Answered By: Kristina Harris
Last Updated: Feb 22, 2019     Views: 11

The IRB only approves protocols in which informed consent can occur in a language/dialect in which the participants are fluent. In multilingual countries, it is acceptable to prepare consent documents in the official language of the country, but it is required that the person obtaining informed consent is fluent in at least one of the dialects/languages in which a participant is fluent. Participants may not be recruited if they are not fluent in at least one of the following: (a) the language of the consent form, or (b) one of languages/dialects spoken by the person(s) obtaining informed consent. Note that persons obtaining informed consent must also complete an IRB-approved training module regarding protection of human subjects. Either the NIH or FHI online modules are recommended but other training methods can be considered by the IRB and will be approved if they adequately train the research assistant regarding best practices of informed consent, research safety/confidentiality, voluntary research participation and the related Belmont Report principles of justice, beneficence, and respect for persons.

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