WVU Institutional Review Boards
The WVU IRBs ensure that human subject research at WVU includes appropriate protections
for participants and conforms to federal regulations.
IRB Meeting Dates
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:
- To approve, require modifications to secure approval, or disapprove all research
activities overseen and conducted under the auspices of WVU.
- To suspend or terminate approval of research not being conducted in accordance
with the IRB’s requirements or that has been associated with unexpected serious
harm to participants.
- To observe, or have a third party observe, the consent process.
- To observe, or have a third party observe, the conduct of research.
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.
Quality Improvement Program
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 contact:
Kasandra Lambert, MPH, MA, CIP
Continuous Improvement and Education Manager, WVU OHRP
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.