This procedure outlines the responsibilities of the Investigator, OIRB and IRB regarding the informed consent process and documentation of informed consent.

This procedure outlines the responsibilities of the Investigator, IRB, and OIRB for handling Investigator and Institutional Conflicts of Interest.

This procedure outlines the responsibilities of the investigator, OIRB and IRB with regard to suspension or termination of IRB-Approved research and administrative hold.

This procedure outlines the responsibilities of the investigator, OIRB and IRB for continuing review of research approved by the convened IRB.

This procedure lists responsibilities of the investigator, ORIB and IRB for communication among IRBs.

This procedure documents the requirements for determining an exemption from Human Subjects research regulations, including the responsibilities of the Investigator, OIRB and IRB. An attachment that details federal criteria for determining exemption is also included in the document.

This procedure lists the responsibilities delegated to the investigators, OIRB and IRB, and Institutional Official to ensure proper maintenance, development and use of IRB policies.

This procedure describes how human materials or data not involving human subjects may be classified as Not Human Subjects Research.

This procedure lists responsibilities of the investigator, IRB, OIRB, and sponsor for waiver to the informed consent process in research planned for emergency settings.

This procedure lists responsibilities of the investigator, OIRB and IRB for carrying out the initial review using the expedited procedure.