IRB Notes: Interactions between eCoI and eIRB

The interactions between eCoI and eIRB

The new conflict of interest reporting system housed in Big Brain, eCoI  has been up and running since late August. This system asks researchers to report Outside Activities and Conflicts of Interest (CoIRs) in one report; previously, this required two disclosures (one in the “old” CoIR disclosure system; the other in Big Brain).

1) CoIR Compliance in eIRB: Anytime a researcher has an eCoI submission “in the works” (awaiting signature by department chair/dean; awaiting revisions after having been returned from one of the signers) or overdue, then the eCoI blocks projects from being submitted or moved through the eIRB system.

Signers are able to review/sign CoI disclosures as soon as they are submitted to eCoI; they receive an email notification within 24 hours of the eCoI submission, with a link taking them directly to the form needing review/signing. The necessary signatures (typically from Department Chair and a Dean) can happen in any order. Once those 2 signatures are obtained, compliance for eIRB functioning has been established. (A form awaiting only the CoI Office signature does NOT cause eIRB non-compliance.)

If you’re not sure why there is a non-compliance issue when trying to make an eIRB submission, check the left vertical navigation plane in your eIRB project, and click on “Visual CoIR RCR” under “RCR/COIR compliance.”

2) eIRB projects and researcher conflicts: If a researcher has a financial conflict related to an IRB study, then it is crucial to answer “yes” to that researcher’s personnel entry in the Initial Review Questionnaire (IRQ) when the study is submitted to the eIRB.

AND, it is important that the new study involving a conflict be added to the researcher’s eCoI record. This is done by going to the Project Tab in the eCoI record and clicking on “add a project.”  **NEW: Anyone listed as a researcher’s “contact” in eCoI (on the My Signers tab) is now able to enter the project on the researcher’s behalf.  (The contact may add/edit projects and travel entries but not the CoI disclosure itself.) It is CRUCIAL that the questions are answered in as much as detail as possible, so a contact (e.g., study coordinator) will need the researcher’s input.**NEW

Questions? Call the Research Integrity Office at 503-494-7887.