Chairperson's Duties
The Chair will perform or cause to be performed the following functions of the IRB:
- Conduct and preside over IRB meetings
- Call and conduct emergency IRB meetings, as necessary;
- Review and approve appropriate requests for expedited reviews, according to IRB policy and consistent with federal regulations
- Review, approve or disapprove appropriate requests for Single Subject Exceptions (Compassionate Use), Premature Study Entry, and Emergency Use IND applications as permitted by IRB policies and federal regulations
- Recommend actions in emergency situations to protect research subjects and to remain in compliance with regulations
- Recommend new member appointments to the IRB
- Review IRB Policies and Procedures and recommend changes as necessary
- Advise investigators on policies, procedures and regulations
- Possess an understanding of the IRB Manual, Dignity Health and hospital policies and procedures governing research, and applicable laws and regulations including those issued by the FDA and OHRP
- Make determinations as to applicability of expedited versus full review of protocols, amendments and protocol changes
- Recommend for the appointment a candidate for the IRB Vice Chair Interact and communicate with medical staff, the Medical Executive Committee, hospital president, accountable executive for research, the HRPO and others as necessary
- Education of all IRB members, investigators and others directly involved with research
- Review adverse event reports promptly, making recommendations for action and implement changes as necessary
- Ensure the IRB performs the duties as outlined in IRB Policies and Procedures, the IRB Manual, Dignity Health Policies and Procedures, and the federal and state statutes and regulations, including maintaining necessary records
- Give notice of any serious or continuing non-compliance with IRB requirements by investigators to hospital administration the hospital governing board, the trial sponsor, and FDA or OHRP, when appropriate
- When necessary, call special meetings of the IRB or IRB Executive Committee
- The Chair or his designee shall have authority to act upon (approve, disapprove, or move to modify) expedited reviews, including medical record review; minor amendment and minor changes in the research protocol, including consent changes; and Compassionate Use in Single Subject Drug exceptions and Humanitarian Use devices. Such action will be presented at the next regularly scheduled IRB meeting for discussion, comment or modification as appropriate
For additional information, please call the East Valley Regional IRB at (480) 728-3582.
