Institutional Review Board
Review Outcomes & Approvals
Following the Review of either an Expedited or Full review the reviewer(s) can return on of three decisions; Approved, Approval Pending or Disapproved. Discussion on a full review may be deferred or tabled prior to the committee reaching a decision.
Approval: For studies which meet Federal and Institutional criteria for approval as laid out in 45 CFR 46.111, including:
Risks to subjects are minimized
There is an appropriate risk-to-benefit ratio
The selection of subjects is equitable
Appropriate procedures are followed for obtaining and documenting informed consent, or waiving or altering informed consent documentation or procedures
The research plan has adequate provisions for monitoring the data collected in order to ensure subject safety
Additional safeguards are included to protect the rights and welfare of any vulnerable populations involved in the research
Approval Pending: For studies which otherwise meet the above criteria for approval, but for which minor changes are required before approval may be granted. These changes can include anything from minor alterations to the study design to requests for the Investigator to re-write or re-word certain study documents, the consent form, for example. If the Board agrees, review of the Investigator's response to these requested changes may be undertaken by a Designated Reviewer, expediting the process.
Deferred: For research proposals which require substantive or complex changes, or additional information, before they meet approval criteria. The Board may vote to defer a final decision of approval or disapproval until the Investigators have had time to adequate respond the Board's concerns. Once the Investigator has responded, the study will again be reviewed by a fully convened IRB.
Disapproval: If a study does not meet approval criteria, and the Board cannot see that a deferral would change the situation, the Board may vote to disapprove a proposed study. If disapproved, no proposed study procedures may take place, and the study may not be re-submitted for review.
Tabled: If, due to a loss of quorum, or lack of time or expertise, the Board is unable to provide adequate review of a study, then the review may be postponed until another meeting.
For the IRB to pass any of these motions, a majority of the voting members must agree.
The timeline for expedited submissions will differ depending on the complexity of the submission and the number of submissions under review at that time. The committee does their best to process submissions as quickly as possible. Typical turnaround from submission date, to notification of approval, is two weeks, however the process can take as long as four weeks. Researchers should expect receive a letter from the committee four weeks after submission. If the review is taking longer than four weeks the researcher should contact the IRB.
A Full Review requires a meeting of the IRB committee. A quorum must be present for any vote. The IRB chairperson assigns submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination. Full meeting of the committee are scheduled on an as needed basis. It can take as long as one month after submission for the committee to make a decision so plan accordingly.