Across the Board

Additional Full IRB Committee Meetings

2009 Sep 2 Posted by Courtney Jarboe

Due to the number of studies referred to the Full IRB Committee for review, an additional meeting was scheduled. Now there are two meetings held each month. Studies that do not involve prisoners as research participants will be reviewed on the first Wednesday of every month. Prisoner-based research studies will be reviewed on the third Wednesday of every month.

Here are some common questions we receive about the Full Review.

How do I know my study will be reviewed by the Full IRB Committee?

If your study involves greater than minimal risk to research participants, deception, or involves prisoners, it will be reviewed by the Full IRB Committee. However, if the IRB reviewer, during the initial review of the study determines that he or she cannot review the study at the expedited level because of some other aspect (i.e., does not fall into an expedite or exempt category of research, involves unethical research practices), they can refer the study to the Full IRB Committee. All referrals must be ready for Full IRB review at least 2 weeks prior to the IRB Committee meeting. Otherwise, the study will not be reviewed at that particular meeting and will have to wait until the next convened meeting.

If an IRB reviewer refers a study to the Full IRB Committee, the doctoral learner and mentor will receive a letter from the IRB indicating as to why the study must be reviewed in this manner.

My study has been referred to the Full IRB Committee, what do I do?

When a study is referred to the Full IRB Committee, a member of the IRB Office staff will assist you and your mentor through the Full Review process. It is important that learners review the initial IRB reviewer’s evaluation form and any other documents posted by the IRB (i.e. referral letter, deferred documents, etc.).

A week before the meeting, an IRB Office staff member will request to hold a conference call with the learner and mentor to explain the full review process and answer any questions they may have.

The Friday before the meeting, the learner and mentor will receive a preliminary evaluation document from the IRB Committee. This document includes any preliminary concerns and questions the committee has for the learner and/or mentor. It is important that the learner go through this document with their mentor and respond to the request as soon as possible.

What happens at the Full IRB Committee meeting?

The meeting occurs via teleconference. Reviewers from each school attend in addition to, a non-scientist, prisoner representative, and external member. At this time, mentors are encouraged to attend this meeting to answer any last minute questions of the committee as well as clarify anything on behalf of the learner.

The mentor, if he/she attends the meeting, is dismissed for the deliberation of the study. The reviewers discuss the following items regarding the study.

+Risk and Benefit Assessment
+Selection of Participants
+Informed Consent
+Data Monitoring
+Privacy and Confidentiality
+Special Populations (if applicable)
+Other ethical, procedural, and/or methodological concerns

Once the deliberation has completed, a motion will be made to:

Approve,
Approve with Stipulations,
Defer for Minor Revisions,
Defer for Major Revisions,
Disapprove, or
Table

the study as it was presented to the Full IRB Committee. To learn more about each decision, check out the Research and Scholarship Center on iGuide. Within 7-10 business days, a decision letter and findings document will be posted in the study on IRBNet.

If you have any questions about the Full Review, please email researchandscholarship@capella.edu.

September 2, 2009 | Filed under: IRB Committee
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