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Recommended Change for Student Designation

To reduce unnecessary COI reporting and comply with institutional and federal reporting requirements, please review the definition of "Investigator" and ensure that personnel designated as a PI or Co-I meet this definition when listed on the Personnel Tab of a research protocol application in WVU+kc.  Note that all PIs and Co-Is must complete a Conflict of Interest in Research Disclosure before a protocol application can be submitted for review and approval.  For WVU Policy and Federal Regulations, graduate and undergraduate students are generally not considered Investigators. Postdoctoral scholars and fellows may be considered Investigators if designated as such by the Principal Investigator on a case-by-case basis.  

We highly encourage students, residents, fellows, and others seeking to fulfill degree, program, or rotation requirements be designated as "Study Personnel" rather than a Co-I in most cases. 

Read Full Article: Recommended Change for Student Designation

Conflict of Interest (COI) Disclosure Required Before You Can Submit

As previously publicized, the requirement to complete a COI disclosure is a federal requirement. Effective March 15th, an up-to-date COI disclosure for every principal investigator (PI) and co-investigator (CO-I) listed on the study submission will be required before you can submit. To clarify what this means, the WVU+kc system will not allow you to submit until the PI and all CO-Is on your protocol submission have an up-to-date COI disclosure status. CO-Is that are no longer working on your study must be removed. Please ensure you update the Personnel tab in WVU+kc with the current study team.

Read Full Article: Conflict of Interest (COI) Disclosure Required Before You Can Submit

IRB Application Changes

Effective Friday, December 20, changes will be made to IRB applications in the WVU+kc system. These changes, which will impact several protocol types, are as follows:

Studies that include an international research site are not eligible for Flex. 

Read Full Article: IRB Application Changes

IRB sign-off and UA designation processes changing May 11, 2019

In ongoing efforts to improve efficiency and reduce burden, research submissions in WVU+kc will no longer require sign-off by a unit administrator (UA). Instead, UAs will receive notifications of study submissions via email that require no additional action.

Also, changes to UA designation can now be made electronically by requesting a modification.

Read Full Article: IRB sign-off and UA designation processes changing May 11, 2019