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Research Community Services


WVU IRBs

WVU IRBs

WVU OHRP facilitates the operation of the Blue IRB and the GOLD IRB.

IRB Info
Research Support

Research Support

WVU OHRP provides services focused on assisting the research community with protocol submissions.

Research Support
Quality Improvement Plan

Quality Improvement Program

The Quality Improvement Program supports our goals of excellence in research at WVU.

QIP

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 Members

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.

Institutional Authority

The IRB derives its authority from WVU policy. Under Federal Regulations, the authority includes:

  1. To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of WVU.
  2. 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.
  3. To observe, or have a third party observe, the consent process.
  4. To observe, or have a third party observe, the conduct of research.

Research

Submission Management

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.

Reviews

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

External/Central IRBs

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.

Training

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 Plan

The QIP measures and improves human research protection effectiveness, quality, and compliance.

The program assists WVU OHRP and the research community to ensure compliance with institutional policies, and regulatory requirements. QIP Reviews will be completed by WVU affiliated employees referred to as QIP Consultants.

Review Types

Administrative

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.

Onsite

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.

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