This policy differentiates case reports from human subjects research.

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 OIRB and the IRB for documentation of convened IRB proceedings.

This procedure outlines the responsibilities of the investigator, OIRB and IRB for approving a waiver or alteration of the consent process and the waiver of consent documentation.

Clinical investigations involving human subjects and drugs, biologics, devices or test articles are subject to review. In order to comply with federal regulations, the IRB will determine what types of applications and exemptions (when applicable) are required for the study. This document describes various types of studies and instructions for submission and compliance.

This policy describes the process by which the IRB determines if risks are minimized for participants in a proposed project. Review process and relevant definitions are included in the document.

This policy requires the implenmentation of a quality assurance and quality improvement program to monitor compliance with federal regulations and improve the Human Research Protection Program processes

This policy outlines the requirements for formulating contracts with sponsors of proposed research.

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 for continuing review of research approved by the convened IRB.