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Why might the Board modify the informed consent document (ICD)?

DOCUMENT ICD informed consent
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Why might the Board modify the informed consent document (ICD)?

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Under federal regulations, the Board has the authority to modify the submitted ICD. The Board may modify language to ensure that the document includes the required elements of an informed consent. The Board may also make changes to an ICD to make it easier to read and/or more understandable to a study subject. For more information, please see Informed Consent Document Template.

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