By: Robert Krell, President, Krell Clinical Communications
One thing that’s always bothered me about informed consent documents is that they’re more commonly referred to as informed consent “forms” (ICFs). “Form” is a bothersome word because it suggests to the reader that all we want from them is to complete the form by signing it, as if it were simply an application form to be part of a study. So potential study participants may be inclined to do what they think is expected of them—sign the form—and be done with it. No need to even read it if the investigator just wants a signature at the end of the form.
There’s another problem with the word “form.” It belittles the importance of the study participant’s decision whether to participate in the study. The word “form” does not suggest contemplation, which is the heart of the informed consent process. Form suggests expediency. Fill in the blank spaces and sign the form, please, and then we can get started.
Think of the term pro forma: as a matter of form. It suggests that we don’t really want anyone to study the form, we’re just providing it because we have to…it’s a matter of form. But that’s not true. We want potential study participants to really understand what will happen in the study and what their role will be.
And what kind of form is an informed consent form anyway? If it were a real form, the reader would have to fill in information on every page. In reality, informed consent forms are 16 pages or more of unbroken text that do not ask readers to fill in anything until the last page, where they can provide their name, signature, and date.
The word form, in my opinion, is also disrespectful when it is used to ask potential study participants to offer their physical body as part of a medical experiment that may or may not offer any significant benefit to the study participant and may in fact, pose serious risk. Risk, I might add, that they may not face if they decide not to participate in the study.
For these reasons, I recommend using the word “document” instead of “form”: Informed Consent Document. It sounds better. It’s more respectful and contemplative. Makes you want to read it; sounds important because an Informed Consent Document is important. It is not a form. It is a document that speaks to the reader and says, “I am important to you, read me.”
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