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In the event that a study will enroll adult subjects who are temporarily or permanently incapable of giving informed consent, the subject’s legally authorized representative may provide permission for the subject to be enrolled in the study, provided the IRB has approved enrollment of decisionally impaired subjects.

Explicit IRB approval is required to enroll decisionally impaired subjects as a study population, or to enroll a single decisionally impaired subject.

For more information, please refer to the Tufts MC / TUHS IRB Investigator Manual.