By: Robert Krell, President, Krell Clinical Communications
Since half of the adult readers in the US are reading at eighth grade or below, would it be safe to assume that the average reader of an informed consent form (ICF) might have math skills that are also at or below eighth grade?
When it comes to informed consent, we should probably keep the math as simple as possible. Here is a typical example of the kind of numerical references that one often encounters in informed consent forms:
Between the clinic visits, you will have a telephone call from the study staff every 3 months after your last clinic visit. The first telephone visit will be at visit 9, which is 15 months after visit 3.
The first sentence is simple enough on the math side, although the sentence length is too long, which brings the reading level up to tenth grade. The second sentence is the real problem. It challenges one to figure out what the relationship is between visit 9 and visit 3. To what end? In addition, why does the reader need to know that it is 15 months between visits 9 and 3? Why not simply say:
Between the clinic visits, you will have a telephone call from the study staff every 3 months after your last clinic visit. The first telephone call will be after visit 9.
Then, end it there. How does the time between visits 9 and 3 help the potential study participant decide whether to sign up for the study? In fact, because it’s confusing, it probably gives the potential participant a reason not to sign up.
Here’s what may be happening to ICFs. Almost every bit of information from the protocol that is meant to explain something to Investigators, ends up in the ICF. It may be great information for Investigators, but that doesn’t mean potential study participants need to know it also.
Developing a good informed consent document is as much a question of what to leave out that is not necessary for the participant to know, as it is a question of what to include. However, if it is something that the participant should know and it involves numbers, just keep it simple. Even if the information is true. Yes, there are 15 months between visits 9 and 3. There may also be 15 months between visits 10 and 4, and 1 month between visits 10 and 9. Does the information help the reader? If not, leave it out. Keeping it simple will help the reader understand why the numbers are there in the first place.
I invite you to comment.