IRB Member FAQs

This page provides answers to frequently asked questions from ED/SBS IRB members

My flight is delayed, a family emergency has come up, etc. and I am unable to attend the IRB meeting. However, I have reviewed the protocols and my notes are in ARROW, does that help?

No. IRB Staff and other members of the committee are unable to see your notes in ARROW. If a situation such as this were to arise, it will be necessary for you to create a summary of your notes to e-mail to the Staff Reviewer so that they can be read into the IRB minutes.

Is it okay to vote AGAINST approving a protocol?

Yes, in fact IRB Staff feel that NO votes in particular are important when IRB minutes are reviewed by outside entities. Mixed votes serve as indicators that the committee does not just rubber stamp every project that is submitted, and that there is thorough review, thoughtful discussion, and consideration of all submitted projects.

I am the Primary Reviewer on a study and have some specific questions that will need to be answered before I am comfortable recommending approval. Can I contact the PI myself?

This requires a 3-part response:
  • Yes. IRB members can contact the PI directly. However, unless the PI is a colleague/someone you are familiar with, it may be better to let the Staff Reviewer act as your liaison, as researchers are more accustomed to dealing with IRB Staff;
  • The PI may tell you to contact the student(s) or other study team members;
  • It is important to remember that—even if you as a reviewer get your questions answered—the details gained from any conversations with a PI must be included in the protocol application. Therefore, the protocol would need to go back to the Study Team after IRB review in order to ask the researchers to add the additional information.

What if I have a Conflict of Interest?

It is important to let IRB Staff know when you discover that you have a COI with any of the studies that are being reviewed by the full committee. When it is time for the vote on a submission where a member has a COI, quorum could be affected. If you are listed as a member of the study team, or have a direct role in a project, the IRB member must leave the room for the final discussion and vote. If there is not actual COI, but as a member you do not want to give the perception of any bias, it is acceptable to just abstain during the vote.

I can’t open some of the documents in an application I am reviewing.  Can someone on the IRB Staff help me at the meeting?

Please contact the assigned IRB Staff Reviewer well in advance of the meeting if this happens. It is not appropriate to note at the meeting, for example, “…the recruitment file won’t open, but I am sure its fine…” It is also possible that the file is corrupt, and it may be necessary for staff to contact the study team to provide an accessible file in the application.

Keywords:frequently asked questions, ED/SBS IRB members, FAQs   Doc ID:43424
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-09-05 12:07 CDTUpdated:2018-10-16 14:55 CDT
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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