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Submissions :: Protocol review process :: Full Board Meeting

Full Board Meeting

The federal regulations dictate the membership for the Board which must consist of five members of various and experienced backgrounds; at least one member must be a scientist, one must be a non-scientist, and one may not be affiliated with the institution.  Every effort is made to include members who have expertise that is pertinent to the protocols reviewed at the meeting, and where necessary, guest experts are invited to give commentary at meetings.  The Board meetings generally occur twice per month (with the exception of December) and typically last two hours.  The Board reviews protocols requesting continuations, modifications, as well as new protocols.  Your protocol will be assigned to a Primary Reviewer and a Secondary Reviewer who will carefully review the protocol and prepare comments on it (though all the Board members read every protocol on the agenda).  The Primary Reviewer generally summarizes the protocol and starts the discussion; the Secondary will also weigh in, as well as any other Board members who have concerns or questions.  The Primary Reviewer will make one of the following designations for the Board’s vote:

  • Approved/ Exempted: The protocol is approved without any revisions and the researcher can begin data collection. The approval period is for one year; an exemption period is for four years.
  • Approved/ Exempted Pending Minor Modifications: The Board feels that the protocol has a few items that need clarification, but that the overall protocol does not need full board review again.  The minor modifications do not change the nature of the protocol and can be reviewed administratively. 
  • Withheld Approval/ Exemption Pending Major Modifications: The difference in this category from the previous category is that the changes and/ or clarifications requested by the Board could change the level of risk in the protocol and/or significantly alter the intent of the protocol as described.  This designation requires that the protocol receive full board review again.
  • Not Approved: The Board feels that the study as proposed will not be able to meet the ethical standards of the IRB unless major changes are enforced as recommended by the Board. This designation requires that the protocol receive full board review again.
  • Tabled: In some cases, the Board may decide to delay action because of a lack of information in the protocol, or because the Board lacks specific members needed to approve a protocol (i.e. a prison representative for a study involving prisoners). This designation requires that a protocol be reviewed in a full board meeting again.
In most cases, the staff member who pre-reviewed your protocol will be present at the meeting and will take copious notes regarding the Board’s comments about your protocol.  If the protocol is approved without any revisions, you will receive an approval letter from the Board which will include your stamped consent forms (if applicable). If the protocol falls into the remaining four categories, the pre-reviewer will send you a detailed letter outlining the steps you need to take to modify your protocol so that it can be approved by the Board.  The letter will include information describing when you need to resubmit your protocol to make the agenda for the next meeting, if necessary, and how to resubmit your materials.  If you have questions regarding the decision, please contact your pre-reviewer.

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