Process

The Principal Investigator determines that research will involve human subjects. PI completes and submits an application to the Compliance Coordinator in Research Support Services who then determines what level of review is needed (exempt, expedited, full) and initiates the appropriate review process for that level. The Compliance Coordinator communicates the results of the review to the PI (exemption, approval, recommendations, etc).

PI provides progress report at the time of continuing review, which is due at intervals no less often than 12 months.

The Compliance Coordinator maintains record of all protocol approvals, disapprovals, continuing reviews, and other actions of the IRB, as well as Federal and institutional written policies and procedures.

The University of Memphis assures compliance of Federal regulations by all collaborators in human subject research.

The IRB shall report to appropriate University and federal government officials:

1. any unanticipated problems involving risks to subjects or serious or continuing noncompliance with IRB requirements

2. and any suspension or termination of IRB approval of research.

Communication:

1. Investigators: The IRB Chair, IRB members, and the Compliance Coordinator communicate with investigators concerning review procedures, Federal and University policies, assistance with application, etc.

2. IRB members: IRB Chair discusses proposed policy changes and implementation with IRB members, and the Compliance Coordinator schedules meetings, forwards applications for review, and lists recommendations and suggested modifications.

3. University personnel: Department Chairs instruct faculty about University policy as it relates to the IRB. The IRB Chair and its members and the Compliance Coordinator are available to discuss any details of policies and procedures.

4. Subjects: Investigators must be available to discuss any concerns the subjects in their research may have. The consent form must include a contact phone number of the investigator, as well as the IRB Chair. The Chair is available to discuss any concerns about the subjects' rights as subjects.

Training:

1. Investigators: The IRB Chair and its members, and the Compliance Coordinator are available to discuss any details of policy, procedure, suggestions, etc. that an investigator might have. Faculty advisors are available to discuss policy with their students who might be conducting research.

2. IRB members: Copies of Federal regulations and guidelines and other resources are housed in Research Support Services. The IRB Chair also provides guidance to the IRB.

3. IRB Chair and Compliance Coordinator: Conferences and an internet list service allow interaction with IRB staff at other institutions.

4. University personnel: The IRB Chair and its members and the Compliance Coordinator are available to discuss any details of policy, procedure, suggestions, etc.

An institutional self-audit is completed annually in Research Support Services.