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Addressing Literacy Barriers in Consent Discussions

Difficulty reading a form quickly does not mean someone cannot understand a study.

Representative research photograph: Addressing Literacy Barriers in Consent Discussions
Photo: Unknown photographer · License: Public domain · Cropped and resized.
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Difficulty reading a form quickly does not mean someone cannot understand a study. Recognizing literacy needs without embarrassment helps staff present information accessibly. The goal is to make important information understandable, rather than obtain a signature as efficiently as possible.

Define the workflow

Short sentences, familiar words and activity schedules can support the discussion. Reading information aloud should not alter approved content or bypass applicable witness arrangements. Offer a respectful private conversation instead of drawing attention to reading difficulty in front of other people.

Worked example

For example, a candidate repeatedly says they will read the form at home but cannot describe the visit plan. The coordinator does not label this reluctance. They review visits together using a simple schedule. The investigator considers the appropriate consent pathway and support needs, and the candidate can raise questions orally.

Practical checks

  • Ask the person which format makes information easier for them to review.
  • Support technical terms with plain explanations and check that important meaning is preserved.
  • Consider any necessary witness or alternative documentation process within the approved study framework.

Decision and boundaries

A useful process helps someone explain important procedures and choices; reading speed is not the success measure. Support needs should be traceable without unnecessary sharing of personal details. Local rules and ethics approvals still apply, and staff should not assume a universal exception to signature requirements.

Frequently asked questions

Is reading the form aloud enough?
Not necessarily. Opportunities for questions, assessment of understanding and applicable consent arrangements must be considered together.
Does a support need automatically exclude participation?
No. Suitable communication support and study conditions should be assessed instead of deciding solely on reading difficulty.

Sources

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