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Large Print and Visual Access to Study Information

Information may exist on paper without being accessible to the person receiving it.

Representative research photograph: Large Print and Visual Access to Study Information
Photo: NUSF · License: CC0 · Cropped and resized.
Published
Updated

Information may exist on paper without being accessible to the person receiving it. Visual access depends on font size and contrast, as well as any tools the individual uses. Asking about these preferences before the appointment can prevent avoidable barriers.

Define the workflow

When preparing a large-print version, review layout, signature spaces, version identifiers and content completeness together. Enlarging text alone can displace tables or hide important footnotes. Work with the document owner to arrange whatever review and approval the study requires for the intended version.

Worked example

For example, a candidate can read a risk table but cannot see a faint grey explanation. Staff investigate a suitable accessible version and explain the information clearly during the discussion. They provide space for the person’s own magnifier, while recognizing that a screenshot does not replace controlled documentation.

Practical checks

  • Ask about preferred text size, contrast and any assistive tools used for reading.
  • Check that tables, footnotes and document identifiers remain visible in the enlarged version.
  • Evaluate materials under realistic reading conditions rather than only on a staff member’s screen.

Decision and boundaries

Acceptance means the individual can review all important information in a suitable format while its relationship to the current document remains clear. An accessible copy should not introduce different consent meaning. Visual support needs should be separated from medical eligibility decisions, with clinical questions referred to the investigator.

Frequently asked questions

Can an online large-print form be used?
Not without confirming the correct study version and applicable approvals. Similar appearance does not establish equivalent content.
Is having a relative read the form enough?
That may be useful support if preferred, but direct information access, confidentiality and applicable consent arrangements still require consideration.

Sources

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