Outcomes of IRB Review

An IRB review may result in the following outcomes:

1.                   The research project is considered exempt from further review and the IRB chair informs the PI that research may begin immediately.

2.                   The research project qualifies for an expedited review and is assigned by the IRB chair to a member of the IRB committee who reviews the application and judges the research project:

  • Approved. The proposal is within acceptable guidelines and the IRB chair informs the PI that research may begin immediately; or

  • Not Approved. The proposal requires a full IRB review.

3.                   The research project requires a full IRB review and is considered in a regularly convened IRB meeting where it may be judged:

  • Approved as written and the IRB chair informs the PI that research may begin immediately; or

  • Not Approved as written. The IRB chair informs the PI of the parts of the proposal that were not acceptable. The PI may rewrite and resubmit the proposal; or

  • Disapproval. The IRB chair informs the PI that the research project may not be done under the auspices of Trinity College.

IRB decisions and requirements for revisions, if any, are conveyed to investigators in writing, with the provision of an opportunity for appeal by the investigator in the case of disapproval. Although research may receive IRB approval, the department chair or other administrative officials may conclude that the research project does not meet the policies and goals of the college and may disapprove, suspend, or terminate a project. However, IRB decisions to require modifications in, disapprove, suspend or terminate a project are final. No other committee or official can override these IRB decisions. Further, no committee or official can approve an investigator to conduct any human subject's research that the IRB has not approved. [See 45 CFR 46.112.]

The IRB's approval may be suspended if the following conditions are not followed:

  • No subjects may be involved in any study procedure prior to the IRB approval date or after the expiration date (not more than 1 year). (PIs are responsible for initiating Continuing Review proceedings.) 
  • All unanticipated or serious adverse events must be reported to the IRB within 5 working days. 
  • All protocol modifications must be IRB approved prior to implementation. This includes any change of procedures, investigator, or faculty adviser.

  • All protocol deviations must be reported to the IRB within 5 working days. 

  • All recruitment materials and methods must be approved by the IRB prior to being used.