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Determinations

Determinations

  • Approval – The study is approved as submitted
  • Pending – The protocol and/or consent form require minor revisions, such as wording changes, with replacement language provided. The needed revisions are agreed upon at the meeting. These revisions are presented to the Principal Investigator for incorporation by simple concurrence. The IRB Chair may approve the study upon receipt and approval of the revisions without further action by the IRB. Note: Approval of the protocol application will not be granted and certification will not be issued until all deficiencies, if any, are corrected to the satisfaction of the IRB Chair.
  • Deferred for substantive issues (major stipulations) – Regarding the protocol and/or consent form must be addressed. This action is taken if substantial modification or clarification is required, or insufficient information is provided to judge the protocol application adequately (e.g., the risks and benefits cannot be assessed with the information provided). IRB approval of the proposed research must not occur until subsequent review of the material the PI submitted by the convened IRB.

If the application is deferred the following will occur:

  1. The IRB Chair informs the investigator in writing of the IRB’s decision, questions and concerns.
  2. The investigator’s response is sent to the IRB Chair.
  3. In order to receive approval for a deferred protocol, it must be submitted for full IRB review at a subsequent, convened meeting of the same IRB. The IRB Chair provides the IRB with the investigator’s response, the revised protocol and the previously submitted protocol. The item is placed on the agenda for a future meeting.
  4. The protocol application is given full IRB review again.
  5. The outcome of the IRB’s deliberations is once again communicated to the investigator in writing.
  6. The IRB’s determination concerning the subsequent amended submission will be documented in the minutes of that meeting.
  • Disapproved – Questions are of such significance that the IRB feels approval of the study is unwarranted. Approval of a previously disapproved protocol requires full IRB review. (If using the expedited review procedure the reviewer(s) may not disapprove the research. In such cases the protocol will be referred to the full board.)
  • Appeals: If the IRB makes a decision by expedited review that the investigator believes to be unduly restrictive, the investigator may appeal to the full IRB board.