IRB Glossary of Terms

The primary role of the Institutional Review Board is to protect the rights and welfare of human research participants. University policy requires prior IRB approval of all Human Subjects research, regardless of funding source.

 GLOSSARY

• Adverse Events- any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form. (21 CFR 312.32 [4-1-92])

• Anonymous data collection  - means that even the researcher does not know the identity of the subjects.

• Confidential data collection  - means that the researcher knows or could come to know the identity of the subjects either directly or indirectly but will not release identifying information to others.

• Human subject - a living individual about whom an investigator conducting research obtains data, either through intervention or interaction with the individual or through use of his or her identifiable private information. (45 CFR 46)

• Interaction  - includes communication or interpersonal contact between investigator and subject. (45 CFR 46)

• Intervention - includes both physical procedures and manipulations of the subject or the subject's environment that are performed for research purposes. (45 CFR 46)

• Principal investigator - an employee, faculty member, or student of USM who accepts responsibility for the research.

• Research - a systematic empirical investigation designed to develop or contribute to generalizable knowledge. (45 CFR 46)

   Adapted with permission from The University of Memphis