Polaris

SOP# IRB-007.0CompanyEffective Date: DD/MMM/YYBy majority vote of the members present, the board may reach one of the followingdecisions regarding each advertisement:1. Unconditional approval – approved as presented.2. Conditional approval – approved, subject to specific modifications.3. Disapproved – the Board has decided they cannot ethically approve theadvertisement.4. Deferred – no decision can be made yet, pending evaluation of additionalrequested information.If the Board approves an advertisement subject to modifications, it must specify, bymajority vote of the members present, whether the changes will require full Boardapproval or may be approved by the Chairperson or Primary Reviewer on behalf ofthe Board.C. Notification to the InvestigatorThe Board will provide the Investigator with written notification of its decision toapprove, disapprove, defer, or modify the advertisement (Attachment B). If anadvertisement is disapproved, the reasons for such disapproval will be documented.The decisions of the Board will be included in the files maintained by the Secretary.IV.References21 CFR 56.111(a)(3) – Selection of SubjectsICH Guidelines for Good Clinical Practice (E6) part 3.1 – Responsibilities45 CFR 46.11 – Criteria for IRB Approval of ResearchV. AttachmentsAttachment A – Advertisement Review ChecklistAttachment B – IRB Review Results FormIRB-007.0.doc© 2004 by CRC Press LLC