The primary role of the Human Subjects Institutional Review Board is to protect the rights and welfare of human research participants. University policy requires that all research reviewed regardless of funding source. If human subject data will be aggregated, analyzed, or summarized for publication whether inside or outside the University), it requires IRB submission and review.

Glossary of Terms

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

* Confidential data collection means that the researcher knows the identity of the subjects either directly or through the use of a master list used for coding but will not release identifying information when sharing the data with others.

* A human subject under 45 CFR 46 is defined as "a living individual about whom an investigator conducting research obtains:

1. data through intervention or interaction with the individual, or
2. identifiable private information."

* "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 is an employee, faculty member, or student of UM who accepts responsibility for the research.

* Research is defined in 45 CFR 46 as a systematic empirical investigation designed to develop or contribute to generalizable knowledge.