To minimize language barriers

[Guest guest]

Hi,

Misunderstandings are more likely to occur when investigators and participants speak different languages.

The information should be in a language that is understandable to the participant, which may necessitate translation of advertisements, ICD and other study-related materials, and/or, if necessary, having someone on site who can answer questions.

The ICD cannot contain exculpatory or "release" language; that is, the ICD language cannot waive or appear to waive any participant rights or to release or appear to release the investigator, the sponsor, or the institution or its agents from liability for negligence.

Strategies which help to minimize language barriers:

Use an effective process of translation and back-translation when an ICD must be translated from one language to another. This process must include adequate pretesting of the consent document to determine that it is comprehensible to individuals who will be recruited for a research project.

Enlist the help of individuals who can act as "cultural experts" on ways in which to communicate difficult scientific concepts for study populations who may be unfamiliar with the biomedical problem being investigated.

Keep the consent document as short as possible, using simple language and a format that is clear and understandable for potential research participants.

The issue of using family members when there is a language barrier is a grey area. Most participants feel more comfortable if one or more family members are available to help them with decision-making, though this is not always the case. Additionally, excluding family or friends from the discussion may eliminate bias for or against participation; however, this must be balanced with the participant's wishes. Tailor the discussion to the participant's needs.

Dr. Smita