Updates

There has been a delay of the Revised Common Rule.

In response to rising costs associated with growing regulatory demands related to clinical research, fees associated with reviews of industry sponsored clinical trials involving human subjects research will be increasing as of July 1, 2019.

Part 1: Overview

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.

WVU's Procurement Contracting and Payment Services department is offering a new prepaid card program effective (July 1) for all payments to participants in human subjects research. The new system, the Vincent Prepaid Card System is available now. For more information and assistance contact Procurement Contracting and Payment Services.

Starting July 1, 2020  WVU Health Sciences Center/Morgantown-based WVU Medicine clinical trials must be registered with the WVCTSI Clinical Trials Center of Excellence and obtain approval prior to starting patient enrollment.

WVU OHRP will no longer accept the following as Flex protocol submissions:

Federal Regulatory and institutional policy requires that PIs/Co-PIs have an Up-to-Date Conflict of Interest Disclosure on file with with WVU COI Office. 

Protocol submissions requiring Full Board review are now due 14 days prior to scheduled meetings, check the WVU OHRP website for specific due dates.

IMPACT TO PENDING/IN PROGRESS APPLICATIONS: On Fri, Dec 20, new questions will be added that track student research, clinical trials, and clarify Flex Model eligibility.