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

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

This procedure lists the responsibilities of the investigator, IRB and OIRB for conducting data and safety monitoring for Human Subjects research.

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 outlines the responsibilities for the investigator, institution and IRB to determine that necessary resources are available for care and safety of human research participants.

This procedure outlines the responsibilities of the investigator, OIRB and IRB for determining that research risks to subjects are minimized.

This procedure outlines the responsibilities of the OIRB and the IRB for documentation of convened IRB proceedings.

This procedure outlines the responsibilities of the OIRB and the IRB for documentation of research undergoing initial or continuing review by the expedited procedure.

This procedure outlines the responsibilities of the investigator, OIRB and IRB for emergency use of FDA-Regulated test articles. This document also includes basic elements and disclosures included in informed consent for emergency use of test articles.

This procedure lists the responsibilities of investigators, OIRB and IRB for ensuring that all investigators are qualified to perform their role (s) in conducting research.