Review Process
Expedited and Exempt Review (No More than Minimal Risk)
If a study does not require full board review, an initial reviewer will undertake the review individually, consulting with other IRB members or special experts as needed and appropriate. Reviewers strive to complete the initial reading of each application within two weeks of receiving it, although this is not always possible, depending on schedules and volume. After initial review, the reviewer will send any questions, comments, or requests for adjustment through the Cayuse IRB system and the application will be routed back to the PI for a response. The PI is requested to respond to the review within one week. It is not required that all changes requested by the reviewer be made exactly as requested without discussion. If the PI has questions or concerns, they should be shared with the reviewer, so that the reviewer can help find solutions, if at all possible. If you have not heard from your reviewer within 3 weeks, check in with the IRB Administrator.
The primary reviewer may review and approve a study that does not require full board approval under one of two categories: Expedited or Exempt. The criteria for approving studies as Expedited or Exempt are outlined in the federal regulations (45 CFR 46.110 or 45 CFR 46.104). In all cases, whether Full Board, Expedited, or Exempt, the PI must request review of any changes to the approved protocol before implementing them and report any problems that arise during the study.
When the review and any discussion is complete, the PI (and the Faculty Advisor, if the PI is a student) will receive a notification that the Study has been approved and may proceed. It is highly unusual for a study at UNI to be disapproved. Most often, the reviewers have resolvable concerns regarding the procedures or participant materials and will recommend changes to the PI during the review process. In the rare event that the reviewer and PI cannot reach an agreement on the changes needed, the PI may request that the application be forwarded to the entire IRB for further review and discussion.
Full Board Review (More than Minimal Risk)
In the event that a study is reviewed by the full committee, the investigator will be invited but not required to attend the meeting. Investigators are encouraged to accept the invitation in order to save time in the process by discussing the study at the meeting and answering any questions that the IRB members have. Investigators who wish to attend the meeting must inform the IRB Administrator.
For full IRB review, the application in the Cayuse system is shared with the Full Committee and all members may comment on the submission. In preparing for the meeting, the Chair or other primary IRB reviewer may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to ensure a thorough evaluation of risks and benefits of the proposed research. The protocols undergoing initial review are presented and discussed individually by the IRB, in addition to those protocols under the oversight of the full board that are undergoing continuing review.
Regulations allow an IRB member to attend a full board meeting via phone or online meeting software, provided all meeting participants can hear and communicate with one another.
After complete and individual discussion, each protocol is voted upon for one of four possible dispositions. The board may vote to (1) approve a study; (2) table a study; (3) approve a study with explicit conditions; (4), or disapprove a study. A study may be tabled either because the board did not have sufficient time, or expertise, or appropriate members present (i.e., absence of prisoner advocate for a study involving prisoners) to vote on the study or because the board needed substantive clarification or modifications regarding the protocol or informed consent documents to determine whether to approve or disapprove the study. A study may be approved with explicit conditions when the convened IRB is able to stipulate specific revisions that require simple concurrence by the investigator. If the IRB approves a study with explicit conditions, then the primary IRB reviewer or Chair may subsequently approve the revised research protocol on behalf of the board, after determining that the investigator has incorporated the specified explicit conditions into his or her project. In a rare circumstance, the study may be disapproved because the protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas. A principal investigator has the right to appeal the disapproval of their research protocol to the board and asked to have the decision reconsidered.
See IRB Meetings for additional details.
Documentation of Special Determinations
If the protocol disposition is "Approved" or "Approved with Explicit Conditions" and the protocol requests inclusion of a vulnerable population(s), special determinations for the vulnerable population(s) may be made during the meeting as well. These will be documented in the minutes and communicated to the investigator(s).
The minutes will also document if the study was determined to be More than Minimal Risk or No More than Minimal Risk. Studies reviewed by the full board initially that are determined by the IRB to be no more than minimal risk may be subsequently reviewed through an expedited process if the IRB so decides.
If a waiver of consent or waiver of documentation of consent is granted, whether by the full board or through Expedited or Exempt review, this will be noted in the IRB minutes (for full board studies) and in the protocol file.