those who volunteer for psychology studies may well harbour false hope that the studies will offer them individualized help. While it’s true that, in some cases, students involved in educational research may learn new skills that will help them in their academic life and those involved in qualitative interviews may feel empowered from telling their stories, research participants must be made to understand that research study involvement cannot guarantee personal or individualized benefit. How to ensure this? First, it must be more than simply a routine statement on a consent form. As I’ve said before, consent is much more than a form. It’s a process that is merely represented, in many cases, by a form. Concepts like randomization, risk and benefit must be clearly explained during the research process and ideally, participants should be provided with understandable information about the goals and purposes of the study. Care must be taken in recruitment processes to avoid role confusion — the caring physician may not be the ideal person to recruit her own patients for a study and the engaged and passionate professor might be better to have a research assistant introduce a study to a classroom of students.
Each study and potential case of TM is different. Researchers must be aware of the kinds of messages that they explicitly (through consent forms) and implicitly (through “already-standing” therapeutic relationships) send to participants when discussing benefit and obtaining consent. Research ethics boards need to be vigilant about reading consent forms carefully, examining consent processes, identifying “already-standing” therapeutic relationships and engaging in discussions with researchers about these kinds of issues so that pitfalls, like TM, can be avoided.