Polaris

SOP# IRB-003.0F. VotingCompanyEffective Date: DD/MMM/YYAny board member with a conflicting interest in a proposal will abstain fromdeliberations and voting on that proposal, except to provide information as requestedby the Board. Such abstentions will be recorded in the minutes.By majority vote of the members present, the Board may reach one of the followingdecisions regarding each proposal:1. Unconditional approval – approved as presented.2. Conditional approval – approved, subject to specific modifications, such aschanges to the consent form.3. Disapproved – the board has decided that they cannot ethically approve theresearch.4. Deferred – no decision can be made yet, pending evaluation of additionalrequested information.If the Board approves a proposal subject to modifications, it must specify, by majorityvote of the members present, whether the changes will require full Board approval ormay be approved by the Chairperson or primary reviewer on behalf of the Board.A summary of the Board’s discussions and a record of its decisions, including but notlimited to the final disposition of each proposal, will be made by the IRB Secretary.The meeting minutes will reflect the number of “Yes,” “No,” and “Abstain” votes.Copies of the meeting minutes will be submitted to the members of the Board forreview and approval at the next meeting. Minutes of the meetings will be signed bythe Chairperson following review and approval by the individual members of theBoard.G. Notification to the InvestigatorThe Board will provide the Investigator with written notification of its decision toapprove, disapprove, defer, or modify the research proposal. (See Attachment C forthe IRB Review Results Form.) If a proposal is disapproved, the reasons for suchdisapproval will be documented. The Investigator will also be notified of the durationof the Board’s approval, which will never exceed one year. The decisions of theBoard will be included in the files maintained by the Secretary.H. Confidentiality of the Review ProcessDuring the initial or continuing review of the research, material provided to IRBmembers will be considered confidential and the board members will assure theconfidentiality of the information provided to them.IRB-003.0.doc© 2004 by CRC Press LLC