The ABCs of GCP: Therapeutic Misconception Edition

6 Aug

With recruitment for the mint tea study well underway, we’re getting a lot of interest from individuals seeking an alternative “therapy” for their osteoarthritis. From a recruitment perspective, this is great! From a bioethics perspective, however, it warrants some pause for consideration.

Good clinical practice (GCP) is a set of guidelines for the design and conduct of research involving human participants (aka clinical trials). One of, if not THE primary goal of GCP is the protection of participants. Fundamental to this is the informed consent process. Indeed, the informed consent form (ICF) is an essential document for any clinical trial.

Within the GCP guidelines, therefore, is a list of 20 specific items recommended for inclusion in each ICF, including a description of the study, a statement that it involves research, and a summary of the associated risks and benefits. What this list does NOT explicitly address, but is nevertheless an important consideration for ICFs, is the concept of therapeutic misconception (TM).

Though there is some debate regarding the precise definition of TM, it basically is what it sounds like – a misunderstanding that there is a direct therapeutic benefit to be gained by virtue of participating in a clinical trial. Specifically, Canada’s 2nd edition of the Tri-Council Policy Statement (TCPS2), defines TM as “a misunderstanding, on the part of participants, of the purpose, benefits, and/or risks of clinical trials.”

From a researcher’s perspective, what can be especially counterintuitive about the concept of TM is that it is in our very nature to WANT to be able to “treat” our participants. After all, if they’re getting better, then our intervention must be working. But contrary to our expectations and good intentions, it is important to remember that the immediate goal of research is to produce generalizable knowledge, NOT to provide therapy. After all, we’re in research to advance health on a global scale, not just within a single study or a single participant.

As researchers, therefore, it is important that we take precautions to avoid perpetuating TM. This is best achieved by maintaining a clear distinction for participants, and indeed for ourselves, between therapeutic treatment and research. Blurring the lines between the two can be especially challenging when research facilities begin to “feel” like actual doctors’ offices (with their sterile devices and white lab coats), or when physicians become too closely involved in recruiting patients for their own research studies.

Consider this: how many times do you use words like “therapy” or “treatment” in your ICF, or refer to your investigational product as such? Can you see how that may be suggestive of clinical care rather than of investigative research, and therefore potentially misleading for participants?

That being said, I’m definitely not one to preach. In fact, I just caught myself almost typing investigational “therapy” instead of “product” (go figure, eh?).

Definitely something worth thinking about …

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