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Is it necessary to explain to the subjects ahead of time how data from the study will be used?

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Is it necessary to explain to the subjects ahead of time how data from the study will be used?

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Yes. If data obtained will be made available to any person or organization other than the subject, the investigator, and the investigator’s staff, the informed consent must disclose: the person or agencies to whom information will be furnished; the purpose of the disclosure; and the nature of the information to be furnished.

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