Completion requirements
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9. Patient Involvement in the Informed Consent Process
Patient representatives can work with the trial organisers to design the informed consent. They can help ensure that the informed consent documentation:
- Is written entirely in understandable and non-technical or scientific language.
- Does not contain persuasive language.
- Explains that participation in the study is entirely voluntary.
- Provides fair perspectives on the possible disadvantages and risks of participation.
- Outlines any direct benefits for the individual and any other beneficial outcomes of the study, including furthering our understanding of the research topic.
