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.