WVU OHRP provides services focused on assisting the research community with protocol submissions.
Research SupportThe Quality Improvement Program supports our goals of excellence in research at WVU.
QIPThe WVU IRBs ensure that human subject research at WVU includes appropriate protections for participants and conforms to federal regulations.
WVU OHRP facilitates the operation of two Institutional Review Boards (IRB), the GOLD board and the BLUE board. WVU OHRP staff reviews research submissions prior to the IRB review. Note that not all research protocol submissions require the review of a convened full board. Please refer to the Guidance page for more information.
The IRB members are volunteers who are passionate about WVU research. The WVU IRB approval times are faster than the national average.
Convened Full Board meetings are held monthly to review and approve submissions from the research community and to discuss information related to research, including regulatory and participant concerns, events, and procedural items.
The IRB derives its authority from WVU policy. Under Federal Regulations, the authority includes:
Protocol applications are submitted using the WVU+kc protocol management system. Upon submission, the application could be stopped before reaching the IRB for review if approval is required for Bio-Safety, Radiation Safety, or for Data Protection. Once approvals are complete, submission is sent to the WVU OHRP.
The WVU OHRP staff performs an initial review of the information submitted in WVU+kc. During this review, the PI and research staff may be asked to clarify or make revisions to the application. The review assists the IRB members and the research staff by decreasing the approval time and improving the quality of the protocol application. After this review, the submission is reviewed for approval by the WVU OHRP staff or it is sent to a WVU IRB Member or a Full Board for review and approval. Review the Guidance page for more information
WVU OHRP is required to review, acknowledge, and monitor submissions sent to external/central IRBs and assists with completing the needed agreements, resolving issues and addressing concerns. WVU is responsible for all research conducted under its auspices regardless of the type of IRB approval. Review the Guidance page for more information.
WVU OHRP provides training materials and offers group and one-on-one customized training sessions. Refer to the About page for more information.
The Quality Improvement Program (QIP) measures and improves human research protection effectiveness, quality, and compliance.
The goals of the WVU OHRP QIP are to enhance the caliber of research at WVU and to increase the effectiveness of WVU's Human Research Protection Program (HRPP) by providing research program oversight, education, and outreach to the research community. One way to reach these goals is post-approval monitoring. Post-approval monitoring is a routine compliance review of IRB approved research studies. The review is meant to be an educational process by relaying best research practices.
The WVU OHRP QIP team performs different types of post-approval monitoring activities to ensure the rights and welfare of research participants are protected. The Principal Investigator (PI) and their research personnel should fully cooperate with all routine monitoring conducted by the QIP team, regulatory agencies, funding agencies, or study sponsors. In addition, the PI must implement the appropriate corrective and preventative actions to resolve any observations and ensure that their research aligns with applicable federal regulations, state laws, and WVU policies.
For questions regarding WVU OHRP's Quality Improvement Program, please email wvuohrpqip@mail.wvu.edu.
Review Types
Administrative Reviews are documentation reviews completed by WVU OHRP staff. The results are used internally to gain efficiencies and to improve the submission processes. You will not be notified if your protocol submission is reviewed. In rare cases, you may be asked to make a revision. A summary of the results is provided to the IRB Chairs and the IRBs at the monthly meetings.
Directed (“for cause”) and random periodic ("not for cause”) reviews will be conducted to assess compliance, to identify areas for improvement, and suggest recommendations based on policies and procedures. The results will be reported to the PI, the OHRP Director, and the IRB members\chairs. Required Actions that result from an Onsite review require a response from the PI outlining the resolution and the date the action will be completed.
