1. COI Office Review:
COI disclosures fall into two categories: those without outside interests and those with outside interests. Forms which report no outside financial interests are immediately put into "Final" status by the Workflow system and no COI Office review occurs under normal circumstances.
Once submitted, COI disclosures which report outside financial interests are immediately emailed to the COI Office staff and the status of "Enroute" is reported by Workflow. The COI Office staff will first review the disclosure to verify that it is complete. If additional information is required, an email will be sent to the disclosing individual.
2. COI Committee Review:
A summary of each disclosure with outside interests will be prepared by the COI Office and presented to the COI Committee for their review. The COI Committee will review the summary, research activity of the disclosing individual and any other pertinent information. They will then determine what action is necessary or request additional facts. Depending on the nature of the outside interest, the options the COI Committee may choose are to manage, reduce or eliminate the interest. In the alternative, if the outside interest does not rise to the point of requiring one of the previously noted actions, the COI Committee may determine that no action is necessary or request that a best practices memorandum be put into place.
3. Compliance Review:
In order for any type of research or sponsored program activity to be commenced, a current and complete COI disclosure must be verified by various IU offices. Those offices include Contracts & Grants, IRB, Clinical Trials Office and IACUC. If a current COI disclosure has not been filed, the researcher will be contacted to request that they do so immediately. If it has been filed but requires COI Committee review, the COI Office will expedite the disclosure so that it is reviewed at the next COI Committee meeting. Failure to have a current disclosure on file or to provide additional information requested by the COI Office may result in a delay of study approval and/or release of research funds.