What are the expectations for review and follow up by requesting agencies?
Agencies must implement a review protocol for requests for informed consent that includes sign off from administrative or medical supervisory staff. This signoff is reflected on the CAB Informed Consent Submission Checklist and Medical/Dental Consent Overview. This review is critical since incomplete packets or the use of forms from the Surrogate Decision Making Committee (SDMC) are unacceptable when seeking informed consent from the CAB for a class member and will be returned to the originating requestor. In addition, agencies are to maintain a chronology of contacts following submission of its request for informed consent, with local CAB representatives and CAB Central Office in SI. This chronology is to include all dates of verbal or phone contact, questions from CAB and follow up actions taken by the agency. Written correspondence should be utilized to confirm multiple verbal or phone contacts.
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