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VII. Management of the IRB Process

1. IRB Chair– The VPR recommends to the President individuals willing to serve as IRB Chairperson. It is the Vice President for Research’s responsibility to formalize the appointment through a written appointment letter. Chairpersons are appointed to a three (3) year term; their appointments may be renewed for additional terms, but should not exceed three consecutive terms or a total of nine (9) consecutive years on the IRB. The Chairperson should be a respected, active member of the University community who is well-informed in regulations relevant to the use of human participants in research. Whenever the IRB Chair is not available to conduct IRB business, he/she may designate a board member to assume his/her responsibilities during the period of his/her absence.

Responsibilities of the IRB Chair include: (i) determining the type of review appropriate for new protocols (exempt, expedited, full board); (ii) insuring that submitted protocols receive expeditious review; (iii) serving as primary reviewer of protocols when appropriate or delegating this responsibility to another IRB member; (iv) conducting the business of full board meetings following basic parliamentary rules, (v) convening expedited review panels when necessary and appropriate; (vi) reviewing on behalf of the IRB, revisions to protocols/consent documents required as a condition of approval, (vii) reviewing serious adverse experience reports; (viii) recommending to the VPR new and/or replacement IRB members;(ix) reviewing reports of non-compliance in coordination with Regulatory Services ; (x) assess and recommend appropriate IRB training for the IRB, investigators, and support Staff; (xi) serve as a resource for investigators and IRB members regarding issues related to University and federal policies.

2. IRB Staff – IRB Staff is part of the Office of Research Administration and provides administrative support to the IRB. The IRB Staff is an integral part of the IRB, but serves in a non-voting, ex-officio capacity.

The IRB Staff: (i) provides administrative support to the IRB and investigators in all aspects of the IRB process; (ii) assists investigators throughout the protocol submission, review and approval processes, and provides information regarding protocol status; (iii) organizes, coordinates and attends all IRB meetings and records detailed minutes of all meetings; iv) maintains all IRB records (e.g., agendas, minutes, policies, regulations, reference materials and individual protocol files) in a secure environment; (v) maintains the electronic system for tracking IRB protocols (e.g., new protocol submissions, protocol/informed consent modifications, annual continuation applications, safety reports, adverse event documentation, etc.); (vi) coordinates with IRB Chair for follow-thru on all action items resulting from IRB meetings (e.g., modifications to protocol documentation, Informed Consent changes, etc.); (vii) works with IRB Chair/Vice Chair to evaluate investigator responses to documentation changes to determine appropriateness; (viii) is designated responsibility and authority by the IRB to conduct review of exempt research and make exempt determinations in accordance with 45 CFR 46.101, including documentation of the specific exempt category or categories which apply; (ix) keeps abreast of changes to federal rules/regulations and updates IRB Chair regarding changes; (x) is designated responsibility and authority by the IRB and IRB Chair to conduct review and initial evaluation of issues of non-compliance and make determinations of serious or non-serious, resolution plans for non-serious issues, and escalation plans for serious issues; and (xi) organizes and coordinates a comprehensive campus outreach program to communicate regulatory requirements, university policies/procedures, and provides guidance on proper protocol preparations.

3. Principal Investigator

a). The Principal Investigator (PI) is the person who directs a research project or program and is responsible for the design, conduct, and reporting of research. The PI is responsible for the protection of human subjects and the ethical conduct of research in compliance with federal regulations and University policies and procedures. The PI is responsible for obtaining IRB approval prior to initiation of any research involving human subjects, submitting continuing review reports in a timely manner, and obtaining approval for any protocol modifications prior to initiation. The PI is responsible for obtaining informed consent and data from human subjects in a manner consistent with federal regulations and in accordance with an IRB-approved protocol. The PI is responsible for submitting prompt reports of any unanticipated problems involving risks to subjects or others, or non-compliance with federal regulations or determinations of the IRB. The PI is responsible for maintaining confidentiality of human subject data, and for maintaining records and documentation in accordance with federal regulations and University policies.

b). Students may act as the PI of an IRB Study. However, the student’s instructor or mentor on the project must be listed as the Faculty Advisor/Supervising Investigator on the IRB protocol. Oftentimes, the student’s thesis or dissertation advisor is listed as faculty advisor. If the advisor changes over time through the course of the student’s academic career, the IRB protocol must be updated accordingly. Faculty Advisors share responsibility with a student PI and maintain certain authority over the student-led research; please see the defined role of Faculty Advisor/Supervising Investigator for details.

4. Faculty Advisor/Supervising Investigator- This role is required when the Principal Investigator (PI) is a student. The faculty advisor is responsible for oversight of the ethical conduct of research and data collection, and for ensuring that the research is conducted in compliance with federal regulations and University policies and procedures, in accordance with an IRB-approved protocol. The faculty advisor is responsible for ensuring appropriate qualifications of the student PI, and for vetting the protocol’s purpose, design, methodology, and procedures. The faculty advisor is also responsible for record retention in compliance with federal regulations and University policies (for example, if the student leaves the University, the faculty advisor must take over recordkeeping duties to meet retention policies). The faculty advisor is responsible for ensuring that reporting requirements are met, including continuing review reports, unanticipated problems involving risks to subjects or others, or non-compliance with federal regulations or determinations of the IRB.

5. Resources- The University provides adequate facilities and equipment to support the operation of the IRB in the performance of the functions described in this document.

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