II. ROLE AND AUTHORITY OF THE IRB

• Procedures for 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.
• Procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.
• Procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the OHRP, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval.

The role of the IRB is to protect the rights and welfare of human subjects in research activities conducted by KSU faculty, staff, or students, as well as research conducted by non-KSU personnel on the campus of KSU. The IRB conducts initial reviews of proposed research and monitors continuing research in order to safeguard the rights and welfare of human subjects. The IRB's functions include:

• a.To determine and certify that all projects approved by the IRB conform to the ethical guidelines, regulations, and policies regarding the protection of human research participants; and
• b.To assist researchers in conducting ethical research that complies with federal regulations and is safe for the human subjects involved.

The IRB should not place undue burdens on researchers but should help to create a collaborative environment in which all faculty, staff, and students are following standard practices regarding research integrity and protection of human subjects.

The IRB has the authority to approve, require modifications in order to secure approval, or disapprove all research activities that fall within its jurisdiction in accordance with federal regulations and institutional policies. The IRB has the authority to observe or have a third party observe and monitor research activities in order to protect human subjects. In so doing, the IRB also has the authority to require periodic progress reports, oversee the conduct of studies, and to suspend or terminate approval of a study due to noncompliance. In cases where there is a dispute between researchers and the IRB specifically regarding the protocol review process, the researcher may pursue an appeal.

Research that has been reviewed and approved by the IRB may be subject to review and