Document Status

The Disclosure status is the document-specific status that describes where the disclosure is in the lifecycle process.

The Disclosure document’s status changes throughout its lifecycle as follows:

 

Table 217 Disclosure Document - Document-Specific Status Descriptions

Disclosure- Status	Description
In progress	Initial status upon create new or update of existing record.
Submitted for Review	Status upon submission and during the review process
Approved	Status if approved by the COI Administrator
Disapproved	Status if disapproved by the COI Administrator

 

Disposition Status is the Review-related status as determined by the COI Reviewers and/or COI Administrator.:

 

Table 218 Disclosure Document - Disposition Status or Review-Specific Status Descriptions

Review-Specific Status	Description
In Progress
Submitted For Review
Under Review by COI Reviewer
Under COI Office Review
Under COI Committee Review
Best Practices Memo
No Further Action
Disclosed Interests Eliminated
Disclosed Interests Reduced
Disclosed Interests Managed
No Conflict Exists
Exempt
Disclosed Interests Unmanageable

 

Example Scenarios

Here are some real-world functional business needs for Reporters (Researchers) and how using this e-doc fulfills them:

Institutions have different forms on which Internal Disclosures are made. For example, an institution may require reporters to complete a report of outside financial interest on an “event” (aka “transactional”) basis. This Internal Disclosure would be associated with a particular proposal or an IRB application and ensures that the reporter does not have any conflicts or outside interest that must be divested or managed for that particular proposal or IRB protocol. 

Other institutions may require a certain class of users (e.g., all faculty) to complete an “annual” internal disclosure whether or not they engage in human participant research or apply for outside funding. Some institutions require both “event based” and “annual” types of disclosures.  The workflow routing for each type of form is different and because they are asked for different purposes, the questions differ from form to form. Other differences between form types include the scope of individuals who are required to fill out the form, and the time frame that the form is considered “in effect” and available for completion. For example, some schools have annual disclosure processes that run on annual cycles. 

Here are some real-world functional business needs for COI Administrators and how using this e-doc fulfills them:

After a researcher completes an internal disclosure of a disclosable financial interest, it will be marked as submitted for review by a conflict of interest administrator.  The conflict of interest administrator will perform an initial evaluation to determine whether review or actions are required to manage the potential conflict of interest.  An evaluation might conclude that no further action is required, or it may conclude that the internal disclosure needs to be reviewed by the institution’s conflict of interest committee.  Administrators need to be able to search and find internal disclosure as well as information about where the internal disclosure is in the “review” process, and whether a conclusion to the review is complete.

Users who have responsibility for the administration of COI rules at universities need to be able to record the “status” of these steps of review (e.g., “No further action required – not a conflict of interest” or “Pending in front of committee” or “management plan in place”, etc.) so that the COI administrator can record the “status” for each internal disclosure of significant financial interests as it moves through the process of that institution.  Other administrative actions may indicate that there is a relationship between a reporter’s financial entity and a proposal, award, or IRB protocol.  An administrator may also need to return the internal disclosure for additional information in the event that there is insufficient detail in the internal disclosure.