4.1.1 The Institutional Review Board shall include one community representative, one student representative, an Executive Secretary of the IRB, one representative from the Provost's Office, a lawyer, and at least six faculty members. Faculty members will be selected according to the University's research needs but shall include at least one member whose primary concern is in a scientific area and at least one in a nonscientific area. The community representative may not be affiliated with the University or part of the immediate family of someone affiliated with the institution. The IRB may not consist entirely of men or entirely of women, or entirely of members of the same profession.
4.1.2 The Committee may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues that require expertise beyond or in addition to that available on the Committee. These individuals shall have no voting rights.
4.1.3 The IRB may not have a member participating in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (45 CFR 46.107)
4.1.4 Appointments to the IRB shall be made by the President on recommendation from the Provost. All faculty representatives shall serve for three-year terms, with one-third rotation each year. Non-faculty representatives shall serve for one-year terms. The chair shall be appointed annually by the President from the faculty members.
The Executive Secretary of the IRB shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed; scientific evaluations, if any, that accompany the proposals; approved sample consent documents; progress reports submitted by investigators; and reports of injuries to subjects;
(2) Minutes of IRB meetings taken in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution;
(3) Records of continuing review activities;
(4) Copies of all correspondence between the IRB and the investigators;
(5) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution (e.g., full-time employee, part-time employee, member of Board of Trustees, consultant);
(6) Written procedures for the IRB;
(7) Statements of significant new findings provided to subjects.
(NOTE: IRB records shall be retained for at least three years after completion of the research.) (45 CFR 46.115)
4.3 IRB Functions and Operation
4.3.1 Deciding whether an expedited or full review will be required, or whether a research project is exempt from IRB review (see Section 6 for details)
4.3.2 Conducting its review and reporting its findings and actions: The IRB shall notify investigators and the Provost in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
4.3.3 Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review. The IRB shall conduct continuing review of approved research involving human subjects at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research. A second review may be required if (a) a long interval has elapsed between IRB review and project initiation; (b) the proposed effort is in a rapidly changing scientific area; or (c) the principal investigator wishes to change procedures after the proposed project has been reviewed by the IRB. In no case will work take place without at least an annual review. (45 CFR 46.109)
4.3.4 The IRB shall require that information given to subjects as part of informed consent complies with procedures described in this document (see Section 7). It may require that additional information be given to the subjects when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects. The IRB shall require documentation of informed consent or may waive documentation in accordance with procedures described in this document.
4.3.5 The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, the Provost, and the DHHS (if federally funded). (45 CFR 46.113)
4.3.6 The IRB shall be responsible for reporting to the Provost and DHHS (if federally funded) any serious or continuing non-compliance by investigators with the requirements and determinations of the IRB. (45 CFR 46.103, 46.108)