Jurisdiction of the IRB

 

The IRB is a University standing committee established by Charleston Southern University to protect the rights and welfare of human and animal research subjects recruited to participate in research activities conducted under the auspices of the University. The IRB has the authority to approve, require modifications in, disapprove or suspend all research activities that fall within its jurisdiction as specified by federal regulations and policies of the University and affiliated institutions.

The IRB functions independently of, but in coordination with, other university committees. For example, the Graduate Council may be consulted in research that is conducted for master's thesis credit. The IRB, however, makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected.

Charleston Southern University's IRB reserves the right to review all research, even research that is exempt from review under the federal regulations. The IRB has jurisdiction over all research, thereby providing broader protection than that required by the federal regulations. The IRB's authority to approve, require modifications in or disapprove research derives from both federal law and university policy.

In brief, research is defined as the collection of data for the purpose of broadening the knowledge base of a discipline. The information gathered is intended to potentially be available for professional presentation or publication. Research does not include information gathered only for the assessment of a particular program in which the information will be only viewed by individuals directly involved with the program. Research also does not include information gathered only for use within the classroom situation.

Research that has been reviewed and approved by the IRB may be subject to further review and disapproval by officials of the institution. Those officials may not, however, approve research if it has been disapproved by the IRB. Furthermore, approved research is subject to continuing IRB review and must at a minimum be re-evaluated annually and more frequently in some cases.

The IRB reviews all research; as such it is not concerned with whether or not a particular activity is performed with therapeutic intent. This includes, but is not limited to, development of protocols that guide research that is conducted for therapeutic purposes. The IRB conducts risk/benefit assessments for research on therapies, for example, determining if the risks of a study are justified by a therapy provided as part of the study. Benefit alone is not used to justify risks presented by the research.

Establishment of the IRB