But in clinical settings, such as the PCCR, consent is critically important. Informed consent documents (ICDs) need to be prepare for each study, and they are complex and complicated instruments. For example, there are 13 elements that must be included in an ICD. It has to be written at an appropriate level (which is usually 8th-grade reading level), and the patient must not be coerced into signing. It can take a great deal of time and energy to prepare ICDs and there is now a growing body of evidence about how well they relay important information to research participants.But there is a real challenge here as well. So much research occurs in clinical settings. And this blurs the line between what a physician would if allowed to simply treat a patient and what a physician or research is allowed to do if that same patient is a participant in a research project. In the former case, a doctor would do whatever he or she felt was in the patient’s best interests- vary treatment, frequency of visits, etc. But when there is a research protocol, that same doctor cannot vary from it. However, patients, despite being given an ICD which explains this to them, often misunderstand this. They believe that everything being done to them and for them when they are in research is done because ti si the best thing for them. This is not the case in research. Studies have shown that when asked, they will tell you that they are getting the best treatment, even when assigned to a placebo group or to a no-treatment group. This is how Lidz and Appelbaum describe it: “The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research.” (1)
I am always on the look-out for this when new research is planned. Please read more on this to avoid such problems if ever you do research involving patients.
1. Lidz CW, Appelbaum PS. The therapeutic misconception: problems and solutions. Med Care 2002;40(9Suppl):V55-63