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The waiver states explicitly that, \u201cThe above referenced application was reviewed by expedited review procedures and is determined to be exempt from the requirement for IRB approval (45 CFR 46. 104d, Category\/Subcategory 4(iii)). The Reviewer approved waiver of HIPPA authorization in accordance with applicable regulations.\u201d Informed consent was not obtained as the IRB approved waiver of HIPPA authorization.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics and consent to participate"}}]}}