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Legally Authorized Representative

a person authorized either by statute or by court appointment to make health care decisions on behalf of another person who is, incompetent, or has impaired decision-making ability.

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Legally Effective Informed Consent

consent of a subject, or if the subject is incapacitated, incompetent, or has impaired decision-making ability, then the consent of the subject's Legally Authorized Representative (LAR) or surrogate.

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Life-threatening

diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.

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Limited IRB Review

a review process involving at least one member of the IRB that is required when determining research is exempt under 1) identifiable and sensitive educational tests, survey procedures, interview procedures, or observation of public behavior (46.104[d][2][iii]); OR 2) identifiable and sensitive benign behavioral interventions (46.104[d][3][i][c])

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