Designing consent materials visually
Layout, icons and figures can support the text of consent materials and the discussion in which consent is sought: a consent form laid out with white space and simple icons, a visit schedule a participant can follow, a graphic for a complicated treatment schedule, icons revised for what they could be taken to mean, and visual aids used in the consent discussion.
Layout of the consent form
A consent form can be laid out with a clear structure, a clean design, white space and simple icons that support the text, such as icons that explain the study procedures. One sponsor updated its global informed consent template in this way.
Font size and style that reflect the needs of the reader help enhance the writer's message. Writers are recommended to keep adequate white space by working toward a 50/50 balance between printed and unprinted areas on each page.
The visit schedule
The visit schedule in a consent form is often very complicated and not easy to understand. Sometimes the flow chart from the clinical trial protocol is slightly adapted and put into the form, and protocol flow charts are usually not very patient friendly. A visit schedule that is easy to understand helps the person decide whether to take part, and also serves as a helpful overview throughout the trial.
Such a schedule can be designed in many different ways. In one made-up example, a key to all the icons used sits above the schedule, and for each visit the schedule gives the trial period, when the visit takes place, where it takes place, at the study site or at home, and the visit number. In a column marked with a clock, the author can fill in the approximate duration of the visit. The duration is very important to participants, because people want to know whether they are coming for a five-minute blood draw or for a five-hour visit with many different assessments.
Patient experts shown a similar example gave quite positive feedback: they found it quite easy to read and understand, and felt that the icons helped their understanding. So such appealing visit schedules are worth the effort of creating them.
A complicated treatment schedule
In some studies the treatment schedule is very complicated, with participants taking several tablets at different time points, and it may be challenging to describe in text. If it is not described well, participants may not understand how to take their tablets, and there is a high risk of non-compliance. A simple graphic added to the text may support understanding. In one medication administration figure, it is already pretty clear even without the text that the participant takes one tablet from each container, in the morning, with a glass of water. So a graphic in addition to the text may also increase compliance.
Icons and what they could be taken to mean
In the TransCelerate educational toolkit on clinical data reuse, a broken chain stands for the removed link between a participant's identity and their clinical data. One sponsor adapted the toolkit's poster in response to potential concerns about an undesired association with slavery or a shift of focus away from the content. It revised the human figure, replaced the chain with a bow and removed some of the icons.
Visual aids in the consent discussion
Informed consent is a process of information exchange that can include both written and visual materials. Visual aids can include a graphic illustration used in discussions between patient and doctor, and short videos that explain the purpose of a specific clinical trial or describe the procedures involved.