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 delegates responsibilities of the Investigator, OIRB and IRB for ensuring prompt reporting of unanticipated problems encountered in research.

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

This procedure outlines responsibilities of the investigator, IRB and OIRB for review of decisionally impaired adults involved in human subjects research including assent

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

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

This procedure outlines responsibilities for dealing with compliance issues with Human Subjects regulations or IRB requirements or determinations.

This procedure outlines the responsibilities of the investigator, OIRB and IRB for the selection and recruitment of subjects in research.

This procedure outlines the responsibilities of the investigator, IRB, and OIRB for maintaining the privacy of research subjects.

This procedure outlines responsibilities for the Investigator, OIRB and IRB for the identification and communication of Human Subjects research to Non-UAB-Affiliated performance sites.