Office of Research & Sponsored Programs

IRB Manual Review Process

Review Process

 

Expedited and Exempt Reviews (No more than Minimal Risk)

If the study does not require full board review, the 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 email any questions, comments, or requests for adjustment to the PI, and if a student PI, to the Faculty Advisor. The PI is requested to respond within one week with answers to the questions posed by the reviewer, any questions the PI may have, further discussion as needed, and/or edited documents. 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.

Communications between the PI and the reviewer are most efficient if the following guidelines are followed by the investigator:

1.       Respond directly to the reviewer, by “Reply All” email, not by starting a new email string.

2.       Insert (or keep) the IRB protocol number in the Subject line. 

3.       Respond to ALL items, not just some, and preferably in the same email, in the same order as listed in the review. 

4.       Mark any changes made to edited documents by highlighting or color coding them.

5.       Always, always, copy the IRB Administrator on ALL communications. 

6.       If you have not heard from your reviewer within 3 weeks, check in with the IRB Administrator.  Likely the cause is work overload, but it may be possible that a communication has gotten missed. 

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 46.101). Expedited approval means that the study must be reviewed again periodically, at least annually. Exempt approval means the study does not need standard continuing review and approval.  In all cases, whether Full Board, Expedited, or Exempt, the PI must request review of any changes to the protocol before implementing them and report any problems that arise during the study. 

When the review and any discussion is complete, the reviewer will send an approval email to the PI and the Faculty Advisor, if the PI is a student, indicating that the study 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.  Upon arrival, investigators or visitors should be seated in the reception area and wait to be called into the meeting at the appropriate time. 

For full IRB review, a complete set of documents is sent to each IRB member who will review the protocol and supporting documentation in detail prior to the meeting. 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 insure 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 given 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 approve a study, table a study, approve a study with explicit conditions, or disapprove a study. A study may be tabled either because the Board did not have sufficient time, or expertise, or appropriate personnel 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 his research protocol to the Board and asked to have the decision reconsidered.

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.

 

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