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Planning Hearing Access During Consent

People with hearing access needs do not all prefer the same communication method.

Representative research photograph: Planning Hearing Access During Consent
Photo: Shixart1985 · License: CC BY 2.0 · Cropped and resized.
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People with hearing access needs do not all prefer the same communication method. Some may use written explanations, suitable sign-language interpretation or their own assistive device. The discussion format can be arranged around the individual’s preferences before the appointment.

Define the workflow

A quiet setting, a visible face, orderly turn-taking and enough time can affect communication. Speaking louder should not be assumed to solve every barrier. Interpretation, remote connections and written support need consideration for confidentiality and consistency with approved study information.

Worked example

For example, a candidate uses lip-reading but the speaker is backlit during a remote discussion. Staff adjust the camera and lighting, prevent simultaneous speech and provide a written question channel. If communication remains unclear, they do not move to signatures simply to mark the appointment as completed.

Practical checks

  • Ask directly about the person’s preferred communication method and any tools they use.
  • Assess background noise, lighting, facial visibility and turn-taking as one communication arrangement.
  • Define how to reschedule or obtain support if important information is lost during the discussion.

Decision and boundaries

Evaluate the arrangement through the person’s ability to ask questions and explain important information. Hearing support needs should not be interpreted as impaired decision-making capacity. Allowing extra time and resources should be accompanied by investigator review of compatibility with study requirements and the applicable consent framework.

Frequently asked questions

Does every hearing impairment require sign language?
No. Communication preferences differ, so discuss the method with the individual instead of relying on assumptions.
Can a relative’s explanation be sufficient?
Preferred support can be considered, while preserving independent questions, confidentiality and accurate communication of study information.

Sources

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