Review Outcomes
Categories of Action
The IRB may make one of the following determinations as a result of its review of all research.
Approval: The protocol and accompanying documents are approved as submitted. Final approval will commence on the day the study is approved by an action of the convened IRB or Chairperson or designee and, if appropriate, expire within one (1) year minus one day of the meeting date for studies approved by the full board.
Approvals are always considered conditional. The conditions for continued approval, and the time frame (if any) within which they must be met will be clearly stated in the approval letter. If the conditions of the approval are not met, approval may be withdrawn.
Withheld Approval: Minor modification of, or addition to, a protocol or accompanying document(s) is required. Changes will be voted upon during the IRB’s meeting, as well as the terms of approval. The Investigator will be informed in writing of the required changes and requested information and must provide the IRB with the changes or information.
The IRB Chairperson or his/her designee, such as a subcommittee has the authority to review the information via expedited review unless the IRB requires that the material or information be reviewed by the full IRB, the reviewer or another individual delegated by the IRB to review the response.
Tabled: Significant questions are raised by the proposal requiring its reconsideration after additional information is received from the Investigator. Key information is missing such that the IRB cannot make a final determination.
Disapproval: The proposal fails to meet one or more criteria used by the IRB for approval of research. Disapproval cannot be given through the expedited review mechanism and may only be given by majority vote at a convened meeting of the IRB. Risks outweigh the benefits of the study.
Voting Process
A vote is taken for all submissions requiring approval by the full committee. The number of members voting for or against the outcome is recorded in the minutes. The names of those voting one way or the other are not recorded, except in the case of abstentions. Votes are recoded by virtual platform polling system. The final determination is made by simple majority.
Any member may abstain from voting if he or she desires and this decision will be recorded in the minutes. An abstention is typically used when a member has not read the protocol or believes they do not have enough knowledge on the subject matter and cannot contribute to the discussion. Unlike a recusal, an abstaining member still counts toward quorum.
Post-Approval Event Determinations
The committee occasionally is asked to make determinations on post-approval events, including internal adverse events or protocol violations and incidents. Here are the specific determinations (and accompanying definitions) the committee must make about these events:
- An unanticipated problem involving risk to participants or others is defined as: an unexpected, research-related event where the risk exceeds the nature, severity, or frequency described in the protocol, study consent form, cover letter, or other study information previously reviewed and approved by the IRB.
- Noncompliance is defined as: failure to follow state or federal regulation, or the University policies, or determinations of the IRB for the protections of the rights and welfare of research subjects.
- Serious Noncompliance is defined as: failure to follow state or federal regulations or University policies or determinations of the IRB for the protection of the rights and welfare of research subjects and that, in the judgment of the IRB, results in, or indicates a potential for a) a significant risk to enrolled or potential subjects or others, or b) compromises the integrity of the University.
- Continuing Noncompliance is defined as: a pattern of noncompliance that continues to occur after a report of noncompliance and a corrective action plan have been reviewed and approved by the IRB.
The Committee may request additional corrective action plans and refer the event to unit leadership and report to the Associate Academic Vice President for Research. The Committee may also suspend or terminate IRB approval.
Minutes
IRB meeting minutes are prepared by IRB staff after all stipulations and comments from the meeting are received. The minutes document attendance, outcomes, regulatory determinations, and stipulations for each reviewed submission. They also summarize discussions of controverted issues and other relevant topics and include a report of submissions reviewed under expedited procedures.
Notification of the finalized minutes are distributed via email to all committee members who attended the meeting. Only those present at the convened meeting may vote on the minutes. Members may request edits or additional information regarding discussed studies.
Approved minutes are stored in OneAegis and are available for auditor review.