CliniGA CRO

CliniGA CRO Blog

Using Teach-Back Questions During Consent

Teach-back invites a person to explain information in their own words.

Representative research photograph: Using Teach-Back Questions During Consent
Photo: Shixart1985 · License: CC BY 2.0 · Cropped and resized.
Published
Updated

Teach-back invites a person to explain information in their own words. A signature alone does not demonstrate understanding. The technique can help staff identify where their explanation needs improvement, rather than test the participant’s ability to repeat formal language.

Define the workflow

Select a few issues that matter to the decision: the study purpose, major burdens, uncertainty and the option to leave. Questions should feel conversational. An incomplete or incorrect explanation is addressed without blame, and staff can try another way of presenting the information when necessary.

Worked example

For example, a candidate describes visits as blood collection only and has missed the daily recording task. The coordinator opens a sample schedule and shows when the diary is completed. The candidate is then invited to describe how a study week would fit into their own life.

Practical checks

  • Prepare open-ended questions about issues that could influence the participation decision.
  • Change the explanation when a gap appears, without presenting misunderstanding as the person’s failure.
  • Document resolved and unresolved questions sufficiently to support the next discussion and appropriate follow-up.

Decision and boundaries

Success means being able to make sense of important activities and choices, rather than repeating identical sentences. Teach-back does not replace required consent documentation or investigator assessment. Language, hearing and fatigue barriers need separate attention; a need for clearer explanation should not automatically be interpreted as impaired decision-making capacity.

Frequently asked questions

Is teach-back needed for every detail?
Focusing on decision-critical issues can make the discussion more useful. Consider the study process and the individual’s information needs.
What happens when an answer is incorrect?
Explain the information differently, allow questions and reassess whether the important uncertainty has been resolved before moving forward.

Sources

  1. EMA — ICH E6 Good Clinical Practice
  2. FDA — Informed consent guidance