Consent forms for clinical trials are too aggressiveBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4879 (Published 13 August 2013) Cite this as: BMJ 2013;347:f4879
- Richard J Wassersug, adjunct professor, psycho-oncology, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada
I have the privilege of being a cancer patient as well as a cancer researcher. So I have looked at informed consent forms for clinical trials from both sides of the fence. But it wasn’t until I had to produce one for my own research that I began to understand why every consent form that I had read as a patient had made me uncomfortable. It wasn’t anything about the study itself that bothered me—it was the language used in the forms.
I had assumed that the researchers simply didn’t know how to write a document that was reader friendly, but then I found out that my own university’s institutional review board actually required me to write in that same unfriendly manner.
What I have learnt from having to design consent forms for my own clinical trials is that two contradictory principles drive their language. One says that the form should be in clear, plain English that could be understood by someone without a university degree. The other principle is that because the forms are legal documents they should be written in the precise language of a contract. I was told by the institutional review board officer at my university that I must structure any statements about rights, privileges, and responsibilities in the second person throughout. This led to pages full of statements where every paragraph began with the word “You”—a long numbered list of “You will,” “You can,” “You may,” and so on.
Now here’s the problem. This may be legally unambiguous, but it sure isn’t very friendly or particularly inviting to someone volunteering to participate in a clinical trial. Indeed, the last time I was confronted with so many statements that all began with the second person personal pronoun was when I was facing a dressing down by a vice principal back in grammar school. It went something like, “You realise how much trouble you are in? You hear me? You better not do that again! You understand? You better watch out!”
Multiple strings of second person directives tend to characterise disciplinary hearings rather than instruments designed to inform. Consent forms for clinical trials are supposed to be in simple, neutral language. However, most adults, if they are lucky, are never subjected repeatedly to a series of statements that all begin with “You” in anything that could be considered normal discourse. The sentence form is confrontational and accusatory.
Consider these statements as they might appear on a clinical trial consent form:
1. You are free to leave this study at any time.
2. You will be asked to provide blood samples every two months.
3. You may feel some discomfort from this procedure.
4. You will be asked to fill in a questionnaire about any side effects you experience.
Now ask yourself how often as an adult you have been challenged by four or more sentences together that pointed a linguistic finger directly at you like that.
Sentences that begin with “You” tend to have negative connotations. Sure, we might be lucky and see the words “You won” on a lottery ticket. But that is a single sentence. For most of us, consecutive sentences that all start with “You” provoke anxiety, no matter how simple and straightforward the wording is that follows.
There is no need for the text in consent forms to be so unfriendly. Take the four representative sentences listed above. They could all still meet the letter of the law with more comfortable wording. For example:
1. All participants are free to leave this study at any time.
2. Participants, such as yourself, will be expected to provide blood samples every two months.
3. This procedure may cause you some discomfort.
4. If you join this study, we’ll be asking you to fill in a questionnaire on the side effects you experience.
As cancer research advances and more drugs are discovered that can help control disease progression, there will be an explosion in need for clinical trial participants. This will be particularly true as we attempt to learn the best order in which to give drugs. With one drug, we can assess its effectiveness with one series of clinical trials. But let’s say we have two drugs, A and B. If we want to know whether A first then B, or B first then A, or A and B together is best for patients, we need three series of trials. If we have three drugs to investigate, the number of trials rockets up. We really need patients to help us out. It is time to remove from consent forms the unnecessary and negative message implicit in strings of repetitive, second person, declarative statements that can push patients away.
If we are serious about getting more patients to join clinical trials, we need to consider more carefully the psycholinguistics of the language used in consent forms. I hope you agree.
Cite this as: BMJ 2013;347:f4879
Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
Provenance and peer review: Not commissioned; not externally peer reviewed.