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.

Comments

[J. Vijayakumar]

Clinical trials are conducted mainly in tertiary care hospitals, that have infrastructure and expertise to do drug trials. The patients coming to those places have frustration because previous treatments didn't cure their problem. In that context, if the PI or his delegate want them to participate in a study and try to explain the Informed consent document, only 10-20% of the patients will hear what [it is] about at that time. They [the patients] are in a position to give their consent without understanding them [the informed consent document] fully, but when you call them for the follow-up and for drawing specimens, they very often withdraw from the study because at that point in time only, they catch that the study they consented for is all about experimentation. If the patient is assisted by family members and other relatives and the ICD [informed consent document] has been made [completed], we can expect greater study compliance. So keeping this in mind, we must make ICDs that contain only the critical essentials about the study procedures to help the clinical trial industry become fully professional.

[Georgann Vanderjagt RN MSN]

I am a study coordinator at a medical center in the Southwest. Since we have our own IRB, I am involved in writing ICFs and Assents to fit our IRB's general consent requirements. I use pictures and bullet points whenever possible. Wanting to make sure my subjects (adolscents and their parents) understood what I was communicating to them through the ICF and my general discussion regarding the study details, I decided to develop a simple test to assess their understanding. I presented it in a non-threatening way, stating I was evaluating whether I did a good job of explaining the study details. The parents and subject could discuss the answers together. The sponsor's monitor liked the idea and thought the questions were very pertinent. However, when I tried to get the quiz approved by our IRB, they would not okay the quiz. Although I did not receive a written reply as to why they refused to approve the quiz, the IRB coordinator communicated to me that the committee was concerned as to what should be done if the subject/parents were unable to pass the quiz!

Da! I would do more teaching, as that's my purpose of assessing understanding. I wonder if the IRB was responding out of fear that we would be liable if there was evidence that our subjects were improperly informed. I don't know for sure. The IRB coordinator did say I could verbally ask the questions and assess their knowledge level and therefore, that is what I've choosen to do. I continue to believe testing subject's understanding is a good idea.