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.
Here’s the story: Expression of therapeutic misconception amongst Egyptians: a qualitative pilot study
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.
Research Ethics Blog 
Can we just unpack the whole thing and admit that subjects are co-inquirers into their own lives, bodies and experiences? If they participated more fully in the process, I’m hoping/guessing that they’d a) have a better sense of what’s really going on and b) a sense of the risks/benefits.
Less hiding behind the ‘researcher’ abstraction and more about people learning with and about people would make me happier.
But then again, the EthicsBunnies might have issues of this in medical contexts.
Still trying to work out how to more fully engage subjects in my research without it appearing too ‘messy’ for the funding agencies.
Thanks for this insight and stuff!
Anticipating, redressing and helping prospective volunteers cope with TM is a team effort. Ethics reviewers and PIs must anticipate TM in their risk-benefit analysis. PIs that have an “already-standing” therapeutic relationship with prospective volunteers need to recognize their patients’ vulnerability to TM and work from the trust established in therapy to reveal and discuss the changes in the relationship from therapy to research. It is helpful in this effort for reviewers to see that PIs imbue the informed consent process with the notion that the social benefit of research is the sole justification for the risk assumed by volunteers and that the, “if any,” qualifier applies only to potential benefit accruing to individual volunteers. Ethics reviewers should ensure the inclusion of the commonly ignored informed consent requirement in the Common Rule of “[a] description of any benefits to the subject or to others which may reasonably be expected from the research” (§46.116(a)(3)). The inclusion of this requirement in the documentation of the informed consent process and an offer to share appropriate research results and finding, the social benefit which may reasonably be expected from research, with volunteers and the communities from which they are recruited would go a long way towards making the distinction between therapy and research clear to prospective volunteers mitigating TM.
Renée LLanusa-Cestero, M.A., C.I.P.
rllanusa@bellsouth.net
Anticipating, redressing and helping prospective volunteers cope with TM is a team effort. Ethics reviewers and PIs must anticipate TM in their risk-benefit analysis. PIs that have an “already-standing” therapeutic relationship with prospective volunteers need to recognize their patients’ vulnerability to TM and work from the trust established in therapy to reveal and discuss the changes in the relationship from therapy to research. It is helpful in this effort for reviewers to see that PIs imbue the informed consent process with the notion that the social benefit of research is the sole justification for the risk assumed by volunteers and that the, “if any,” qualifier applies only to potential benefit accruing to individual volunteers. Ethics reviewers should ensure the inclusion of the commonly ignored informed consent requirement in the Common Rule of “[a] description of any benefits to the subject or to others which may reasonably be expected from the research” (§46.116(a)(3)). The inclusion of this requirement in the documentation of the informed consent process and an offer to share appropriate research results and finding, the social benefit which may reasonably be expected from research, with volunteers and the communities from which they are recruited would go a long way towards making the distinction between therapy and research clear to prospective volunteers mitigating TM.
Renée LLanusa-Cestero, M.A., C.I.P.
rllanusa@bellsouth.net
I just recently started reading your blog. Very important issues. I was wondering if you would comment on the following scenario, which happened to me a couple of years ago. I was diagnosed with early stage breast cancer. My nodes were negative and it was stage I. Also, I had a gene expression test called Oncotype, which indicated that my 10 year risk of distant recurrence was 5 percent if I took tamoxifen for 5 years. After completing surgery and radiation, I went to a medical oncologist to start endocrine therapy. I was perimenopausal, so not a candidate for an aromatase inhibitor. Thus, the standard therapy was tamoxifen.
My oncologist (also the director of the cancer center) offered me participation in a clinical trial for premenopausal women with hormone receptor positive BC (the SOFT trial). The trial is designed to find out if there is an advantage to treating premenopausal women with aromatase inhibitors instead of tamoxifen. There are three arms, tamoxifen, tamoxifen combined with ovarian suppression, and an aromatase inhibitor combined with ovarian suppression. (It later turned out that I didn’t qualify for the trial but that isn’t relevant for the purposes of this discussion.)
I read over the materials I was given and consulted with my internist and GYN. Since I was very low risk to begin with, it was clear that any benefit I would receive from the two experimental arms would be very small. Whether there was any benefit at all was unknown — that’s what the trial was designed to test. Both my internist and GYN were of the opinion that the potential harm (physically and psychologically) of undergoing sudden artificial menopause (through surgery, radiation or monthly injections) outweighed the very small and unknown potential benefit, so they advised me not to participate.
When I informed the oncologist that I wasn’t interested in participating she seemed surprised and wanted to know why. She hadn’t actually recommended one way or the other whether I should participate. Yet I felt that the fact that she had offered me participation in the trial implied something. If the potential benefit was very small in my case, and there were known potential harms (e.g., heart disease and osteoporosis) why didn’t she tell me that? Why even offer me participation in the trial in the first place?
The kicker came when I later had some symptoms that could have been side effects from tamoxifen (it wasn’t clear at the time). She told me that even if I stopped the tamoxifen I should not go on an aromatase inhibitor because ovarian suppression was way too drastic in my case, given my low risk.
I eventually moved on to a different oncologist.
Your thoughts?
Thanks, Marilyn, It’s difficult for me to comment on your specific case, given the fact that I don’t know all the details and the individual context.
What I did note about your story, however, is that you did have the opportunity for open communication with your internist and gynecologist, who discussed the very important notions of individual risk and benefit in your case.
You may well have fit the inclusion criteria to some degree, however on an individual, basis, participation involved a greater potential risk than benefit.
Your case, or what I know of it only from what you’ve said, demonstrates clearly that patients do often feel that “something is implied” (namely, benefit or therapy) when their own physician recommends them for possible inclusion in the trial. The most critical step, however, is clearly the one you carried out with your internist and gynecologist – the step in which potential participants, usually along with the researcher, consider their own potential individual risks and benefits before they rush to provide consent.
Thanks for sharing such a personal story.
Nancy