3. Authority of IRBs
The University IRBs have jurisdiction over non-exempt research involving human subjects conducted under the auspices of University and affiliate sites. All University and affiliate faculty, students, and staff must obtain IRB approval before conducting research involving human subjects. "Retroactive" IRB approval is not permitted under federal regulations and University policy. Failure to obtain IRB approval may preclude the use of human subjects research data collected without approval, and could result in other institutional sanctions.
IRBs are authorized to
- determine when projects do not require exemption determination or IRB oversight;
- grant exemptions from IRB review;
- approve, disapprove, or require modifications to research protocols;
- monitor or observe the consent process and the conduct of human subject research to ensure that the rights and welfare of research participants are adequately protected;
- suspend or terminate approval of research not being conducted in accordance with the IRBs' requirements or that is associated with unexpected serious harm to research participants;
- along with University and affiliate deans, department heads, program directors and unit administrators, ensure that non-exempt human subject research activities are conducted as approved by the IRB; and
- investigate human subject research activities conducted by University or affiliate investigators without prior IRB approval.
University and affiliate researchers conducting non-exempt human subjects research must take direction from the IRB Chair. Collaborating researchers from non-University and non-affiliated sites are under the same obligations.