Rarely do the changes required for approval go back to the full Board for review. Finally, if a study is disapproved, a letter is sent to the investigator with the reasons for the disapproval. Continuing Reviews are reviewed by a subcommittee consisting of three IRB members including the Executive Secretary of the IRBs. The results of the reviews are entered into the joint minutes for the appropriate meeting. The actions of the subcommittee are reviewed and sustained by the Board.
Board members having an interest in a particular protocol or amendment refrain from voting.
Because of the large number of new full protocols discussed at the average Board meeting, this detailed review by a subcommittee followed by oversight by the Board provides a substantive review of Expedited Proposals, Continuing Reviews and Amendments Methodist Division IRB - New Expedited, Continuing Reviews, Amendments are reviewed by the entire Board membership. Board members having an interest in a particular protocol or amendment refrain from voting. The minutes of the on-campus IRBs are generated as joint minutes, for convenience and because they follow the structure of the agendas for the two meetings. The letter informs the Principal Investigator of the decision of the Board and of the changes required to get the study approved, if it was approved with requested changes. Working from the agenda for the meeting, these changes and decisions are incorporated to generate the minutes of the meeting.