UNMC is recommending that study teams utilize the "teach-back" method during the informed consent process for their clinical studies. This method will enhance the informed consent process, ensuring participants are well-prepared before consenting and enrolling in clinical studies.
Our aim is to empower clinical research investigators and coordinators with the tools and knowledge to ensure that research study participants are fully informed and understand all aspects of the informed consent form.
Ethical Responsibility in Research
Disclosure: It's our duty to provide all necessary information to potential research participants.
Decision-making: We must ensure that participants can make informed decisions based on the information provided.
The Importance of Health Literacy
"Health literacy plays a crucial role in maintaining a healthy lifestyle and making informed decisions about our health care. Yet, a report from the HHS Surgeon General in 2019 highlighted that only 12% of Americans possess proficient health literacy skills. This underscores the importance of clear communication in the informed consent process."
Reference: HHS Surgeon General Reports and Publications, 2019
Consent Teach Back: A Strategy for Clarity
A strategy to improve the researcher’s ability to explain the ICD content in a way that is clear and understandable.
An opportunity to facilitate understanding of why a participant may or may not want to participate.
A tool to assure that the participant is provided with sufficient opportunity to discuss the information given to them and to consider whether or not to participate
The 5 T’s of Teach Back
Triage: Concentrate on one topic at a time.
Tools: Utilize models, written tools, posters, graphics, etc., to aid in explaining the desired information.
Take Responsibility: Phrase it as, “I want to make sure I did a good job explaining…”
Tell Me: Encourage the participant to express their understanding in their own words. Be specific about what you expect them to relay back.
Try Again: If the participant's understanding isn't clear, revisit the topic.
Reference: Anderson, Leister and DeRego, Health Literacy Research and Practice, 2020
Evaluating Understanding with Teach-Back
- Participant’s Understanding of the Study:
- Appreciating the Consequences of Participation:
- Recognizing it's a research study
- Potential benefits (or lack thereof)
- Impact on current or future treatments
- Confidentiality and data access
- Participant’s Reasoning/Decision Process:
- Awareness of other options
- Understanding that participation is VOLUNTARY
- Participant’s Ability to Make a Choice.