IRB Chair

The Institutional Review Board (IRB) Chair provides essential leadership and oversight for the institutions human subjects protection committee. This position is responsible for convening and chairing IRB committee meetings ensuring timely communication of Board decisions to investigators and exercising signature authority for official IRB correspondence and actions. The Chair plays a critical role in maintaining regulatory compliance by staying informed of FDA and OHRP regulation changes developing and implementing IRB policies accordingly and monitoring federal guidelines impacting Board activities.

• Convene and chair the IRB meetings.
• Communicate the decisions of the Board to the investigators.
• Exercise signature authority for correspondence regarding administrative and expedited actions of the Board including HHS form 596 or HHS310.
• Receive and keep apprised of all FDA and OHRP regulation changes and report these to all IRB members.
• Develop and initiate appropriate changes in IRB policy.
• Review materials submitted for the emergency use of investigational devices or biologics.
• Review Continuing Review reports Amendments and other items that may qualify for an expedited reviews 45 CFR 46. 110 and 21 CFR 56. 110.
• Determine which studies need verification from sources other than the investigators that no material changes have occurred since the previous IRB review.
• Participate in the review of new exempt and expedited protocols in conjunction with other members of the subcommittee and the IRB office staff.
• Represent the IRB in collaboration with the Vice Dean of Research in intra and extramural deliberations with individuals or agencies regarding IRB activities or protocol management. This includes being available during routine and other inspections of the Boards activities by federal agencies.
• Monitor Federal regulations and changes therein that impact the Board activities and administrative management of protocols.

Experience as a medical schooIRB Chair.

Extensive knowledge of state and federal regulations for human subjects research and HIPAA for Research regulations.

Experience with regulatory aspects of drug device and other Federal Drug Administration regulations.

Must have a faculty appointment with Macon & Joan Brock Virginia Health Sciences at Old Dominion University.

Must be available to Chair monthly IRB Meetings at date/time set by the institution.

Review IRB submissions that qualify for Expedited Review and other nonconvened business.

Assist with development of policy and procedures for the IRB.

Must be a current member of the 1^st Thursday IRB or the 3^rd Tuesday IRB for the Macon & Joan Brock Virginia Health Sciences at Old Dominion University.