Consent Participants Can Understand: From Information to Voluntary Choice
Treat consent as an ongoing process, with clear key information, risks, voluntariness, data use and comprehension checks.
Consent is a communication process
Informed consent involves understandable information, an opportunity for questions, a voluntary decision and continuing respect for that decision. A signed form alone does not establish valid consent.
Lead with key information
Begin with a concise explanation of purpose, intervention or randomisation, major risks, expected benefit, duration and alternatives. Do not bury decision-critical information in legal language.
Core content
Purpose and experimental aspects
Procedures, visits and duration
Foreseeable risks and discomforts
Benefits and reasonable alternatives
Privacy, access, retention and data sharing
Costs, payments and research-related injury information
Voluntary participation and withdrawal
Contact details for questions and harm
Support comprehension
Use short sentences, plain language and clear headings. Participant testing and teach-back provide stronger evidence of understanding than a readability score alone.
Ongoing consent
New risks, protocol changes or other information that could influence the decision may require re-consent. Long-term studies should periodically confirm willingness and understanding.
References
Accessed 20 June 2026. Apply current local requirements.