Protection of human subjects is a shared responsibility of the PI/Researcher, advisor, the IRB, and the University. Any research activity involving human subjects that will be publicly disseminated and undertaken by any faculty, staff, employee or student at Saint Mary’s University of Minnesota must be reviewed and approved by the IRB prior to commencing the research activity.

Saint Mary’s University of Minnesota uses the federal definition of research as defined in the Federal Common Rule (45 CFR 46.102): “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

The following activities are deemed not to be research:

I. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary
criticism, legal research, and historical scholarship), including the collection and use of
information, that focus directly on the specific individuals about whom the information is
collected.

II. Public health surveillance activities, including the collection and testing of information
or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public
health authority. Such activities are limited to those necessary to allow a public health authority
to identify, monitor, assess, or investigate potential public health signals, onsets of disease
outbreaks, or conditions of public health importance (including trends, signals, risk factors,
patterns in diseases, or increases in injuries from using consumer products).

III. Collection and analysis of information, biospecimens, or records by or for a criminal
justice agency for activities authorized by law or court order solely for criminal justice or
criminal investigative purposes.

IV. Authorized operational activities (as determined by each agency) in support of
intelligence, homeland security, defense, or other national security missions.