Writing informed consent forms for patients who are asked to take part in clinical trials could be really challenging. The writer (the investigator) on the one hand has to fulfill the content requirements of such forms from ethical guidelines and ethics review board, and on the other hand he has to present the content in a way that all the eligible participants in his study can understand. Here are a few suggestions for what to bear in mind when explaining the trial to your patients:
1. Let research be the main topic, not treatment. Of course, treatment procedures are necessary to explain to the reader, but the treatment should be clearly presented as part of a trial.
2. Clarify the consent form is not merely information about a study, but that the information is conveyed because the reader is supposed to use it as a decision support in the consent process. This could be stated for instance by use of metainformation such as “You are asked to take part in a medical study. The information you get in this form and from your physician is supposed to help you decide whether or not you want to take part in the study”.
3. Clarify the relationship between the reader and the writer. It is a possible source of confusion that the actors in the consent process (and the whole trial situation) have dual roles: The doctor is also an investigator, and the patient is also a trial participant. Being a trial participant have other implications than being “only” a patient.
4. Orient the information to the target reader, i.e. the possible trial participant (not a regular patient, not the ethics review board). Explain the implications of consenting and of refusing.
5. Explain expert terms; do not avoid them. Consent form most often have to consist of information about complex medical research. Expert terms might be necessary in order to make the information sufficiently precise. Use them, and explain them in lay terms.