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Consent Discussion Process 

The consent process should allow for an exchange of information between the investigator and the subject. Even the best document is no substitute for two-way communication, interaction, and listening.

• For complex or detailed studies, consider sending information and consent document in advance to allow potential participant time to review and think of questions.
• Introduce yourself and take time to ask questions to assess prospective participant’s knowledge, experience, frame of mind, health literacy, motives, etc.
• Actively listen!
• Use plain language.  Be specific and concreate in communication.
• Clarify what is and what is not part of the research (e.g., what will occur regardless of their participation such as standard of care procedures).
• Describe foreign or technical concepts.
• Use visual aids, glossary of terms, video or audio, illustrations, models or samples of interventional products. 
• Provide foundational education as needed (e.g., what is disease and standard treatment; what is a clinical trial, research purpose you are partnering with them to discover or solve)
• If you are treatment provider, clarify that this is “research” to prevent therapeutic misconception.
• If you are in a position of authority, reiterate that participation is totally voluntary and withdrawal is always an option (e.g., teachers, employers).
• Use teach-back open-ended questions to assess understanding and clarify misperceptions.
• After the study, evaluate your process by asking participant what they wish they would have known.