Consumers examine and review participant information and consent forms, discuss and analyze the suitability of language, format and presentation as materials that are 'easy to read' are more acceptable to a potential research participant. Consumers use checklists that assist them identify ambiguous phrases, technical jargon and socially or culturally inappropriate language. Consumers develop appraisal skills that will assist them to decide if the aims of a study, the treatment schedule, side effects and, risks as set out in the protocol are consistent with the participant information.
By the end of this module, you will be able to:
- Outline concepts of reading age and readability of documents.
- Explain the purpose of informed consent documents.
- Critique the suitability of trial participant consent documents.
- Outline the process of language translation.
- Demonstrate how informed consent documents reflect what a trial involves.
- Describe the constraints related to informed consent.
Reviewing participant information sheets
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Please feel free to download the checklist for reviewing patient information sheets.
Learning activity: what is the participant information sheet?
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