General Questions

What is the Institutional Review Board (IRB) and what is its purpose? The existence of the IRB, its composition and responsibilities are governed by the Code of Federal Regulations (45 CFR 46). The UAF IRB is made up of UAF faculty, staff and Fairbanks community members. Members come from diverse backgrounds including scientific and non-scientific areas. The IRB conducts initial and continuing review of UAF research projects in order to ensure protection of the rights, safety and well-being of human subjects participating in the project.
 

How long does the IRB review process take? All IRB Protocol applications undergo an initial administrative review by a ORI staff member. This review will be to check for completeness of your application and to determine if the project is "exempt". You will receive the results of this review within 10 business days. You should expect the reviewer to have some questions or ask for clarification on some aspect of your protocol. Once you have responded to the reviewer's questions you will be informed whether or not your application is "exempt" and has been approved, or is being sent to the IRB for further review and approval.

IRB review may be either "expedited" or "full" depending on the level of risk to the research subjects/participants. This determination is made by one of the IRB co-chairs. All protocols requiring "expedited" or "full" review are distributed to the entire IRB. The only difference is that "expedited" reviews are assigned to one or two members who may decide to either approve or approve with modifications. Expedited reviewers may not deny a protocol. If the expedited reviewer does not support approval, the protocol goes to "full" review and is placed on the agenda for the next IRB meeting.Expedited reviews are typically concluded within 10 business days. However, the reviewer(s) typically have questions they want answered or modifications that they want made before they give final approval. Once the PI responds, a final decision is typically made within 10 business days.

Action on a protocol that requires or has been referred for "full" review can only be decided by a majority vote of a quorum of IRB members at a convened meeting. If the IRB determines that there are enough questions or issues related to the protocol it will be "tabled" for reconsideration at the next meeting (provided the PI provides a response by the next meeting deadline). The PI will receive the results of the IRB review within 10 business days of the meeting date.

Note: You may not begin your research until the IRB has given your application full and unconditional approval.


What does the IRB look for in an application? The IRB needs to be assured that the research is 1) of sound design, given the proposed use of human subjects; 2) that there is e equitable selection of subjects; 3) that there is a reasonable balance in the risks and benefits to the participants; and, 4) that the informed consent process is appropriate and comprehensive.
 

How often does the IRB meet? The IRB meets once a month during the fall and spring semesters. Meetings will be called as needed during the summer. A quorum of the IRB must be present for decisions to be “official.” Information about upcoming meetings is available from the IRB Homepage.
 

When do applications need to be submitted in order to be reviewed by full committee at the next meeting? IRB protocol applications are accepted at anytime. Application requiring full review must be received at least 10 business days prior to the next scheduled IRB meeting. Information about upcoming meetings is available on the IRB Homepage.

Note: Most IRB protocol applications at UAF are either "exempt" or are reviewed through the "expedited" process.
 

Where do I submit my IRB application? New applications must be submitted electronically through IRBNet.

How do I know when my application has been approved? You will receive written notification of the status of your application following IRB review. The IRB will identify any required revisions at that time.

Note: You may not begin your research until the IRB has given your application full and unconditional approval.

How do I modify an application that has already been approved? Any time you need to change an approved IRB Protocol you must submit a Modification Request (available on the Forms page of this web site) and all new or revised instruments, measures, consent documents, etc., as appropriate. Modifications must be reviewed and approved by the IRB prior to their implementation.
 

How do I know the IRB will understand my proposed research? The IRB is a standing board of at least five individuals, including faculty, researchers and at least one member who is not affiliated with the university. Individual experiences and interests lead to a diverse committee. When the IRB receives a protocol that requires expertise beyond that available on the Board, it may seek assistance from qualified persons outside its membership. While outside experts may inform the IRB’s decision, they do not vote on the IRB Protocol applications presented for review.