Informed Consent Forum

Whose party is it?

By: Robert Krell, President, Krell Clinical Communications

Why do so many informed consent forms (ICFs) start with “We are inviting you to…(join, take part, participate, volunteer for)…”

It sounds like the potential study participant is being invited to a party. When I hear the word invite I cannot help but think of something fun with cupcakes and refreshments.

Of course, that may be a narrow interpretation of the word invite. There are other legitimate uses. You could invite someone to give you an opinion. A political candidate could invite criticism by their remarks.

One of my e-dictionaries says invite can be used to make a polite request such as “She invited him to sit down.” That sounds okay, but then they give the example of [invited to fill out]…an application for a job.” That sounds odd, especially in today’s job-cutting environment. Aren’t most applicants told that they need to fill out an application (implies the possibility of a job) or they can fill out an application (implies no possibility of a job) or please fill out an application (implies they want you to take the job), but you are invited to fill out an application? I don’t think so.

My Encarta® online World English Dictionary provides some interesting insight to the word invite. Not only do they say it means to ask someone to come, go, do, or say something, the verb invite also means:

• to encourage or provoke something that might not have happened otherwise

That’s the problem with using the word invite. It is a subtle attempt to cause something to happen that might not have otherwise happened. In other words, it’s an inducement, a subtle way of trying to persuade someone to do something. My Encarta online thesaurus gives 3 synonyms for invite in this order: ask, tempt, invitation.

We all know that an informed consent form (ICF) is not meant to tempt the reader into participating in a study. Tempt (verb):

1. To cause desire or craving to arise in somebody
2. to persuade or attempt to persuade somebody to do something considered wrong
3. to invite or attract somebody

I think the use of the word invite in ICFs is an innocent attempt to ask the reader to consider participating in the study. However, we don’t want to tempt the potential participant into thinking the study is going to be a lot of fun. So why not just say, “You are being asked to participate…” instead of “You are being invited to participate…?

I invite you to comment.

Words on Paper

By: Robert Krell, President, Krell Clinical Communications

It seems that the more information that is put into informed consent forms (ICFs); the less they communicate.

Is there a limit to the amount of information a study participant can understand? Perhaps, but that seems unlikely.

Is it that the writers of informed consent documents are just not communicating well enough? I think this is more likely the problem. But it’s not just the writers, it’s also the reviewers and everyone who is involved in the document’s development.

At a meeting with a major pharmaceutical company, we asked who currently writes the informed consent document. The answer was, “the scientists who developed the protocol.” We were not surprised since this is a common practice. In many companies, if the scientists who developed the protocol do not write the first draft of the informed consent document, they have a major role in review and revisions. And rightly so, they understand the protocol better than anyone.

The issue, however, is not who knows more about the protocol. It’s about who knows how to communicate more clearly to a study-participant audience.

If you ask a PhD scientist to explain a protocol point to another scientist, no problem. Now ask the same scientist to explain the point to an eighth-grade student. This might not work as well for several reasons. First, their vocabularies are significantly different. Second, an eighth-grader understands less about both clinical trials and the disease state.  

In radio communication, a sender and a receiver must both be at the same frequency for communication to take place. In the case of informed consent documents, it is unfair and impractical to ask the receiver of the information to tune in to the correct frequency. It is simply too high (out of range) for an eighth-grade reader to tune in to a post-graduate reading level. It is possible, however, for the sender of informed consent information to lower the reading level for the study participant. This, of course, would require involving healthcare writers who specialize in writing to lay audiences as the principal authors of informed consent documents.

What we need to keep in mind is that simply putting words on paper is not a measure of how well, or if at all, those words have communicated to the readers. There are other rules of writing an informed consent document that will determine the effectiveness of communication:

1. Use familiar vocabulary
2. Keep the sentence structure simple
3. Keep paragraphs short and relevant to a single topic
4. Fully explain unknown concepts at a proper reading level
5. Define unfamiliar words in lay terms
6. Organize content in an order that is, above all, logical to the reader
7. Avoid bad writing and bad organization
8. Avoid overly technical protocol details that will not affect the participant
9. Use visuals, diagrams, charts, or tables that support key points and explanations
10. Lay out the document in a reader-friendly format that will aid complete reading

A good informed consent document is far more than words on paper. It does everything possible to communicate and inform the reader about the study.

What do you think? Keep me informed.

Let's take the form out of informed consent forms

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.”